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Discuss about the US healthcare system over the course of the semester- so much so that it all might blend together and make it hard to pick out interesting tidbits or specific challenges.
You\’re getting a lot of information about the US healthcare system over the course of the semester- so much so that it all might blend together and make it hard to pick out interesting tidbits or specific challenges. I find that one of the best ways to do this is to directly compare aspects of our healthcare system to one that is completely different (which is pretty much all of them!). For this assignment, you are going to compare and contrast the US healthcare system with that of another country from the list below. This is a structured paper- that means you must address all the points below for full points. This paper must be 3-4 pages, in full APA format (see https://owl.english.purdue.edu/owl/resource/560/18/ (Links to an external site.)for a template), and use a minimum of 5 references, 3 of which must be peer-reviewed articles published after 2005 (click here to see how to find these articles in the UCF Library (Links to an external site.)). Wikipedia or other types of unofficial sources may not be used. The entire paper must be written in your own words- do not plagiarize or use any direct quoting. The paper must be written in full sentences and in paragraph form (i.e. no bullets or numbered lists). Please be sure to proofread your paper for grammar and spelling before submitting- if you are not completely comfortable with your writing skills, you can set up in-person or online appointments with the UCF Writing Center for free help with formatting, outlining, proofreading, etc.Potential countries:AustraliaBrazilCanadaChinaCosta RicaDenmarkEgyptFranceGermanyIndiaIsraelJapanLebanonMexicoRussiaSaudi ArabiaSingaporeSouth AfricaSwedenVietnamThe paper will include 3 sections (please separate them using subheadings):Section 1: Compare and contrast basic health outcomes (including but not limited to measures such as infant mortality, rates of chronic and/or infectious disease, life expectancy, health insurance coverage, use of drugs/alcohol/tobacco, rates of obesity, etc.). Include at least 7 different health-related statistics in this section and address why you chose the indicators you selected (e.g. personal interest, a large disparity between the countries, parity between the countries, etc.). This site should get you started (and yes, you can use it as one of your references: World Health Organization Statistics, 2015 (Links to an external site.)).Section 2: Discuss strengths and weaknesses of BOTH systems- for example, cost, quality, access, technology, workforce, demographics, external challenges such as political situation or war, etc. Provide at least 2 strengths and 2 weaknesses for each country.Section 3: Compare and contrast both countries on their handling of TWO of the following issues:Substance abuse and mental healthDemographicsHealth information technologyHealthcare coverage and insuranceHealthcare workforceIndividuals with disabilitiesIndividuals living in povertyRural healthcareEnd of life optionsTip: Be sure to do some initial research BEFORE you settle on your country of choice to ensure that you can find all of the information required to complete the paper.Exceptional papers may be awarded 5 extra credit points. | https://www.rushtermpapers.com/discuss-about-the-us-healthcare-system-over-the-course-of-the-semester-so-much-so-that-it-all-might-blend-together-and-make-it-hard-to-pick-out-interesting-tidbits-or-specific-challenges/ |
Answers To Fitness Questions
#1 What weighs more, a pound of fat or a pound of muscle?
The two weight exactly the same. A pound is a pound is a pound! You probably remember your teacher in junior high school asking you what weight more, “A pound of feathers or a pound of rocks?”, they are the same! The only difference between a pound of muscle and a pound of fat is the fact that a pound of fat takes up more space than a pound of muscle, which can give it the illusion that is somehow weighs more.
#2 Will I get too big/bulky if I lift weights?
This question is often asked by a lot of women who are worried about becoming too big if they lift weights. At the end of the day the process of building muscle is VERY hard and pretty darn slow. Even the most dedicated lifters who follow very strict diet parameters gain an average of 5 pounds per muscle per year. You also have to be eating more calories than you burn each day and have the right amount of protein ingestion. So if you are worried about getting too big, don’t because it is very hard to do so. You will notice your body composition does change in a positive way as your body will become more defined.
#3 How often should I exercise?
This just depends on your goals and preferences. The National Academy of Sports Medicine suggests that you exercise at least 150 minutes a week at a moderate rate, more if you are looking to attain fitness goals like muscle gain or fat loss, etc which you would like to be hitting the gym 4-6 times a week. Also when it comes to this question, you also have to factor in soreness, which you don’t want to work the same muscle group when its very sore, work a different muscle group and give the soreness a couple days to go away.
#4 What is the best way to lose weight?
The best way to lose weight is VERY simple, and that is to just be in what is called a caloric deficit. This means that you want to eat less calories than you are burning on a daily basis, which is also known as your Basal Metabolic Rate (BMR). So say you burn 3000 calories a day and want to lose a pound a week, well considering 3500 calories equates to a pound, you can cut out around 500 calories per day out of your diet and lose a pound per week. If you want to find out what your personal BMR is, click here.
#5 Do I need to hire a personal trainer?
The answer to this question really depends on your goals and personality. If you need motivation and accountability, then a personal trainer can be excellent for you to have. But in todays day and age, with internet access at the click of a button, you can do anything from research popular workout plans to learn how to do each and every exercise with correct form.
#6 How much weight should you lift?
Start slow, and go from there. This is really great advice when starting out in the gym. Feel out the weights, don’t try to lift big out of the gate, that will come later if you want it to. Lifting lighter weights can still provide fitness benefits like improved cardiovascular health and build muscle as well. It can also help you prepare your muscles for heavier weights. Focus first on good form, then increase the weight as you go.
#7 Why are my muscles sore?
Whenever you place stress on your muscles via lifting weights, you create microscopic tears in the muscle fibers, which causes soreness in your muscles. Your body repairs these microscopic tears allowing for muscle growth or hypertrophy. This soreness can come the day of or show up a day or two later, which is referred to as Delayed Onset Muscle Soreness (DOM’s).
#8 How long should I workout?
A workout that runs 60 to 90 minutes is great, any workout that lasts longer than 90 minutes will put you at risk of overtraining which can cause adverse physical and mental symptoms that can range from tendon and ligament injuries to anxiety and mood changes.
#9 Cardio 1st or Weight Training 1st?
Honestly you can try both and see what you prefer, but doing warmup first with some sort of cardio will get your more prepared to do your workout routine, providing a more smooth transition. A warmup of 5 to 10 minutes will suffice.
#10 Whats My Target Heart Rate?
The National Academy of Sports Medicine gives one a simple formula of finding out what your MAX heart rate is which is essential to create your target heart rate for the zone(s) you want to exercise in. That formula is 220 beats per minute (BPM) – AGE. So if your 40 years old then your Maximum Heart Rate is 180. If you want to exercise at 80 percent of your MAX, then 144 is your Target Heart Rate (THR), which this number was created by simple multiplying 180 by 0.80.
For an even more widespread example of different heart rate zones and MAX’s, check out this site – Your Target Heart Rate Zone
#11 Should I eat before I workout?
Some prefer to eat before a workout others don’t, but you should definitely have something to eat before going to the gym. Keep it light, and lean more towards carbohydrates as they will provide you with energy for the workout.If you are going to be doing your workout later at night, eat a large carboydrate meal a couple hours before the workout.
Also keep your carbohydrate intake regular throughout the day. Carbohyrdates and fats go hand in hand when it comes to burning fat as carbohyrdates or glycogen is used for energy during workouts. If you don’t have enough glycogen stores, then your body will utilize muscle as the preferred energy form leading to losing the gains you’ve worked so hard to get!
#12 Do Carbs Make You FAT?
No they don’t, eating to much food makes you fat. Like we talked about on #4, you burn a certain amount of calories just maintaining homestasis as well as whatever your daily activity level consists of. If you surpass the calorie amount of what you expend daily, your Basil Metabolic Rate + Activity Level you will gain weight.
This is the case with eating too much of anything, it isn’t the foods fault its the person being in a caloric surplus. | http://www.actforlibraries.org/answers-to-fitness-questions-you-may-have/ |
Preperation:
15 minutes
Cook:
20 minutes
Serves:
4
Pancetta & Rocket Pizza
with Red Square Cheese & Balsamic Figs
Ingredients
2 cups (250g) grated Mil Lel Mozzarella
2 x 140g pieces Tasmanian Heritage Red Square Washed Rind cheese, sliced
¼ cup water
¼ cup brown sugar
60g dried figs, thinly sliced
1 tablespoon balsamic vinegar
2 tablesspoons olive oil
1 clove garlic, crushed
2 x 30cm pizza bases or use store-bought bases
16 thin slices pancetta or bacon
100g rocket
2 tablespoons olive oil, extra
Sea salt and freshly ground black pepper, to taste
Tasmanian Heritage
Red Square
Instructions
Heat water and brown sugar in a saucepan, stirring to dissolve sugar, and then boil for 10 minutes.
Add figs and vinegar and allow to cool.
Combine oil with garlic and brush over pizza dough.
Sprinkle with Mozzarella, arrange pancetta on top and bake at 220°C for 10-15 minutes or until cooked and golden.
Cover with slices of Tasmanian Heritage Red Square cheese.
Combine extra oil with 2 tablespoons fig syrup and use to dress rocket.
Place rocket in the centre of each pizza and then sprinkle with figs.
Serve immediately. | http://www.tasmanianheritage.com.au/recipes/pancetta-rocket-pizza-with-red-square-cheese-balsamic-figs/ |
TECHNICAL FIELD
BACKGROUND ART
CITATION LIST
PATENT DOCUMENT
SUMMARY OF INVENTION
PROBLEMS TO BE SOLVED BY THE INVENTION
MEANS FOR SOLVING THE PROBLEMS
EFFECT OF THE INVENTION
BRIEF DESCRIPTION OF DRAWINGS
MODE FOR CARRYING OUT THE INVENTION
REFERENCE SIGNS LIST
The present invention relates to a train control system which performs travel control of a train and more specifically, relates to a train control system capable of making trains travel while narrowing train intervals.
2002-67957
Conventionally, a train control system which performs travel control of trains is known. As this type of a train control system, for example, a train control system disclosed in Japanese Laid-open (Kokai) Patent Application Publication No. is known. The train control system is configured that, for example, block sections are provided by dividing a traveling rail (track) of a train at intervals of several hundred meters and travel control of trains is performed in each of the block sections.
2002-67957
Patent Document 1: Japanese Laid-open (Kokai) Patent Application Publication No.
However, in the conventional train control system, a train travel control is performed in each of block sections. In general, a length of one block section is set to several hundred meters, so that the distance (train interval) between a train and a preceding train cannot be shortened less than one block interval, so that the train interval is long.
Therefore, taking the above-described existing problems into consideration, an object of the invention is to provide a train control system capable of performing train travel control while narrowing the train interval
In order to achieve the object, a train control system according to an aspect of the present invention includes: an on-board device which is mounted on a train traveling on a railroad track and has an vehicle radio set capable of performing wireless communication; a fixed radio set which is disposed along the railroad track and capable of performing wireless communication with vehicle radio set by a time division multiple access method, in which time synchronization is performed to allow each of the vehicle radio sets and the fixed radio sets to communicate with each other only in an allocated time slot; and a ground device which calculates distance from the train to a stop point before the preceding train on the basis of the location information of the train obtained by the wireless communication between the vehicle radio set and the fixed radio set, and the on-board device generates a stop pattern from the train on which the on-board device is mounted to the stop point on the basis of the distance to the stop point, which is transmitted from the ground device, and performs a travel control so that the train on which the on-board device is mounted travels at a speed equal to or less than the stop pattern.
The train control system according to an aspect of the present invention has a configuration of performing the travel control of the trains so that the train travels at a speed equal to or less than the stop pattern generated on the basis of the distance from the train on which the on-board device is mounted to the stop point just before the preceding train, which is obtained by wireless communication by the time division multiple access method between the fixed radio set and the vehicle radio set. Consequently, the train can be traveled to the stop point just before the preceding train. By properly setting the location of the stop point, the interval to the preceding train (the train interval) can be narrowed while maintaining safety.
FIG. 1
is a block diagram illustrating an embodiment of a train control system according to the present invention.
FIG. 2
is an explanatory diagram explaining travel control of a train in the train control system of the embodiment.
FIG. 3
is an explanatory diagram illustrating time slots allocated to fixed radio sets and vehicle radio sets in wireless communication in the embodiment.
Hereinbelow, an embodiment of the present invention will be described with reference to the accompanying drawings.
FIG. 1
is a block diagram illustrating an embodiment of a train control system according to the present invention.
FIG. 1
In , a train control system 10 of the embodiment performs a train travel control and includes on-board device 1 having a vehicle radio set VRS1, a plurality of wayside radio sets WRS1 to WRS7, a station radio set SRS1, and a ground device 2. In the embodiment, the station radio set SRS1 and the wayside radio sets WRS1 to WRS7 correspond to fixed radio sets according to the present invention.
The on-board device 1 is mounted on a train traveling on a railroad track R, performs travel control on a train on which the on-board device 1 is mounted, and the on-board device 1 detects the location of the train and includes, for example, the vehicle radio set VRS1 and the on-board device body VC1.
The vehicle radio set VRS1 can wirelessly communicate various information among the plurality of wayside radio sets WRS1 to WRS7 and the station radio set SRS1 while traveling and the vehicle radio set VRS1 is connected to the on-board device body VC1.
The on-board device body VC1 is connected to the vehicle radio set VRS1 by, for example, a wired cable, performs travel control of the train on which the on-board device 1 is mounted on the basis of various information received by the vehicle radio set VRS1, and detects the train location of the train on which the on-board device 1 is mounted.
FIG. 2
The on-board device body VC1 detects the train location of the train on which the on-board device 1 is mounted by wireless communication between the vehicle radio set VRS1 and the fixed radio sets (WRS1 to WRS7 and SRS1) and transmits information of the train location to the ground device 2 via the vehicle radio set VRS1 and the fixed radio sets (WRS1 to WRS7 and SRS1). The location information of a train A transmitted to the ground device 2 is used to calculate the distance from the train A to a stop point (refer to ) before a preceding train B.
Specifically, the on-board device body VC1 measures the distance (distance measurement) between a fixed radio set and the vehicle radio set VRS1 by propagation delay time of an radio wave in transmission and reception of wireless communication between the vehicle radio set VRS1 and the fixed radio set, detects the train location of the train on which the on-board device 1 is mounted on the basis of, for example, the distance measurement result and location information of each of the wayside radio sets preliminarily stored in the on-board device body VC1, and transmits the information of the train location to the ground device 2 via each of the fixed radio sets.
FIG. 2
FIG. 2
The on-board device body VC1 generates a stop pattern (refer to ) from the train A on which the on-board device 1 is mounted to the stop point on the basis of the distance to the stop point transmitted from the ground device 2, and performs travel control so that the train A travels at speed equal to or less than the stop pattern. The stop pattern is a pattern of speed until the train A reaches the stop point to be stopped, and, for example, as illustrated in , the stop pattern is a pattern in which the train speed decreases as the train approaches the stop point and is zero at the stop point.
The station radio set SRS1 is installed at in a base station, for example, it is connected to the ground device 2 by a wired cable, wirelessly transmits, to the wayside radio set, control information and a control instruction from the ground device 2 to a train and a wayside radio set, and wirelessly receives, from the wayside radio set, information from the train and the wayside radio set to the ground device 2.
The wayside radio sets WRS1 to WRS7 transmit to and receive from the vehicle radio set VRS1 and the station radio set SRS1 various information. The plurality of the wayside radio sets WRS1 to WRS7 is spatially separated and arranged along a railroad track R which is a moving route of the train, and the plurality of the wayside radio sets WRS1 to WRS7 are propagation type radio sets, in which adjacent wayside radio sets wirelessly communicate with each other to transmit information by relaying the information. Each of the wireless communications between the fixed radio sets (WRS1 to WRS7, and SRS1) and the vehicle radio set VRS1 is performed by the time division multiple access (TDMA) method which will be described later.
FIG. 2
The ground device 2 calculates the distance from the train A to the stop point before the preceding train B on the basis of the location information of the train obtained by the wireless communication between the vehicle radio set VRS1 and the fixed radio set, and transmits the information of the calculated distance to the stop point to the on-board device body VC1 via the vehicle radio set VRS1, the station radio set SRS1 and the plurality of wayside radio sets WRS1 to WRS7. In the embodiment, as illustrated in , the stop point is located at a position which is set in front of the rear end of the preceding train B by preset allowance distance d0.
The ground device 2 also has the function of controlling and managing communication of the vehicle radio set VRS1, the station radio set SRS1, and the plurality of wayside radio sets WRS1 to WRS7, and thus, the ground device 2 controls and manages communication of each of the radio sets so as to perform a communication by the time division multiple access (TDMA) method in which time synchronization is performed to allow each of the vehicle radio sets and the fixed radio sets to communicate with each other only in an allocated time slot.
FIG. 3
1
2
n
n
0
1
2
n
i
i
A network (TDMA network) of wireless communication among the radio sets (VRS1, WRS1 to WRS7, and SRS1) configured as described above is controlled in a manner in which, as illustrated in , one transmission can be done in T/N (ms), that is, time obtained by dividing one period T (msec) by N pieces. For example, sequence numbers such as to, t, t, ..., t are assigned to the N pieces of unit times. After the last number t, to follows. The numbers are repeated in such a manner. t, t, t, ..., t are expressed as t (0≤ i ≤ N - 1) as a general form. t is called a time slot, and i is called time slot number. N denotes the number of time slots. For example, one period T (msec) is set to 500 msec, the number N of time slots is set to 256, and one time slot T/N is set to about 2 msec. The period T, the number N of time slots, and the time slot T are not limited to those values but can be variously set.
One period T of the wireless communication network (TDMA network) is, for example, constructed by being sectioned to a distance measurement block for measuring distances between the vehicle radio set VRS1 and two wayside radio sets WRS selected by the ground device 2, a VRS transmission block in which the vehicle radio set VRS1 is a transmission source, a synchronization block for synchronizing transmission and reception operations of the radio sets, and the like. Each block is made by predetermined number of time slots.
FIG. 1
The ground device 2 also has the function of selecting a fixed radio set to be provided for radio transmission and reception for measuring the distance to the vehicle radio set VRS1. For example, the ground device 2 recognizes the initial location of a train, recognizes the train location in a real-time manner so as to follow the travel of the train on the basis of information of the train location from the on-board device 1, and selects the closest two fixed radio sets which are located in the backward and forward directions of the vehicle radio set VRS1, as a distance measurement radio set pair provided for transmission and reception for measuring distance to the vehicle radio set VRS1. The ground device 2 transmits, for example, a distance measurement instruction to the selected distance measurement radio set pair and the vehicle radio set VRS1 via the station radio set SRS1 and the wayside radio set. For example, as illustrated in , in the case in which the train A is located between the wayside radio set WRS6 and the wayside radio set WRS7, the ground device 2 selects WRS6 and WRS7 as the distance measurement radio set pair, and transmits a distance measurement instruction to the distance measurement radio set pair (WRS6 and WRS7) and the vehicle radio set VRS1 mounted on the train A.
FIGS. 1 to 3
FIG. 1
Next, in the train control system 10 of the embodiment, the operation of detecting the train location and the operation of travel control will be described with reference to . As illustrated in , the location detection and travel control of the train A in the case in which the train A is traveling between the wayside radio sets WRS6 and WRS7 and the preceding train B is traveling between the wayside radio sets WRS1 and WRS2 will be described. Since the travel control of the preceding train B is performed on the basis of the location of the train (not illustrated) ahead of the preceding train B in a manner similar to that of the train A, a description thereof will be omitted. The following description is based on assumption that the ground device 2 recognizes that the train A is traveling between the wayside radio sets WRS6 and WRS7 on the basis of the previous train location information transmitted from the on-board device 1.
First, the operation of detecting the train location will be described.
The ground device 2 selects WRS6 and WRS7 as the closest two wayside radio sets located in the backward and forward directions of the vehicle radio set VRS1 mounted on the train A, and generates a distance measurement instruction for the distance measurement radio set pair (WRS6 and WRS7) and the vehicle radio set VRS1 mounted on the train A. The ground device 2 selects WRS1 and WRS2 as the closest two wayside radio sets located in the backward and forward directions of the vehicle radio set VRS1 mounted on the preceding train B, and generates a distance measurement instruction for the distance measurement radio set pair (WRS1 and WRS2) and the vehicle radio set VRS1 mounted on the preceding train B. The distance measurement instruction generated by the ground device 2 is transmitted to the station radio set SRS1 via a wired cable. When time is a transmission time slot allocated to the station radio set SRS1, the station radio set SRS1 transmits the received distance measurement instruction by wireless communication to the first wayside radio set WRS1, and the second wayside radio set WRS2 receives the distance measurement instruction in the same time slot. When time is a transmission time slot allocated to the second wayside radio set, the second wayside radio set transmits the received distance measurement instruction by wireless communication to the third wayside radio set WRS adjacent to the second wayside radio set. Hereinbelow, transmission and reception is similarly performed among the wayside radio sets so that the information is sequentially relayed and transmitted to the wayside radio set at the end of the control area of the network.
FIG. 1
As illustrated in , each of the wayside radio sets WRS1 to WRS7 and the vehicle radio set VRS1 executes an instruction when the transmitted instruction includes an instruction to itself. Since instructions to the vehicle radio set VRS1 mounted on the train A and the distance measurement radio set pair WRS6 and WRS7, are included, in a predetermined time slot in a distance measurement block, the vehicle radio set VRS1 and the distance measurement radio set pair WRS6 and WRS7 execute wireless communication for distance measurement. The on-board device body VC1 mounted on the train A measures distances between the radio sets (WRS6-VRS1, WRS7-VRS1) on the basis of propagation delay time of radio waves for distance measurement, and detects the train location of the train A on which the vehicle radio set VRS1 is mounted on the basis of the distance measurement result and the location information of the wayside radio sets preliminarily stored in a storage (not illustrated). The vehicle radio set VRS1 mounted on the train A transmits train location information of the train A on which the vehicle radio set VRS1 is mounted in a time slot for transmission allocated to the vehicle radio set VRS1. The train location information is received by a wayside radio set positioned closest to the vehicle radio set VRS1. The wayside radio set which received the train location information transmits the received train location information to the station radio set SRS1 in the time slot for transmission allocated to the wayside radio set. The transmitted train location information is sequentially relayed by the wayside radio sets existing between the station radio set SRS1 and the wayside radio set in a time division manner as described above, and is transmitted to the ground device 2 via the station radio set SRS1 and the wired cable. In such a manner, the transmission direction of information from the ground device 2 and that of information from the train are opposite to each other.
FIG. 2
Sine instructions to the vehicle radio set VRS1 mounted on the preceding train B and the distance measurement radio set pair WRS1 and WRS2, are included, the vehicle radio set VRS1 mounted on the preceding train B and the distance measurement radio set pair WRS1 and WRS2 executes wireless communication for distance measurement in a predetermined time slot in the distance measurement block. The on-board device body VC1 mounted on the preceding train B detects the train location of the preceding train B on the basis of the distance measurement results between the radio sets (WRS1-VRS1, WRS2-VRS1) and location information of the wayside radio sets preliminarily stored in a storage. The on-board device body VC1 mounted on the preceding train B transmits the information of the detected train location to the ground device 2 via the fixed radio sets. For example, as illustrated in , when the train A and the preceding train B travel, the on-board device body VC1 detects the train location of the train A on which the on-board device body VC1 is mounted and the preceding train B at times (T1, T2, T3, ...) in a real-time manner, and transmits the train location information to the ground device 2 via the radio sets (the vehicle radio set and the fixed radio set) as necessary.
Next, the operation of the travel control of the train will be described.
The ground device 2 calculates the distance from the train A to the stop point just before the preceding train B on the basis of the train location information transmitted via the fixed radio sets from the on-board devices 1 mounted on the train A and the preceding train B. In a manner similar to the distance measurement instruction, the ground device 2 transmits the information of the calculated distance to the stop point to the on-board device body VC1 via the station radio set SRS1, the plurality of wayside radio sets WRS1 to WRS7, and the vehicle radio set VRS1.
FIG. 2
The on-board device body VC1 generates a stop pattern (refer to ) from train A on which the on-board device body VC1 is mounted to the stop point on the basis of the distance to the stop point transmitted from the ground device 2, and performs travel control so that the train A travels at a speed equal to or less than the stop pattern. The on-board device body VC1 sets, for example, the allowance distance d0 to be shorter than the conventional one fixed block section length (for example, hundreds meters) and performs a travel-control so that the train A is allowed to travel close to the rear end of the preceding train B to be stopped. The on-board device body VC1 generates stop patterns at times (T1, T2, T3, ...) on the basis of the distance information at the times. As described above, the stop pattern is updated as necessary on the basis of the distance to the preceding train.
The train control system 10 according to the embodiment has a configuration of performing the travel control of the trains so that the train travels at a speed equal to or less than the stop pattern generated on the basis of the distance to the stop point just before the preceding train, which is obtained by wireless communication by the time division multiple access method between the fixed radio set and the vehicle radio set. Consequently, the train can be traveled to the stop point just before the preceding train. By properly setting the position of the stop point, the interval to the preceding train (the train interval) can be narrowed while maintaining safety.
In the embodiment, it has been described that the train location is detected by the on-board device and the train information is transmitted from the on-board device 1 to the ground device 2. However, the invention is not limited to the embodiment. For example, each train location may be detected on the ground device and the train location information based on the detection result may be transmitted from the ground device 2 to the on-board device 1 mounted on each train.
Although the embodiment has been described that the number of wayside radio sets is seven, obviously, the number of wayside radio sets installed is not limited to seven. For example, the number of wayside radio sets can be increased and decreased in accordance with the length of the control target area of the ground device 2.
1
2
10
SRS1
WRS1 to WRS7
VRS1
R
B
on-board device
ground device
train control system
station radio set
wayside radio set
vehicle radio set
railroad track
preceding train | |
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Reuben sandwich
Reuben sandwich
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6 min
4 min
Very Easy
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Ingredients
Number of serving:
2
8 Slices Rye bread
2 tablespoons
Butter
4 tablespoons Thousand Island dressing
1 Lb. Corned
beef
, cooked, sliced thin
1 Cup Sauerkraut, drained
4 Slices Swiss cheese
Preparation
Butter one side each slice of rye bread, then place the buttered side down on the hot flat top or heated skillet.
Spread ½ tablespoon of the Thousand island dressing onto each of the top sides of rye bread.
Add four ounces of the corned beef evenly on each of the rye bread slices.
Evenly and gently add ¼ cup of the sauerkraut on top of each sandwich and the corned beef slices.
Add one slice of Swiss cheese to each sandwich.
Spread ½ tablespoon of the Thousand island dressing onto one side of each of the remaining slices of rye bread. Then place the slices with the dressed sides down. Then butter the top sides of the remaining rye bread.
When the bottom rye bread is nice and grilled, use a flat spatula to flip the sandwich and grill the other side. The sandwich is done when both sides are grilled nicely to golden brown and the cheese has melted.
To Serve: Transfer the grilled sandwiches to a serving plate and cut in half. Serve with a kosher dill pickle wedge if desired.
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In "Eggless Chocolate Cake" how many ml is 1 tin condensed milk? | https://en.petitchef.com/recipes/other/reuben-sandwich-fid-1241630 |
how many stars are in the universe?
be specific.
26 Answers
- duke_of_urlsLv 71 month agoFavorite Answer
1,224,735,648,065,637,635,965,784
This number is a extremely precise (specific), but not accurate, number of stars in the Observable Universe.
Not enough is known yet to even have an estimate about the size of the Entire Universe, which could have a radius at Least 3x10^23 times the radius of the Observable Universe (a number about a third the size of the number I made up above).
An accurate (according to the current estimate in Wikipedia) number of stars in the Observable Universe is 1 x 10^24 (a septillion). This number is accurate, but not precise.
By the way, the estimate of the number of stars in the Observable Universe, last time I looked (a few months ago), was 3 x 10^23, so it's about 3x larger than that, now.
- 4 weeks ago
Impossible to give an exact number because new stars are constantly being created.
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- goringLv 61 month ago
roughly one trillion trillion stars in the physical Universe without counting the stars in Holywood.
The calculation is based on the mass of our galaxy and the number of galaxy in the Universe.
Archimedes calculated the numbers of grain of sand in the Universe to be 1 x10^60 grains of average sized grains
Thus one trillion trillion is =1 x 10 ^24 so that would means there are more grains of sand than Stars
that seems to be way off proportions
- daniel gLv 71 month ago
Think of it like all the grains of sand on all the earths beaches.
Billions to the 10th power.
- perfectlybakedLv 71 month ago
That is unknown in general... meaning no one has the specific answer... not even the late Stephen Hawking.
There is also that concept of "countless" and I'll bet it would be harder to count the stars than it would be trying to count how many blades of grass exist on Earth.
- CliveLv 71 month ago
Lots. Nobody can be more specific than that. | https://uk.answers.yahoo.com/question/index?qid=20191114052631AAskG3e |
TECHNICAL FIELD OF THE INVENTION
This invention relates to a power source device in which a plurality of switching circuits performing a power conversion respectively commonly use a switching element and, more particularly, to a power source device provided with an inverter circuit for improving any distortion of an input from an AC power source by means of a chopper circuit and for supplying to a load circuit a low frequency output synchronized with the AC power source.
BACKGROUND ART
An example of the power source device of this kind has been disclosed in Japanese Patent Laid-Open Publication No. 2-282809, in which the power source devices comprise, as shown in FIG. 24, a boosting chopper circuit for improving the input current distortion by means of switching elements Q1 and Q2, inductor L1 and diodes D5 and D6, and a buck converter for limiting a load current by means of switching elements Q1-Q4 and inductor L2.
Referring more specifically to FIG. 24, there are connected, in parallel to a smoothing capacitor C, series connections respectively of diodes D1 and D2, of diodes D3 and D4, of the diodes D5 and D6, of the switching elements Q1 and Q2 and of the switching elements Q3 and Q4. A junction point between the switching elements Q1 and Q2 and a junction point between the diodes D1 and D2 are connected. Further, a junction point between the switching elements Q3 and Q4 and junction point between the diodes D3 and D4 are connected. Between the junction point of the switching elements Q1 and Q2 and the junction point of the switching elements Q3 and Q4, a series connection of the inductor L2 and a load Z is connected. Between the junction point of the diodes D5 and D6 and the junction point of the switching elements Q1 and Q2, a series connection of an AC power source P through a filter circuit F to the inductor L1 is connected.
In this case, a control circuit (not shown) is controlling ON/OFF operation of the switching elements Q1-Q4 with outputs ON/OFF signals to gate electrodes of the switching elements Q1-Q4, so that, in positive half cycles of AC source power, the switching element Q1 is alternately made ON and OFF, the switching elements Q2 and Q3 are made OFF and the switching element Q4 is made ON. In negative half cycles, on the other hand, the switching element Q2 is alternately made ON and OFF, the switching elements Q1 and Q4 are made OFF and the switching element Q3 is made ON.
The operation of the conventional device of FIG. 24 shall be described with reference to FIG. 25. First, when the AC power source P is in the positive half cycle so that the switching elements Q1 and Q4 are ON and the switching elements Q2 and Q3 are OFF, a current flows, as shown in FIG. 25a, through a path of the AC power source P, filter circuit F, diode D5, switching element Q1 and inductor L1, to have an energy accumulated in the inductor L1. Also, a current flows from the smoothing capacitor C through a path of the switching element Q1, inductor L2, load circuit Z and switching element Q4 to cause a voltage at the smoothing capacitor C dropped by the inductor L2 and supplied to the load circuit Z. Further, with the current flowing to the inductor L2, an energy is accumulated in the inductor L2.
Next, as the switching element Q1 only is made OFF, a voltage is generated across the inductor L1 by the accumulated energy in the inductor L1, and this voltage is charged through the diode D2 in the smoothing capacitor C as superposed on a voltage of the AC power source P. That is, as shown in FIG. 25b, a current flows through a path of the AC power source P, filter circuit F, diode D5, smoothing capacitor C, diode D2 and inductor L1, to cause the energy in the inductor L1 discharged. Due to this, there is always flowing a current of high frequency from the AC power source P, and any input current distortion is improved by shaping the waveform of the current by means of the filter circuit F. At the smoothing capacitor C, further, there is obtained a voltage higher than a peak value of the AC power source P. Still further, a regenerative current owing to the accumulated energy in the indutor L2 flows through a path of the inductor L2, load circuit Z, switching element Q4 and diode D2. Thereafter, the operation of FIGS. 25a and 25b is repeated as a result of the turning ON and OFF at a high frequency of the switching element Q1, and a DC voltage in one direction is supplied to the load circuit Z.
Next, in the negative half cycle of the AC power source P in which the switching elements Q1 and Q4 are OFF and the switching elements Q2 and Q3 are ON, a current flows, as shown in FIG. 25c, through a path of the AC power source P, filter circuit F, inductor L1, switching element Q2 and diode D6, and an energy is accumulated in the inductor L1. From the smoothing capacitor C, further, a current flows through a path of the switching element Q3, load circuit Z, inductor L2 and switching element Q2, to cause the voltage at the smoothing capacitor C dropped by the inductor L2 and supplied to the load circuit Z. Still further, with the current flowing to the inductor L2, an energy is accumulated in the inductor L2.
Next, as the switching element Q2 only is made OFF, a voltage is generated across the inductor L1 by the accumulated energy in the inductor L1, and this voltage is charged in the smoothing capacitor C through the diode D1 as superposed on the voltage of the AC power source P. That is, as shown in FIG. 25d, a current flows through a path of the AC power source P, filter circuit F, inductor L1, diode L1, smoothing capacitor C and diode D6, and the energy in the inductor L1 is discharged. Due to this, there is always flowing a current of high frequency from the AC power source P, and any distortion in the input current is improved by shaping the waveform of the current by means of the filter circuit F. At the smoothing capacitor C, further, there is obtained a voltage higher than the peak value of the AC power source P. Still further, a regenerative current owing to the accumulated energy in the inductor L2 flows through a path of the inductor L2, diode D1, switching element Q3 and load circuit Z. Thereafter, the operation of FIGS. 25c and 25d is repeated as a result of the turning ON and OFF at a high frequency of the switching element Q2, and a reverse directional DC voltage is supplied to the load circuit Z. With the foregoing operation, a square wave voltage of the polarity inverting in synchronism with every half cycle of the AC power source P is supplied to the load circuit Z.
In the positive half cycles of the AC power source, as has been described, the switching element Q1 operates concurrently as a switching element of a chopper circuit and as a switching element of an inverter circuit. In the negative half cycles of the AC power source, on the other hand, the switching element Q2 operates concurrently as the switching element of the chopper circuit and as the switching element in the inverter circuit.
As another conventional example, there may be shown in FIG. 26 a power source device, which comprises a boosting and dropping chopper circuit for improving the input distortion by means of the switching elements Q1 and Q2, inductor L1 and diodes D1, D2 and D5-D10, and a buck converter for limiting the load current by means of the switching elements Q1-Q4 and inductor L2. In this case, a series circuit of the diodes D1 and D2 and a series connection of the diodes D3 and D4 are connected in inverse parallel to the smoothing capacitor C, and a series connection of the switching elements Q3 and Q4 are connected in parallel to the smoothing capacitor C. A series connection of the diodes D5 and D6 and a series connection of the switching elements Q1 and Q2 are connected in inverse parallel, and a circuit of a series connection in the order of the diode D7, switching elements Q1 and Q2 and diode D8 and a series circuit of the diodes D9 and D10 are connected in inverse parallel to the smoothing capacitor C. Further, a junction point between the diodes D1 and D2 and a junction point between the switching elements Q1 and Q2 are connected, and a junction point between the diodes D3 and D4 and a junction point between the switching elements Q3 and Q4 are connected. Still further, the inductor L1 is connected between the junction point of the switching elements Q1 and Q2 and a junction point of the diodes D9 and D10, a series connection of the inductor L2 and load circuit Z is connected between the junction point of the switching elements Q1 and Q2 and the junction point of the switching elements Q3 and Q4, and the AC power source P is connected between a junction point of the diodes D5 and D6 and the junction point of the diodes D9 and D10.
Referring further to this power source device with reference to FIG. 26 and additionally to FIG. 27, initially in the positive half cycle of the AC power source P in which the switching elements Q1 and Q4 are ON and the switching elements Q2 and Q3 are OFF, a current flows, as shown in FIG. 26a, through a path of the AC power source P, filter circuit F, diode D5, switching element Q1 and inductor L1, and an energy is accumulated in the inductor L1. Further, a current flows from the smoothing capacitor C through a path of the diode D7, switching element Q1, inductor L2, load circuit Z and switching element Q4, and a voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. Also, with the current flowing to the inductor L2, an energy is accumulated in the inductor L2.
When the switching element Q1 only is made OFF, next, a voltage is generated across the inductor L1 by the accumulated energy in the inductor L1, and is charged through the diode D9 in the smoothing capacitor C. That is, as shown in FIG. 26b, a current flows through a path of the inductor L1, diode D9, smoothing capacitor C, diode D2 and inductor L1, and the energy in the inductor L1 is discharged. Due to this, the current from the AC power source P is caused not to flow directly to the smoothing capacitor C, but the current once made to flow to the inductor L1 is accumulated therein as the energy, and a regenerative current owing to such accumulated energy is caused to flow to the smoothing capacitor C, so that any rush current upon connection of the AC power source P can be prevented. At the smoothing capacitor C, further, a voltage lower than the peak value of the AC power source P can be obtained. Further, a regenerative current owing to an accumulated energy in the inductor L2 flows through a path of the inductor L2, load circuit Z, switching element Q4 and diode D2. Thereafter, the operation of FIGS. 26a and 26b is repeated by the high frequency ON/OFF operation of the switching element Q1, and the DC voltage in one direction is supplied to the load circuit Z.
Next, in the negative half cycle of the AC power source P in which the switching elements Q1 and Q4 are OFF and the switching elements Q2 and Q3 are ON, a current flows, as shown in FIG. 27a, through a path of the AC power source P, filter circuit F, inductor L1, switching element Q2 and diode D6, and an energy is accumulated in the inductor L1. Also, a current flows from the smoothing capacitor C through a path of the switching element Q3, load circuit Z, inductor L2, switching element Q2 and diode D8, and the voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. Also, with the current flowing to the inductor L2, an energy is accumulated in the inductor L2.
When the switching element Q2 only is made OFF, next, a voltage is generated across the inductor L1 by the accumulated energy in the inductor L1, and is charged in the smoothing capacitor C through the diode D1. That is, as shown in FIG. 27b, a current flows through a path of the inductor L1, diode D1, smoothing capacitor C and diode D10, and the energy in the inductor L1 is discharged. The current from the AC power source P is thereby caused not to flow directly to the smoothing capacitor C, and the current flowing to the inductor L1 is once accumulated therein as the energy, and the regenerative current owing to this accumulated energy is made to flow to the smoothing capacitor C, so that any rush current upon connection of the AC power source P can be prevented. Further, there can be also obtained at the smoothing capacitor C a voltage lower than the peak value of AC power source P. Further, a regenerative current owing to the accumulated energy in the inductor L2 flows through a path of the inductor L2, diode D1, switching element Q3 and load circuit Z. Thereafter, the operation of FIGS. 27a and 27b is repeated by the high frequency ON/OFF operation of the switching element Q2, and a DC voltage in reverse direction is supplied to the load circuit Z. With the foregoing operation, a square wave voltage of the polarity inverting in synchronism with every half cycle of the AC power source P is supplied to the load circuit Z.
In the conventional example of FIGS. 24 and 25, however, the switching elements are used commonly in the boost converter and the buck converter so that the currents of both buck-boost converters are caused to flow as superposed to the commonly used switching elements, the withstand amount of current is enlarged, and any effect of cost reduction attained by reducing the number of the switching elements through the common use is rather decreased. Further, as the control signals for the switching elements are also used in common, the independence of control with respect to each circuit is lost so that, in an event where the control is to be made for rendering an output power constant, for example, there arises an instance where an input power is excessively over or below the output power. When the input power is excessively over the output power, a surplus energy is accumulated in the smoothing capacitor so as to raise the voltage across the smoothing capacitor, the voltage applied to the parts is increased, and there arises a problem that a stress is given to the parts according to circumstances.
Such phenomenon becomes particularly remarkable in an event where the conventional device is applied to, for example, a starting device of a high pressure discharge lamp because, in the step of starting the high pressure discharge lamp, the load is low in the impedance and it becomes necessary to supply a large current to the load. That is, there must be provided a constant ON duty in order to let the large current flow to the load but, as the load is low in the impedance, the output power is less. In contrast, the input power will be of an amount in accordance with the ON duty, and there arises a problem that the input power becomes excessively large.
Further, in the conventional example of FIGS. 26 and 27, there are advantages that the voltage of the smoothing capacity is enabled to be set lower than the source voltage, and further any rush current upon connection of the power source can be prevented, since the switching elements are used commonly in both buck-boost converters and buck converters. However, because of the increase in the withstand amount of current of the commonly used switching elements as being the problem in the conventional example of FIGS. 24 and 25, there are problems that a cost reduction is difficult to be contrived, and the independence of control with respect to every circuit is also difficult to be maintained.
DESCRIPTION OF THE INVENTION
The present invention is to overcome the foregoing problems, and to provide a power source device which prevents the switching current flowing through the switching elements used commonly in such two power source circuits as chopper circuit and inverter circuit from being increased, and maintains the independence of the control of the chopper circuit and inverter circuit. It is also an object to provide a power source device in which buck-boost converter and buck converter using in common the switching elements are employed, so that the degree of setting freedom of the voltage of smoothing capacitor with respect to the source voltage can be made high, and, not only the prevention of the rush current upon connection of the power source, but also the reduction of the withstand amount of current of the switching elements is reduced with an operation performed to have the currents of the buck-boost converter and buck converter cancelled each other, while maintaining the independence with respect to each of the circuits.
According to the present invention, this object is to be established by a power source device comprising at least two power converting circuits respectively having at least one switching means, the switching means being provided for being used in common as elements forming at least two of the different power converting circuits, and a control means formed to have a period in which, among currents flowing from the different power converting circuits to the commonly used switching elements, the current flowing from at least one power converting circuit will be of an inverse polarity with respect to the current flowing from at least the other one power converting circuit, so as to flow in mutually cancelling directions.
Here, the switching means should be one of switching element and rectifying element, as will be clear from following description with reference to embodiments.
In the present invention, therefore, it is possible to reduce the currents flowing to the switching elements commonly used in a plurality of switching circuits. It is also possible to have the control of the plurality of switching circuits provided with the independence.
Other objects and advantages of the present invention shall become clear from the following description detailed with reference to embodiments shown in drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a circuit diagram showing a preferable basic formation of the power source device according to the present invention,
FIGS. 2a-2c are explanatory circuit diagrams showing the operation in one of polarities of the power source in one concrete embodiment according to the present invention,
FIGS. 3a-3c are circuit diagrams showing an operation in the other power source polarity in the embodiment of FIGS. 2a-2c,
FIG. 4 is an operational waveform diagram at respective parts in the embodiment of FIGS. 2a-2c,
FIGS. 5a-5d are circuit diagrams showing an operation in one power source polarity of another embodiment of the present invention,
FIGS. 6a-6d are circuit diagrams showing an operation in the other power source polarity of the embodiment of FIGS. 5a-5d,
FIG. 7 is an operational waveform diagram at respective parts in the embodiment of FIGS. 5a-5d,
FIGS. 8a-8d are circuit diagrams showing an operation in one power source polarity of still another embodiment according to the present invention,
FIGS. 9a-9d are circuit diagrams showing an operation in the other power source polarity of the embodiment of FIGS. 8a-8d,
FIG. 10 is an operational waveform diagram at respective parts in the embodiment of FIGS. 8a-8d,
FIG. 11 is a circuit diagram showing still another embodiment according to the present invention,
FIG. 12 is an explanatory diagram showing a first group of working aspects from a viewpoint of current loop in the power source device according to the present invention,
FIG. 13 is an explanatory diagram showing a second group of working aspects from a viewpoint of other current loop in the present invention,
FIG. 14 is an explanatory diagram showing a first group of working aspects relative to switching operation of the power source device according to the present invention,
FIG. 15 is an explanatory diagram showing a second group of working aspects relative to another switching operation in the present invention,
FIG. 16 is an explanatory diagram showing a third group of working aspects relative to still another switching operation in the present invention,
FIG. 17 of an explanatory diagram showing a fourth group of working aspects relative to still another switching operation in the present invention,
FIG. 18 is an explanatory diagram showing a fifth group of working aspects relative to still another switching operation in the present invention,
FIG. 19 is a circuit diagram showing another embodiment according to the present invention,
FIGS. 20a-20c are circuit diagrams showing an operation in one power source polarity in still another embodiment according to the present invention,
FIGS. 21a-21c are circuit diagrams showing an operation in the other power source polarity of the embodiment of FIG. 20,
FIGS. 22a-22c are circuit diagrams showing an operation in one power source polarity of still another embodiment of the present invention,
FIGS. 23a-23c are circuit diagrams showing an operation in the other power source polarity of the embodiment of FIGS. 20a-20c,
FIG. 24 is a circuit diagram showing a formation of a conventional power source device,
FIGS. 25a-25d are circuit diagrams showing an operation of the conventional power source device of FIG. 24,
FIGS. 26a and 26b are circuit diagrams showing an operation in one power source polarity of a conventional power source device, and
FIGS. 27a and 27b are circuit diagrams showing an operation in one power source polarity of the power source device of FIGS. 26a and 26b.
BEST MODE FOR WORKING THE INVENTION
FIG. 1 shows a preferable embodiment of the present invention, which has a circuit formation in which a circuit of first and second switching elements Q1 and Q2 connected in series with their forward direction made to coincide and respectively provided with an inverse directional current passing element connected in parallel and a circuit of third and fourth switching elements Q3 and Q4 connected in series with their forward direction made to coincide and respectively provided with an inverse directional current passing element connected in parallel are connected in parallel with a capacitor EC to be in the same polarity, a circuit of first and second rectifying elements D5 and D6 connected in parallel to the capacitor EC so as to be in the same polarity as the current passing elements provided in parallel to the first to fourth switching elements and to coincide at an end of the first rectifying element D5 with an end of each of the first and third switching elements Q1 and Q3, a series circuit of an AC power source AC and a first inductor L1 is connected, through a filter not shown, between a junction point of the two rectifying elements D5 and D6 and a junction point of the first and second switching elements Q1 and Q2, and a series circuit of a load circuit L and a second inductor L2 is connected between a junction point of the first and second switching elements Q1 and Q2 and a junction point of the third and fourth switching elements Q3 and Q4. The series circuit of the AC power source AC and first inductor L1 is connected on the source AC side to the junction point of the first and second switching elements Q1 and Q2, while the series circuit of the load circuit L and second inductor L2 is connected on the load circuit L side to the junction point of the first and second switching elements Q1 and Q2, so that the potential of the load circuit L will be stable in the high frequency. It is also possible to so arrange that the operation will be reversed.
In FIG. 11, there is shown another aspect of the present invention, which power source device has such circuit arrangement that a circuit of the first and second switching elements Q1 and Q2 respectively provided with an inverse directional current passing element connected in parallel and mutually connected in series with their forward direction made to coincide, a circuit of the third and fourth switching elements Q3 and Q4 respectively provided with an inverse directional current passing element connected in parallel and mutually connected in series with their forward direction made to coincide, and a circuit of fifth and sixth switching elements Q5 and Q6 respectively provided with an inverse directional current passing element connected in parallel and mutually connected in series with their forward direction made to coincide are connected in parallel to the capacitor EC to be in the same polarity; the series connection of the AC power source AC and first inductor L1 is connected between the junction point of the first and second switching elements Q1 and Q2 and the junction point of the fifth and sixth switching elements Q5 and Q6; and the series connection of the load circuit L and second inductor L2 is connected between the junction point of the first and second switching elements Q1 and Q2 and the junction point of the third and fourth switching elements Q3 and Q4.
In any case employing either one of the foregoing circuit arrangements, it is preferable that the switching elements respectively provided with the parallel connection of the inverse directional current passing element comprise respectively a field effect transistor having an inverse directional parasitic diode. It may be also possible to use a bipolar transistor having a diode connected in inverse parallel thereto.
While in the followings the optimum working aspects shall be enumerated with reference to current loops in these circuit arrangements, a definition of terms in which general use current loops occur repeatedly hereinafter shall be preliminarily referred to:
A1) A term having at least a period in which a state at which a current of first power converting circuit forms a closed loop comprising the first inductor, fifth rectifying element, capacitor, second field effect transistor and power source, as well as a state at which a current of second power converting circuit forms a closed loop comprising the capacitor, third field effect transistor, second inductor, load circuit and second field effect transistor are caused to concurrently exist. This term shall be referred to simply as [A1] in the following description.
A2) A term having at least a period in which a state at which the current from the first power converting circuit forms a closed loop comprising the first inductor, power source, first field effect transistor, capacitor and sixth rectifying element, as well as a state at which the current from the second power converting circuit forms a closed loop comprising the capacitor, first field effect transistor, load circuit, second inductor and fourth field effect transistor are caused to concurrently exist. This term shall be referred to simply as [A2] in the following description.
B1) A term having at least a period in which a state at which the current from the first power converting circuit forms a closed loop comprising the power source, first inductor, fifth rectifying element and first field effect transistor, as well as a state at which the current from the second power converting circuit forms a closed loop comprising the second inductor, load circuit, first field effect transistor and third field effect transistor are caused to concurrently exist. This term shall be referred to simply as [B1] in the following description.
B2) A term having at least a period in which a state at which the current from the first power converting circuit forms a closed loop comprising the power source, second field effect transistor, sixth rectifying element and first inductor, as well as a state at which the current from the second power converting circuit forms a closed loop comprising the second inductor, fourth field effect transistor, second field effect transistor and load circuit are caused to concurrently exist. In the following description, this term shall be referred to simply as [B2].
C1) A term having at least a period in which a state at which the current from the power converting circuit forms a closed loop comprising the first inductor, fifth rectifying element, capacitor, second field effect transistor and power source, as well as a state at which the current from the second power converting circuit forms a closed loop comprising the second inductor, load circuit, second field effect transistor and fourth field effect transistor are caused to concurrently exist. In the following description, this term shall be referred to simply as [C1].
C2) A term having at least a period in which the state at which the current from the first power converting circuit forms a closed loop comprising the first inductor, power source, first field effect transistor, capacitor, sixth rectifying element and first inductor, as well as a state at which the current from the second power converting circuit forms a closed loop comprising the second inductor, third field effect transistor, first field effect transistor and load circuit are caused to concurrently exist. In the following description, this term shall be referred to simply as [C2].
D1) A term having at least a period in which a state at which the current from the first power converting circuit forms a closed loop comprising the power source, first inductor, fifth rectifying element and first field effect transistor, as well as a state at which the current from the second power converting circuit forms a closed loop comprising the second inductor, load circuit, first field effect transistor, capacitor and fourth field effect transistor are caused to concurrently exist. In the following description, this term shall be referred to simply as [D1].
D2) A term, having at least a period in which a state at which the current from the first power converting circuit forms a closed loop comprising the power source, second field effect transistor, sixth rectifying element and first inductor, as well as a state at which the current from the second power converting circuit forms a closed loop comprising the second inductor, third field effect transistor, capacitor and second field effect transistor are caused to concurrently exist. In the following description, this term shall be referred to simply as [D2].
Respective working aspects (&agr;1)-(&agr;3) and (&bgr;1)-(. beta. 6) enumerated in the followings with the foregoing definition made as the premise are corresponding to such current loops as shown in FIG. 12, and respective working aspects (&ggr;1)-(&ggr;6) and (&ggr;1)- (&ggr; 6) are corresponding to such current loops as shown in FIG. 13. In the following description, further, a term "when the polarity of the power source is negative" means "when the polarity of the power source on the side of the junction point of the first and second switching elements Q1 and Q2 is negative", whereas a term "when the polarity of the power source is positive" means that "when the polarity of the power source on the side of the junction point of the first and second switching elements Q1 and Q2 is positive". The working aspects provided with respective control devices in the followings are applicable to the circuit of FIG. 1 and to the circuit of FIG. 11.
(&agr;1) A working aspect provided with a control device formed to operate in the order of [A1]→[B1] when the polarity of the power source is negative, but in the order of [A2]→[B2] when the polarity of the power source is positive.
(&agr;2) A working aspect provided with a control device formed to operate in the order [A1]→[C1] when the polarity of the power source is negative, but in the order of [A2]→[C2] when the polarity of the power source is positive.
(&agr;3) A working aspect provided with a control device formed to operate in the order of [A1]→[D1] when the polarity of the power source is negative, but in the order of [A2]→[D2] when the polarity of the power source is positive.
(&bgr;1) A working aspect provided with a control device formed to operate in the order of [A1]→[B1]→[C1] when the polarity of the power source is negative, but in the order of [A2]. fwdarw.[B2]. fwdarw.[C2] when the polarity of the power source is positive.
(&bgr;2) A working aspect provided with a control device formed to operate in the order of [A1]→[B1]→[D1] when the polarity of the power source is negative, but in the order of [A2]. fwdarw.[B2]. fwdarw.[D2] when the polarity of the power source is positive.
(&bgr;3) A working aspect provided with a control device formed to operate in the order of [A1]→[C1]→[B1] when the polarity of the power source is negative, but in the order of [A2]. fwdarw.[C2]. fwdarw.[B2] when the polarity of the power source is positive.
(&bgr;4) A working aspect provided with a control device formed to operate in the order of [A1]→[C1]→[D1] when the power source polarity is negative, but in the order of [A2]→[C2]→ [D2] when the power source polarity is positive.
(&bgr;5) A working aspect provided with a control device formed to operate in the order of [A1]→[D1]→[B1] when the power source polarity is negative, but in the order of [A2]→[D2]→ [B2] when the power source polarity is positive.
(&bgr;6) A working aspect provided with a control device formed to operate in the order of [A1]→[D1]→[C1] when the power source polarity is negative, but in the order of [A2]→[D2]→ [C2] when the power source polarity is positive.
(&ggr;1) A working aspect provided with a control device formed to operate in the order of [A1]→[B1]→[C1]→[D1] when the power source polarity is negative, but in the order of [A2]→ [B2]. fwdarw.[C2]→[D2] when the power source polarity is positive.
(&ggr;2) A working aspect provided with a control device formed to operate in the order of [A1]→[B1]→[D1]→[C1] when the power source polarity is negative, but in the order of [A2]→ [B2]. fwdarw.[D2]→[C2] when the power source polarity is positive.
(&ggr;3) A working aspect provided with a control device formed to operate in the order of [A1]→[C1]→[B1]→[D1] when the power source polarity is negative, but in the order of [A2→ [C2]. fwdarw.[B2]→[D2] when the power source polarity is positive.
(&ggr;4) A working aspect provided with a control device formed to operate in the order of [A1]→[C1]→[D1]→[B1] when the power source polarity is negative, but in the order of [A2]→ [C2]. fwdarw.[D2]→[B2] when the power source polarity is positive.
(&ggr;5) A working aspect provided with a control device formed to operate in the order of [A1]→[D1]→[B1]→C1] when the power source polarity is negative, but in the order of [A2]→ [D2]. fwdarw.[B2]→[C2] when the power source polarity is positive.
(&ggr;6) A working aspect provided with a control device formed to operate in the order of [A1]→[D1]→[C1]→[B1] when the power source polarity is negative, but in the order of [A2]→ [D2]. fwdarw.[C2]→[B2] when the power source polarity is positive.
(&dgr;1) A working aspect provided with a control device formed to operate in the order of [A1]→[B1]→[C1]→[B2] when the power source polarity is negative, but in the order of [A2]→ [B2]. fwdarw.[C2]→[B2] when the power source polarity is positive.
(&dgr;2) A working aspect provided with a control device formed to operate in the order of [A1]→[B1]→[D1]→[B1] when the power source polarity is negative, but in the order of [A2]→ [B2]. fwdarw.[D2]→[B2] when the power source polarity is positive.
(&dgr;3) A working aspect provided with a control device formed to operate in the order of [A1]→[C1]→[[B1]→C1] when the power source polarity is negative, but in the order of [A2]→ [C2]. fwdarw.[B2]→[C2] when the power source polarity is positive.
(&dgr;4) A working aspect provided with a control device formed to operate in the order of [A1]→[C1]→[D1]→[C1] when the power source polarity is negative, but in the order of [A2]→ [C2]. fwdarw.[D2]→[C2] when the power source polarity is positive.
(&dgr;5) A working aspect provided with a control device formed to operate in the order of [A1]→[D1]→[B1]→[D1] when the power source polarity is negative, but in the order of [A2]→ [D2]. fwdarw.[B2]→[D2] when the power source polarity is positive.
(&dgr;6) A working aspect provided with a control device formed to operate in the order of [A1]→[D1]→[C1]→[D1] when the power source polarity is negative, but in the order of [A2]→ [D2]. fwdarw.[C2]→[D2] when the power source polarity is positive.
Next, preferable working aspects shall be enumerated in the followings with respect to concrete switching procedure, while, prior to that, the definition of generally used switching term hereinafter repeatedly referred to shall be preliminarily described.
a1) A term in which the second and third field effect transistors Q1 and Q3 are made ON. In the following description, this term shall be referred to simply as [a1].
a2) A term in which the first and fourth field effect transistors Q1 and Q4 are made ON. In the following description, this term shall be referred to simply as [a2].
b1) A term in which the first and third field effect transistors Q2 and Q3 are made ON. In the following description, this term shall be referred to simply as [b1].
b2) A term in which the second and fourth field effect transistors Q2 and Q4 are made ON. In the following description, this term shall be referred to simply as [b2].
c1) A term in which the first field effect transistor Q1 is made ON. In the following description, this term shall be referred to simply as [c1].
c2) A term in which the second field effect transistor Q2 is made ON. In the following description, this term shall be referred to simply as [c2].
d1) A term in which the second field effect transistor Q2 is made ON. In the following description, this term shall be referred to simply as [d1].
d2) A term in which the first field effect transistor Q1 is made ON. In the following description, this term shall be referred to simply as [d2].
e1) A term in which the third field effect transistor Q3 is made ON. In the following description, this term shall be referred to simply as [e1].
e2) A term in which the fourth field effect transistor Q4 is made ON. In the following description, this term shall be referred to simply as [e2].
f) A term in which the first to fourth field effect transistors Q1-Q4 are made OFF. In the following description, this term shall be referred to simply as [f].
With the foregoing definition made as a premise, respective working aspects enumerated in the followings correspond to FIGS. 14-18. Also in the following description, the term "when the power source polarity is negative" should mean "when the polarity of the power source on the side of the junction point of the first and second switching elements is negative", and the term "when the power source polarity is positive" should mean "when the polarity of the power source on the side of the junction point of the first and second switching elements is positive". Further, the working aspects provided with each of following control devices are also applicable to the circuit of either FIG. 1 or FIG. 11.
(3A) A working aspect provided with a control device formed to operate in the order to [a1]→[e1] when the power source polarity is negative, but in the order of [a2]→[e2] when the power source polarity is positive.
(3B) A working aspect provided with a control device formed to operate in the order of [a1]→[b1] when the power source polarity is negative, but in the order of [a2]→[b2] when the power source polarity is positive.
(4C) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[e1] when the power source voltage is negative, but in the order of [a2]→[b2]→ [e2] when the power source polarity is positive.
(4J) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[b1] when the power source polarity is negative, but in the order of [a2]→[e2]→ [b2] when the power source polarity is positive.
(1) A working aspect provided with a control device formed to operate in the order of [a1]→[f] when the power source polarity is negative, but in the order of [a2]→[f] when the power source polarity is positive.
(3C) A working aspect provided with a control device formed to operate in the order of [a1]→[c1] when the power source polarity is negative, but in the order of [a2]→[c2] when the power source polarity is positive.
(3C') A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[f] when the power source polarity is negative, but in the order of [a2]→[c2]→ [f] when the power source polarity is positive.
(3C") A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[c1] when the power source polarity is negative, but in the order of [a2]→[f]→ [c2] when the power source polarity is positive.
(4B) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[d1] when the power source polarity is negative, but in the order of [a2]→[b2]→ [d2] when the power source polarity is positive.
(4K) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[d1] when the power source polarity is negative but in the order of [a2]→[e2]→ [d2] when the power source polarity is positive.
(3A') A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[f] when the power source polarity is negative, but in the order of [a2]→[e2]→ [f] when the power source polarity is positive.
(3B') A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[f] when the power source polarity is negative, but in the order of [a2]→[b2]→ [f] when the power source polarity is positive.
(4A) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[c1] when the power source polarity is negative, but in the order of [a2]→[b2]→ [c2] when the power source polarity is positive.
(4L) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[c1] when the power source polarity is negative, but in the order of [a2]→[e2]→ [c2] when the power source polarity is positive.
(4A1) A working aspect provided with a control device formed to operate in the order of [a1][→b1]→[c1]→[f] when the power source polarity is negative, but in the order of [a2]→[b2]. fwdarw. [c2]→[f] when the power source polarity is positive.
(4A2) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[f]→[c1] when the power source polarity is negative, but in the order of [a2]→[b2]. fwdarw. [f]→[C2] when the power source polarity is positive.
(4C1) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[e1]→[f] when the power source polarity is negative, but in the order of [a2]→[b2]. fwdarw. [e2]→[f] when the power source polarity is positive.
(4J1) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[b1]→[f] when the power source polarity is negative, but in the order of [a2]→[e2]. fwdarw. [b2]→[f] when the power source polarity is positive.
(4L1) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[c1]→[f] when the power source polarity is negative, but in the order of [a2]→[e2]. fwdarw. [b2]→[f] when the power source polarity is positive.
(4L2) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[f]→[c1] when the power source polarity is negative, but in the order of [a2]→[e2]. fwdarw. [f]→[c2] when the power source polarity is positive.
(4D) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[e1] when the power source polarity is negative, but in the order of [a2]→[d2]→ [e2] when the power source polarity is positive.
(4F) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[e1] when the power source polarity is negative, but in the order of [a2]→[d2]→ [e2] when the power source polarity is positive.
(2A) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[f] when the power source polarity is negative, but in the order of [a2]→[d2]→ [f] when the power source polarity is positive.
(4E) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[c1] when the power source polarity is negative, but in the order of [a2]→[d2]→ [c2] when the power source polarity is positive.
(4E1) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[c1]→[f] when the power source polarity is negative, but in the order of [a2]→[d2]. fwdarw. [c2]→[f] when the power source polarity is positive.
(4E2) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[f]→[c1] when the power source polarity is negative, but in the order of [a2]→[d2]. fwdarw. [f]→[c2] when the power source polarity is positive.
(3A") A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[e1] when the power source polarity is negative, but in the order of [a2]→[f]→ [e2] when the power source polarity is positive.
(3B") A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[b1] when the power source polarity is negative, but in the order of [a2]→[f]→ [b2] when the power source polarity is positive.
(4G) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[e1] when the power source polarity is negative, but in the order of [a2]→[c2]→ [e2] when the power source polarity is positive.
(4I) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[b1] when the power source polarity is negative, but in the order of [a2]→[c2]→ [b2] when the power source polarity is positive.
(4C3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[b1]→[e1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [b2]→[e2] when the power source polarity is positive.
(4G2) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[f]→[e1] when the power source polarity is negative, but in the order of [a2]→[c2]. fwdarw. [f]→[e2] when the power source polarity is positive.
(4G3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[c1]→[e1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [c2]→[e2] when the power source polarity is positive.
(4I2) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[f]→[b1] when the power source polarity is negative, but in the order of [a2]→[c2]. fwdarw. [f]→[b2] when the power source polarity is positive.
(4I3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[c1]→[b1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [c2]→[b2] when the power source polarity is positive.
(4J3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[e1]→[b1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [e2]→[b2] when the power source polarity is positive.
(2B) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[d1] when the power source polarity is negative, but in the order of [a2]→[f]→ [d2] when the power source polarity is positive.
(4H) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[d1] when the power source polarity is negative, but in the order of [a2]→[c2]→ [d2] when the power source polarity is positive.
(4H2) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[f]→[d1] when the power source polarity is negative, but in the order of [a2]→[c2]. fwdarw. [f]→[d2] when the power source polarity is positive.
(4H3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[c1]→[d1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [c2]→[d2] when the power source polarity is positive.
(4B1) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[d1]→[f] when the power source polarity is negative, but in the order of [a2]→[b2]. fwdarw. [d2]→[f] when the power source polarity is positive.
(4K1) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[d1]→[f] when the power source polarity is negative, but in the order of [a2]→[e2]. fwdarw. [d2]→[f] when the power source polarity is positive.
(4B2) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[f]→[d1] when the power source polarity is negative, but in the order of [a2]→[b2]. fwdarw. [f]→[d2] when the power source polarity is positive.
(4K2) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[f]→[d1] when the power source polarity is negative, but in the order of [a2]→[e2]. fwdarw. [f]→[d2] when the power source polarity is positive.
(4D1) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[e1]→[f] when the power source polarity is negative, but in the order of [a2]→[d2]. fwdarw. [e2]→[f] when the power source polarity is positive.
(4F1) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[b1]→[f] when the power source polarity is negative, but in the order of [a2]→[d2]. fwdarw. [b2]→[f] when the power source polarity is positive.
(4D2) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[f]→[e1] when the power source polarity is negative, but in the order of [a2]→[d2]. fwdarw. [f]→[e2] when the power source polarity is positive.
(4F2) A working aspect provided with a control device formed to operate in the order of [a1]→[d1]→[f]→[b1] when the power source polarity is negative, but in the order of [a2]→[d2]. fwdarw. [f]→[b2] when the power source polarity is positive.
(4B3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[b1]→[d1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [b2]→[d2] when the power source polarity is positive.
(4K3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[e1]→[d1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [e2]→[d2] when the power source polarity is positive.
(4D3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[d1]→[e1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [d2]→[e2] when the power source polarity is positive.
(4F3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[d1]→[b1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [d2]→[b2] when the power source polarity is positive.
(4C2) A working aspect provided with a control device formed to operate in the order of [a1]→[b1]→[f]→[e1] when the power source polarity is negative, but in the order of [a2]→[b2]. fwdarw. [f]→[e2] when the power source polarity is positive.
(4J2) A working aspect provided with a control device formed to operate in the order of [a1]→[e1]→[f]→[b1] when the power source polarity is negative, but in the order of [a2]→[e2]. fwdarw. [f]→[b2] when the power source polarity is positive.
(4A3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[b1]→[c1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [b2]→[c2] when the power source polarity is positive.
(4G1) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[e1]→[f] when the power source polarity is negative, but in the order of [a2][c2]→ [e2]→ [f] when the power source polarity is positive.
(4I1) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[b1]→[f] when the power source polarity is negative, but in the order of [a2]b[c2]→ [b2] →[f] when the power source polarity is positive.
(4L3) A working aspect provided with a control device formed to operate in the order of [a1]→[f][e1]→[c1] when the power source polarity is negative, but in the order of [a2]→[f]→ [e2]→ [c2] when the power source polarity is positive.
(4E3) A working aspect provided with a control device formed to operate in the order of [a1]→[f]→[d1]→[c1] when the power source polarity is negative, but in the order of [a2]→[f]. fwdarw. [d2]→[c2] when the power source polarity is positive.
(4H1) A working aspect provided with a control device formed to operate in the order of [a1]→[c1]→[d1]→[f] when the power source polarity is negative, but in the order of [a2]→[c2]. fwdarw. [d2]→[f] when the power source polarity is positive.
Further, in a period in which a current flows through the parasitic diode of the switching element Q when the power source polarity is negative, and in a period in which a current flows through the parasitic diode of the switching element Q3 when the power source polarity is positive, it may be possible to apply a voltage across the gate and source of the particular element.
In the respective foregoing working aspects, the output to the load should preferably be made in a square wave at a low frequency in synchronism with the power source. Further, while a discharge lamp can be used as the load, it should not be limited thereto.
Embodiment 1
While a first embodiment is shown in FIG. 2 with FIG. 1 made as the basic formation, this power source device is formed such that the series connection of first and second field effect transistors Q1 and Q2, the series connection of third and fourth field effect transistors Q3 and Q4 and the series connection of two rectifying elements D5 and D6 are connected in parallel with the capacitor EC; the series circuit of the power source AC and first inductor L1 connected through a filter not shown is connected between the junction point of the first and second field effect transistors Q1 and Q2 and the junction point of the two rectifying elements D5 and D6; and the series circuit of the load circuit L and second inductor L2 is connected between the junction point of the first and second field effect transistors Q1 and Q2 and the junction point of the third and fourth field effect transistors Q3 and Q4. One end of the power source AC is connected to coincide with the junction point of the first and second field effect transistors Q1 and Q2, and one end of the load circuit L is connected to coincide with the junction of the first and second field effect transistors Q1 and Q2.
The respective field effect transistors Q1-Q4 are driven for their switching as in the followings, by means of ON/OFF signals given by the control device. There is provided a control device CNT formed to operate, when the polarity of the power source AC is negative on the side of the junction point of the first and second field effect transistors Q1 and Q2, in the order of a period in which the second and third field effect transistors Q2 and Q3 are made ON (see FIG. 2a), a period in which the first and third field effect transistors Q1 and Q3 are made ON (see FIG. 2b), and a period in which the first, second, third and fourth field effect transistors Q1, Q2, Q3 and Q4 are made OFF (see FIG. 2c), and to operate, when the polarity of the power source AC is positive on the side of the junction point of the first and second field effect transistors Q1 and Q2, in the order of a period in which the first and fourth field effect transistors Q1 and Q4 are made ON (see FIG. 3a), a period in which the second and fourth field effect transistors Q2 and Q4 are made ON (see FIG. 3b), and a period in which the first, second, third and fourth field effect transistors Q1, Q2, Q3 and Q4 are made OFF (see FIG. 3c).
This power source device comprises a first power converting circuit forming a boost converter and a second power converting circuit forming a buck converter, and the first and second field effect transistors Q1 and Q2 are used in common in the first and second power converting circuits. The operation at the time when the polarity of the power source AC is negative on the side of the junction point of the first and second field effect transistors Q1 and Q2 are shown in FIG. 2 shall be described with reference to the first power converting circuit forming the boost converter and the second power converting circuit forming the buck converter.
Referring first to the first power converting circuit which forming the boost converter, the period in which the first and third field effect transistors Q1 and Q3 are made ON (see FIG. 2b) is a period in which an energy is charged in the first inductor L1 which acts as a choke in the boosting chopper, while the period in which the first through fourth field effect transistors Q1 through Q4 are made OFF (see FIG. 2c) as well as the period in which the second and third field effect transistors Q2 and Q3 are made ON (see FIG. 2a) are periods in which the energy stored in the first inductor L1 is discharged.
Referring next to the second power converting circuit which forming the buck converter, the period in which the second and third field effect transistors Q2 and Q3 are made ON (see FIG. 2a) is a period in which an energy is charged in the second inductor L2 which acts as a choke in the buck, while the period in which the first and third field effect transistors Q1 and Q3 are made ON (see FIG. 2b) and the period in which the first through fourth field effect transistors Q1 through Q4 are made OFF (see FIG. 2c) are periods in which the energy stored in the second inductor L2 is discharged.
Referring to these respects from the viewpoint of current loop, the period in which the second and third field effect transistors Q2 and Q3 are made ON (FIG. 2a) is a term (which shall be referred to as T1) in which a state at which a current of the first power converting circuit CNV1 forms a closed loop comprising the first inductor L1, first rectifying element D5, capacitor EC, second field effect transistor Q2 and power source AC, and a state at which a current of the second power converting circuit CNV2 forms a closed loop comprising the capacitor EC, third field effect transistor Q3, second inductor L2, load circuit L and second field effect transistor Q2 are concurrently existing. Further, the period in which the first and third field effect transistors Q1 and Q3 are made ON (FIG. 2b) is a term (which term shall be referred to as T2) in which a state at which the current of the first power converting circuit CNV1 forms a closed loop comprising the power source AC, first inductor L1, first rectifying element D5 and first field effect transistor Q1, and a state at which the current of the second power converting circuit CNV2 forms a closed loop comprising the second inductor L2, load circuit L, first field effect transistor Q1 and third field effect transistor Q3 are concurrently existing. Further, the period in which the first through fourth field effect transistors Q1 through Q4 are made OFF (FIG. 2c) is a term (which term shall be referred to as T3) in which a state at which the current of the first power converting circuit CNV1 forms a closed loop comprising the first inductor L1, first rectifying element D5, capacitor EC, second field effect transistor Q2 and power source AC, and a state at which the current of the second power converting circuit CNV2 forms a closed loop comprising the second inductor L2, load circuit L, second field effect transistor Q2 and fourth field effect transistor Q4 are concurrently existing.
In the term T1, an effect is realized in that the current flowing through the second field effect transistor Q2 is reduced to decrease any switching loss, since the forward directional current caused by the second power converting circuit CNV2 and the backward directional current by the first power converting circuit CNV1 to flow to the second field effect transistor Q2 are superposed.
In the term T2, an effect is realized in that the current flowing through the first field effect transistor Q1 is decreased to reduce any switching loss, since the forward directional current caused by the first power converting circuit CNV1 and the backward current by the second power converting circuit CNV2 to flow to the first field effect transistor Q1 are superposed.
In the term T3, an effect is realized in that the current flowing through the second field effect transistor Q2 is decreased to reduce any switching loss, since the forward directional current caused by the second power converting circuit CNV2 and the backward directional current by the first power converting circuit CNV1 to flow to the second field effect transistor Q2 are superposed.
The operation in an event where the polarity of the power source AC is inverse is shown in FIG. 3. Further, waveforms at respective parts are shown in FIG. 4, in which there are shown a current IL1 flowing to the first inductor L1, a current IL2 to the second inductor L2, a difference IL2-IL1 between the current to the second inductor L2 and the current to the first inductor L1, a current IQ1 to the first field effect transistor Q1, a current IQ2 to the second field effect transistor Q2, a current IQ3 to the third field effect transistor Q3, a current IQ4 to the fourth field effect transistor Q4, and drive signals VQ1GS-VQ4GS supplied across the gate and source of the respective first to fourth field effect transistors Q1-Q4. In FIG. 4, waveforms for each cycle of switching are shown, and periods t0-t1, t1-t2 and t2-t3 (=t0) are corresponding to the terms T1, T2 and T3, respectively.
Embodiment 2
As Embodiment 2, an operation in an event where the power source voltage is low or the first inductor L1 is large and so on shall be described. The circuit formation and switching operation are the same as in Embodiment 1, but the current loops are partly different. References shall be made to the current loops in the event where the polarity of the power source AC is negative on the side of the junction point of the first and second field effect transistors Q1 and Q2 as shown in FIG. 5. First, a period in which the second and third field effect transistors Q2 and Q3 are made ON (see FIG. 5a) is a term (which shall be referred to as T1) in which there exists a state at which the current of the second power converting circuit CNV2 forms a closed loop comprising the capacitor EC, third field effect transistor Q3, second inductor L2, load circuit L and second field effect transistor Q2. Next, a period in which the first and third field effect transistors Q1 and Q3 are made QN (see FIG. 5b) is a term (which shall be referred to as T2) in which there exist concurrently a state at which the current of the first power converting circuit forms a closed loop comprising the power source AC, first inductor L1, first rectifying element D5 and first field effect transistor Q1, and a state at which the current of the second power converting circuit forms a closed loop comprising the second inductor L2, load circuit L, first field effect transistor Q1 and third field effect transistor Q3. Further, a period in which the first through fourth field effect transistors Q1-Q4 are made OFF (see FIG. 5c or 5d) allows such two states as follows to exist, depending on the magnitude relationship between the current flowing to the first inductor L1 and the current flowing to the second inductor L2:
An event where the absolute value of the current to the first inductor L1 is smaller than the absolute value of the current to the second inductor L2 (see FIG. 5c) will be a term (which shall be referred to as T3) in which there exist concurrently a state at which the current of the first power converting circuit CNV1 forms a closed loop comprising the first inductor L1, first rectifying element D5 and first field effect transistor Q1, and a state at which the current of the second power converting circuit CNV2 forms a closed loop comprising the second inductor L2, load circuit L, first field effect transistor Q1, capacitor EC and fourth field effect transistor Q4. Further, upon coincidence of the absolute value of the current to the first inductor L1 with the absolute value of the current to the second inductor L2 (see FIG. 5d), the currents from the first and second power converting circuits CNV1 and CNV2 are mutually cancelled, as a result of which the sum total of the currents flowing to the switching elements used in common will be zero so that, practically, there is formed no closed loop of the current through the foregoing commonly-used switching elements in the respective power converting circuits, and it becomes a term (which shall be referred to as T4) in which there exists a state at which a closed loop comprising the first inductor L1, first rectifying element D5, capacitor EC, fourth field effect transistor Q4, second inductor L2, load circuit L and power source AC is formed.
Referring to the respective terms T1-T4 of the foregoing in relation to the first power converting circuit forming the boost converter and the second power converting circuit forming the buck converter, the terms T2 and T3 in relation to the first power converting circuit forming the boost converter are the terms for charging an energy in the first inductor L1 which acts as a choke of the boost, and the term T4 is the term for discharging the energy accumulated in the first inductor L1. Further, in relation to the second power converting circuit forming the buck converter, the term T1 is the term for charging an energy in the second inductor L2 acting as a choke in the buck, and the terms T2, T3 and T4 are the terms for discharging the energy accumulated in the second inductor L2.
In the term T2, the forward directional current caused by the first power converting circuit CNV1 and the backward directional current caused by the second power converting circuit CNV2 to flow to the first field effect transistor Q1 are mutually superposed, whereby the current flowing through the first field effect transistor Q1 is decreased, and an effect of reducing any power loss is realized.
In the term T3, the forward directional current caused by the second power converting circuit CNV2 and the backward directional current caused by the first power converting circuit CNV1 to flow to the second field effect transistor Q2 are mutually superposed, whereby the current flowing through the second field effect transistor Q2 is decreased, and an effect of reducing any power loss is realized.
In the term T4, the sum total of the currents flowing to the switching elements used in common is made zero as a result of the mutual cancellation of the currents from the first and second power converting circuits CNV1 and CNV2, there is formed no closed loop of the current through the switching elements used in common in the respective power converting circuits practically, so that, even though the power converting circuits are operating, there flows no current at all to the first and second field effect transistors Q1 and Q2, and an effect of causing no power loss to occur is realized.
The operation in the event where the power source AC is of inverse polarity is shown in FIG. 6. Further, waveforms at respective parts are shown in FIG. 7, in which there are shown the current IL1 flowing to the first inductor L1, the current IL2 to the second inductor L2, a difference IL2-IL1 between the currents to the second and first inductors L2 and L1, the current IQ1 to first field effect transistor Q1, the current IQ2 to the second field effect transistor Q2, the current IQ3 to the third field effect transistor Q3, the current IQ4 to the fourth field effect transistor Q4, and drive signals VQ1GS-VQ4GS respectively supplied across the gate and source of the first through fourth field effect transistors Q1-Q4. In FIG. 7, waveforms for one switching cycle are shown, and respective periods t0-t1, t1-t2, t2-t3 and t3-t4 (=t0) are corresponding to the terms T1, T2, T3 and T4, respectively.
Embodiment 3
A circuit formation of Embodiment 3 is shown in FIG. 8, with FIG. 11 made as the basic formation. In the circuit formation, a difference from Embodiment 1 resides in that, in place of the series circuit of the two rectifying elements D5 and D6, a series circuit of fifth and sixth field effect transistors Q5 and Q6 is provided, in parallel connection with the capacitor C1. The respective field effect transistors Q1-Q6 are subjected to such switching drive as in the following, by means of ON/OFF signals provided from a control device.
First, when the polarity of the power source AC is negative on the side of the junction point of the first and second field effect transistors Q1 and Q2, the circuit operates in the order of a period in which the second, third and sixth field effect transistors Q2, Q3 and Q6 are made ON (see FIG. 8a), a period in which the third field effect transistor Q3 is made ON (see FIG. 8b or 8c) and a period in which the first through sixth field effect transistors Q1 through Q6 are made OFF, whereas, when the polarity of the power source AC is positive on the side of the junction point of the first and second field effect transistors Q1 and Q2 as shown in FIG. 9, the circuit operates in the order of a period in which the first, fourth and fifth field effect transistors Q1, Q4 and Q5 are made ON (see FIG. 9a), a period in which the second and fourth field effect transistors Q2 and Q4 are made ON (see FIG. 9b or 9c), and a period in which the first through sixth field effect transistors Q1 through Q6 are made OFF (see FIG. 9d).
Referring from the viewpoint of the current loop to the operation when the polarity of the power source AC is negative on the side of the junction point of the first and second field effect transistors Q1 and Q2, similarly to Embodiments 1 and 2, the period in which the second, third and sixth field effect transistors Q2, Q3 and Q6 are made ON (FIG. 8a) is a term (which shall be referred to as T1) in which there exist concurrently a state at which the current of the first power converting circuit CNV1 forms a closed loop comprising the power source AC, first inductor L1, sixth field effect transistor Q6 and second field effect transistor Q2, and a state at which the current of the second power converting circuit CNV2 forms a closed loop comprising the capacitor EC, third field effect transistor Q3, second inductor L2, load circuit L and second field effect transistor Q2. In the period in which the third field effect transistor Q3 is made ON (FIG. 8b or 8c), next, there exist two states depending on the magnitude relation between the current flowing to the first inductor L1 and the current to the second inductor L2.
In an event when the absolute value of the current to the first inductor L1 is smaller than the absolute value of the current to the second inductor L2 (FIG. 8b), it becomes a term (which shall be referred to as T2) in which there exist concurrently a state at which the current of the first power converting circuit CNV1 forms a closed loop comprising the power source AC, first inductor L1, fifth field effect transistor Q5 and first field effect transistor Q1, and a state at which the current of the second power converting circuit CNV2 forms a closed loop comprising the second inductor L2, load circuit L, first field effect transistor Q1 and third field effect transistor Q3. Further, upon coincidence of the absolute value of the current of the first inductor L1 with the absolute value of the current of the second inductor L2 (FIG. 8c), the currents from the first and second power converting circuit CNV1 and CNV2 are mutually cancelled, as a result of which the sum total of the currents flowing to the switching elements used in common will be zero, so that, in practice, there is formed no closed loop of the current passing through the commonly used switching elements within the respective power converting circuits, and it becomes a term (which shall be referred to as T3) in which there exists a state forming a closed loop comprising the first inductor L1, fifth field effect transistor Q5, third field effect transistor Q3, second inductor L2, load circuit L and power source AC.
Further, in the period in which the first through sixth field effect transistors Q1 through Q6 are made OFF (FIG. 8d), the currents from the respective first and second power converting circuits CNV1 and CNV2 are mutually cancelled, as a result of which the sum total of the currents flowing to the switching elements used in common will be zero, so that, in practice, there is formed no closed loop of the currents passing through the commonly used switching elements within the respective power converting circuits, and it becomes a term (which shall be referred to as T4) in which there exists a state forming a closed loop comprising the first inductor L1, fifth field effect transistor Q5, capacitor EC, fourth field effect transistor Q4, second inductor L2, load circuit L and power source AC.
The action in the respective terms T1-T4 shall be described in relation to the first power converting circuit forming the boost converter and the second power converting circuit forming the buck converter. With reference to the first power converting circuit forming the boost converter, T1 and T2 are the terms for charging an energy in the first inductor L1 acting as the choke of boost, and the terms T3 and T4 are for discharging the energy accumulated in the first inductor L1. With reference to the second power converting circuit forming the buck converter, the term T1 is for charging an energy in the second inductor L2 acting as the choke of the buck, and the terms T2, T3 and T4 are for discharging the energy accumulated in the second inductor L2.
In the term T1, the current flowing through the second field effect transistor Q2 is decreased as a result that the forward directional current caused by the second power converting circuit CNV2 and the backward directional current caused by the first power converting circuit CNV1 to flow to the second field effect transistor Q2 are mutually superposed, and the effect of reducing the switching loss is realized.
In the term T2, the current flowing through the first field effect transistor Q1 is decreased as a result that the forward directional current caused by the first power converting circuit CNV1 and the backward directional current caused by the second power converting circuit CNV2 to flow to the first field effect transistor Q1 are mutually superposed, and the effect of reducing the switching loss is realized.
In the term T3, the sum total of the currents flowing to the commonly used switching elements will be zero as a result that the currents from the first power converting circuit COVL and from the second power converting circuit CNV2 are mutually cancelled, and, in practice, there is formed no closed loop of the current through the commonly used switching elements within the respective power converting circuits, so that there flows no current at all to the first and second field effect transistors Q1 and Q2, even though the power converting circuits are operating, and the effect of causing no power loss to occur is realized.
In the term T4, the sum total of the currents flowing to the commonly used switching elements as a result that the currents from the first and second power converting circuits CNV1 and CNV2 are mutually cancelled, and, in substance, there is formed no closed loop of the current through the commonly used switching elements within the respective power converting circuits, so that there flows no current at all to the first and second field effect transistors Q1 and Q2, even though the power converting circuits are operating, and the effect of causing no power loss to occur is realized.
The operation in the event where the polarity of the power source AC is inverse is shown in FIG. 9, and waveforms at respective parts are shown in FIG. 10, in which there are shown the current IL1 flowing to the first inductor L1, the current IL2 to the second inductor L2, the difference IL2-IL1 between the currents flowing to the second inductor L2 and to the first inductor L1, the currents IQ1-IQ6 flowing respectively to the first through sixth field effect transistors Q1-Q6, and drive signals VQ1GS-VQ6GS respectively supplied across the gate and source of each of the first to sixth field effect transistors Q1-Q6. In FIG. 10, the waveforms are shown for one cycle of the switching, and the periods t0-t1, t1-t2, t2-t3 and t3-t4 (=t0) are corresponding to the terms T1, T2, T3 and T4, respectively.
Embodiment 4
A circuit formation of Embodiment 4 is shown in FIGS. 20a-20c and FIGS. 21a-21c as an aspect embodying the circuit formation of FIG. 19.
In a half cycle in which the AC power source P is positive and the switching elements Q1 and Q3 are ON but the switching elements Q2 and Q4 are OFF, a current flows, as shown in FIG. 20a, from the AC power source P as a current source through a path of the diode D5, switching element Q1 and inductor L1, to have an energy accumulated in the inductor L1. Also, a regenerative current caused by an accumulated energy in the inductor L2 flows from the inductor L2 as a current source through a path of a diode D1, switching element Q3 and load circuit Z.
Next, when the switching elements Q2 and Q3 are ON but the switching elements Q1 and Q4 are OFF, a regenerative current caused by the accumulated energy in the inductor L1 flows through the inductor L1, and a current from the smoothing capacitor C as a current source flows through the inductor L2. Here, in an event when the current value flowing through the inductor L1 is larger than the current value flowing through the inductor L2, there flows a current from the inductor L1 as a current source, as shown in FIG. 20b, through a path of a diode D9, smoothing capacitor C and diode D2, to have the smoothing capacitor C charged. Further, so long as a current in forward direction is flowing through the diode D2 due to the current loop with the inductor L1 made as the current source, a current in backward direction can also flow through the diode D2 in accordance with its characteristic, so that, from the smoothing capacitor C as a current source, a current flows through a path of the switching element Q3, load circuit Z, inductor L2 and diode D2, and a voltage of the smoothing capacitor C is supplied to the load circuit Z as dropped by means of the inductor L2. At this time, the current of the current loop from the inductor L1 as the source and the current of the current loop from the smoothing capacitor C as its source are flowing in mutually opposite direction so as to cancel each other, and the value of current flowing through the diode D2 is made small.
When on the other hand the value of current flowing through the inductor L1 is smaller than the value of current flowing through the inductor L2, a current flows, as shown in FIG. 20c, from the inductor L1 as the current source through a path of the diode D9, smoothing capacitor C, diode D8 and switching element Q2, and the smoothing capacitor C is charted. Also, a current flows from the smoothing capacitor C as the current source, through a path of the switching element Q3, load circuit Z, inductor L2, switching element Q2 and diode D8, and the voltage of the smoothing capacitor C is supplied to the load circuit Z as dropped by means of the inductor L2. At this time, the current of the current loop from the inductor L1 as the source and the current of the current loop from the smoothing capacitor C as the source are to flow mutually in opposite directions to cancel each other at the switching element Q2 and diode D8, and the value of the current flowing to the switching element Q2 and diode D8 is made small. Thereafter, a state in which the switching elements Q1 and Q3 are ON while the switching elements Q2 and Q4 are OFF and a state in which the switching elements Q2 and Q3 are ON while the switching elements Q1 and Q4 are OFF (FIGS. 20a and 20b or FIGS. 20a and 20c) are repeated at a high frequency, and a DC voltage in one direction is supplied to the load circuit Z.
Next, when the switching elements Q2 and Q4 are ON while the switching elements Q1 and Q3 are OFF in the negative half cycle of the AC power source P, as shown in FIG. 21a, a current flows from the AC power source P as the current source through a path of the inductor L1, switching element Q2 and diode D6, and an energy is accumulated in the inductor L1. Also a regenerative current caused by the accumulated energy in the inductor L2 flows from the inductor L2 as the source through a path of the load circuit Z, switching element Q4 and diode D2.
Next, as the switching elements Q1 and Q4 are made ON while the switching elements Q2 and Q3 are made OFF, a regenerative current caused by the accumulated energy in the inductor L1 flows through the inductor L1, and a current from the smoothing capacitor C as the current source flows through the inductor L2. Here, in an event when the value of the current flowing through the inductor L1 is larger than the value of the current flowing through the inductor L2, the current flows, as shown in FIG. 21b, from the inductor L1 as the current source, through a path of the diode D1, smoothing capacitor C and diode D1, and the smoothing capacitor C is charged. Also with the smoothing capacitor C made as the current source, the current flows through a path of the diode D1, inductor L2, load circuit Z and switching element Q4, and the voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. At the diode D1, at this time, the current of the loop from the inductor L1 as the source and the current of the loop from the smoothing capacitor C as the source are to flow mutually in opposite directions to cancel each other, and the current value at the diode D1 is made small.
In an event when the value of the current flowing through the inductor L1 is smaller than the value of the current flowing through the inductor L2, the current flows, as shown in FIG. 21c, from the inductor L1 as the source through a path of the switching element Q1, diode D7, smoothing capacitor C and diode D10, and the smoothing capacitor C is charged. Also from the smoothing capacitor C as the source, the current flows through a path of the diode D7, switching element Q1, inductor L2, load circuit Z and switching element Q4, and the voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. In the diode D7 and switching element Q1 at this time, the current of the loop from the inductor L1 as the source and the current of the loop from the smoothing capacitor C as the source are to flow mutually in opposite directions to cancel each other, and the current value at the diode D7 and switching element Q1 is made small. Thereafter, a state at which the switching elements Q2 and Q4 are ON while the switching elements Q1 and Q3 are OFF, and a state at which the switching elements Q1 and Q4 are ON while the switching elements Q2 and Q3 are OFF (FIGS. 21a and 21b or FIGS. 21a and 21c) are repeated at a high frequency, and an inverse directional DC voltage is supplied to the load circuit Z. With the foregoing operation, a square wave voltage inverted in the polarity in synchronism with the respective half cycles of the AC power source P is supplied to the load circuit Z.
That is, in the present embodiment, as shown in FIGS. 20b and 20c and FIGS. 21b and 21c, the current on the inductor L1 side and the current on the inductor L2 side flow mutually in opposite directions so as to cancel each other at the switching element Q1 and diodes D7 and D1 or the switching element Q2 and diodes D8 and D2 which are used in common in the buck-boost converter and buck converter, irrespective of the magnitude of the respective values of the currents flowing through the inductors L1 and L2, so that there arises an advantage that the withstand amount of current can be decreased to be able to lower the withstand voltage of the commonly used switching elements and diodes, and the costs can be contrived to be decreased. Further, since the buck- boost operation and the buck operation can be executed independently of each other, there is an advantage that the input power can be controlled in conformity to the output power. Accordingly, it is enabled to cause a large current to flow to the load without exessively enlarging the input power with respect to the output power, even at a state where the load impedance is low, at a starting step of a high pressure discharge lamp in an event when the present embodiment is applied to a lighting device of the high pressure discharge lamp.
Further, with the employment of the controlling arrangement of the present embodiment, there arises an advantage that an excessive voltage can be prevented from occurring as an across voltage of the smoothing capacitor, since the current on the buck converter side is not caused to return to the smoothing capacitor side but its energy is consumed at the load circuit Z, as shown in FIGS. 20 and 21, even at the state where the load impedance is low.
Embodiment 5
A circuit formation of Embodiment 5 is shown in FIGS. 22a-22c and FIGS. 23a-23c as other aspects embodying the circuit formation of FIG. 19.
In the positive half cycle of the AC power source P and when the switching element Q1 is made ON but other switching elements Q2, Q3 and Q4 are made OFF, a current is caused to flow from the AC power source P as the current source through a path of the diode D5, switching element Q1 and inductor L1, and an energy is accumulated in the inductor L1. Also, a regenerative current due to the accumulated energy in the inductor L2 is caused to flow from the inductor L2 as a current source through a path of the diode D1, smoothing capacitor C, diode D4 and load circuit Z.
Next, when the switching elements Q2 and Q3 are ON and the switching elements Q1 and Q4 are OFF, a regenerative current due to the accumulated energy in the inductor L1 flows through this inductor L1, and a current is caused to flow from the smoothing capacitor C as a current source to the inductor L2. Here, in an event when the value of the current flowing through the inductor L1 is larger than the value of the current through the inductor L2, the current flows, as shown in FIG. 22b, from the inductor L1 as the source through a path of a diode D9, smoothing capacitor C and diode D2, to have the smoothing capacitor C charged. Also, the current from the smoothing capacitor C as the current source flows through a path of the switching element Q3, load circuit Z, inductor L2 and diode D2, so that the voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. At this time, the current of the current loop with the inductor L1 made as the current source and the current of the current loop with the smoothing capacitor C made as the current source are flowing in mutually opposite directions at the diode D2 so as to cancel each other, so as to render the value of current flowing to the diode D2 to be smaller. When on the other hand the value of current flowing through the inductor L1 is smaller than the value of current flowing through the inductor L2, the diode D9 and smoothing capacitor C are charged with the inductor L1 made as the current source, as shown in FIG. 22c. Also, the current flows from the smoothing capacitor C as the current source through a path of the switching element Q3, load circuit Z, inductor L2, switching element Q2 and diode D8, and the voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. At this time, the current of the loop from the inductor L1 as the current source and the current of the loop with the smoothing capacitor C as the current source are flowing mutually in opposite directions to cancel each other at the switching element Q2 and diode D8, and the current value at these switching element Q2 and diode D8 becomes smaller. Thereafter, the state at which the switching element Q1 is ON and the switching elements Q2-Q4 are OFF as well as a state in which the switching elements Q2 and Q3 are ON and the switching elements Q1 and Q4 are OFF (FIGS. 22a and 22b or FIGS. 22a and 22c) are repeated at a high frequency, and a DC voltage in one direction is supplied to the load circuit Z.
Next, in the negative half cycle of the AC power source P and when the switching element Q2 is ON while the switching elements Q1, Q3 and Q4 are OFF, a current flows, as shown in FIG. 23a, from the AC power source P through a path of the inductor L1, switching element Q2 and diode D6, and an energy is accumulated in the inductor L1. Further, a regenerative current due to the accumulated energy in the inductor L2 is caused to flow from the inductor L2 as the source through a path of the load circuit Z, diode D3, smoothing capacitor C and switching element Q2.
When the switching elements Q1 and Q4 are ON and the switching elements Q2 and Q3 are OFF, next, a regenerative current due to the accumulated energy of the inductor L1 flows through the inductor L1, and the current from the smoothing capacitor C as the current source flows through the inductor L2. Here, when the value of current flowing through the inductor L1 is larger than the value of current flowing through the inductor L2, a current flows from the inductor L1 as the current source through a path of the diode D1, smoothing capacitor C and diode D10, and the smoothing capacitor C is charged. A current is caused to flow from the smoothing capacitor C as the source through a path of the diode D1, inductor L2, load circuit Z and switching element Q4, and the voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. At this time, the current of the loop with the inductor L1 made as the current source and the current of the loop with the smoothing capacitor C made as the current source are flowing in opposite directions to cancel each other at the diode D1, and the current value is decreased at the diode D1.
When the current value at the inductor L1 is smaller than the current value at the inductor L2, on the other hand, a current flows from the inductor L1 as the current source through a path of the switching element Q1, diode D7, smoothing capacitor C and diode D10, and the smoothing capacitor C is charged. Also a current flows from the smoothing capacitor C through a path of the diode D7, switching element Q1, inductor L2, load circuit Z and switching element Q4, and the voltage at the smoothing capacitor C is supplied to the load circuit Z as dropped by the inductor L2. At this time, the current of the loop with the inductor L1 made as the current source and the current of the loop with the smoothing capacitor C are flowing mutually in opposite directions to cancel each other at the diode D1, and the current value at the diode D7 and switching element Q1 is decreased. Thereafter, a state at which the switching element Q2 is ON and the switching elements Q1, Q3 and Q4 are OFF and a state at which the switching elements Q1 and Q4 are ON and the switching elements Q2 and Q3 are OFF (FIGS. 23a and 23b or FIGS. 23a and 23c) are repeated at a high frequency. With the above operation, a square wave voltage of a polarity inverting in synchronism with the respective half cycles of the AC power source P is supplied.
In the present embodiment, there arise such advantage that, similarly to Embodiment 4, the withstand current amount can be decreased at the switching element Q1, and diodes D7 and D1 or the switching element Q2 and diodes D8 and D2 commonly employed in the buck-boost converter and buck converters, the buck-boost operation and buck operation can be performed independently of each other, and so on. | |
The natural warmth of wood combined with a clean shape make for a stunning visual piece. Use as a single stem bud vase or to propagate a favorite houseplant. Measures approximately 6”h x 3” w x 3” d. Glass test tube included. All wood is ethically sourced and finished with a handmade, natural moisturizer. Wipe with dry cloth. Do not let water sit on the wood. Allow for variances in grain and color. Blackened oak is not a stain, it is a reaction between the wood and an oxidized solution.
More about this maker:
This multi-disciplinary maker handcrafts naturally inspired elements into energized wares for the home. Simple forms are balanced by the skilled blending, or mingling, of collected elements to create one-of-a-kind, visually striking goods. Everything is made to be purposeful and beautiful, to help create an intentional, welcoming space that is as individual as you are. | https://aboutruby.com/products/wooden-bud-vase |
Culinary seekers make the pilgrimage to Helena Stoquelet’s La Bottega del 30 in tiny Villa a Sesta, who brings the passion of her life to this uniquely special farmhouse restaurant, now celebrating 20 straight years with a Michelin star.
VILLA A SESTA, ITALY, February 2, 2017 – La Bottega del 30 is an extraordinary Michelin-starred restaurant in the tiny hamlet of Villa A Sesta in the hills of Tuscany 15 miles east of Sienna. The lifetime achievement of Franco and Helene Stoquelet, and in its 20th year holding a Michelin star, the actual experience of this culinary treasure is a blindingly transcendent example of what the best of haute cuisine, tradition, and passion for life can produce.
Without exaggeration, La Bottega del 30 delivers one of the greatest evenings of fine dining imaginable, intimate, ambitious, daring, exquisite, a treasure of unimaginable proportions that exists in its own space and time, incomparable on many levels, creating its own universe of which it is the master. | https://labottegadel30.it/en/la-bottega-del-30-chiantis-michelin-starred-hideaway-in-paradise/ |
Watch Full Alias Movie Online Sydney Bristow, an agent who has been tricked to believe she is working for the U.S. government, is actually working for a criminal organization named the Alliance of Twelve. Upon learning this, Sydney becomes a double agent for the real CIA.
Alias Season 1 Movie Online Episode List
Sydney Bristow discovers that her job as an agent for SD-6, a top-secret division of the CIA, holds some deadly secrets that threaten the security of the free world. In spite of being warned against it, Sydney reveals her secret to her fiancé, Danny, who later on is murdered. Sydney finds that her father, Jack, is also SD-6 and that the group is not part of the CIA, but actually an enemy of the United States. Sydney seeks the aid of the real CIA and is enlisted as a double agent under the command of operations officer Vaughn. Her mission now is to complete her cases at SD-6 while reporting her findings back to the CIA. But when Sydney finds out that her father is also affiliated with the CIA, she begins to question where his true allegiances really lie.
Sydney returns to SD-6 and is assigned with Dixon to travel to Moscow to retrieve some stolen files. But when Sydney discovers that she has inadvertently given SD-6 access to a nuclear weapon, she is forced to travel to Cairo and face a deadly foe. Meanwhile, Will begins to question the circumstances surrounding Danny's death, and Sydney learns of her father's involvement in the murder.
Sydney's life is in mortal danger as she is sent to Madrid to retrieve a 500-year-old sketch that contains a set of numbers and meets up with her deadly nemesis, K-Directorate agent Anna Espinosa. Meanwhile, Will delves deeper into the cause of Danny's death and discovers a very strange anomaly.
Sydney and Dixon go on a dangerous case involving the safety of the United Commerce Organization. Francie confronts Charlie about his secret date with another woman, and Will continues to get closer to the truth about Danny's murder.
Sydney's secret double agent status is jeopardized after she smuggling a biotech engineer into SD-6 from her mission in Berlin. Will meets a woman who confesses that she was having an affair with Danny shortly before his death. Vaughn informs Sydney that her father may be working for a third secret operative agency.
Sydney goes undercover in a mental institution to get information from Shepard, a man who has been unconsciously programmed to be a deadly assassin. Meanwhile, after Sydney becomes convinced that her father was responsible for the death of her mother 20 years earlier. Will discovers the true identity of the woman who claimed having an affair with Danny and Francie is relieved to learn that Charlie is not having an affair other woman. Marshall finds the computer worm planted in the SD-6 mainframe by the CIA.
While helping Shepard escape from the asylum in Bucharest, Sydney discovers the shocking connection he has with her past. Meanwhile, after tracking the computer virus secretly planted by the CIA, Sloane is confronted by Alliance representative Alain Christophe, who suggests that one or more moles may have infiltrated SD-6. Will continues to investigate the woman claiming to be Danny's mistress and Sydney finds out the truth about her father's involvement in her mother's death 20 years earlier.
Sydney must undergo an extensive lie detector test to satisfy Sloane's frantic search for the SD-6 mole. Meanwhile, with nemesis Anna Espinosa following her every move, Sydney seeks out the connection that a device may have to the 500-year-old prophetic Rambaldi sketch. The mystery of Kate Jones deepens as Will continues to investigate Danny's death; and Sydney discovers that a keepsake from her mother Laura contains more disturbing connections into Jack's past alliances.
Sydney's life is placed in mortal danger when Sloane is informed by his superior that she is the SD-6 mole. Meanwhile, Dixon's life hangs in the balance after he is shot on a mission, and Will realizes that his discovery of Kate Jones' pin could uncover some unexpected information.
Sydney briefs her CIA handler, Agent Vaughn, on her recent captivity at SD-6 and is surprised when he unexpectedly gives her a Christmas gift. Meanwhile Jack has to find a way to save Sydney when he discovers that Sloane has ordered her tortured and killed for being the suspected SD-6 mole. Will may be making the mistake of his life when he begins to research a name heard on a mysterious audiocassette -- SD-6.
Sydney is grateful and proud of her father after he saves her life while on a case in Havana. But her admiration is short lived when Vaughn discovers further evidence that Jack may have been responsible for the deaths of over a dozen CIA officers many years earlier.
When armed intruders take over SD-6, led by McKenas Cole, a man bent on exacting revenge on ex-boss Sloane, Sydney and Jack must work together to save their colleagues. Meanwhile, Will fears that his investigation of SD-6 and its link to the murder of Eloise Kurtz is placing his life in jeopardy.
Vaughn disobeys orders and attempts to help Sydney and Jack avert the destruction of SD-6 headquarters and all its occupants. Meanwhile, McKenas Cole continues his vendetta against Sloane and searches for a mysterious device. A desperate but determined woman convince Will to continue his investigation of SD-6 and the imprisonment of David McNeil.
Sydney and Dixon are sent to Las Vegas to gather information from a K-Directorate agent who has ties to the group that attacked and nearly destroyed SD-6. Meanwhile, Sydney learns some shocking news about Francie's fiancé, Charlie, Will begins his journey in discovering what SD-6 really is, and Jack continues to try to be more of a father to Sydney when he helps her decide whether or not to continue with graduate school.
Vaughn asks Sydney to use her friendship with Sloane's wife, Emily, to gain access to a mysterious Rambaldi book which happens to be under lock and key in a safe at Sloane's home. Meanwhile, Will is kidnapped and told to drop his investigation of SD-6 or risk the lives of his family and friends, including Sydney's.
Sydney is tested by the DSR to discover her mysterious link to a chilling 500-year-old picture and prophecy foretold in a Rambaldi manuscript. Meanwhile, after uncovering the identity of the rogue group leader, "The Man," Sloane learns through fellow Alliance of Twelve member Edward Poole that a close friend may be in cahoots with the enemy.
While the FBI detains and questions Sydney about her past and possible ties to a mysterious Rambaldi doomsday prophecy, Vaughn and Jack must race to free her and find a way to clear her name before her cover is blown and SD-6 is made aware of the situation. Once the rescue op has been launched, in her quest to prove her innocence, Sydney shocks even her usually unflappable father when she makes a chilling discovery that may unravel the mystery of the 500-year-old prophecy – she finds proof that Rambaldi's writings may hold more truth about an alleged weapon of mass destruction - and the fate of her own family.
While on a case to track the activities of Khasinau, a.k.a. "The Man," Sydney runs into her ex-lover, Noah Hicks, who broke her heart and left without saying goodbye five years earlier. Meanwhile, Sydney tells Sloane that she wants to find her mother; Jack is ordered to see CIA psychiatrist Dr. Barnett to help him deal with his churning emotions after discovering that his wife may still be alive; and Will and Francie become suspicious of Sydney's activities after finding one of her airline ticket stubs.
Sloane begins to question where Noah's true allegiances lie, as passion ignites between Sydney and Noah. Meanwhile, Sydney continues to uncover new information about her mother, which disturbes Jack. A rogue assassin known as the Snowman is dispatched by K-Directorate to kill Khasinau, a.k.a. "The Man." Will and Francie confront Sydney about the mysterious airline ticket stub found in her jacket.
In order to catch Khasinau and get closer to finding her mother, Sydney and Vaughn set up an undercover transaction for a Rambaldi artifact with Khasinau's representative, Mr. Sark. But Sydney's cover may be compromised when a SD-6 agent is sent in to thwart the sale. Meanwhile, Will is enticed to continue his investigation of SD-6 when he learns the identity of one of his kidnappers. Emily tells Sydney that she knows about SD-6, which forces Sloane to make the most difficult decision of his life.
Will's life is about to change as he is sent to find the person responsible for leaking information to him about SD-6. Meanwhile, Sloane finds himself on the cusp of finally tracking down Khasinau when SD-6 captures "The Man's" right-hand man, Mr. Sark. Dixon becomes suspicious of Sydney's activities.
In order to save Will's life, Sydney and Vaughn must destroy a familiar looking Rambaldi device, while Jack makes a risky deal with Khasinau's representative, Mr. Sark. Meanwhile, the CIA believes that one of their own is a mole for "The Man"; the Alliance comes to a decision regarding the fate of Emily Sloane; Dixon's suspicions about Sydney intensify; and Sydney finds herself face-to-face with "The Man."
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All relevant data are available from: Behavioral Data: <https://figshare.com/s/7baec8cac1196c8b3bf6> Imaging Data: <https://neurovault.org/collections/SFNPQPDI/>.
Introduction {#sec001}
============
Migraine is among the most prevalent neurological disorders \[[@pone.0184406.ref001]\] and certainly one of the most disabling \[[@pone.0184406.ref002]\]. Its severe socioeconomic impact and the harmful influence on a patient's quality of life are alarming \[[@pone.0184406.ref003]\], which stresses the importance of the improvement of current treatment options. The pharmacological treatment options are either acute (abortive) or preventive (prophylactic). Preventive migraine treatment aims at reducing frequency, severity and duration of attacks. Anticonvulsants are commonly used as preventive migraine treatment with topiramate being among the most widely used. Due to the extensive body of evidence that proves its efficacy, topiramate is considered an evidence-based medication in the preventive treatment of migraine \[[@pone.0184406.ref004]\]. Although effective in reducing migraine attack frequency \[[@pone.0184406.ref005],[@pone.0184406.ref006]\], little is known about the underlying central mode of action in migraine treatment \[[@pone.0184406.ref007]\]. Most of our understanding of modes and sites of action behind its therapeutic efficacy in migraine derives from preclinical animal studies, utilizing different models of trigeminal activation. Topiramate affects glutamatergic and GABAergic transmission, as well as sodium and calcium channels \[[@pone.0184406.ref008],[@pone.0184406.ref009]\]. All of these mechanisms influence trigeminovascular activity and may play a role in migraine although the exact mechanism is not known \[[@pone.0184406.ref007]\].
Storer and Goadsby \[[@pone.0184406.ref010]\] showed that systemically administered topiramate partly inhibited stimulus-evoked cell firing in the trigeminocervical complex, but failed to show an inhibition after local application. The authors concluded that topiramate is likely to act outside of the trigeminocervical complex in cats. However, a study investigating the role of GABA receptors in thalamic neurons in response to nociceptive stimuli in rats finds an effect of anticonvulsants on the thalamus: Neuronal thalamic firing in response to L-glutamate injection and electrical stimulation was inhibited by GABA and valproate \[[@pone.0184406.ref011]\]. Using electrophysiological techniques Andreou et al. showed that topiramate inhibits nociceptive neurotransmission in the trigeminothalamic pathway of rats \[[@pone.0184406.ref012]\]. Activation in the ventroposteromedial (VPM) nucleus of the thalamus after electrophysiological stimulation was significantly inhibited after intravenous administration as well as after local application of topiramate into the thalamus \[[@pone.0184406.ref012]\]. The results indicate that neurons within the thalamus may modulate trigeminal nociceptive transmission. These data imply that topiramate exerts some of its therapeutic effect by an inhibiting effect on the thalamus.
The aim of this study was to investigate the effect of topiramate on the neural activity (measured by blood oxygen level-dependent \[BOLD\] responses) following a standardized experimental trigeminal pain paradigm \[[@pone.0184406.ref013],[@pone.0184406.ref014]\]. Building upon the above mentioned results of animal studies we expected topiramate to have an inhibiting effect on the thalamus.
Materials and methods {#sec002}
=====================
Participants {#sec003}
------------
27 healthy volunteers participated in the experiment. They were recruited using public internet advertisements in 2016. 2 participants were excluded from the analysis due to technical problems, 2 participants withdrew consent after the first session. The final sample included 23 participants (10 male; age: 19 to 34 years, M = 24.4). None of the volunteers reported a history of neurological, psychiatric or pain disorders, specifically no headache disorders. None of the subjects reported contraindications for topiramate. The study was approved by the local ethics committee (Ärztekammer Hamburg; PV4084) and participants gave written informed consent. Volunteers were remunerated for participation.
Experimental design and task {#sec004}
----------------------------
This study had a placebo-controlled, crossover, randomized and double-blind design. The two identical sessions were separated by at least a two weeks wash-out period. Initially participants took an oral dose of either 100mg topiramate or placebo, which was followed by a waiting phase of 1 hour to reach tmax of topiramate \[[@pone.0184406.ref009]\]. Prior to the experimental phase, blood samples were drawn and in their first session participants completed a training session to familiarize with the task. In the experimental phase participants performed a standardized trigeminal pain paradigm in the MR scanner, that has been described in detail before \[[@pone.0184406.ref014]\]. In short, 4 different stimuli where applied 15 times each in a pseudorandomized order. Participants perceived either a trigemino-nociceptive stimulus (gaseous ammonia), an olfactorial stimulus (rose odor), a neutral stimulus (air puffs) or a visual stimulus (flickering checkerboard), of which all gaseous stimuli were administered through a Teflon tube to the left nostril. Following each trial, participants had to rate the stimulus intensity (0 = no pain/no sensation to 100 = highest pain imaginable / highest intensity imaginable) and pleasantness (analogous to the intensity ratings from -50 = very pleasant to 50 = very unpleasant), respectively, on a visual rating scale in the scanner.
Medication {#sec005}
----------
Participants were randomly assigned to receive an oral topiramate dose (100mg; Topamax ®; Janssen-Cilag, Neuss, Germany) or placebo in the first session, followed by at least a 2-week washout period before starting the second session with the alternate substance. Placebo pills contained medically non-effective mannitol \[[@pone.0184406.ref015],[@pone.0184406.ref016]\] (Mannitol 99.5 T, highly-dispersed silicon dioxide 0.5 T) and matched the topiramate pills in appearance. Blood samples were drawn 60 min after administration to determine the topiramate plasma concentration at its peak, shortly before the start of the MR measurement. Vital signs (blood pressure, heart rate) were monitored. Possible side effects were assessed via interview.
MRI data acquisition {#sec006}
--------------------
Functional and structural images were acquired on a 3T Siemens Trio scanner (Siemens AG, Erlangen, Germany) using a 32-channel head coil. High-resolution structural T1-weighted images were acquired using a magnetization-prepared rapid gradient echo sequence (1 x 1 x 1 voxel size). Functional images were acquired using an echo planar imaging sequence (repetition time 2.62 seconds, echo time 30 milliseconds, flip angle 80°, field of view 220 x 220 mm). One functional imaging session consisted of \~ 900 to 1100 volumes; while each volume consisted of 40 axial slices (2 mm slice thickness, 1 mm gap). Total scantime was about 55 minutes per session for the whole experiment.
Determination of plasma concentration {#sec007}
-------------------------------------
A 4.9 ml blood sample was drawn from the forearm into a vacuum tube with ethylenediaminetetraacetic acid (EDTA). Plasma was obtained by centrifugation at 1.6 rcf for 7 min at 20°C and stored at -20°C until analyzed using liquid chromatography/mass spectrometry (LC-MS/MS) \[[@pone.0184406.ref017]\]. Calculation of the concentration was based on an internal standard. Analysis of plasma was conducted by AescuLabor Hamburg GmbH.
Behavioral data analysis {#sec008}
------------------------
Behavioral responses were assessed by a visual analogue rating scale (VAS) and averaged across items per session. Data analysis was performed using SPSS Statistics version 22.00 (IBM Corp., Armonk, NY). Significant differences in the average pain intensity ratings between medication and placebo session were tested with a paired t-test. Statistical threshold was set to *p*\<0.05.
MRI statistical analysis {#sec009}
------------------------
Data analysis was performed using statistical mapping software SPM12 (Wellcome Trust Centre of Neuroimaging, <http://www.fil.ion.ucl.ac.uk/spm>) using standard algorithms and parameters unless specified differently. The first 5 pictures of each session were deleted. Preprocessing included slice time correction, data realignment to the mean volume, spatial normalization into MNI (Montreal Neurological Institute) stereotactical space and spatial smoothing (8mm Gaussian kernel).
Single subject analysis was performed based on the general linear model (GLM) as implemented in SPM12. For each session five separate, experimental regressors were included in the design matrix: Four experimental conditions (ammonia, rose odor, air puffs, and visual checker board) and the button presses. These regressors were constructed by convolving stick functions at stimulus onsets with a canonical hemodynamic response function. Additional nuisance was attenuated by including six movement regressors (3 translational and 3 rotational), obtained from the realignment step, for each session into the model. The first-level design subsequently included 22 regressors, 11 for each session (placebo and topiramate). Contrast images of the comparison ammonia \> air puffs were computed for both sessions (medication and placebo). Also contrast images were computed which compared nociceptive processing (ammonia \> air) between medication and placebo session on individual level. Olfactorial and visual stimuli were not used for further analyses on group level.
These contrast images of each participant were then used for group statistics. Since a within-subject comparison between medication and placebo session had already been calculated on subject level, a one--sample t-test across all subjects was computed. Based on results from animal studies we were specifically interested in the effect of topiramate on the thalamus. Successively a small volume correction (SVC: p~(FWE)~ \< 0.05) of the thalamus was performed using a mask obtained from the Harvard-Oxford cortical/subcortical structural atlas (<http://www.cma.mgh.harvard.edu/fsl_atlas.html>). Additionally the whole brain analysis of the differential contrasts between topiramate and placebo is reported at a threshold of p~(FWE)~ \< 0.05 at cluster level. For clustering, the uncorrected p-threshold at voxel level of p 0.001 was used for this and the following analysis. A psychophysiological interaction analysis (PPI) \[[@pone.0184406.ref018]\] was calculated to determine changes in pain-related functional connectivity of the thalamus (identified as a region of interest in preceding analysis) caused by topiramate. A thalamus mask of the right and left thalamus cortex of the Harvard-Oxford cortical/subcortical atlas was used as the seed region. The GLM for the PPI included three regressors (1. the time course extracted from the seed region, 2. pain (ammonia \> air) as the psychological/stimulus variable, 3. the interaction term \[i.e. time series × stimulus variable\]) and additionally 6 movement regressors. A one--sample t-test for the difference between sessions was computed, analogous to the above mentioned second level analysis. A threshold of p~(FWE)~ \< 0.05 (at cluster level) was regarded significant.
Results {#sec010}
=======
Behavioral data {#sec011}
---------------
Mean pain intensity ratings measured by the VAS scale (±SEM) where 58.3 (± 3.6) for the topiramate session and 59.3 (±4.2) for the placebo session. There was no significant difference between mean pain intensity ratings in both sessions.
Physiological data {#sec012}
------------------
The mean plasma concentration of topiramate was 1.38 mg/L (SD = 0.8). Treatment-emergent adverse events were reported by 16 participants. These included mild to moderate dizziness, difficulty with concentration, paresthesia and fatigue.
Imaging data {#sec013}
------------
### Main effects of nociceptive stimulation {#sec014}
During noxious ammonia stimulation throughout both sessions, we observed significantly increased BOLD responses (voxel level FWE-corrected) in several areas typically involved in trigeminal nociceptive processing. These areas included the bilateral thalamus, insular cortex, amygdala, midcingulate cortex (MCC) and anterior cingulate cortex (ACC), cerebellum and brainstem areas ([Fig 1A](#pone.0184406.g001){ref-type="fig"}).
{#pone.0184406.g001}
### Differences in pain processing between topiramate and placebo {#sec015}
When comparing both sessions, we found a significant increase of activation of the thalamus after placebo administration, compared to topiramate (x = 4, y = -8, z = 8, t22 = 4.72, p \< 0.05 SVC). We additionally found an increased activity within the bilateral ACC, rostral anterior cingulate cortex (rACC), MCC and the secondary somatosensory cortices ([Fig 1B](#pone.0184406.g001){ref-type="fig"}). Full details on cluster size, coordinates and statistical values are given in [Table 1](#pone.0184406.t001){ref-type="table"}. No cluster reached significance for the opposite effect (Pain x topiramate \> placebo).
10.1371/journal.pone.0184406.t001
###### Changes in pain processing.
{#pone.0184406.t001g}
MNI coordinates
------------------------------------------------------------------------- --- ----- ----------------- ----- ---- ------
**(A) placebo \> topiramate (Small volume correction of the thalamus)**
Thalamus R 158 4 -8 8 4.72
**(B) placebo \> topiramate (whole brain)**
Secondary somatosensory cortex L 355 -36 -32 26 6.15
Anterior cingulate cortex R 246 8 -2 46 5.79
Secondary somatosensory cortex / Insula R 203 48 -24 6 4.95
Lateral occipital gyrus R 227 28 -68 22 4.94
Thalamus R 217 4 -8 8 4.72
Anterior cingulate cortex L 454 -2 42 -4 4.56
Peak coordinates for the contrast placebo \> topiramate during nociceptive stimulation: (A) Small volume correction of the thalamus at a threshold of p~(FWE)~ \< 0.05 and (B) whole brain contrast placebo \> topiramate at a threshold of p~(FWE)~ \< 0.05 (cluster level).
### Psychophysiological interaction {#sec016}
To further assess the underlying network affected by topiramate, we used the thalamus as a seed region for a psychophysiological interaction (PPI) analysis \[[@pone.0184406.ref018]\]. Under topiramate, the thalamus showed enhanced functional coupling with the precuneus, PCC, MCC, and the secondary somatosensory cortex (p~(FWE)~ \< 0.05, cluster level), when compared to placebo ([Fig 2](#pone.0184406.g002){ref-type="fig"}). The opposite contrast (interaction x placebo \> topiramate) did not reveal any significant activation differences. All PPI results are summarized in [Table 2](#pone.0184406.t002){ref-type="table"}.
{#pone.0184406.g002}
10.1371/journal.pone.0184406.t002
###### Thalamic connectivity during pain.
{#pone.0184406.t002g}
MNI coordinates
-------------------------- --- ------ ----------------- ----- ---- ------
Lateral occipital cortex R 542 50 -62 12 6.69
Inferior frontal gyrus R 298 46 16 14 5.48
Angular gyrus L 2555 -56 -58 38 5.45
Middle temporal gyrus L 407 -64 -36 2 4.69
Peak coordinates for the PPI contrast topiramate \> placebo at a threshold of p~(FWE)~ \< 0.05 (cluster level). The big clusters encompass the precuneus, postcingulate cortex (PCC), midcingulate cortex (MCC), inferior frontal gyrus (IFG) and the secondary somatosensory cortex. A mask of the right and left thalamus cortex from the Harvard-Oxford cortical/subcortical atlas was used as a seed.
Discussion {#sec017}
==========
Our main finding is that topiramate reduces the BOLD effect in several pain transmitting brain areas including the thalamus during nociceptive trigeminal input. Topiramate also increases the functional connectivity of the thalamus to other brain areas of the somatosensory system including the precuneus. This suggests that the effect of attack reduction by topiramate in frequent migraine is not simply a question of where topiramate binds in the brain, but rather of how the presence of topiramate changes network activity.
Trigeminovascular thalamic neurons serve as a relay station for incoming nociceptive signals from brainstem areas as well as multisensory information \[[@pone.0184406.ref019]\]. Central sensitization of central trigeminal and thalamic neurons can alter the perception of somatosensory trigeminovascular inputs and thereby contribute to the development of cutaneous allodynia \[[@pone.0184406.ref020]\]. The current findings thus corroborate animal studies suggesting that migraine-effective anticonvulsants aim at nociceptive trigeminothalamic and trigeminovascular pathways \[[@pone.0184406.ref021]\].
Given the finding of an inhibiting effect on a specific thalamo-cortical network, it could be presumed, that topiramate binds at the thalamus and thereby interrupts the connectivity to the cortex. But analyzing changes in functional connectivity, we did not find any connection between the seed region (thalamus) and other pain-related areas that was interrupted or inhibited by topiramate. On the contrary we found that topiramate increases the functional connectivity of the thalamus to other brain areas of the somatosensory system including the precuneus. An abnormal communication between pain-modulating areas in migraineurs has been demonstrated \[[@pone.0184406.ref022]--[@pone.0184406.ref024]\]. Thalamo-cortical dysrhythmia is imminent to this atypical information processing \[[@pone.0184406.ref025],[@pone.0184406.ref026]\] and plays a major role in migraine pathophysiology \[[@pone.0184406.ref007]\]. Consequently dysfunctional thalamic connectivity presents itself as a fruitful target for preventive medication. Topiramate potentially interrupts, changes or corrects patterns of dysfunctional connectivity present in the migraine brain. This altered functional coupling might be consolidated over time and eventually facilitate the preventive effect of topiramate in migraine. The psychophysiological interaction analysis does not allow for directional interpretation, it rather shows that activation in those areas oscillate in synchrony. The enhanced functional coupling between the thalamus and several brain regions involved in somatosensory processing under topiramate, might therefore constitute the migraine preventive effect, representing the normalization of dysrhythmic functional coupling. Nevertheless this speculation could only be tested with longitudinal approaches, ideally as a connection of fMRI and resting state connectivity or arterial spin labeling which would offer further insight into neuronal connectivity and help to identify network alterations caused by topiramate.
This network, or systems effect of topiramate, would also be consistent with its ability to elicit well known side effects such as cognitive impairment. Cognitive side effects of topiramate are well known and have been described in epilepsy patients \[[@pone.0184406.ref027]\], migraineurs \[[@pone.0184406.ref028]\] and healthy subjects \[[@pone.0184406.ref029]\]. These deficits are reported after single-dose treatment and on steady-dose and encompass reduced attention, psychomotor-speed, working memory and language impairment \[[@pone.0184406.ref029]\]. Some studies also assessed the effects of topiramate on fMRI \[[@pone.0184406.ref030],[@pone.0184406.ref031]\]. Investigating the effect of topiramate on verbal fluency MRI, a positive correlation of topiramate dose with precuneus activity was demonstrated \[[@pone.0184406.ref032]\].
Study limitations {#sec018}
-----------------
We note that no modulatory effect of topiramate on pain perception was found. This was expected, given that topiramate has no antinociceptive properties in the clinically used dose range and it is not used as a pain killer. Another reason why we have not seen a modulatory effect on pain perception, is that the short nature of the experimental pain stimulus differs perceptively from migraine pain. Moreover, in clinical practice, we see that pain modulating effects of preventive medication are often delayed. Our study focusses on central effects of the usual dosage used to treat migraine patients, and our observation of the acute effects of topiramate may shed light on the question how topiramate exerts its effects in migraine treatment. Furthermore, as topiramate is a preventive medication, its long term effects are of central importance. Besides, the effect of topiramate was studied in the healthy system as opposed to the pathophysiological system of migraineurs. At the outset this was crucial as changes in the migraineurs brain caused by topiramate, do not enable us to draw conclusions as to what caused the change: the medication directly, or the reduction of pain caused by the medication. Thus future clinical research should focus on the central effects of topiramate in the pathological system of migraine patients.
Conclusion {#sec019}
==========
Our results corroborate evidence from animal studies suggesting that topiramate modulates nociceptive trigeminal transmission \[[@pone.0184406.ref012]\] with data from healthy human subjects. Topiramate attenuated the pain-related activity of parts of the thalamo-cortical network and enhanced thalamic connectivity to the precuneus, PCC and SII. These results suggest that topiramate targets a system, rather than a single structure. Moreover they could represent changes in (dys)function that consolidate over time constituting to the preventive effect in migraine. As the current study investigated healthy participants, future investigations in a patient's cohort are needed. Pinpointing the mode and locus of action of effective medication will enhance our understanding of migraine pathophysiology.
We wish to thank Dr. Jan Mehnert for helpful advice with data analysis.
[^1]: **Competing Interests:**The authors have declared that no competing interests exist.
| |
by IEEE Computer Society in Washington, D.C .
Written in English
Edition Notes
|Other titles||Human factors in software development.|
|Statement||[edited by] Bill Curtis.|
|Contributions||Curtis, Bill, Dr., IEEE Computer Society., COMPSAC 81 (1981 : Chicago, Ill.)|
|Classifications|
|LC Classifications||QA76.6 .T8644|
|The Physical Object|
|Pagination||730 p. :|
|Number of Pages||730|
|ID Numbers|
|Open Library||OL22010334M|
|ISBN 10||0818605774|
Additional Physical Format: Online version: Tutorial, human factors in software development. Washington, D.C.: IEEE Computer Society Press ; Los Angeles, CA: Order. COVID Resources. Reliable information about the coronavirus (COVID) is available from the World Health Organization (current situation, international travel).Numerous and frequently-updated resource results are available from this ’s WebJunction has pulled together information and resources to assist library staff as they consider how to handle coronavirus. Title: Human factors in software development. Abstract. This book presents an overview of ergonomics/human factors in software development, recent research, and classic papers. Articles are drawn from the following areas of psychological research on programming: cognitive ergonomics, cognitive psychology, and : Curtis, B. This thesis project aims to identify and characterize human factors influencing the software development process from development lifecycle and software management perspectives. Method: The systematic literature review initial search resulted in papers among which 67 journal papers () were picked based on two filtering phases
Human Factors in Software Development and Design brings together high quality research on the influence and impact of ordinary people on the software industry. With the goal of improving the quality and usability of computer technologies, this premier reference is intended for students and practitioners of software engineering as well as researchers, educators, and interested . Mantei, M., and Teorey, T. Cost/~nefit analysis for incorporating human factors in the software lifecycle. Communications of the ACM. 31 (), Google Scholar Digital Library. The first two articles in this series introduced the human factors profession and provided examples of human factors contributions in various industries. This article, Part 3, will focus on one specific industry, software development, and show how human factors engineers participate in the software development process. Abstract: Software engineering is an effort to reduce the cost of producing software by raising programming productivity and lowering maintenance effort and to increase the benefits of software by extending application areas and improving service. Human factors considerations can have a major impact on the software development process and the quality of the software produced.
Software is written by people, either alone or in teams. Ultimately secure code development depends on the actions and decisions taken by the people who develop the code. How do we account for the. Context: Human factors are known to play a critical role in software engineering. Though Human Factors in Software Development have been around for a while, it is not very clear what theories are. a blog by Jeff Atwood on programming and human factors. 28 Apr Programmers Don't Read Books -- But You Should. One of the central themes of is that software developers no longer learn programming from books, as Joel mentioned. Programmers seem to have stopped reading books. Human Factors in Software Engineering: A Review of the Literature K. Ronald Laughery, Jr. and Kenneth R. Laughery, Sr. Micro Analysis and Design, Boulder, CO A critical factor in the increased utilization of computer technology is the availability of by: 6. | https://hezuxowefusymitij.larep-immo.com/tutorial-human-factors-in-software-development-book-14027oe.php |
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One in eight global deaths in 2019 was caused by common bacterial infections, which are the second leading cause of death worldwide, right after ischaemic heart disease, according to a study providing the first global estimate of the lethality of these infections, published in The Lancet last month.
The comprehensive study was published by the Global Research on Antimicrobial Resistance (GRAM) Project, a partnership between the Institute for Health Metrics and Evaluation (IHME) and the University of Oxford.
The study was done using methods from the Global Burden of Diseases, Injuries, and Risk Factors Study (GBD) 2019, a vast research program funded by the Bill and Melinda Gates Foundation, in addition to “a subset of the input data described in the Global Burden of Antimicrobial Resistance 2019 study.”
Full toll of bacterial infection
According to data published in the Lancet, an estimated 7.7 million people died in 2019 due to common bacterial infections with cases associated with the 33 bacterial pathogens—both antibiotic-resistant and non-resistant—“comprising 13.6% of all global deaths and 56.2% of all sepsis-related deaths in 2019.”
Only five of these 33 pathogens—Staphylococcus aureus, Escherichia coli, Streptococcus pneumoniae, Klebsiella pneumoniae, and Pseudomonas aeruginosa—”were responsible for 54.9% of deaths among the investigated bacteria,” the study showed.
“These new data for the first time reveal the full extent of the global public health challenge posed by bacterial infections,” said Dr. Christopher Murray, study co-author and Director of the IHME at the University of Washington’s School of Medicine. He emphasized that it is of utmost importance “to put these results on the radar of global health initiatives … so proper investments are made to slash the number of deaths and infections.”
Stark differences between poor and wealthy regions
As the study points out, “the age-standardized mortality rate linked to the 33 pathogens varied by super-region in 2019” is “highest in sub-Saharan Africa, at 230 deaths per 100 000 population,” but it’s significantly lower in the wealthiest parts of the world, with 52·2 deaths per 100 000 population.
“Iceland had the lowest rate, with 35.7 deaths per 100 000 population in 2019” whereas the Central African Republic was the country with the highest age-standardized mortality rate, with 394 deaths per 100 000 population.
According to The Royal Australian College of General Practitioners, “Australia’s mortality rate per 100,000 residents is placed between 35 and 50,” with the analysis citing “Staphylococcus aureus as the pathogen causing the highest mortality (10.1 deaths per 100,000 people), followed by Escherichia coli (6) and Pseudomonas aeruginosa (3.5).”
Insufficient funding
The study also analyzed the funding levels for infectious disease research, finding that investment into tackling bacterial infections lagged substantially.
Although bacterial infections caused significantly more deaths, researchers established that “they receive comparatively little public health attention relative to their burden, and minimal research funding relative to other diseases with a comparable, or lower, burden.”
Data shows that there was $1.4 billion for Staphylococcus aureus and $800 million for Escherichia coli research compared to $42 billion in funding for HIV research between 2000 and 2017, even though there were 864,000 global deaths linked to HIV/AIDS in 2019, which equaled to around 11% of those linked to bacterial infection over the same period, as RCGP article pointed out.
As Bio.News has reported, the market for antimicrobials, including those that fight bacterial infection, is not set up to support research and development. | https://bio.news/health/common-bacterial-infections-behind-every-eight-death-in-the-world-in-2019/ |
BUSHkids is a non-Government, not-for-profit organisation providing free multidisciplinary allied health services to children aged 0-10 years and their families living in regional and remote areas of Queensland.
We are currently recruiting for:
FAMILY HEALTH SUPPORT WORKERLocation: Mount Isa Type: Full Time
Role Overview
As the Family Health Support Worker you will:
- Provide the crucial liaison between the therapy team and the child’s family and support network by offering comprehensive, skill-based support and programs
- Offer information and health promotion programs to develop the skills and understandings needed for healthy strong families
- Be responsible for a range of administrative duties, and the coordination of maintenance and occupational health and safety issues at a centre level
KEY RESPONSIBILITIES
Program Facilitation
Facilitate a range of programs (centre based or external location) to children and their families to allow optimum development and wellbeing. These programs may include but are not limited to the following:
- Parenting skills programs (e.g. Triple P, 1-2-3 Magic)
- Health Education Sessions (HES) for children and their families
- Skill development group programs for children such as social skills and emotional resilience group programs (e.g. Fun Friends, Friends for Life, PALS)
- Outreach programs to nearby communities (as required)
- Individual programs (as required)
- Home visits (as required)
- Identify and monitor program needs specific to rural and remote children and their families in collaboration with the team, Clinical Services Manager and Professional Lead
Clinical Support
- Provide support and coaching/modelling for parents and children in the implementation of clinician-developed Occupational Therapy, Psychology, and Speech Pathology programs
- Implement and support Centre, home or school based programs to ensure that skills are attained by children and parents/caregivers according to identified goals, as part of the multidisciplinary team
- Consult and liaise with parents/caregivers, health professionals, educational professionals, other agencies, and community members as required
- Support therapy staff in the implementation of programs, groups and individual therapy by providing administrative support as required
- Participate in team decision-making regarding client program, progress and therapy planning by attending Case Management Meetings
- Provide information and appropriate resources to referring health and educational professionals and other agencies as required
Clinical Administration
- Coordinating clinical appointments where required; arranging, cancelling, rescheduling
- Maintain data/accurate records of client service provision in accordance with medico-legal standards – including (but not limited to):
- Entering referrals
- Letters to parents/carers, referrers
- Case Management Meeting Agenda and Minutes; record case notes, update waiting list
- Scanning as required
- Filing as required
- Archiving records as required
- Creating resources/booklets for therapy sessions and groups, where required, including; printing, laminating, binding
Centre Facilitation
- Undertake daily administrative operations at the Centre including:
- Reception duties
- Fulfil the delegated Safety Officer and Fire Warden role in the Centre under the direction of the Maintenance and Safety Coordinator
- Oversee the operation of the Centre, acting as point-of-contact between Brisbane Office and Centre staff regarding Centre issues and coordinating Centre-based tasks
Complete maintenance and safety check reports for the Centre in coordination with the Maintenance and Safety Coordinator:
Qualifications / Other Requirements
- Tertiary Qualifications in Child Health or Child Development, Education and/or Family Wellbeing and Support
- Registration requirements for qualification are current
- Working with Children Blue Card – Positive Notice
Other requirements:
- Current C Class Queensland Drivers Licence
- Proof of Hepatitis B Vaccination status
Your Application
Applicants are to submit a brief resume; contact details for 2 referees (one of whom is to be your current supervisor); and a maximum 2 page written response outlining your suitability for the role addressing the following key selection criteria:
Key Selection Criteria
-
- A qualification or practical experience in child health or educational development and/or family well-being and support
- Experience in presenting information and skills based group presentations to parents and carers
- Demonstrated skills in communication, liaison and consultation with children and adults, other relevant agencies and health professionals
- Demonstrated ability to work co-operatively in a multi-professional team with a strong commitment to contribute to team goals and decisions
- Moderate administrative and computer skills
A full position description can be downloaded here
Please email your application [email protected]
Closing date for applications - Friday 31 March 2017
PROFESSIONAL LEAD – SPEECH–LANGUAGE PATHOLOGISTLocation: ToowongType: Part time Temporary - 12 months
Role Overview
Professional Leads are employed as core members of the Clinical Leadership Team at BUSHkids and play a key role in ensuring workforce support and development is in line with operational requirements and strategic direction. The role involves a combination of clinical supervision, as well as administrative and operational management activities.
The three main roles of the Professional Leads are:
- To provide professional supervision supporting and resourcing staff to provide quality, ethical and accountable services in line with the organisation’s visions, goals and policies, and in line with the code of conduct and practice guidelines of the discipline. This includes providing targets, monitoring and managing activity levels and outcomes for staff.
- To be an active Clinical Leadership Team member contributing to BUSHkids service development in line with strategic and operational plan. This includes discipline specific direction and expertise at the organisational level to help support continuous improvement and operational service delivery across disciplines and sites.
- To undertake operational and administrative management tasks as required.
Key Accountabilities and Tasks
Professional Supervision
- Provide professional supervision to allocated team members across all sites of the BUSHkids organisation
- Utilise high level skills to support and guide allocated team members on service delivery issues
- Providing Team members with advice, support and direction to promote their personal and professional development and increase job satisfaction
Professional Development
- Facilitate, implement and review the performance and development of individual team members through the performance, appraisal and development process (PADP)
- Identify resources and professional networks to support individual team members personal and professional development
- Provide endorsement of professional development applications in line with PADP
- Support the Clinical Services Manager or delegate by providing advice on professional development needs within clinical streams or at an organisation wide level based on service priorities/direction
- Identify training opportunities that may be utilised by the BUSHkids organisation to meet identified training needs as well as provide income generation for the organisation
Recruitment
- Provide yearly review of role descriptions for allocated disciplines
- Participate in recruitment processes as required
- For all new staff - complete required documentation during allocated probationary periods
- Contribute to orientation of new clinical team members
Workload Management
- Monitor and review staff members clinical efficiency
- Support staff to manage centre issues
Service Direction
- Provide clinical expertise to help support the ongoing review and planning of BUSHkids services to ensure optimal outcomes for clients and equitable, efficient and transparent service delivery across the organisation
- Lead on organisational projects in consultation with the Clinical Services Manager or delegate
- Provide support in the development of policies and guidelines as required
Reporting
- Provide monthly reporting in line with operational and strategic reporting requirements
- Provide copies of PADPs and Supervision Agreements for HR storage
- Report any issues that need addressing in a timely manner to the Clinical Services Manager or delegate
Team Building
- Develop professional networks among clinical team members
- Facilitate the discipline specific monthly team meeting to support the discipline within the larger organisation
Meetings Professional Leads will be required to attend
-
- Fortnightly meetings with the Clinical Services Manager or delegate
- Clinical Services sub-committee meetings
- Other relevant meetings as requested by the Clinical Services Manager or delegate
Conference
- Professional leads are required to be involved in the planning, facilitation and evaluation of the BUSHkids Annual Conference. This may include the organisation or delivery of professional development or project work at the Conference
Research
- Support the Clinical Services Manager or delegate in identifying and developing research opportunities within the BUSHkids organisation
Mandatory Requirements
- Qualified and suitably experienced Speech-Language Pathologist with experience providing supervision for Speech-Language Pathologists
- Registration and/or memberships relevant to qualifications
- An understanding of how to work with vulnerable families who may face barriers to accessing services
- Experience or understanding of provision of services for children and families living in rural, regional and remote locations.
Desirable Qualities
- Experience / qualifications in rural / remote practice
- Experience in community capacity building or workforce/parent education
- Relevant Post-Graduate Training
- Training in Professional Supervision
Additional Information
- The successful applicant is required to provide certified copies of qualifications prior to the commencement of employment at BUSHkids
- BUSHkids is a not-for profit organisation – the ongoing duration of this position is dependent on available funding and at the discretion of Clinical Services Manager or delegate and CEO according to service needs
Your Application
Applicants are to submit a brief resume; contact details for 2 referees (one of whom is to be your current supervisor); and a maximum 2 page written response outlining your suitability for the role addressing the following key selection criteria: | http://bushkids.org.au/get-involved/career-opportunities |
Extracts from this document...
Introduction
Dhruv Medepalli
Inclined Plane Lab
Design
Aspect 1
Research:
If an object is placed upon a surface that is inclined at a certain angle then that will decide the acceleration in which the object is going down the inclined plane. When looking at an inclined plane it is important to see what forces are acting upon it to see what the object is doing. In our case of there was Fn, Gravitational Force and, Fd.These forces act upon the object to see where it is going. In an inclined plane there will always be at least two forces acting upon the object which would be weight (pointing downwards) and force normal (pointing forwards). Force normal as always been the opposite of the gravitational force, but that is not true because we now of horizontal planes, but this is a inclined plane and the truth is that Force Normal is always perpendicular to the surface the object is on.
Works Cited:
http://www.glenbrook.k12.il.us/gbssci/Phys/Class/vectors/u3l3e.html
Defining the Problem: How does an angle constantly being inclined affect the acceleration for a car on a frictionless plane?
Variables:
Dependent: Acceleration of the car
Independent: Angle of inclination
Controlled: Length of Ramp
Controlled: Distance of Motion Detector from Ramp
Controlled: coefficient of Friction (negligible)
Aspect 2:
Length of Ramp:
Middle
4.70
.62
.59
.61
5.00
.60
.60
.60
5.28
.64
.63
.64
5.57
.69
.69
.69
Aspect 2:
After recording the two trials and getting two accelerations for one angle, we average the two acceleration and we get the average acceleration through this table and below is the graph of the average acceleration:
Degrees
Average Acceleration (m/s)
2.87
.22
2.98
.27
3.27
.33
3.55
.35
3.84
.40
4.42
.53
4.70
.61
5.00
.60
5.28
.64
5.57
.69
Considering in mind that this
Conclusion
Aspect 3
For the few weaknesses I had I can say there are simple solutions for them to be avoided next time. With the motion detector I think we could first find a proper height for both the ramp and the car to be placed at and whenever we raised the ramp we would raise the motion detector by the same amount. Next was the time management where as always we could have stopped rushing and taken our time even though it was scarce, this was because we had to do this lab during a time with constraints. The last weakness was with the acceleration and my solution is to increase the length of the ramp and let the car run for more time and thus we will get a more detailed acceleration. To remove systemic/ random error next time we would have to make sure we have more time for the experiment and set up properly.
This student written piece of work is one of many that can be found in our International Baccalaureate Physics section.
Found what you're looking for? | https://www.markedbyteachers.com/international-baccalaureate/physics/ibphysicshl-inclined-plane-lab.html |
Persevere: Calligraphy of Resistance
Over the last few months, artist Tauba Auerbach has written out the word 'Persevere' thousands of times.
A series of posters and public installations are now aiming to raise money and awareness for organizations including the Committee to Protect Journalists and GEMS (Girls Education and Mentoring Services).
"My favorite exercise in Daniel T Ames’ Compendium of Practical and Ornamental Penmanship shows the word persevere written in lowercase script. Each letter is surrounded by a loop, similar to the a in the @ symbol. The loops are all the same but the letters are different, so the exercise teaches you to maintain a rhythm amidst otherwise varying circumstances. "
"Calligraphy has become the activity during which I reflect on what’s happening in the world, what’s at stake, and what I’m willing to do about it. Maybe I’ve just needed something to do with my hands while I think. Until now, my politics have manifest mostly in quotidian, domestic choices like being vegan, composting and riding a bike. Feel free to roll your eyes. I support a few organizations. Big deal. I’ve always spoken my mind, but probably too politely. Besides, all of these choices are luxuries, and none of them registers as a sacrifice because they actually make my life more enjoyable. They are also, clearly, not sufficient."
"While doing calligraphy I’ve listened to a lot of speeches made by activists and philosophers. I’ve asked myself frequently if revolutionary change can take place without violence, and I’ve heard many sound arguments for why it cannot. Nonetheless, I remain certain that violence = no change, and that it is a doomed methodology for achieving it. In my view, violent means not only don’t justify but also don’t result in peaceful ends because the notion of an “end” is flawed. Now is the end. Every moment is the end. Civilization will always be in a state of becoming, so how we become what we want to be is what we are."
"Over the last few months, I’ve probably written the word persevere thousands times and in of hundreds ways. I’ve needed the time to think about what I can truly offer, about what a real contribution might be. I have some ideas, but I don’t yet know if any of them are any good. In the meantime, I’m offering these drawings to support and thank some of the people I’ve held in my mind as I’ve written the word."
ACTIONS
Persevere posters are available from Diagonal Press for $25
100% of profits benefit the Committee to Protect Journalists, GEMS (Girls Education and Mentoring Services), Chinese American Planning Council, and PLSE (Philadelphia Lawyers for Social Equity)
Good Trouble
Author account for the Good Trouble hive-mind. | https://www.goodtroublemag.com/home/persevere-calligraphy-of-resistance |
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Effect of transport stress on physiological responses of male bovines.
Forty-eight slaughter bulls were transported by road in groups of eight for approximately 30 min, 3 h and 6 h in two replicates. Animal welfare during the transport process was assessed. Loadings and unloadings were evaluated with a scoring method. Heart rates were monitored at the farm before loading and during all stages of transport. Blood samples were taken from all animals a week before transport and at sticking and analysed in terms of haematological values: hematocrit, haemoglobin, red and white blood cells (RBC and WBC), differential WBC counts and neutrophil:lymphocyte ratio. Glucose, creatine kinase, lactate and cortisol were also determined. To evaluate differences in meat quality, pH and water-holding capacity (WHC) were measured 24 h after slaughter. The loading and unloading scores were very low (low stress) but were associated with changes in heart rate, especially loading. Animals recovered their resting heart rate during the journey in medium and long transports. On the other hand, animals transported around 30 min maintained an elevated heart rate during the whole journey. All animals showed a stress response with significantly higher (p < 0.05) levels of erythrocyte series, N:L ratio, glucose and lactate. Animals transported for 3 and 6 hours had significantly (P<0.05) higher levels of cortisol than controls or 30 min transports, without differences between control and the shortest journey. Different transport times did not influence meat quality. Under good conditions, the transport had a slight effect on welfare, meat quality or physiological parameters related with stress.
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The materials used to create a Mesopotamian home were comparable but not identical to those used today: mud brick, mud plaster, and wooden doors, all of which were naturally accessible throughout the city, though wood was not prevalent in some Sumerian cities. The Babylonians made use of limestone and sand for their buildings, which gave them a more durable material. But even they used mud brick and plaster for their interiors.
Mesopotamia is famous for its advanced civilization during its time. This included a sophisticated urban life filled with public works and institutions such as libraries, universities, medical centers, observatories, and theaters. The people also enjoyed many innovations that changed how we live today, such as the water clock, the steam engine, and paper money. All of this was possible because of the abundant resources found in Mesopotamia.
Mesopotamia was known as the "Land Between Rivers" because most of it is situated between two large rivers, the Tigris and the Euphrates. However, parts of modern-day Iraq and Syria were once dry land occupied by several small lakes. This allowed the people of Mesopotamia to develop agriculture as well as aquaculture (the raising of fish for food) on a large scale.
Mesopotamian family were responsible for building their own homes. While mud bricks and wooden doors were the most common building materials, reeds were also utilized. The Tigris and Euphrates Rivers provided many opportunities for water-driven mills to produce flour from wheat or barley.
The cities of Mesopotamia were built on raised mounds called "tells". These served as defenses against invasion as well as providing better drainage for irrigated agriculture. The Assyrians are known for their large fortified cities, but the early civilizations of Mesopotamia also included small towns with walls and gates. None of these ancient cities remain today, but based on historical evidence we can learn a lot about life in those times.
Most houses in Mesopotamia were made of sun-dried mud bricks that were mixed in front of the house with the help of a hand mill and then shaped by hand or with simple tools. The mortar used to bind the bricks together was made of sand and gravel mixed with animal fat or oil. Wooden beams supported overhanging roofs which usually consisted of flat boards attached to the wall with nails or leather straps.
The main city of Mesopotamia was Ur, which at its height was home to 20,000 people.
How did Mesopotamia make use of their surroundings to create construction materials? Mesopotamians traded grain for necessities like stone and wood. Why did several Sumerian city-states spring up at the Tigris and Euphrates river mouths? Because the area adjacent to the rivers was fertile farmland, while the land farther out was dry desert. How did the Egyptians build such a large empire? By trading with other countries for resources that they needed to build their cities and keep themselves fed.
Mesopotamia was a series of flat plains bordered by mountains to the east and west. The only natural resource they had access to is water, which is why several city-states sprung up along the banks of the Tigris and Euphrates Rivers. The Egyptians built an empire because they were able to trade resources with other countries. They got wheat and barley from the Indus River Valley in what is now Pakistan, cotton from as far away as present-day Iraq, and copper from central Europe.
Mesopotamia was also home to many small kingdoms and city-states who were sometimes allies and sometimes enemies. One example is Babylon and Sumer. Babylon was built by Henshaw, a king from the southern kingdom of Sumer. He took advantage of the gap left by his enemy, Lagash, who had died. Henshaw claimed the throne and started building a city to show his strength. Today's Baghdad was once part of his empire.
Mesopotamia was abundant in mud, clay, and reeds, which they used to build their towns. Mesopotamia required commerce for the majority of other necessary items, such as metal ores and wood. The only two significant natural resources are oil and water. They obtained most metals from abroad or from their own mines.
Mesopotamia was also rich in livestock, especially cattle and sheep. Their grazing allowed farmers to cultivate land that would otherwise be useless because it is too dry or too wet. Fish were also important for food but mostly for ceremonial purposes. Oysters, clams, and seaweed were harvested from the coast. Frogs and snakes were also eaten but not for pleasure; instead, they were used as medicines for illnesses.
Mesopotamia had very few minerals. All the metals needed for tools and weapons came from outside sources. Salt was mined in limited quantities but mainly from foreign imports. Potash and sulfur came from rocks in some areas but mostly from abroad.
Mesopotamia had plenty of trees for building materials but mostly for fuel. Oak was the main tree used for building houses and ships. Wood was also used for musical instruments and bows.
In conclusion, Mesopotamia was a poor country with little industry and no wealth apart from oil fields.
Mesopotamia was the birthplace of the world's earliest cities. There were no trees on the property. As a result, most structures were composed of earth that had been sun-dried and transformed into bricks. The Mesopotamians built the world's first columns, arches, and roofs out of bricks. They also developed techniques for making glass and iron.
Mesopotamia is also where writing was invented. Before this time, all important information was passed down orally. The Mesopotamians used symbols to record this information. These symbols are what we today call letters or words. Through these writings, they were able to keep track of trade deals, military victories, and other important events/people in their society.
Writing made it possible for them to create libraries. Previously, books were kept in temples or private homes. By building their own libraries, the Mesopotamians were able to expand their knowledge beyond what could be contained in small spaces such as temples or houses.
Mesopotamia was also the home of many scientific discoveries. They invented mathematics, science, medicine, agriculture, technology, architecture, and much more. Because these ideas were shared with people all over the world, they have survived even after the civilizations that created them died out.
Mesopotamia has been called the cradle of civilization because of its importance in bringing about major changes in all aspects of life.
1. Mesopotamian Brick Making Making Bricks in Mesopotamia Man discovered that clay could be baked and moulded in the sun to form a construction material as early as 8000 BC in Ancient Mesopotamia (part of current Iraq). Mesopotamian bricks were formed of ceramic material. The process of making bricks was not very sophisticated - flat pieces of clay were simply dried in the sun - but they showed an ability to innovate which led to many improvements over time.
Brick making had several purposes. It was done for home use as well as for building projects. People also used bricks to protect their crops from the rain and, when planted in fields, they provided some of the most important tools for farming: the plow and the harrow. Farmers would mix mud with straw or wood chips and then pack it into mold shapes to make brick plows. These were used to turn over soil before planting or to break up hardpan soil so that water could reach root systems below the surface.
In addition to these practical uses, bricks were prized for their appearance and built-in lightness. They are used today in buildings all over the world where they provide weight savings and allow for easy construction of tall structures.
Bricks have been used by humans for various forms of construction since ancient times. The Egyptians made use of limestone which they cut into fine powder and mixed with ash to make a soft paste that they molded into shape. | https://bindleyhardwareco.com/what-did-mesopotamians-build-with |
Mayor Edwin M. Lee last night introduced Alejandro Murguía as the City’s 6th Poet Laureate, at Friends of the San Francisco Public Library’s third San Francisco International Poetry Festival kickoff event in Kerouac Alley.
Poet, editor, translator, literary organizer and educator, Murguía is the author of Southern Front (Bilingual Review Press) and This War Called Love: Nine Stories (City Lights Books), both recipients of the American Book Award. His most recent book of poems, Native Tongue (CC. Marimbo Press, Berkeley) was published in February 2012. His other books of poetry are Spare Poems (Luna’s Press, 2001) and Oracíon a la Mano Poderosa (Editorial Pocho-Che, 1972).
Murguía, a professor of Latino/Latina studies at San Francisco State University, is also the author of the non-fiction book, The Medicine of Memory: A Mexica Clan in California (University of Texas Press). The book draws on memories—his own and his family’s reaching back to the 18th century—to (re)construct the forgotten Chicano-indigenous history of California.
Born in California, Murguía has spent nearly his entire literary life in San Francisco. A long-time literary activist, he published first books by José Montoya, Roberto Vargas, Nina Serrano, Elias-Hruska-Cortes and raúlsalinas and edited Tin-Tan Magazine. He co-edited anthologies including Volcán: Poetry from Central America (City Lights Books, 1984) and Time to Greez! Incantations from the Third World (Glide Publications, 1974). As a translator, his projects have included Angel in the Deluge (City Lights Books, 1993) by Rosario Murillo.
A longtime literary organizer, in addition to participating in the San Francisco International Poetry Festival, Murguía organized the Flor Y Canto en el Barrio festivals in 2008 and 2011 and has been an active participant in Litquake since its inception.
Honoring our City’s great legacy of encouraging cross cultural dialogue, Friends of the San Francisco Public Library, in partnership with the San Francisco Public Library, the Mayor’s Office of Protocol and Emeritus San Francisco Poet Laureate Jack Hirschman, present this landmark event that brings more than 18 poets from all around the world to San Francisco for free and open-to-the-public poetry and music. The four-day festival kicks off Thursday, July 26 in Kerouac Alley in North Beach, followed by public poetry readings, translation workshops and children’s programs, on Friday and Saturday, July 27-28, in Civic Center Plaza and the San Francisco Main Library, and then concludes on Sunday, July 29 with the North Beach Poetry Crawl. More information at sfipf.org. | https://sfpl.org/releases/2012/07/27/alejandro-murguia-named-sf-poet-laureate/ |
Q:
If you have an array of fixed size, and you need to go through it !n number of times, how does using binary search change the time complexity?
We want to find all permutations of a string of length n. Then, you are to search an array of fixed constant size, say 3000 and check if the string is in the array.
String arr[3000];
Because we will have !n permutations, we need to do !n searches.
Also, what difference does it make when you check 2 different strings against an element in the array versus just checking 1 string?
What is the time complexity?
My thoughts is that it will take at worst, log2(3000) to go through the array once. Time complexity of that is O(log2(3000)) which is O(1).
Now, you need to go through this array !n times so time complexity is O(!n).
So the binary search reducing the number of searches required should not be the focus when analyzing the time complexity of this algorithm.
My question is, binary search does reduce the number of searches and if you are gonna go through it n! times, shouldn't this be a significant difference?
Any insight to better my understanding is appreciated.
A:
Big O complexity analysis only deals with quantities that are subject to change, by definition. That you get vacuous answers when all your quantities are constant is expected.
The constant factors are relevant when comparing two algorithms of equal Big-O, so your change from 3000 -> log2(3000) is a factor of about 200.
Thus you use the binary search because you are doing more than Big-O analysis. You have also estimated the constant factors, and see an easy 200x speedup
But equally you can have multiple terms in your complexity. You might say:
Let n be the input string length
Let m be the size of arr
Our algorithm is O( n * n! * log(m) ) (n for the string equality, n! for the permutations, log(m) for the binary searching)
It also rather depends on a model of cost. Usually this maps back to some abstract machine, e.g. we assume that operations have a certain cost. E.g. You might compare sorting algorithms by just the count of comparisons, or by just the count of swaps, or by the counts of both comparisons and swaps.
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In August 2018, the first domestic verification test on Internet voting that uses blockchain and My Number cards was conducted. This test was led by Tsukuba City in Ibaraki Prefecture. The city was working on a project to ask the public to devise trial (verification test) ideas that utilize civil ingenuity to socially implement innovative technologies, including the IoT, AI and big data analysis, and support outstanding trials. An Internet voting system was utilized for the final review to select Tsukuba Society 5.0 Social Implementation Trial Support Projects from proposed trials. My Number cards were used for identifying voters.
There are four basic conditions for fair Internet voting as shown below. The first is to confirm the validity of voters. The second is to keep votes secret. The third is to prevent multiple voting. Lastly, the fourth is to prevent votes from being tampered with.
The characteristics of blockchain are that it securely records all the transactions (voting in this case) that participants make without being tampered with. This means that combining blockchain with a voter authentication mechanism makes it possible to achieve an Internet voting system that meets the four basic conditions.
Although Internet voting in Tsukuba was carried out in such a way that voters vote with terminals in prepared polling stations, the system was built to make it possible to vote from homes and other places. When these efforts progress further and technical knowledge is accumulated in the future, we may be able to select our representatives from homes and other places using Internet voting.
Blockchain technology is not perfected yet, even though many expect it to drive the digitization and systematization of various economic and social activities ranging from financial activities to Internet voting. Since the inception of bitcoin started in 2008, it is safe to say that the technological development of blockchain has just begun. Blockchain has much potential but there are also many issues that need to be resolved. To make the full use of blockchain, many new technologies have to be incorporated going forward.
There are several issues surrounding blockchain, and this article introduces three representative ones. The first is a low real-time processing capability. Blockchain involves a process to record transactions in a block periodically. In addition, there is a rule that, since several computers may create separate blockchains concurrently, the longest blockchain shall be considered legitimate after a certain period of time. For this reason, it takes some time to determine whether a blockchain record is legitimate, making it less suitable for transactions that require a formidable real-time capability.
The second is low throughput. This is related to the fact that the amount of data per block is fixed and transactions are recorded periodically. When a multitude of transactions occur instantaneously, some of them cannot fit into a data block and are queued for the next block. Computer clusters that compose a blockchain performs enormous computations to generate blocks and such computing power is used for earning rewards by completing computations faster than other computers. The number of transactions in unit time is determined by how blockchain works, regardless of the computer's processing power.
The third is security. Warnings are especially increasing regarding smart contracts that use blockchain as a program runtime environment. A smart contract makes it possible to distribute a program and implement it on all computers that have joined in a blockchain by embedding the program into the blockchain. To prevent malicious programs from being distributed, a mechanism to identify the safety of programs to deal with should be developed on a continuous basis.
Efforts to solve problems with blockchain are being proactively made around the world. As for security problems with smart contracts, for example, there are development case studies involving Fujitsu Laboratories Ltd. and Fujitsu Research and Development Center (China). The two developed a technology to verify risks in smart contracts in advance and identify to what part of the program those risks detected during verification are located.
Specifically, they developed an algorithm to identify risky transactional flows on Ethereum, a runtime environment for blockchain applications, which makes it possible to detect various risks in smart contracts that may be overlooked when done manually, in a comprehensive manner.
They also developed a technology that not only detects risks but also identifies with a high degree of accuracy to what part of the source code those discovered risks are located. Portions of the source code that correspond to the detected risks are identified by inferring a corresponding relationship between the execution file and an execution file for debugging with source code information embedded. Incorporating and making use of this technology will significantly improve the security of smart contracts.
Blockchain was developed as a technology for realizing bitcoin virtual currency. Since then, new blockchain technologies that are improved and enhanced versions of the bitcoin blockchain have arrived one after another, each of them generating its own virtual currency. According to CoinMarketCap, which announces the transaction values and volumes of and the market capitalization of virtual currencies issued around the world, 1,900 or more virtual currencies were issued as of August 2018.
Some of those new blockchains resolved issues that the bitcoin blockchain had. For example, EOS, an organization founded in June 2017, achieved faster processing speed by such means as allowing a person elected by participants' votes incorporate a mechanism to generate blocks efficiently. The bitcoin blockchain can process only several transactions per second, whereas EOS is looking to process several million transactions per second.
EOS was founded to achieve a distributed platform for smart contracts that companies can utilize in their business activities. This concept is similar to that of Ethereum but with an additional unique characteristic that Ethereum lacks, which is no transaction fees are charged.
Another characteristic of EOS is that they have garnered a reputation for their technological prowess. For example, in China, the China Center for Information Industry Development (CCID) has been publishing the results of virtual currency evaluations based on the Global Public Blockchain Technology Assessment Index and, according to the June 2018 result, EOS was ranked first overall. The rankings are made from technological, applicability and innovation perspectives and EOS was also ranked first in the technological category. As a side note, Ethereum came in second overall.
To overcome the constraints of blockchain, activities for developing distributed ledger technologies based on non-blockchain principles have also begun. A prime example of this is IOTA, a virtual currency under development for the IoT.
IOTA is designed to be used for exchanging data between IoT devices. The IoT requires instant exchanges of enormous amounts of real-time data. Collecting information from a multitude of sensors and generating big data increases the value of information. However, the price of each piece of sensor information is not so high and countless transactions occur. Charging a fee each time a transaction is recorded will not help IOTA prevail. For this reason, a mechanism to make transactions free of charge was devised for IOTA in addition to a higher level of real-time performance and throughput. It is called Tangle.
In Tangle, a person who wants to make a transaction approves other transactions. Then, they associate their transaction with the two transactions that they approved and record it. For this reason, the overall transaction record is composed in such a way that transactions are associated with one another in a complex manner, rather than in the form of a simple chain.
Since Tangle has no rules that hinder real-time performance and throughput, such as blocks, each participant can approve transactions promptly and independently. In addition, offline approval is also accepted, thereby making it easy to boost real-time performance and throughput. The overall consistency, including approvals made offline, is ensured by synchronizing them when back online.
The development of solutions leveraging IOTA has also begun. For example, Taipei, Taiwan has launched a joint scheme to realize a smart city using IOTA along with the IOTA Foundation, which has taken the lead for IOTA. The first project is to develop digital citizen cards with embedded TangleIDs. The supposed purposes of issuing digital citizen cards are to exercise voting rights, to provide medical record information and to use government-related services.
For the manufacturing industry, Fujitsu demonstrated how to use IOTA to manage the traceability of products at Hannover Messe 2018. To implement the traceability of products and parts throughout a supply chain, a mechanism to mutually link numerous different management systems are required. Using IOTA may make it possible to perform traceability across ID supply chains efficiently.
Blockchain was created to realize virtual currency and this technology is developing rapidly. One cannot help but expect surprising developments to start from both technical and usage aspects. Blockchain may penetrate into daily life as an infrastructure platform that supports a new society, just like the Internet has grown immensely.
Graduated from the faculty of Engineering, Tohoku University in 1985 and joined Nikkei Business Publications, Inc. in the same year. As a reporter and assistant editor for Nikkei Data Pro, Nikkei Communication, and Nikkei Network, covered and wrote about advanced technologies related to communication/information processing as well as trends in standardization/commercialization. Chief Editor of Nikkei Byte in 2002, Chief Editor of Nikkei Network in 2005 and Chief Editor of Nikkei Communication in 2007. Publisher of ITpro, Nikkei Systems, Tech-On!, Nikkei Electronics, Nikkei Monozukuri, Nikkei Automotive, etc. before becoming Director of the Overseas Business Division in January 2014. Has been in his current post since September 2015. Has been writing the series Jido Unten ga Tsukuru Mirai (A Future with Self-Driving Cars) since August 2016 on Nikkei Online Edition. Issued Sekai Jido Unten Kaihatsu Project Souran (An Overview of Global Self-Driving Development Projects) in December 2016 and Sekai Jido Unten/Connected Car Kaihatsu Souran (An Overview of Global Self-Driving/Connected Car Development) in December 2017. Serving in the CEATEC Award Review Panel since 2011. | https://blog.global.fujitsu.com/fgb/2018-09-20/tsukuba-implements-blockchain-based-e-vote-more-next-gen-blockchains-aimed-at-better-performance-and-iot-support-arriving/ |
My mentor Brian Tracy suggests the ABCDE method to prioritize, he says: it is the most powerful priority setting tool that you can use every day.
This technique is so simple and effective, that if applied consistently, can make you one of the most efficient and effective people in your field.
Call me old-fashioned, but I still believe in “thinking on paper.” Here is how it works: write down everything you have to do for the coming days. Next, you place an A, B, C, D, or E next to every item before you start with the first task.
Items with an A are defined as something very important, something that absolutely has to get done, not negotiable. Doing this task will have very serious positive consequences if you do it OR very serious negative ones if not done. So it’s absolutely critical to carefully consider this, think about what would happen if you did NOT do this, if the consequences are really bad you are less likely to blow it off A items are your frogs! Big, huge ugly frogs!
If you have several A tasks, you can number them: i.e A1, A2, etc. 1 is the biggest frog, 2 second biggest and so forth.
B items are tasks that you SHOULD do, but it has only mild consequences if you don’t. You can look at these as your tadpoles, If not done, someone may be inconvenienced or unhappy if you don’t do the task, but it is definitely NOT as important as an A task.
However, the rule is: never do a B task as long as there’s. an A task left to be done.
C tasks are items that would be nice to do but there aren’t really any consequences to speak of if you don’t do them. These activities really don’t have an effect on your business.
D tasks are items that are meant to be delegated… things that could AND should be done by somebody else.
The rule: delegate anything and everything that someone else can do, this allows you to free up time to take care of A tasks that can only be done by you
Finally, E items are tasks to be eliminated. Delete them from your to-do list since they won’t make any difference whatsoever. This may be a task that at some point was important, but is no longer relevant, so every minute you spend on an E task is taking time away from an A task or activity that would actually make a REAL difference.
Once you start applying this method of prioritizing you will be organized and ready to get more IMPORTANT things done faster. The Key to making the ABCDE method work for you is to discipline yourself to start immediately, not tomorrow, NOW. | https://balance6.biz/vodcast/011-how-to-prioritize/ |
Paisley is a strong psychic medium, who has been naturally gifted from birth, when she was a teenager she had a powerful visitation from her grandfather, at the time that he passed which cemented her calling in connecting with the spirit realm. Since then, she has also developed and evolved as a talented energy healer. Enthusiastic about giving spiritual counsel and feeling like she is a guide herself, she enjoys helping others to explore their current situation and advising them on their spiritual journey. It is the empath and intuit in her that is attracted to helping others and giving of herself for the better of another, to help humanity upgrade for the new world, that she believes is being created in these demanding and uncertain times.
With an incredible combination of spiritual knowledge and skill, Paisley currently works with energy, uses tarot and oracle cards, jewellery, and photos (psychometry) to perform in depth spiritually informative readings. She is also a Reiki practitioner and an extraordinarily sensitive end-of-life doula. Paisley is talented at using all her Clair’s throughout readings, she can feel aches and pains, taste, smell, hear and see useful information during a consult. She can use her mediumship skills in readings when the spirit willingly comes forward and prides herself on passing on messages of hope and clarification, from their spirit guides.
A naturally gifted, but also well cultured psychic Reader with a great awareness of the many trials and tribulations life can deliver. Her compassionate perspective provides you with immediate relief and deep connection to your past, better understanding of your present and extreme confidence for the future.
Find out how your life can genuinely change for the better by connecting with a live psychic, Paisley is waiting for your call.
Sophisticated and naturally gifted psychic, Jada has been connected to spirit, from an incredibly early age. She fortunately was encouraged to nurture and develop her gifts from childhood, giving her the skills to not only cultivate those instinctual intelligence but to also develop and learn many other spiritual expertise. She is well versed in the mechanics of the quantum plane, the afterlife, sacred geometry, astrology, numerology, and the kabbalah tree of life journey, applying all of them to her consults to provide a thorough and unique reading, which can provide extraordinary insight and positive direction.
Being so broadly proficient in all these supernatural talents make it easy for her to tap into anyone's energy no matter where they reside. She loves to read tarot cards and receive intuitive guidance from spirit as part of that process. With a passion for helping people to understand the deep connection we all have to each other and the spirit world. Jada genuinely believes that in this space, we can find authentic healing, peace, and love.
From experience, she is completely aware of the amount of people that are seeking information about love. She thoroughly understands the manifestations of romantic relationships, spending years studying twin flames, karmic and soul mate ties. Whilst not each connection needs to have a title applied, certain connections manifest with regularity. Others are incited with insane intensity and sometimes that close tie can be confused in a narcissist/empath union. She is an expert at finding the identifiers to assist her clients and specialises in navigating the stormier waters in these connections.
Find out how your life can profoundly change for the better, by connecting to a live psychic, Jada is waiting for your call.
Ariana offers a rare combination of Spiritual Healing, Psychic Talent, Clairvoyance and Psychic Mediumship. A psychic reading with her will enlighten your understanding of your current situation, offer spiritual solace and deliver inspired direction for your life. If you are ready to change your life, she is ready to take your call.
A qualified Reiki Practitioner gifted with strongly established connections to the Angelics’, Ascended Masters and Star Beings; a reading with Ariana is transformative in nature, offering a sense of renewed purpose, spirit and clarity.
Ariana’s work with Kuthumi, Quan Yin and Saint Germain provides a rare opportunity to simultaneously gain Spiritual Insight and Healing on very many levels.
A caring and compassionate Psychic Reader with a deep understanding of the human condition, her kind and gentle manner provides you with an immediate sense of spiritual connection and support. Find out how your life can really change for the better by connecting with a live psychic, Ariana is waiting for your call.
Cecelia is an authentic clairvoyant, medium and energy healer. A trusted and authentic reader, she have been providing psychic guidance and healing for over 38 years. With gifted and skilled direction Cecelia guides you through life's most challenging times, she is ready to take your call.
Cecelia is a well respected and accomplished Healer and Medium. She was born with the psychic gifts of clairvoyance, clairaudience and clairsentience. As one of the very first Australian Phone Psychics, she has been providing enlightened guidance and healing for over 38 years to people all over the world.
Cecelia reads with extraordinary insight and compassion, using her psychic energy to focus with crystal clarity on your soul’s signature journey this lifetime. She provides inspired guidance on love and relationship issues, as well as money and business. Highly skilled in Spiritual communication, she provides solace and illuminating advice to those who are feeling overwhelmed by life’s challenging issues. With gifted and skilled direction Psychic Cecelia guides you in accessing your potential and connecting with what it is you really want your life to look like.
An in-depth consultation with Cecelia will provide you with a new understanding of your situation and life’s purpose. You will continue to experience Cecelia’s messages of love and healing energy long after the reading is finished.
"Cecelia opened my mind and spirit to the energies moving in my life. Her compassion enabled me with more grace and acceptance than I thought humanly possible. She identified my fears and who I was, and how I was dealing with situations and loved ones. An absolutely accurate reading of my character and the immediate challenges I was facing. I cannot speak highly enough of Cecelia's guidance and psychic ability."
Find out how your life can really change for the better by connecting with a live psychic, Cecelia is waiting for your call. | https://cecelia.com.au/ctm_psychic_skill/energy-healer/ |
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Moderate Bias? Exploring anti-bias training in the context of online content moderation
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Unconscious bias has a powerful impact on individuals in any work environment, but the magnitude, frequency and velocity of the decisions made every day by individuals responsible for content moderation on social media or gaming platforms increases that impact many times over. ADL will bring its experts on anti-bias education to the table with the tech and human rights community to explore the application of anti-bias education concepts in the context of online content moderation in an effort to shape thinking around a form of anti-bias training aimed specifically at content moderators of online platforms.
Moderators
Daniel Kelley
Associate Director, Center for Technology and Society, ADL
Ensuring justice and fair treatment to all in digital environments. Challenging hate, bias and harassment in games, the game community and the game industry.
Speakers
NS
Nicola Straker
Education Director, NY/NJ, ADL
Thursday June 13, 2019 10:30am - 11:45am BST
Carthage 2 (Laico)
Countering Online Harassment and Hate Speech and Violent Extremism
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Anti-Defamation League (ADL)
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Content Moderation
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Need help? | https://rightscon2019.sched.com/event/PvgW/moderate-bias-exploring-anti-bias-training-in-the-context-of-online-content-moderation |
Course Description:
PART I The Earth and its formation; plate tectonics; physical and chemical processes; erosion and deposition; Quaternary geology; Rock types; igneous, sedimentary, metamorphic; geological maps and terminology; role of geology in civil engineering. PART II Setting the context using the soil mechanics triangle; soil composition and chemistry ¿ clay bonding and double layer; classification and identification; phase relationships; soil compaction and improvement techniques; effective stress concept and flow of water in soils; permeability and flow nets; drained and undrained shear strength; site investigation.
Review
- Evaluation Date:
- October 20, 2016
- Evaluated:
- William Simpkins
- Comments:
-
It emphasizes more soil mechanics concepts than our 201, but appears to cover the basic geology concepts covered in 201. | https://sites.engineering.iastate.edu/studyabroad/classlist/838 |
Within MARLISCO the educational material “Know Feel Act! To Stop Marine Litter” has been prepared to inform, sensitise and enable European teachers and students to take action to tackle the problem of litter in our seas and coasts. The material has been designed to primarily serve youth aged 10-15 yrs, but can be used also by educators outside the formal schooling system.
This is a joint product of the MARLISCO consortium and within the project duration (2012-2015) it will be translated and applied in the 15 partner countries. Within the MARLISCO project the material is solely shared in its electronic form (but partners are welcome to raise additional funds to produce it in hardcopies!).
The material contains 17 activities, each combining a learning activity part (4 pages) and a worksheet for students (1 page). The activities are self-standing and can be applied separately or combined in clusters, so to meet the needs of the educator.
Citation: Alampei Iro, Malotidi Vicky, Vlachogianni Thomie & Scoullos Michael, “Know, Feel, Act! to Stop Marine Litter: Lesson plans and activities for middle school learners” © MIO-ECSDE, 2014.
The authors will welcome your requests or recommendations at [email protected]
Special thanks to all MARLISCO partners that enriched the material with their ideas, especially Luigi Alcaro, Flávia Silva, Demetra Orthodoxou, Tom Doyle, Damien Haberlin, Kathrin Kopke, Joana Veiga, Isabelle Poitou, Ryan Metcalfe and Bonny Hartley. Sincere thanks to Richard Thompson for his valuable evaluation comments.
NEW! RUSSIAN VERSION (February 2019)
ARABIC VERSION (May 2015): UNEP/MAP through the EcAp-MED project co-funded by the EU and the Mediterranean Trust Fund of the Barcelona Convention adapted, translated and printed this educational material into Arabic for distribution in many countries of the Mediterranean sea.
DOWNLOAD THE EDUCATIONAL PACK IN ENGLISH (ONE FILE)
DOWNLOAD THE EDUCATIONAL PACK IN ARABIC (ONE FILE)
DOWNLOAD THE EDUCATIONAL PACK IN RUSSIAN (ONE FILE)
Contents
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Description
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Introduction, Scope and Contents
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This section presents the scope and contents of the educational material, as well as the partners, sponsors, etc. Download intro
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Notes for the Educator
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This how-to-use section contains tips and methodological guidelines for the educator, to support him/her in the implementation of the activities Download educator’s notes
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SECTION A: GETTING TO KNOW MARINE LITTER.
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A1 Identification and Classification of Marine Litter
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In this activity learners familiarise themselves with marine litter by playing classification and description games. They brainstorm ideas on the concept of “litter” and discover that objects disposed of improperly, may end up as marine litter.
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A2 Experimenting with Litter Items
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In this activity, learners experiment with litter items and test some of their characteristics and effects on the environment. Learners investigate the degradation time of various materials and the role of weather conditions on the degradation process.
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A3 Tracking Marine litter
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In this activity, learners use diagrams, local and global maps in order to illustrate the point that marine litter items continue “travelling” from place to place, creating a problem of global dimensions, with no borders.
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A4 Guessing the Top-10
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In this activity, learners work in groups to guess litter items most commonly found on beaches. They compare their assumptions to published data from national or international research or to real data recorded through their own field research. They reflect on specific consumption habits that generate marine litter and think about how changes in these behaviours can prevent its generation.
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SECTION B: LAND & SEA BASED SOURCES
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B1 Seeing the Unseen…
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In this activity, learners observe, record and classify litter found in their immediate surroundings. They reflect on how this litter found its way there, how it can make its way to the marine environment and how to prevent this from happening.
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B2 The Root Causes of Litter
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In this activity learners study the most commonly found marine litter items according to their origin and types of activities that generate them. They study data, make graphs and discover how our collective trash becomes marine litter.
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B3 Diving Deeper: Critical Thinking and Media Literacy
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In this activity, learners work on one or more press articles related to marine litter. They analyse the causes, and think about the actors involved in terms of their responsibilities, values and benefits including possible ways of addressing the problem.
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B4 Taking Inventory of Our Habits
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In this activity, learners read the findings of published surveys on the general public’s opinions on various issues relating to marine litter. They then prepare and conduct their own survey of local residents from their school area so as to identify perceptions, attitudes and behaviours related to marine litter.
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SECTION C: EXPLORING THE IMPACTS
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C1 All Tied Up
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In this activity, learners “experience” what marine animals may feel when entangled in litter items. The activity can serve as a stimulus for further exploration on ingestion and entanglement and the threats they pose to marine life.
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C2 Animal Tales
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In this activity learners simulate reactions of certain marine animals that come into contact with litter items. Learners listen to descriptions of each marine animal’s characteristics and then try to identify the type of litter that may harm them.
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C3 How Harmful is It?
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In this activity, learners estimate how harmful certain marine litter items are based on their perceptions. Learners express their personal views and work towards reaching a class consensus. They then compare these outcomes with the relevant literature on the impact of marine litter on animals and humans.
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C4 Can we Afford Marine Litter?
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In this activity, learners work on a given case study presenting the economic implications of marine litter and analyse these implications taking into account a list of related parameters.
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SECTION D: WORKING TOWARDS SOLUTIONS
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D1 Policy Tools to Fight Marine Litter
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In this activity, learners are introduced to international efforts focused on fighting marine litter and pollution in general. They conduct research on major policy tools for the protection of the Regional Seas of Europe and study basic information including the aims of conventions and strategies, involved countries, targeted ecosystems, milestones and activities.
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D2 Envisioning the Future
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In this activity learners focus on a nearby natural site -a coast, wetland, etc.- that is important to them and envision how they would like this site to be in the future. They do not only reflect on the “envisioned” (desired, ideal) future of the site, but also on their role in shaping it. With this activity learners are encouraged to take ownership and responsibility for their behaviours and actions.
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D3 Opportunity for Change
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In this activity, learners reflect on what may keep them from acting in a more environmentally responsible manner. They identify their reasons and personal motives and think about the best way to overcome these barriers. Afterwards, they commit to a “greener” routine for a set period of time and monitor their new habits.
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D4 Joint Action!
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In this activity learners organise a clean up project in their local area in collaboration with the municipal or state agency responsible for the site. Learners will ‘adopt’ this site and seek to inform the local community on the impact of marine litter and how to keep the site clean.
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D5 Going Public!
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In this activity, learners analyse visual messages of environmental campaigns and gain insights into how visual means are constructed to influence behaviour and decision making. Furthermore, they design and organise their own awareness-raising campaign or event in their municipality, school or local beach, etc.
Exrra Literature: Interested educators may find useful also this list of open free to download teaching and learning resources targeted in teaching about marine litter. Acess list in Exhel. | https://marlisco.eu/education.ga.html |
Labels
Monday, March 18, 2013
Trickster Part 1
Trickster is a character in the Worm-verse who presents a variety of special challenges and questions for JAGS.
His basic capability is that given two objects "within his range" (which is considerable) of roughly equal size and mass, he can teleport-swap them with each other. He can do this "instantly" (the closer, the faster) and can, for example:
Swap his team, who is surrounded, with various gun-men surrounding them at the time of fire.
Swap himself with your friend--so as you are about to hit him, you wind up hitting your friend.
Swap a garbage-truck sized monster with an actual garbage truck.
More mundanely, teleport himself or someone else, away from or into danger if there's a mannequin or something available to swap.
There's more--but that's enough to start with.
Teleportation In JAGS
Teleportation in JAGS comes in three or four flavors. There's Tactical Teleport which is just an expensive form of movement and lets you teleport around as a long action (meaning if you teleport away or teleport close to a combatant they can hit you on the way in or out). This is "safe" in terms of the game rules (it doesn't overbalance combat).
There is Strategic / Long-Range Teleport (and gates) which let you cover long distances--again, as a long action.
There is Flicker which is basically the "blink" power which lets you move in or out of combat before you can be hit (it still costs an action) and lets you 'teleport-dodge.'
There is Snatch which lets you teleport someone or something to you.
There is no "swap" power.
How The Game System Treats Teleporting People
Teleporting other people is usually "pretty bad." Sure, maybe you're teleporting your buddy out of danger--but if you can teleport enemies--and, say, teleport them a pretty good distance--then you could teleport them to prison (an inescapable prison--or, I dunno, the Phantom Zone). If that's extreme, how about "up in the air" (if they can't fly or take the fall easily).
If it has to be from one solid ground to another (which isn't terribly unreasonable) then you, at very least, could have an iron box or something to teleport them into. Put a thick lexan window in it if you have to be able to see the target zone.
The way we handle doing unpleasant things to people that doesn't involve outright damage is with a Resisted Attack. This compares your attack's Intensity and their Damage Points and ADP and there's a resisted roll. The more you succeed your roll by (the better you roll) the greater you can screw them over. This is how Mind Control works. This is how Fear powers work. It's how nerve toxins work--and so on (disease, trapping someone in another dimension, and so on).
Resisted Attacks go from A+ (where any success is death or close to it) (Death Ray) to D+ where the best success still leaves someone able to flee, usually (weak tear-gas). There are some pretty good guidelines for making up Resisted Attack levels (there are four) and assigning a letter-grade and figuring out the cost.
Players are expected to be able to do that with some GM assistance--so having a Teleport Other power isn't too hard to figure out.
How bad is the worst case? Well, it's probably distance based in this case. Probably the best roll gives a success when the target is still at an extreme range. It could also be the level of match necessary (a really good roll allows a less-close swap).
NOTE: This changes two things about the character right away. (1) The power's ability is moderated by how bad-ass the target is (so Trickster probably cannot Swap Crawler--a villain the size of a garbage truck--unless he has a very high power) (2) It does not "always work." It can fail on him--something that doesn't seem possible in the Worm-verse.
These rules are here because (a) it's a game--so things that always work on opponents are generally not a big part of the terrain and (b) the based-on-damage-points construction makes the same "Cause Fear" power that works on mooks ineffective against Darth Vader even if the build the GM went with didn't include some special anti-fear powers. I can discuss this more--but it's part of the theory that we'd prefer simpler characters to complex characters and do not want to have large lists of defenses just to make sure that characters don't fall prey to unusual attacks at every turn.
Teleporting Two People
The above power would work fine for just teleporting someone somewhere (a "Beam Me Up" power). However, that's not how Tricker's power works--it hits two objects at once. We could model this as two to-hit rolls, but that doesn't really do the power the way we'd want to. That's certainly not how it plays (and that would suck up a lot of actions).
The most likely way to do it is to treat it as Area-Target with Selective fire. This is used for "smart bomb" style attacks where you can damage just-your-enemies. In this case it can hit "everyone" and then Trickster can pick and choose sets of two people to swap. This makes it (right now) about 1.5x more expensive.
We need to determine if this is the right call: if it was more cost effective for Jack Slash to buy Area-Target, Selective with his knife than to buy extra attacks every other Round that's probably not the behavior we want to encourage. We like having extra attacks every other Round.
But so far, this is how we're doing it.
Teleport As a Defense Or In Response To An Offense
So now we get to the situation where someone says "I shoot Trickster" and he says "I swap your buddy with me and you shoot your friend." This is using the power as (a) a 'Blocking' action. Usually when you block an attack or teleport-dodge out of the way, it just misses (the GM can try to determine where the attack goes--but even if there is another character "roughly in the line of fire" it is in no way guaranteed to hit that target. It is also using it as (b) an attack on someone else when a person shoots at you.
This is a general violation of the JAGS battle rules. However, there's a way: Damage Fields are things like being electrified, or being on fire, or have acidic blood or whatever. When you are hit, they trigger and, usually, damage the attacker.
This is what Trickster has--with the exceptions that: (a) he does have to declare an action unlike a Damage Field--but it's a blocking-style action so he can do it when attacked and (b) it triggers the Area Target so he can, in response to an attack, spend REA on a "block" and then swap groups of two as he wants--if he can make the rolls necessary to do it--which he probably can--all his points are there.
NOTE: to swap someone into the line of fire you probably need a higher-level success than swapping them just to a location.
The 4 levels of success would probably look like:
Standard Level: Target is Teleported
Major Level: Target will miss with an attack (necessary as a Block)
Critical and Catastrophic Level: Target is hit with incoming attack or targets the wrong person.
This rates a B+ which is fairly "kind" to him since directing other's attacks at teammates is pretty effective.
NOTE: this configuration allows him to react to attacks on his person. He can (and would) buy Bodyguard to react to attacks on other members of his 'team.'
What Does This Cost
Right now, let's assume he puts about 64 AP into it--an astonishing half his points. The Rating for Swap is B+ and it has a delivery system of "6" which is Area of Effect Selective. When we add usable as Block Defense that's probably / 1.3. This means:
For 8 Archetype Points he gets 14 Intensity.
With 64 AP invested he gets 111 Intensity. That's ... a LOT.
It's not enough to do a garbage truck though (although he can swap any of the characters created).
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We had the good fortune of connecting with Mike Habs and we’ve shared our conversation below.
Hi Mike, how have you been keeping yourself busy during quarantine?
Lately I’ve been able to work on a lot of the little things and the projects I’ve been wanting to get around to, but haven’t always had the time. One of them was making my own paint from scratch. I’ve been able work through the foundational elements, and it’s helped me create a lot of new visual effects. I’ve also had more time to just clean and organize my studio efficiently and get more of the small things in order – it’s not always exciting, but it’s helped me think through and complete my new work much more effectively for some weird reason. Focusing on maintaining simple improvements like these has helped me take the work into some new directions that I’m really excited about. It’s been a very difficult time all around, but reminding myself that this will pass, and trying to use the time productively and work towards new ideas has helped keep me at ease.
Let’s talk shop? Tell us more about your career, what can you share with our community?
My work as an artist/painter for the past few years has mainly focused on trying to visually communicate or transcribe the ideas behind punk rock music. The work itself emphasizes my appreciation of modern street art and graffiti culture along with different aspects of fine art. During the creation process, I look to metaphors within the songs, analyze the lyrics, incorporate them in hidden ways, and try to map out the overall feeling I take away from the music.
In terms of subject matter I tend to search for songs that resonate with my personal life/environment, and ultimately try to transcribe how the song feels. Whether painting a piece in the studio or on the side of a building outside, creating the paintings and videos keeps pushing me to challenge myself in unique ways and help the work evolve over time.
Quarantine and lockdown has been a very tough time for everyone. The main thing I would want to share right now is to just try and use the time to focus and develop something you really enjoy doing and will be better off for in the future. Whether it’s drawing, learning, or spending time with your family, when this is all over that thing hopefully that thing can then become a bigger part of the future.
A mural of Mike’s and his artwork is currently on display at the W Hotel (W Beverly Hills). His work was recently featured in “From Street to Cotemporary” (alongside Chaz Boroquez, Moncho 1929, Jose ‘Prime’ Reza, Danny Minnick, & Carlos Ramirez), has been archived in the Stonewall Museum, on the set of NBC’s “Will & Grace,” and exhibited during Art Basel Miami 2017.
The Shoutout series is all about recognizing that our success and where we are in life is at least somewhat thanks to the efforts, support, mentorship, love and encouragement of others. So is there someone that you want to dedicate your shoutout to?
When I came to Los Angeles the murals and artwork from Moncho 1929 I would see on the street were a massive inspiration. His imagery, aesthetic, and the concepts behind his work really encouraged me to always keep pushing my style into new and unfamiliar territories. The advice and support along the way he’s provided has really helped keep me going and recognize the value in hard work, consistency, and persistence. Other artists along the way like Chaz Boroquez, Shepard Fairey, This Is Addictive, Casper Brindle, Prime(K2S), and CAB(K2S) who have taken the time to listen and offer advice have also each brought unique perspectives to learn from and I’m so damn thankful for each one of them.
Finally, Donato Sepulveda from Hubble Studio is a close friend of mine who has helped me significantly over the past few years, helped me avoid many headaches, and navigate the crazy waters of Los Angeles. Thanks homie. The support from all of my family, friends, fans, and galleries has been my fuel since the beginning and to be honest, every bit of it really helps – so a huge thank you to everyone that’s helped me get here! | https://shoutoutla.com/mike-habs-artist-painter/ |
Army Corps of Engineers deployed to help fight coronavirus
Army Corps of Engineers is headed to New York to meet with Gov. ... Department of Housing and Urban Development during the Clinton administration, wants to use the Army Corps to help retrofit unused buildings, ...
Timothy J. Rafter
Rafter had been employed as a group leader by the Army Corps of Engineers at the Troy Lock and Dam, was previously employed at the N.Y.S.
New York projects get $621 million federal windfall
Army Corps of Engineers to work on Black Rock Channel between Buffalo and Tonawanda, and $6.2 million will support health-related facilities and equipment at Clarkson University.
Cohoes floating solar array plan inspires federal legislation
Army Corps of Engineers and the Bureau of Land Reclamation will study the feasibility of placing floating solar panels on their reservoirs and make the study results public.
Emmet Joseph McNamara
Army Corps of Engineers.
Great Sacandaga RV plan gets park agency's OK
Army Corps of Engineers and National Grid, Lynch said.
Port of Albany board chair named to Bethlehem IDA amid tensions over Beacon Island
Army Corps of Engineers remains the lead agency for the National Environmental Policy Act review process and final review is still needed. 106631457_112322 beaconisland Work resumes on Beacon Island at the site ...
Commentary: Old problems shouldn't stall clean energy progress
Today, the Army Corps of Engineers and the National Marine Fisheries Service are evaluating plans being developed to both secure the remaining fly ash and move forward with the project.
Letter: Champlain Hudson project dangerous for river life
The National Marine Fisheries Service and the Environmental Protection Agency urged the Army Corps of Engineers to deny or withhold a dredging permit associated with a 500-foot wharf and expressed concerns over ...
Port of Albany walks away from $29.5 million for wind turbine project
Army Corps of Engineers.
Thomas E. Orsini
Army Corps. of Engineers in Berlin, Germany from 1980 - 1984 and was honorably discharged with the rank of captain.
Agencies flag port's wind tower site over fish, wetlands
Army Corps of Engineers on the permit, which would allow it to move forward with construction of a 500-foot wharf at Beacon Island, the 82-acre waterfront parcel where towers will be assembled before being ...
How fast should we wean off of fossil fuels? Some look to Europe, others say look at the climate
The builders, though, recently said that line would likely be delayed from 2025 to 2026 due to supply chain snags and regulatory hurdles.And here in the Capital Region, a planned factory for wind turbine towers ...
Conrad Hoffman
Army Corps of Engineers in both Germany and Vietnam. Connie was former city engineer for Troy and Mechanicville and town engineer for Stillwater. A professional engineer and land surveyor, he was a Fellow in the ...
Cement plant owner is conducting study on waste-to-fuel
Army Corps of Engineers That, however, has environmentalists worried. ... Army Corps of Engineer’s Engineer Research and Development Center is spending $3.4 million to work with Geocycle, studying how debris ...
Kayaking the Hudson Eagles Recreation Area
Army Corps of Engineers began altering the river to create and maintain a shipping channel.
Sleepy Hollow Lake fears solar threat to water
Army Corps of Engineers still needs to approve their plan and the runoff issue should be part of the study.
Kingston's reimagining of its waterfront gets Sen. Schumer's backing
Army Corps of Engineers to re-work the bulkhead along the creek to stabilize the shoreline and prevent flooding. Schumer set the stage for this investment by securing a $100,000 grant for the Corps of Engineers ...
William T. Brennan
Army Corps of Engineers and a veteran of Operation Desert Storm, peacefully entered life eternal on February 8, 2022. ... As a young man, he joined the 411th Engineer Brigade, a major combat engineer command of ...
Greene County solar farm gets state OK
Army Corps of Engineers approval since part of it is in a wetland. [email protected] 518 454 5758 @RickKarlinTU solar panel.JPG Hecate Energy received state approval Tuesday for a 50 MW solar farm it wants to build in Greene County. | https://www.timesunion.com/search/?action=search&channel=business&inlineLink=1&searchindex=solr&query=%22Army+Corps+of+Engineers%22 |
FEBRUARY 18, 2021 | 7 p.m.
register by 2 p.m. february 18
Award-winning composer and pianist Daniel Kelly brilliantly reinterprets texts from Shakespeare’s most beloved plays as lyrics for original jazz songs featuring Nicole Zuraitis’ powerhouse vocals. The audience will not only enjoy a live, concert performance but will engage with the artists in real-time to collaborate on work!
Master class with the artist
FEBRUARY 19, 2021 | 12 p.m.
register by 10 a.m. february 19
In a made-for-us workshop, Kelly will instruct and mentor collaborative composition in a unique professional development experience that any musician, actor or teacher will appreciate. A maximum of 25 spaces are available to reserve. | https://usao.edu/arts-and-culture/dwpas/20-21-shakespeare-in-jazz.html |
AN intriguing piece developed for Pulse, the City of Culture theatre legacy project, returns in an updated guise in Dance Limerick next week.
The theatre-contemporary dance piece, (Allow) Everything Sometimes, evolved from the a project developed by dance artist Nora Rodriguez, in collaboration with Shane Vaughan and Kevin Kiely Jr, which was performed in the Red Cross Hall last year.
The piece was eclectic and dreamlike - unsurprising to discover the idea emanated from a dream that Rodriguez had - but no less compelling given the central performances of three very impressive performers, meeting at the intersection of dance, poetry, theatre and film.
Ms Rodriguez explained that fraternal ties, memories and death were the themes explored, inviting the audience to “explore all avenues of creation within a framework of impermanence”.
“Things do or do not last. What shifts them back into the fold of memory, or of unknowing? What use is the written word in darkness, or the spoken word in silence?
“The piece does not seek to answer these and other questions, but to highlight their existence, allowing room for further exploration by the audience, so that they can reach their own interpretation or conclusions. Shane, Kevin and I hope that, with our diverse performance skills of dance, poetry, theatre and film, we are creating something moving, thought-provoking and unique for the audience to experience.”
(Allow) Everything Sometimes takes place in St John’s Church on June 11 and June 12 at 8pm. See www.dancelimerick.ie.
Pictured at the Irish World Academy of Dance, UL were, Dr. Sandra, Inspector Oliver Nally and Anna Banko Szumacher who will perform at the concert | PICTURES: Alan Place
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Archive for the ‘Brainwash’ Category
When I first started blogging I thought I’d write only about how a GIS developer might go about programming applications. But in reading recent blog posts, I realized I’m missing half the story. So, here are some thoughts on how GIS developers get programmed.
As discussions between adherents of different programming packages and methodologies become heated, I find it helpful to look at several things: Nostalgia, the Stanislavski Method of Physical Action, and the Stockholm Syndrome.
Nostalgia
This word was originally intended to describe what we now refer to as “Post Traumatic Stress Disorder“. I’ve seen many a user succumb to this when a sofware package they know & love gets replaced by something “better”. When Arc8.0 came out many programmers became nostalgic in the original sense of the word. I still occasionally hear people wish for the return of AML … but lately this has been nostalgia in the modern sense of the word.
This method of acting involves going through a lot of repetitive physical action in rehearsal to get inside of an emotion. I wonder though, when people repeat the same series of physical keystrokes/mouseclicks over & over if somehow there’s a common emotional state at which they arrive?
Sometimes, at first, using new software can make me angry. In looking back, the hardest to learn software has often turned out to have the most lasting impact. I haven’t used vi in years. It was hard for me to learn, yet I remember it, and wish I could use those keystrokes in editors today. I’d like to think these fond memories are based on sheer utility, but I suspect there’s something else going on, perhaps as a hostage I’ve become loyal to my captor?
We’ve all heard the jokes about “drinking the koolaid” of a particular software vendor. Seriously though, maybe we should think about what sort of vulnerabilities to mass hysteria evolution has wired into our genes as we seek recognition from our group’s alpha male.
In sum: not only do we program software – software programs us. We need to be conscious of this.
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Dubai: Major solvency and liquidity indicators showing the resilience of the UAE’s financial system amid the COVID-19 pandemic have remained robust, according to the UAE Central Bank’s Financial Stability Report (FSB) for the year 2020 . The report provides a comprehensive overview of the development of the UAE economy and financial system in 2020. CBUAE projects that the UAE economy is expected to recover during 2021 and 2022 following the effects of the COVID-19 pandemic. CBUAE expects the United Arab Emirates’ GDP to grow by 2.4 percent in 2021 and 3.8 percent in 2022, and that non-oil GDP will expand by about 4 percent in both years.
TESS mitigation risks
According to the findings of CBUAE, the Targeted Economic Support Scheme (TESS) was effective in reducing the risks of the pandemic by ensuring continued credit flow and helping individuals and companies affected by the effects of COVID-19 to address temporary problems. with the repayment of debt. . During 2020, the CBUAE closely monitored developments in the banking sector, particularly asset quality and the growth of lending. CBUAE’s financial stability report shows that the UAE banking sector remains resilient, with sustained lending capacity.
“CBUAE has worked tirelessly to ensure that important sectors of the country’s economy are able to withstand this crisis. CBUAE’s launch of the Targeted Economic Support Scheme came at the right time and ensured that banks could ease funding and liquidity pressures and maintain their lending capacity, providing the necessary assistance to individuals and businesses, ”said Khaled Mohamed Balama, Governor of the Central Bank of the UAE. The effects of the pandemic led to higher bank costs, lower operating income and lower profitability. The total capital and liquidity buffers remain well above the regulatory requirements.
Stress tests
CBUAE said it conducted regular top-down solvency and liquidity stress tests using a number of hypothetical adverse scenarios at different stages of the COVID-19 crisis. The stress test results indicated that the UAE banking system has solid capital and liquidity buffers to withstand the significant hypothetical shocks. “Our support continues, as most of the support measures provided by CBUAE will remain until 2021. “Together with the financial sector of the UAE, we are paving the way for gradual economic recovery and remain vigilant for the challenges ahead, while still maintaining the UAE’s financial and monetary stability,” said Balama. A separate section of the report is devoted to climate risk, which is at the forefront of regulatory focus worldwide and in the UAE. The financial stability report emphasizes the importance of the UAE banks considering integrating the risk of climate change into their lending and operating processes. Detailed information on the payment systems operated by the CBUAE is also included in the report, as well as the benefits and risks of new technologies and cyber security. The report emphasizes the importance of adequately managing risks associated with new technologies and increasing competition from innovative market entrants. Continued focus on risks is important as the UAE strengthens its role as the largest FinTech hub in the Middle East. The financial stability report also covers the other key sectors of the UAE financial market, such as the insurance sector, finance companies, exchanges and capital markets. | https://emirati.today/pages/uae-central-bank-finds-the-banking-sector-resilient-in-its-new-financial-stability-report.html |
Greenpeace called upon the 188 states at the 8th meeting of the Convention on Biological Diversity (CBD) being held in Curitiba, capital of the Brazilian southern state of Paraná, to maintain the moratorium on the field trials and commercial releases of Terminator seed technology which was agreed six years ago.
"Some states like New Zealand along with a number of biotech companies now want to sneak language into the text that would actually allow for a ‘case by case’ assessment of such technologies to open the door to field testing, while they officially claim to uphold the moratorium", said Greenpeace International’s Benedikt Haerlin from the Convention.
"This technology threatens biodiversity, farmers rights and the environment – what is needed is a ban on these technologies and not an erosion of the moratorium under the pretext of scientific impact and risk assessment," said Haerlin.
Terminators, or GURTS (Genetic Use Restriction Technologies), are a class of genetic engineering technologies which allow companies to introduce seeds whose sterile offspring cannot reproduce, preventing farmers from re-planting seeds from their own fields.
The seeds could also be used to introduce specific traits which would only be triggered off by the application of proprietary chemicals provided exclusively by the same companies.
Terminator technologies would allow companies to prevent the public from accessing the results of future breeding, which is the present rationale of plant breeders’ rights and even patents. The moratorium adopted by the Convention on Biodiversity in 2000, discussed the need for more information on the socio-economic, cultural and environmental impacts of these technologies.
"Nothing in the past six years has changed the status quo. Rather, all the additional information we now have on the impact of these technologies confirms that sterility is not a viable means to protect agricultural biodiversity, that it poses a potential threat to food security and that it would have severe impacts on the livelihoods of farmers around the world," concluded Haerlin. | https://www.brazzil.com/5876-greenpeace-urges-in-brazil-ban-on-terminator-technologies/ |
Ethical framework has been developed to guide companies on vaccine policy
Five central questions emerged from discussions convened by the Gibs Centre for Business Ethics
Only 49% of South Africans say they will get vaccinated within a year, the Edelman Trust Barometer reports. Fearing exposure to the coronavirus, other employees do not want to be in the same workplace environment. Customers have similar fears.
How can and should companies respond? Make the vaccine mandatory and fire unvaccinated staff, overriding individual rights? Ignore the concerns of other staff and customers, possibly endangering their health, and risk alienating them?
These are questions that powerfully express a classic moral dilemma: what do you do when individual freedom collides with the public good? Discovery’s recent decision to order all employees to be vaccinated was a decisive and bold response. Should other SA companies follow Discovery’s lead?
As with all moral dilemmas, a simple or single answer is elusive. Yet a morally rigorous examination of various courses of action is possible and necessary. Corporates need to justify their decisions and actions in the public domain, citing reasons that have normative force. This is where conversations between corporate leaders, ethicists and health professionals become invaluable.
The Centre for Business Ethics of the Gordon Institute of Business Science (Gibs) convened and facilitated discussions between SA corporate managers and public health and business ethics scholars from Harvard, Vienna and Warwick universities. The result is an ethical framework that encourages an organisation’s decisionmakers to explore and debate five key questions to achieve the most appropriate response. This response may end up being similar to or different from Discovery’s.
The questions are the following:
Is our decision legal: does it respond to local laws and societal demands?
Does it adhere to the company’s policies and values?
Can it pass the “newspaper test”: if revealed in the public domain would it tarnish the organisation's reputation and stakeholder trust?
Are we following the “golden rule”: do unto others what you would have done to yourself, putting ourselves in the shoes of affected parties.
Would we sleep soundly at night after making the decision?
The tension between individual freedom and the public good is expressed in law. SA’s constitution enshrines the rights to bodily integrity and the freedom of religion, belief and opinion. Compulsory vaccination would clearly encroach on these individual rights. Companies also need to consider the Employment Equity Act, which protects employees against unfair discrimination, including on the grounds of belief.
Companies are equally obliged under the Occupational Health & Safety Act to take reasonable and practical steps to ensure a safe working environment underscored by the foundational medical principle of “first do no harm”.
Halton Cheadle and Glenda Gray, prominent experts in law and public health, respectively, have defended mandatory vaccination on constitutional grounds. Their argument is based on employers’ health and safety obligations, with the premise that no constitutional right is absolute. The constitutional debate will inevitably continue and intensify.
Core values
In the absence of a clear legal answer, can company values help establish a moral imperative? Discovery’s decision was explained by CEO Adrian Gore in terms of the organisation’s core purpose and values: “to make people healthier and to enhance and protect their lives” and “acting as a force for social good”. Companies could also strengthen the capacity for some of their unvaccinated employees to work remotely, but this is not always possible in the case of front-line staff.
How could a company’s response pass the newspaper test? Some employees are “vaccine hesitant” for what they believe are genuine health concerns. As such, companies have a responsibility and opportunity to engage respectfully with employees and address the reasons for vaccine hesitancy with educational programmes — and to do so publicly.
But what if some remain opposed to vaccines despite authoritative information? Putting oneself in others’ shoes is crucial to act fairly towards all the stakeholders of the company, as well as other fellow citizens. High vaccination rates may lead to herd immunity — is it fair that all should benefit through the actions of some? Can one really defend “opting out”? Surely every citizen has duties towards the vulnerable who, for reasons of medical contraindications, cannot be vaccinated? Are we not all responsible for protecting life, safeguarding our health system and supporting struggling businesses?
The final question should be whether the response chosen allows one to sleep soundly, that one can in good conscience say there are good ethical reasons for the decisions and actions taken. Ethical frameworks do not aim to generate straightforward or pristine solutions. Their purpose is rather to generate a process of broad stakeholder engagement and rigorous decision-making, enabling organisations to develop their own morally nuanced approaches to the conflict between individual freedom and the public good. | |
Improving the radiological image
Prof. Rui Almeida gives an analysis on his research which was applied to general radiology exams.
The main goal of this research was to assess the effect of an internal and participative intervention aimed through the implementation of best practices and quality improvement applied to general radiology exams. Therefore, a quality improvement cycle was conducted in a radiology department considering a total of 5 criteria and 13 sub-criteria of quality assessment. At baseline, 11 of the criteria/sub-criteria presented quality failures but during the revaluation the improvements were significant in 8 of the criteria/subcriteria. So, the internal quality assessment cycle has been useful and effective as a routine tool for continuous quality improvement of the healthcare process.
The access to healthcare services has increased worldwide, but the quality of care provided to the patients still is a global health challenge (Scott et al. 2014). In this context, an imaging department (public or private), has a great importance in a networked organisational structure, since its contribution to the clinical diagnosis is crucial in most cases (Macedo and Rodrigues 2009; Almeida et al. 2010). Thus, the need to provide better healthcare services to patients goes through the implementation of quality management programmes, defined as "the set of structural elements and activities which specific purpose is the continuous quality improvement" (Saturno 2008; Juran et al. 1990).
Three main starting points can be identified in quality management programmes aiming the continuous quality improvement of the radiology departments, in particular, 1) quality improvement cycles, 2) quality monitoring and 3) quality planning (Saturno 2008; Palmer 1990). In the specific case of quality improvement cycles, they start with the identification of an opportunity for improvement (quality problem) in some aspect of the offered services, with the purpose of "taking advantage" of the opportunity to improve or "solve" the identified problem (Saturno 2008; Juran et al. 1990; Figueiredo and Gama 2012).
The quality of the product/service provided in a radiology department consists on "obtaining precise/ accurate diagnostic information with the lowest dose of exposure to all hazardous factors that is reasonably achievable and at a minimal, realistic cost." (Erturk et al. 2005). So, repeat exposures should be avoided due to poor image quality, because it increases the risks to the patient and the costs to the department, and, at the same time, can reduce t he accuracy of image interpretation, and may even result in dissatisfaction among patients, workers and the institution itself (Erturk et al. 2005; Felício and Rodrigues 2010).
General radiology procedures continue to be the one with the highest number of examinations performed worldwide (around 3.6 billion examinations per year) and is expected to continue to increase due to the introduction of new digital technologies and the increase in the number of equipment (UNS CEAR 2008; Teles et al. 2012). Thus, we should have a concern with the quality of this procedures, especially with the image quality and the technical parameters, through their optimisation, since they influence the quality and also the patient safety.
Therefore, considering that the general strategic lines of a radiology department must ensure processes that correspond to the patient needs, performed according to the best available scientific evidence, and to develop a culture of continuous improvement through teamwork and the involvement of all department stakeholders, the present study consisted in evaluating the effect of an internal and participative intervention to implement the best practices and improve the quality applied to general radiology examinations. In order to achieve this goal, a quality improvement cycle directed to the radiological image was carried out in order to maximise its quality based on criteria and interventions defined by the radiographers themselves.
Materials and methods:
Based on a quality improvement cycle with a quasi-experimental design before-after, following the SQUIRE (Standards for Quality Improvement Reporting Excellence) guidelines, six sequential methodological steps were developed in a public radiology department in Portugal (Taylor et al. 2013; Portela et al. 2015):
- Identification and prioritisation of the quality problem: 6 radiographers
performed a qualitative analysis using the nominal group technique adapted with
two other techniques: 1) brainstorming on the possible problems and 2) preliminary
and final voting using a prioritisation matrix focused on the following
criteria: problem frequency, gravity, dependence on internal efforts to solve
it and solution costs. The quality of general radiology exams was prioritised.
- Analysis of the problem causes: A cause-andeffect diagram and a qualitative
analysis of all potential causes of the prioritised problem were performed.
This study was focused only on the measurement of the causes in which there was
scientific evidence of its relation to the problem and that would allow to
develop criteria and indicators to measure quality.
- Development of quality criteria: A group of 4 experts in the radiology field
developed a list of quality criteria and sub-criteria related to the image
quality of general radiology, using a format that included its definitions,
exceptions and clarifications. Face, content and criterion-related validity were
analysed and considered adequate for all the criteria. Moreover, through a
pilot study and using a sample of 30 exams and 2 independent evaluators, all
criteria were identified with consistent reliability (general agreement
observed above 95% for all criteria).
- Evaluation of the quality level: Systematic random samples and convenience
samples (n=60) were used considering a total of 5 criteria and 13 subcriteria of
quality assessment. Data were collected using different data sources according
to the analysed criteria. The initiative of the evaluation was decided by the
radiographers (internal evaluation), in which they were responsible for the
data collection, performing a cross-evaluation.
- Quality improvement intervention: It was based on a structured and
participatory planning method. The ideas generated to answer what should be done
to improve the quality of general radiology examinations allowed to distribute,
through an affinity diagram, four main groups of actions to be implemented: 1)
Radiographers training on "dosimetry and technical parameters to be used
according to the anatomical region under study" and "image
post-processing”, 2) Physicians training on “national and international
legislation about the principles of Justification, Optimisation and Dose
Limitation” in relation to the prescription of radiological examinations, which
should contain adequate clinical information so that radiographers can
evaluate, programme and perform these examinations according to the patients
clinical situation, in order to obtain the best diagnostic images, 3)
Organisation of work procedures and establishment of standards related to image
postprocessing and 4) Dissemination of the study results through the
elaboration of a storyboard (with the inclusion of the activities progress and awareness-raising
actions to monitor the results). After establishing these actions, a Gantt
diagram was used to supervise their implementation.
- Revaluation of the quality level: 18 weeks after the improvement intervention
and 24 months after the initial evaluation, a new quality level evaluation was
carried out based on the same assumptions expressed in step 5.
Results
Initial evaluation of the quality level
The level of compliance with the quality criteria under study was evaluated for a confidence level of 95% (Table 1) and it was observed that the percentages of compliance in the initial assessment were between 33.3% and 100%. The quality criteria with the highest levels of compliance were the following: "(3.1) Positioning of the patient and the anatomical region under study" and "(3.7) Collimation", both with 100%, and "(3.4) mAs" with 98.3% (C.I 95%, 95.1-100). On the other hand, the quality criteria with the lowest levels of compliance were: "(5.1) Adequacy of the “S” value", "(1) The radiological examination prescribed by the physician should contain adequate clinical information regarding the anatomical region under study" and “(5.3) Inclusion of the initial letters of the name and surname of the radiographer” with compliance rates of 33.3% (C.I. 95%, 21.4-45.2), 50.0% (C.I. 95%, 37.3 -62.7) and 68.3% (C.I. 95%, 56.5-80.1), respectively.
Analysis of quality defects and intervention prioritisation
A Pareto diagram was constructed according to the initial evaluation data, where it was possible to identify the most problematic quality criteria, called "vital few from the trivial many" according to the "Pareto principle". Thus, in the initial evaluation, 4 quality criteria (5.1, 1, 5.3 and 5.4), which together represented 60.92% of the total defects found, were considered as priorities in the actions/interventions to be established to improve quality.
Revaluation of the quality level
After completing the quality improvement intervention plan, there were improvements (absolute and relative) in all quality criteria that had defects in the initial evaluation.
The minimum relative improvement was 19% for quality sub-criteria "(3.4.1) Automatic Exposure Control" and "(3.4.1.1) Ionisation Chambers", and maximum for the sub-criteria "(4) Diagnostic reference levels", "(5.4) Radiographic Markers/Indicators" and "(3.4) mAs" with 79%, 88% and 100%, respectively.
It was found that improvements in quality levels were statistically significant (p <0.05) in eight of the criteria and sub-criteria. Considering that two of the quality criteria already had 100% of compliance in the initial evaluation, this represents a significant improvement in more than half of the total criteria evaluated.
Considering these data and those in the initial evaluation, it was possible to construct the before-after Pareto graph (Figure 1), where we can observe and compare the values of the defects in the two evaluations performed. It was possible to verify that quality criteria 1, 5.1, 3.3 and 5.3 represented 66.67% of the noncompliance cases verified in the re-evaluation. Thus, in a new intervention planning, these should be the main criteria to be considered in establishing the actions and tasks to be performed, not neglecting all others that still presented defects.
Through Table 1 and Figure 1, we can also observe that the total of quality failures decreased from 174 in the initial evaluation to 75 in the revaluation, which corresponds to an absolute improvement of about 43% (marked improvement area in the Pareto graph).
It was verified for the four quality criteria on which the improvement activities were most important during the intervention, statistically significant improvements ranging from 33% to 88%.
Conclusion
Although the use of quality improvement cycle in healthcare services is still rudimentary, especially in the radiology departments, the quality criteria based on scientific evidences and the results obtained by assessing their level of compliance, before and after intervention, demonstrated that the internal quality improvement cycle was useful to ensure better image quality through optimised and safer procedures.
Despite the fact that quality culture is still not properly incorporated in the analysed department, the use of this participatory method allowed to open doors to the implementation of quality management internal activities, with the inclusion of all stakeholders. A quality problem has been prioritised, which should continue to be the target of the evaluation cycle, but many others are identified and can be now analysed using the same methodology since the improvements were evident and most of them significant.
The rational intervention, based on data from an evaluation of valid and reliable quality criteria, the voluntary accountability of radiographers, and the audit and feedback of partial results, proved to be useful to improve significantly the quality of this healthcare service.
The development of evidence-based quality criteria has contributed to the improvement achieved, and the fact that the image quality is now higher has contributed to an increase in patient safety by reducing repeat examinations and more favourable conditions for performing better diagnostic imaging.
Despite the good results obtained, the improvement margin is still great. From the four quality criteria on which improvement activities were most pronounced during the intervention, three of them remain the most problematic criteria after re-evaluation, which can be explained in several ways. On the one hand, the other quality criteria have low levels of defects and, therefore, the margin for improvement is much lower. On the other hand, the resistance to change and the technical- scientific knowledge of some radiographers may have influenced the improvement of these criteria, which still have a good margin of progression.
Due to the great variability processes into a radiology department, caution is necessary in extrapolating the results of the levels of compliance with the quality criteria of this study to other services. However, regarding the effectiveness of the quality improvement cycle method, consistent statistical significance has proven to be a very promising, useful and effective approach for improving the image quality problem of general radiology exams, which will certainly bring benefits to other departments.
Key Points
- The
implementation of quality management programme is defined as "the set of
structural elements and activities specific purpose is the continuous quality
improvement"
- Strategic
actions of a radiology department must ensure processes that correspond to the
patient needs performed according to the best available scientific evidence
- In
this study, the minimum relative improvement was 19% for the quality sub-criteria
“Automatic exposure control” and “Ionisation chambers”, and maximum for the
sub-criteria “Radiographic markers/indicators” and “mAs” with 88% and 100%, | https://healthmanagement.org/c/healthmanagement/issuearticle/effects-of-an-internal-and-participatory-intervention |
Time Series Demystified - Understanding the basics of Time Series
Every one of us is familiar with Time, yet it is hard to define and understand it. Time is not something we can see, touch, or taste, but we can measure its passage. Physicists define time as the progression of events from the past to the present into the future. Whenever data or observations recorded at regular time intervals, we are looking at Time Series data. In this blog, I will try to explain some of the basics of the Time Series and how it can be used for forecasting or in the prediction of the future.
Table of Contents
What is Time Series?
Time Series Real-world examples
Components of Time Series
Classification of Time Series data
Mathematical model for Time Series Analysis
What is Time Series?
A time series is nothing but a set of observations taken at the specified time, usually at regular intervals. Time series is looking at data over time to predict or forecast what will happen in the future, based on patterns or trends that occurred from the previous time periods.
In machine learning, a series of statistical observations taken at a specified time is called a Time Series. The statistical set of data is then analyzed and used to predict the future.
What makes the Time Series model different from other types of predictive models, is that the prediction is based on a given time, looking at a sequence of observations over time.
We can always guess by looking at a trend on a graph that the trend will probably continue, but a Time Series forecast can give us a better-estimated figure for how long it could continue with the same trend.
Time Series Real-world examples
Time series is everywhere. The most common, basic example of a time series is seasonal sales revenue. During the holiday or festival season, the sales go up, and during the off-seasons, sales go down each year.
Another interesting example is, say we have a sensor device recording the number of vehicles that cross an intersection every 30 minutes. We can then use these numbers to predict the traffic at this particular intersection in the next 30 minutes. If the traffic is going to spike up, then the trip planning app could re-route the drivers to avoid delays and distribute the traffic load to other routes.
Other examples of time series in real-world are:
Stock price prediction
Weather forecasts
Population prediction using birth and death rate
Detection of anomalies in the field of Cyber Security
Sales/Production forecasting
Study of telephone/online traffic
Medical devices measuring and visualizing the vitals
and many more…..
Components of Time Series
Time series can be decomposed into four components, each expressing a particular aspect of the movement of the values of the time series.
They are: Trend, Seasonality, Cycles, Irregularities
Seasonal and Cyclic Variations are short-term fluctuations, whereas the trend is long-term movements and irregularities are unknowns.
1. Trend - this refers to the overall long term direction of the series
The trend shows the general tendency of the data to increase or decrease during a long period of time. It can either be upward, downward or stable depending on the tendency. The population, agricultural production, items manufactured, number of births and deaths, are some of the examples showing some kind of tendencies of movement.
2. Seasonality - this refers to the repeated behavior of data which occurs at regular intervals
The seasonality tends to repeat itself over a certain period of time. They almost have the same pattern during a period of 12 months. This variation will be present in a time series if the data are recorded hourly, daily, weekly, quarterly, or monthly.
Due to natural conditions like climatic changes or seasons, we can get this type of variations in time series. Few examples of this: production of fruits/crops depend on seasons, the sale of umbrellas and raincoats will be high in the rainy season, and the sale of electric fans and A.C. shoots up in summer seasons.
The effect of man-made conventions such as some festivals, holiday season recurs themselves year after year. During such periods, the sales and prices go up.
3. Cycles — this occurs when a series follows an up-and-down pattern that is not seasonal
The series is likely cyclical if the variations are based on previous values of the series rather than directly on time. For example, when the value of stocks goes up, it gives confidence in the market, so more people invest making prices go up, and vice versa, therefore stocks show a cyclical pattern.
4. Irregularities — this refers to strange dips or jumps in a series.
These variations are unforeseen, uncontrollable, unpredictable, and are erratic. Some of the examples are earthquakes, wars, floods, famines, and any other disasters. Currently, the pandemic is also a very good example of this variation. During this pandemic, many businesses either incurred a huge loss or made more profit. For example, online sales have really gone up whereas local shop owners faced a huge loss because of a decrease in sales.
Some of the examples of Time Series that I mentioned earlier are represented as graphs for better understanding.
Classification of Time Series data
The Time Series data can be classified into two types:
Data or measurements captured at regular intervals - Metrics
Data or measurements captured at irregular intervals - Events
In the examples shown above, all four measurements are captured at regular intervals depicting metrics.
Time Series data can be captured whenever an event happens regardless of the time interval. Event Logs and traces used for bug fixing and resolve issues are good examples of events.
Linear and nonlinear Time Series data
If we plot the time series data on a graph in accordance with time t, the pattern of the data clustering shows the type of trend. If the set of data cluster around a straight line, then the trend is linear otherwise it is non-linear (Curvilinear).
Univariate and Multivariate Time Series
The Time Series that has a single value at each time step is called Univariate Time Series. Eg, every day in the weather forecast.
The Time Series that has multiple values at each time step is called Multivariate Time Series. Eg, the latitude and longitude of the path of a car
Stationary and Non-stationary Time Series
If the behavior of the Time Series doesn’t change over time, then it is called stationary Time Series. These types of time series are really well suited for predictions. The reverse, which is non-stationary data is that that doesn’t have a constant behavior. The trend and seasonality sudden changes make it very difficult to predict. In such cases, we will have to train for a limited period of time.
Mathematical Model for Time Series Analysis
Mathematically, a time series is given as
Here, y is the value of the variable under study at time t. If the variable is observed at various time period t1, t2, t3, …, tn, then the time series is
Additive Model for Time Series Analysis
If yt is the time series value at time t and Ut, Vt, Xt, and Zt are the trend value, seasonal, cyclic, and random fluctuations at time t respectively, then according to the Additive Model, a time series can be expressed as
This model assumes that all four components of the time series act independently of each other.
Multiplicative Model for Time Series Analysis
The multiplicative model assumes that the various components in a time series operate proportionately to each other. According to this model
Mixed models
Different assumptions lead to different combinations of additive and multiplicative models as shown below:
Some of the terms that are used in the Time Series analysis are:
Noise - a complete set of random values that are not predictable and this type of data will not be of much use in prediction.
Innovations - the spikes in a Time Series that are unpredictable. In other words, they cannot be predicted based on past values.
Autocorrelation - is a type of serial dependence. Specifically, autocorrelation is when a time series is linearly related to a lagged version of itself.
To conclude, Time Series analysis is more useful because it uses past data to predict the future, which can be used in various different fields for planning and execution. I have explained the basics of the Time Series in this blog and hope this will be useful for people to understand it better.
Happy Analyzing! | https://www.numpyninja.com/post/time-series-demystified-understanding-the-basics-of-time-series |
Follow this link for full answer
Long story short, who killed Osiris and why?
Seth, the god of disorder, murdered his brother Osiris, the god of order. Seth was furious because his wife, Nephthys, had conceived a child, named Anubis, by Osiris. The murder happened at a banquet when Seth invited guests to lie down in a coffin he had made for the king.
Beyond that, who was Anubis wife? goddess Anput
As it, when did Osiris die?
Osiris ruled the world of men after Ra left the world to rule the heavens. He was murdered by his brother Set, who later dismembered his body and scattered the remains. The grieving Isis reassembled the parts and magically brought him back to life.
Why did Ra curse nut?
In the days before Ra had left the land, before he had begun to grow old, his great wisdom told him that if the goddess Nut bore children, one of them would end his reign among men. So Ra laid a curse upon Nut - that she should not be able to bear any child upon any day in the year. | https://amaanswers.com/who-was-osiris-married-to |
Related Info
Sites of historical events
The year of 2017 marks the beginning of centenary celebrations of the Republic of Latvia which will reach its culmination in 2018 and last for five years. The European Heritage Days in Latvia will contribute to celebration by bringing in spotlight sites of historical events – heritage sites and objects related to significant events and outstanding personalities on an international, national or county level . This category of cultural monuments demonstrates, perhaps most directly, that cultural heritage does not only comprise old buildings, paintings, sculptures, rocks, and discoveries. Our cultural heritage is the story of us, of human beings, our quality of life, and our values; it is a conversation about our future. It is through our heritage that we discover who we are, what we have accomplished, what we are capable of, and what we can expect in the future. Our cultural heritage gives us a foundation for understanding and discussion, and creates a bridge between history and people, between cultures, traditions, and beliefs
The European Heritage Days in Latvia are coordinated by State Inspection for Heritage Protection and supported by the State Culture Capital Foundation.
Information and programme in Latvian: http://mantojums.lv/lv/aktualitates/eiropas-kulturas-mantojuma-dienas/
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Hello, my name is Philip Guardione and I was born in Catania (Sicily-Italy).
After I graduated from the "Professional State High School" in my city, I already had it clear in my mind that I harbored a secret passion for cooking! That's why I decided to go to Milan and work as "sous-chef de cuisine" for one of the most famous international Chefs, Mr Sergio Mei in the Four Seasons Hotel.
I was lucky to gain the esteem of Mr Mei and his colleagues quite quickly. They appreciated in particular my passion for cooking and my good qualities of organizing in general. Ever since then I have been cooking with the same passion and enthusiasm for years in many famous restaurants and hotels, such as "Il Carpaccio" and "Taillevont" in Paris.
I have learned a lot of "secrets", and I am still improving my culinary knowledge every day. You know: you can gain really marvellous insights into a country's culture through its food!
Food is the âsoulâ of a country and both Italian and Sicilian cuisine are among the best in the world! I love sharing my personal recipes with people. For me it is quite an exciting experience to know that somehow you can take home with you a little bit of Italy, so please feel free to do it anytime! | https://www.newtravelservices.net/en/65-199-content/sicily/sicilian-gastronomy/our-chef?s=0&c=41 |
My personal existential doomsday clock ticked closer to midnight this week with the confirmation that while we devote and frustrate our energies trying to save endemic species like Māui dolphins here, unless humanity, takes dramatic action to change our trajectory, a million species across the planet are doomed.
An international panel of experts in the UN’s Intergovernmental Science-Policy Platform on Biodiversity and Ecosystem Services (IPBES), this week released a summary of an upcoming 1,500-page report on the state of biodiversity on Earth. They said that land use changes including deforestation and wetland loss; exploitation and extraction; pollution; climate change, and pests threaten every ecosystem and every species group everywhere around the world.
The report acknowledges that we’ve already accelerated species loss, reducing biological and ecological diversity and resilience beyond the scale of usual natural forces. Our collective change and extinction impacts, especially since the ‘great acceleration’ after the Second World War are of geological scale. While species take millions of years to evolve, none can withstand the ravages of homo-capitalist, modern economic ‘man’. As we increase access to the world’s remaining remote places like deep oceans and remnant dense forests, and as we discover new species of fish or plants, we develop new ways of harvesting and exploiting them. They are appropriated for commercial use, and invariably them and their ecosystems are diminished. Capitalist extraction is effective at taking but not so good at giving back. So we consume the wilds, create property rights to alienate labour, land, resources and life, churn it up to make consumer goods – actually bads, that are ultimately destined for a landfill or an ocean sink. We swallow up all that’s rare and beautiful, and leave waste and despoliation in exchange. The IPBES report said our adverse impacts put our future human existence at stake, as well as that of planetary diversity and processes. And sadly, we saw this coming, looming doom is no surprise. No wonder there’s an extinction rebellion. What we need is a revolution.
The Government’s announced Zero Carbon Act proposals show the inadequacy of multi-party Parliamentary democracy to make big changes when they’re needed. Conservative political forces resist change in their own self-interest. It is disappointing, but no real surprise, to see our best chance at legislating for binding greenhouse gas emission reductions, traded off as agriculture wins exemptions. Just at the time we should be shining a spotlight on the multiple levels of harm inflicted on Earth by meat and dairy farming, we’re making concessions to let them off the hook for methane emissions. Add nutrient enrichment and habitat loss, there’s a big ecological footprint in your milk and your steak. It’s really disturbing, and Orwellian, to hear Green Party co-leader James Shaw blaming urban motorists for climate change, to placate farmers. We might understand this of National, and of New Zealand First, but it’s as if the Greens are now apologists for mediocrity and a lack of environmental ambition. They’re overseeing the continuation of existing privileges, not with a bang but a whimper. If this is our nuclear-free moment, then that moment has already passed, unfulfilled, hope withered on the vine.
Because the underwhelming decision on climate change follows the disappointments of the non-binding marijuana referendum, timid welfare responses, the jettison of a recommended capital-gains based redistributive tax system, labour reform limitations, and KiwiBuild’s failure to deliver affordable homes, I’m too cynical to expect much improvement in frameworks to protect endangered species from extraction, waste or exploitation. There’s no real foreseeable solution to the plastic production problem, and the clean up of the coastal contamination from the Fox River landfill is mostly left to volunteers. There’s a certain inevitable trajectory to what population and consumption pressures are doing to the limited capacity of the planet. Even the most progressive governments seem to have little real power to front change that’s required to tackle the major – truly existential -problems of our time, to stand up to established sectors and systems, and to deflect destruction that’s already in train. If we struggle here in New Zealand to alter the domestic economy’s contribution to human inequality and species and ecosystems loss, there’s little prospect of averting the anthropocene’s impact across the world, in countries bigger or smaller, richer or poorer.
There’s no appropriately radical Parliamentary agenda here in New Zealand to question the growth paradigm that accelerates the biodiversity crisis as well as the climate change emergency.
In geological time scales, nature cares for no individual or species, and all shall go. Alfred, Lord Tennyson wrote in the poem “Memoriam’, ‘from scarped cliff and quarried stone, she cried, ten thousand types have gone, I care for nothing, all shall go’. But that humans have exercised their power to misuse and abuse nature so to leave it depleted and filled with plastic already, and to obliterate, and continue to threaten individuals, species, ecosystems and life, is an indictment on us, and on capitalism.
When you look at the way people and interest groups react when it’s suggested that they should pay more tax to address inequity, or to internalise environmental costs, or that they should eat less meat to ease the ecological burden on land and water (and animals), it’s clear few are prepared to sacrifice much for the greater biotic good. Heaven forbid that they might forego cell phones to save ancient rain forests in the Congo. Or products with palm oil to save Orangutans, or give up net caught fish for Māui and Hector’s dolphins. Government response is inadequate, but it reflects the apathy of humanity who want their cake and to eat it too.
Photos from space show us how fragile and finite is our beautiful planet. But if survival depends on us sacrificing growth and middle class quality of life luxuries and aspirations to attenuate our effects, then we’ve failed already and the planet’s also fucked. | https://thedailyblog.co.nz/2019/05/12/fragile-finite-fucked/ |
Law Enforcement Against Prohibition (LEAP).
Prohibition has never worked, as proven throughout history.
Around the world many judges, lawyers, officers from the police, customs, and intelligence organisations, as well as many other experts, are challenging the failed concept of the “war on drugs”. This policy, in place for decades now in many countries despite its manifest, abject and repeated failure, criminalises great swathes of our populations, causes health problems, social problems and untold suffering, and funds organised crime and terrorist groups, rather than providing potentially enormous tax revenue to the state.
It is time for a mature, calm debate about the issue, rather than hysterical, tabloid headlines.
I am honoured to be one of this group speaking out.
LEAP Statement of Principles
1. LEAP does not promote the use of drugs and is deeply concerned about the extent of drug abuse worldwide. LEAP is also deeply concerned with the destructive impact of violent drug gangs and cartels everywhere in the world. Neither problem is remedied by the current policy of drug prohibition. Indeed, drug abuse and gang violence flourish in a drug prohibition environment, just as they did during alcohol prohibition.
2. LEAP advocates the elimination of the policy of drug prohibition and the inauguration of a replacement policy of drug control and regulation, including regulations imposing appropriate age restrictions on drug sales and use, just as there are age restrictions on marriage, signing contracts, alcohol, tobacco, operating vehicles and heavy equipment, voting and so on.
3. LEAP believes that adult drug abuse is a health problem and not a law-enforcement matter, provided that the abuse does not harm other people or the property of others.
4. LEAP believes that adult drug use, however dangerous, is a matter of personal freedom as long as it does not impinge on the freedom or safety of others.
5. LEAP speakers come from a wide divergence of political thought and social conscience and recognize that in a post-prohibition world it will take time to strike a proper regulatory balance, blending private, public and medical models to best control and regulate “illicit drugs.” LEAP speakers are free to advocate their view of better post-prohibition stratagems without toeing a LEAP “party line.”
6. LEAP recognizes that even in a post-prohibition world, still, drugs can be dangerous and potentially addictive, requiring appropriate regulation and control. Even in a free-market economy, reasonable regulation for the purposes of public health is a long-standing, accepted principle. Such regulation must not allow casual, unfettered or indiscriminate drug sales.
7. LEAP believes that government has a public health obligation to accurately ascertain the risks associated with the use of each “illicit drug” and a duty to clearly communicate that information to the public by means of labeling and warnings similar to what is done regarding food, tobacco, alcohol and medicine.
8. LEAP believes that an inordinate number of people have been misguidedly incarcerated for violation of zero-tolerant, nonviolent, consensual “drug crimes.” The end of drug prohibition will allow those persons to be promptly released, to have their record of conviction expunged, and their civil rights completely restored. However, the repeal of drug prohibition does not imply the exoneration from charges for connected offenses, such as violent crimes, gun crimes, theft, or driving under the influence of drugs. Furthermore, LEAP believes that people using alcohol or other drugs must be held accountable for any misbehavior, which harms other people or property of others, while under the influence of mind-altering substances.
9. LEAP believes that persons suffering from drug abuse afflictions and addiction, who want help, should be provided with a variety of help, including drug treatment and drug maintenance, even for uninsured addicts. LEAP believes that with an end to drug prohibition and regained control of criminal justice expenditures, a fraction of those savings would be more than sufficient to pay for expanded addiction services.
10. LEAP recognizes that different “illicit drugs” pose differing risks of harm. As such, in a post-prohibition world, LEAP recognizes that an appropriate set of regulations and control for one substance may not be a suitable or sufficient regulation and control for another substance. LEAP believes that the nation states of the world and various states within the United States must be given the regulatory latitude to try new models that wisely balance the notions of freedom over one’s own body with the need for common sense regulation of drugs to reduce death, disease, addiction and harm. | https://anniemachon.ch/annie_machon/2010/12/law-enforcement-against-prohibition-leap.html |
Tawakkalna health status confirmation needed to fly from Saudi Arabia
Saudis and expatriates in Saudi Arabia continue to receive coronavirus vaccines, with 7,868,232 people inoculated so far, according to the Ministry of Health
Updated 24 April 2021
Arab News
April 24, 2021 01:10
JEDDAH: Saudi Arabia’s General Authority of Civil Aviation (GACA) has told airlines operating in the Kingdom that boarding passes must only be issued to passengers whose health status, as recorded by the Tawakkalna application, is “immune” or “not been confirmed with infection.”
Airlines and the Saudi Data and Artificial Intelligence Authority were instructed to work quickly and as a matter of urgency to ensure that passenger data is linked to the application. GACA said that Tawakkalna status alone will be sufficient proof that a person is not suffering from coronavirus infection, and there will be no need for supporting documents.
The authority also instructed that a mechanism must be provided to contact by text message those passengers whose health status does not meet requirements and inform them that their bookings have to be canceled. It stressed the importance of protecting the rights of travelers when canceling their bookings.
Meanwhile Saudis and expatriates in the Kingdom continue to receive coronavirus vaccines, with 7,868,232 people inoculated so far, according to the Ministry of Health (MoH).
The ministry on Friday reported 1,098 new coronavirus cases, meaning that 410,191 people in the Kingdom have contracted the disease since the beginning of the pandemic. There are 9,660 active cases, and 1,205 patients are in critical condition.
Of the new cases, 454 are in the Riyadh region, 244 in the Makkah region, 171 in the Eastern Province and 42 in the Madinah region.
FASTFACT
The total number of coronavirus cases in KSA reached 410,191.
Meanwhile, an additional 1,205 patients have recovered from the disease, bringing the total number of recoveries to 393,653.
Nine more deaths related to COVID-19 were reported, raising the death toll to 6,878.
Health authorities have so far conducted 16,477,359 PCR tests, including 63,320 in the previous 24 hours.
Saudi health clinics set up by the ministry as testing hubs or treatment centers have helped hundreds of thousands of people around the Kingdom.
Among those testing hubs are Taakad (make sure) centers and Tetamman (rest assured) clinics.
Taakad centers provide COVID-19 testing for those who show no, or mild, symptoms or believe they have come into contact with an infected individual, while Tetamman clinics offer treatment and advice to those with virus symptoms, such as fever, loss of taste and smell, and breathing difficulties.
Appointments for either service can be made through the ministry’s Sehhaty app.
Rawasheen in Makkah: A civilized window to the past and present
Architectural designs reflect the identity of the holy city, and a culture that is still present in the minds of Makkans
Updated 24 April 2021
Tareq Al-Thaqafi
April 24, 2021 00:21
MAKKAH: Visitors to Makkah can see Makkan Islamic architecture throughout the city’s central area and main streets, where Rawasheen and Hijazi doors are still present on the facades of hotels overlooking the Grand Mosque.
These architectural designs reflect the identity of Makkah, and a culture that is still present in the minds of Makkans, who see it as an extension of the past, and an embodiment of the holy city’s historical wealth.
Architect Talal Samarkandi told Arab News that Rawasheen — the elaborate patterned wooden window frames found in old buildings in Makkah and Jeddah that maximize natural light and air flow — are rooted in Hijazi architectural heritage, constructed with rare wooden tools, which used to be purchased from India, Indonesia and Sudan.
“The heritage is featured on doors, windows and mashrabiyas (a type of projecting oriel window enclosed with carved wood latticework),” Samarkandi told Arab News, adding that beautiful inscriptions used to decorate the sharabeesh holes in ceilings and doors. “People believed that the house was identified by its door, and thus, made sure that their doors and windows were beautiful and stylish.”
He added that timber was used for environmental purposes, as wood is a poor conductor of heat and is used for ventilation.
Rawasheen — the elaborate patterned wooden window frames found in old buildings in Makkah and Jeddah that maximize natural light and air flow — are rooted in Hijazi architectural heritage, constructed with rare wooden tools, which used to be purchased from India, Indonesia and Sudan. (Supplied)
According to Samarkandi, Hijazi people cared a lot about the quality of their houses’ interiors and temperatures. Rawasheen helped them reduce the consumption of energy to cool the inside of buildings. Rawasheen served as panoramic windows for mothers to watch their children in the streets while maintaining total privacy. They were also the “social media” of the age, allowing people to communicate with their surroundings. These stylish windows were also used as trade portals, where people could dangle baskets tied to a rope to buy goods from street vendors outside.
Embracing the Makkan legacy promotes the heritage and architectural charm of the city, and creates a new touristic destination for visitors from different cultural backgrounds.
Dr. Samir Barqah, History researcher
“Mashrabiyas were placed in front of the Rawasheen to cool houses, with holes in them that allowed fresh air to enter the rooms of the houses,” Samarkandi added.
One of the advantages of the Hijazi customs in old buildings was respecting rights and duties, he noted. Owners of taller buildings could not stare at their neighbors in lower buildings; mashrabiyas were closed and tilted from the top.
The art of inscriptions on doors developed and flourished. At the time, carpenters used to engrave their names on the doors, with some now centuries old.
Wooden doors were also carved in Islamic architectural patterns, forms and shapes, such as the five-pointed star that represents Islam’s five pillars, the eight-pointed star usually placed at the base of the dome over the seat of a ruler or person of power, the 12-pointed star that represents the months of the year, and the crescent, which is related to the moon in all tribes, used to determine the Qibla.
HIGHLIGHT
Wooden doors were also carved in Islamic architectural patterns, forms and shapes, such as the five-pointed star that represents Islam’s five pillars, the eight-pointed star usually placed at the base of the dome over the seat of a ruler or person of power, the 12-pointed star that represents the months of the year, and the crescent, which is related to the moon in all tribes, used to determine the Qibla.
“Each country has its own architectural trends, which are inspired by its culture and history. Our trends kicked off in Makkah, where we see a lot of these architectural features in the central area and the main facades of Makkah’s streets,” he added.
History researcher Dr. Samir Barqah suggested Makkah has a unique architectural legacy. “Makkah has witnessed different architectural cultures over the years,” he said.
“Embracing the Makkan legacy promotes the heritage and architectural charm of the city, creates a new touristic destination for visitors from different cultural backgrounds, and encourages pilgrims to stay longer in Makkah, which would boost the economy and create hundreds of jobs for nationals,” he told Arab News.
Most people are disciplined and respect instructions, but this long pandemic may have made some feel bored and, consequently, a bit careless with regard to precautionary measures. Soaad Al-Aali
Updated 24 April 2021
MOHAMMED AL-KINANI
April 24, 2021 00:14
JEDDAH: Saudis and expats must not put social traditions ahead of following strict health and safety rules designed to stop the spread of the coronavirus disease (COVID-19), a top sociologist has warned.
Speaking as the rate of infections in the country rose above 1,000 new cases a day, Jeddah-based Soaad Al-Aali told Arab News that the temptation to hold social gatherings could ultimately result in unnecessary deaths.
In January, the daily COVID-19 caseload in the Kingdom had dropped to nearly 100, but while the majority of people were adhering to preventive measures, she said social traditions were causing some to overlook regulations.
“Saudis are experiencing their first real crisis in the history of their country. With their love for their country, the majority of Saudi people, if not all, have shown a great response to the instruction of the concerned health authorities despite their traditional tendency to intimate social gatherings and meetings,” she added.
However, she said there would always be a small minority who ignored rules. “They are found in nearly all societies. Most people are disciplined and respect instructions, but this long pandemic may have made some feel bored and, consequently, a bit careless with regard to precautionary measures.”
Al-Aali added that the rollout of COVID-19 vaccination programs in the Kingdom may also have lulled some people into a false sense of security over spreading the virus.
“The introduction of the vaccine has surely given people a feeling that the pandemic will soon be something to remember,” she said, adding that dropping their guard could potentially lead to more COVID-19 deaths.
Most people are disciplined and respect instructions, but this long pandemic may have made some feel bored and, consequently, a bit careless with regard to precautionary measures.
Soaad Al-Aali
In Jeddah, authorities have been conducting inspection tours around the city to ensure visitors to public parks, seafront locations, and shops stick to health and safety regulations.
On its Twitter account, the municipality said its teams had carried out 4,049 checks, while also confiscating 30 tons of vegetables and food of unknown origin being sold by street vendors.
In addition, municipality officials recorded 38 violations of precautionary measures among weekend seafront picnickers after having made 337 inspection tours in the area. In a statement, the municipality said it had stepped up and would continue its efforts to ensure rules on social distancing, public gatherings, and the wearing of face masks were being adhered to.
“These efforts come as part of the municipality’s plans to utilize its apparatus and equipment to regularly clean parks and disinfect seating areas, waste containers, and children’s playing zones.”
The statement added that anyone wishing to report suspected violations of COVID-19 health and safety measures could call 940.
Dr. Maysoon Khoja has been appointed as dean of admission and student affairs at Saudi Electronic University.
Khoja completed a bachelor’s degree in accounting from King Abdul Aziz University in 2001, and a master’s degree in accounting and financial management from the University of Essex in the UK in 2010.
She also worked as an assistant professor of accounting at the University of Essex in 2018.
Khoja has been an assistant professor of accounting at the Saudi Electronic University since May 2018. Before that, she was supervisor of the Jeddah female branch of the university from September to November 2019, and was the vice dean for the female section at the College of Administrative and Financial Sciences between April and December 2020.
She has worked as the quality unit coordinator at the College of Administrative and Financial Sciences since February 2020, chair of the study plans committee in the accounting department since September 2020, and is a standing committee member of psychological and social counseling at the university.
Khoja is also a member of the board at the College of Administrative and Financial Sciences, and the chairman of the students rights committee of the college.
Her training and workshops at the University of Essex included three levels of academic writing skills, an NVivo software training workshop, and a qualitative data in academic research workshop.
At the National Commission for Academic Accreditation and Assessment in Riyadh, she hosted a workshop on the characterization of courses and field experience, and gave a SwiftAssess training course at the Saudi Electronic University.
Khoja’s areas of interest in research include accounting education, corporate governance and auditing. | |
New undersea maps lead to hydrothermal vent and species discoveries
December 13, 2018, Schmidt Ocean Institute
Carbonate flange on the side of the Z mount, fluid is coming out underneath the flange and is ponded underneath it. The fluid is at 290 C and it's in contact over a few mm with 2C seawater. That sharp interface between two fluids that have different refractive indexes, or changes of speed of light which makes them a reflective mirror like surface. You can see the image of Subastian reflected. Credit: Schmidt Ocean Institute
A spectacular new hydrothermal vent field, named JaichMatt, has been discovered during an expedition aboard Schmidt Ocean Institute's R/V Falkor. The vents were identified using Monterey Bay Aquarium Research Institution's (MBARI) Dorado autonomous underwater vehicle to conduct exploratory seafloor surveys with one meter lateral resolution. Simultaneously, MBARI's new Low Altitude Survey System was used from Schmidt Ocean Institute's remotely operated vehicle SuBastian to map the previously discovered Auka Vent field at centimeter scale resolution using co-located multibeam sonar, scanning laser Lidar, and stereo photography. The biological communities and the geological and geochemical characteristics of these vent fields were then explored and sampled using ROV SuBastian.
Principal Investigators Drs. Robert Zierenberg from University of California Davis, Victoria Orphan from California Institute of Technology, and David Caress from MBARI, along with scientists from Oregon State University, the Universidad Autónoma de Baja California, the Centro de Investigación Científica y de Educación Superior de Ensenada (CICESE), and the Scripps Institution of Oceanography, demonstrated the multi-disciplinary use of submarine robotics while investigating an area of unique geologic activity where submarine volcanism in heavily sedimented basins results in high temperature venting with unusual chemistry and geology. The nested-scale mapping approach allowed the team to efficiently progress from large scale exploratory seafloor coverage to precision targeted sampling on and around the vents. The detailed maps also allow for quantification of various microbial and animal communities in precise relation to geologic features and areas of focused and diffuse hydrothermal fluid flow. "By using submarine robotics for seafloor mapping in combination with remotely operated vehicles, the science team has been able to interactively explore and sample animals, microbes, rocks, and sediment" said Dr. Caress.
The new vent field name, JaichMaat, translates to liquid metal in an ancient language of the indigenous people of Mexico surrounding the region, in reference to the reflective hydrothermal fluid and seawater interface that was found ponded along the roof of a large cavern in the hydrothermal mound. The new vent field consists of multiple hydrothermal calcite mounds up to 25 meters high that were venting fluids at temperatures as high as 287° C. Groups of animals common in non-hydrothermal settings, including anemones, were also observed for the first time in dense accumulations at the base of the mounds, and many previously unknown species were identified.
The new vent field name, JaichMaat, translates to liquid metal in an ancient language of the indigenous people of Mexico surrounding the region, in reference to the reflective hydrothermal fluid and seawater interface that was found ponded along the roof of a large cavern in the hydrothermal mound. Credit: Schmidt Ocean Institute
This expedition successfully showcased new approaches to multi-scale seafloor mapping allowing oceanographers to more efficiently explore the deep ocean. In addition to identifying sites of hydrothermal venting, the combined mapping and ROV exploration also sampled the first volcanic rocks collected in both the North and South Pescadero Basins, confirming that in these basins the continental rifting that has formed the Gulf of California has transitioned to seafloor spreading and the volcanic formation of new oceanic crust. The Pescadero Basin is a unique site for studying microbial extremophiles involved in methane and hydrocarbon metabolism and an important location to try to understand how vent fauna colonize similar sites around the globe. The detailed mapping will further allow investigation of the geological and geochemical controls on habitat suitability for different animal and microbial communities. The Pescadero Basin vents harbor unique biology and geology compared to other nearby hydrothermal vent sites. This system was discovered in 2015 on a MBARI research cruise, and has been visited by scientists only a few times. Research Specialist Jennifer Paduan observed that this exquisite system is different due to the interaction of hydrothermal fluids with sediment, "The hydrothermal structures here are beautiful. The animals and the bacteria that are supported by the vents are different because the chemistry of the fluids is different than the usual sulfide type chimneys."
Hydrothermal vents are an expression of submarine volcanism that is a globally important process and play a vital part in shaping the surface of our planet. "The deep ocean is still one of the least explored frontiers in the solar system," said Principal Investigator Robert Zierenberg. "Maps of our planet are not as detailed as those of Mercury, Venus, Mars or the moon, because it is hard to map underwater. This is the frontier." The vents at the Southern Pescadero Basin offer a unique opportunity to compare microbial and animal community compositions between vents with different chemistries and mineral deposits. Microbes at these vents form the basis of the food web here, and gaining insight into the vent communities helps us understand the whole ecological system.
Oasisia tube worm at the top of the Matterhorn chimney. The white area is where tube worms are covered by bacterial mat in the area of most intense fluid flow from the top of the chimney. Credit: Schmidt Ocean Institute
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This release is centered around four cantatas taken from the composer's Harmonischer Gottesdienst ('Music for Religious Services'), a collection of cantatas for solo voice, flute, oboe or violin, and harpsichord that, on account of it's idiomatic writing for voice, it's relation to the instrumental parts and the many indications concerning interpretation, rests among the great achievements of the period. One of Telemann's characteristic skills was his ability to imbue the arias with the sort of brilliance that we normally associate with solo concertos (consider the radiance of the initial aria in Deine Toten werden leben), and this extends to his often virtuosic use of the recorder in the works - an instrument with which he was obviously familiar. Indeed, that Telemann was a more than competent player himself can be seen from the quality and quantity of music that he wrote for the recorder, and it is two of his lesser-known creations for the instrument - the E minor Partita and the Trio Sonata in G minor - which form the remainder of this highly engaging disc. Gemma Bertagnolli is widely considered to be one of the leading sopranos in Early Music. She is a favoured soloist of such celebrities as Rene Jacobs, Rinaldo Alessandrini, Fabio Biondi, Diego Fasolis, Trevor Pinnock, Ton Koopman, Ottavio Dantone and many others. Her voice is powerful, lyrical and passionate, always conveying the emotional message of the text. On this new recording (2012) Gemma joins the Early Music group of Stefano Bagliano, also a specialist in the field, in Cantatas for solo soprano, recorder and continuo, drawn from Die Harmonische Gottesdienst, brilliant works displaying vocal and instrumental virtuosity of a high level.
Tracks: | https://towerrecords.com/products/g-p-telemann-cantatas-chamber-music-with-recorder |
As a community ecologist I am interested in combining theoretical and empirical approaches to understand the causes and consequences of biodiversity. As a concerned citizen I am interested in understanding the response of communities to ongoing environmental change. In order to be useful for conservation and management of natural resources, ecological models must be improved to reduce prediction uncertainty. My current interests focus on developing process-based joint species distribution models that can account for demography, dispersal limitation and species interactions in order to better predict potential future changes in the distribution and abundance of organisms.
At ArtDatabanken, I have developed models for the distribution of forest beetle species in the county of Dalarna and studied the effect of old-forest connectivity on beetle distributions and species richness in the context of planning for green infrastructure. Currently I am working on the development of hierarchical models for metapopulation dynamics of wood-inhabiting fungi (polypores or bracket fungi).
Previously I have worked on biodiversity-ecosystem functioning research at the IfM-GEOMAR in Kiel, using experiments with metacommunities of marine diatoms. My interests then shifted to functional and theoretical ecology, and, driven by enthusiasm for complexity science and systems ecology, I did my PhD at the Stockholm Resilience Centre, switching model system from marine unicellular algae to wetland plants (vascular plants and bryophytes).
With wetland vegetation as a model system, my doctoral research was broadly concerned with mechanistic modelling of climate change effects on the response capacity and functioning of plant communities and metacommunities. I used approaches based on functional traits to understand climate change effects on wetland plant communities and estimate consequences for wetland functioning and resulting ecosystem service potential. I developed metacommunity simulation models to study the regional response capacity of whole metacommunities to shifting climatic niches and investigate the relative importance of species interactions and differences in dispersal capacity on predictions. I am interested in developing models that are parsimonious yet adequately capture ecological complexity, which remains one of the major current challenges in predictive ecology. | https://internt.slu.se/cv-originalen/helen-moor/ |
What is automobile engineering? Automotive engineering, including aerospace engineering and marine architecture, is a field of automotive science, integrating elements of automotive, electrical, mechanical, computer, and structural science. It combines advance knowledge of the physical and technical characteristics of cars, trucks, buses, and other vehicles with advances in knowledge about the mechanisms of operation and maintenance of those same cars and trucks. In this way, it advances the science of automobiles.
Automobile engineering also takes into account issues of design and fabrication of vehicles. Designing and fabricating vehicles are a discipline that engineers learn and practice. As vehicles become more complex in function and structure, engineers have to continue to develop new designs for handling these changes. They also must make certain that future innovations do not render present designs obsolete. Automotive engineering is involved in all aspects of motor vehicle manufacture, from conception to completion of the vehicle.
Automotive engineering is divided into two major branches: motor vehicle design and mechanical engineering. Motor vehicle design includes the study, development, and manufacture of vehicles. The basis for designing a vehicle is understanding how a vehicle functions, as well as its best possible use in current situations. Motor vehicle engineers are involved in the concept and development of automobiles. They oversee the entire lifecycle of a vehicle, from conception to delivery. In addition to designing and producing vehicles, they can also repair and service them.
Automotive manufacturing engineers are primarily responsible for producing automobiles on a large scale. Their job is to build prototypes, determine the optimum production rate, and establish quality standards. They oversee the assembly line, set manufacturing standards, and inspect the finished product. Automobile manufacturing engineers are involved in the entire process from conception to delivery.
Motorized vehicle engineers are essentially concerned with designs for production vehicles. They focus on creating the maximum reliability and efficiency from the designs. They test the designs, make changes, and fine tune the operation of the vehicle. An automobile engineer must be skilled at designing, testing, and maintaining the production engines, transmissions, clutches, and brakes. They are often called upon to develop new or improved ways to protect the integrity of the vehicles from harsh weather conditions, to inspect the performance of factory parts, and to inspect customer supplied vehicles before release.
Internal combustion engines create motion energy that causes the vehicle to move. An internal combustion engine engineer is responsible for the design, development, testing, and maintaining of the internal combustion engine system. These engineers may think of them as the blueprints for an engine. They carefully plan every aspect of the engine and test the engine under controlled conditions to ensure that it is safe and effective. They may think of themselves as having “the blueprints” for the engine because they have designed, developed, tested, and maintained the engine in all kinds of conditions, both extreme hot and cold, and wet and dry.
A person that might be a self-driving car engineer is called a mechanical engineer. They may work for a vehicle manufacturer or a person that develops, manufactures, or provides self-driving cars. The job of a mechanical engineer is to look at how the automobile engine system works. They will examine combustion, intake, exhaust, drive trains, transmissions, clutches, brakes, and other components of the engine. The person that designed the engine will likely be the engineer that is responsible for controlling the entire autonomous system of the car. They will build it, maintain it, and upgrade it whenever necessary.
What is automobile engineering can be a very fulfilling career choice in India. If you are interested in studying in India, there are many scholarships and training programs available. Many engineers have found their career stepping out of the country to work in the automobile sector of India. | https://velxu.com/2021/08/22/what-is-automobile-engineering/ |
Complementary pathways for admission to third countries
Complementary pathways are safe and regulated avenues that complement refugee resettlement and by which refugees may be admitted in a country and have their international protection needs met while they are able to support themselves to potentially reach a sustainable and lasting solution. They do not only offer refugees with alternatives to resorting to irregular means and dangerous onward movement, but they can also facilitate the acquisition and retention of skills that can help refugees attain a sustainable solution in the future.
Complementary pathways are not meant to substitute the protection afforded to refugees under the international protection regime, including through resettlement but rather complement it and serve as an important expression of global solidarity and international cooperation and a contribution to more equitable responsibility sharing.
Complementary pathways must be carefully designed and implemented in such a way that the rights of refugees and continuing international protection needs are safeguarded. UNHCR works with States, civil society, private sector, academia, governmental organizations and refugees to identify, establish and expand complementary pathways for admission to third countries that will meet the continuous international protection needs of refugees.
Complementary pathways for admission may include one or a combination of the following:
- Humanitarian admission programmes, which provides individuals in need of international protection with effective protection in a third country;
- Community sponsorship of refugees, which allows individuals, groups of individuals, or organizations to directly engage in refugee admission efforts by providing financial, emotional, social and/or settlement support to help newly-arrived refugees integrate in a third country;
- Humanitarian visas, which are often used to admit individuals in need of international protection to a third country where they are given the opportunity to formally apply for asylum;
- Family reunification for family members, including those for extended family members;
- Labour mobility schemes, by which a person may enter or stay in another country through safe and regulated avenues for purposes of employment, with the right to either permanent or temporary residence;
- Education programmes, including private and community or institution-based scholarships, traineeships, and apprenticeship programmes;
- Other safe and regulated avenues distinct from those mentioned above may be used to admit refugees to third countries.
A particular feature of complementary pathways is that refugees can access them directly, making use of publically available information and existing administrative mechanisms, and thus securing their own solutions. This is already happening without the help of humanitarian actors. Each year, refugees and people eligible for international protection use existing avenues that are not designed with refugees in mind to move across borders. However, others who could be eligible to do the same are sometimes prevented by legal, administrative and practical barriers.
Complementary pathways should be part of a progressive approach to solutions, with ongoing protection and continuous advancement towards greater enjoyment of legal, civil, political, economic, cultural, and social rights for refugees benefiting from possible opportunities in third countries. | https://www.unhcr.org/en-us/complementary-pathways.html |
APY stands for Annual Percentage Yield. This measures the real rate of return on your principal tokens amount by taking into account the effect of compounding interest. In the case of STASH, your $STASH tokens represent your principal, and the compound interest is added periodically on every Rebase event (Every 15 minutes).
Your new principal amount is then equal to your current $STASH token amount, plus your new rebase token amount. This total amount is what gets calculated for your next rebase rewards.
It is important to note that your balance will grow not linearly but exponentially over time. This is the power of Compounding Interest. | https://docs.stash.capital/features/compounding-apy |
These Alps are well known for the abundance of multipitch rock climbs. Though Chamonix has its fair share of great rock, it is the place climbing crowds flock to in summer. Many other mountain ranges and valleys offer a huge variety of climbs for all levels, from beginners to experts. Come with me as we explore these lesser known areas in Switzerland, France and Italy. One doesn’t need to be a very experienced/high level rock climber to go on a climbing holiday.
2 thoughts on “Multipitch Rock Climbing”
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Omar Elmenawi
What is the duration, climbing level, and price of this trip?
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Joaquin Cordero
Hello id like to climb multipitch routes in switzerland. Im experienced rockclimber. | https://www.swissguides.com/summer/multipitch-rock-climbing/ |
Living with dementia can cause seniors to withdraw from normal activities, but it is important for them to maintain their interests. Staying active can stir memories, boost self-esteem, reduce anxiety, and lead to better moods. However, it is also vital to make sure the activities they engage in are safe to perform. Here are a few fun and safe activities seniors with dementia can enjoy.
1. Scrapbooking
Create a scrapbook from old family photos your loved one has at home. You can also take photos and clippings from your loved one’s favorite sports team to create a scrapbook that pertains to his or her interests. This is a safe activity that helps seniors use their creative thinking skills and recall special people who played an important role in their lives. Scrapbooking also helps seniors socialize, which could lead to more happiness and less stress or anxiety.
Creating a scrapbook is one of the many ways seniors can boost their health and enjoy a high quality of life. Seniors who want to remain healthy as they age can benefit in a variety of ways when they receive professional non-medical in-home care. Prescott, AZ, Home Care Assistance is here to help your loved one accomplish daily tasks, prevent illness, and focus on living a healthier and more fulfilling life.
2. Working on Puzzles
Piecing together a puzzle is a great exercise for seniors with dementia. It is important for seniors to participate in safe activities that stimulate their cognitive function, which is exactly what puzzle-building does. Putting a puzzle together could increase your loved one’s memory and visual perception and facilitate interactions with others, which is something seniors with dementia generally have difficulty doing. Working on puzzles gives family caregivers and friends a unique way to connect with their loved ones.
3. Reading
Looking at books is a great activity for seniors with dementia, and building a small home library could make this activity more interesting and interactive. All you need is a small bookshelf and some books. Your loved one can use the books he or she already owns, or you can search online for his or her favorite novels. Reading is a great way to boost memory and thinking skills. As your loved one adds books to the collection, make sure you read the stories together. Collecting books from childhood and young adult years may stir good memories that had a positive impact on your loved one’s life.
4. Baking Simple Recipes
If your loved one enjoyed cooking prior to developing dementia, encourage him or her to continue with this activity. Family caregivers can create a list of simple recipes seniors can cook without overworking themselves. Most seniors with dementia get stressed or agitated at times, but baking is a great way for them to release stress. By modifying this activity, your loved one can continue to do what he or she enjoys without compromising his or her safety.
Seniors with dementia or other types of cognitive decline may need assistance with cooking, baking, and other daily tasks. Some seniors need occasional assistance at home, and oftentimes the family members who take care of them need time away to run errands, take a nap, go to work, or take a vacation. Prescott, AZ, respite care experts from Home Care Assistance are available on an as-needed basis, giving your family peace of mind that your loved one will remain safe and comfortable while you relax or focus on other important responsibilities.
5. Painting
Self-expression is important for seniors, especially those living with dementia. Painting is a safe craft that allows seniors to be as creative as possible, and it can enhance communication skills, boost brain function, and lead to more social interaction. When seniors with dementia paint, the entire brain is stimulated. Check with local organizations to find out if they offer art programs for seniors with cognitive conditions such as dementia.
Many families have no experience in specialized home care for seniors, which can make life a bit more challenging when an elderly loved one is diagnosed with dementia. The Prescott, AZ, dementia care experts at Home Care Assistance are here to help. We designed a program called the Cognitive Therapeutics Method, which uses mentally engaging activities to slow the progression of dementia, and all of our live-in and respite caregivers are expertly trained in dementia care. To learn about our revolutionary dementia care plans, give us a call at 928-771-0105 today. | http://www.homecareassistanceprescott.com/activities-that-are-safe-for-seniors-with-dementia/ |
The course is intended for students in the planning stages of their own short films. The aim of the course is for students to have exposure to a range of directing styles in order to better execute their vision. However, all students interested in learning the practical techniques of directing are welcome.
Mode of study
Seminar, discussion
Prerequisites and co-requisites
No
Course contents
Although a script poses infinite possibilities for realization common situations frequently occur. This course will examine such basic occurrences (three or four person dialogue, movement shots, car scenes, landscapes, cityscapes) and how various directors have interpreted them in the short film form.
We will analyze specific situations and the rudiments of directing them. Our analysis will be deepened by an examination of well-constructed short films and to constructively critize films with various weaknesses.
The course is intended for students both who plan to direct their own short films and for those looking for skills to critique and analyze short films. Students interested in learning the full spectrum of film analysis from various dramatic styles to the practical techniques of directing are welcome.
Recommended or required reading
Katz, Steven. Shot by Shot, Michael Wiese Production, 1991
Assessment methods and criteria
Examinations:
Final
Writing assignment: A two page (double-spaced) essay comparing and contrasting the structure of two films of their choice shown in the course. The paper has to be submitted by November 30, 2017. Please send it by email (no paper copies) to: [email protected] with the subject: Short Films Practical Analysis--NameOfYourCourse (APP, CET,...etc). Papers not submitted in this fashion will not be graded.
Grading:
The course grade will be calculated as follows:
-Active participation in seminar discussions (20%)
-Final writing assignment(80%)
Note
Detailed syllabus available upon request in FAMU International office.
Schedule for winter semester 2019/2020:
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06:00–08:0008:00–10:0010:00–12:0012:00–14:0014:00–16:0016:00–18:0018:00–20:0020:00–22:0022:00–24:00
|Mon
||
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room 107
Room No. 1
(Lažanský palác)
MAREK P.
19:00–22:00
(lecture parallel1)
once in two weeks, start Sept 30
|Tue
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|Wed
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|Thu
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|Fri
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|Date||Day||Time||Tutor||Location||Notes||No. of paralel|
|Mon||19:00–22:00||Pavel MAREK||Room No. 1
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Lažanský palác
|once in two weeks, start Sept 30||lecture parallel1|
Schedule for summer semester 2019/2020: | https://kurzy.amu.cz/en/predmet311SFP1.html |
GCSE Results Revealed
Today we are once again celebrating the successes of our Year 11 students as they come back into school to collect their GCSE results.
This year group has always been a special one for us at Queen’s Park High School due to their size, but whilst small in number, they have always made up for this through their vibrancy, personality and mutual support. It has been incredibly rewarding to see them grow into the young people they are today.
This year, we are thrilled to see our higher ability students out perform all expectations with 17% of grades awarded being grades 9-7 (old A*/A) including 4% of these at Grade 9. The top grade was awarded to students across a record number of subjects (12 in total) including maths, physics, chemistry, biology, English, photography, art, history, geography and sports studies. Particular mention needs to be given to the following students who have not only achieved outstanding academic results but have also contributed above and beyond to the wider life of the school through their involvement in Queen’s Park High School’s Rowing Club, our school productions or student leadership roles:
- Ioan Gwenter – 7 Grade 9s, 2 Grade 8s, 1 Grade 7 and an A* in Further Maths
- Julia Neill – 5 Grade 9s, 4 Grade 8s, 1 Grade 7 and an A in Further Maths
- Dan Williams – 2 Grade 9s, 6 Grade 8s, 1 Grade 7 and a C in Further Maths
Other outstanding performances came from: twins Megan and Charlie Dixon, Ben Baker, Kamila Glowacka and Kristine Tiskus.
Headteacher Lyndsay Watterson commented:
"I am incredibly proud of our students and am delighted to see their hard work has paid off and that they have been rewarded by some outstanding results. This cohort approached the exams with real maturity and an overall sense of positivity despite the pressures and obstacles that lay ahead. They worked hard, sought advice and supported each other admirably. For each and every student, today is about celebrating their own personal success and determining their next steps in their academic journey, whatever that may be. It has been a privilege for us as staff to be able to support and help shape their futures.
We pride ourselves at Queen’s Park for our family feel, the fact that all our students are known and nurtured and when looking through the results this year we were thrilled to be able to pick out so many success stories for students who have had to overcome significant personal barriers throughout their educational journey, a number of whom who only joined us from Year 9 upwards. I hope we have played our part in setting them up for successful futures, whether this be here at Queen’s Park in the 6th Form or elsewhere. We wish them all the best of luck."
Mrs Cutler, Key Stage 4 Leader added,
"I am immensely proud of all students collecting their results today. Two years ago they were set the challenge of working hard, being resilient when faced with challenges and to show great determination to reach the top of their ‘Mars bar’ hill, and they have all certainly done that. I look forward to seeing a large number of them returning to us in September to embark on their next challenge. Well done!"
For students looking to secure places in the school’s 6th Form, there are a small number of places remaining and anyone wanting to submit an application should contact:
Mrs Prydden (Head of 6th Form) by e-mail at [email protected] for further information. Mrs Prydden will also be available in school from 10am-12pm on Friday 23rd August. | https://www.qphs.cheshire.sch.uk/news/?pid=17&nid=3&storyid=130 |
In New York City on November 16, 2015
It’s almost too much for human eyes, not to mention feet. We’re at the Museum of Modern Art’s Picasso Sculpture exhibition, a massive, mind-altering collection that probably never will be shown again. Many of these works were never exhibited by Pablo Picasso when he was alive. But he comes alive again in this exhibit, which is extraordinarily well arranged. It's in 11 chronologically-sequenced galleries on the revamped fourth floor, where many of the approximately 140 pieces are positioned to allow a 360-degree view.
This body of work not only spans more than six decades (1902 through 1964), it consists of art made from an incredible array of materials and found objects: Bronze, plaster, wood, iron, sheet metal, clay, ceramics, pebbles, bicycle seats and handlebars, gas stove parts, sprinkler cans, children’s toys, forks and spoons, hardware, and more. These often are ingeniously applied to create beauty, grotesqueness, humor, lasciviousness, and just plain clever zaniness.
The exhibition begins with Picasso’s early works and first cubist sculptures done in Barcelona and Paris during the period 1902-1909. Among the pieces of this time is his 1909 Head of a Woman that presaged his cubist period.
After putting aside sculpting for several years, Picasso experimented with cubist sculpting during the period 1912-1915. At this time, he explored developing hybrid sculpted art that puzzled people – “Do you hang it on the wall or place it on a pedestal?” One of these was his sheet metal Guitar, done in 1914.
There was another sculpting hiatus after that until Picasso was requested to submit a monument for the tomb of the poet Guillaume Apollinaire. He worked on several potential monuments from 1927 into1931, experimenting with salvaged metal. These are some of his most abstract pieces and all were rejected as being too radical for the tomb. One of these was his 1930 Woman in the Garden.
In 1930, Picasso purchased the Chateau de Boisgeloup, which had enough room for his first sculpture studio. During the years 1930-1932, he produced there a number of surrealistic white plaster pieces, many of them overtly erotic with noses, eyes, and mouths in the shape of male and female sexual organs. His 1931 Bust of a Woman exemplified the period.
Picasso began experimenting with imprinting plaster sculptures with everyday objects in his Boisgeloup sculpture studio during the years 1933-1937. One was his 1933 Head of a Warrior whose eyes began as tennis balls.
During the war years, 1939-1945, Picasso was adjudged by the Nazis to be a “degenerate” and condemned to stay in Paris, where his art was prohibited. He secretly produced a number of pieces and his sense of humor never left him. His 1942 Bull’s Head, for example, consisted of a head fashioned from a bronzed leather bicycle seat with handlebar horns.
Paris and Picasso were liberated in 1944 and the artist set up a residence and studio in Vallauris on the French Riviera. There, during the period 1945-1953, he tested the limits of ceramic vessels and assemblages. One of the pieces of the time was his 1950 bottle titled Kneeling Woman.
During the years 1952-1958, Picasso was a parent of two children, Claude and Paloma, who influenced his work at Vallauris and later at a new residence outside Cannes. Incredibly, one of Claude’s toy cars can be seen as a plausible face in his 1951-52 Baboon and Young bronze. The ingenious use of found objects also is shown by his playful 1958 Bird, which is painted scrap wood, with screw eyes and fork feet.
The exhibit ends with the decade 1954-1964, Picasso’s final sculpturally-productive period. It’s in MOMA’s light-filled Gallery 11, where his sheet metal sculptures (some large) seem to be made of paper and floating on air. His 1962 Head of a Woman is one of these.
For those few who are intrepid enough to take a virtual tour via our more than 100 images from the Picasso Sculpture exhibit, here’s a link to start touring:
https://leightons.smugmug.com/NewYork/Picasso-at-Play/
Cheers, | http://www.5backroad.com/journal/2015/11/23/picasso-at-play |
LHC Kritiks in Switzerland, Germany and Austria survived the first ruling on their case by the European Court for Human Rights, August 29th. So did CERN's Large Hadron Collider, which will go ahead while the court action continues. A stunningly quick decision by the ECHR only 3 days after the complaint was filed against CERN and its 20 member countries from the EC denies any Interim Measures that would have forced CERN to suspend operations of the LHC.
Soon to be the world's most powerful atom smasher and the biggest and most costly science experiment ever, the $10 billion LHC straddles the borders of Switzerland and France, near Geneva. CERN, the giant European nuclear physics lab, has completed the 17 mile underground construction of the ring accelerator and is now in the first stages of start-up. It's goal is to unlock the secrets of the early Universe, through unparalled high energy collisions of hadrons, protons at first and then heavy lead ions. Critics believe that the LHC could pose enormous dangers to the planet.
Markus Goritschnig, a spokesman for LHC Kritiks said, "This quick decision of the court to dismiss the claim for Interim Measures is not a negative sign as such. The Court is studying the whole appeal in detail now. Only the claim for Interim Measures was rejected, not the appeal itself." The Court gave no reasons for dismissing the preliminary injuction to stop LHC operations.
"The case before the European Court of Human Rights," said Dr James Gillies, chief spokesman for CERN, commenting on the Court case in the Telegraph, "contains the same arguments that we have seen before and we have answered these in extensive safety reports."
All 12 points in the LHC Kritiks arguments are being considered by the ECHR. Other safety hazards have been studied in the latest CERN LHC Safety Assessment Group report, including other theoretical objects and dangers that might be produced at the LHC like micro black holes. MBH is the main focus in the Court suit. CERN concludes there is no risk.
LHC Kritiks strongly disagree on the level of risk and CERN's claim that they have addressed it. "In the complaint", said Markus Goritschnig, "we took all the safety arguments into consideration that were given by CERN in their standard reactions to the global risk. They will have to produce a better LSAG report."
There are three principal signatories to the suit, one each from Switzerland, Germany and Austria. In the suit Dr Otto E. Rössler's theories on mBH figure prominently, though he is not involved with the court challenge. In answer to Dr James Gillies, he told me that CERN still has not disproved his general relativistic theory on mBH or proved that neutron stars are immune to mBH because mBH don't exist. Dr Rössler said these, the most dense stars, are not attacked by mBH because they are protected by their own superfluidity, so mBH pass through them as there is no friction. MBH can exist in space, he insists. Dr Rössler said, "This unproven argument does not impart any security onto earth as CERN alleges."
Dr Rössler added that there is further confirmation of his theory that mBH do not evaporate, contrary to what Professor Stephen Hawking states, through his Hawking radiation theory. "I just learned about an earlier proof of non-evaporation given by Vladimir Belinski, Institute des Hautes Etudes Scientifiques at Bures-sur-Yvette, France, in Physics Letters A. (Vol 209, p 13)
The authors of the Euro suit have included a new study on the mBH question, not considered in the LSAG report as both are recent documents. The paper by Dr Rainer Plaga, a German physicist, that supports Dr Rössler on possible mBH production and dangers, uses quantum physics arguments as CERN does. Markus Goritschnig thinks that Dr Plaga's work is a compelling contribution to the argument for dangerous mBH. "Plaga says the first consequence of producing black holes in lower dimensions would be a disastrous explosion. Then the semi-stable black hole would intensively radiate, consuming 17,000T of material each year. It would be unremovable, undestroyable, and surely endanger the planet as a whole."
Dr Rössler is due to meet with the Swiss President, Pascal Couchepin, this fall on LHC safety issues. According to a spokeswoman for the ECHR, "The proceedings before the Strasbourg Court are expected to take several years."
References: | https://www.science20.com/big_science_gambles/stop_cern_euro_court_action_slips_and_slides_forward |
AI systems generally work by ingesting large amounts of labelled training data, analyzing the data for correlations and patterns, and subsequently using these patterns to make predictions about future states.
The science of getting a computer to act without programming is the next big revolution in technology; Assured Systems is deeply involved in providing specialized hardware platforms specifically designed for these applications.
AI programming focuses on three cognitive skills: learning, reasoning and self-correction. The systems are learning processes; this aspect of AI programming focuses on acquiring data and creating rules for how to turn the data into actionable information. The rules called algorithms, provide computing devices with step-by-step instructions for completing a specific task. | https://www.assured-systems.com/us/sector/ai-deep-learning/ |
UNDP/OIMT Green Energy Support internship programme enhances the academic life experience of passionate students as interns and empowers them to become socially responsible, innovative, and environmentally conscious leaders of tomorrow. We bridge the gap between textbook learning and real-time industry experience by taking interns behind the scenes of the world’s leading clean energy and sustainability initiatives, while learning to take into consideration the local context.
Furthermore, during the internship you will have the opportunity to obtain an official certification in project management in controlled environment. Being a part of our dynamic unit, you will also gain worldwide connections with other top-talented interns and UN staff from other agencies; our office is located at the UN City in Copenhagen, giving you the opportunity to interact with people outside the UNDP OIMT unit.
Duties and Responsibilities
- Support in drafting of business cases for renewable energy solutions (solar hybrid systems);
- Support in providing guidelines on energy efficient solutions to country offices;
- Provide support to optimize usage of diesel generators in UNDP offices;
- Assist during installation of IOT energy sensor units in country offices worldwide;
- Support the team in procuring green energy solution equipment ranging from market research , requests for quotation and technical evaluation;
- Support in daily monitoring and operation of installed renewable solutions;
- Assist the team in organizing internal and external meetings with third parties;
- Draft and update the units` documentation to support the continuous improvement of the Green Energy team processes and procedures, instructions and templates for best practice;
- Assist the project manager during the installation of renewable energy solutions (solar hybrid systems) in UNDP country offices worldwide.
Competencies
- Technological Awareness: Has interest and understanding of renewable energy engineering, sustainable development-oriented areas of work;
- Innovation: Interest in developing sustainable solutions for UNDP country offices around the world, focusing on green energy and energy efficiency;
- Problem Solving: Good analytical skills in gathering and consolidating data and research for practical implementation;
- Teamwork: Communicates effectively when working in teams and independently;
- Communication: Communicates effectively when working in teams and has a proactive attitude with a goal-oriented mind-set;
- Planning and Organization: Good in organizing and structuring various tasks and responsibilities;
- Collaboration: Displays cultural, gender, religion, race, nationality and age sensitivity and adaptability and Interest and motivation in working in an international organization;
- Commitment to Continuous Learning: Consistently approaches work with energy and a positive, constructive attitude, responding positively to feedback and differing points of view;
- Delivery: UNDP OIMT unit is ISO 9001:2015, ISO 20000:2011 and ISO 27001:2013 certified, thus all works shall be compliant with the international standard with focus on high quality, continuous improvements and customer satisfaction.
Required Skills and Experience
You must meet one of the following requirements:
- You are currently in the final year of your bachelor’s degree; or You are currently enrolled in a Master’s degree; or
- You have graduated no longer than 1 year to the deadline of the application from a master’s degree or equivalent studies in the field of renewable energy engineering, electrical engineering or in a related field.
- Experience or knowledge in the field of: Environment, Energy or Electrical Engineering, Climate Change, or other relevant fields is required;
- Technical knowledge of the main renewable energy technologies is a strong advantage;
- Experience/Knowledge in sizing Hybrid PV systems (with diesel generator) is a strong advantage;
- Experience/Knowledge in energy efficiency and/or electric vehicles is a strong advantage;
- Knowledge of software tools for hybrid renewable energy systems is an advantage;
- Knowledge of HOMER and PV*Sol is an advantage;
- Knowledge and a proficient user of Microsoft Office productivity tools is an advantage;
- Knowledge or experience with specific Office 365 tools (or their consumer equivalents) such as Planner (Trello), Teams (Slack), Yammer (Workplace by Facebook), OneDrive (Dropbox, Google Drive), Power BI (Tableau), etc. is a strong advantage;
- SharePoint knowledge, preferably SharePoint Online is an advantage;
- Working with gathering, consolidating and analysing either quantitative and qualitative data from databases and reports is an advantage;
- Demonstrated experience presenting work to both technical and non-technical is an advantage;
- Demonstrated professional or academic experience in any of the UNDP Member States is an advantage;
- Fluent in written and spoken English is mandatory. Knowledge of French and other UN languages is an advantage.
Conditions
- In accordance with the UNDP Internship policy, UNDP interns are eligible to receive a monthly stipend, with the rate that varies depending on the duty location. The stipend will be paid monthly, and part-time internship arrangements are prorated accordingly.
- Where an intern is financially supported by an institution, government or third party, UNDP will, subject to the rules of such institution, government or a third party, pay the intern the difference, if any, between the external financial support provided and the applicable UNDP stipend.
- Except for the stipend, all other expenses connected with the internship will be borne by the intern, sponsoring government or institutions.
- Interns are not considered staff members and may not represent UNDP in any official capacity;
- Interns are responsible for securing adequate medical insurance for the duration of their internship with UNDP and must provide a medical certificate of good health prior to starting the internship. UNDP will not reimburse the medical insurance of the intern. Any costs arising from accidents and illness incurred during an internship assignment will be the responsibility of the intern.
- The purpose of the Internship Programme is not to lead to further employment with UNDP, but to complement an intern’s studies. Therefore, there should be no expectation of employment at the end of an internship.
- UNDP accepts no responsibility for costs arising from accidents and/or illness or death incurred during the internship;
- The intern is responsible for obtaining necessary visas and arranging travel to and from the duty station where the internship will be performed;
- Interns are not eligible to apply for, or be appointed to, any post in UNDP during the period of the internship;
- The intern must provide proof of enrolment in health insurance plan;
- Interns are not staff members and may not represent UNDP in any official capacity;
- You are expected to work full time, but flexibility is allowed for your education programme;
- Eligibility for residency and undertaking internship in Denmark;
- The intern will have to make his/her own arrangements for internship, travel, VISA, accommodation etc. | https://youthopportunitieshub.com/green-energy-support-internship-in-the-united-nations/ |
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If Google Street View is available, the image is from the best available vantage point looking, if possible, towards the location of the monument. Where it is not available, the satellite view is shown instead.
Latitude: 55.3743 / 55°22'27"N
Longitude: -3.3241 / 3°19'26"W
OS Eastings: 316190
OS Northings: 609720
OS Grid: NT161097
Mapcode National: GBR 5679.EG
Mapcode Global: WH6WF.X59T
Entry Name: Bodesbeck, standing stone 1180m E of
Scheduled Date: 27 January 2010
Source: Historic Environment Scotland
Source ID: SM12719
Schedule Class: Cultural
Category: Prehistoric ritual and funerary: standing stone
Location: Moffat
County: Dumfries and Galloway
Electoral Ward: Annandale North
Traditional County: Dumfriesshire
The monument comprises a single large monolith likely to be Neolithic or early Bronze Age in date (the third or second millennium BC). The stone occupies a position approximately 385m above sea level on the SE side of Moffatdale, where it sits on a terrace to the north of Bodesbeck Burn.
The earthfast stone measures around 1.25m in breadth by approximately 0.6m in thickness at the base, and stands to a height of around 1.45m.
The area to be scheduled is circular on plan, centred on stone, to include the remains described and an area around in which evidence relating to its erection and use may survive, as shown in red on the accompanying map.
Source: Historic Environment Scotland
Cultural Significance
The monument's cultural significance can be expressed as follows:
Intrinsic characteristics
This is a prominent standing stone that apparently still stands where it was erected it in prehistory. Buried deposits are likely to survive in the immediate area and may retain valuable information about the purpose of the monument, the people who created and used it, the methods used in its creation, dating evidence for its erection and for any later activity associated with the stone, including contemporary ceremonial and ritual landscapes. Standing stone sockets can contain packing stones and other archaeological material such as burial deposits. Other related features may surround them, including smaller stone settings, pits, burials and timber structures. It is clear that in some instances single standing stones represent the only surviving component of a larger stone monument (such as a stone alignment). The potential presence of associated artefacts and/or important environmental information in a pit beneath the stone, or in surrounding pits, reinforces the potential of the monument.
In this case, considerable effort would have been required to transport, position and erect the stone, demonstrating that it was a significant and worthwhile achievement to those who were responsible. Where it has been possible to date comparable monuments, they typically derive from the third or second millennium BC.
Contextual characteristics
The monument is a good representative of a widespread class. It has the potential to contribute to a better understanding of standing stones, particularly those of the Dumfries and Galloway area. Although there is a notable concentration of these monuments in Dumfries and Galloway, where there has been a long tradition of the erection of standing stones and related monuments such as stone circles and burial cairns, this example is one of relatively few in eastern Dumfries and Galloway. Due to the near total absence of evidence for settlement sites from the Neolithic, standing stones such as this are one of the main sources for archaeology to enhance understanding of the period and its socio-economic structure. The position of such monuments in the landscape is an apparently important factor in their location. This particular example stands on a terrace at the edge of Moffat Dale and has spectacular commanding views up and down the valley. It is also visible on the skyline when viewed from the side-valley of Bodesbeck Burn. Comparing and contrasting this monument with other examples of its type can give us valuable information on how and why the Neolithic and Bronze-Age peoples of the area placed such monuments in the landscape. Although the distribution of this type of monument does not appear to be uniform in eastern Dumfriesshire and Galloway, the connection to other similar monuments can also sometimes be an important factor in their location.
National Importance
The monument is of national importance because it has an inherent potential to contribute to the understanding of the past, in particular Neolithic and Bronze-Age standing stones and the part they played in ritual beliefs and practices. The loss of this well preserved and particularly carefully sited monument would significantly diminish our future ability to appreciate and understand this type of monument and its place within the landscape. Spatial analysis of this and other contemporary monuments may reveal valuable information on the layout and patterns of Neolithic and Bronze-Age ritual sites within the landscape. The loss of the monument would impede our understanding of the distribution of such monuments within the landscape and the nature and purpose of their erection and use.
Source: Historic Environment Scotland
Bibliography
RCAHMS records the site as NT10NE 10. The Dumfries and Galloway SMR as MDG8731.
References:
RCAHMS 1997, Eastern Dumfriesshire: An Archaeological Landscape, Edinburgh: RCAHMS. | https://ancientmonuments.uk/120904-bodesbeck-standing-stone-1180m-east-of-annandale-north-ward |
Robotics and Automation for agriculture and forestry.
[Closed]
Work description
- Collecting images with different sensors in real context and its annotation with phenotypic characteristics relevant to the agronomic process. - Create image datasets to test and validate neural networks for robots applied in forestry and agriculture. - Establish causal relationships between phenotypic characteristics derived from images and useful attributes for the agronomic process. - Validate robotics solutions for agriculture in a real context.
Academic Qualifications
MSc in Agronomy
Minimum profile required
Proven experience in using deep learning algorithms for precision agriculture context applications.The jury may not award the scholarship if the quality of the candidates is inferior to that intended. | https://www.inesctec.pt/en/opportunities/robotics-and-automation-for-agriculture-and-forestry-AE2021-0305 |
The University of Notre Dame will formally sign the Rome Call for AI Ethics on Thursday (Oct. 27), together with the University of Navarra in Spain, Catholic University of Croatia, SWPS University in Poland, Schiller International University in Spain, Chuo University in Japan, University of Johannesburg and University of Florida.
The signing will coincide with a Global University Summit on the Rome Call, held on Oct. 26-27 and co-organized by the Pontifical Academy for Life, IBM and Notre Dame. Hosted by the Notre Dame-IBM Technology Ethics Lab and held in-person and virtually, the summit will explore ways in which universities can use the complementary roles of research, education and policy in the development of human-centered approaches to artificial intelligence (AI).
“It’s an honor for the University of Notre Dame to host this global summit and support efforts to promote an ethical approach to artificial intelligence,” said John T. McGreevy, the University’s Charles and Jill Fischer Provost. “Notre Dame has long recognized the importance of incorporating responsibility and accountability into our teaching and research. As the world’s technological capabilities increase in areas such as AI, we will continue to identify new ways in which we can advance knowledge in service to humankind.”
Msgr. Vincenzo Paglia, president of the Pontifical Academy for Life, said, “Education is the key process that enables people, especially the fragile (young and old), not to be subjected to the innovative process but to be able to be participatory actors in it. This initiative is the moment to translate these theoretical value instances into academic practices that can produce adequate guidance and social transformation.”
Darío Gil, senior vice president and director of research at IBM, said, “At IBM, we believe that creating and deploying cutting-edge technologies like AI will transform how we live and work and that this future must be developed responsibly and ethically. As one of the first signers of the Rome Call for AI Ethics, IBM is proud to continue its collaboration with the Pontifical Academy for Life and other like-minded institutions across industry, academia, government and society to ensure we are collectively building a future that is supportive and inclusive of every single person.”
Along with a formal signing ceremony of the new partners, the two-day gathering will include keynote speakers, roundtables and networking events to define collaborative strategies universities can take around the Rome Call for AI Ethics.
The event will be emceed by Francesca Rossi, IBM fellow and AI ethics global leader, together with Rev. Robert A. Dowd, C.S.C., vice president and associate provost for interdisciplinary initiatives at Notre Dame, and Erin Klawitter, associate director of the Notre Dame-IBM Technology Ethics Lab. Archbishop Paglia and IBM’s Gil will provide remarks at the signing ceremony.
The Rome Call for AI Ethics – established in 2020 and originally signed by the Pontifical Academy for Life, IBM, Microsoft, FAO and the Italian Ministry of Innovation – is a commitment to promote an ethical approach to the design, development and deployment of AI. It seeks to advance a sense of shared responsibility among international organizations, governments, institutions and the private sector to create a future in which digital innovation and technological progress are focused on humanity.
A complete summit agenda is available here. A full list of participating organizations is available here.
Following the summit, the network of participating universities will collaborate regularly to share updates, discuss innovative ideas and democratize AI ethics solutions. | https://news.nd.edu/news/notre-dame-to-sign-rome-call-for-ai-ethics-host-global-university-summit/ |
It is a common trope in discussions of human health research, particularly as to its appropriate regulation, to frame the analysis in terms of the private and public interests that are at stake. Too often, in our view, these interests are presented as being in tension with each other, sometimes irreconcilably so. In this section, the authors grapple with this (false) dichotomy, both by providing deeper insights into the nature and range of the interests in play, as well as by inviting us to rethink attendant regulatory responses and responsibilities. This is the common theme that unites the contributions.
The section opens with the chapter from Postan (Chapter 23) on the question of the return of individually relevant research findings to health research participants. Here an argument is made – adopting a narrative identity perspective – that greater attention should be paid to the informational interests of participants, beyond the possibility that findings might be of clinical utility. Set against the ever-changing nature of the researcher–participant relationship, Postan posits that there are good reasons to recognise these private identity interests, and, as a consequence, to reimagine the researcher as interpretative partner of research findings. At the same time, the implications of all of this for the wider research enterprise are recognised, not only in resource terms but also with respect to striking a defensible balance of responsibilities to participants while seeking to deliver the public value of research itself.
As to the concept of public interest per se, this has been tackled by Sorbie in Chapter 6, and various contributions in Section IB have addressed the role and importance of public engagement in the design and delivery of robust health research regulation. In this section, several authors build on these earlier chapters in multiple ways. For example, Taylor and Whitton (Chapter 24) directly challenge the putative tension between public and private interests, arguing that each is implicated in the other’s protection. They offer a reconceptualisation of privacy through a public interest lens, raising important questions for existing laws of confidentiality and data protection. Their perspective requires us to recognise the common interest at stake. Most uniquely, however, they extend their analysis to show how group privacy interests currently receive short shrift in health research regulation, and they suggest that this dangerous oversight must be addressed adequately because the failure to recognise group privacy interests might ultimately jeopardise the common public interest in health research.
Starkly, Burgess (Chapter 25) uses just such an example of threats to group privacy – the care.data debacle – to mount a case for mobilising public expertise in the design of health research regulation. Drawing on the notion of deliberative public engagement, he demonstrates how this process cannot only counter asymmetries of power in the structural design of regulation but also how the resulting advice about what is in the public interest can bring both legitimacy and trustworthiness to resultant models of governance. This is of crucial importance, because as he states: ‘[i]t is inadequate to assert or assume that research and its existing and emerging regulation is in the public interest’. His contribution allows us to challenge any such assertion and to move beyond it responsibly.
The last two contributions to this section continue this theme of structural reimagining of regulatory architectures, set against the interests and values in play. Vayena and Blassime (Chapter 26) offer the example of Big Data to propose a model of adaptive governance that can adequately accommodate and respond to the diverse and dynamic interests. Following principles-based regulation as previously discussed by Sethi in Chapter 17, they outline a model involving six principles and propose key factors for their implementation and operationalisation into effective governance structures and processes. This form of adaptive governance mirrors the discussions by Kaye and Prictor in Chapter 10. Importantly, the factors identified by the current authors – of social learning, complementarity and visibility – not only lend themselves to full and transparent engagement with the range of public and private interests, they require it. In the final chapter of this section, Brownsword (Chapter 27) invites us to address an overarching question that is pertinent to this entire volume: ‘how are the interests in pushing forward with research into potentially beneficial health technologies to be reconciled with the heterogeneous interests of the concerned who seek to push back against them?’ His contribution is to push back against the common regulatory response when discussing public and private interests: namely, to seek a ‘balance’. While not necessarily rejecting the balancing exercise as a helpful regulatory device at an appropriate point in the trajectory of regulatory responses to a novel technology, he implores us to place this in ‘a bigger picture of lexically ordered regulatory responsibilities’. For him, morally and logically prior questions are those that ask whether any new development – such as automated healthcare – poses threats to human existence and agency. Only thereafter ought we to consider a role for the balancing exercise that is currently so prevalent in human health research regulation.Collectively, these contributions significantly challenge the public/private trope in health research regulation, but they leave it largely intact as a framing device for engaging with the constantly changing nature of the research endeavour. This is helpful in ensuring that on-going conversations are not unduly disrupted in unproductive ways. By the same token, individually these chapters provide a plethora of reasons to rethink the nature of how we frame public and private interests, and this in turn allows us to carve out new pathways in the future regulatory landscape. Thus:
Private interests have been expanded as to content (Postan) and extended as to their reach (Taylor and Whitton).
Moreover, the implications of recognising these reimagined private interests have been addressed, and not necessarily in ways resulting in inevitable tension with appeals to public interest.
The content of public interest has been aligned with deliberative engagement in ways that can increase the robustness of health research regulation as a participative exercise (Burgess).
Systemic oversight that is adaptive to the myriad of evolving interests has been offered as proof of principle (Vayena and Blassime).
The default of seeking balance between public and private interests has been rightly questioned, at least as to its rightful place in the stack of ethical considerations that contribute to responsible research regulation (Brownsword).
23.1 Introduction
This chapter offers a perspective on the long-running ethical debate about the nature and extent of responsibilities to return individually relevant research findings from health research to participants. It highlights the ways in which shifts in the research landscape are changing the roles of researchers and participants, the relationships between them, and what this might entail for the responsibilities owed towards those who contribute to research by taking part in it. It argues that a greater focus on the informational interests of participants is warranted and that, as a corollary to this, the potential value of findings beyond their clinical utility deserves greater attention. It proposes participants’ interests in using research findings in developing their own identities as a central example of this wider value and argues that these could provide grounds for disclosure.
23.2 Features of Existing Disclosure Guidance
This chapter is concerned with the questions of whether, why, when and how individually relevant findings, which arise in the course of health research, should be offered or fed-back to the research participant to whom they directly pertain.Footnote 1 Unless otherwise specified, what will be said here applies to findings generated through observational and hands-on studies, as well as those using previously collected tissues and data.
Any discussion of ethical and legal responsibilities for disclosure of research findings must negotiate a number of category distinctions relating to the nature of the findings and the practices within which they are generated. However, as will become clear below, several lines of demarcation that have traditionally structured the debate are shifting. A distinction has historically been drawn between the intended (pertinent, or primary) findings from a study and those termed ‘incidental’ (ancillary, secondary, or unsolicited). ‘Incidental findings’ are commonly defined as individually relevant observations generated through research, but lying outwith the aims of the study.Footnote 2 Traditionally, feedback of incidental findings has been presented as more problematic than that of ‘intended findings’ (those the study set out to investigate). However, the cogency of this distinction is increasingly questioned, to the extent that many academic discussions and guidance documents have largely abandoned it.Footnote 3 There are several reasons for this, including difficulties in drawing a bright line between the categories in many kinds of studies, especially those that are open-ended rather than hypothesis-driven.Footnote 4 The relevance of researchers’ intentions to the ethics of disclosure is also questioned.Footnote 5 For these reasons, this chapter will address the ethical issues raised by the return of individually relevant research results, irrespective of whether they were intended.
The foundational question of whether findings should be fed-back – or feedback offered as an option – is informed by the question of why they should. This may be approached by examining the extent of researchers’ legal and ethical responsibilities to participants – as shaped by their professional identities and legal obligations – the strength of participants’ legitimate interests in receiving feedback, or researchers’ responsibilities towards the research endeavour. The last of these includes consideration of how disclosure efforts might impact on wider public interests in the use of research resources and generation of valuable generalisable scientific knowledge, and public trust in research. These considerations then provide parameters for addressing questions of which kinds of findings may be fed-back and under what circumstances. For example, which benefits to participants would justify the resources required for feedback? Finally, there are questions of how, including how researchers should plan and manage the pathway from anticipating the generation of such findings to decisions and practices around disclosure.
In the past two decades, a wealth of academic commentaries and consensus statements have been published, alongside guidance by research funding bodies and professional organisations, making recommendations about approaches to disclosure of research findings.Footnote 6 Some are prescriptive, specifying the characteristics of findings that ought to be disclosed, while others provide process-focused guidance on the key considerations for ethically, legally and practically robust disclosure policies. It is not possible here to give a comprehensive overview of all the permutations of responses to the four questions above. However, some prominent and common themes can be extracted.
Most strikingly, in contrast to the early days of this debate, it is rare now to encounter the bald question of whether research findings should ever be returned. Rather the key concerns are what should be offered and how.Footnote 7 The resource implications of identifying, validating and communicating findings are still acknowledged, but these are seen as feeding into an overall risk/benefit analysis rather than automatically implying non-disclosure. In parallel with this shift, there is less scepticism about researchers’ general disclosure responsibilities. In the UK, researchers are not subject to a specific legal duty to return findings.Footnote 8 Nevertheless, there does appear to be a growing consensus that researchers do have ethical responsibilities to offer findings – albeit limited and conditional ones.Footnote 9 The justifications offered for these responsibilities vary widely, however, and indeed are not always made explicit. This chapter will propose grounds for such responsibilities.
When it comes to determining what kinds of findings should be offered, three jointly necessary criteria are evident across much published guidance. These are captured pithily by Lisa Eckstein et al. as ‘volition, validity and value’.Footnote 10 Requirements for analytic and clinical validity entail that the finding reliably measures and reports what it purports to. Value refers to usefulness or benefit to the (potential) recipient. In most guidance this is construed narrowly in terms of the information’s clinical utility – construed as actionability and sometimes further circumscribed by the seriousness of the condition indicated.Footnote 11 Utility for reproductive decision-making is sometimes included.Footnote 12 Although some commentators suggest that ‘value’ could extend to the non-clinical, subjectively determined ‘personal utility’ of findings, it is generally judged that this alone would be insufficient to justify disclosure costs.Footnote 13 The third necessary condition is that the participant should have agreed voluntarily to receive the finding, having been advised at the time of consenting to participate about the kinds of findings that could arise and having had the opportunity to assent to or decline feedback.Footnote 14
Accompanying this greater emphasis on the ‘which’ and ‘how’ questions is an increasing focus upon the need for researchers to establish clear policies for disclosing findings, that are explained in informed consent procedures, and an accompanying strategy for anticipating, identifying, validating, interpreting, recording, flagging-up and feeding-back findings in ways that maximise benefits and minimise harms.Footnote 15 Broad agreement among scholars and professional bodies that – in the absence of strong countervailing reasons – there is an ethical responsibility to disclose clinically actionable findings is not, however, necessarily reflected in practice, where studies may still lack disclosure policies, or have policies of non-disclosure.Footnote 16
Below I shall advance the claim that, despite a greater emphasis upon, and normalisation of, feedback of findings, there are still gaps, which mean that feedback policies may not be as widely instituted or appropriately directed as they should be. Chief among these gaps are, first, a continued focus on researchers’ inherent responsibilities considered separately from participants’ interests in receiving findings and, second, a narrow conception of when these interests are engaged. These gaps become particularly apparent when we attend to the ways in which the roles of researchers and participants and relationships between them have shifted in a changing health research landscape. In the following sections, I will first highlight the nature of these changes, before proposing what these mean for participants’ experiences, expectations and informational interests and, thus, for ethically robust feedback policies and practices.
23.3 The Changing Health Research Landscape
The landscape of health research is changing. Here I identify three facets of these changes and consider how these could – and indeed should – have an effect on the practical and ethical basis of policies and practices relating to the return of research findings.
The first of these developments is a move towards ‘learning healthcare’ systems and translational science, in which the transitions between research and care are fluid and cyclical, and the lines between patient and participant are often blurred.Footnote 17 The second is greater technical capacities, and appetite, for data-driven research, including secondary research uses of data and tissues – sourced from patient records, prior studies, or biobanks – and linkage between different datasets. This is exemplified by the growth in large-scale and high-profile of genomic studies such as the UK’s ‘100,000 Genomes’ project.Footnote 18 The third development is increasing research uses of technologies and methodologies, such as functional neuroimaging, genome-wide association studies, and machine-learning, which lend themselves to open-ended, exploratory inquiries rather than hypothesis-driven ones.Footnote 19 I wish to suggest that these three developments have a bearing on disclosure responsibilities in three key respects: erosion of the distinction between research and care; generation of findings with unpredictable or ambiguous validity and value; and a decreasing proximity between researchers and participants. I will consider each of these in turn.
Much of the debate about disclosure of findings has, until recently, been premised on there being a clear distinction between research and care, and what this entails in terms of divergent professional priorities and responsibilities, and the experiences and expectations of patient and participants. Whereas it has been assumed that clinicians’ professional duty of care requires disclosure of – at least – clinically actionable findings, researchers are often seen as being subject to a contrary duty to refrain from feedback if this would encourage ‘therapeutic misconceptions’, or divert focus and resources from the research endeavour.Footnote 20 However, as health research increasingly shades into ‘learning healthcare’, these distinctions become increasingly untenable.Footnote 21 It is harder to insist that responsibilities to protect information subjects’ interests do not extend to those engaged in research, or that participants’ expectations of receiving findings are misconceived. Furthermore, if professional norms shift towards more frequent disclosure, so the possibility that healthcare professionals may be found negligent for failing to disclose becomes greater.Footnote 22 These changes may well herald more open feedback policies in a wider range of studies. However, if these policies are premised solely on the duty of care owed in healthcare contexts to participants-as-patients, then the risk is that any expansion will fail to respond adequately to the very reasons why findings should be offered at all – to protect participants’ core interests.
Another consequence of the shifting research landscape, and the growth of data-driven research in particular, lies in the nature of findings generated. For example, many results from genomic analysis or neuroimaging studies are probabilistic rather than strongly predictive, and produce information of varying quality and utility.Footnote 23 And open-ended and exploratory studies pose challenges precisely because what they might find – and thus their significance to participants – are unpredictable and, especially in new fields of research, may be less readily validated. These characteristics are of ethical significance because they present obstacles to meeting the requirements (noted above) for securing validity, value and ascertaining what participants wish to receive. And where validity and value are uncertain, robust analysis of the relative risks and benefits of disclosure is not possible. Given these challenges, it is apparent that meeting participants’ informational interests will require more than just instituting clear disclosure policies. Instead, more flexible and discursive disclosure practices may be needed to manage unanticipated or ambiguous findings.
Increasingly, health research is conducted using data or tissues that were collected for earlier studies, or sourced from biobanks or patient records.Footnote 24 In these contexts, in contrast to the closer relationships entailed by translational studies, researchers may be geographically, temporally and personally far-removed from the participants. This poses a different set of challenges when determining responsibilities for disclosing research findings. First, it may be harder to argue that researchers working with pre-existing data collections hold a duty of care to participants, especially one analogous to that of a healthcare professional. Second, there is the question of who is responsible for disclosure: is it those who originally collected materials, manage this resource or generate the findings? Third, if consent is only sought when the data or tissues are originally collected, it is implausible that a one-off procedure could address in detail all future research uses, let alone the characteristics, of all future findings.Footnote 25 And finally, in these circumstances, disclosure may be more resource-intensive where, for example, much time has elapsed or datasets have been anonymised. These observations underscore the problems of thinking of ‘health research’ as a homogenous category in which the respective roles and expectations of researchers and participants are uniform and easily characterised, and ethical responsibilities attach rigidly to professional identities.
Finally, it is also instructive to attend to shifts in wider cultural and legal norms surrounding our relationships to information about ourselves and the increasing emphasis on informational autonomy, particularly with respect to accessing and controlling information about our health or genetic relationships. There is increased legal protection of informational interests beyond clinical actionability, including the interest in developing one’s identity, and in reproductive decision-making.Footnote 26 For example, European human rights law has recognised the right to access to one’s health records and the right to know one’s genetic origins as aspects of the Article 8 right to respect for private life.Footnote 27 And in the UK, the legal standard for information provision by healthcare professionals has shifted from one determined by professional judgement, to that which a reasonable patient would wish to know.Footnote 28
When taken together, the factors considered in this section provide persuasive grounds for looking beyond professional identities, clinical utility and one-off consent and information transactions when seeking to achieve ethically defensible feedback of research findings. In the next section, I will present an argument for grounding ethical policies and practices upon the research participants’ informational interests.
23.4 Re-focusing on Participants’ Interests
What emerges from the picture above is that the respective identities and expectations of researchers and participants are changing, and with them the relationships and interdependencies between them. Some of these changes render research relationships more intimate, akin to clinical care, while other makes them more remote. And the roles that each party fulfils, or are expected to fulfil, may be ambiguous. This lack of clarity presents obstacles to relying on prior distinctions and definitions and raises questions about the continued legitimacy of some existing guiding principles.Footnote 29 Specifically, it disrupts the foundations upon which disclosure of individually relevant results might be premised. In this landscape, it is no longer possible or appropriate – if indeed it ever was – simply to infer what ethical feedback practice would entail from whether not an actor is categorised as ‘a researcher’. This is due not only to ambiguity about the scope of this role and associated responsibilities. It also looks increasingly unjustifiable to give only secondary attention to the nature and specificity of participants’ interests: to treat these as if they are a homogenous group of narrowly health-related priorities that may be honoured, provided doing so does not get in the way of the goal of generating generalisable scientific knowledge. There is a need to revisit the nature and balance of private and public interests at stake. My proposal here is that participants’ informational interests, and researchers’ particular capacities to protect these interests, should comprise the heart of ethical feedback practices.
There are several reasons why it seems appropriate – particularly now – to place participants’ interests at the centre of decision-making about disclosure. First, participants’ roles in research are no less in flux than researchers’. While it may be true that the inherent value of any findings to participants – whether they might wish to receive them and whether the information would be beneficial or detrimental to their health, well-being, or wider interests – may not be dramatically altered by emerging research practices, their motivations, experiences and expectations of taking part may well be different. In the landscape sketched above, it is increasingly appropriate to think of participants less as passive subjects of investigation, but rather as partners in the research relationship.Footnote 30 This is a partnership grounded in the contributions that participants make to a study and in the risks and vulnerabilities incurred when they agree to take part. The role of participant-as-partner is underscored by the rise of the idea that there is an ethical ‘duty to participate’.Footnote 31 This idea has escaped the confines of academic argument. Implications of such a duty are evident in in public discourse concerning biobanks and projects such as 100,000 Genomes. For example, referring to that project, the (then) Chief Medical Officer for England has said that to achieve ‘the genomic dream’, we should ‘agree to use of data for our own benefit and others’.Footnote 32 A further compelling reason for placing the interests of participants at the centre of return policies is that doing so is essential to building confidence and demonstrating trustworthiness in research.Footnote 33 Without this trust there would be no participants and no research.
In light of each of these considerations, it is difficult to justify the informational benefits of research accruing solely to the project aims and the production of generalisable knowledge, without participants’ own core informational interests inviting corresponding respect. That is, respect that reflects the nature of the joint research endeavour and the particular kinds of exposure and vulnerabilities participants incur.
If demonstrating respect was simply a matter of reciprocal recognition of participants’ contributions to knowledge production, then it could perhaps be achieved by means other than feedback. However, research findings occupy a particular position in the vulnerabilities, dependencies and responsibilities of the researcher relationship. Franklin Miller and others argue that researchers have responsibilities to disclose findings that arise from a particular pro tanto ethical responsibility to help others and protect their interests within certain kinds of professional relationships.Footnote 34 These authors hold that this responsibility arises because, in their professional roles, researchers have both privileged access to private aspects of participants’ lives, and particular opportunities and skills for generating information of potential significance and value to participants to which they would not otherwise have access.Footnote 35 I would add to this that being denied the opportunity to obtain otherwise inaccessible information about oneself not only fails to protect participants from avoidable harms, it also fails to respect and benefit them in ways that recognise the benefits they bring to the project and the vulnerabilities they may incur, and trust they invest, when doing so.
None of what I have said seeks to suggest that research findings should be offered without restriction, or at any cost. The criteria of ‘validity, value and volition’ continue to provide vital filters in ensuring that information meets recipients’ interests at all. However, providing these three conditions are met, investment of research resources in identifying, validating, offering and communicating individually relevant findings, may be ethically justified, even required, when receiving them could meet non-trivial informational interests. One question that this leaves unanswered, of course, is what counts as an interest of this kind.
23.5 A Wider Conception of Value: Research Findings as Narrative Tools
If responsibilities for feedback are premised on the value of particular information to participants, it seems arbitrary to confine this value solely to clinical actionability, unless health-related interests are invariably more critical than all others. It is not at all obvious that this is so. This section provides a rationale for recognising at least one kind of value beyond clinical utility.Footnote 36
It is suggested here that where research findings support a participant’s abilities to develop and inhabit their own sense of who they are, significant interests in receiving these findings will be engaged. The kinds of findings that could perform this kind of function might include, for example, those that provide diagnoses that explain longstanding symptoms – even where there is no effective intervention – susceptibility estimates that instigate patient activism, or indications of carrier status or genetic relatedness that allow someone to (re)assess of understand their relationships and connections to others.
The claim to value posited here goes beyond appeals to ‘personal utility’, as commonly characterised in terms of curiosity, or some unspecified, subjective value. It is unsurprising that, thus construed, personal utility is rarely judged to engage sufficiently significant interests to warrant the effort and resources of disclosing findings.Footnote 37 However, the claim here – which I have more fully discussed elsewhereFootnote 38 – is that information about the states, dispositions and functions of our bodies and minds, and our relationships to others (and others’ bodies) – such as that conveyed by health research findings – is of value to us when, and to the extent that, it provides constitutive and interpretive tools that help us to develop our own narratives about who we are – narratives that constitute our identities.Footnote 39 Specifically, this value lies not in contributing to just any identity-narrative, but one that makes sense when confronted by our embodied and relational experiences and supports us in navigating and interpreting these experiences.Footnote 40 These experiences include those of research participation itself. A coherent, ‘inhabitable’ self-narrative is of ethical significance, because such a narrative is not just something we passively and inevitably acquire. Rather, it is something we develop and maintain, which provides the practical foundations for our self-understanding, interpretive perspective and values, and thus our autonomous agency, projects and relationships.Footnote 41 If we do indeed have a significant interest in developing and maintaining such a narrative, and some findings generated in health research can support us in doing so, then my claim is that these findings may be at least as valuable to us as those that are clinically actionable. As such, our critical interests in receiving them should be recognised in feedback policies and practices.
In response to concern that this proposal constitutes an unprecedented incursion of identity-related interests into the (public) values informing governance of health research, it is noted that the very act of participating in research is already intimately connected to participants’ conceptions of who they are and what they value, as illustrated by choices to participate motivated by family histories of illness,Footnote 42 or objections to tissues or data being used for commercial research.Footnote 43 Participation already impacts upon the self-understandings of those who choose to contribute. Indeed, it may often be seen as contributing to the narratives that comprise their identities. Seen in this light, it is not only appropriate, but vital, that the identity-constituting nature of research participation is reflected in the responsibilities that researchers – and the wider research endeavour – owe to participants.
23.6 Revisiting Ethical Responsibilities for Feeding Back Findings
What would refocusing ethical feedback for research findings to encompass the kinds of identity-related interests described above mean for the responsibilities of researchers and others? I submit that it entails responsibilities both to look beyond clinical utility to anticipate when findings could contribute to participants’ self-narratives and to act as an interpretive partner in discharging responsibilities for offering and communicating findings.
It must be granted that the question of when identity-related interests are engaged by particular findings is a more idiosyncratic matter than clinical utility. This serves to underscore the requirement that any disclosure of findings is voluntary. And while this widening of the conception of ‘value’ is in concert with increasing emphasis on individually determined informational value in healthcare – as noted above – it is not a defence of unfettered informational autonomy, requiring the disclosure of whatever participants might wish to see. In order for research findings to serve the wider interests described above, they must still constitute meaningful and reliable biomedical information. There is no value without validity.Footnote 44
These two factors signal that the ethical responsibilities of researchers will not be discharged simply by disclosing findings. There is a critical interpretive role to be fulfilled at several junctures, if participants’ interests are to be protected. These include: anticipating which findings could impact on participants’ health, self-conceptions or capacities to navigate their lives; equipping participants to understand at the outset whether findings of these kinds might arise; and, if participants choose to receive these findings, ensuring that these are communicated in a manner that is likely to minimise distress, and enhance understanding of the capacities and limitations of the information in providing reliable explanations, knowledge or predictions about their health and their embodied states and relationships. This places the researcher in the role of ‘interpretive partner’, supporting participants to make sense of the findings they receive and to accommodate – or disregard – them in conducting their lives and developing their identities.
This role of interpretive partner represents a significant extension of responsibilities from an earlier era in which a requirement to report even clinically significant findings was questioned. The question then arises as to who will be best placed to fulfil this role. As noted above, dilemmas about who should disclose arise most often in relation to secondary research uses of data.Footnote 45 These debates err, however, when they treat this as a question focused on professional and institutional duties abstracted from participants’ interests. When we attend to these interests, the answer that presents itself is that feedback should be provided by whoever is best placed to recognise and explain the potential significance of the findings to participants. And it may in some cases be that those best placed to do this are not researchers at all, but professionals performing a role analogous to genetic counsellors.
Even though the triple threshold conditions for disclosure – validity, value and volition – still apply, any widening of the definition of value implies a larger category of findings to be validated, offered and communicated. This will have resource implications. And – as with any approach to determining which findings should be fed-back and how – the benefits of doing so must still be weighed against any resultant jeopardy to the socially valuable ends of research. However, if we are not simply paying lip-service to, but taking seriously, the ideas that participants are partners in, not merely passive objects of, research, then protecting their interests – particularly those incurred through participation – is not supererogatory, but an intrinsic part of recognising their contribution to biomedical science, their vulnerability, trust and experiences of contributing. Limiting these interests to receipt of clinically actionable findings is arbitrary and out of step with wider ethico-legal developments in the health sphere. Just because these findings arise in the context of health research is not on its own sufficient reason for interpreting ‘value’ solely in clinical terms.
23.7 Conclusion
In this chapter, I have argued that there are two shortcomings in current ethical debates and guidance regarding policies and practices for feeding back individually relevant findings from health research. These are, first, a focus on the responsibilities of actors for disclosure that remains insufficiently grounded in the essential questions of when and how disclosure would meet core interests of participants; and, second, a narrow interpretation of these interests in terms of clinical actionability. Specifically, I have argued that participants have critical interests in accessing research findings where these offer valuable tools of narrative self-constitution. These shortcomings have been particularly brought to light by changes in the nature of health research, and addressing them becomes ever more important as the role participants evolves from one of an object of research, to active members of shared endeavours. I have proposed that in this new health research landscape, there are not only strong grounds for widening feedback to include potentially identity-significant findings, but also to recognise the valuable role of researchers and others as interpretive partners in the relational processes of anticipating, offering and disclosing findings.
24.1 Introduction
Privacy and public interest are reciprocal concepts, mutually implicated in each other’s protection. This chapter considers how viewing the concept of privacy through a public interest lens can reveal the limitations of the narrow conception of privacy currently inherent to much health research regulation (HRR). Moreover, it reveals how the public interest test, applied in that same regulation, might mitigate risks associated with a narrow conception of privacy.
The central contention of this chapter is that viewing privacy through the lens of public interest allows the law to bring into focus more things of common interest than privacy law currently recognises. We are not the first to recognise that members of society share a common interest in both privacy and health research. Nor are we the first to suggest that public is not necessarily in opposition to private, with public interests capable of accommodating private and vice versa.Footnote 1 What is novel about our argument is the suggestion that we might invoke public interest requirements in current HRR to protect group privacy interests that might otherwise remain out of sight.
It is important that HRR takes this opportunity to correct its vision. A failure to do so will leave HRR unable to take into consideration research implications with profound consequences for future society. A failure will undermine legitimacy in HRR. It is no exaggeration to say that the value of a confidential healthcare system may come to depend on whether HRR acknowledges the significance of group data to the public interest. It is group data that shapes health policies, evaluates success, and determines the healthcare opportunities offered to members of particular groups. Individual opportunity, and entitlement, is dependent upon group classification.
The argument here is three-fold: (1) a failure to take common interests into account when making public interest decisions undermines the legitimacy of the decision-making process; (2) a common interest in privacy extends to include group interests; (3) the law’s current myopia regarding group privacy interests in data protection law and the duty of confidence law can be corrected, to a varying extent, through bringing group privacy interests into view through the lens of public interest.
24.2 Common Interests, Public Interest and Legitimacy
In this section, we seek to demonstrate how a failure to take the full range of common (group) interests into account when making public interest decisions will undermine the legitimacy of those decisions.
When Held described broad categories into which different theories of public interest might be understood to fall, she listed three: preponderance or aggregative theories, unitary theories and common interest theories.Footnote 2 When Sorauf earlier composed his own list, he combined common interests with values and gave the category the title ‘commonly-held value’.Footnote 3 We have separately argued that a compelling conception of public interest may be formed by uniting elements of ‘common interest’ and ‘common value’ theories of public interest.Footnote 4 It is, we suggest, through combining facets of these two approaches that one can overcome the limitations inherent to each. Here we briefly recap this argument before seeking to build upon it.
Fundamental to common interest theories of the public interest is the idea that something may serve ‘the ends of the whole public rather than those of some sector of the public’.Footnote 5 If one accepts the idea that there may be a common interest in privacy protection, as well as in the products of health research, then ‘common interest theory’ brings both privacy and health research within the scope of public interest consideration. However, it cannot explain how – in case of any conflict – they ought to be traded-off against each other – or other common interests – to determine the public interest in a specific scenario.
In contrast to common interest theories, commonly held value theories claim the ‘public interest emerges as a set of fundamental values in society’.Footnote 6 If one accepts that a modern liberal democracy places a fundamental value upon all members of society being respected as free and equal citizens, then any interference with individual rights should be defensible in terms that those affected can both access and have reason to endorseFootnote 7 – with discussion subject to the principles of public reasoning.Footnote 8 Such a commitment is enough to fashion a normative yardstick, capable of driving a public interest determination. However, the object of measurement remains underspecified.
It is through combining aspects of common interest and common value approaches that a practical conception of the public interest begins to emerge: any trade-off between common interests ought to be defensible in terms of common value: for reasons that those affected by a decision can both access and have reason to endorse.Footnote 9
An advantage of this hybrid conception of public interest is its connection with (social) legitimacy.Footnote 10 If a decision-maker fails to take into account the full range of interests at stake, then not only do they undermine any public interest claim, but also the legitimacy of the decision-making process underpinning it.Footnote 11 Of course, this does not imply that the legitimacy of a system depends upon everyone perceiving the ‘public interest’ to align with their own contingent individual or common interests. Public-interest decision-making should, however, ensure that when the interests of others displace any individual’s interests, including those held in common, it should (ideally) be transparent why this has happened and (again, ideally) the reasons for displacement should be acceptable as ‘good reasons’ to the individual.Footnote 12 If the displaced interest is more commonly held, it is even more important for a system practically concerned with maintaining legitimacy, to transparently account for that interest within its decision-making process.
Any failure to account transparently for common interests will undermine the legitimacy of the decision-making process.
24.3 Common Interests in (Group) Privacy
In this section, the key claim is that a common interest in privacy extends beyond a narrow atomistic conception of privacy to include group interests.We are aware of no ‘real definition’ of privacy.Footnote 13 There are, however, many stipulative or descriptive definitions, contingent upon use of the term within particular cultural contexts. Here we operate with the idea that privacy might be conceived in the legal context as representing ‘norms of exclusivity’ within a society: the normative expectation that some states of information separation are, by default, to be maintained.Footnote 14 This is a broad conception of privacy extending beyond the atomistic one that Bennet and Raab observe to be the prevailing privacy paradigm in many Western societies.Footnote 15 It is not necessary to defend a broad conception of privacy in order to recognise a common interest in privacy protection. It is, however, necessary to broaden the conception in order to bring all of the possible common interests in privacy into view. As Bennet and Raab note, the atomistic conception of privacy
fails to properly understand the construction, value and function of privacy within society.Footnote 16
[P]rivacy, as a whole or in part, represents control over transactions between person(s) and other(s), the ultimate aim of which is to enhance autonomy and/or to minimize vulnerability.Footnote 17
Nearly thirty years after the definition was first offered, Margulis recognised that his early attempt at a consensus definition
failed to note that, in the privacy literature, control over transactions usually entailed limits on or regulation of access to self (Allen, 1998), sometimes to groups (e.g., Altman, 1975), and occasionally to larger collectives such as organisations (e.g., Westin, 1967).Footnote 18
The adjustment is important. It allows for a conception of privacy to recognise that there may be relevant norms, in relation to transactions involving data, that do not relate to identifiable individuals but are nonetheless associated with normative expectation of data flows and separation. Not only is there evidence that there are already such expectations in relation to non-identifiable data,Footnote 19 but data relating to groups – rather than just individuals – will be of increasing importance.Footnote 20There are myriad examples of how aggregated data have led to differential treatment of individuals due to association with group characteristics.Footnote 21 Beyond the obvious examples of individual discrimination and stigmatisation due to inferences drawn from (perceived) group membership, there can be group harm(s) to collective interests including, for example, harm connected to things held to be of common cultural value and significance.Footnote 22 It is the fact that data relates to the group level that leaves cultural values vulnerable to misuse of the data.Footnote 23 This goes beyond a recognition that privacy may serve ‘not just individual interests but also common, public, and collective purposes’.Footnote 24 It is recognition that it is not only individual privacy but group privacy norms that may serve these common purposes. In fact, group data, and the norms of exclusivity associated with it, are likely to be of increasing significance for society. As Taylor, Floridi and van der Sloot note,
with big data analyses, the particular and the individual is no longer central. … Data is analysed on the basis of patterns and group profiles; the results are often used for general policies and applied on a large scale.Footnote 25
This challenges the adequacy of a narrow atomistic conception of privacy to account for what will increasingly matter to society. De-identification of an individual as a member of a group, including those groups that may be created through the research and may not otherwise exist, does not protect against any relevant harm.Footnote 26 In the next part, we suggest that not only can the concept of the public interest be used to bring the full range of privacy interests into view, but that a failure to do so will undermine the legitimacy of any public interest decision-making process.
24.4 Group Privacy Interests and the Law
The argument in this section is that, although HRR does not currently recognise the concept of group privacy interests, through the concept of public interest inherent to both the law of data protection and the duty of confidence, there is opportunity to bring group privacy interests into view.
24.4.1 Data Protection LawThe Council of Europe Convention for the Protection of Individuals with regard to Automatic Processing of Personal Data (hereafter, Treaty 108) (as amended)Footnote 27 cast the template for subsequent data protection law when it placed the individual at the centre of its object and purposeFootnote 28 and defined ‘personal data’ as:
any information relating to an identified or identifiable individual (‘data subject’)Footnote 29
This definition narrows the scope of data protection law even further than data relating to an individual. Data relating to unidentified or unidentifiable individuals fall outside its concern. This blinkered view is replicated through data protection instruments from the first through to the most recent: the EU General Data Protection Regulation (GDPR).
The GDPR is only concerned with personal data, defined in a substantively similar and narrow fashion to Treaty 108. In so far as its object is privacy protection, it is predicated upon a relatively narrow and atomistic, conception of privacy. However, if the concerns associated with group privacy are viewed through the lens of public interest, then they may be given definition and traction even within the scope of a data protection instrument like the GDPR. The term ‘the public interest’ appears in the GDPR no fewer than seventy times. It has a particular significance in the context of health research. This is an area, such as criminal investigation, where the public interest has always been protected.Our argument is that it is through the application of the public interest test to health research governance in data protection law, that there is an opportunity to recognise in part common interests in group privacy. For example, any processing of personal data within material and territorial scope of the GDPR requires a lawful basis. Among the legal bases most likely to be applicable to the processing of personal data for research purposes is either that the processing is necessary for the performance of a task carried out in the public interest or in the exercise of official authority vested in the controller (Article 6(1)(e)), or, that it is necessary for the purposes of the legitimate interests pursued by the controller (Article 6(1)(f)). In the United Kingdom (UK), where universities are considered to be public authorities, universities are unable to rely upon ‘legitimate interests’ as a basis for lawful processing. Much health research in the UK will thus be carried out on the basis that it is necessary for the performance of a task in the public interest. Official guidance issued in the UK is that the organisations relying upon the necessity of processing to carry out a task ‘in the public interest’
should document their justification for this, by reference to their public research purpose as established by statute or University Charter.Footnote 30
Mere assertion that a particular processing operation is consistent with an organisation’s public research purpose will provide relatively scant assurance that the operation is necessary for the performance of a task in the public interest. More substantial justification would document justification relevant to particular processing operations. Where research proposals are considered by institutional review boards, such as university or NHS ethics committees, then independent consideration by such bodies of the public interest in the processing operation would provide the rationale. We suggest this provides an opportunity for group privacy concerns to be drawn into consideration. They might also form part of any privacy impact assessment carried out by the organisation. What is more, for the sake of legitimacy, any interference with group interests, or risk of harm to members of a group or to the collective interests of the group as a whole, should be subject to the test that members of the group be offered reasons to accept the processing as appropriate.Footnote 31 Such a requirement might support good practice in consumer engagement prior to the roll out of major data initiatives.
Admittedly, while this may provide opportunity to bring group privacy concerns into consideration where processing is carried out by a public authority (and the legal basis of processing is performance of a task carried out in the public interest), this only provides limited penetration of group privacy concerns into the regulatory framework. It would not, for example, apply where processing was in pursuit of legitimate interests or another lawful basis. There are other limited opportunities to bring group privacy concerns into the field of vision of data protection law through the lens of public interest.Footnote 32 However, for as long as the gravitational orbit of the law is around the concept of ‘personal data’, the chances to recognise group privacy interests are likely to be limited and peripheral. By contrast, more fundamental reform may be possible in the law of confidence.
24.4.2 Duty of ConfidenceAs with data protection and privacy,Footnote 33 there is an important distinction to be made between privacy and confidentiality. However, the UK has successfully defended its ability to protect the right to respect for private and family life, as recognised by Article 8 of the European Convention on Human Rights (ECHR), by pointing to the possibility of an action for breach of confidence.Footnote 34 It has long been recognised that the law’s protection of confidence is grounded in the public interestFootnote 35 but, as Lord Justice Briggs noted in R (W,X,Y and Z) v. Secretary of State for Health (2015),
the common law right to privacy and confidentiality is not absolute. English common law recognises the need for a balancing between this right and other competing rights and interests.Footnote 36
The argument put forward here is consistent with the idea that the protection of privacy and other competing rights and interests, such as those associated with health research, are each in the public interest. The argument here is that when considering the appropriate balance or trade-off between different aspects of the public interest, then a broader view of privacy protection than has hitherto been taken by English law is necessary to protect the legitimacy of decision-making. Such judicial innovation is possible.The law of confidence has already evolved considerably over the past twenty or so years. Since the Human Rights Act 1998Footnote 37 came into force in 2000, the development of the common law has been in harmony with Articles 8 and 10 of the ECHR.Footnote 38 As a result, as Lord Hoffmann put it,
What human rights law has done is to identify private information as something worth protecting as an aspect of human autonomy and dignity.Footnote 39
Protecting private information as an aspect of individual human autonomy and dignity might signal a shift toward the kind of narrow and atomistic conception of privacy associated with data protection law. This would be as unnecessary as it would be unfortunate. In relation to the idea of privacy, the European Court of Human Rights has itself said that
The Court does not consider it possible or necessary to attempt an exhaustive definition of the notion of ‘private life’ … Respect for private life must also comprise to a certain degree the right to establish and develop relationships with other human beings.Footnote 40
It remains open to the courts to recognise that the implications of group privacy concerns have a bearing on an individual’s ability to establish and develop relations with other human beings. Respect for human autonomy and dignity may yet serve as a springboard toward a recognition by the law of confidence that data processing impacts upon the conditions under which we live social (not atomistic) lives and our ability to establish and develop relationships as members of groups. After all, human rights are due to members of a group and their protection has always been motivated by group concerns.Footnote 41One of us has argued elsewhere that English Law took a wrong turn when R (Source Informatics) v. Department of HealthFootnote 42 was taken to be authority for the proposition that a duty of confidence cannot be breached through the disclosure of non-identifiable data. It is possible that the ratio in Source Informatics may yet be re-interpreted and recognised to be consistent with a claim that legal duties may be engaged through use and disclosure of non-identifiable data.Footnote 43 In some ways, this would simply be to return to the roots of the legal protection of privacy. In her book The Right to Privacy, Megan Richardson traces the origins and influence of the ideas underpinning the legal right to privacy. As she remarks, ‘the right from the beginning has been drawn on to serve the rights and interests of minority groups’.Footnote 44 Richardson recognises that, even in those cases where an individual was the putative focus of any action or argument,
Once we start to delve deeper, we often discover a subterranean network of families, friends and other associates whose interests and concerns were inexorably tied up with those of the main protagonist.Footnote 45
As a result, it has always been the case that the right to privacy has ‘broader social and cultural dimensions, serving the rights and interests of groups, communities and potentially even the public at large’.Footnote 46 It would be a shame if, at a time when we may need it most, the duty of confidence would deny its own potential to protect reasonable expectations in the use and disclosure of information simply because misuse had the potential to impact more than one identifiable individual.
24.5 Conclusion
The argument has been founded on the claim that a commitment to the protection of common interests in privacy and the product of health research, if placed alongside the commonly held value in individuals as free and equal persons, may establish a platform upon which one can construct a substantive idea of the public interest. If correct, then it is important to a proper calculation of the public interest to understand the breadth of privacy interests that need to be accounted for if we are to avoid subjugating the public to governance, and a trade-off between competing interests, that they have no reason to accept.
Enabling access to the data necessary for health research is in the public interest. So is the protection of group privacy. Recognising this point of connection can help guide decision-making where there is some kind of conflict or tension. The public interest can provide a common, commensurate framing. When this framing has a normative dimension, then this grounds the claim that the full range of common interests ought to be brought into view and weighed in the balance. One must capture all interests valued by the affected public, whether individual or common in nature, to offer them a reason to accept a particular trade-off between privacy and the public interest in health research. To do otherwise is to get the balance of governance wrong and compromise its social legitimacy.
That full range of common interests must include interests in group data. An understanding of what the public interest requires in a particular situation is short-sighted if this is not brought into view. An implication is that group interests must be taken into account within an interpretation and application of public interest in data protection law. Data controllers should be accountable for addressing group privacy interests in any public interest claim. With respect to the law of confidence, there is scope for even more significant reform. If the legitimacy of the governance framework, applicable to health data, is to be assured into the future, then it needs to be able to see – so that it might protect – reasonable expectations in data relating to groups of persons and not just identifiable individuals. Anything else will be a myopic failure to protect some of the most sensitive data about people simply on the grounds that misuse does not affect a sole individual but multiple individuals simultaneously. That is not a governance model that we have any reason to accept and we have the concept of public interest at our disposal to correct our vision and bring the full range of relevant interests into view.
25.1 Introduction
This chapter will develop the role that deliberative public engagement should have in health research regulation. The goal of public deliberation is to mobilise the expertise that members of the public have, to explore their values in relation to specific trade-offs, with the objective of recommendations that respect diverse interests. Public deliberation requires that a small group is invited to a structured event that supports informed, civic-minded consideration of diverse perspectives on public interest. Ensuring that the perspectives considered are inclusive of perspectives that might otherwise be marginalised or silenced requires explicitly designing the small group in relation to the topic. Incorporating public expertise enhances the trustworthiness of policies and governance by explicitly acknowledging and negotiating diverse public interests. Trustworthiness is distinct from trust, so the chapter begins by exploring that distinction in the context of the example of care.data and the loss of trust in the English National Health Service’s (NHS) use of electronic health records for research. While better public engagement prior to the announcement might have avoided the loss of trust, subsequent deliberative public engagement may build trustworthiness into the governance of health research endeavours and contribute to re-establishing trust.
25.2 Trustworthiness of Research Governance
Some activities pull at the loose threads of social trust. These events threaten to undermine the presumption of legitimacy that underlie activities directed to public interest. The English NHS care.data programme is one cautionary tale (NHS, 2013).Footnote 1 The trigger event was the distribution of a pamphlet to households. The pamphlet informed the public that a national database of patients’ medical records would be used for patient care, to monitor outcomes, and that research would take place on anonymous datasets. The announcement was entirely legitimate within the existing regulatory regime. The Editor-in-Chief of the British Medical Journal summarises, ‘But all did not go to plan. NHS England’s care.data programme failed to win the public’s trust and lost the battle for doctors’ support. Two reports have now condemned the scheme, and last week the government decided to scrap it.’Footnote 2
The stimulation of public distrust is often characterised by a political deployment of a segment of the public, but it may lead to a wider rejection of previously non-controversial trade-offs. In the case of care.data, the first response was to ensure better education about benefits and enhanced informed consent. The Caldicott Report on the care.data programme called for better technology standards, publication of disclosure procedures, an easy opt-out procedure and a ‘dynamic consent’ process.Footnote 3
There are good reasons to doubt that improved regulation and informed consent procedures alone will restore the loss, or sustain current levels, of public trust. It was unlikely that the negative reaction to care.data had to do with an assessment of the adequacy of the regulations for privacy and access to health data. Moreover, everything proposed under care.data was perfectly lawful. It is far more likely that the reaction had to do with a rejection of what was presented as a clear case of justified use of patients’ medical records. The perception was that the trade-offs were not legitimate, at least to some of the public and practitioners. The destabilisation of trust that patient information was being used in appropriate ways, even with what should have been an innocuous articulation of practice, suggests a shift in how the balance between access to information and privacy are perceived. Regulatory experts on privacy and informed consent may strengthen protection or recalibrate what is protected. But such measures do not develop an understanding and response to how a wider public might assign proportionate weight to privacy and access in issues related to research regulation. Social controversy about the relative weight of important public interests demonstrates the loss of legitimacy of previous decisions and processes. It is the legitimacy of the programmes that require public input.
The literature on public understanding of science also suggests that merely providing more detailed information and technical protections is unlikely to increase public trust.Footnote 4 Although alternative models of informed consent are beyond the scope of this chapter, it seems more likely that informed consent depends on relationships of trust, and that trust, or its absence, is more of a heuristic approach that serves as a context in which people make decisions under conditions of limited time and understanding.Footnote 5 Trust is often extended without assessment of whether the conditions justify trust, or are trustworthy. It also follows that trust may not be extended even when the conditions seem to merit trust. The complicated relationship between trust and trustworthiness has been discussed in another chapter (see Chuong and O’Doherty, Chapter 12) and in the introduction to this volume, citing Onora O’Neill, who encourages us to focus on demonstrating trustworthiness in order to earn trust.
The care.data experience illustrates how careful regulation within the scope of law and current research ethics, and communicating those results to a wide public, was not sufficient for the plan to be perceived as legitimate and to be trusted. Regulation of health research needs to be trustworthy, yet distrust can be stimulated despite considerable efforts and on-going vigilance. If neither trust nor distrust are based on the soundness of regulation of health research, then the sources of distrust need to be explicitly addressed.
25.3 Patients or Public? Conceptualising What Interests Are Important
It is possible to turn to ‘patients’ or ‘the public’ to understand what may stabilise or destabilise trust and legitimacy in health research. There is considerable literature and funding opportunities related to involving patients in research projects, and related improved outcomes.Footnote 6 The distinction between public and patients is largely conceptual, but it is important to clarify what aspects of participants’ lives we are drawing on to inform research and regulation, and then to structure recruitment and the events to emphasise that focus.Footnote 7 In their role as a patient, or caregivers and advocates for family and friends in healthcare, participants can draw on their experiences to inform clinical care, research and policy. In contrast, decisions that allocate across healthcare needs, or broader public interests, require consideration of a wider range of experiences, as well as the values, and practical knowledge that participants hold as members of the public. Examples of where it is important to achieve a wider ‘citizen’ perspective include funding decisions on drug expenditures and disinvestment, and balancing privacy concerns against benefits from access to health data or biospecimens.Footnote 8 Considerations of how to involve the public in research priorities is not adequately addressed by involving community representatives on research ethics review committees.Footnote 9
Challenges to trust and legitimacy often arise when there are groups who hold different interpretations of what is in the public interest. Vocal participants on issues are often divide into polarised groups. But there is often also a multiplicity of public interests, so there is no single ‘public interest’ to be discovered or determined. Each configuration of a balance of interests also has resource implications, and the consequences are borne unevenly across the lines of inequity in society. There is democratic deficit when decisions are made without input from members of public who will be affected by the policy but have not been motivated to engage. This deficit is best addressed by ‘actively seek(ing) out moral perspectives that help to identify and explore as many moral dimensions of the problem as possible’.Footnote 10 This rejects the notions that bureaucracies and elected representatives are adequately informed by experts and stakeholders to determine what is in the interests of all who will be affected by important decisions. These decisions are, in fact, about a collective future, often funded by public funds with opportunity costs. Research regulation, like biotechnology development and policy, must explicitly consider how and who decides the relative importance of benefits and risks.
The distinction between trust and trustworthiness, between bureaucratic legitimacy and perceived social licence, gives rise to the concern that much patient and public engagement may be superficial and even manipulative.Footnote 11 Careful consideration must be given to how the group is convened, informed, facilitated and conclusions or recommendations are formulated. An earlier chapter considered the range of approaches to public and patient engagement, and how different approaches are relevant for different purposes (see Aitkin and Cunningham-Burley, Chapter 11).Footnote 12 To successfully stimulate trust and legitimacy, the process of public engagement requires working through these dimensions.
25.4 Conceptualising Public Expertise: Representation and Inclusiveness
The use of the term ‘public’ is normally intended to be as inclusive as possible, but it is also used to distinguish the call to public deliberation from other descriptions of members of society or stakeholders. There is a specific expertise called upon when people participate as members of the public as opposed to patients, caregivers, stakeholders or experts. Participants are sought for their broad life perspective. As perspective bearers coming from a particular structural location in society, with ‘experience, history and social knowledge’,Footnote 13 participants draw on their own social knowledge and capacity in a deliberative context that supports this articulation without presuming that their experiences are adequate to understand that of others’, or that there is necessarily a common value or interest
‘Public expertise’ is what we all develop as we live in our particular situatedness, and in structured deliberative events it is blended with an understanding of other perspectives, and directed to develop collective advice related to the controversial choices that are the focus of the deliberation. Adopting Althusser’s notion of hailing or ‘interpellation’ as ideological construction of people’s role and identity, Berger and De Cleen suggest that calling people to deliberate ‘offers people the opportunity to speak (thus empowering them) and a central aspect of how their talk is constrained and given direction (the exercise of power on people)’.Footnote 14 In deliberation, the manifestations of public expertise is interwoven with the overall framing, together co-creating the capacity to consider the issues deliberated from a collective point of view.Footnote 15 Political scientist Mark Warren suggests that ‘(r)epresentation can be designed to include marginalized people and unorganized interests, as well as latent public interests’.Footnote 16 As one form of deliberation, citizen juries, captured in the name and process, the courts have long drawn on public to constitute a group of peers who must make sense and form collective judgments out of conflicting and diverse information and alternative normative weightings.Footnote 17
Simone Chambers, in a classic review of deliberative democracy, emphasised two critiques from diversity theory, and suggested that these would be a central concern in the next generation of deliberative theorists: (1) reasonableness and reason-giving; (2) conditions of equality as participants in deliberative activities.Footnote 18 The facilitation of deliberative events is discussed below, but participants can be encouraged and given the opportunity to understand each other’s perspectives in a manner that may be less restrictive than theoretical discussions suggest. For example, the use of narrative accounts to explain how participants come to hold particular beliefs or positions provide important perspectives that might not be volunteered or considered if there was a strong emphasis on justifying one’s views with reasons in order for them to be considered.Footnote 19
The definition and operationalisation of inclusiveness is important because deliberative processes are rarely large scale, focussing instead on the way that small groups can demonstrate how a wider public would respond if they were informed and civic-minded.Footnote 20 Representation or inclusiveness is often the starting place for consideration of an engagement process.Footnote 21 Steel and colleagues have described three different types of inclusiveness that provides conceptual clarity about the constitution of a group for engagement: representative, egalitarian and normic diversity.Footnote 22
Representative diversity requires that the distribution of the relevant sub-groups in the sample reflects the same distribution as in the reference population. Egalitarian inclusiveness requires equal representation of people from each relevant sub-group so that each perspective is given equal representation. In contrast to representative diversity, Egalitarian diversity ignores the size of each sub-group in the population, and emphasises equal representation of each sub-group. Normic diversity requires the over-representation of sub-groups who are marginalised or overwhelmed by the larger, more influential or mainstream groups in the population. Each of these concepts aim for a symmetry, but the representative approach presumes that symmetry is the replication of the population, while egalitarian and normic concepts directly consider asymmetry of power and voice in society.
Attempts to enhance the range of perspectives considered in determining the public interest(s) is likely to draw on the normic and egalitarian concepts of diversity, and de-emphasise the representative notion. The goal of deliberative public engagement is to address a democratic deficit whereby some groups have been the dominant perspectives considered on the issues, even if none have prevailed over others. It seeks to include a wider range of input from diverse citizens about how to live together given the different perspectives on what is ‘in the public interest. Normic diversity suggests that dominant groups are less present in the deliberating group, and egalitarian suggests that it is important to have similar representation across the anticipated diverse perspectives. The deliberation must be informed about, but not subjugated by, dominant perspectives, and one approach is to exclude dominant perspectives, including those of substance experts, from participating in the deliberation, but introduce their perspectives and related information through materials and presentations intended to inform participants. Deliberative participants must exercise their judgement and critically consider a wide range of perspectives, while stakeholders are agents for a collective identity that asserts the importance of one perspective over others.Footnote 23 It is also challenging to identify the range of relevant perspectives that give particular form to the public expertise for an issue, although demographics may be used to ensure that participants reflect a range of life experiences.Footnote 24 Specific questions may also suggest that particular public perspectives are important to include in the deliberating group. For example, in Californian deliberations on biobanks it was important to include Spanish-only speakers because, despite accounting for the majority of births, they were often excluded from research regulation issues (normic diversity), and they were an identifiable group who likely had unique perspectives compared to other demographic segments of the California population (egalitarian diversity).Footnote 25
25.5 Mobilising Public Expertise in Deliberation
As previously discussed, mobilising public expertise requires considerable support. To be credible and legitimate, a deliberative process must demonstrate that the participants are adequately informed and consider diverse perspectives. Participants must respectfully engage each other in the development of recommendations that focus on reasoned inclusiveness but fully engage the trade-offs required in policy decisions.
It seems obvious that participation in an engagement to advise research regulation must be informed about the activities to be regulated. This is far from a simple task. An engagement can easily be undermined if the information provided is incomplete or biased. It is important to provide not only complete technical details, but also ensure that social controversies and stakeholder perspectives are fairly represented. This can be managed by having an advisory of experts, stakeholders and potential knowledge users. Advisors can provide input into the questions and the range of relevant information that participants must consider to be adequately informed. It is also important to consider how best to provide information to support comprehension across participants with different backgrounds. One approach is to utilise a combination of a background booklet and a panel of four to six speakers.Footnote 26 The speakers, a combination of experts and stakeholders, are asked to be impassioned, explaining how or why they come to their particular view. This will establish that there are controversies, help draw participants into the issues and stimulate interest in the textual information.
Facilitation is another critical element of deliberative engagement. Deliberative engagement is distinguished by collective decisions supported by reasons from the participants – the recommendations and conclusions are the result of a consideration of the diverse perspectives reflected in the process and among participants. The approach to facilitation openly accepts that participants may re-orient the discussion and focus, and that the role of facilitation is to frame the discussion in a transparent manner.Footnote 27 Small groups of six to eight participants can be facilitated to develop fuller participation and articulation of different perspectives and interests than is possible in a larger group. Large group facilitation can be oriented to giving the participants as much control over topic and approach as they assume, while supporting exploration of issues and suggesting statements where the group may be converging. The facilitator may also draw closure to enable participants to move on to other issues by suggesting that there is a disagreement that can be captured. Identifying places of deep social disagreement identifies where setting policy will need to resolve controversy about what is genuinely in the public’s interest, and where there may be a need for more nuanced decisions on a case-by-case basis. The involvement of industry and commercialisation in biobanks is a general area that has frequently defied convergence in deliberation.Footnote 28
Even if recruitment succeeds in convening a diverse group of participants, sustaining diversity and participation across participants requires careful facilitation. The deliberative nature of the activity is dynamic. Participants increase their level of knowledge and understanding of diverse perspectives as facilitation encourages them to shift from an individual to a collective focus. Premature insistence on justifications can stifle understanding of diverse perspectives, but later in the event, justifications are crucial to produce reasons in support of conclusions. Discussion and conclusions can be inappropriately influenced by participants’ personalities, as well as the tendency for some participants to position themselves as having authoritative expertise. It is well within the expertise of the public to consider whether claims to special knowledge or personalities are lacking substantive support for their positions. But self-reflective and respectful communication is not naturally occurring, and deliberation requires skilled facilitation to avoid dominance of some participants and to encourage critical reflection and participation of quieter participants. The framing of the issues and information as well as facilitation inevitably shapes the conclusions, and participants may not recognise that issues and concerns important to them have been ruled out of scope.
Assessing the quality of deliberative public engagement is fraught with challenges. Abelson and Nabatchi have provided good overviews of the state of deliberative civic engagement, assessing its impacts and assessment.Footnote 29
There are recent considerations of whether and under what conditions deliberative public engagement is useful and effective.Footnote 30 Because deliberative engagement is expensive and resource intensive, it needs to be directed to controversies where the regulatory bodies want, and are willing, to have their decisions and policies shaped by public input. Such authorities do not thereby give up their legitimate duties and freedom to act in the public interest or to consult with experts and stakeholders. Rather, activities such as deliberative public engagement are supplemental to the other sources of advice, and not determinative of the outcomes. This point is important for knowledge users, sponsors and participants to understand.
How, then, might deliberative public engagement have helped avoid the negative reaction to care.data? It is first important to distinguish trust from trustworthiness. Trust, sometimes considered as social licence, is usually presumed in the first instance. As a psychological phenomenon, trust is often a heuristic form of reasoning that supports economical use of intellectual and social capital.Footnote 31 There is some evidence that trust is particularly important with regard to research participation.Footnote 32 Based on previous experiences, we develop trust – or distrust – in people and institutions. There is a good chance that many people whose records are in the NHS would approach the use of their records for other purposes with a general sense of trust. Loss of trust often flows from abrupt discovery that things are not as we presumed, which is what appears to have happened in care.data. On the other hand, trustworthiness of governance is when the governance system has the characteristics that, if scrutinised, would support that it is worthy of trust.
Given this understanding, it might have been possible to demonstrate trustworthiness of governance of the NHS data by holding deliberative public engagement and considering its recommendations for data management. Also, public trust might not have been as widely undermined if the announcement of extension of access to include commercial partners provided a basis for finding the governance trustworthy. Of course, distrust of critical stakeholders and members of public will still require direct responses to their concerns.
It is important to note that trustworthiness that can stand up to scrutiny is the goal, rather than directing efforts at increasing trust. Since trust is given in many cases without reflection, it can often be manipulated. By aiming at trustworthiness, arrived at through considerations that include deliberative public input, the authorities demonstrate that their approach is trustworthy. Articulating how controversies have been considered with input from informed and deliberating members of public would have demonstrated that the trust presumed at the outset was, in an important sense, justified. Now, after the trust has been lost and education and reinforced individual consent has not addressed the concerns, deliberation to achieve legitimate and trustworthy governance may have a more difficult time stimulating wide public trust, but it may remain the best available option.
25.6 Conclusion
Deliberative public engagement has an important role in the regulation of health research. Determining what trade-offs are in the public interest requires a weighing of alternatives and relative weights of different interests. Experts and stakeholders are legitimate advocates for the interests they represent, but their interests manifest an asymmetry of power. Including a well-designed process to include diverse public input can increase the legitimacy and trustworthiness of the policies. Deliberative engagement mobilises a wider public to direct their collective experience and expertise. The resulting advice about what is in the public interest explicitly builds diversity in the recruitment of the participants and in the design of the deliberation.
Deliberative public engagement is helpful for issues where there is genuine controversy about what is in the public interest, but it is far from a panacea. It is an important complement to stakeholder and expert input. The deliberative approach starts with careful consideration of the issues to be deliberated and how the diversity is to be structured into the recruitment of a deliberating small group. Expert and stakeholder advisors, as well as decision-makers who are the likely recipients of the conclusions of the deliberation, can help develop the range of information necessary for deliberation on the issues to be informed. Participants need to be supported by exercises and facilitation that helps them develop a well-informed and respectful understanding of diverse perspectives. Facilitation then shifts to support the development of a collective focus and conclusions with justifications. Diversity and asymmetry of power is respected through the conceptualisation and implementation of inclusiveness, the development of information, and through facilitation and respect for different kinds of warranting. There must be a recognition that the role of event structure and facilitation means that the knowledge is co-produced with the participants, and that it is very challenging to overcome asymmetries, even in the deliberation itself. Another important feature is the ability to identify persistent disagreements and not force premature consensus on what is in the public interest. In this quality, it mirrors the need for, and nature of, regulation of health research to struggle with the issue of when research is in ‘the public interest’.
It is inadequate to assert or assume that research and its existing and emerging regulation is in the public interest. It is vital to ensure wide, inclusive consideration that is not overwhelmed by economic or other strongly vested interests. This is best accomplished by developing, assessing and refining ways to better include diverse citizens in the informed reflections about what is in our collective interests, and how to best live together when those interests appear incommensurable.
26.1 Introduction
In recent times, biomedical research has begun to tap into larger-than-ever collections of different data types. Such data include medical history, family history, genetic and epigenetic data, information about lifestyle, dietary habits, shopping habits, data about one’s dwelling environment, socio-economic status, level of education, employment and so on. As a consequence, the notion of health data – data that are of relevance for health-related research or for clinical purposes – is expanding to include a variety of non-clinical data, as well as data provided by research participants themselves through commercially available products such as smartphones and fitness bands.Footnote 1 Precision medicine that pools together genomic, environmental and lifestyle data represents a prominent example of how data integration can drive both fundamental and translational research in important domains such as oncology.Footnote 2 All of this requires the collection, storage, analysis and distribution of massive amounts of personal information as well as the use of state-of-the art data analytics tools to uncover new disease-related patterns.
To date, most scholarship and policy on these issues has focused on privacy and data protection. Less attention has been paid to addressing other aspects of the wicked challenges posed by Big Data health research and even less work has been geared towards the development of novel governance frameworks.
In this chapter, we make the case for adaptive and principle-based governance of Big Data research. We outline six principles of adaptive governance for Big Data research and propose key factors for their implementation into effective governance structures and processes.
26.2 The Case for Adaptive Principles of Governance in Big Data Research
For present purposes, the term ‘governance’ alludes to a democratisation of administrative decision-making and policy-making or, to use the words of sociologist Anthony Giddens, to ‘a process of deepening and widening of democracy [in which] government can act in partnership with agencies in civil society to foster community renewal and development.’Footnote 3
Regulatory literature over the last two decades has formalised a number of approaches to governance that seem to address some of the defining characteristics of Big Data health research. In particular, adaptive governance and principles-based regulation appear well-suited to tackle three specific features of Big Data research, namely: (1) the evolving, and thus hardly predictable nature of the data ecosystem in Big Data health research – including the fast-paced development of new data analysis techniques; (2) the polycentric character of the actor network of Big Data and the absence of a single centre of regulation; and (3) the fact that most of these actors do not currently share a common regulatory culture and are driven by unaligned values and visions.Footnote 4
Adaptive governance is based on the idea that – in the presence of uncertainty, lack of evidence and evolving, dynamic phenomena – governance should be able to adapt to the mutating conditions of the phenomenon that it seeks to govern. Key attributes of adaptive governance are the inclusion of multiple stakeholders in governance design,Footnote 5 collaboration between regulating and regulated actors,Footnote 6 the incremental and planned incorporation of evidence in governance solutionsFootnote 7 and openness to cope with uncertainties through social learning.Footnote 8 This is attained by planning evidence collection and policy revision rounds in order to refine the fit between governance and public expectations; distributing regulatory tasks across a variety of actors (polycentricity); designing partially overlapping competences for different actors (redundancy); and by increasing participation in policy and management decisions by otherwise neglected social groups. Adaptive governance thus seems to adequately reflect the current state of Big Data health research as captured by the three characteristics outlined above. Moreover, social learning – a key feature of adaptive governance – can help explore areas of overlapping consensus even in a fragmented actor network like the one that constitutes Big Data research.
Principles based regulation (PBR) is a governance approach that emerged in the 1990s to cope with the expansion of the financial services industry. Just as Big Data research is driven by technological innovation, financial technologies (the so-called fintech industry) have played a disruptive role for the entire financial sector.Footnote 9 Unpredictability, accrual of new stakeholders and lack of regulatory standards and best practices characterise this phenomenon. To respond to this, regulators such as the UK Financial Services Authority (FSA), backed-up by a number of academic supporters of ‘new governance’ approaches,Footnote 10 have proposed principles-based regulation as a viable governance model.Footnote 11 In this model, regulation and oversight relies on broadly-stated principles that reflect regulators orientations, values and priorities. Moreover, implementation of the principles is not entirely delegated to specified rules and procedures. Rather, PBR relies on regulated actors to set up mechanism to comply with the principles.Footnote 12 Principles are usually supplemented by guidance, white papers and other policies and processes to channel the compliance efforts of regulated entities. See further on PBR, Sethi, Chapter 17, this volume.
We contend that PBR is helpful to set up Big Data governance in the research space because it is explicitly focussed on the creation of some form of normative alignment between the regulator and the regulated; it creates conditions that can foster the emergence of shared values among different regulated stakeholders. Since compliance is not rooted on box-ticking nor respect for precisely-specified rules, PBR stimulates experimentation with a number of different oversight mechanisms. This bottom-up approach allows stakeholders to explore a wide range of activities and structures to align with regulatory principles, favouring the selection of more cost-efficient and proportionate mechanisms. Big data health research faces exactly this need to create stakeholders’ alignment and to cope with the wide latitude of regulatory attitudes that is to be expected in an innovative domain with multiple newcomers.
The governance model that we propose below relies on both adaptive governance – as to its capacity to remain flexible to future evolutions of the field – and PBR – because of its emphasis on principles as sources of normative guidance for different stakeholders.
26.3 A Framework to Develop Systemic Oversight
The framework we propose below provides guidance to actors that have a role in the shaping and management of research employing Big Data; it draws inspiration from the above-listed features of adaptive governance. Moreover, it aligns with PBR in that it offers guidance to stakeholders and decision-makers engaged at various levels in the governance of Big Data health research. As we have argued elsewhere, our framework will facilitate the emergence of systemic oversight functions for the governance of Big Data health research.Footnote 13 The development of systemic oversight relies on six high-order principles aimed at reducing the effects of a fragmented governance landscape and at channelling governance decisions – through both structures and processes – towards an ethically defensible common ground. These six principles do not predefine which specific governance structures and processes shall be put in place – hence the caveat that they represent high-order guides. Rather, they highlight governance features that shall be taken into account in the design of structures and processes for Big Data health research. Equally, our framework is not intended as a purpose-neutral approach to governance. Quite to the contrary; the six principles we advance do indeed possess a normative character in that they endorse valuable states of affairs that shall occur as a result of appropriate and effective governance. By the same token, our framework suggests that action should be taken in order to avoid certain kinds of risks that will most likely occur if left unattended. In this section, we will illustrate the six principles of systemic oversight – adaptivity, flexibility, monitoring, responsiveness, reflexivity and inclusiveness – while the following section deals with the effective interpretation and implementation of such principles in terms of both structures and processes.
Adaptivity: adaptivity is the capacity of governance structures and processes to ensure proper management of new forms of data as they are incorporated into health research practices. Adaptivity, as presented here, has also been discussed as a condition for resilience, that is, for the capacity of any given system to ‘absorb disturbances and reorganize while undergoing change so as to still retain essentially the same function, structure, identity and feedbacks.’Footnote 14 This feature is crucial in the case of a rapidly evolving field – like Big Data research – whose future shape, as a consequence, is hard to anticipate.
Flexibility: flexibility refers to the capacity to treat different data types depending on their actual use rather than their source alone. Novel analytic capacities are jeopardising existing data taxonomies, which rapidly renders regulatory categories constructed around them obsolete. Flexibility means, therefore, recognising the impact of technical novelties and, at a minimum, giving due consideration to their potential consequences.
Monitoring: risk minimisation is a crucial aim of research ethics. With the possible exception of highly experimental procedures, the spectrum of physical and psychological harms due to participation in health research is fairly straightforward to anticipate. In the evolving health data ecosystem described so far, however, it is difficult to anticipate upfront what harms and vulnerabilities research subjects may encounter due their participation in Big Data health research. This therefore requires on-going monitoring.
Responsiveness: despite efforts in monitoring emerging vulnerabilities, risks can always materialise. In Big Data health research, privacy breaches are a case in point. Once personal data are exposed, privacy is lost. No direct remedy exists to re-establish the privacy conditions that were in place before the violation. Responsiveness therefore prescribes that measures are put in place to at least reduce the impact of such violations on the rights, interests and well-being of research participants.
Reflexivity: it is well known that certain health-related characteristics cluster in specific human groups, such as populations, ethnic groups, families and socio-economic strata. Big data are pushing the classificatory power of research to the next level, with potentially worrisome implications. The classificatory assumptions that drive the use of rapidly evolving data-mining capacities need to be put under careful scrutiny as to their plausibility, opportunity and consequences. Failing to do so will result in harms to all human groups affected by those assumptions. What is more, public support for, as well as trust in, scientific research may be jeopardised by the reputational effects that can arise if reflexivity and scrutiny are not maintained.
Inclusiveness: the last component of systemic oversight closely resonates with one of the key features of adaptive governance, that is, the need to include all relevant parties in the governance process. As more diverse data sources are aggregated, the more difficult it becomes for research participants to exert meaningful control on the expanding cloud of personal data that is implicated by their participation.Footnote 15 Experimenting with new forms of democratic engagement is therefore imperative for a field that depends on resources provided by participants (i.e. data), but that, at the same time, can no longer anticipate how such resources will be employed, how they will be analysed and with which consequences. See Burgess, Chapter 25.
These six principles can be arranged to form the acronym AFIRRM: our model framework for the governance of Big Data health research.
26.4 Big Data Health Research: Implementing Effective Governance
While there is no universal definition of the notion of effective governance, it alludes in most cases to an alignment between purposes and outcomes, reached through processes that fulfil constituents’ expectations and which project legitimacy and trust onto the involved actors.Footnote 16 This understanding of effective governance fits well with our domain of interest: Big Data health research. In the remainder of this chapter, drawing on literature on the implementation of adaptive governance and PBR, we discuss key issues to be taken into account in trying to derive effective governance structures and oversight mechanism from the AFIRRM principles.
The AFIRRM framework endorses the use of principles as high-level articulations of what is to be expected by regulatory mechanisms for the governance of Big Data health research. Unlike the use of PBR in financial markets where a single regulator expects compliance, PBR in the Big Data context responds to the reality that governance functions are distributed among a plethora of actors, such as ethics review committees, data controllers, privacy commissioners, access committees, etc. PBR within the AFIRRM framework offers a blueprint for such a diverse array of governance actors to create new structures and processes to cope with the specific ethical and legal issues raised by the use of Big Data. Such principles have a generative function in the governance landscape, that is, in the process of being created to govern those issues.
The key advantage of principles in this respect is that they require making the reason behind regulation visible to all interested parties, including publics. This amounts to an exercise of public accountability that can bring about normative coherence among actors with different starting assumptions. The AFIRRM principles stimulate a bottom-up exploration of the values at stake and how compliance with existing legal requirements will be met. In this sense, the AFIRRM principles perform a formal, more than a substantive function, precisely because we assume the substantive ethical and legal aims of regulation that have already been developed in health research – such as the protection of research participants from the risk of harm – to hold true also for research employing Big Data. What AFIRRM principles do is to provide a starting point for deliberation and action that respects existing ethical standards and complies with pre-existing legal rules.
The AFIRRM principles do not envision actors in the space of Big Data research to self-regulate, but they do presuppose trust between regulators and regulated entities: regulators need to be confident that regulated entities will do their best to give effect to the principles in good faith. While some of the interests at stake in Big Data health research might be in tension – like the interest of researchers to access and distribute data, and the interests of data donors to control what their personal data are used for – developing efficient governance structures and processes that meet stakeholders’ expectations is of advantage for all interested parties to begin with conversations based on core agreed principles. Practically, this requires all relevant stakeholders to have a say in the development and operationalisation of the principles at stake.
Adaptive governance scholarship has identified typical impediments to effective operationalisation of adaptive mechanisms. A 2012 literature review of adaptive governance, network management and institutional analysis identified three key challenges to the effective implementation of adaptive governance: ill-defined purposes and objectives, unclear governance context and lack of evidence in support of blueprint solutions.Footnote 17
Let us briefly illustrate each of these challenges and explain how systemic oversight tries to avoid them. In the shift from centralised forms of administration and decision-making, to less formalised and more distributed governance networks that occurred over the last three decades,Footnote 18 the identification of governance objectives is no longer straightforward. This difficulty may also be due to the potentially conflicting values of different actors in the governance ecosystem. In this respect, systemic oversight has the advantage of not being normatively neutral. The six principles of systemic oversight determinedly aim at fostering an ethical common ground for a variety of governance actors and activities in the space of Big Data research. What underpins the framework, therefore, is a view of what requires ethical attention in this rapidly evolving field, and how to prioritise actions accordingly. In this way, systemic oversight can provide orientation for a diverse array of governance actors (structures) and mechanisms (processes), all of which are supposed to produce an effective system of safeguards around activities in this domain. Our framework directs attention to critical features of Big Data research and promotes a distributed form of accountability that will, where possible, emerge spontaneously from the different operationalisations of its components. The six components of systemic oversight, therefore, suggest what is important to take into account when considering how to adapt the composition, mandate, operations and scope of oversight bodies in the field of Big Data research.
The second challenge to effective adaptive governance – unclear governance context – refers to the difficulty of mapping the full spectrum of rules, mechanisms, institutions and actors involved in a distributed governance system or systems. Systemic oversight requires mapping the overall governance context in order to understand how best to implement the framework in practice. This amounts to an empirical inquiry into the conditions (structures, mechanisms and rules) in which governance actors currently operate. In a recent study we showed that current governance mechanisms for research biobanks, for instance, are not aligned with the requirements of systemic oversight.Footnote 19 In particular, we showed that systemic oversight can contribute to improve accountability of research infrastructures that, like biobanks, collect and distribute an increasing amount of scientific data.
The third and last challenge to effective operationalisation of adaptive mechanisms has to do with the limits of ready-made blueprint solutions to complex governance models. Political economist and Nobel Laureate Elinor Ostrom has written extensively on this. In her work on socio-ecological systems, Ostrom has convincingly shown that policy actors have the tendency to buy into what she calls ‘policy panaceas’,Footnote 20 that is, ready-made solutions to very complex problems. Such policy panaceas are hardly ever supported by solid evidence regarding the effectiveness of their outcomes. One of the most commonly cited reasons for their lack of effectiveness is that complexity entails high degrees of uncertainty as to the very phenomenon that policy makers are trying to govern.
We saw that uncertainty is characteristic of Big Data research too (see Section 26.2). That is why systemic oversight refrains from prescribing any particular governance solution. While not rejecting traditional predict-and-control approaches (such as informed consent, data anonymisation and encryption), systemic oversight does not put all the regulatory weight on any particular instrument or body. The systemic ambition of the framework lies in its pragmatic orientation towards a plurality of tools, mechanisms and structures that could jointly stabilise the responsible use of Big Data for research purposes. In this respect, our framework acknowledges that ‘[a]daptation typically emerges organically among multiple centers of agency and authority in society as a relatively self-organized or autonomous process marked by innovation, social learning and political deliberation’.Footnote 21
Still, a governance framework’s capacity to avoid known bottlenecks to operationalisation is a necessary but not a sufficient condition to its successful implementation. The further question is how the principles of the systemic oversight model can be incorporated into structures and processes in Big Data research governance. With structures we mean actors and networks of actors involved in governance, and organised in bodies charged with oversight, organisational or policy-making responsibilities. Processes, instead, are the mechanisms, procedures, rules, laws and codes through which actors operate and bring about their governance objectives. Structures and processes define the polycentric, redundant and experimental system of governance that an adaptive governance model intends to promote.Footnote 22
26.5 Key Features of Governance Structures and Processes
Here we follow the work of Rijke and colleaguesFootnote 23 in identifying three key properties of adaptive governance structures: centrality, cohesion and density. While it is acknowledged that centralised structures can be effective as a response to crises and emergencies, centralisation is precisely a challenge in Big Data; our normative response is to call for inclusive social learning among the broad array of stakeholders, subject to challenges of incomplete representation of relevant interests (see further below). Still, this commitment can help to promote network cohesion by fostering discussion about how to implement the principles, while also promoting the formation of links between governance actors, as required by density. In addition, this can help to ensure that governance roles are fairly distributed among a sufficiently diverse array of stakeholders and that, as a consequence, decisions are not hijacked by technical experts.
The governance space in Big Data research is already populated by numerous actors, such as IRBs, data access committees and advisory boards. These bodies are not necessarily inclusive of a sufficiently broad array of stakeholders and therefore they may not be very effective at promoting social learning. Their composition could thus be rearranged in order to be more representative of the interests at stake and to promote continued learning. New actors could also enter the governance system. For instance, data could be made available for research by data subjects themselves through data platforms.Footnote 24
Network of actors (structures) operating in the space of health research do so through mechanisms and procedures (processes) such as informed consent and ethics review, as well as data access review, policies on reporting research findings to participants, public engagement activities and privacy impact assessment.
Processes are crucial to effective governance of health research and are a critical component of the systemic oversight approach as their features can determine the actual impact of its principles. Drawing on scholarship in adaptive governance, we present three such features (components) that are central to the appropriate interpretation of the systemic oversight principles.
Social learning: social learning refers to learning that occurs by observing others.Footnote 25 In governance settings that are open to participation by different stakeholders, social learning can occur across different levels and hierarchies of the governance structures. According to many scholars, including Ostrom,Footnote 26 social learning represents an alternative to policy blueprints (see above) – especially when it is coupled with and leading to adaptive management. Planned adaptations – that is, previously scheduled rounds of policy revision in light of new knowledge – can be occasions for governance actors to capitalise on each other’s experience and learn about evolving expectations and risks. Such learning exercises can reduce uncertainty and lead to adjustments in mechanisms and rules. The premise of this approach is the realisation that in complex systems characterised by pronounced uncertainty, ‘no particular epistemic community can possess all the necessary knowledge to form policy’.Footnote 27 Social learning – be it aimed at gathering new evidence, at fostering capacity building or at assessing policy outcomes – is relevant to all of the six components of systemic oversight. The French law on bioethics, for instance, prescribes periodic rounds of nationwide public consultation – the so-called Estates General on bioethics.Footnote 28 This is an example of how social learning can be fostered. Similar social learning can be triggered even at smaller scales – for instance in local oversight bodies – in order to explore new solutions and alternative designs.
Complementarity: complementarity is the capacity of governance processes to fulfil both the need for processes to be functionally compatible and to ensure procedural correspondence between processes and the phenomena they intend to regulate. Functional complementarity refers to the distribution of regulatory functions across a given set of processes exhibiting partial overlap (see redundancy, above). This feature is crucial for both monitoring and reflexivity. Procedural complementarity, on the other hand, refers to the temporal alignment between governance processes and the activities that depend on such processes. One prominent example, in this respect, is the timing of ethics review processes, or that of data access requests processing.Footnote 29 For instance, the European General Data Protection Regulation (GDPR) prescribes a maximum 72-hour delay between detection and notification of privacy breaches. This provision is an example of procedural complementarity that would be of the utmost importance for the principle of responsiveness.
Visibility: governance processes need to be visible, that is, procedures and their scope need to be as publicly available as possible to whomever is affected by them or must act accordingly to them. The notion of regulatory visibility has recently been highlighted by Laurie and colleagues, who argue for regulatory stewardship within ecosystems to help researchers clarify values and responsibilities in health research and navigate the complexities.Footnote 30 Recent work also demonstrates that currently it is difficult to access policies and standard operating procedures of prominent research institutions like biobanks. In principle, fair scientific competition may militate against disclosure of technical details about data processing, but it is hard to imagine practical circumstances in which administrators of at least publicly funded datasets would not have incentives to share as much information as possible regarding the way they handle their data. Process visibility goes beyond fulfilling a pre-determined set of criteria (for instance, for auditing purposes). By disclosing governance processes and opportunities for engagement, actors actually offer reasons to be trusted by a variety of stakeholders.Footnote 31 This feature is of particular relevance for the principles of monitoring and reflexivity, as well as to improve the effectiveness of inclusive governance processes.
26.6 Conclusion
In this chapter, we have defended adaptive governance as a suitable regulatory approach for Big Data health research by proposing six governance principles to foster the development of appropriate structures and processes to handle critical aspects of Big Data health research. We have analysed key aspects of implementation and identified a number of important features that can make adaptive regulation operational. However, one might legitimately ask: in the absence of a central regulatory actor endowed with clearly recognised statutory prerogatives, how can it be assumed that the AFIRRM principles will be endorsed by the diverse group of stakeholders operating in the Big Data health research space? Clearly, this question does not have a straightforward answer. However, to increase likelihood of uptake, we have advanced AFIRRM as a viable and adaptable model for the creation of necessary tools that can deliver on common objectives. Our model is based on a careful analysis of regulatory scholarship vis-à-vis the key attributes of this type of research. We are currently undertaking considerable efforts to introduce AFIRRM to regulators, operators and organisations in the space of research or health policy. We are cognisant of the fact that the implementation of a model like AFIRRM needs not be temporally linear. Different actors may take initiative at different points in time. It cannot be expected that a coherent system of governance will emerge in a synchronically orchestrated manner through the uncoordinated action of multiple stakeholders. Such a path could only be imagined if a central regulator had the power and the will to make it happen. Nothing indicates, however, that regulation will assume a centralised character anytime soon. Nevertheless, polycentricity is not in itself a barrier to the emergence of a coherent governance ecosystem. Indeed, the AFIRRM principles – in line with its adaptive orientation – rely precisely on polycentric governance to cope with the uncertainty and complexity of Big Data health research.
27.1 Introduction
New technologies, techniques, and tests in healthcare, offering better prevention, or better diagnosis and treatment, are not manna from heaven. Typically, they are the products of extensive research and development, increasingly enabled by high levels of automation and reliant on large datasets. However, while some will push for a permissive regulatory environment that is facilitative of beneficial innovation, others will push back against research that gives rise to concerns about the safety and reliability of particular technologies as well as their compatibility with respect for fundamental values. Yet, how are the interests in pushing forward with research into potentially beneficial health technologies to be reconciled with the heterogeneous interests of the concerned who seek to push back against them?
A stock answer to this question is that regulators, neither over-regulating nor under-regulating, should seek an accommodation or a balance of interests that is broadly ‘acceptable’. If the issue is about risks to human health and safety, then regulators – having assessed the risk – should adopt a management strategy that confines risk to an acceptable level; and, if there is a tension between, say, the interest of researchers in accessing health data and the interest of patients in both their privacy and the fair processing of their personal data, then regulators should accommodate these interests in a way that is reasonable – or, at any rate, not manifestly unreasonable.
The central purpose of this chapter is not to argue that this balancing model is always wrong or inappropriate, but to suggest that it needs to be located within a bigger picture of lexically ordered regulatory responsibilities.Footnote 1 In that bigger picture, the paramount responsibility of regulators is to act in ways that protect and maintain the conditions that are fundamental to human social existence (the commons). After that, a secondary responsibility is to protect and respect the values that constitute a group as the particular kind of community that it is. Only after these responsibilities have been discharged do we get to a third set of responsibilities that demand that regulators seek out reasonable and acceptable balances of conflicting legitimate interests. Accordingly, before regulators make provision for a – typically permissive – framework that they judge to strike an acceptable balance of interests in relation to some particular technology, technique or test, they should check that its development, exploitation, availability and application crosses none of the community’s red lines and, above all, that it poses no threat to the commons.
The chapter is in three principal parts. First, in Section 27.2, we start with two recent reports by the Nuffield Council on Bioethics – one a report on the use of Non-Invasive Prenatal Testing (NIPT),Footnote 2 and the other on genome-editing and human reproduction.Footnote 3 At first blush, the reports employ a similar approach, identifying a range of legitimate – but conflicting – interests and then taking a relatively conservative position. However, while the NIPT report exemplifies a standard balancing approach, the genome-editing report implicates a bigger picture of regulatory responsibilities. Second, in Section 27.3, I sketch my own take on that bigger picture. Third, in Section 27.4, I speak to the way in which the bigger picture might bear on our thinking about the regulation of automated healthcare and research technologies. In particular, in this part of the chapter, the focus is on those technologies that power smart machines and devices, technologies that are hungry for human data but then, in their operation, often put humans out of the loop.
27.2 NIPT, Genome-Editing and the Balancing of Interests
In its report on the ethics of NIPT, the Nuffield Council on Bioethics identifies a range of legitimate interests that call for regulatory accommodation. On the one side, there is the interest of pregnant women and their partners in making informed reproductive choices. On the other side, there are interests – particularly of the disability community and of future children – in equality, fairness and inclusion. The question is: how are regulators to ‘align the responsibilities that [they have] to support women to make informed reproductive choices about their pregnancies, with the responsibilities that [they have] … to promote equality, inclusion and fair treatment for all’?Footnote 4 In response to which, the Council, being particularly mindful of the interests of future children – in an open future – and the interest in a wider societal environment that is fair and inclusive, recommends that a relatively restrictive approach should be taken to the use of NIPT.
In support of the Council’s approach and its recommendation, there is a good deal that can be said. For example, the Council consulted widely before drawing up the inventory of interests to be considered: it engaged with the arguments rationally and in good faith; where appropriate, its thinking was evidence-based; and its recommendation is not manifestly unreasonable. If we were to imagine a judicial review of the Council’s recommendation, it would surely survive the challenge.
However, if the Council had given greater weight to the interest in reproductive autonomy together with the argument that women have ‘a right to know’ and that healthcare practitioners have an interest in doing the best that they can for their patients,Footnote 5 leading to a much less restrictive recommendation, we could say exactly the same things in its support.
In other words, so long as the Council – and, similarly, any regulatory body – consults widely and deliberates rationally, and so long as its recommendations are not manifestly unreasonable, we can treat its preferred accommodation of interests as acceptable. Yet, in such balancing deliberations, it is not clear where the onus of justification lies or what the burden of justification is; and, in the final analysis, we cannot say why the particular restrictive position that the Council takes is more or less acceptable than a less restrictive position.
Turning to the Council’s second report, it hardly needs to be said that the development of precision gene-editing techniques, notably CRISPR-Cas9, has given rise to considerable debate.Footnote 6 Addressing the ethics of gene editing and human reproduction, the Council adopted a similar approach to that in its report on NIPT. Following extensive consultation – and, in this case, an earlier, more general, reportFootnote 7 – there is a careful consideration of a range of legitimate interests, following which a relatively conservative position is taken. Once again, although the position taken is not manifestly unreasonable, it is not entirely clear why this particular position is taken.
Yet, in this second report, there is a sense that something more than balancing might be at stake.Footnote 8 For example, the Council contemplates the possibility that genome editing might inadvertently lead to the extinction of the human species – or, conversely, that genome editing might be the salvation of humans who have catastrophically compromised the conditions for their existence. In these short reflections about the interests of ‘humanity’, we can detect a bigger picture of regulatory responsibilities.
27.3 The Bigger Picture of Regulatory Responsibilities
In this part of the chapter, I sketch what I see as the bigger – three-tier – picture of regulatory responsibilities and then speak briefly to the first two tiers.
27.3.1 The Bigger Picture
My claim is that regulators have a first-tier ‘stewardship’ responsibility for maintaining the pre-conditions for any kind of human social community (‘the commons’). At the second tier, regulators have a responsibility to respect the fundamental values of a particular human community, that is to say, the values that give that community its particular identity. At the third tier, regulators have a responsibility to seek out an acceptable balance of legitimate interests. The responsibilities at the first tier are cosmopolitan and non-negotiable. The responsibilities at the second and third tiers are contingent, depending on the fundamental values and the interests recognised in each particular community. Conflicts between commons-related interests, community values and individual or group interests are to be resolved by reference to the lexical ordering of the tiers: responsibilities in a higher tier always outrank those in a lower tier. Granted, this does not resolve all issues about trade-offs and compromises because we still have to handle horizontal conflicts within a particular tier. But, by identifying the tiers of responsibility, we take an important step towards giving some structure to the bigger picture.
27.3.2 First-Tier Responsibilities
Regulatory responsibilities start with the existence conditions that support the particular biological needs of humans. Beyond this, however, as agents, humans characteristically have the capacity to pursue various projects and plans whether as individuals, in partnerships, in groups, or in whole communities. Sometimes, the various projects and plans that they pursue will be harmonious; but often – as when the acceptability of the automation of healthcare and research is at issue – human agents will find themselves in conflict with one another. Accordingly, regulators also have a responsibility to maintain the conditions – conditions that are entirely neutral between the particular plans and projects that agents individually favour – that constitute the context for agency itself.Building on this analysis, the claim is that the paramount responsibility for regulators is to protect, preserve, and promote:
the essential conditions for human existence (given human biological needs);
the generic conditions for human agency and self-development; and,
the essential conditions for the development and practice of moral agency.
These, it bears repeating, are imperatives in all regulatory spaces, whether international or national, public or private. Of course, determining the nature of these conditions will not be a mechanical process. Nevertheless, let me indicate how the distinctive contribution of each segment of the commons might be elaborated.
In the first instance, regulators should take steps to maintain the natural ecosystem for human life.Footnote 9 At minimum, this entails that the physical well-being of humans must be secured: humans need oxygen, they need food and water, they need shelter, they need protection against contagious diseases, if they are sick they need whatever treatment is available, and they need to be protected against assaults by other humans or non-human beings. When the Nuffield Council on Bioethics discusses catastrophic modifications to the human genome or to the ecosystem, it is this segment of the commons that is at issue.
Second, the conditions for meaningful self-development and agency need to be constructed: there needs to be sufficient trust and confidence in one’s fellow agents, together with sufficient predictability to plan, so as to operate in a way that is interactive and purposeful rather than merely defensive. Let me suggest that the distinctive capacities of prospective agents include being able: to form a sense of what is in one’s own self-interest; to choose one’s own ends, goals, purposes and so on (‘to do one’s own thing’); and to form a sense of one’s own identity (‘to be one’s own person’).
Third, the commons must secure the conditions for an aspirant moral community, whether the particular community is guided by teleological or deontological standards, by rights or by duties, by communitarian or liberal or libertarian values, by virtue ethics, and so on. The generic context for moral community is impartial between competing moral visions, values, and ideals; but it must be conducive to ‘moral’ development and ‘moral’ agency in the sense of forming a view about what is the ‘right thing’ to do relative to the interests of both oneself and others.
On this analysis, each human agent is a stakeholder in the commons where this represents the essential conditions for human existence together with the generic conditions of both self-regarding and other-regarding agency. While respect for the commons’ conditions is binding on all human agents, it should be emphasised that these conditions do not rule out the possibility of prudential or moral pluralism. Rather, the commons represents the pre-conditions for both individual self-development and community debate, giving each agent the opportunity to develop his or her own view of what is prudent, as well as what should be morally prohibited, permitted or required.
27.3.3 Second-Tier Responsibilities
Beyond the stewardship responsibilities, regulators are also responsible for ensuring that the fundamental values of their particular community are respected. Just as each individual human agent has the capacity to develop their own distinctive identity, the same is true if we scale this up to communities of human agents. There are common needs and interests but also distinctive identities.
In the particular case of the United Kingdom: although there is not a general commitment to the value of social solidarity, arguably this is actually the value that underpins the NHS. Accordingly, if it were proposed that access to NHS patient data – data, as Philip Aldrick has put it, that is ‘a treasure trove … for developers of next-generation medical devices’Footnote 10 – should be part of a transatlantic trade deal, there would surely be an uproar because this would be seen as betraying the kind of healthcare community that we think we are.
More generally, many nation states have expressed their fundamental (constitutional) values in terms of respect for human rights and human dignity.Footnote 11 These values clearly intersect with the commons’ conditions and there is much to debate about the nature of this relationship and the extent of any overlap – for example, if we understand the root idea of human dignity in terms of humans having the capacity freely to do the right thing for the right reason,Footnote 12 then human dignity reaches directly to the commons’ conditions for moral agency.Footnote 13 However, those nation states that articulate their particular identities by reference to their commitment to respect for human dignity are far from homogeneous. Whereas in some communities, the emphasis of human dignity is on individual empowerment and autonomy, in others it is on constraints relating to the sanctity, non-commercialisation, non-commodification and non-instrumentalisation of human life.Footnote 14 These differences in emphasis mean that communities articulate in very different ways on a range of beginning-of-life and end-of-life questions as well as on questions of acceptable health-related research, and so on.
Given the conspicuous interest of today’s regulators in exploring technological solutions, an increasingly important question will be whether, and if so, how far, a community sees itself as distinguished by its commitment to regulation by rule and by human agents. In some smaller-scale communities or self-regulating groups, there might be resistance to a technocratic approach because automated compliance compromises the context for trust and for responsibility. Or, again, a community might prefer to stick with regulation by rules and by human agents because it is worried that with a more technocratic approach, there might be both reduced public participation in the regulatory enterprise and a loss of flexibility in the application of technological measures.
If a community decides that it is generally happy with an approach that relies on technological measures rather than rules, it then has to decide whether it is also happy for humans to be out of the loop. Furthermore, once a community is asking itself such questions, it will need to clarify its understanding of the relationship between humans and robots – in particular, whether it treats robots as having moral status, or legal personality, and the like.
These are questions that each community must answer in its own way. The answers given speak to the kind of community that a group aspires to be. That said, it is, of course, essential that the fundamental values to which a particular community commits itself are consistent with (or cohere with) the commons’ conditions.
27.4 Automated Healthcare and the Bigger Picture of Regulatory Responsibility
One of the features of the NHS Long Term PlanFootnote 15 – in which the NHS is described as ‘a hotbed of innovation and technological revolution in clinical practice’Footnote 16 – is the anticipated role to be played by technology in ‘helping clinicians use the full range of their skills, reducing bureaucracy, stimulating research and enabling service transformation’.Footnote 17 Moreover, speaking about the newly created unit, NHSX (a new joint organisation for digital, data and technology), the Health Secretary, Matt Hancock, said that this was ‘just the beginning of the tech revolution, building on our Long Term Plan to create a predictive, preventative and unrivalled NHS’.Footnote 18
In this context, what should we make of the regulatory challenge presented by smart machines and devices that incorporate the latest AI and machine learning algorithms for healthcare and research purposes? Typically, these technologies need data on which to train and to improve their performance. While the consensus is that the collection and use of personal data needs governance and that big datasets (interrogated by state of the art algorithmic tools) need it a fortiori, there is no agreement as to what might be the appropriate terms and conditions for the collection, processing and use of personal data or how to govern these matters.Footnote 19
In its recent final report on Ethics Guidelines for Trustworthy AI,Footnote 20 the European Commission (EC) independent high-level expert group on artificial intelligence takes it as axiomatic that the development and use of AI should be ‘human-centric’. To this end, the group highlights four key principles for the governance of AI, namely: respect for human autonomy, prevention of harm, fairness and explicability. Where tensions arise between these principles, then they should be dealt with by ‘methods of accountable deliberation’ involving ‘reasoned, evidence-based reflection rather than intuition or random discretion’.Footnote 21 Nevertheless, it is emphasised that there might be cases where ‘no ethically acceptable trade-offs can be identified. Certain fundamental rights and correlated principles are absolute and cannot be subject to a balancing exercise (e.g. human dignity)’.Footnote 22
In line with this analysis, my position is that while there might be many cases where simple balancing is appropriate, there are some considerations that should never be put into a simple balance. The group mentions human rights and human dignity. I agree. Where a community treats human rights and human dignity as its constitutive principles or values, they act – in Ronald Dworkin’s evocative terms – as ‘trumps’.Footnote 23 Beyond that, the interest of humanity in the commons should be treated as even more foundational (so to speak, as a super-trump).
It follows that the first question for regulators is whether new AI technologies for healthcare and research present any threat to the existence conditions for humans, to the generic conditions for self-development, and to the context for moral development. It is only once this question has been answered that we get to the question of compatibility with the community’s particular constitutive values, and, then, after that, to a balancing judgment. If governance is to be ‘human-centric’, it is not enough that no individual human is exposed to an unacceptable risk or is not actually harmed. To be fully human-centric, technologies must be designed to respect both the commons and the constitutive values of particular human communities.
Guided by these regulatory imperatives, we can offer some short reflections on the three elements of the commons and how they might be compromised by the automation of research and healthcare.
27.4.1 The Existence Conditions
Famously, Stephen Hawking remarked that ‘the advent of super-intelligent AI would be either the best or the worst thing ever to happen to humanity’.Footnote 24 As the best thing, AI would contribute to ‘[the eradication of] disease and poverty’Footnote 25 as well as ‘[helping to] reverse paralysis in people with spinal-cord injuries’.Footnote 26 However, on the downside, some might fear that in our quest for greater safety and well-being, we will develop and embed ever more intelligent devices to the point that there is a risk of the extinction of humans – or, if not that, then a risk of humanity surviving ‘in some highly suboptimal state or in which a large portion of our potential for desirable development is irreversibly squandered’.Footnote 27 If this concern is well-founded, then communities will need to be extremely careful about how far and how fast they go with intelligent devices.
Of course, this is not specifically a concern about the use of smart machines in the hospital or in the research facility: the concern about the existential threat posed to humans by smart machines arises across the board; and, indeed, concerns about existential threats are provoked by a range of emerging technologies.Footnote 28 In such circumstances, a regulatory policy of precaution and zero risk is indicated; and while stewardship might mean that the development and application of some technologies that we value has to be restricted, this is better than finding that they have compromised the very conditions on which the enjoyment of such technologies is predicated.
27.4.2 The Conditions for Self-Development and Agency
The developers of smart devices are hungry for data: data from patients, data from research participants, data from the general public. This raises concerns about privacy and data protection. While it is widely accepted that our privacy interests – in a broad sense – are ‘contextual’,Footnote 29 it is important to understand not just that ‘there are contexts and contexts’ but that there is a Context in which we all have a common interest. What most urgently needs to be clarified is whether any interests that we have in privacy and data protection touch and concern the essential conditions (the Context).
If, on analysis, we judge that privacy reaches through to the interests that agents necessarily have in the commons’ conditions – particularly in the conditions for self-development and agency – it is neither rational nor reasonable for agents, individually or collectively, to authorise acts that compromise these conditions (unless they do so in order to protect some more important condition of the commons). As Bert-Jaap Koops has so clearly expressed it, privacy has an ‘infrastructural character’, ‘having privacy spaces is an important presupposition for autonomy [and] self-development’.Footnote 30 Without such spaces, there is no opportunity to be oneself.Footnote 31 On this reading, privacy is not so much a matter of protecting goods – informational or spatial – in which one has a personal interest, but protecting infrastructural goods in which there is either a common interest (engaging first-tier responsibilities) or a distinctive community interest (engaging second-tier responsibilities).
By contrast, if privacy – and, likewise, data protection – is simply a legitimate informational interest that has to be weighed in an all things considered balance of interests, then we should recognise that what each community will recognise as a privacy interest and as an acceptable balance of interests might well change over time. To this extent, our reasonable expectations of privacy might be both ‘contextual’ and contingent on social practices.
27.4.3 The Conditions for Moral Development and Moral Agency
As I have indicated, I take it that the fundamental aspiration of any moral community is that regulators and regulatees alike should try to do the right thing. However, this presupposes a process of moral reflection and then action that accords with one’s moral judgment. In this way, agents exercise judgment in trying to do the right thing and they do what they do for the right reason in the sense that they act in accordance with their moral judgment. Accordingly, if automated research and healthcare relieves researchers and clinicians from their moral responsibilities, even though well intended, this might result in a significant compromising of their dignity, qua the conditions for moral agency.Footnote 32
Equally, if robots or other smart machines are used for healthcare and research purposes, some patients and participants might feel that this compromises their ‘dignity’ – robots might not physically harm humans, but even caring machines, so to speak, ‘do not really care’.Footnote 33 The question then is whether regulators should treat the interests of such persons as a matter of individual interest to be balanced against the legitimate interests of others, or as concerns about dignity that speak to matters of either (first-tier) common or (second-tier) community interest.
In this regard, consider the case of Ernest Quintana whose family were shocked to find that, at a particular Californian hospital, a ‘robot’ displaying a doctor on a screen was used to tell Ernest that the medical team could do no more for him and that he would soon die.Footnote 34 What should we make of this? Should we read the family’s shock as simply expressing a preference for the human touch or as going deeper to the community’s constitutive values or even to the commons’ conditions? Depending on how this question is answered, regulators will know whether a simple balance of interests is appropriate.
27.5 Conclusion
In this chapter, I have argued that it is not always appropriate to respond to new technologies for healthcare and research simply by enjoining regulators to seek out an acceptable balance of interests. My point is not that we should eschew either the balancing approach or the idea of ‘acceptability’ but that regulators should respond in a way that is sensitised to the full range of their responsibilities.
To the simple balancing approach, with its broad margin for ‘acceptable’ accommodation, we must add the regulatory responsibility to be responsive to the red lines and basic values that are distinctive of the particular community. Any claimed interest or proposed accommodation of interests that crosses these red lines or that is incompatible with the community’s basic values is ‘unacceptable’ – but this is for a different reason to that which applies where a simple balancing calculation is undertaken.
Most fundamentally, however, regulators have a stewardship responsibility in relation to the anterior conditions for humans to exist and for them to function as a community of agents. We should certainly say that any claimed interest or proposed accommodation of interests that is incompatible with the maintenance of these conditions is totally ‘unacceptable’ – but it is more than that. Unlike the red lines or basic values to which a particular community commits itself – red lines and basic values that may legitimately vary from one community to another – the commons’ conditions are not contingent or negotiable. For human agents to compromise the conditions upon which human existence and agency is itself predicated is simply unthinkable.
Finally, it should be said that my sketch of the regulatory responsibilities is incomplete – in particular, concepts such as the ‘public interest’ and the ‘public good’ need to be located within this bigger picture; and, there is more to be said about the handling of horizontal conflicts and tensions within a particular tier. Nevertheless, the ‘take home message’ is clear. Quite simply: while automated healthcare and research might be efficient and productive, new technologies should not present unacceptable risks to the legitimate interests of humans; beyond mere balancing, new technologies should be compatible with the fundamental values of particular communities; and, above all, these technologies should do no harm to the commons’ conditions – supporting human existence and agency – on which we all rely and which we undervalue at our peril.
The sheer diversity of topics in health research makes for a daunting task in the development, establishment, and application of oversight mechanisms and various methods of governance. The authors of this section illustrate how this task is made even more complex by emerging technologies, applications and context, as well as the presence of a variety of actors both in the research and the governance landscape. Nevertheless, key themes emerge, and these sometimes trouble existing paradigms and parameters, and shift and widen our regulatory lenses. A key anchor is the relationship between governance and time: be it the urgent nature of research conducted in global health emergencies; the appropriate weight given to historical data in establishing evidence, anticipating future risk, benefit or harm; or the historical and current forces that have shaped regulatory structures as we meet them today. The perspectives explored in this section can be seen to illustrate different kinds of liminality, which result in regulatory complexity but also offer potential for new kinds of imaginaries, norms and processes.
A first kind of shift in lens is created by the nature of research contexts: for example, whether research is carried out in labs, in clinical settings, traditional healing encounters or, indeed, in a pandemic. These spaces might be the site where values, interests or rules conflict, or they might be characterised by the absence of regulation. Additional tension might be brought about in the interaction of what is being regulated, with how it is being regulated: emerging interventions in already established processes, traditional interventions in more recently developed but strongly established paradigms, or marginal interventions precipitated to the centre by outside forces (crises, economic profit, unexpected findings, imminent or certain injury or death). These shifts give rise to considerations of flexibility and resilience in regulation, of the legitimacy and authority of different actors, and the epistemic soundness in the development and deployment of innovative, experimental, or less established practices.
In Chapter 28, Ho addresses the key concept of risk, and its role within the governance of artificial intelligence (AI) and machine learning (ML) as medical devices. Using the illustration of AI/ML as clinical decision support in the diagnosis of diabetic retinopathy, the author situates their position in qualified opposition to those who perceive governance as an impediment to development and economic gain and those who favour more oversight of AI/ML. In managing such algorithms as risk objects in governance, Ho advocates a governance structure that re-characterises risk as a form of iterative learning process, rather than a rule-based one-time evaluation and regulatory approval based on the quantification of future risk.
The theme of regulation as obstacle is also explored in the following chapter (Chapter 29) by Lipworth et al., in the context of autologous mesenchymal stem cell-based interventions. Here, too, the perspective of the authors is set against those who see traditional governance and translational pathways as an impediment to addressing life-threatening and debilitating illnesses. They also resist the reimagination of healthcare as a marketplace (complete with aggressive marketing and dubious claims) where the patient is seen as a consumer, and the decision to access emerging and novel (unproven and potentially risky) interventions merely as a matter of shared decision-making between patient and clinician. The authors recommend the strengthening a multipronged governance framework, which includes professional regulation, marketplace regulation, regulation of therapeutic products, and research oversight.
In Chapter 30, Haas and Cloatre also explore the difficult task of aligning interventions and products within established regulatory and translational pathways. Here, however, the challenge is not novel or emerging interventions, but traditional or non-conventional medicine, which challenges establishes governance frameworks based on the biomedical paradigm, and yet which millions of patients worldwide rely on as their primary form of healthcare. Here, uncertainty relates to the epistemic legitimacy of non-conventional forms of knowledge gathering. Actors in conflict with established epistemic processes are informed by historical and contextual evidence and practices that far predate the establishment of current frameworks. Traditional and non-conventional interventions are, nevertheless, pushed towards hegemonic governance pathways, often in the ‘scientised and commercial’ forms, in order to gain recognition and legitimacy.
When considering pathways to legitimacy, a key role is played by ethics, in its multiple forms. In Chapter 31, Pickersgill explores ethics in its multiple forms through the eyes of neuroscience researchers, who in their daily practice experience the ethical dimensions of neuroscience and negotiate ethics as a regulatory tool. Ethics can be seen as obstacle to good science, and the (institutional) ethics of human research is often seen as prone to obfuscation and in lack of clear guidance. This results in novel practices and norms within the community, which are informed by a commitment to doing the right thing and by institutional requirements. In order to minimise potential subversion (even well-meant) of ethics in research, Pickersgill advocates the development of governance that arises not only from collaborations between scientists and regulators but also those who can act as critical friends to both of these groups of actors.
Ethics guidance and ethical practices are also explored by Ganguli-Mitra and Hunt (Chapter 32), this time in the context of research carried out in global health emergencies (GHEs). These contexts are characterised by various factors that complicate ethical norms and practices, as well as trouble existing frameworks and paradigms. GHEs are sites of multiple kinds of practices (humanitarian, medical, public health, development) and of multiple actors, whose goals and norms of conduct might be in conflict in a context that is characterised by urgency and high risk of injury and death. Using the examples of recent emergencies, the authors explore the changing nature of ethics and ethical practices in extraordinary circumstances.
In the final chapter of this section (Chapter 33), Arzuaga offers an illustration of regulatory development, touching upon the many actors, values, interests, and forces explored in the earlier chapters. Arzuaga reports on the governance of advanced therapeutic medicinal products (ATMPs) in Argentina, moving from a situation of non-intervention on the part of the state, to the establishment of a governance framework. Here, the role of hard and soft law as adding both resilience and flexibility to regulation is explored, fostering innovation without abdicating ethical concerns. Arzuaga describes early, unsuccessful attempts at regulating stem cell-based interventions, echoing the concerns presented by Lipworth et al., before exploring a more promising exercise in legal foresighting, which included a variety of actors and collaboration, as well a combination of top-down models and bottom-up, iterative processes.
28.1 Introduction
The regulatory governance of Artificial Intelligence and Machine Learning (AI/ML) technologies as medical devices in healthcare challenges the regulatory divide between research and clinical care, which is typically of pharmaceutical products. This chapter considers the regulatory governance of an AI/ML clinical decision support (CDS) software for the diagnosis of diabetic retinopathy as a ‘risk object’ by the Food and Drug Administration (FDA) in the United States (US). The FDA’s regulatory principles and approach may play an influential role in how other countries govern this and other software as a medical device (SaMD). The disruptions that AI/ML technologies can cause are well publicised in the lay and academic media alike, although the more serious ‘risks’ of harm are still essentially anticipatory. In some quarters, there is a prevailing sense that a ‘light-touch’ approach to regulatory governance should be adopted to ensure that the advancement of AI – particularly in ways that are expected to generate economic gain – should not be unduly burdened. Hence, in response to the question of whether regulation of AI is needed now, scholars like Chris Reed have responded with a qualified ‘No’. As Reed explains, the use of the technology in medicine is already regulated by the profession, and regulation will be adapted piecemeal as new AI technologies come into use anyway.Footnote 1 A ‘wait and see’ approach is likely to produce better long-term results than hurried regulation based on a very partial understanding of what needs to be regulated. It is also perhaps consistent with this mind-set that the commercial development and application of AI and AI-based technologies remain largely unregulated.
This chapter takes a different view on the issue, and argues that the response should be a qualified ‘Yes’ instead, partly because there is already an existing regulatory framework in place that may be adapted to meet anticipated challenges. As a ‘risk object’, the regulation of AI/ML medical devices cannot be understood and managed separately from a broader ‘risk culture’ within which it is embedded. Contrary to what an approach in ‘command-and-control’ suggests, regulatory governance of AI/ML medical devices should not be understood merely as the application of external forces to contain ills that must somehow be managed in order to derive the desired effects. Arguably, it is this limited conception of ‘risks’ and its relationship with regulation that give rise to liminality. As Laurie and others clearly explains,Footnote 2 a liminal space is created contemporaneously with the uncertainties generated by new and emerging technologies. Drawing on the works of Arnold van Gennep and Victor Turner, ‘liminality’ is presented as an analytic to engage with the processual and experiential dynamics of transitional and transformational inter-structural boundary or marginal spaces. It is itself an intermediary process in a three-part pattern of experience, that begins with separation from an existing order, and concludes with re-integration into a new world.Footnote 3 Mapping liminal spaces and the changing boundaries entailed can help to highlight gaps in regulatory regimes.Footnote 4
Risk-based evaluation is often a feature of such liminal spaces, and when they become sites for battles of power and values, ethical issues arise. Whereas liminality has been applied to account for human experiences within regulated spaces, this chapter considers the epistemic quality of ‘risks’ and its situatedness within regulatory governance as a discursive practice and as a matter of social reality. In this respect, regulation is not necessarily extrinsic to its regulatory object, but constitutive of it. Concerns about ‘risks’ from technological innovations and the need to tame them have been central to regulatory governance.Footnote 5 Whereas governance has been a longstanding cultural phenomenon that relates to ‘the system of shared beliefs, values, customs, behaviours and artifacts that members of society use to cope with their world and with one another, and that are transmitted from generation to generation through learning’,Footnote 6 it is the regulatory turn that is especially instructive. Here, regulatory response is taken to reduce the uncertainty and instability of mitigating potential risks and harms and by directing or influencing actors’ behaviour to accord with socially accepted norms and/or to promote desirable social outcomes, and regulation encompasses any instrument (legal or non-legal in character) that is designed to channel group behaviour.Footnote 7 The high connectivity of AL/ML SaMDs that are capable of adapting to their digital environment in order to optimise performance suggests that the research agenda persists beyond what may be currently limited to the pilot or feasibility stages of medical device trials. If continuous risk-monitoring is required to support the use of SaMDs in a learning healthcare system, more robust and responsive regulatory mechanisms are needed, not less.Footnote 8
28.2 AI/ML Software as Clinical Decision Support
In April 2018, the FDA granted approval for IDx-DR (DEN180001) to be marketed as the first AI diagnostic system that does not require clinician interpretation to detect greater than a mild level of diabetic retinopathy in adults diagnosed with diabetes.Footnote 9 In essence, this SaMD applies an AI algorithm to analyse images of the eye taken with a retinal camera that are uploaded to a cloud server. A screening decision is made by the device as to whether the individual concerned is detected with ‘more than mild diabetic retinopathy’ and, if so, is referred to an eye care professional for medical attention. Where the screening result is negative, the individual will be rescreened in twelve months. IDx-DR was reviewed under the FDA’s De Novo premarket review pathway and was granted Breakthrough Device designation,Footnote 10 as the SaMD is novel and of low to moderate risk. On the whole, the regulatory process did not detract substantially from the existing regulatory framework for medical devices in the USA. A medical device is defined broadly to include low-risk adhesive bandages to sophisticated implanted devices. In the USA, a similar approach is adopted in the definition of the term ‘device’ in Section 201(h) of the Federal Food, Drug and Cosmetic Act.Footnote 11
For regulatory purposes, medical devices are classified based on their intended use and indications for use, degree of invasiveness, duration of use, and the risks and potential harms associated with their use. At the classification stage, a manufacturer is not expected to have gathered sufficient data to demonstrate that its proposed product meets the applicable marketing authorisation standard (e.g. data demonstrating effectiveness). Therefore, the focus of the FDA’s classification analysis is on how the product is expected to achieve its primary intended purposes.Footnote 12 The FDA has established classifications for approximately 1700 different generic types of devices and grouped them into sixteen medical specialties referred to as ‘panels’. Each of these generic types of devices is assigned to one of three regulatory classes based on the level of control necessary to assure the safety and effectiveness of the device. The class to which the device is assigned determines, among other things, the type of premarketing submission/application required for FDA clearance to market. All classes of devices are subject to General Controls,Footnote 13 which are the baseline requirements of the FD&C Act that apply to all medical devices. Special Controls are regulatory requirements for Class II devices, and are usually device-specific and include performance standards, postmarket surveillance, patient registries, special labelling requirements, premarket data requirements and operational guidelines. For Class III devices, active regulatory review in the form of premarket approval is required (see Table 28.1).
|Class||Risk||Level of regulatory controls||Whether clinical trials required||Examples|
|I||Low||General||No||Gauze, adhesive bandages, toothbrush|
|II||Moderate||General and special||Maybe||Suture, diagnostic X-rays|
|III||High||General and premarket approval||Yes||Pacemakers, implantable defibrillators, spinal cord stimulators|
Clinical trials of medical devices, where required, are often non-randomised, non-blinded, do not have active control groups, and lack hard endpoints, since randomisation and blinding of patients or physicians for implantable devices will in many instances be technically challenging and ethically unacceptable.Footnote 14 Table 28.2 shows key differences between clinical trials of pharmaceuticals in contrast to medical devices.Footnote 15 Class I and some Class II devices may be introduced into the US market without having been tested in humans through an approval process that is based on predicates. Through what is known as the 510(k) pathway, a manufacturer needs to show that its ‘new’ device is at least as safe and effective as (or substantially equivalent to) a legally marketed predicate device (as was the case for IDx-DR).Footnote 16
|Pharmaceuticals||Medical devices|
|Phase||Participants||Purpose||Stage||Participants||Purpose|
|0|
(Pilot/exploratory ; not all drugs undergo this phase)
|10–15 participants with disease or condition||Test very small (subtherapeutic) dosage to study effects and mechanisms||Pilot/early feasibility/|
first-in-human
|10–15 participants with disease or condition||Collect preliminary safety and performance data to guide development|
|I|
(Safety and toxicity)
|10–100 healthy participants||Test safety and tolerance|
Determine dosing and major adverse effects
|Feasibility||20–30 participants with disease or condition||Assess safety and efficacy of near-final or final device design|
Guides design of pivotal study
|II|
(Safety and effectiveness)
|50–200 participants with disease or condition||Test safety and effectiveness|
Confirm dosing and major adverse effects
|III|
(Clinical effectiveness)
|>100–1000 participants with disease or condition||Test safety and effectiveness|
Determine drug–drug interaction and minor adverse effects
|Pivotal||>100–300 participants with disease or condition||Establish clinical efficacy, safety and risks|
|IV|
(Post-approval study)
|>1000||Collect long-term data and adverse effects||Post-approval study||>1000||Collect long-term data and adverse effects|
The nature of regulatory control is changing; regulatory control does not arise solely through the exertion of regulatory power over a regulated entity but also acts intrinsically from within the entity itself. It is argued that risk-based regulation draws on different knowledge domains to constitute the AI/ML algorithm as a ‘risk object’, and not merely to subjugate it. Risk objectification renders the regulated entity calculable. Control does not thereby arise because the regulated entity behaves strictly in adherence to specific commands but rather because of the predictability of its actions. Where risk cannot be precisely calculated however, liminal spaces may help to articulate various ‘scenarios’ with different degrees of plausibility. These liminal spaces are thereby themselves a means by which uncertainty is managed. Typically, owing to conditions that operate outside of direct regulatory control, liminal spaces can either help to maintain a broader regulatory space to which they are peripheral, or contribute to its re-configuration through a ‘domaining effect’. This aspect will be considered in the penultimate section of this chapter.
28.3 Re-embedding Risk and a Return to Sociality
The regulatory construction of IDx-DR as a ‘risk object’ is accomplished by linking the causal attributes of economic and social risks, and risks to human safety and agency, to its constitutive algorithms reified as a medical device.Footnote 17 This ‘risk object’ is made epistemically ‘real’ when integrated through a risk discourse, by which risk attributions and relations have come to define identities, responsibilities, and socialities. While risk objectification has been effective in paving a way forward to market approval for IDx-DR, this technological capability is pushed further into liminality. The study that supported the FDA’s approval was conducted under highly controlled conditions where a relatively small group of carefully selected patients had been recruited to test a diagnostic system that had a narrow usage criteria.Footnote 18 It is questionable whether the AI/ML feature was itself tested, since the auto-didactic aspect of the algorithm was locked prior to the clinical trial, which greatly constrained the variability of the range of outputs.Footnote 19 At this stage, IDx-DR is not capable of evaluating the most severe forms of diabetic retinopathy that requires urgent ophthalmic intervention. However, IDx-DR is capable of ML, which is a subset of AI and refers to a set of methods that have the ability to automatically detect patterns in data in order to predict future data trends or for decision-making under uncertain conditions.Footnote 20 Deep learning (DL) is in turn a subtype of ML (and a subfield of representation learning) that is capable of delivering a higher level of performance, and does not require a human to identify and compute the discriminatory features for it. From the 1980s onwards, DL software has been applied in computer-aided detection systems, and the field of radiomics (a process that extracts large number of quantitative features from medical images) is broadly concerned with computer-aided diagnosis systems, where DL has enabled the use of computer-learned tumour signatures.Footnote 21 It has the potential to detect abnormalities, make differential diagnoses and generate preliminary radiology reports in the future, but only a few methods are able to manage the wide range of radiological presentations of subtle disease states. In the foreseeable future, unsupervised AI/ML will test the limits of conventional means of regulation of medical devices.Footnote 22 The challenges to risk assessment, management and mitigation will be amplified as AI/ML medical devices change rapidly and become less predictable.Footnote 23
Regulatory conservatism reflects a particular positionality and related interests that are at stake. For many high-level policy documents on AI, competitive advantage for economic gain is a key interest.Footnote 24 This position appears to support a ‘light touch’ approach to regulatory governance of AI in order to sustain technological development and advance national economic interests. If policymakers, as a matter of socio-political construction, consider regulation as impeding technological development, then regulatory governance is unlikely to see meaningful progression. Not surprisingly, the private sector has had a dominant presence in defining the agenda and shape of AI and related technologies. While this is not in and of itself problematic, the narrow regulatory focus and absence of broader participation could be. For instance, it is not entirely clear to what extent the development of AI/ML algorithms is determined primarily by sectorial interests.Footnote 25
Initial risk assessment is essentially consequentialist in its focus on intended use of the SaMD to achieve particular clinical outcomes. Risk characterisation is abstracted to two factors:Footnote 26 (1) significance of the information provided by the SaMD to the healthcare decision; and (2) state of the healthcare situation or condition. Risk is thereby derived from ‘objective’ information that is provided by the manufacturer on intended use of the information provided by the SaMD in clinical management. Such use may be significant in one of three ways: (1) to treat or to diagnose, (2) to drive clinical management or (3) to inform clinical management. The significance of an intended use is then associated with a healthcare situation or condition (i.e. critical, serious or non-serious). Schematically, Table 28.3 presents the risk characterisation framework based on four different levels of impact on the health of patients or target populations. Level IV of the framework (e.g. SaMD that performs diagnostic image analysis for making treatment decisions in patients with acute stroke, or screens for mutable pandemic outbreak that can be highly communicable through direct contact or other means) relates to the highest impact while Level I (e.g. SaMD that analyses optical images to guide next diagnostic action of astigmatism) relates to the lowest.Footnote 27
|State of healthcare situation or condition||Significance of information provided by SaMD to healthcare decision|
|Treat or diagnose||Drive clinical management||Inform clinical management|
|Critical||IV||III||II|
|Serious||III||II||I|
|Non-serious||II||I||I|
To counter the possible deepening of regulatory impoverishment, regulatory governance as concept and process will need to re-characterise risk management as a form of learning and experimentation rather than rule-based processes, thus placing stronger reliance on human capabilities to imagine alternative futures instead of quantitative ambitions to predict the future. Additionally, a regulatory approach that is based on total project lifecycle needs to be taken up. This better accounts for modifications that will be made to the device through real-world learning and adaptation. Such adaptation enables a device to change its behaviour over time based on new data and optimise its performance in real time with the goal of improving health outcomes. As the FDA’s conventional review procedures for medical devices discussed above are not adequately responsive to assess adaptive AI/ML technologies, the FDA has proposed for a premarket review mechanism to be developed.Footnote 28 This mechanism seeks to introduce a predetermined change control plan in the premarket submission, in order to give effect to the risk categorisation and risk management principles, as well as the total product lifecycle approach, of the IMDRF. The plan will include the types of anticipated modifications (or pre-specifications) and associated methodology that is used to implement the changes in a controlled manner while allowing risks to patients to be managed (referred to as Algorithm Change Protocol). In essence, the proposed changes will place on manufacturers a greater responsibility of monitoring the real-world performance of their medical devices and to make available the performance data through periodic updates on what changes were made as part of the approved pre-specifications and the Algorithm Change Protocol. In totality, these proposed changes will enable the FDA to evaluate and monitor, collaboratively with manufacturers, an AI/ML software as a medical device from its premarket development to postmarket performance. The nature of the FDA’s regulatory oversight will also become more iterative and responsive in assessing the impact of device optimisation on patient safety.
As the IMDRF also explains, every SaMD will have its own risk category according to its definition statement even when it is interfaced with other SaMD, other hardware medical devices or used as a module in a larger system. Importantly, manufacturers are expected to have an appropriate level of control to manage changes during the lifecycle of the SaMD. The IMDRF labels any modifications made throughout the lifecycle of the SaMD, including its maintenance phase, as ‘SaMD Changes’.Footnote 29 Software maintenance is in turn defined in terms of post-marketing modifications that could occur in the software lifecycle processes identified by the International Organization for Standardization.Footnote 30 It is generally recognised that testing of software is not sufficient to ensure safety in its operation. Safety features need to be built into the software at the design and development stages, and supported by quality management and post marketing surveillance after the SaMD has been installed. Post market surveillance includes monitoring, measurement and analysis of quality data through logging and tracking of complaints, clearing technical issues, determining problem causes and actions to address, identify, collect, analyse and report on critical quality characteristics of products developed. However, monitoring software quality alone does not guarantee that the objectives for a process are being achieved.Footnote 31
As a concern of Quality Management System (QMS), the IMDRF requires that maintenance activities preserve the integrity of the SaMD without introducing new safety, effectiveness, performance and security hazards. It recommends that a risk assessment, including considerations in relation to patient safety and clinical environment and technology and systems environment, should be performed to determine if the changes affect the SaMD categorisation and the core functionality of SaMD as set out in its definition statement. The proposed QMS complements the risk categorisation framework through its goal of incorporating good software quality and engineering practices into the device. Principles underscoring QMS are set out in terms of organisational support structure, lifecycle support processes, and a set of realisation and use processes for assuring safety, effectiveness and performance. These principles have been endorsed by the FDA in its final guidance to describe an internally agreed upon understanding (among regulators) of clinical evaluation and principles for demonstrating the safety, effectiveness and performance of the device, and activities that manufacturers can take to clinically evaluate their device.Footnote 32
28.4 Regulatory Governance as Participatory Learning System
In this penultimate section of this chapter, it is argued that the regulatory approach considered in the preceding sections is intended to support a participatory learning system comprising at least two key features: (1) a platform and/or mechanisms that enable constructive engagement with, and participation of, members of society; and (2) the means by which a common fund of knowledges (to be explained below) may be pooled to generate an anticipatory knowledge that could guide collective action. In some instances, institutionalisation could advance this agenda, but it is beyond the scope of this manuscript to examine this possibility to a satisfactory degree.
There is a diverse range of modalities through which constituents of a society engage in collaborative learning. As Annelise Riles’s PAWORNET illustrates, each modality has its own goals, character, strengths and limitations. In her study, Riles observes that networkers did not understand themselves to share a set of values, interests or culture.Footnote 33 Instead, they understood themselves to be sharing their involvement in a certain network that was a form of institutionalised association devoted to information sharing. What defined networkers most of all was the fact that they were personally and institutionally connected or knowledgeable about the world of specific institutions and networks. In particular, it was the work of creating documents, organising conferences or producing funding proposals that generated a set of personal relations that drew people together and also created divisions of its own. In the author’s own study,Footnote 34 ethnographic findings illustrate how the ‘publics’ of human stem cell research and oocyte donation were co-produced with an institutionalised ‘bioethics-as-public-policy’ entity known as the Bioethics Advisory Body. In that context, the ‘publics’ comprised institutions and a number of individuals – often institutionally connected – that represented a diverse set of values, interests and perhaps cultures (construed in terms of their day-to-day practices in the least). These ‘publics’ resemble a network in a number of ways. They were brought into a particular set of relationship within a deliberative space created mainly by the consultation papers and reinforced through a variety of means that included public meetings, conferences, and feedback sessions. Arguably, even individual feedback from a public outreach platform known as ‘REACH’ encompassed a certain kind of pre-existing (sub-) network that has been formed with a view to soliciting relatively more spontaneous and independent, uninvited forms of civil participatory action. But this ‘network’ is not a static one. It varied with, but was also shaped by, the broader phenomenon of science and expectations as to how science ought to be engaged. In this connection, Riles’s observation is instructive: ‘It is not that networks “reflect” a form of society, therefore, nor that society creates its artifacts … Rather, it is all within the recursivity of a form that literally speaks about itself’.Footnote 35
A ‘risk culture’ that supports learning and experimentation rather than rule-based processes must embed the operation of AI and related technologies as ‘risk objects’ within a common fund of knowledges. Legal processes are inherent to understanding the risk, such as that of a repeat sexual offence under ‘Megan’s Law’, which encompasses the US community notification statutes relating to sexual offenders.Footnote 36 Comprising three tiers, this risk assessment process determines the scope of community notification. In examining the constitutional basis of Megan’s Law, Mariana Valverde et al. observe that ‘the courts have emphasised the scientific expertise that is said to be behind the registrant risk assessment scale (RRAS) in order to argue that Megan’s Law is not a tool of punishment but rather an objective measure to regulate a social problem’.Footnote 37 However, reliance on Megan’s Law as grounded in objective scientific knowledge has given rise to an ‘intermediary knowledge in which legal actors – prosecutors and judges – are said not only to be more fair but even more reliable and accurate in determining a registrant’s risk of re-offence’.Footnote 38 In this, the study also illustrates a translation from scientific knowledge and processes to legal ones, and how the ‘law’ may be cognitively and normatively open.
Finally, the articulation of possible harms and dangers as ‘risks’ involves the generation of ‘anticipatory knowledge’, which is defined as ‘social mechanisms and institutional capacities involved in producing, disseminating, and using such forms [as] … forecasts, models, scenarios, foresight exercises, threat assessments, and narratives about possible technological and societal futures’.Footnote 39 Like Ian Hacking’s ‘looping effect’, anticipatory knowledge is about knowledge-making about the future, and could operate as a means to gap-filling. The study by Hugh Gusterson of the Reliable Replacement Warhead (RRW) program is illustrative of this point, where US weapons laboratories could design new and highly reliable nuclear weapons that are safe to manufacture and maintain.Footnote 40 Gusterson shows that struggle over the RRW Program, initiated by the US Congress in 2004, occurred across four intersecting ‘plateaus of nuclear calculations’ – geopolitical, strategic, enviropolitical, and technoscientific – each with its own contending narratives of the future. He indicates that ‘advocates must stabilise and align anticipatory knowledge from each plateau of calculation into a coherent-enough narrative of the future in the face of opponents seeking to generate and secure alternative anticipatory knowledges’.Footnote 41 Hence the interconnectedness of the four plateaus of calculation, including the trade-offs entailed, was evident in the production of anticipatory knowledge vis-à-vis the RRW program. In addition, the issues of performativity and ‘social construction of ambiguity’ were also evident. Gusterson observes that being craft items, no two nuclear weapons are exactly alike. However, the proscription of testing through detonation meant that both performativity and ambiguity over reliability became matters of speculation, determined through extrapolation from the past to fill knowledge ‘gaps’ in the present and future. This attempt at anticipatory knowledge creation also prescribed a form that the future was to take. Applying a similar analysis from a legal standpoint, Graeme Laurie and others explain that foresighting as a means of devising anticipatory knowledge is neither simple opinion surveying nor mere public participation.Footnote 42 It must instead be directed at the discovery of shared values, the development of shared lexicons, the forging of a common vision of the future and the taking of steps to realise the vision with the understanding that this is being done from a position of partial knowledge about the future. As we have considered earlier on in this chapter, this visionary account captures the approach that has been adopted by the IMDRF impressively well.
28.5 Conclusion
Liminality highlights the need for a processual-oriented mode of regulation in order to recognise the flexibility and fluidity of the regulatory context (inclusive of its objects and subjects) and the need for iterative interactions, as well as to possess the capacity to provide non-directive guidance.Footnote 43 If one considers law as representing nothing more than certainty, structure and directed agency, then we should rightly be concerned as to whether the law can envision and support the creation of genuinely liminal regulatory spaces, which is typified by uncertainty, anti-structure and an absence of agency.Footnote 44 The crucial contribution of regulatory governance however, is its conceptualisation of law as an epistemically open enterprise, and in respect of which learning and experimentation are possible.
29.1 Introduction
Clinical innovation is ubiquitous in medical practice and is generally viewed as both necessary and desirable. While innovation has been the source of considerable benefit, many clinical innovations have failed to demonstrate evidence of clinical benefit and/or caused harm. Given uncertainty regarding the consequences of innovation, it is broadly accepted that it needs some form of oversight. But there is also pushback against what is perceived to be obstruction of access to innovative interventions. In this chapter, we argue that this pushback is misguided and dangerous – particularly because of the myriad competing and conflicting interests that drive and shape clinical innovation.
29.2 Clinical Innovation and Its Oversight
While the therapeutics lifecycle is usually thought of as one in which research precedes clinical application, it is common for health professionals to offer interventions that differ from standard practice, and that have either not (yet) been shown to be safe or effective or have been shown to be safe but not yet subjected to large phase 3 trials. This practice is often referred to as ‘clinical innovation’.Footnote 1 The scope of clinical innovation is broad, ranging from minor alterations to established practice – for example using a novel suturing technique – to more significant departures from standard practice – for example using an invasive device that has not been formally tested in any population.
For the most part, clinical innovation is viewed as necessary and desirable. Medicine has always involved the translation of ideas into treatment and it is recognised that ideas originate in the clinic as well as in the research setting, and that research and practice inform each other in an iterative manner.Footnote 2 It is also recognised that the standard trajectory of research followed by health technology assessment, registration and subsidisation may be too slow for patients with life-limiting or debilitating diseases and that clinical innovation can provide an important avenue for access to novel treatments.Footnote 3 There are also limitations to the systems that are used to determine what counts as ‘standard’ practice because it is up to – usually commercial – sponsors to seek formal registration for particular indications.Footnote 4While many clinical innovations have positively transformed medicine, others have failed to demonstrate evidence of clinical benefit,Footnote 5 or exposed patients to considerable harm – for example, the use of transvaginal mesh for the treatment of pelvic organ prolapse.Footnote 6 Many innovative interventions are also substantially more expensive than traditional treatments,Footnote 7 imposing costs on both patients and health systems. It is therefore broadly accepted that innovation requires some form of oversight. In most jurisdictions, oversight of innovation consists of a combination of legally based regulations and less formal governance mechanisms. These, in turn, can be focused on:
1. the oversight of clinical practice by professional organisations, medical boards, healthcare complaints bodies and legal regimes;
2. the registration of therapeutic products by agencies such as the US Food and Drug Administration, the European Medicines Agency and Australia’s Therapeutic Goods Administration;
3. consumer protection, such as laws aimed at identifying and punishing misleading advertising; and
4. the oversight of research when innovation takes place in parallel with clinical trials or is accompanied by the generation of ‘real world evidence’ through, for example, clinical registries.
The need for some degree of oversight is relatively uncontroversial. But there is also pushback against what is perceived to be obstruction of access to innovative interventions.Footnote 8 There are two main arguments underpinning this position. First, it is argued that existing forms of oversight create barriers to clinical innovation. Salter and colleagues, for example, view efforts to assert external control over clinical innovation as manifestations of conservative biomedical hegemony that deliberately hinders clinical innovation in favour of more traditional translational pathways.Footnote 9 It has also been argued that medical negligence law deters clinical innovationFootnote 10 and that health technology regulation is excessively slow and conservative, denying patients the ‘right to try’ interventions that have not received formal regulatory approval.Footnote 11Second, it is argued that barriers are philosophically and politically inappropriate on the grounds that patients are not actually ‘patients’, but rather ‘consumers’. According to these arguments, consumers should be free to decide for themselves what goods and services they wish to purchase without having their choices restricted by regulation and governance systems – including those typically referred to as ‘consumer’ (rather than ‘patient’) protections. Following this line of reasoning, Salter and colleaguesFootnote 12 argue that decisions about access to innovative interventions should respect and support ‘the informed health consumer’ who:
assumes she/he has the right to make their own choices to buy treatment in a health care market which is another form of mass consumption…Footnote 13
and who is able to draw on:
a wide range of [information] sources which include not only the formally approved outlets of science and state but also the burgeoning information banks of the internet.Footnote 14
There are, however, several problems with these arguments. First, there is little evidence to support the claim that there is, in fact, an anti-innovative biomedical hegemony that is creating serious barriers to clinical innovation. While medical boards can censure doctors for misconduct, and the legal system can find them liable for trespass or negligence, these wrongs are no easier to prevent or prove in the context of innovation than in any other clinical context. Product regulation is similarly facilitative of innovation, with doctors being free to offer interventions ‘off-label’ and patients being allowed to apply for case-by-case access to experimental therapies. The notion that current oversight systems are anti-innovative is therefore not well founded.
Second, it is highly contestable that patients are ‘simply’ consumers – and doctors are ‘simply’ providers of goods and services – in a free market. For several reasons, healthcare functions as a very imperfect market: there is often little or no information available to guide purchases; there are major information asymmetries – exacerbated by misinformation on the internet; and patients may be pressured into accepting interventions when they have few, if any, other therapeutic options.Footnote 15 Furthermore, even if patients were consumers acting in a marketplace, it would not follow that the marketplace should be completely unregulated, for even the most libertarian societies have regulatory structures in place to prevent bad actors misleading people or exploiting them financially (e.g. through false advertising, price fixing or offering services that they are unqualified to provide).
This leaves one other possible objection to the oversight of clinical innovation – that patients are under the care of professionals who are able to collaborate with them in making decisions through shared decision-making. Here, the argument is that innovation (1) should not be overseen because it is an issue that arises between a doctor and a patient, and (2) does not need to be overseen because doctors are professionals who have their patients’ interests at heart. These are compelling arguments because they are consistent with both the emphasis on autonomy in liberal democracies and with commonly accepted ideas about professionals and their obligations.
Two objections can, however, be raised. First, these arguments ignore the fact that professionalism is concerned not only with patient well-being but also with commitments to the just distribution of finite resources, furthering scientific knowledge and maintaining public trust.Footnote 16 The second problem with these arguments is that they are premised on the assumption that all innovating clinicians are consistently alert to their professional obligations and willing to fulfil them. Unfortunately, this assumption is open to doubt. To illustrate this point, we turn to the case of autologous mesenchymal stem cell-based interventions.
29.3 The Case of Autologous Mesenchymal Stem Cell Interventions
Stem cell-based interventions are procedures in which stem cells – cells that have the potential to self-replicate and to differentiate into a range of different cell types – or cells derived from stem cells are administered to patients for therapeutic purposes. Autologous stem cell-based interventions involve administering cells to the same person from whom they were obtained. The two most common sources of such stem cells are blood and bone marrow (haematopoietic) cells and connective tissue (mesenchymal) cells.
Autologous haematopoietic stem cells are extracted from blood or bone marrow and used to reconstitute the bone marrow and immune system following high dose chemotherapy. Autologous mesenchymal cells are extracted most commonly from fat and then injected – either directly from the tissue extracts or after expansion in the laboratory – into joints, skin, muscle, blood stream, spinal fluid, brain, eyes, heart and so on, in order to ‘treat’ degenerative or inflammatory conditions. The hope is that because mesenchymal stem cells may have immunomodulatory properties they may support tissue regeneration.
The use of autologous haematopoietic stem cells is an established standard of care therapy for treating certain blood and solid malignancies and there is emerging evidence that they may also be beneficial in the treatment of immunological disorders, such as multiple sclerosis and scleroderma. In contrast, evidence to support the use of autologous mesenchymal stem cell interventions is weak and limited to only a small number of conditions (e.g. knee osteoarthritis).Footnote 17 And even in these cases, it is unclear what the precise biological mechanism is and whether the cells involved should even be referred to as ‘stem cells’Footnote 18 (we use this phrase in what follows for convenience).
Despite this, autologous mesenchymal stem cell interventions (henceforth AMSCIs) are offered for a wide range conditions for which there is no evidence of effectiveness, including spinal cord injury, motor neuron disease, dementia, cerebral palsy and autism.Footnote 19 Clinics offering these and other claimed ‘stem cell therapies’ have proliferated globally, primarily in the private healthcare sector – including in jurisdictions with well-developed regulatory systems – and there are now both domestic markets and international markets based on stem cell tourism.Footnote 20
While AMSCIs are relatively safe, they are far from risk-free, with harm potentially arising from the surgical procedures used to extract cells (e.g. bleeding from liposuction), the manipulation of cells outside of the body (e.g. infection) and the injection of cells into the bloodstream (e.g. immunological reactions, fever, emboli) or other tissues (e.g. cyst formation, microcalcifications).Footnote 21 Despite these risks, many of the practitioners offering AMSCIs have exploited loopholes in product regulation to offer these interventions to large numbers of patients.Footnote 22 To make matters worse, these interventions are offered without obvious concern for professional obligations, as evident in aggressive and misleading marketing, financial exploitation and poor-quality evidence-generation practices.
First, despite limited efficacy and safety, AMSCIs are marketed aggressively through clinic websites, advertisements and appearances in popular media.Footnote 23 This is inappropriate both because the interventions being promoted are experimental and should therefore be offered to the minimum number of patients outside the context of clinical trials, and because marketing is often highly misleading. In some cases, this takes the form of blatant misinformation – for example, claims that AMSCIs are effective for autism, dementia and motor neuron disease. In other cases, consumers are misled by what have been referred to as ‘tokens of legitimacy’. These include patient testimonials, references to incomplete or poor-quality research studies, links to scientifically dubious articles and conference presentations, displays of certification and accreditation from unrecognised organisations, use of meaningless titles such as ‘stem cell physician’ and questionable claims of ethical oversight. Advertising of AMSCIs is also rife with accounts of biological processes that give the impression that autologous stem cells are entirely safe – because they come from the patient’s own body – and possess almost magical healing qualities.Footnote 24
Second, AMSCIs are expensive, with patients paying thousands of dollars (not including follow-up care or the costs associated with travel).Footnote 25 In many cases, patients take drastic measures to finance access to stem cells, including mortgaging their houses and crowd-sourcing funding from their communities. Clinicians offering AMSCIs claim that such costs are justified given the complexities of the procedures and the lack of insurance subsidies to pay for them.Footnote 26 However, the costs of AMSCIs seem to be determined by the business model of the industry and by a determination of ‘what the market will bear’ – which in the circumstances of illness, is substantial. Furthermore, clinicians offering AMSCIs also conduct ‘pay-to-participate’ clinical trials and ask patients to pay for their information to be included in clinical registries. Such practices are generally frowned upon as they exacerbate the therapeutic misconception and remove any incentive to complete and report results in a timely manner.Footnote 27
Finally, contrary to the expectation that innovating clinicians should actively contribute to generating generalisable knowledge through research, clinics offering AMSCIs have proliferated in the absence of robust clinical trials.Footnote 28 Furthermore, providers of AMSCIs tend to overstate what is known about efficacyFootnote 29 and to misrepresent what trials are for, arguing that they simply ‘measure and validate the effect of (a) new treatment’.Footnote 30 Registries that have been established to generate observational evidence about innovative AMSCIs are similarly problematic because participation is voluntary, outcome measures are subjective and results are not made public. There are also problems with the overall framing of the registries, which are presented as alternatives – rather than supplements – to robust clinical trials.Footnote 31 And because many AMSCIs are prepared and offered in private practice, there is lack of oversight and independent evaluation of what is actually administered to the patient, making it impossible to compare outcomes in a meaningful way.Footnote 32
While it is possible that doctors offering autologous stem cell interventions simply lack awareness of the norms relating to clinical innovation, this seems highly unlikely, as many of these clinicians are active participants in policy debates about innovation and are routinely censured for behaviour that conflicts with accepted professional obligations. A more likely explanation, therefore, is that the clinicians offering autologous stem cell interventions are motivated not (only) by concern for their patients’ well-being, but also by other interests such as the desire to make money, achieve fame and satisfy their intellectual curiosity. In other words, they have competing and conflicting interests that override their concerns for patient well-being and the generation of valid evidence.
29.4 Implications for Oversight of Clinical Innovation
Unfortunately, the case of AMSCIs is far from unique. Other situations in which clinicians appear to be abusing the privilege of using their judgement to offer non-evidence-based therapies include orthopaedic surgeons over-using arthroscopies for degenerative joint disease,Footnote 33 assisted reproductive technology specialists who offer unproven ‘add-ons’ to traditional in-vitro fertilisationFootnote 34 and health professionals engaging in irresponsible off-label prescribing of psychotropic medicines.Footnote 35
Clinicians in all of these contexts are embedded in a complex web of financial and non-financial interests such as the desire to earn money, create product opportunities, pursue intellectual projects, achieve professional recognition and career advancement, and develop knowledge for the good of future patientsFootnote 36 – all of which motivate their actions. Clinicians are also susceptible to biases such as the ‘optimism bias’, which might lead them to over-value innovative technologies and they are impacted upon by external pressures, such as industry marketingFootnote 37 and pressure from patients desperate for a ‘miracle cure’.Footnote 38
With these realities in mind, arguments against the oversight of innovation – or, more precisely, a reliance on consumer choice – become less compelling. Indeed, it could be argued that the oversight of innovation needs to be strengthened in order to protect patients from exploitation by those with competing and conflicting interests. That said, it is important that the oversight of clinical innovation does not assume that all innovating clinicians are motivated primarily by personal gain and, correspondingly, that it does not stifle responsible clinical innovation.
In order to strike the right balance, it is useful – following Lysaght and colleaguesFootnote 39 – for oversight efforts to be framed in terms of, and account for, three separate functions: a negative function (focused on protecting consumers and sanctioning unacceptable practices, such as through tort and criminal law); a permissive function (concerned with frameworks that license health professionals and enable product development, such as through regulation of therapeutic products); and a positive function (dedicated to improving professional ethical behaviour, such as through professional registration and disciplinary systems). With that in mind, we now present some examples of oversight mechanisms that could be employed.Those with responsibility for overseeing clinical practice need to enable clinicians to offer innovative treatments to selected patients outside the context of clinical trials, while at the same time preventing clinicians from exploiting patients for personal or socio-political reasons. Some steps that could be taken to both encourage responsible clinical innovation and discourage clinicians from acting on conflicts of interest might include:
requiring that all clinicians have appropriate qualifications, specialisation, training and competency;
mandating disclosure of competing and conflicting interests on clinic websites and as part of patient consent;
requiring that consent be obtained by an independent health professional who is an expert in the patient’s disease (if necessary at a distance for patients in rural and remote regions);
ensuring that all innovating clinicians participate in clinical quality registries that are independently managed, scientifically rigorous and publicly accessible;
requiring independent oversight to ensure that appropriate product manufacturing standards are met;
ensuring adequate pre-operative assessment, peri-operative care and post-operative monitoring and follow-up;
ensuring that patients are not charged excessive amounts for experimental treatments, primarily by limiting expenses to cost-recovery; and
determining that some innovative interventions should be offered only in a limited number of specialist facilities.
Professional bodies (such as specialist colleges), professional regulatory agencies, clinical ethics committees, drugs and therapeutics committees and other institutional clinical governance bodies would have an important role to play in ensuring that such processes are adhered to.
There may also be a need to extend current disciplinary and legal regimes regarding conflicts of interest (or at least ensure better enforcement of existing regimes). Many professional codes of practice already require physicians to be transparent about, and refrain from acting on, conflicts of interest. And laws in some jurisdictions already recognise that financial interests should be disclosed to patients, that patients should be referred for independent advice and that innovating clinicians need to demonstrate concern for patient well-being and professional consensus.Footnote 40
With respect to advertising, there is a need to prevent aggressive and misleading direct-to-consumer advertising while still ensuring that all patients who might benefit from an innovative intervention are aware that such interventions are being offered. With this in mind, it would seem reasonable to strengthen existing advertising oversight (which, in many jurisdictions, is weak and ad hoc). It may also be reasonable to prohibit innovating clinicians from advertising interventions directly to patients – including indirectly through ‘educational’ campaigns and media appearances – and instead develop systems that alert referring doctors to the existence of doctors offering innovative interventions.
Those regulating access to therapeutic products need to strike a balance between facilitating timely access to the products that patients want, and ensuring that those with competing interests are not granted licence to market products that are unsafe or ineffective. In this regard, it is important to note that product regulation is generally lenient when it comes to clinical innovation and it is arguable that there is a need to push back against current efforts to accelerate access to health technologies – efforts that are rapidly eroding regulatory processes and creating a situation in which patients are being exposed to an increasing number of ineffective and unsafe interventions.Footnote 41 In addition, loopholes in therapeutic product regulation that can be exploited by clinicians with conflicts of interest should be predicted and closed wherever possible.Although clinical innovation is not under the direct control of research ethics and governance committees, such committees have an important role to play in ensuring that those clinical trials and registries established to support innovation are not distorted by commercial and other imperatives. The task for such committees is to strike a balance between assuming that all researcher/innovators are committed to the generation of valid evidence and placing excessive burdens on responsible innovators who wish to conduct high-quality research. In this regard, research ethics committees could:
ensure that participants in trials and registries are informed about conflicts of interest;
ensure that independent consent processes are in place so that patients are not pressured into participating in research or registries; and
consider whether it is ever acceptable to ask patients to ‘pay to participate’ in trials or in registries.
Research ethics committees also have an important role in minimising biases in the design, conduct and dissemination of innovation-supporting research. This can be achieved by ensuring that:
trials and registries have undergone rigorous, independent scientific peer review;
data are collected and analysed by independent third parties (e.g. Departments of Health);
data are freely available to any researcher who wants to analyse it; and
results – including negative results – are widely disseminated in peer-reviewed journals.
While this chapter has focused on traditional ‘top-down’ approaches to regulation and professional governance, it might also be possible to make use of what Devaney has referred to as ‘reputation-affecting’ regulatory approaches.Footnote 42 Such approaches would reward those who maintain their independence or manage their conflicts effectively with reputation-enhancing measures such as access to funding and publication in esteemed journals. In this regard, other parties not traditionally thought of as regulators – such as employing institutions, research funders, journal reviewers and editors and the media – might have an important role to play in the oversight of clinical innovation.
Importantly, none of the oversight mechanisms we have suggested here would discourage responsible clinical innovation. Indeed, an approach to the oversight of clinical innovation that explicitly accounts for the realities of competing and conflicting interests could make it easier for well-motivated clinicians to obtain the trust of both individual patients and broader social licence to innovate.
29.5 Conclusion
Clinical innovation has an important and established role in biomedicine and in the development and diffusion of new technologies. But it is also the case that claims about patients’ – or consumers’ – rights and about the sanctity of the doctor–patient relationship, can be used to obscure both the risks of innovation and the vested interests that drive some clinicians’ decision to offer innovative interventions. In this context, adequate oversight of clinical innovation is crucial. After all, attempts to exploit the language and concept of innovation not only harms patients, but also threatens legitimate clinical innovation and undermines public trust. Efforts to push back against the robust oversight of clinical innovation need, therefore, to be viewed with caution.
30.1 Introduction
Governments and stakeholders have struggled to find a common ground on how to regulate research for different (‘proven’ or ‘unproven’) practices. Research on traditional, alternative and complementary medicines is often characterised as following weak research protocols and as producing evidence too poor to stand the test of systematic reviews, thus rendering individual case studies results insignificant. Although millions of people rely on traditional and alternative medicine for their primary care needs, the regulation of research into, and practice of, these therapies is governed by biomedical parameters. This chapter asks how, despite efforts to accommodate other forms of evidence, regulation of research concerning traditional and alternative medicines is ambiguous as to what sort of evidence – and therefore what sort of research – can be used by regulators when deciding how to deal with practices that are not based on biomedical epistemologies. Building on ideas from science and technology studies (STS), in this chapter we analyse different approaches to the regulation of traditional and non-conventional medicines adopted by national, regional and global governmental bodies and authorities, and we identify challenges to the inclusion of other modes of ‘evidence’ based on traditional and hybrid epistemologies.
30.2 Background
Non-conventional medicines are treatments that are not integrated to conventional medicine and are not necessarily delivered by a person with a degree in medical science. This may include complementary, alternative and traditional healers who may derive their knowledge from local or foreign knowledges, skills or practices.Footnote 1 For the World Health Organization (WHO), traditional medicine may be based on explicable or non-explicable theories, beliefs and experiences of different indigenous cultures.Footnote 2 That being said, traditional medicine is often included within the umbrella term of ‘non-conventional medicine’ in countries where biomedicine is the norm. However, this is often considered a misnomer insofar as traditional medicine may be the main source of healthcare in many countries, independent of its legitimate or illegitimate status. Given the high demand for traditional and non-conventional therapies, governments have sought to bring these therapies into the fold of regulation, yet, the processes involved to accomplish this task have been complicated by the tendency to rely on biomedicine’s standards of practice as a baseline. For example, the absence of and/or limited data produced by traditional and non-conventional medicine research and the unsatisfactory methodologies that do not stand the test of internationally recognised norms and standards for research involving human subjects have been cited as common barriers to the development of legislation and regulation of traditional and non-conventional medicine.Footnote 3 In 2019, the WHO reported that 99 out of 133 countries considered the absence of research as one of the main challenges to regulating these fields.Footnote 4 At the same time, governments have been reluctant to integrate traditional and non-conventional medicines as legitimate healthcare providers because their research is not based on the ‘gold standard’, namely multi-phase clinical trials.Footnote 5 Without evidence produced through conventional research methodologies, it is argued that people are at risk of falling prey to charlatans who peddle magical cures – namely placebos without any concrete therapeutic value – or that money is wasted on therapies and products based on outdated or disparate bodies of knowledge rather than systematic clinical research.Footnote 6 While governments have recognised to some extent the need to accommodate traditional and non-conventional medicines for a variety of reasonsFootnote 7 – including the protection of cultural rights, consumer rights, health rights, intellectual property and biodiversityFootnote 8 – critics suggest that there is no reason why these modalities of medicine should be exempted from providing quality evidence.Footnote 9
Picking up on some of these debates, this chapter charts the challenges arising from attempts to regulate issues relevant to research in the context of traditional and alternative medicine. From the outset, it explores what kinds of evidence and what kinds of research are accepted in the contemporary regulatory environment. It outlines some of the sticky points arising out of debates about research of traditional and non-conventional medicines, in particular, the role of placebo effects and evidence. Section 30.4 explores two examples of research regulation: WHO’s Guidelines for Methodologies on Research and Evaluation of Traditional Medicine and the European Directive on Traditional Herbal Medicine Products (THMPD). Both incorporate mixed methodologies into research protocols and allow the use of historical data as evidence of efficacy, thus recognising the specificity of traditional medicine and non-conventional medicine. However, we argue that these strategies may themselves become subordinated to the biomedical logics, calling into question the extent to which other epistemologies or processes are allowed to shape what is considered as acceptable evidence. Section 30.5 focuses on the UK, as an example of how other processes and rationalities, namely economic governmentalities, shape the spaces that non-conventional medicine can inhabit. Section 30.6 untangles and critically analyses the assumptions and effects arising out of the process of deciding what counts as evidence in healthcare research regulations. It suggests that despite attempts to include different modalities, ambiguities persist due to acknowledged and unacknowledged hierarchies of knowledge-production explored in this chapter. The last section opens up a conversation about what is at stake when the logic underpinning the regulation of research creates a space for difference, including different medical traditions and what counts as evidence.Footnote 10
30.3 Evidence-Based Medicine and Placebo Controls
Evidence-based medicine (EBM) stands for the movement which suggests that the scientific method allows researchers to find the best evidence available in order to make informed decisions about patient care. To find the best evidence possible, which essentially means that the many is more significant than the particular, EBM relies on multiple randomised controlled trials (RCTs) and evidence from these is eventually aggregated and compared.Footnote 11 Evidence is hierarchically organised, whereby meta-reviews and systematic reviews based on RCTs stand at the top, followed by non-randomised controlled trials, observational studies with comparison groups, case series and reports, single case studies, expert opinion, community evidence and individual testimonies at the bottom. In addition to reliance on quantity, the quality of the research matters. Overall, it means that the best evidence is based on data from blinded trials, which show a causal relation between therapeutic interventions and the effect, and isolates results from placebo-effects.
From a historical perspective, the turn to blinded tests represented a significant shift in medical practice insofar as it diminished the relevance of expert opinion, which was itself based on a hierarchy of knowledge that tended to value authority and theory over empirical evidence. Physicians used to prescribe substances, such as mercury, that although believed to be effective for many ailments, were later found to be highly toxic.Footnote 12 Thus, the notion of evidence arising out of blinded trials closed the gap between science and practice, and also partially displaced physicians’ authority. Blinded trials and placebo controls had other effects: they became a tool to demarcate ‘real’ medicine from ‘fake’ medicine, proper doctors from ‘quacks’ and ‘snake-oil’ peddlers. By exposing the absence of a causal relationships between the therapy and the physical effect, some therapies and knowledges associated with them were rebranded as fraudulent or as superstitions. While the placebo effect might retrospectively explain why some of these discarded therapies were seen as effective, in practice, EBM’s hierarchy of evidence dismisses patients’ subjective accounts.Footnote 13 While explanations about the placebo effect side-lined the role of autosuggestion in therapeutic interventions, they did not clarify either the source or the benefits of self-suggestion.
Social studies suggest that the role of imagination has been overlooked as a key element mediating therapeutic interactions. Phoebe Friesen argues that, rather than being an ‘obstacle’ that modern medicine needed to overcome, imagination ‘is a powerful instrument of healing that can, and ought to be, subjected to experimental investigations.’Footnote 14 At the same time, when the positive role of the placebo effect and self-suggestion has been raised, scholarship research has pointed out dilemmas that remain unsolved, for example: Is it ethical to give a person a placebo in the conduct of research on non-orthodox therapies, and when is it justifiable, and for which conditions? Or, could public authorities justify the use of tax-payers money for so-called ‘sham’ treatments when people themselves, empowered by consumer choice rhetoric and patient autonomy, demand it? As elaborated in this chapter, some governments have been challenged for using public money to fund therapies deemed to be ‘unscientific’, while others have tightened control, fearing that self-help gurus, regarded as ‘cultish’ sect-leaders, are exploiting vulnerable patients.
To the extent that physiological mechanisms of both placebo and nocebo effects are still unclear, there does not seem to be a place in mainstream public healthcare for therapies that do not fit the EBM model because it is difficult to justify them politically and judicially, especially as healthcare regulations rely heavily on science to demonstrate public accountability.Footnote 15 And yet, while the importance of safety, quality and efficacy of therapeutic practices cannot be easily dismissed, the reliance on EBM as a method to demarcate effective from non-effective therapies dismisses too quickly the reasons why people are attracted to these therapies. When it comes to non-conventional medicines, biomedicine and the scientific method do not factor in issues such as patient choice or the social dimension of medical practice.Footnote 16 In that respect, questions as to how non-conventional medicine knowledges can demonstrate whether they are effective or not signal broader concerns. First, is it possible to disentangle the reliance of public accountability from science in order to solve the ethical, political, social and cultural dilemmas embedded in the practice of traditional and alternative medicine? Second, if we are to broaden the scope of how evidence is assessed, are there other processes or actors that shape what is considered effective from the perspective of healthcare regulation, for example, patient choice or consumer rights? And, finally, if science is not to be considered as the sole arbiter of healing, what are the spaces afforded for other epistemologies of healing? Without necessarily answering all of these questions, the aim of this chapter is to signpost a few sticky points in these debates. The next section explores three examples, at different jurisdictional levels – national, regional and international – of how healthcare regulators have sought to provide guidelines on how to incorporate other types of evidence into research dealing with traditional and non-conventional medicine.
30.4 Integration as Subordination: Guidelines and Regulations on Evidence and Research Methodologies
Traditional medicine has been part of the WHO’s political declarations and strategies born in the lead up to the 1978 Declaration of Alma Ata.Footnote 17 Since then, the WHO has been at the forefront of developing regulations aimed at carving out spaces for traditional medicines. However, the organisation has moved away from its original understanding of health, which was more holistic and focused on social practices of healing. Regional political mobilisations underpinned by postcolonial critiques of scientific universalism were gradually replaced again by biomedical logics of health from the 1980s onwards.Footnote 18 This approach, favouring biomedical standards of practice, can be appreciated to some extent in the ‘General Guidelines for the Research of Non-Conventional Medicines’, which is prefaced by the need to improve research data and methodologies with a view of furthering the regulation and integration of traditional herbal medicines and procedure-based therapies.Footnote 19 The guidelines state that conventional methodologies should not hamper people’s access to traditional therapies; and instead, reaffirms the plurality of non-orthodox practices.Footnote 20 Noting the great diversity of practices and epistemologies framing traditional medicine, the guidelines re-organised them around two broad classifications – medicines and procedure-based therapies.
Based on these categories, the guidelines suggest that efficacy can be demonstrated through different research methodologies and types of evidence, including historical evidence of traditional use. To ensure safety and efficacy standards are met, herbal medicines ought to be first differentiated through botanical identification based on scientific Latin plant names. Meanwhile, the guidelines leave some room for the use of historical records of traditional evidence of efficacy and safety, which should be demonstrated through a variety of sources including literature reviews, theories and concepts of system of traditional medicine, as well as clinical trials. It also affirms that post-marketing surveillance systems used for conventional medicines are relevant in monitoring, reporting and evaluating adverse effects of traditional medicine.
More importantly, the guidelines contemplate the use of mixed methodologies, whereby EBM can make up for the gaps of evidence of efficacy in traditional medicine. And, where claims are based on different traditions, for example, Traditional Chinese Medicine (TCM) and Western Herbalism, the guidelines require evidence linking them together; and where there is none, scientific evidence should be the basis. If there are any contradictions between them, ‘the claim used must reflect the truth, on balance of the evidence available’.Footnote 21 Although these research methodologies give the impression of integrating traditional medicine into the mainstream, the guidelines reflect policy transformations since the late 1980s, when plants appeared more clearly as medical objects in the Declaration of Chiang Mai.Footnote 22 Drawing on good manufacturing practice guidelines as tools to assess the safety and quality of medicines, WHO’s guidelines and declarations between 1990 and 2000 increasingly framed herbal medicines as an object of both pharmacological research and healthcare governance.Footnote 23
WHO’s approach resonates with contemporary European Union legislation, namely the Directive 2004/24/EC on the registration of traditional herbal medicines.Footnote 24 This Directive also appears to be more open to qualitative evidence based on historical sources, but ultimately subordinates evidence to the biomedical mantra of safety and quality that characterises the regulation of conventional medicines. Traditional herbal medicine applications should demonstrate thirty years of traditional use of the herbal substances or combination thereof, of which fifteen years should be in the European Union (EU). In comparison with conventional medicines requiring multiphase clinical trials in humans, the Directive simplifies the authorisation procedure by admitting bibliographic evidence of efficacy. However, applications must be supplemented with non-clinical studies – namely, toxicology studies – especially if the herbal substance or preparation is not listed in the Community Pharmacopeia.Footnote 25 In the end, these regulations subordinate traditional knowledges to the research concepts and methodologies of conventional medicine. Research centres of non-conventional medicines in the EU also align mission statements to integration-based approaches, whereby inclusion of traditional and non-conventional medicine is premised on their modernisation through science.Footnote 26 However, as we argue in the next section, science is not the sole arbiter of what comes to be excluded or not in the pursuit of evidence. Indeed, drawing on the UK as a case study, we argue that economic rationalities are part of the regulatory environment shaping what is or is not included as evidence in healthcare research.
30.5 Beyond Evidence: The Economic Reasoning of Clinical Guidelines
Despite there being no specific restrictions preventing the use of non-conventional treatments within the National Health Service (NHS), authorities involved in the procurement of health or social care work have been under increasing pressure to define the hierarchy of scientific evidence in public affairs. For example, under pressure of being judicially reviewed, the Charities Commission opened up a consultation that produced new guidance for legal caseworkers assessing applications from charities promoting the use of complementary and alternative medicine. Charities have to define their purpose and how this benefits publics. For example, if the declared purpose is to cure cancer through yoga, it will have to demonstrate evidence of public benefit, based on accepted sources of evidence and EBM’s ‘recognised scales of evidence’. Although observations, personal testimonies or expert opinion are not excluded per se, they cannot substitute scientific medical explanation.Footnote 27 For the Commission, claims that fail the scientifically-based standard are meant to be regarded as cultural or religious beliefs.
There have also been more conspicuous ways in which evidence, as understood through a ‘scientific-bureaucratic-medicine’ model, has been used to limit the space for non-conventional medicines.Footnote 28 Clinical guidelines are a key feature of this regulatory model – increasingly institutionalised in the UK since the 1980s. The main body charged with this task is the National Institute for Health and Care Excellence (NICE), a non-departmental public body with statutory footing through the Health and Social Care Act 2012. The purpose of NICE clinical guidelines is to reduce variability in both quality and availability in the delivery of treatments and care and to confirm an intervention’s effectiveness. Although not compulsory, compliance with the guidelines is the norm and exceptions are ‘both rare and carefully documented’Footnote 29 because institutional performance is tied to their implementation and non-adherence may have a financial impact.Footnote 30 Following a campaign by ‘The Good Thinking Society’, an anti-pseudoscience charity, NHS bodies across London, Wales and the North of England have stopped funding homeopathic services.Footnote 31 Meanwhile, an NHS England consultation also led to the ban of the prescription of products considered to be of ‘low clinical value’, such as homeopathic and herbal products. Responding to critics, the Department of Health defended its decision to defund non-conventional medicine products stating they were neither clinically nor cost effective.Footnote 32 However, it is also worth noting that outside of the remit of publicly funded institutions, traditional and non-conventional medicines have been tolerated, or even encouraged, as a solution to relieve the pressure from austerity healthcare policies. For example, the Professional Standards Authority (PSA) has noted that accredited registered health and social care practitioners – which include acupuncturists, sports therapists, aromatherapy practitioners, etc. – could help relieve critical demand for NHS services.Footnote 33 This raises questions about what counts as evidence and how different regulators respond to specific practices that are not based on biomedical epistemologies, particularly what sort of research is acceptable in healthcare policy-making. What we have sought to demonstrate in this section is the extent to which, under the current regulatory landscape, the production of knowledge has become increasingly enmeshed with various layers of laws and regulations drafted by state and non-state actors.Footnote 34 Although the discourse has focused on problems with the kind of evidence and research methodologies used by advocates of non-conventional medicine, a bureaucratic application of EBM in the UK has limited access to traditional and non-conventional medicines in the public healthcare sector. In addition to policing the boundaries between ‘fake’ and ‘real’ medicines, clinical guidelines also delimit which therapies should be funded or not by the state. Thus, this chapter has sketched the links between evidence-based medicine and law, and the processes that influence what kind of research and what kind of evidence are appropriate for the purpose of delivering healthcare. Regulation, whether through laws implementing the EU Directives on the registration of traditional herbal medicines, or clinical guidelines produced by NICE, can be seen as operating as normative forces shaping healthcare knowledge production. The final section analyses the social and cultural dimensions of knowledge production and it argues that contemporary regulatory approaches discussed in the preceding sections assume non-conventional knowledges follow a linear development. Premised upon notions of scientific progress and modernity, this view ultimately fails to grasp the complexity of knowledge-production and the hybrid nature of healing practices.
30.6 Regulating for Uncertainty: Messy Knowledges and Practices
Hope for a cure, dissatisfaction with medical authority, highly bureaucratised healthcare systems or limited access to primary healthcare, are among some of the many reasons that drive people to try untested as well as the unregulated pills and practice-based therapies from traditional and non-conventional medicines. While EBM encourages a regulatory environment averse to the miracle medicines or testimonies of overnight cures and home-made remedies, Lucas Richert argues ‘unknown unknowns fail to dissuade the sick, dying or curious from experimenting with drugs’.Footnote 35 The problem, however, is the assumption that medicines, and also law, progress in a linear trajectory. In other words, that unregulated drugs became regulated through standardised testing and licensing regulations that carefully assess medicines quality, safety and efficacy before and after they are approved into the market.Footnote 36
Instead, medicines’ legal status may not always follow this linear evolution. We have argued so far that the regulatory environment of biomedicine demarcates boundaries between legitimate knowledge-makers/objects and illegitimate ones, such as street/home laboratories and self-experimenting patients.Footnote 37 But ‘evidence’ also acts as a signpost for a myriad of battles to secure some kind of authority over what is legitimate or not between different stakeholders (patient groups, doctors, regulators, industry, etc.).Footnote 38 Thus, by looking beyond laboratories and clinical settings, and expanding the scope of research to the social history of drugs, STS scholarship suggests that the legal regulation of research and medicines is based on more fragmented and dislocated encounters between different social spaces where experimentation happens.Footnote 39 For example, Mei Zhan argues that knowledge is ‘always already impure, tenuously modern, and permanently entangled in the networks of people, institutions, histories, and discourses within which they are produced’.Footnote 40 This means neither ‘Western’ biomedical science or ‘traditional’ medicines have ever been static and hermeneutically sealed spaces. Instead, therapeutic interventions and encounters are often ‘uneven’ and messy, linking dissimilar traditions and bringing together local and global healing practices, to the point that they constantly disturb assumptions about ‘the Great Divides’ in medicine. For example, acupuncture’s commodification and marketisation in Western countries reflects how Traditional Chinese Medicine has been transformed through circulation across time and space, enlisting various types of actors from different professional healthcare backgrounds – such as legitimate physicians, physiotherapists, nurses, etc. – as well as lay people who have not received formal training in a biomedical profession. New actors with different backgrounds take part in the negotiations for medical legitimacy and authority that are central to the reinvention of traditional and non-conventional medicine. These are processes of ‘translocation’ – understood as the circulation of knowledges across different circuits of exchange value – which reconfigure healing communities worldwide.Footnote 41
So, in the process of making guidelines, decisions and norms about research on traditional and non-conventional medicines, the notion of ‘evidence’ could also signify a somewhat impermanent conclusion to a struggle between different actors. As a social and political space, the integration of traditional medicine and non-conventional medicine is not merely a procedural matter dictated by the logic of medical sciences. Instead, what is accepted or not as legitimate is constantly ‘remodelled’ by political, economic and social circumstances.Footnote 42 In that sense, Stacey Langwick argues that evidence stands at the centre of ontological struggles rather than simply being contestations of authority insofar it is a ‘highly politicized and deeply intimate battle over who and what has the right to exist’.Footnote 43 For her, determination of what counts as evidence is at the heart of struggles of postcoloniality. When regulations based on EBM discard indigenous epistemologies of healing or the hybrid practices of individuals and communities who pick up knowledge in fragmented fashion, they also categorise their experiences, histories and effects as non-events. This denial compounds the political and economic vulnerability of traditional and non-conventional healers insofar as their survival depends on their ability to adapt their practice to conventional medicine, by mimicking biomedical practices and norms.Footnote 44 Hence, as Marie Andree Jacobs argues, the challenge for traditional and non-conventional medicines lies in translating ‘the alternativeness of its knowledge into genuinely alternative research practices’ and contributes to reimagining alternative models of regulation.Footnote 45
30.7 Conclusion
This chapter analysed how regulators respond to questions of evidence of traditional and non-conventional medicines. It argued that these strategies tend to subordinate data that is not based on EBM’s hierarchies of evidence, allowing regulators to demarcate the boundaries of legitimate research as well as situating the ‘oddities’ of non-conventional medicines outside of science (e.g. as ‘cultural’ or ‘religious’ issues in the UK’s case). In order to gain legitimacy and authority, as exemplified through the analysis of specific guidelines and regulations of research of traditional and non-conventional medicines, the regulatory environment favours the translation and transformation of traditional and non-conventional medicines into scientised and commercial versions of themselves. Drawing on STS scholarship, we suggested understanding these debates as political and social struggles reflecting changes about how people heal themselves and others in social communities that are in constant flux. More importantly, they reflect struggles of healing communities seeking to establish their own viability and right to exist within the dominant scientific-bureaucratic model of biomedicine. This chapter teased out limits of research regulation on non-conventional medicines, insofar practices and knowledges are already immersed in constantly shifting processes, transformed by the very efforts to pin them down into coherent and artificially closed-off systems. By pointing out the messy configurations of social healing spaces, we hope to open up a space of discussion with the chapters in this section. Indeed, how can we widen the lens of research regulation, and accommodate non-conventional medicines, without compromising the safety and quality of healthcare interventions? At the very minimum, research on regulation could engage with the social and political context of medicine-taking, and further the understanding of how and why patients seek one therapy over another.
31.1 IntroductionFootnote 1
Over the last decade or so, sociologists and other social scientists concerned with the development and application of biomedical research have come to explore the lived realities of regulation and governance in science. In particular, the instantiation of ethics as a form of governance within scientific practice – via, for instance, research ethics committees (RECs) – has been extensively interrogated.Footnote 2 Social scientists have demonstrated the reciprocally constitutive nature of science and ethics, which renders problematic any assumption that ethics simply follows (or stifles) science in any straightforward way.Footnote 3
This chapter draws on and contributes to such discussion through analysing the relationship between neuroscience (as one case study of scientific work) and research ethics. I draw on data from six focus groups with scientists in the UK (most of whom worked with human subjects) to reflect on how ethical questions and the requirements of RECs as a form of regulation are experienced within (neuro)science. The focus groups were conducted in light of a conceptual concern with how ‘issues and identities interweave’; i.e. how personal and professional identities relate to how particular matters of concern are comprehended and engaged with, and how those engagements themselves participate in the building of identities.Footnote 4 The specific analysis presented is informed by the work of science and technology studies (STS) scholar Sheila Jasanoff and other social scientists who have highlighted the intertwinement of knowledge with social order and practices.Footnote 5 In what follows, I explore issues that the neuroscientists I spoke with deem to be raised by their work, and characterise how both informal ideas about ethics and formal ethical governance (e.g. RECs) are experienced and linked to their research. In doing so, I demonstrate some of the lived realities of scientists who must necessarily grapple with the heterogenous forms of health-related research regulation the editors of this volume highlight in their Introduction, while seeking to conduct research with epistemic and social value.Footnote 6
31.2 Negotiating the Ethical Dimensions of Neuroscience
It is well known that scientists are not lovers of the bureaucracies of research management, which are commonly taken to include the completion of ethical review forms. This was a topic of discussion in the focus groups: one scientist, for instance, spoke of the ‘dread’ (M3, Group 5) felt at the prospect of applying for ethical approvals. Such an idiom will no doubt be familiar to many lawyers, ethicists and regulatory studies scholars who have engaged with life scientists about the normative dimensions of their work.
Research governance – specifically, ethical approvals – could, in fact, be seen as having the potential of hampering science, without necessarily making it more ethical. In one focus group (Group 1), three postdoctoral neuroscientists discussed the different terms ethics committees had asked them to use in recruitment materials. One scientist (F3) expressed irritation that another (F2) was required to alter a recruitment poster, in order that it clearly stated that participants would receive an ‘inconvenience allowance’ rather than be ‘paid’. The scientists did not think that this would facilitate recruitment into a study, nor enable it to be undertaken any more ethically. F3 described how ‘it’s just so hard to get subjects. Also if you need to get subjects from the general public, you know, you need these tricks’. It was considered that changing recruitment posters would not make the research more ethical – but it might prevent it happening in the first place.All that being said, scientists also feel motivated to ensure their research is conducted ‘ethically’. As the power of neuroimaging techniques increases, it is often said that it becomes all the more crucial for neuroscientists to engage with ethical questions.Footnote 7 The scientists in my focus groups shared this sentiment, commonly expressed by senior scientists and ethicists. As one participant reflected, ‘the ethics and management of brain imaging is really becoming a very key feature of […] everyday imaging’ (F2, Group 4). Another scientist (F1, Group 2) summarised the perspectives expressed by all those who participated in the focus groups:
I think the scope of what we can do is broadening all the time and every time you find out something new, you have to consider the implications on your [research] population.
What scientists consider to be sited within the territory of the ‘ethical’ is wide-ranging, underscoring the scope of neuroscientific research, and the diverse institutional and personal norms through which it is shaped and governed. One researcher (F1, Group 2) reflected that ethical research was not merely that which had been formally warranted as such:
I think when I say you know ‘ethical research’, I don’t mean research passed by an ethics committee I mean ethical to what I would consider ethical and I couldn’t bring myself to do anything that I didn’t consider ethical in my job even if it’s been passed by an ethics committee. I guess researchers should hold themselves to that standard.
Conflicts about what was formally deemed ethical and what scientists felt was ethical were not altogether rare. In particular, instances of unease and ambivalence around international collaboration were reflected upon in some of the focus group discussions. Specifically, these were in relation to collaboration with nations that the scientists perceived as having relatively lax ethical governance as compared to the UK. This could leave scientists with a ‘slight uneasy feeling in your stomach’ (F2, Group 4). Despite my participants constructing some countries as being more or less ‘ethical’, no focus group participant described any collaborations having collapsed as a consequence of diverging perspectives on ethical research. However, the possibility that differences between nations exist, and that these difference could create problems in collaboration, was important to the scientists I spoke with. There was unease attached to collaborating with a ‘country that doesn’t have the same ethics’ (F2, Group 4). To an extent, then, an assumption of a shared normative agenda seemed to have significance as an underpinning for cross-national team science.
The need to ensure confidentiality while also sharing data with colleagues and collaborators was another source of friction. This was deemed to be a particularly acute issue for neuroscience, since neuroimaging techniques were seen as being able to generate and collect particularly sensitive information about a person (given both the biological salience of the brain and the role of knowledge about it in crafting identities).Footnote 8 The need to separate data from anything that could contribute to identifying the human subject it was obtained from impacted scientists’ relationships with their research. In one focus group (Group 3), M3 pointed out that no longer were scientists owners of data, but rather, they were responsible chaperones for it.
Fears were expressed in the focus groups that neuroscientific data might inadvertently impact upon research participants, for instance, affecting their hopes for later life, legal credibility and insurance premiums. Echoing concerns raised in both ethics and social scientific literatures, my participants described a wariness about any attempt to predict ‘pathological’ behaviours, since this could result in the ‘labelling’ (F1, Group 4) or ‘compartmentalising’ (F2, Group 4) of people.Footnote 9 As such, these scientists avoided involving themselves in research that necessarily entailed children, prisoners, or ‘vulnerable people’ (F2, group 4). Intra-institutional tensions could emerge when colleagues were carrying out studies that the scientists I spoke with did not regard as ethically acceptable.Some focus group participants highlighted the hyping of neuroscience, and argued that it was important to resist this.Footnote 10 These scientists nevertheless granted the possibility that some of the wilder promises made about neuroscience (e.g. ‘mind reading’) could one day be realised – generating ethical problems in the process:
there’s definitely a lot of ethical implications on that in terms of what the average person thinks that these methods can do and can’t do, and what they actually can do. And if the methods should get to the point where they could do things like that, to what extent is it going to get used in what way. (F1, group 1)
Scientists expressed anxiety about ‘develop[ing] your imaging techniques’ but then being unable to ‘control’ the application of these (F2, Group 4). Yet, not one of my participants stated that limits should be placed on ‘dangerous’ research. Developments in neuroscience were seen neither as intrinsically good nor as essentially bad, with nuclear power sometimes invoked as a similar example of how, to their mind, normativity adheres to deployments of scientific knowledge rather than its generation. More plainly: the rightness or wrongness of new research findings were believed to ‘come down to the people who use it’ (F1, Group 1), not to the findings per se. Procedures almost universally mandated by RECs were invoked as a way of giving licence to research: ‘a good experiment is a good experiment as long as you’ve got full informed consent, actually!’ (F1, Group 3). Another said:
I think you can research any question you want. The question is how you design your research, how ethical is the design in order to answer the question you’re looking at. (F2, Group 2)
Despite refraining from some areas of work themselves, due to the associated social and ethical implications my participants either found it difficult to think of anything that should not be researched at all, or asserted that science should not treat anything as ‘off-limits’. One scientist laughed in mock horror when asked if there were any branches of research that should not be progressed: ‘Absolutely not!’ (F1 Group 3). This participant described how ‘you just can’t stop research’, and prohibitions in the UK would simply mean scientists in another country would conduct those studies instead. In this specific respect, ethical issues seemed to be somewhat secondary to the socially produced sense of competition that appears to drive forward much biomedical research.
31.3 Incidental Findings within Neuroimaging ResearchThe challenge of what to do with incidental findings is a significant one for neuroscientists, and a matter that has exercised ethicists and lawyers (see Postan, Chapter 23 in this volume).Footnote 11 They pose a particular problem for scientists undertaking brain imaging. Incidental findings have been defined as ‘observations of potential clinical significance unexpectedly discovered in healthy subjects or in patients recruited to brain imaging research studies and unrelated to the purpose or variables of the study’.Footnote 12 The possibilities and management of incidental findings were key issues in the focus group discussions I convened, with a participant in one group terming them ‘a whole can of worms’ (F1, Group 3). Another scientist reflected on the issue, and their talk underscores the affective dimensions of ethically challenging situations:
I remember the first time [I discovered an incidental finding] ’cos we were in the scanner room we were scanning the child and we see it online basically, that there might be something. It’s a horrible feeling because you then, you obviously at this point you know the child from a few hours, since a few hours already, you’ve been working with the child and it’s … you have a personal investment, emotional investment in that already but the important thing is then once the child comes out of the scanner, you can’t say anything, you can’t let them feel anything, you know realise anything, so you have to be just really back to normal and pretend there’s nothing wrong. Same with the parents, you can’t give any kind of indication to them at all until you’ve got feedback from an expert, which obviously takes so many days, so on the day you can’t let anything go and no, yeah it was, not a nice experience. (F2, Group 2)
Part of the difficulties inherent in this ethically (and emotionally) fraught area lies in the relationality between scientist and research subject. Brief yet close relationships between scientists and those they research are necessary to ensure the smooth running of studies.Footnote 13 This intimacy, though, makes the management of incidental findings even more challenging. Further, the impacts of ethically significant issues on teamwork and collaboration are complex; for instance, what happens if incidental findings are located in the scans of co-workers, rather than previously unknown research subjects? One respondent described how these would be ‘even more difficult to deal with’ (F1, Group 1). Others reflected that they would refrain from ‘helping out’ by participating in a colleague’s scan when, for instance, refining a protocol. This was due to the potential of neuroimaging to inadvertently reveal bodily or psychological information that they would not want their colleagues to know.
The challenge of incidental findings is one that involves a correspondence between a particular technical apparatus (i.e. imaging methods that could detect tumours) and an assemblage of normative imperatives (which perhaps most notably includes a duty of care towards research participants). This correspondence is reciprocally impactful: as is well known, technoscientific advances shift the terrain of ethical concern – but so too does the normative shape the scientific. In the case of incidental findings, for example, scientists increasingly felt obliged to cost in an (expensive) radiologist into their grants, to inspect each participant’s scan; a scientist might ‘feel uncomfortable showing anybody their research scan without having had a radiologist look at it to reassure you it was normal’ (F1, Group 3). Hence, ‘to be truly ethical puts the cost up’ (F2, Group 4). Not every scientist is able to command such sums from funders, who might also demand more epistemic bang for the buck when faced with increasingly costly research proposals. What we can know is intimately linked to what we can, and are willing to, spend. And if being ‘truly ethical’ indeed ‘puts the cost up’, then what science is sponsored, and who undertakes this, will be affected.
31.4 Normative Uncertainties in Neuroscience
Scientific research using human and animal subjects in the UK is widely felt to be an amply regulated domain of work. We might, then, predict that issues like incidental findings can be rendered less challenging to deal with through recourse to governance frameworks. Those neuroscientists who exclusively researched animals indeed regarded the parameters and procedures defining what was acceptable and legal in their work to be reasonable and clear. In fact, strict regulation was described as enjoining self-reflection about whether the science they were undertaking was ‘worth doing’ (F1, Group 6). This was not, however, the case for my participants working with humans. Rather, they regarded regulation in general as complicated, as well as vague: in the words of two respondents, ‘too broad’ and ‘open to interpretation’ (F1, Group 2), and ‘a bit woolly’ and ‘ambiguous’ (F2, group 2). Take, for instance, the Data Protection Act: in one focus group (Group 3) a participant (F1) noted that a given university would ‘take their own view’ about what was required by the Act, with different departments and laboratories in turn developing further – potentially diverging – interpretations.
Within the (neuro)sciences, procedural ambiguity can exist in relation to what scientists, practically, should do – and how ethically valorous it is to do so. Normative uncertainty can be complicated further by regulatory multiplicity. The participants of one focus group, for example, told me about three distinct yet ostensibly nested ethical jurisdictions they inhabited: their home department of psychology, their university medical school and their local National Health Service Research Ethics Committee (NHS REC). The scientists I spoke with understood these to have different purviews, with different procedural requirements for research, and different perspectives on the proper way enactment of ethical practices, such as obtaining informed consent in human subjects research.
Given such normative uncertainty, scientists often developed what we might term ‘ethical workarounds’. By this, I mean that they sought to navigate situations where they were unsure of what, technically, was the ‘right’ thing to do by establishing their own individual and community norms for the ethical conduct of research, which might only be loosely connected to formal requirements. In sum, they worked around uncertainty by developing their own default practices that gave them some sense of surety. One participant (F1, Group 2) described this in relation to drawing blood from people who took part in her research. To her mind, this should be attempted only twice before being abandoned. She asserted that this was not formally required by any research regulation, but instead was an informal standard to which she and colleagues nevertheless adhered.In the same focus group discussion, another scientist articulated a version of regulatory underdetermination to describe the limits of governance:
not every little detail can be written down in the ethics and a lot of it is in terms of if you’re a researcher you have to you know make your mind up in terms of the ethical procedures you have to adhere to yourself and what would you want to be done to yourself or not to be done … (F2, Group 2)
Incidental findings were a key example of normative uncertainty and the ethical workarounds that resulted from this. Although ‘not every little detail can be written down’, specificity in guidelines can be regarded as a virtue in research that is seen to have considerable ethical significance, and where notable variations in practice were known to exist. The scientist quoted above also discussed how practical and ethical decisions must be made as a result of the detection of clinically relevant incidental findings, but that their precise nature was uncertain: scientists were ‘struggling’ due to being ‘unsure’ what the correct course of action should be. Hence, ‘proper guidelines’ were invoked as potentially useful, but these were seemingly considered to be hard to come by.The irritations stimulated by a perceived lack of clarity on the ethically and/or legally right way to proceed are similarly apparent in the response of this scientist to a question about her feelings upon discovering, for the first time, a clinically relevant incidental finding in the course of her neuroimaging work:
It was unnerving! And also because it was the first time I wasn’t really sure how to deal with it all, so I had to go back in the, see my supervisor and talk to them about it and, try to find out how exactly we’re dealing now with this issue because I wasn’t aware of the exact clear guidelines. (F2, Group 2)
Different scientists and different institutions were reported to have ‘all got a different way of handling’ (F2, Group 4) the challenge of incidental findings. Institutional diversity was foregrounded, such as in the comments of F1 (Group 1). She described how when working at one US university ‘there was always a doctor that had to read the scans so it was just required’. She emphasised how there was no decision-making around this on behalf of the scientist or the research participant: it was simply a requirement. On the other hand, at a different university this was not the case – no doctor was on call to assess neuroimages for incidental findings.An exchange between two researchers (F1 and F2, Group 2) also illustrates the problems of procedural diversity. Based in the same university but in different departments, they discussed how the complexities of managing incidental findings was related, in part, to practices of informed consent. Too lengthy a dialogue to fully reproduce here, two key features stood out. First, differences existed in whether the study team would, in practice, inform a research subject’s physician in the event of an individual finding: in F2’s case, it was routine for the physician to be contacted, but F1’s participants could opt out of this. However, obtaining physician contact details was itself a tricky undertaking:
we don’t have the details of the GP so if we found something we would have to contact them [the participant] and we’d have to ask them for the GP contact and in that case they could say no, we don’t want to, so it’s up to them to decide really, but we can’t actually say anything directly to them what we’ve found or what we think there might be because we don’t know, ’cos the GP then will have to send them to proper scans to determine the exact problem, ’cos our scans are obviously not designed for any kind of medical diagnosis are they? So I suppose they’ve still got the option to say no. (F2, Group 2)
It is also worth noting at this point the lack of certitude of the scientists I spoke with about where directives around ethical practice came from, and what regulatory force these had. F1 (Group 1) and F2 (Group 2) above, for instance, spoke about how certain processes were ‘just required’ or how they ‘have to’ do particular things to be ‘ethical’. This underscores the proliferation and heterogeneity of regulation the editors of this volume note in their Introduction, and the challenges of comprehending and negotiating it in practice by busy and already stretched professionals.
31.5 Discussion
The ethical aspects of science often require discursive and institutional work to become recognised as such, and managed thereafter. In other words, for an issue to be regarded as specifically ethical, scientists and universities need to, in some sense, agree that it is; matters that ethicists, for instance, might take almost for granted as being intrinsically normative can often escape the attention of scientists themselves. After an issue has been characterised by researchers as ethical, addressing it can necessitate bureaucratic innovation, and the reorganisation of work practices (including new roles and changing responsibilities). Scientists are not always satisfied with the extent to which they are able, and enabled, to make these changes. The ethics of neuroscience, and the everyday conversations and practices that come into play to deal with them, can also have epistemic effects: ethical issues can and do shape scientists relationships with the work, research participants, and processes of knowledge-production itself.
The scientists I spoke with listed a range of issues as having ethical significance, to varying degrees. Key among these were incidental findings. The scientists also engaged in what sociologist Steven Wainwright and colleagues call ‘ethical boundary work’; i.e. they sometimes erected boundaries between scientific matters and normative concerns, but also collapsed these when equating good science with ethical science.Footnote 14 This has the effect of enabling scientists to present research they hold in high regard as being normatively valorous, while also bracketing off ethical questions they consider too administratively or philosophical challenging to deal with as being insufficiently salient to science itself to necessitate sustained engagement.
Still, though, ethics is part and parcel of scientific work and of being a scientist. Normative reflection is, to varying degrees, embedded within the practices of researchers, and can surface not only in focus group discussions but also in corridor talk and coffee room chats. This is, in part, a consequence of the considerable health-related research regulation to which scientists are subject. It is also a consequence of the fact that scientists are moral agents: people who live and act in a world with other persons, and who have an everyday sense of right and wrong. This sense is inevitably and essentially context-dependent, and it inflects their scientific practice and will be contoured in turn by this. It is these interpretations of regulation in conjunction with the mundane normativity of daily life that intertwine to constitute scientists’ ethical actions within the laboratory and beyond, and in particular that cultivate their ethical workarounds in conditions of uncertainty.
31.6 Conclusion
In this chapter I have summarised and discussed data regarding how neuroscientists construct and regard the ethical dimensions of their work, and reflected on how they negotiate health-related research regulation in practice. Where does this leave regulators? For a start, we need more sustained, empirical studies of how scientists comprehend and negotiate the ethical dimensions of their research in actual scientific work, in order to ground the development and enforcement of regulation.Footnote 15 What is already apparent, however, is that any regulation that demands actions that require sharp changes in practice, to no clear benefit to research participants, scientists, or wider society, is unlikely to invite adherence. Nor are frameworks that place demands on scientists to act in ways they consider unethical, or which place unrealistic burdens (e.g. liaising with GPs without the knowledge of research participants) on scientists that leave them anxious and afraid that they are, for instance, ‘breaking the law’ when failing to act in a practically unfeasible way.
It is important to recognise that scientists bring to bear their everyday ethical expertise to their research, and it is vital that this is worked with rather than ridden over. At the same time, it takes a particular kind of scientist to call into question the ethical basis of their research or that of close colleagues, not least given an impulse to conflate good science with ethical science. Consequently, developing regulation in close collaboration with scientists also needs the considered input of critical friends to both regulators and to life scientists (including but not limited to social scientific observers of the life sciences). This would help mitigate the possibility of the inadvertent reworking or even subverting of regulation designed to protect human subjects by well-meaning scientists who inevitably want to do good (in every sense of the word) research.
32.1 Introduction
Global health emergencies (GHEs) are situations of heightened and widespread health crisis that usually require the attention and mobilisation of actors and institutions beyond national borders. Conducting research in such contexts is both ethically imperative and requires particular ethical and regulatory scrutiny. While global health emergency research (GHER) serves a crucial function of learning how to improve care and services for individuals and communities affected by war, natural disasters or epidemics, conducting research in such settings is also challenging at various levels. Logistics are difficult, funding is elusive, risks are elevated and likely to fluctuate, social and institutional structures are particularly strained, infrastructure destroyed. GHER is diverse. It includes biomedical research, such as studies on novel vaccines and treatments, or on appropriate humanitarian and medical responses. Research might also include the development of novel public health interventions, or measures to strength public health infrastructure and capacity building. Social science and humanities research might also be warranted, in order to develop future GHE responses that better support affected individuals and populations. Standard methodologies, including those related to ethical procedures, might be particularly difficult to implement in such contexts.
The ethics of GHER relates to a variety of considerations. First are the ethical and justice-based justifications to conduct research at all in conditions of emergency. Second, the ethics of GHER considers whether research is designed and implemented in an ethically robust manner. Finally, ethical issues also relate to questions arising in the course of carrying out research studies. GHER is characterised by a heterogeneity (of risk, nature, contexts, urgency, scope) which itself gives rise to various kinds of ethical implications:Footnote 1 why research is done, who conducts research, where and when it is conducted, what kind of research is done and how. It is therefore difficult to fully capture the range of ethical considerations that arise, let alone provide a one-size-fits-all solution to such questions. Using illustrations drawn from research projects conducted during GHEs, we discuss key ethical and governance concerns arising in GHER – beyond those traditionally associated with biomedical research – and explore the future direction of oversight for GHER. After setting out the complex context of GHER, we illustrate the various ethical issues associated with justifying research, as well as considerations related to context, social value and engagement with the affected communities. Finally, we explore some of the new orientations and lenses in the governance of GHER through recent guidelines and emerging practices.
32.2 The Context of Global Health Emergency Research
GHEs are large-scale crises that affect health and that are of global concern (epidemics, pandemics, as well as health-related crises arising from conflicts, natural disasters or forced displacement). They are characterised by various kinds of urgency, driven by the need to rapidly and appropriately respond to the needs of affected populations. However, effective responses, treatments or preventative measures require solid evidence bases, and the establishment of such knowledge is heavily dependent on findings from research (including biomedical research) carried out in contexts of crises.Footnote 2 As the Council for International Organizations of Medical Sciences (CIOMS) guidelines point out: ‘disasters can be difficult to prevent and the evidence base for effectively preventing or mitigating their public health impact is limited’.Footnote 3 Generating relevant knowledge in emergencies is therefore necessary to enhance the care of individuals and communities, for example through treatments, vaccines or improved palliative care. Research can also consolidate preparedness for public health and humanitarian responses (including triage protocols) and contribute to capacity building (for example, by training healthcare professionals) in order to strengthen health systems in the long run. Ethical consideration and regulation must therefore adapt to both immediate and urgent issues, as well as contribute to developing sustainable and long-term processes and practices.
Adding to this is the fact that responses to GHEs involve a variety of actors: humanitarian responders, health professionals, public health officials, researchers, media, state officials, armed forces, national governments and international organisations. Actors conducting both humanitarian work and research can encounter particular ethical challenges, given the very different motivations behind response and research. Such dual roles might, at times, pull in different directions and therefore warrant added ethical scrutiny and awareness, even where such actors might be best placed to deliver both aims, given their presence and knowledge of the context, and especially if they have existing relationships with affected communities.Footnote 4 Medical and humanitarian responses to GHEs are difficult contexts for ethical deliberation – for ethics review and those involved in research governance – where various kinds of motivations and values collide, potentially giving rise to conflicting values and aims, or to incompatible lines of accountabilityFootnote 5 (for example, towards humanitarian versus research organisations or towards national authorities versus international organisations).
Given the high level of contextual and temporal complexity, and the heightened vulnerability to harm of those affected by GHEs, there is a broad consensus within the ethics literature that research carried out in such contexts requires both a higher level of justification and careful ongoing ethical scrutiny. Attention to vulnerability is, of course, not new to research ethics. It has catalysed many developments in the field, such as the establishment of frameworks, principles, and rules aiming to ensure that participants are not at risk of additional harm, and that their interests are not sacrificed to the needs and goals of research. It has also been a struggle in research governance, however, to find appropriate regulatory measures and measures of oversight that are not overly protectionist; ones that do not stereotype and silence individuals and groups but ensure that their interests and well-being are protected. The relationship between research and vulnerability becomes particularly knotty in contexts of emergency. How should we best attend to vulnerability when it is pervasive?Footnote 6 On the one hand, all participants are in a heightened context of vulnerability when compared to populations under ordinary circumstances. On the other hand, those individuals who suffer from systematic and structural inequality, disadvantage and marginalisation, will also see their potential vulnerabilities exacerbated in conditions of public health and humanitarian emergencies. The presence of these multiple sources and forms of vulnerability adds to the difficulty in determining whether research and its design are ethically justified.
32.3 Justifying Research: Why, Where and When?
While research is rightly considered an integral part of humanitarian and public health responses to GHEs,Footnote 7 and while there may indeed, as the WHO suggests, be an ‘ethical obligation to learn as much as possible, as quickly as possible’,Footnote 8 research must be ethically justified on various fronts. At a minimum, GHER must not impede current humanitarian and public health responses, even as it is deployed with the aim of improving future responses. Nor should it drain existing resource and skills. Additionally, the social value of such research derives from its relevance to the particular context and the crisis at hand.Footnote 9 Decisions regarding location, recruitment of participants, as well as study design (including risk–benefit calculations) must ensure that scientific and social value are not compromisedFootnote 10 in the process. The Working Group on Disaster Research Ethics (WGDRE), formed in response to the 2004 Indian Ocean tsunami, has argued that while ethical research can be conducted in contexts of emergencies, such research must respond to local needs and priorities, in order avoid being opportunistic.Footnote 11 Similar considerations were reiterated during the 2014–2016 Ebola outbreak. Concern was expressed that ‘some clinical sites could be perversely incentivized to establish research collaborations based on resources promised, political pressure or simply the powers of persuasion of prospective researchers – rather than a careful evaluation of the merits of the science or the potential benefit for patients. Some decision-makers at clinical sites may not have the expertise to evaluate the scientific merits of the research being proposed’.Footnote 12 Such observation reflects considerations that have been identified in a range of GHE settings.
The question of social value is not only related to the ultimate or broad aims of research. Specific research questions can only be justified if these cannot be investigated in non-crisis conditions,Footnote 13 and as specified above, where the answers to such questions is expected to be of benefit to the community in question – or to relevantly similar communities, be it during the current emergency, or in the future. Relatedly, research should be conducted within settings that are most likely to benefit from the generation of such knowledge, perhaps because they are the site of cyclical disasters or endemic outbreaks that frequently disrupt social structures. Given the heightened precarity of GHE contexts, the risk of exposing study participants to additional harm is particularly salient, and such potential risk must therefore be systematically justified. If considerations of social value are key, these need to extend to priority-setting in GHER. Yet, the funding and development of GHER is not immune to how research priority is set globally. Consequently, this divergence (between the kind of research that is currently being funded and developed, and the research that might be required in specific contexts of crisis) will present particular governance challenges at the local, national, and global levels. Stakeholders from contexts of scarce resources have warned that priority-setting in GHE might mirror broader global research agendas, where the health concerns and needs of low- and middle-income countries (LMICs) are systematically given lower priority.Footnote 14 The global research agenda is not generally directed by the specific needs arising from crises (especially crisis in resource-poor contexts), and yet the less well-funded and less resilient health systems of LMICs frequently bear the brunt and severity of crises. The ethical challenges associated with conducting research in contexts of crisis therefore are consistently present at all levels, from the broader global research agenda, to the choice of context and participants, from how research is designed and conducted, to how research data and findings are used and shared.
32.4 Justifying Research: What and How?
GHER includes a wide range of activities, from minimally invasive collection of dataFootnote 15 and systems research aimed at strengthening health infrastructure,Footnote 16 to more controversial procedures including testing of experimental therapeutics and vaccines.Footnote 17 A common issue of GHER, one that has arisen prominently during recent epidemics and infectious disease outbreaks, is the challenge to long-established standards and trials designs, in particular to what is known as the ‘gold standard’: randomised, double-blind clinical trials as the standard developmental pathway for new drugs and interventions. The ethical intuitions and debates often pull in different direction. As discussed earlier in the chapter, the justification for conducting research in crises must be ethically robust, as must research design and deployment. Equally, in the context of the COVID-19 pandemic, a strong argument has been made for the need to ensure methodologically rigorous research design and not to accept lower scientific standards as a form of ‘pandemic research exceptionalism’.Footnote 18 At the time of writing, human challenge trials – the intentional infection of research participants with the virus – proposed as a way to accelerate the development of a vaccine for the novel coronavirus, remain ethically and scientifically controversial. While some commentators have suggested that this may be a rapid and necessary route to vaccine development,Footnote 19 others have argued that the criteria for ethical justification of human challenge studies, including social value and fair participation selection, are not likely to be met.Footnote 20
Such tensions are particularly heightened in contexts of high infectious rates, morbidity and mortality. During the 2014–2016 Ebola outbreak in West Africa, several unregistered interventions were approved for use as investigational therapeutics. Importantly, while these were approved for emergency use, they were to be deployed under the MEURI scheme: ‘monitored emergency use of unregistered and experimental interventions (MEURI)’,Footnote 21 that is, through a process where results of an intervention’s use are shared with the scientific and medical community, and not under the medical label of ‘compassionate use’. This approach allows clinical data to be compiled and thus contributes to the process of generating generalisable evidence. The deployment of experimental drugs was once again considered – alongside the deployment of experimental vaccines – early during the 2018 Ebola outbreak in the Democratic Republic of the Congo.Footnote 22 This time, regulatory and ethical frameworks were in place to approve access to five investigational therapeutics under the MEURI scheme,Footnote 23 two of which have since shown promise during the clinical trials conducted in 2018. The first Ebola vaccine, approved in 2019, was tested through ring vaccine trials first conducted during the 2014–2016 West African outbreak. Methods and study designs need to be aligned with the needs of the humanitarian response, and yet it is not an easy task to translate the values of humanitarian responses onto research design. How experimental interventions should be deployed under the MEURI scheme was heavily debated and contested by local communities, who saw these interventions as their only and last resort against the epidemic.
While success stories in GHER heavily depend on global cooperation, suitable infrastructure, and often collaboration between the public and private sector, such interventions are unlikely to succeed without the collaboration and engagement of local researchers and communities, and without establishing a relationship based on trust. Engaging with communities and establishing relationships of trust and respect are key to successful research endeavours in all contexts, but are particularly crucial where social structures have broken down and where individuals and communities are at heightened risk of harm. Community engagement, especially for endeavours not directly related to response and medical care, is also particularly challenging to implement. These challenges are most significant in sudden-onset GHE such as earthquakes,Footnote 24 if prior relationships do not exist between researchers and the communities. During the 2014–2016 Ebola outbreak, the infection and its spread caused ‘panic in the communities by the lack of credible information and playing to people’s deepest fears’.Footnote 25 Similarly, distrust arose during the subsequent outbreak in eastern DRC, a region already affected by conflict, where low trust in institutions and officials resulted in low acceptance of vaccines and a spread of the virus.Footnote 26 Similarly, in the aftermath of Hurricane Katrina there was widespread frustration and distrust of the US federal response by those engaged in civil society and community-led responses.Footnote 27 However, such contexts have also given rise to new forms solidarity and cooperation. The recent Ebola outbreaks, the aftermath of Katrina, the 2004 Indian Ocean tsunami and the Fukushima disaster have also given rise to unprecedent levels engagement and leadership by members of the affected communities.Footnote 28 Given that successful responses to GHEs are heavily dependent on trust as well as on the engagement and ownership of response activities by local communities, there is little doubt that successful endeavours in GHER will also depend on establishing close, trustworthy and respectful collaborations between researchers, responders, local NGOs, civil society and members of the affected population.
32.5 Governance and Oversight: Guidelines and Practices
The difficulty of conducting GHER is compounded by much complexity at the level of regulation, governance and oversight. Those involved in research in these contexts are working in and around various ethical frameworks including humanitarian ethics, medical ethics, public health ethics and research ethics. Each framework has traditionally been developed with very different actors, values and interests in mind. Navigating these might result in various kinds of conflicts or dissonance, and at the very least make GHER a particularly challenging endeavour. Such concerns are then compounded by regulatory complexity, including existing national laws and guidelines, international regulations and guidance produced by different international bodies (for example, the International Health Regulations 2005 by the WHO and Good Clinical Practice by the National Institute for Health Research in the United Kingdom), all of which are engaged in a context of urgency, shifting timelines and rapidly evolving background conditions. Two recent pieces of guidance are worth highlighting in this context. The first are the revised CIOMS guidelines, published in 2016, which have a newly added entry (Guideline 20) specifically addressing GHER. The CIOMS guidelines recognise that ‘[d]isasters unfold quickly and study designs need to be chosen so that studies will yield meaningful data in a rapidly evolving situation. Study designs must be feasible in a disaster situation but still appropriate to ensure the study’s scientific validity’.Footnote 29 While reaffirming the cornerstones of research ethics, Guideline 20 also refers to the need to ensure equitable distribution of risks and benefits; the importance of community engagement; the need for flexibility and expediency in oversight while providing due scrutiny; and the need to ensure the validity of informed consent obtained under conditions of duress. CIOMS also responds to the need for flexible and alternative study designs and suggests that GHER studies should ideally be planned ahead and that generic versions of protocols could be pre-reviewed prior to a disaster occurring.
Although acting at a different governance level to CIOMS, the Nuffield Council on Bioethics has also recently published a report on GHER,Footnote 30 engaging with emerging ethical issues and echoing the central questions and values reflected in current discussions and regulatory frameworks. Reflecting on the lessons learned from various GHEs over the last couple of decades, the report encourages the development of an ethical compass for GHER that focuses on respect, reducing suffering, and fairness.Footnote 31 The report is notable for recommending that GHER endeavours attend not just to whose needs are being met (that is, questions of social value and responsiveness) but also to who has been involved in defining those needs. In other words, the report reminds us that beyond principles and values guiding study design and implementation, ethical GHER requires attention to a wider ethics ecosystem that includes all stakeholders, and that upholding fairness is not only a feature of recruitment or access to the benefits of research, but must also exist in collaborative practices with local researchers, authorities and communities.
All guidelines and regulations need interpretation on the ground,Footnote 32 at various levels of governance, as well as by researcher themselves. The last couple of decades have seen a variety of innovative and adaptive practices being developed for GHER, including the establishment of research ethics committees specifically associated with humanitarian organisations. Similarly, many research ethics committees that are tasked with reviewing GHER protocols have adapted their standard procedures in line with the urgency and developing context of GHEs.Footnote 33 Such strategies include convening ad-hoc meetings, prioritising these protocols in the queue for review, waiving deadlines, having advisors pre-review protocols and conducting reviews by teleconference.Footnote 34 Another approach can be found in the development of pre-approved, or pre-reviewed protocol templates, which allow research ethics committees to conduct an initial review of proposed research ahead of a crisis occurring, or to review generic policies for the transfer of samples and data. Following their experience in reviewing GHER protocols during the 2014–2016 Ebola outbreak, members of the World Health Organization Ethics Review Committee recommended the formation of a joint research ethics committee for future GHEs.Footnote 35 A need for greater involvement and interaction between ethics committees and researchers has been indicated by various commentators, pointing to the need for ethical review to be an ongoing and iterative process. One such model for critical and ongoing engagement, entitled ‘real-time responsiveness’,Footnote 36 proposes a more dynamic approach to ethics oversight for GHER, including more engagement between researchers, research ethics committees, and advisors once the research is underway. An iterative review process has been proposed for research in ordinary contextsFootnote 37 but is particularly relevant to GHER, given the urgency and rapidly changing context.
It is important to also consider how to promote and sustain the ethical capacities of researchers in humanitarian settings. Such capacities include the following, which have been linked to ethical humanitarian action:Footnote 38 foresighting (the ability to anticipate potential for harms), attentiveness (especially for the social and relational dynamics of particular GHE contexts), and responsiveness to the often-shifting features of a crisis, and their implications for the conduct of the research. These capacities point to the role of virtues, in addition to guidelines and principles, in the context of GHER. As highlighted by O’Mathuna, humanitarian research calls for virtuous action on the part of researchers in crisis settings ‘to ensure that researchers do what they believe is ethically right and resist what is unethical’.Footnote 39 Ethics therefore is not merely a feature of approval or bureaucratic procedure. It must be actively engaged with at various levels and also by all involved, including by researchers themselves.
32.6 New Orientations and Lenses
As outlined above, GHEs present a distinctive context for the conduct of research. Tailored ethics guidance for GHER has been developed by various bodies, and it has been acknowledged that GHER can be a challenging fit for standard models to ethics oversight and review. As a result, greater flexibility in review procedures has been endorsed, while emphasising the importance of upholding rigorous appraisal of protocol. Particular attention has been given to the proportionality of ethical scrutiny to the ethical concerns (risk of harm, issues of equity, situations of vulnerability) associated with particular studies. Novel approaches, such as the preparation and pre-review of generic protocols, have also been incorporated into more recent guidance documents (e.g. CIOMS) and implemented by research ethics committees associated with humanitarian organisations.Footnote 40 These innovations reflect the importance of temporal sensitivity in GHER and in its review. As well as promoting timely review processes for urgent protocols, scrutiny is also needed to identify research that does not need to be conducted in an acute crisis and whose initiation ought to be delayed.
Discussions about GHER, and on disaster risk reduction more broadly, also point to the importance of preparedness and anticipation. Sudden onset events and crises often require quick response and reaction. Nonetheless, there are many opportunities to lay advance groundwork for research and also for research ethics oversight. In this sense, pre-review of protocols, careful preparation of standard procedures, and even research ethics committees undertaking their own planning procedures for reviewing GHER, are all warranted. It also suggests that while methodological innovation and adaptive designs may be required, methodological standards should be respected in crisis research and can be promoted with more planning and preparation.
32.7 Conclusion
Research conducted in GHEs present a particularly difficult context in terms of governance. While each kind of emergency presents its own particular challenge, there are recurring patterns, characterised by urgency in terms of injury and death, extreme temporal constraints, and uncertainty in terms of development and outcome. Research endeavours have to be ushered through a plethora of regulation at various levels, not all of which have been developed with GHER in mind. Several sectors are necessarily involved: humanitarian, medical, public health, and political to name just a few. Conducting research in these contexts is necessary, however, in order to contribute to a robust evidence-base for future emergencies. Ethical considerations are crucial in the implementation and interpretation of guidance, and in rigorously evaluating justification for research. Governance must find a balance between the protection of research participants, who find themselves in particular circumstances of precarity, and the need for flexibility, preparedness, and responsiveness as emergencies unfold. Novel ethical orientations suggest the need, at times, to rethink established procedures, such as one-off ethics approval, or gold standard clinical trials, as well as to establish novel ethical procedures and practice, such as specially trained ethics committees, and pre-approval of research protocols. However, the ethics of such research also suggest that time, risk and uncertainty should not work against key ethical considerations relating to social value, fairness in recruitment or against meaningful and ongoing engagement with the community in all phases of response and research. A dynamic approach to the governance of GHER will also require supporting the ability of researchers, ethics committees and those governing research to engage with and act according to the ethical values at stake.
33.1 Introduction
Research in the field of regenerative medicine, especially that which uses cells and tissues as therapeutic agents, has given rise to new products called ‘advanced therapies’ or advanced therapeutic medicinal products (ATMPs). These cutting-edge advances in biomedical research have generated new areas for research at both an academic and industrial level and have posed new challenges for existing regulatory regimes applicable to therapeutic products. The leading domestic health regulatory agencies in the world, such as the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), have regulated therapeutic tissues and cells as biological medicines and are currently making efforts to establish a harmonised regulatory system that facilitates the process of approval and implementation of clinical trials.
In the mid-2000s, the Argentine Republic did not have any regulations governing ATMPs, and governance approaches to them were weak and diverse. Although the process of designing a governance framework posed significant challenges, Argentina started to develop a regulatory framework in 2007. After more than ten years of work, this objective was achieved thanks to local efforts and the support of academic institutions and regulatory agencies from countries with more mature regulatory frameworks. In 2019, however, Argentina was leading in the creation of harmonised regulatory frameworks in Latin America.
In this chapter I will show how the framework was developed from a position of state non-intervention to the implementation of a governance framework that includes hard and soft law. I will identify the main objectives that drove this process, the role of international academic and regulatory collaborations, milestones and critical aspects of the construction of normative standards and the ultimate governance framework, and the lessons learned, in order to be able to transfer them to other jurisdictions.
33.2 The Evolution of Regulation of Biotechnology in Argentina: Agricultural Strength and Human Health Fragmentation
Since its advent in the middle of the 1990s, modern biotechnology has represented an opportunity for emerging economies to build capacity alongside high-income countries, thereby blurring the developed/developing divide in some areas (i.e. it represents a ‘leapfrog’ technology similar to mobile phones). For this to occur, and for maximum benefit to be realised, an innovation-friendly environment had to be fostered. Such an environment does not abdicate moral limits or public oversight but is characterised by regulatory clarity and flexibility.Footnote 1 The development of biotechnology in the agricultural sector in Argentina is an example of this. Although it had not been a technology-producing country, Argentina faced a series of favourable conditions that allowed the rapid adoption of genetically modified crops.Footnote 2 At the same time, significant institutional decisions were made, especially with regard to biosecurity regulations, with the creation of the National Commission for Agricultural Biotechnology (CONABIA) in 1991.Footnote 3 These elements, together with the fact that Argentina has 26 million hectares of arable land, made the potential application of these technologies in Argentina – and outside the countries of origin of the technology, especially the USA – possible. This transformed Argentina into an exceptional ‘landing platform’ for the rapid adoption of these biotechnological developments. The massive incorporation of Roundup Ready (RR) soybean is explained by the reduction of its production costs and by the expansion of arable land. This positioned Argentina as the world’s leading exporter of genetically modified soybean and its derivatives.Footnote 4
The development of biotechologies directed at human health was more complex and uncertain, and unfolded in a more contested and dynamic setting, which resulted in it evolving at a much slower pace, with regulation also developing more slowly, involving a greater number of stakeholders. This context, as will be demonstrated below, offered opportunities for developing new processual mechanisms aimed at soliciting and developing the views and concerns of diverse stakeholders.Footnote 5
33.3 First Steps in the Creation of A Governance Framework for Cell Therapies
The direct antecedent of stem cells for therapeutic purposes is the hematopoietic progenitor cell (HPC), which has been extracted from bone marrow to treat blood diseases for more than fifty years and is considered an ‘established practice’.Footnote 6 HPC transplantation is regulated by the Transplant Act 1993, and its regulatory authority is the National Institute for Transplantation (INCUCAI), which adopted regulations governing certain technical and procedural aspects of this practice in 1993 and 2007.Footnote 7 This explains the rationale by which many countries – including Argentina – started regulating cell therapies under the a transplantation legal framework. However, Argentina’s active pursuit of regenerative medicine research aimed at developing stem cell solutions to health problems required something more, and despite its efforts to promote this research, there were no regulations or studies related to ethics and the law in this field.Footnote 8
In 2007, the Advisory Commission on Regenerative Medicine and Cellular Therapies (Commission) was created under the National Agency of Promotion of Science and Technology (ANPCYT) and the Office of the Secretary of Science and Technology was transformed into the Ministry of Science, Technology and Productive Innovation (MOST) in 2008.Footnote 9 The Commission comprised Argentinian experts in policy, regulation, science and ethics, and was set up initially with the objective of advising the ANPCYT in granting funds for research projects in regenerative medicine.Footnote 10 However, faced with a legal gap and the increasing offer of unproven stem cells treatments to patients, this new body became the primary conduit for identifying policy needs around stem cell research and its regulation, including how existing regulatory institutions in Argentina such INCUCAI and the National Administration of Drugs, Food and Medical Technology (ANMAT), would be implicated.
The Commission promoted interactions with a wide range of stakeholders from the public and private sectors, the aim being to raise awareness and interest regarding the necessity of forging a governance framework for research and products approval in the field of regenerative medicine. In pursuing this ambitious objective, the Commission wanted to benefit from lessons from other regions or countries.Footnote 11 In 2007, it signed a Collaborative Agreement between the Argentine Secretary of Science and Technology and the University of Edinburgh’s AHRC SCRIPT Centre (the Arts and Humanities Research Council Research Centre for Studies in Intellectual Property & Technology Law).Footnote 12 This collaboration, addressed in greater detail below, extended to 2019 and was a key factor in the construction of the regulatory framework for ATMPs in Argentina.
33.4 From Transplants to Medicines
In 2007, in an attempt to halt the delivery of untested stem cell–based treatments that were not captured by the current regulatory regime applicable to HPCs, the Ministry of Health issued Resolution MS 610/2007, under the Transplant Act 1993. The 610/2007 Resolution states ‘activities related to the use of human cells for subsequent implantation in humans fall within the purview of the Transplant Authority (INCUCAI)’.Footnote 13 This Resolution formally recognises INCUCAI’s competence to deal with activities involving the implantation of cellular material into humans. However, it is very brief and does not specify which type of cell it applies to, nor any specific procedures (kind of manipulation) to which cells it can be subject, an issue that is, in any event, beyond the scope of the Act.Footnote 14 This Resolution is supplemented by Regulatory Decree 512/95, which, in Article 2, states that ‘any practice that involves implanting of human cells that does not fall within HPC transplantation is radically new and therefore is considered as experimental practice until it is demonstrated that it is safe and effective’.
To start a new experimental practice, researchers or medical practitioners must seek prior authorisation from INCUCAI by submitting a research protocol signed by the medical professional or team leader who will conduct the investigation, complying with all requirements of the regulations, including the provision of written informed consent signed by the research subjects, who must not be charged any monies to participate in the procedure. In May 2012, INCUCAI issued Resolution 119/2012, a technical standard to establish requirements and procedures for the preparation of cellular products. Substantively, it is in harmony with international standards of good laboratory and manufacturing practices governing this matter. However, very few protocols have been filed with INCUCAI since 2007, and the delivery of unproven stem cell treatments continued to grow, a situation that exposed INCUCAI’s difficulties in policing the field and reversing the growth of health scams.Footnote 15
Another attempt to regulate was the imposition of obligations to register some cellular-based products as biological medicaments. The ANMAT issued two regulations under the Medicines Act 1964:Footnote 16 Dispositions 7075/2011 and 7729/2011. These define ‘biological medicinal products’ as ‘products derived from living organisms like cells or tissues’, a definition that captures stem cell preparations, and they are categorised in both Dispositions as ATMPs. Cellular-based or biological medicaments must be registered with the National Drugs Registry (REM), and approval for marketing, use and application in humans falls within the scope of the Medicines Act and its implementing regulations. Cellular medicine manufacturers must register at the ANMAT as manufacturing establishments, and they must request product registration before marketing or commercialising their products.
Importantly, the ANMAT regulations do not apply in cases where ATMPs are manufactured entirely by an authorised medical centre, to be used exclusively in that centre. In that case, the local health authority maintains the right for approval. Like all regulations issued by the national Ministry of Health under the Medicines Act, the provisions of Dispositions 7075/2011 and 7729/2011 apply only in areas of national jurisdiction, in cases where interprovincial transit is implicated, or where ATMPs are imported or exported. In short, the Medicines Act is not applicable so long as the product does not leave the geographic jurisdiction of the province. And within the provinces, regulatory solutions were inconsistent; for example, in one they were regulated as transplants and in another as medicines.
As alluded to above, while imperfect regulatory attempts were pursued, the offer of unproven treatments with cells continued to grow. As in many countries, it was usual to find publications in the media reporting the – almost magical – healing power of stem cells, with little or no supporting evidence, and such claims have great impact on public opinion and on the decisions of individual patients. Moreover, the professionals offering these ‘treatments’ took refuge in the independence of medical practice and the autonomy that it offers, but it seems clear that some of the practices reported were directly contrary to established professional ethics, and they threatened the safety of patients receiving the treatments.Footnote 17 In addition to the safety issues, given that these were experimental therapies (that have not been proven to be safe and effective), health insurers have stated their refusal to cover them (and one can anticipate the same antipathy to indemnifying patients who chose to accept them and are injured by them). Indeed, patients filed judicial actions demanding payment of such treatments by both health insurance institutions and the national and provincial state (as guarantors of public health).Footnote 18
The regulatory regime – by virtue of its silence, its imperfect application to regenerative medicine and concomitant practices, and its shared authority between national and provincial bodies – permitted unethical practices to continue, and decisions of some courts have mandated the transfer of funds from the state (i.e. the social welfare system) to the medical centres offering these experimental cellular therapies. In short, the regime established a poorly coordinated regulatory patchwork that was proving to be insufficient to uniformly regulate regenerative medicine – and stem cell – research and its subsequent translation into clinical practice and treatments as ATMPs. Moreover, attempts by regulatory authorities to stop these practices, though valiant, also proved ineffective.
33.5 Key Drivers for the Construction of the Governance FrameworkThe landscape described above endured until 2017, when the Interministerial Commission for Research and Medicaments of Advanced Therapies (Interminsterial Commission) was created. This new body, jointly founded by the Ministry of Science and Technology (MOST) and the Ministry of Health (MOH), which also oversaw INCUCAI and ANMAT, was set up to:
1. Advise the MOST and MOH in the subjects of their competence.
2. Review current regulations on research, development and approval of products in order to propose and raise for the approval of the competent authority, a comprehensive and updated regulatory framework for advanced therapies.
3. Promote dissemination within the scientific community and the population more broadly on the state of the art relating to ATMPs.
Led by a coordinator appointed by the MOST, the Interministerial Commission focused its efforts first on adopting a new regulatory framework that was harmonised with the EMA and FDA, and that recognised the strengths of local institutions in fulfilling its objectives. The strategy to create the governance framework was centred in three levels of norms: federal law, regulation and soft law. The proposal was accepted by both Ministries and efforts were made to put in force, first, the regulatory framework and soft law in order to stop the delivery of unproven treatments. These elements would then be in force while a bill of law was sent to the National Parliament.
On September 2018, the new regulatory framework was issued through ANMAT Disposition 179/2018 and an amendment to the Transplant Law giving competence to INCUCAI to deal with hematopoietic progenitor cells (CPH) in their different collection modalities, the cells, tissues and/or starting materials that originate, compose or form part of devices, medical products and medicines, as well as cells of human origin of autologous use used in the same therapeutic procedure with minimal manipulation and to perform the same function of origin.The Interministerial Commission benefitted immensely from the work of the original Commission, which was formed in 2007 and which collaborated across technical fields and jurisdictional borders for a decade, moving Argentina from a position of no regulation for ATMPs, to one of imperfect regulation (limited by the conditions of the time). The original Commission undertook the following:
1. Undertaking studies on the legislation of Argentina and other countries to better understand how these technical developments might be shaped by law (i.e. through transplant, medicines or a sui generis regime).
2. Proposing a governance framework adapted to the Argentine legal and cultural context, harmonised with European and US normative frameworks.
3. Communicating this initiative to all interested sectors and managing complex relationships to promote debate in society, and then translate learnings from that debate into a normative/governance plan.Footnote 19
The work of the Commission was advanced through key collaborations; first and foremost with the University of Edinburgh (2007–2019). This collaboration had several strands and an active institutional relationship.Footnote 20
Other collaborations involved the Spanish Agency for Medicaments, the Argentine judiciaryFootnote 21 and the creation of the Patient Network for Advanced Therapies (APTA Network) to provide patients with accurate information about advances in science and their translation into healthcare applications. All this was accompanied by interactions with a range of medical societies in order to establish a scientific position in different areas of medicine against the offer of unproven treatments.Footnote 22
33.6 Current Legal/Regulatory FrameworkThe current legal framework in force and proposed by the Interministerial Commission is the result of a collaboration work focused on identifying the different processes involved in research and approval of ATMPs and set up an effective articulation between its parts. It consists of laws and regulations and establishes a coordinated intervention of both authorities, ANMAT and INCUCAI, in the process of approval of research and products. The system operates as follows:
1. Medicaments Law establishes ANMAT with competence to regulate the scientific and technical requirements at national level applicable to clinical pharmacology studies, the authorisation of manufacturing establishments, production, registration and authorisation of commercialisation, and surveillance of Advanced Therapy Medicaments.Footnote 23
2. Transplants Law establishes INCUCAI with competencies to regulate the stages of donation, obtaining, and control of cells and/or tissues from human beings when they are used as starting material in the production of an ATMP.Footnote 24
3. Manufacturing establishments that produce ATMP must be authorised by ANMAT.
4. When an ATMP is developed and used within the same facility, the donation, procurement, production and control stages are ruled under the INCUCAI regulations. INCUCAI must request the intervention of ANMAT for the evaluation and technical assistance in the stages of the manufacturing process, in order to guarantee that they meet the same standards as the rest of the Advanced Therapy Medications.
5. Cell preparations containing cells of human origin with minimal manipulation are not considered medications and will be under the INCUCAI regulations.
Finally, the newly amended Argentine Civil Commercial Code 2015 establishes the ethico-legal requirements for clinical trials. Specifically, Article 58 states that investigations in human beings through interventions, such as treatments, preventative methods, and diagnostic or predictive tests, whose efficacy or safety are not scientifically proven, can only be carried out if specific requirements are met relating to consent, privacy, and a protocol that has received ethical approval, etc.
Laws and regulations above described combine to form a reasonably comprehensive normative system applicable to research, market access approval and pharmacovigilance for ATMPs, harmonised with international standards.
Importantly, and interestingly, though many stakeholders in the period 2011–2017 reported a preference for command-and-control models of regulation (i.e. state-led, top-down approaches)Footnote 25 and many elements of the prevailing regime do now reflect this, the framework itself emerged through a bottom-up, iterative process, which sought to connect abstract concepts and models of governance with actual experience and the national social and legal normative culture. While the Commission, together with a key circle of actors, shaped the process, a wide variety of stakeholders from academia, regulatory bodies, medical societies, researchers, patients and social media cooperated to advance the field. Their efforts were very much an example, imperfectly realised, of legal foresighting.Footnote 26
To complete the normative framework currently in force, it would be advisable to maintain a soft law design to provide support to regulatory bodies to maintain updated proceedings as well as the flexibility to accompany the advances of science. Finally, it would be prudent to count on a federal law that regulates clinical research, and fundamentally to provide the regulatory authority a robust policy power to stop the advance of eventual unproven treatments across the country as a legal warranty for the protection of patients and research human subjects.
33.7 Conclusion
The design and adoption of a governance framework for regenerative medicine research and ATMPs in the Argentine Republic has been a decade-long undertaking that has relied on the strengths and commitment of key institutions like MOST, MOH, ANMAT and INCUCAI and on the ongoing engagement with a range of stakeholders.
To achieve the current normative framework, it was necessary to amend existing legal instruments and issue new laws and regulations.
The new framework exemplifies a more joined-up regime that is harmonised with other important regulatory agencies like EMA and the FDA. This is important because the development of ATMPs is increasingly global in nature, and it is expected that Argentine regulators will work closely with international partners in multiple ways to support safe and effective innovation that will benefit a wider segment of the population, including, importantly, traditionally marginalised groups.
This section of the volume offers a contemporary selection of examples of where existing models of law and regulation are pushed to their limits. Novel challenges are arising that require reflection on appropriate and adaptive regulatory responses, especially where ethical concerns raise questions about the acceptability of the research itself. The focus in this section is on how these examples create disturbances within regulatory approaches and paradigms, and how these remain a stubborn problem if extant approaches are left untouched. The reference to ‘responsive’ here highlights the temporally limited nature of law and regulation, and the reflexivity and adaptability that is required by these novel challenges to health research regulation. The choice of examples is illustrative of existing and novel research contexts where the concepts, tools, and mechanisms discussed in Part I come into play.
The first part of this section speaks to nascent challenges in the field of reproductive technologies, an area of health research often characterised by its disruptiveness to particular legal and social norms. The first two contributions to this theme focus on human gene editing, a field of research that erupted in global public ethical and policy debates when the live birth of twin girls, Lulu and Nana, whose genes had been edited in vitro, was announced by biophysician He Jiankui in 2018. For Isasi (Chapter 34), recent crises such as this provide opportunity to transform not only global policy on human germline gene editing, but collective behaviours in this field. In this chapter, she analyses the commonalities and divergences in international normative systems that regulate gene editing. For Isasi, a policy system that meaningfully engages global stakeholders can only be completely effective if we achieve both societal consensus and governance at local and global levels. For Chan (Chapter 35), the existence of multiple parallel discourses highlighted by Isasi can be used to facilitate broader representation of views within any policy solution. Chan considers the wider lessons that the regulatory challenges of human germline gene editing pose for the future of health research regulations. She posits that human germline gene editing is a ‘contemporary global regulatory experiment-in progress’, which we can use to revisit current regulatory frameworks governing contentious science and innovation.
For the authors of the next two chapters, the order upon which existing regulatory approaches were built is being upended by new, dynamic sociotechnical developments that call into question the boundaries that law and regulation has traditionally relied upon. First, Hinterberger and Bea (Chapter 36) challenge us to consider how we might reconsider normative regulatory boundaries in their chapter on human animal chimeras – an area of biomedical research where our normative distinctions between human and animal are becoming more blurred as research advances. Here, the authors highlight the potential of interspecies research to perturb lasting, traditional regulatory models in the field of biomedical research. Next, McMillan (Chapter 37) examines the fourteen-day limit on embryo research as a current example of an existing regulatory tool – here a legal ‘line in the sand’ – that is being pushed to its scientific limits. She argues that recent advancements in in vitro embryo research challenge us to disrupt our existing legal framework governing the processual entity that is the embryo in vitro. For McMillan, disrupting our existing regulatory paradigms in embryo research enables essential policy discussion surrounding how we can, and whether we should, implement enduring regulatory frameworks in such a rapidly changing field.
For the second part of this section, the final two chapters examine the downstream effects of health research regulation in two distinct contexts. For these authors, it is clear that innovation in research practice and its applications requires us not only to disrupt our normative regulatory frameworks and systems, but to do so in a way that meaningfully engages stakeholders (see Laurie, Introduction). Jackson (Chapter 38) challenges the sufficiency of giving patients information about the limited evidence-base behind ‘add-on’ treatments that are available in fertility clinics, as a mechanism for safely controlling their use. For Jackson, regulation of these add-ons needs to go further; she argues that these treatments should be deemed by the Human Fertilisation and Embryology Authority – the regulator of fertility clinics and research centres in the UK – as ‘unsuitable practices’. She highlights the combination of a poor evidence base for the success of these ‘add-on’ treatments and patients’ understandable enthusiasm that these might improve fertility treatment outcomes. Her contribution confronts this ‘perfect storm’ of the uncertain yet potentially harmful nature of these add-ons, which are routinely ‘oversold’ in these clinics, yet under-researched. Jackson’s offering gives us an example of an ongoing and increasing practice and process that requires us to disrupt prevailing regulatory norms. In the final chapter of this section, Harmon (Chapter 39) offers human enhancement as an example of how a regulatory regime, catalysed by disruptive research and innovation, has failed to capture key concepts. For Harmon, greater integration of humans and technology requires our regulatory frameworks to engage with ‘identity’ and ‘integrity’ more deeply, yet the current regulatory regime’s failure to do so provides a lack of support and protection for human wellbeing.
Together, these chapters provide detailed analyses of carefully chosen examples and/or contexts that instantiate the necessity for reflexivity in a field where paradigms are (and should be) disturbed by health research and innovation. It is clear that particular regulatory feedback loops within and across particular regulatory spaces need to be closed in order to deliver authentic learning back to the system and to its users (see Laurie, Introduction and Afterword). A key theme in this section is the call to approach health research regulation as a dynamic endeavour, continually constituted by scientific processes and engaged with stakeholders and beneficiaries. In doing so, this section provides grounded assessments of HRR, showing the positive potential of responsive regulation as new approaches to health research attempt to meet the demands of an ever-changing world.
34.1 Introduction
Gene editing technologies consist of a set of engineering tools, such as CRISPR/Cas9, that seek to deliberately target and modify specific DNA sequences of living cells.Footnote 1 They can enable both ex vivo and in vivo deletions and additions to DNA sequences at both somatic and germline cell levels. While technical and safety challenges prevail, particularly regarding germline applications, these technologies are touted as transformational for the promotion and improvement of health and well-being. Furthermore, their enhanced simplicity, efficiency, precision, and affordability had spurred their development. This in turn, has brought to the fore scientific and socio-political debates concerning their wide range of actual and potential applications together with their inexorable ethical implications.
The term ‘inevitable’ refers to the certainty or the unavoidability of an occurrence. Such was the worldwide response after the 2018 announcement – and later confirmationFootnote 2– of the live birth of twin girls whose genomes were edited during in vitro fertilisation procedures. While foreseeable, shock followed and ignited intense national and international debates. China was placed at the epicentre of controversy, as the ubiquitous example of inadequate governance and moral failure. Yet, as the facts of the case unfolded, it became clear that the global community shared a critical level of responsibility.Footnote 3 Crisis can provoke substantial changes in governance and fundamentally alter the direction of a given policy system. While the impact of the shock is still being felt, the subsequent phase of readjustment has yet to take place. A ‘window of opportunity’ is thereby present for collective assessment of its impact, for ascertaining accountability, and for enacting resulting responses. Reactionary approaches can be predicted, as demonstrated by the wave of policies in the 1990s and 2000s following the derivation of the first human embryonic stem cell line or the birth of ‘Dolly’ the cloned mammal. Indeed, the ‘embryo-centric’ approach that characterised these past debates is still present.Footnote 4 Additionally, the globalisation phenomenon has permeated the genomics field, reshuffling the domain of debate and action from the national to the international. A case in point are the past International Gene Editing Summits aimed at fostering global dialogue.Footnote 5
So far, human gene editing (HGE) has stimulated a new wave of policy by an extensive range of national and international actors (e.g. governments, professional organisations, funding agencies, etc.). This chapter outlines some of the socio-ethical issues raised by HGE technologies, with focus on human germline interventions (HGI), and addresses a variety of policy frameworks. It further analyses commonalities as well as divergences in approaches traversing a continuum of normative models.
34.2 Navigating Normative Systems for HGE
Across jurisdictions, the regulation of genomics research has generally followed a linear path combining ‘soft’ and ‘hard’ approaches that widely consider governance as a ‘domestic matter’.Footnote 6 Driven by scientific advances and changes in societal attitudes that resulted in greater technological uptake, genomics has increasingly become streamlined. This is reflected in the departure from the exceptionalist regulation of somatic gene therapy, now ruled by the general biomedical research framework, or in the increasing acceptance of reproductive technologies, where pre-implantation genetic diagnosis is no longer considered as an experimental treatment.
Normative systems cluster a broad range of rules or principles governing and evaluating human behaviour, thereby establishing boundaries between what should be considered acceptable or indefensible actions. They are influenced by local historical, socio-cultural, political and economic factors. Yet, international factors are not without effect. These systems are enacted by a recognised legitimate authority and unified by their purpose, such as the protection of a common good. Often, they encompass set criteria for imposing punitive consequences in the form of civil and criminal sanctions, or by moral ones, in the form of social condemnation for deviations. The boundaries normative systems impose are sometimes set arbitrarily, while in others, these divisions are systematically designed. Thus, they either create invisible or discernible ethical thresholds by making explicit the principles and values underpinning them.
At the same time, normative systems are often classified by their coercive or binding nature, as exemplified in the binary distinction between ‘soft’ and ‘hard’ law. While this categorisation is somewhat useful, it is important to note that ‘hard’ and ‘soft’ laws are not necessarily binary; rather, they often act as mutually reinforcing or complementary instruments. The term ‘soft law’ refers to policies that are not legally binding or are of voluntary compliance, such as those emanating from self-regulatory bodies (e.g. professional guidelines, codes of conduct) or by international agencies (e.g. declarations) without formal empowered mechanisms to enforce compliance, including sanctions. In turn, ‘hard law’ denotes policies that encompass legally enforceable obligations, such regulations. They are of binding nature to the parties involved and can be coercively enforced by an appropriate authority (e.g. courts).
In the context of HGI, normative systems have opted for either a public ordering model consisting of state-led, top-down legislative approaches, or a private ordering one, which adopts a bottom-up, self-regulatory approach. In between them, there is also a mix of complex public–private models. Normative systems are present in a continuum from permissive, to intermediate, and to restrictive, reflecting attitudes towards scientific innovation, risk tolerance and considerations for proportional protections to cherished societal values (e.g. dignity, identity, integrity, equality and other fundamental freedoms). The application of HGE technologies in general, and HGI in particular, are regulated in over forty countries by a complex set of legislation, professional guidelines, international declarations, funding policies and other instruments.Footnote 7 Given their diverse nature, these norms vary in their binding capacity (e.g. legislation vs self-regulation), their breadth and their scope (e.g. biomedical research vs clinical applications vs medical innovation). Notwithstanding all the previously stated heterogeneity in normative models, harmonised core elements are still present between them.
Resistance towards applying HGE in the early stages of development commonly rest on beliefs regarding the moral – and fortiori legal – status of the embryo, social justice and welfare concerns. Their inheritable capacity, in turn, brings to the fora issues such as intergenerational responsibility and the best interests of the future child, together with concerns regarding their population (e.g. genetic diversity), societal (e.g. discrimination, disability) and political impacts (e.g. public engagement, democracy).Footnote 8 Remaining safety and efficacy challenges are also of chief importance and often cited to invoke the application of the ‘precautionary principle’. Lastly, fears over ‘slippery slopes’ leading to problematic (e.g. non-medical or enhancements) uses and eugenic applications are at the centre of calls for restrictive normative responses.Footnote 9 However, across these systems the foundational principles underpinning a given norm and reflecting a society’s or an institution’s common vision and moral values are not always sufficiently substantiated, if at all articulated. As such, calls for caution to protect life, dignity and integrity, or against eugenic scenarios, appear as mere blanket or rhetorically arguments used for political expediency. As a consequence, the thresholds separating what is deemed as an acceptable or indefensible practice remain obscure and leave an ambiguous pathway to resolve the grey areas, mostly present in the transition towards clinical applications.
An unprecedented level of policy activity followed the rapid development of HGE. National and international scientific organisations, funding and regulatory agencies, as well advocacy groups have responded to these advances by enacting ‘soft laws’ appealing for caution, while others have opted for assessing the effectiveness of extant ‘hard’ and ‘soft’ policies.
34.2.1 National Policy Frameworks
Normative systems are often conceptualised using a hierarchy that differentiates between restrictive, intermediate and permissive approaches. Under this model, restrictive policies set up ethical and political boundaries by employing upstream limits – blank bans or moratoria – to interventions irrespective of their purpose. Pertaining to the application of HGI, restrictive approaches essentially outlaw or tightly regulate most embryo and gamete research. Supported by concerns over degrading dignity and fostering commodification of potential life, these approaches are based on attributing a moral – personhood or special – status to embryos, and thus advocating for robust governmental controls. Stipulations forbidding ‘genetic engineering on human germ cells, human zygotes or human embryos’Footnote 10 or stating that no ‘gene therapy shall be applied to an embryo, ovum or fetus’Footnote 11 exemplify this model.
While apparently wide-ranging, restrictive policies contain several potential loopholes. Among their major shortcomings are their reliance on research exceptions for therapeutic interventions that are deemed beneficial or life preserving to the embryo, or which are necessary in order to achieve a pregnancy. Terminological imprecisions will render as inapplicable a norm once a particular intervention could be considered as medical innovation or standard medical practice. Similar gaps are present in norms referencing specific technologies and in legal definitions of what constitute a embryo or a gamete, as all of these could later be outpaced by scientific advances, such as those brought by developments in the understanding of embryogenesis, organoids, and pluripotent stem cells. Indeed, the growth of HGE technologies has brought back to centre stage reflections over what is a reproductive cell. Evocative of the debates that took place during the peak of the stem cell era, the scientific, legal, and moral status of these entities continue to be tested, while at the same time remaining as the most prevalent policy benchmark. Whether silent or overtly present in distinct conceptualisations (e.g. developmental capacity or precise time period), criteria defining these early stages of human development are at the core of policies directing the permissibility of certain interventions.
The most favoured policy position is, however, an intermediate one, in which restrictions are applied downstream by banning research with reproductive purposes. Yet, this position considers permissible the practices that are directed at fundamental scientific research activities, such as investigating basic biology or aspects of the methodology itself. Policies adopted in countries such the Netherlands,Footnote 12 reflect this moderate perspective by outlawing any intervention directed at initiating – including attempts to initiate – a pregnancy with an embryo – or a reproductive cell – that has been subject to research or whose germline has been intentionally altered. Balancing social and scientific concerns, this approach calls for modest governance structures, yet close oversight. Nevertheless, it is at the risk of internal inconsistencies and ambiguities, given that norms are often the result of political compromises, which seem necessary in order to achieve policy adoption. A case in point are those research policies that confer moral and legal status to the human embryo while – at the same time – mandating their destruction after a certain period of time, or in ambiguous norms regarding the permissibility of clinical translation.
Largely misinterpreted, liberal models do not necessarily postulate a laissez-faire or a blanket unregulated approach. Rather, they provide significant scientific freedom predicated on the strength of their governance frameworks. They seek to promote scientific advances as a tool for social progress. In the context of HGI, liberal policiesFootnote 13 allow for basic and reproductive research while banning clinical implementation. Given that these approaches depend on the effectiveness of their governance structures (e.g. licensing, oversight) with decisions often on a case-by-case or a de-facto basis, they are at the risk of arbitrary applications and system failure. Moreover, when the model rests on self-regulatory approaches devoid of effective enforcement mechanisms, they risk being – or being perceived to be – self-serving and following a market consumer model.
Throughout policy models, the progression from research to clinical purposes is at times blurred in the peculiarities of such approaches. In fact, uncertainty regarding the scope of requirements is particularly present when there are permissible exceptions to norms forbidding HGE in reproductive cells. This is the case of Israel, which outlaws ‘using reproductive cells that have undergone a permanent intentional genetic modification (germline gene therapy) in order to cause the creation of a person’,Footnote 14 yet permits to apply to a research licence ‘for certain types of genetic intervention’ provided that ‘human dignity will not be prejudiced’.Footnote 15 Similarly in France where ‘eugenic practice aimed at organizing the selection of persons’ and alteration(s) ‘made to genetic characteristics in order to modify the offspring of a person’ are banned,Footnote 16 yet at the same time the law exempts interventions aiming ‘for the prevention and treatment of genetic diseases’Footnote 17 without providing further guidance. | https://core-cms.prod.aop.cambridge.org/core/books/cambridge-handbook-of-health-research-regulation/reimagining-health-research-regulation/12B5F691B9DC3EA57B1B28365A9906E0 |
Baker Hughes, a GE Company as a new opportunity for an Equipment Maintenance Technician to join our Artificial Lift team in Midland, TX.
Test, assemble, disassemble and perform visual inspection of mechanical assemblies.
Replaces expendable parts, gaskets, seals, lines, and fittings.
May perform machining, painting, and/or shipping processes.
Compliance with HS&E policies and procedures.
General technical knowledge in fluid power technology and mechanical devices.
Imagine One is searching for a Lead Artificial Intelligence (AI) Engineer. The Lead AI Engineer will be responsible for leading a team in the design and implementation of data-driven solutions for Enterprise Information Technology programs.
MS Computer Science, Data Science, Engineering, Physics, Mathematics or related field (Required). PHD preferred.
Experience with AI programing languages and tools, architectures and data modeling.
Uses scientific methods, processes, algorithms and systems to extract knowledge and insights from data in various forms, both structured and unstructured.
Uses statistics, data analysis, machine learning and related methods to understand and analyze actual phenomena with data.
Employs techniques and theories drawn from many fields within the context of mathematics, statistics, information science, and computer science.
Applies principles of management and utilization of resources resulting in successful data-science and big-data projects.
Designs solutions and performs business analytics (BA). Performs continuous iterative exploration and investigation of past business performance to gain insight and drive business planning.
Designs solutions and uses BA to develop new insights and understanding of business performance based on data and statistical methods.
Designs solutions and uses metrics to measure past performance as well as guide business planning based on data and statistical methods to support business intelligence (BI), including querying, reporting, online analytical processing (OLAP), and alerts to answer questions such as what happened, how many, how often, where the problem is, and what actions are needed.
Designs solutions and applies BA techniques related to management science, statistical analysis, explanatory modeling, predictive modeling, and fact-based management to drive human or automated decision making.
Designs solutions and applies BA methods to answer questions like why is this happening, what if these trends continue, what will happen next (predict), and what is the best outcome that can happen (optimize).
Designs solutions and implements knowledge base (KB) technologies used to store complex structured and unstructured information used by an enterprise’s IT system.
Designs solutions and implements multi-layered technology platforms that automate and enhance IT operations by using analytics and machine learning to analyze big data collected from various IT operations tools and devices, to automatically spot and react to issues in real time manifesting AI Operations (AIOps).
Designs and implements AIOps solutions by incorporating technologies related to automation, AI, ML, domain algorithms, rules and patterns, real time processing, monitoring, and data source integration.
We currently have an opportunity for a full-time Funeral Director/Arranger at "Historic" Palm Downtown Mortuary, Las Vegas, NV. This position offers a great opportunity for a qualified candidate. Compensation is commensurate with experience. The following is the primary role of the director.
Counsel with and coordinate desired arrangements with client families and other third parties to carry out selected funeral, cremation and cemetery services.
Maintain a JD Power score of 950 or above.
Maintain a complete knowledge of all products and services offered to client families and be able to explain the justifiable differences and benefits between each product and service offered; Dignity Plan knowledge and knowledge of HMIS+ is a benefit.
Assist the client family with the selection of appropriate and desired merchandise and/or services, ensuring that all options have been presented.
Execute and finalize all financial arrangements for purchases of merchandise and services selected by the client, and secure payment for such merchandise and/or services in accordance with company policy.
May be required to direct/assist and/or coordinate funeral and interment services.
Ensure that all required paperwork is completed timely and accurately.
Maintain necessary licensure and/or other certification to meet any local, state, or federal regulations.
Maintain knowledge of applicable company policies and procedures, and ensure that they are carried out at all times.
Attend all required meetings as scheduled. Ensure that all required safety requirements and procedures are followed when performing any task.
Maintain "Service Excellence" with knowledge and compassion.
The above duties are not intended to be an all-inclusive list of duties and responsibilities for this position, nor are they intended to be a listing of skills and abilities to do the job. The purpose is to describe only the general nature of the position.
Facebook is seeking an HR Business Partner to support our Artificial Intelligence organization. The ideal candidate will contribute at both hands-on and strategic levels to cultivate an amazing and innovative Facebook culture as the organization grows and scales. This is a full-time role located in our New York office.
Become a driving force in changing the way we run our business. Our Data Science and Artificial Intelligence (AI) team in Advanced Business Analytics provides BASF-wide data-driven decision-making solutions for multiple business application areas.
We understand Artificial Intelligence systems as systems able to sense the environment, identify patterns, recommend a decision, and learn to adapt from feedback. We are seeking a professional like you, with a strong background in machine learning and statistics, as well as thinking in complete systems, to design and implement them across BASF's business applications.
The total rewards that you receive as a BASF employee go way beyond a paycheck. From competitive health and insurance plans, to robust retirement benefits that include company-matching contributions, to making sure you never stop learning, we believe investing in you is investing in our success. Working for a large, global organization, you'll have a chance to grow professionally and personally, expand your network and build a rewarding and dynamic career.BASF provides interesting and challenging learning and development opportunities to help you make the most of your talents and your job.
Leveraging your extensive educational background in Science, Mathematics, Statistics, Computer Science, Data Science, or a related discipline, along with your relevant professional work experience, you will lead, execute, and coordinate innovative data analytics initiatives and establishing sustainable solutions.
Your strong experience with statistical toolkits and programming languages (e.g., R, Python, XGBoost) and experience with enabling IT environments (e.g., Hadoop, Spark) will be a valued asset as you drive the diffusion of AI within BASF and work creatively on new applications for AI.
Your familiarity with different analytical areas of expertise in AI (e.g., machine/reinforcement learning, statistics, analytics) will be critical as you explore technical possibilities and create ideas together with internal non-AI-expert business partners.
Successfully engaging inside and outside the organization, you will coordinate outreach to academic experts and our technology providers to continuously enhance our internal skillsets.
The data and design (d+d) team in JP Morgan is a rapidly growing team responsible for transforming the way we and our clients do business - balancing the art of decision making with science. We are data scientists and engineers, design strategists and product managers.
We model our payment network which represents 20% of global US$ flow, to derive insights and create new revenue generating data products. We work with our clients as well as our product, sales, service and operations teams.
We need strategic problem solvers and people leaders who are fluent in data science. If you enjoy breaking down business challenges in creative ways and leading teams to deliver state-of-the-art data products to fulfill these challenges, then the data+design team would like to speak with you.
We are looking for a Product Manager who can leverage data to help J.P. Morgan rethink how it runs its business.
Identify business problems and opportunities to create unique sources of value that can keep the strategy ahead of external trends and competitors. We clear 20% of US$ globally, how can we put this data to good use?
Manage a team of data scientists, data engineers, and design strategists to drive the right kind of decision-making from solution concepting into data modeling into technical development. Marrying analytical chops with client empathy is critical to succeeding in this role.
Work with smart and accomplished teammates who have the experience, talent, skills and personalities to create data products that are developed with people in mind. You will represent a different way of working -human-centered - iterative - collaborating in small multidisciplinary teams.
Hybrid at your core: You combine deep strategic and business insight with a quantitative background. This is an incredible opportunity for hybrid thinkers that love to learn and synthesize in a high-performing culture.
Strategy Consulting Expertise: 5+ years of work experience, 3+ years of experience in top tier management consulting firm. Superb at problem structuring, integrating thinking, problem solving towards practical business impact.
Ability to influence multiple high level stakeholders across several functions. Outstanding presentation skills, including presenting technical concepts to non-technical audiences.
Demonstrated ability to supervise and lead complex quantitative analyses. Familiarity with a broad set of statistical and machine learning techniques on large datasets.
Highly articulate, built upon an underlying fundamental clarity of thought. General ability to root out fundamental issues, bring order from chaos, synthesize elegant conceptual frameworks, and drive to clear decisions.
Primary focus of building something of significance. Self-confidence, poise, and personal presence that inspires confidence in others.
The world's most important corporations, governments and institutions entrust us with their business in more than 100 countries. The Corporate & Investment Bank provides strategic advice, raises capital, manages risk and extends liquidity in markets around the world.
J.P. Morgan Treasury Services (TS) is one of the world's largest providers of treasury management services.
J.P. Morgan's TS business is a full-service provider of innovative cash management, trade, liquidity, commercial card, and escrow services - specifically developed to meet the challenges treasury professionals face today. More than 135,000 corporations, financial institutions, governments and municipalities in over 180 countries and territories entrust their business to J.P. Morgan. | https://job-descriptions.mightyrecruiter.com/r/artificial-foliage-arranger |
The key to sustainable development in the footwear industry through the principles of circular economy lies in taking care of the design, as well as the introduction of innovative and more resource efficient materials and processes to reduce or avoid the use of water, energy, hazardous chemicals and to minimise emissions and waste. In fact, the environmental footprint is already being considered as another requirement of the footwear through eco-design. In this sense, previous studies carried out by INESCOP regarding its environmental impact in terms of carbon footprint showed that 15% of it corresponds to the assembly processes, mainly by adhesive joints, due to their content on organic solvents, hazardous chemicals and polymers from fossil origin. Therefore, this paper focuses on recent developments carried out by INESCOP on more sustainable adhesives and adhesion processes for the upper-to-sole assembly in the footwear manufacturing process, through different approaches. Firstly, bio-based reactive polyurethane hot melt adhesives have been synthesised using polyols from different renewable sources. Secondly, the use of the low-pressure plasma surface treatment to improve the adhesion of polymeric materials used as soling materials was assessed in order to reduce volatile organic compounds emissions, as well as the use of hazardous chemicals for total automation of the bonding process.
https://doi.org/10.1177/0954406220957706
2020, Proceedings of the Institution of Mechanical Engineers, Part C: Journal of Mechanical Engineering Science, № 3, p. 585-596
Adhesives in the Footwear Industry
Elena Orgilés‐Calpena, Francisca Arán‐Aís, Ana M. Torró‐Palau, Miguel Angel Martínez Sánchez
https://doi.org/10.1002/9781119749882.ch4
2020, Progress in Adhesion and Adhesives, p. 69-91
Hybrid polyhydroxyurethanes: How to overcome limitations and reach cutting edge properties? | https://ouci.dntb.gov.ua/en/?backlinks_to=10.23939%2Fchcht07.01.079&p=1&exclude=1818-1724 |
Methanotrophic bacteria utilize methane as their sole carbon and energy source. Studies of the model Type II methanotroph Methylosinus trichosporium OB3b have provided insight into multiple aspects of methanotrophy, including methane assimilation, copper accumulation, and metal-dependent gene expression. Development of genetic tools for chromosomal editing was crucial for advancing these studies. Recent interest in methanotroph metabolic engineering has led to new protocols for genetic manipulation of methanotrophs that are effective and simple to use. We have incorporated these newer molecular tools into existing protocols for Ms. trichosporium OB3b. The modifications include additional shuttle and replicative plasmids as well as improved gene delivery and genotyping. The methods described here render gene editing in Ms. trichosporium OB3b efficient and accessible. | https://www.scholars.northwestern.edu/en/publications/recent-advances-in-the-genetic-manipulation-of-methylosinus-trich |
Introduction {#Sec1}
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*Yarrowia lipolytica* is a well-known non-conventional yeast, which is generally recognized as safe (Liu et al. [@CR20]). Due to its strong lipogenesis capability and high protein expression levels, *Y. lipolytica* is widely researched for the production of both bulk and fine chemicals, including organic acids, fatty acid-derived biofuels and chemicals, polyunsaturated fatty acids, single-cell proteins, terpenoids, and other valuable products (Rymowicz et al. [@CR32]; Cui et al. [@CR6]; Yin et al. [@CR54]; Xue et al. [@CR52]; Kamzolova et al. [@CR15]; Blazeck et al. [@CR3]; Sun et al. [@CR42]; Liu et al. [@CR21], [@CR22]; Gao et al. [@CR10]). Meanwhile, a large range of substrates can be effectively utilized by *Y. lipolytica*, including not only glucose and glycerol but also xylose, cellobiose, and other industrial wastes, which has made it into a hot topic of recent biorefinery research (Ledesma-Amaro and Nicaud [@CR19]; Zeng et al. [@CR55]). Metabolic engineering is a rapidly developing field that purposely uses genetic recombination technologies to modify cellular metabolic pathways, change cell characteristics, and combines with other technologies such as biochemical engineering to construct new metabolic pathways for the synthesis of specific products (Stephanopoulos [@CR41]; Nielsen and Keasling [@CR26]; Chen et al. [@CR4]). For instance, the overexpression of the endogenous acetyl-CoA carboxylase (ACC1) and diacylglycerol acyltransferase (DGA1) genes in *Y. lipolytica* increased the lipid content to 41.4%, a 4.7-fold improvement over the parental strain (Tai and Stephanopoulos [@CR43]). Subsequently, the aldehyde dehydrogenase gene was introduced to improve the strain's resistance to oxidative stress, after which the lipid content reached up to 90% (Xu et al. [@CR50]). Metabolic engineering was also employed to produce other products in *Y. lipolytica* in recent years with good results, which attracted increasing attention to the metabolic engineering research of this yeast (Yin et al. [@CR54]; Beopoulos et al. [@CR1]; Rutter et al. [@CR31]; Blazeck et al. [@CR3]; Kildegaard et al. [@CR16]; Liu et al. [@CR21], [@CR22]). With the increasing number of metabolic engineering studies in *Y. lipolytica*, various genetic engineering tools have been developed to meet the demands (Hussain et al. [@CR13]). These tools include URA blast, TRP1 blast, Cre/LoxP systems for recycling selection markers, and transcription activator-like effector nucleases (TALENs) for gene knock-out and knock-in (Cheon et al. [@CR5]; Fickers et al. [@CR8]; Rigouin et al. [@CR29]; Gao et al. [@CR10]). While these tools have been established in *Y. lipolytica*, they suffer from various limitations and remain not fully conducive to efficient, high-throughput genetic engineering.
The CRISPR/Cas system, which emerged at an opportune time, to some extent solves the traditional problems. The CRISPR/Cas system consists of mainly two components, a Cas9 protein and the corresponding sgRNA (Shi et al. [@CR39]). As shown in Fig. [1](#Fig1){ref-type="fig"}, CRISPR/Cas systems based on different types of Cas proteins can be classified into three groups---knock-out/in-oriented CRISPR/Cas9, CRISPR interference (CRISPRi), and CRISPR activation (CRISPRa) (Sharma et al. [@CR38]). When the sgRNA recognizes the targeted sequence, the Cas9 protein catalyzes a double-strand break (DSB) in the targeted DNA, which induces either random deletion and insertion or the introduction of heterologous genes through partially complementary donor DNA (O'Connell et al. [@CR27]; Ran et al. [@CR28]). CRISPRi is used for gene repression via a catalytically deactivated Cas9 (dCas9), which has no cleavage activity, but can nevertheless bind the DNA and repress the expression of the gene targeted by the gRNA (Larson et al. [@CR18]). In order to enhance the repression activity, transcriptional repressors, such as Krüppel associated box (KRAB) domain, is usually expressed as a fusion with the Cas9 protein (Zhang et al. [@CR56]). Similarly, CRISPRa was developed for targeted gene activation by fusing dCas9 to transcriptional activators that bind promoters of targeted genes and improve gene expression levels (Simeonov et al. [@CR40]). These technologies offer important solutions, including multi-gene targeting and marker-free integration, which promote the development of metabolic engineering in *Y. lipolytica*.Fig. 1The CRISPR/Cas genome editing platform for *Yarrowia lipolytica*. **a** CRISPR/Cas9 method for gene knock-out/knock-in. When the sgRNA recognizes the targeted sequence, which is located before a protospacer adjacent motif (PAM) site, the Cas9 protein will catalyze the formation of a double-strand break (DSB) in the targeted DNA. In order to repair the genome, two kinds of repair mechanisms can be used. The non-homologous end-joining (NHEJ) repair mechanism, which is dominant in *Y. lipolytica*, can quickly repair the genome at the expense of the deletion or insertion of a few nucleotides, which can lead to the frameshift mutations in the targeted gene. Additionally, in the presence of a homologous sequence, cells can use the donor DNA to introduce nested heterologous genes or disrupt a targeted gene by homologous recombination (HR), homology-mediated end-joining (HMEJ), and microhomology-mediated end-joining (MMEJ) repair mechanisms. **b** CRISPRi and CRISPRa methods for gene interference and activation, respectively. A catalytically deactivated Cas9 (dCas9), which has no cleavage activity, can be fused with different effector domains to control gene expression. When the targeted region is recognized, the dCas9 fusion protein with the transcriptional repressor domain binds the DNA to repress gene expression. Similarly, the fusion protein of dCas9 and a transcriptional activator domain binds to targeted regions to improve the gene expression level
In this review, we summarize the expression strategies and recent applications of the CRISPR/Cas system in *Y. lipolytica*, followed by a brief discussion of future prospects of this system. We hope to provide a practical reference for genome editing in *Y. lipolytica*.
Development of a CRISPR/Cas9 system for *Y. lipolytica* {#Sec2}
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Cas9/dCas9 expression strategies {#Sec3}
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As the first CRISPR research in *Y. lipolytica* by Schwartz et al. ([@CR34]), both expression of the active Cas9 protein in the CRISPR/Cas9 system and dCas9 in CRISPRi and CRISPRa systems after that has been engineered using a strong constitutive promoter as well as a SV40 nuclear localization signal (Gao et al. [@CR9]; Schwartz et al. [@CR36]; Schwartz et al. [@CR37]; Schwartz and Wheeldon [@CR33]; Holkenbrink et al. [@CR12]; Zhang et al. [@CR56]). There are two general strategies for the expression of Cas9/dCas9---one based on plasmids and the other on chromosomal integration. In the plasmid-based setup, Cas9/dCas9 can be cloned into an autonomously replicating plasmid (ARP) for recycling of marker genes, or a non-ARP for transient expression, both of which showed a high editing efficiency in *Y. lipolytica* (Schwartz et al. [@CR34]). In addition, Holkenbrink et al. ([@CR12]) established an EasyCloneYALI genetic toolbox in which Cas9 is integrated into the genome for easier transformation protocols. With this system, highly efficient genome editing only requires an sgRNA expression cassette, a strategy that is also of interest for CRISPRi and CRISPRa systems.
sgRNA expression strategies {#Sec4}
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### Promoter engineering to improve the genome editing efficiency {#Sec5}
Efficient genome editing mainly depends on the level of sgRNA transcription. Therefore, many studies have focused on promoter engineering in recent years. Gao et al. ([@CR9]) and Wong et al. ([@CR49]) used a polymerase II promoter (Pol II) to transcribe sgRNAs in *Y. lipolytica*. In this system, sgRNAs were flanked by hammerhead (HH) and hepatitis delta virus (HDV) ribozymes. Due to the strength of Pol II and self-processed RNA cleavage, sgRNAs can be successfully released. Similar research was also previously carried out by Schwartz et al. ([@CR34]). However, the efficiency was quite low, and in order to further improve the editing efficiency, Schwartz et al. ([@CR34]) adopted a synthetic RNA polymerase III promoter (Pol III) strategy in which differently designed Pol III promoters were individually and combinatorically used to optimize the knockout efficiency. The SCR1-tRNA^Gly^ hybrid Pol III achieved an efficiency of nearly 100% after 4 days of outgrowth, and was consequently frequently utilized to express sgRNAs in later studies. In very recent research, Morse et al. ([@CR25]) established a T7 polymerase-based CRISPR/Cas system in different yeasts, including *Y. lipolytica*. Here, the sgRNAs were expressed from a T7 promoter which was transcribed by a heterologous mutant T7 polymerase, and the genome editing efficiency reached nearly 60%. The establishment of promoter engineering strategies has laid the foundation for further development of the CRISPR/Cas system in *Y. lipolytica*.
### Multiplex sgRNA expression strategy {#Sec6}
Multiplex sgRNA expression strategies have been widely applied to the CRISPR/Cas system in *Y. lipolytica*. Gao et al. ([@CR9]) investigated the efficiency of simultaneous single, double, and triple gene disruption in *Y. lipolytica*. The final result showed that the frequency of single-disruption events approached 100%, while for double disruption, it was nearly 36%, and reached 19% for triple disruption. Holkenbrink et al. ([@CR12]) established a multi-sgRNA expression system, in which multiplex sgRNAs that target different genes can be constructed rapidly through the BioBricks assembly. Additionally, a multiplex sgRNA expression strategy has been used for CRISPRi and CRISPRa (Zhang et al. [@CR56]; Schwartz et al. [@CR36]); however, in these cases, the multiplex sgRNAs were usually designed to target a single desired gene rather than multiplex different genes. The reasoning for this is that when the targeting is biased towards a single gene, the efficiency can be lower, and multi-gene targeting has a better efficacy for gene interference and activation. These examples demonstrate that multiplex sgRNA expression plays an important role in the CRISPR/Cas system.
CRISPRS/Cas system for knock-out/knock-in and repression or activation of genes {#Sec7}
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Gene knock-out or knock-in {#Sec8}
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In the field of metabolic engineering, a highly efficient homologous recombination (HR) system of microbes is essential for gene knock-out/knock-in, which in turn is a prerequisite for investigating the functions of the targeted genes. However, the system is in direct competition with the stronger non-homologous end-joining (NHEJ) mechanism in most organisms including *Y. lipolytica* (Ueno et al. [@CR45]; Decottignies [@CR7]). Consequently, a high HR efficiency usually requires homologous arms with a length of more than 1 kb. In order to enhance the HR efficiency, chemical and biological approaches for inactivation of the NHEJ repair pathway in *Y. lipolytica* were adopted. Verbeke et al. ([@CR46]) identified the ku70 and ku80 genes in *Y. lipolytica*, which play a role in the NHEJ repair mechanism after the formation of DSB. While the disruption of ku80 did not affect the HR efficiency, it was significantly improved by ku70 disruption. In the corresponding knockout strain, the efficiency of HR mediated by only 50-bp homologous arms can be increased to 43%. Interestingly, Kretzschmar et al. ([@CR17]) proved that ku80 disruption can also increase the HR efficiency to 80% with long homologous arms 1 kb in length. Moreover, they observed the highest HR efficiency up to 85% with ku70 disruption. In addition, based on the ku70 disruption, Jang et al. ([@CR14]) added hydroxyurea into the medium to synchronize the cell cycle to the S-phase, which has been proved to induce the HR in *Y. lipolytica* (Tsakraklides et al. [@CR44]). The experiment demonstrated that 50-bp homologous arms can yield an HR efficiency of 46% and 100-bp homologous arms can reach up to 100%. Although these strategies have been developed to improve HR efficiency, it is quite difficult to knock out multiple genes simultaneously even in an NHEJ-knockout strain. Moreover, the use of multiple selection markers is not conducive to further metabolic engineering and industrial utilization of the resulting strains (Wagner and Alper [@CR47]). Fortunately, the emergence of the CRISPR/Cas system offers the possibility to solve these problems.
CRISPR/Cas9 system for *Y. lipolytica* was first established by Schwartz et al. ([@CR34]). In their research, more attention was paid to finding the best Pol III promoter to improve the genome editing efficiency. The final result indicated that a combination of SCR1 and tRNA Pol III promoters was the best choice. Based on these results, a standardized markerless gene integration tool for pathway engineering was subsequently established by Schwartz et al. ([@CR35]). By knocking out 17 genes using an autonomously replicating CRISPR/Cas9 plasmid as well as the repair fragment, five loci which offer efficient gene integration were identified. These repair fragments as well as the CRISPR/Cas9 plasmids together comprise a standardized tool that allows efficient genome editing in any of the five loci. In order to verify the practical applicability of this tool, the multigene pathway for lycopene biosynthesis was subsequently integrated into the *Y. lipolytica* genome. Importantly, repair fragments were designed to easily insert any targeted genes, and these plasmids can be removed in a day, which has the potential to significantly accelerate the construction of any metabolic pathway in *Y. lipolytica*.
Comparable to the above approach, Holkenbrink et al. ([@CR12]) established a CRISPR/Cas9-based toolbox for engineering *Y. lipolytica*. In the system, Cas9 and sgRNA were separately expressed from two different plasmids, and the Cas9 protein was subsequently integrated into the genome. A total of 11 loci which did not affect cell growth were selected to design the sgRNAs and repair fragment. Both marker-mediated integration and CRISPR/Cas9-based marker-free genome editing had a high efficiency. Additionally, the use of this toolbox for multiplex gene knockouts was tested. For single gene disruption, the efficiency was above 80%, and it varied from 6 to 66% for double gene disruption. However, for triple gene disruption, no successful transformants were found. To simplify the plasmid construction process, 90-bp double-stranded oligonucleotides were used as the template to repair the DSB by HR, and the editing efficiency reached 100%, which further demonstrated the validity of this toolbox.
Interestingly, Gao et al. ([@CR11]) recently established a dual-sgRNA-mediated gene knockout and integration strategy for *Y. lipolytica*. By designing paired sgRNAs for single genes, both non-coding and coding regions of the targeted gene could be cleaved precisely. The result was further confirmed by knocking out six genes. Moreover, based on a new homology-mediated end-joining (HMEJ) strategy, which was recently established in animal embryo and tissue cells (Xuan et al. [@CR51]; Yao et al. [@CR53]), researchers also applied this HMEJ strategy to *Y. lipolytica*. Strikingly, the efficiency was twice as high as that of HR.
Taken together, fast developments of the CRISPR/Cas9 system provide a great deal of convenience for metabolic engineering in *Y. lipolytica*. Both marker-free integration and multi-gene editing are powerful tools to overcome traditional shortcomings in HR systems, facilitating further metabolic engineering of this yeast.
Sequence-specific repression or activation of genes {#Sec9}
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In the CRISPR/Cas9 system, the original purpose of the Cas9 protein was to bind the DNA and cleave the targeted gene sequence. However, it was found that a dCas9 variant which has no cleavage activity can also specifically bind the targeted DNA (Ma et al. [@CR23]). Importantly, dCas9 can be fused to transcriptional repressors and activators to further repress or activate gene expression. Subsequently, CRISPRi and CRISPRa manipulations have been quickly applied to many different organisms, including *Y. lipolytica*.
Schwartz et al. ([@CR36]) were the first to establish the CRISPRi system in *Y. lipolytica*. The purpose was to repress NHEJ to enhance HR efficiency. In the verification experiments, eight of nine target genes were efficiently repressed. In order to further improve the HR efficiency, a multiplex sgRNA expression strategy as well as a dCas9 fusion protein with the Mxi1 repressor was adopted to repress the ku70 and ku80 genes. The subsequent rate of HR was nearly 90%. Additionally, a microhomology-mediated end-joining (MMEJ) mechanism, which is independent of the NHEJ mechanism, was found in *Y. lipolytica*. Homology regions of only 8 bp can be used to repair the genome with the MMEJ after DSB formation. Subsequently, Zhang et al. ([@CR56]) used the four different repression proteins dCpf1, dCas9, dCas9-KRAB, and dCpf1-KRAB, to rapidly develop the CRISPRi system in *Y. lipolytica*. Notably, the researchers found that there was no explicit relation between target sites and repression efficiency. Therefore, multiplex sgRNAs were simultaneously expressed to improve the system's efficiency, and rates of gene repression as high as 85% and 92% were achieved using dCpf1 and dCas9, respectively. Furthermore, the possibility of double and triple gene interference using the CRISPRi system was explored in this research. The final results showed that the combined repression events successfully occurred in *Y. lipolytica*, which demonstrated that CRISPRi was indeed a powerful tool for metabolic engineering of *Y. lipolytica*.
In addition to the gene interference system, the dCas9 protein has also been fused to transcription activators to activate the target genes, which is known as CRISPRa. Based on the previously established CRISPRi technology, Schwartz and Wheeldon ([@CR33]) rapidly developed CRISPRa manipulation in *Y. lipolytica*. Considering that transcription activators have an enormous influence on the activation efficiency, researchers firstly compared four different activators and found that the synthetic tripartite activator VPR yielded the highest activation. After that, the dCas9-VPR fusion protein was used to activate two β-glucosidase genes---BGL1 and BGL2---which enabled *Y. lipolytica* to grow on cellobiose robustly. By designing multiplex sgRNAs targeting the promoters of the two β-glucosidase genes, researchers eventually found that sgRNAs near to the core promoter region could greatly increase the activation degree. The expression level of BGL1 increased 112-fold, while that of BGL2 increased 43-fold. Moreover, the activation of both genes simultaneously also yielded a high efficiency.
In summary, dCas9-mediated gene repression and activation is playing increasingly more important roles. Consequently, more silent regions in the genome of *Y. lipolytica* can be activated to explore their encoded functions. Furthermore, the correlation between gene expression and cellular phenotypes can be understood in significantly more detail, which will further deepen metabolic engineering research in *Y. lipolytica*.
Applications of the CRISPR/Cas system in *Y. lipolytica* {#Sec10}
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As shown in Table [1](#Tab1){ref-type="table"}, the CRISPR/Cas system has been quickly applied in metabolic engineering of *Y. lipolytica* following its introduction.Table 1Recent applications of the CRISPR/Cas system in *Yarrowia lipolytica*sgRNA expression strategyCas9/dCas9 expression strategyApplicationEditing efficiencyReferencesSCR1-tRNA^Gly^ ; HH-HDVPlasmid-basedKnockout studies of XDH and XKS--Rodriguez et al. [@CR30]SCR1-tRNA^Gly^Plasmid-basedCRISPR/Cas9 tool for targeted, markerless gene integration\~ 50%Schwartz et al. [@CR35]SCR1-tRNA^Gly^Plasmid-basedDisrupting TRP1--Wagner et al. [@CR48]SCR1-tRNA^Gly^ ; dual sgRNA cleavagePlasmid-basedA dual-cleavage strategy for gene integration14.3--32.6%Gao et al. [@CR11]tRNA promoter; Biobrick assembly; multiplex sgRNA targetGenomic integrationCRISPR/Cas9 tool for marker-free gene integration90%Holkenbrink et al. [@CR12]HH-HDV; multiplex sgRNA targetPlasmid-basedCRISPR/Cas9 tool for gene knockout28--98%Gao et al. [@CR9]SCR1-tRNA^Gly^Plasmid-basedDisrupting TRP1--Markham et al. [@CR24]SCR1-tRNA^Gly^Plasmid-basedCRISPR/Cas9 tool\~ 90%Schwartz et al. [@CR34]SCR1-tRNA^Gly^Plasmid-basedKnocking out glycogen synthesis--Bhutada et al. [@CR2]T7 promoterPlasmid-basedKnocking out the CAN1 gene60%Morse et al. [@CR25]SCR1-tRNA^Gly^ ; multiplex sgRNA targetPlasmid-basedEnhancing HR90%Schwartz et al. [@CR36]SCR1-tRNA^Gly^ ; Golden-Brick assembly; multiplex sgRNA targetPlasmid-based dCas9 and dCas9-KRABCRISPRi tool for gene repression92%Zhang et al. [@CR56]SCR1-tRNA^Gly^ ; multiplex sgRNA targetPlasmid-based dCas9-VPR fusion proteinCRISPRa system for activation of cryptic sugar metabolism--Schwartz and Wheeldon [@CR33]HH-HDVPlasmid-basedYaliBricks-based CRISPR/Cas9 tool12.5%Wong et al. [@CR49]--, not stated
Rodriguez et al. ([@CR30]) used CRISPR/Cas9 to knock-out the xylulose kinase and xylitol dehydrogenase genes in *Y. lipolytica* in the xylose metabolic pathway. The knockout strains demonstrated that both genes are essential for xylitol/xylose metabolism. Based on these result as well as further study in *Escherichia coli*, researchers engineered xylose utilization in *Y. lipolytica*, which enabled it to grow on xylose robustly. Bhutada et al. ([@CR2]) used the CRISPR/Cas9 system to knock out the glycogen synthase gene in *Y. lipolytica* because they found it was too challenging to knock out this gene using HR in a triacylglycerol (TAG) synthesis-deficient strain. The final result showed that glycogen synthesis played a competing role in the TAG accumulation process and the deletion of this gene improved the lipid content by 60%. Markham et al. ([@CR24]) engineered *Y. lipolytica* to produce triacetic acid lactone. In this research, the TRP1 gene was disrupted by CRISPR/Cas9 to introduce an available selection marker. Similar to this research, Wagner et al. ([@CR48]) also knocked out TRP1 with CRISPR/Cas9 in order to establish a piggyBac transposon system in *Y. lipolytica*.
Compared to the gene knock-out/knock-in-oriented CRISPR/Cas9 method, both CRISPRi and CRISPRa methods are still in their infancy. Although Schwartz et al. ([@CR36]) and Zhang et al. ([@CR56]) individually established the CRISPRi system, and Schwartz and Wheeldon ([@CR33]) subsequently established the CRISPRa system, there are few applications of these two methods in *Y. lipolytica*. However, we believe that the need to engineer *Y. lipolytica* for the tailored production of specific chemicals will greatly expand the use of CRISPRi and CRISPRa systems in metabolic engineering research of this organism in the near future.
Conclusions and perspectives {#Sec11}
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Compared to the widely used yeast model organism *Saccharomyces cerevisiae*, the non-conventional yeast *Y. lipolytica* has a stronger lipogenesis ability. Therefore, *Y. lipolytica* has been increasingly explored for the production of lipid-related products via metabolic engineering. The adaptation of genetic tools from *S. cerevisiae* to *Y. lipolytica* would enable more rapid and convenient strain engineering and facilitate reaching the full potential of *Y. lipolytica*. The emergence and application of the CRISPR/Cas system undoubtedly accelerates the rate of metabolic engineering for *Y. lipolytica* strain improvement. Although the CRISPR/Cas system has been firmly established in this yeast, there still is much room for further improvement. For instance, problems related to multi-gene editing efficiency, more precise site-directed mutagenesis in the genome as well as high-throughput screening technology after genome editing need to be addressed. However, we believe that these problems can be solved and that increasing numbers of applications of CRIPSR/Cas in *Y. lipolytica* will quickly come available in the near future.
This work was financially supported by the National Natural Science Foundation of China (Grant Nos. 21776131 and 21476111), the Program for Innovative Research Teams in Universities of Jiangsu Province, the Priority Academic Program for the Development of Jiangsu Higher Education Institutions, the Jiangsu Synergetic Innovation Center for Advanced Bio-Manufacture (No. XTD1814), and the Åforsk Foundation.
This article does not contain any studies with human participants or animals performed by any of the authors.
Conflict of interest {#FPar1}
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The authors declare that they have no conflicts of interest.
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Sleep Problems May Spur Development Of Amyloid Plaques, Leading To Alzheimer's
In case you didn’t know, sleep is critical to proper functioning. It gives our brains a moment to rest, allowing neurons to reconnect or make new connections, thus consolidating memory, and improving focus, attention, and vigilance the next day. Studies have shown that losing sleep can even lead to the destruction of brain cells, and that’s not including the effects of lost sleep on the immune system and the heart. Now, a new study shows that getting a poor night’s rest might also encourage the development of Alzheimer’s disease.
Researchers from the University of Wisconsin, Madison found that people who reported trouble sleeping were more likely to have amyloid deposits present in their brains. As a sticky protein called beta-amyloid progressively clumps together in a person’s brain, it forms into plaques, which go on to block neuronal signals. Eventually, they trigger inflammation too, which further destroys cells. Amyloid plaques are a hallmark of Alzheimer’s disease, along with neurofibrillary tangles, which are made of dysfunctional tau proteins that disrupt cellular communication. It’s unclear exactly how the two develop, but once they do, the brain and its functions deteriorate after only a few years.
For the current study, which was presented on Monday at the American College of Neuropsychopharmacology annual meeting in Phoenix, Ariz., researcher Ruth Benca and her team looked at sleep quality and amyloid levels in 98 healthy patients aged 50 to 73 who participated in the Wisconsin Registry for Alzheimer’s Prevention. They completed questionnaires about their sleep and related problems, and then underwent brain scans so the team could observe any amyloid deposits. Patients who had trouble sleeping were more likely to have amyloid deposits, specifically in the cerebral cortex, which plays a critical role in memory, attention, awareness, and thought.
Previous studies have also found correlations between lost sleep and reduced brain function. One 2012 study, for example, found that participants who woke up more than five times within an hour of sleep, or those who spent less than 85 percent of their time in bed sleeping, were more likely to have amyloid plaques. Another study found that having sleep apnea, which causes a person to repeatedly stop breathing during sleep, was associated with a higher level of tangles.
Still, it’s unclear which came first, cognitive decline or sleep problems. “We still need to determine whether sleep disturbance promotes amyloid deposition in the brain, or if a neurodegenerative process produces disordered sleep,” Benca said in a press release. If the scientists can figure that out, they’ll be better equipped to identify biomarkers of Alzheimer’s sooner.
Over five million Americans live with Alzheimer’s, according to the Alzheimer’s Association. Another 500,000 die each year from the disease, which typically develops after age 65 and affects women more than twice as much as men.
Source: Benca R, et al. At The American College of Neuropsychopharmacology Annual Meeting. 2014. | https://www.medicaldaily.com/sleep-problems-may-spur-development-amyloid-plaques-leading-alzheimers-313542 |
We need only explore the ascetic within ourselves to begin to understand the nature of asceticism’s inner wholeness. No one can avoid austerity, and even when we are forced by circumstance to accept it, we find that we can live with less. We learn. We learn that our existence is not as dependent upon material acquisition as we had mistakenly thought. Even during involuntary austerity, we are forced to move from the world of the senses and sense objects to the world of the mind and intellect. In great austerity, we have to reason to endure, and in doing so we find a world that is larger in its scope than that of the mind and the five senses.
The mind is no doubt more spacious and accommodating than the body, but intellect is more spacious and accommodating than the mind. With our five senses, we can experience a mountain and we can experience gold, but only in the mind can we encounter a mountain of gold. In the mental world, there are many more possibilities than we find in the physical world. Above the senses and the mind, stands reason, for with our discriminating faculty we can make sense of our physical and mental experiences, and determine how to respond to them such that our lives become more meaningful and free. For example, although some experiences may feel good to the mind and senses, with our intellect we can determine whether or not they are good for our true selves. From sense objects to the senses, to the mind, and from there to touch the intellect constitutes a progression within the material hierarchy, beyond which lies the self. As the Gita informs us, “It is said that senses are superior to the sense objects, the mind is superior to the senses, and moreover, the intellect is superior to the mind. Superior even to the intellect is the self.” (3.42) It is when we leap from the last step on the ladder of the material hierarchy to the realm beyond reason that we find the self and become whole, landing on the ground of being.
This leap, however, involves voluntary austerity. It involves intentionally going within in pursuit of one’s fortune, a journey fueled in part by the well-reasoned conclusion that the world of things and thoughts has little to do with the self. It should be noted that the reasoning supporting the self’s superiority to the intellect lies in understanding its categorical difference from matter. The self is the perceiver, the thinker, the knower in this world, and merely expresses its capacity to be so through the instruments of the senses, mind, and intellect. It is the self—consciousness—that brings matter to life and underlies the entire material existence. Of all of our human experiences, we should marvel most at one: the experience that we experience, while matter, in contrast, is that which is experienced, lacking any capacity to experience independent of consciousness. To turn inward, to pursue a more meaningful life above the relentless call of the mind and senses, is reasonable, while the means to do so transcend the limits of reason. From austerity, we turn to abnegation.
The ascetic’s abnegation—his or her renunciation of personal interests in favor of the interests of others—is at the heart of the ascetic’s spiritual practice. The sacred Hindu text, Srimad Bhagavatam, informs us in an advocacy of devotional asceticism that “giving up aggression toward others is the highest gift.” The ascetic accomplishes this by eradicating his or her ego of exploitation within the context of replacing it with an ego of dedication. His or her renunciation and austerity is thus is a by-product of their dedication. That which appears on its surface to be negative and world-denying has its origin in something sublime.
In yoga we learn that giving is getting, something that contradicts reason yet is nonetheless readily experienced by anyone who gives. The mystery of the ascetic’s fullness—how he or she lives without many of the things we think we need to survive and be happy—is unveiled as much as one begins to give. When we give of ourselves we gain wisdom and understanding of the nature of the self. This gain is not something one can hold up and show to others, yet it is tangible, as tangible as one’s very self.
In this world, there are those who have and those who have not. Each, however, thinks the opposite about the other. The worldly think they have and that the mystic has not, while the mystics know that they have and the worldly have not. Again, this is the mystic’s mantra: “Go within or go without.”
8 Responses to Go Within or Go Without
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Ultimately, asceticism requires that the ego also be as deprived of gratification and excess as would be the physical and mental bodies of the ascetic.
This is where actual asceticism begins with the fasting of the ego from prestige, honor and notoriety.
Unless and until the ego is disciplined and denied the gratification that it seeks, the actual asceticism never takes place nor does self-realization occur.
Physical and mental asceticism are not complete asceticism if in fact the ego is not included in the ascetic discipline of denial of gratification.
Asceticism must be practiced on all levels of being before it can lead to actual transcendental existence.
Superficial physical asceticism without actual subjugation of ego might make for a successful occupation, but it cannot open the door of transcendental realization.
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Very nice article, lots of good points.
The older and more tired of material life I get, the more I think about the freedoms of ascetic life.
The lesson of “giving is getting” is also easily learned in family life. The more we give to our family members, the more we receive in return. But family life often lacks the simplicity and serenity of ascetic life. Ultimately we need to unload all of our burdens and entanglements in order to prepare for the next phase of our journey.
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How about “go without and go within”?
If we go within for the sake of not going without, then at what point does our spiritual pursuit translate into an occupation instead of self-realization?
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Hari Krishna,
I like the positive view of austerity presented in this article. In our consumer society, austerity nearly always carries a negative connotation. The idea of austerity as a way to reach the superior pleasure of the soul within is rarely mentioned.
It has been said that the essence and ultimate goal of austerity is to give up our exploitative material ego and also that this giving up is a by-product of devotion. So devotion will produce austerity, but how useful is the practice of austerity in producing devotion?
Worminstool says the denial of gratification of the ego can open the door to transcendental realisation, but how can the practice of austerity alone enable one to realise the self? How can the negative process of denying the material ego enable us to realise our ‘true’ ego or spiritual self?
Given all this, how useful do you think the 4 regulative principles (no meat, intoxication etc) are to aspiring devotees? How does the practice of these restrictions help us achieve the ultimate goal of giving up our material ego? What emphasis or importance should be placed on their practice? | https://harmonist.us/2022/03/go-within-or-go-without/ |
Define organizational behavior. How can learning OB help you in your daily life?
Organizational behavior refers to the study of behavior patterns of individuals in an organization. The knowledge gained from the study of the actions of members of an organization is used to interpret their relationships with the organization. Understanding organizational behavior has enabled me to develop better relationships with my colleagues both at the workplace and my social life. Thus it helps me to achieve both organizational and social objectives.
How does the systematic study of OB help managers become more effective?
Systematic study of OB enables managers to become more effective since it enhances the managers’ ability to influence processes or events at the workplace. It enables the managers to make better or informed decisions. Consequently, they will be able to manage conflicts, remain committed to their strategies or ideas and assist various teams to achieve their job targets. For example, a manager who understands the organizational behavior will be able to influence processes such as marketing by linking the abilities of the marketers and the sales targets. He will only assign achievable targets given the capabilities of the marketers.
Describe Myers-Briggs type indicator personality framework. Based on the framework, what would you think is you personality type and why?
The framework is a questionnaire-based psychometric test that assesses individuals’ perception of the world and how such individuals arrive at decisions. The framework is informed by the psychological type theory. According to the framework, there are sixteen possible personality combinations. These are categorized as extraversion verses introversion, sensing verses intuition, thinking verses feeling and judgment verses perception. My personality combination is introversion, sensing, thinking and perception. This is because as an introvert, I focus on influence, depth of knowledge and thinking. I also trust only information that can be verified by the five senses. Thus sensing is my preferred perceiving function. As a thinker, I evaluate decisions based on causality, consistence, logic and the accepted set of rules.
Assuming that the average employee’s work-life is 50 years, list the dominant values in today’s workplace by cohort
The values associated with employees at the existential stage of their careers include lack of conformity, self loyalty and the need for autonomy. Employees at the pragmatic stages of their careers are ambitious, more loyal to their careers and are also hard workers. The values associated with generation x employees include loyalty to relationships, flexibility and leisure.
How does perception affect the decision making process?
Perception leads to a discrepancy between the actual situation and the desired situation in decision making. This problem is attributed to the fact that the individual might underrate the influence of the forces within his control while making decisions or he might overate the influence of the forces he can not control while making decisions. Besides, perceptions are based on the individual’s attitude, intentions, and the situation rather than facts.
Bounded rationality verses rational decision-making
Bounded rationality is characterized by acceptable solutions instead of the ideal one. This means that decisions made under this framework are satisfactory but not optimal. The rational decision making process on the other hand is based on a framework that systematically helps the decision maker to evaluate the available options in order to pick the best alternative. Thus unlike bounded rationality, rational decision making focuses on the optimal solution. | https://essaybizlab.com/management-and-organizational-behavior-critical-writing/ |
What is the main purpose of a film review?
Page Contents
What is the main purpose of a film review?
The main purpose of a movie review is to inform the reader about the film and its ideas.
What makes a film successful?
However, a few of the common factors that contribute to a successful film include: a compelling storyline; a well written script; great actors who have a reach to the audience; a visionary director alongside a director of photography and editor and….. the list just goes on and on.
What are the features of a film review?
Features of a film review that are included in this writing checklist are:Title of the film, the year it was made and the director.Summary of the plot (without giving away the end).Your own opinion.Strengths and weaknesses of the film.
What are the main elements of film?
There are five elements of film which is narrative, cinematography, sound, mise-en-scene, and editing.
How do you write a scene?
15:43Suggested clip · 121 secondsHow to Write a Scene – YouTubeYouTubeStart of suggested clipEnd of suggested clip
How do you define a scene?
1 : one of the subdivisions of a play: such as. a : a division of an act presenting continuous action in one place. b : a single situation or unit of dialogue in a play the love scene. c : a motion-picture or television episode or sequence.
How do you end a drama?
Use the following tips to build to and execute a satisfying ending:Make the obstacles tougher and tougher. Create a cause and effect structure. Create a climactic moment that brings together your protagonist and antagonist in one final showdown. Come to the earned conclusion. Avoid cheat endings. | https://www.nbccomedyplayground.com/what-is-the-main-purpose-of-a-film-review/ |
Social research is rather challenging, especially when a student gets to a more advanced level of learning where he or she is required to write theses and dissertation papers. Writing such assignments is an uphill task since a student is required to conduct authoritative literature review. There are a number of literature reviews on different disciplines, which various scholars have written. When a student does a literature review, proper citation and referencing skills are required to acknowledge the work of various authors.
In sociology, sound literature reviews have been achieved in theoretical studies. For example, in his conflict theory, Karl Marx analyzed major social classes that existed in the society. These were the bourgeoisie and the proletariat. The bourgeoisie were the capitalists who own the means of production while the proletariats were the wage laborers who worked for minimal wages under very harsh and unfavorable work environments. In this literature review according to Marx, there was a class conflict between the poor and the rich. The rich class wanted to reap maximum benefits at the expense of the poor majority. In his writings, Marx argued that the only solution to this social was a constant struggle and a revolution to overthrow the rich ruling class, and this would consequently lead to a classless society that is devoid of the rich dominance.
When reviewing such a literature, as put forward by Karl Marx, a scholar needs to form a critique of such a theory. A sociology student should come up with the strengths and limitations of such a theory. In doing so, a student can reject, modify or validate the theory, based on the literature review.
The review of scholarly articles, aimed at finding relevant information refers to literature review. When doing research, it is necessary that the researcher examines related research articles for more insight on the topic being investigated (Cooley, 2000). The rationale for literature review is to enable the researcher to be at par with the topic of study. In essence, any research that does not make reference to other similar works loses the credential of the discipline; since valuable information usually assists in the overall research.
Literature review is essential in doing research since the researcher might not be the first to do the particular research. In real sense, a thorough literature review makes the research easier as compared to doing plain research. The secondary data received from the review of related information may give the required leads, which assist the researcher to get more information useful to the study (Cooley, 2000). Normally, the quality of research is arrived at through comparing the findings of the study to those of the available literature. This means the researcher has to make certain comparison and be able to credit or discredit the findings, as either useful or not useful respectively.
In addition, it is through thorough literature review that an article gains the professional credential, and could be used to assist future researchers. Therefore, any research done ought to follow the guidelines and supported by reliable information retrieved from trusted sources.
In summary, it is noted that literature review is the most useful aspect of a study and that researchers have to do thorough review of the available secondary information. In addition, the review also assists researchers to gain vital information that may aid the final field study. | https://www.write-right.net/blog/literature-review |
Dude, your an idiot, Krakatoa erupted in 1883, over 36 thousand people were killed by the tsunami and eruption, but most people did die by the tsunami. You would not of been able to survive that very easily sweetheart. Lol, I'm 14 and I know more facts bout this than you do buddy.
Eruption of Krakatoa of 1883 It was 6am on August 26 in 1883, when the volcano on Krakatoa, a small island in Indonesia, catastrophically erupted. This earth-shattering event became the greatest natural disaster of the 19th century: the sky was bathed in an unearthly red glow and the fallout was felt around the world.
The eruption of Krakatoa, or Krakatau, in August 1883 was one of the most deadly volcanic eruptions of modern history. It is estimated that more than 36,000 people died.
ABOUT THE READINGS Krakatau, a small volcanic island, lies between Sumatra and Java in Indonesia. Its volcano erupted on August 26, 1883, triggering tidal waves. The eruption became more powerful on August 27. Below are two eyewitness accounts. Indonesia was a colony of the Netherlands in 1883. It was known at that time as the Dutch East Indies. | https://www.reference.com/web?q=1883+eruption+of+krakatoa+people+who+survived&qo=contentPageRelatedSearch&o=600605&l=dir |
- Work with clients and internal designers to create functional, creative, and user-friendly web experiences.
- Build responsive web interfaces from mockups provided by designers.
- Apply best practices to the structure and design of web user experiences.
- Design and build modular and reusable interface code.
- Interface with APIs and external data.
- Design and build web controls from scratch without the use of third-party libraries.
- Create theme-able CSS frameworks without the use of third-party libraries.
- Test, troubleshoot, and debug front-end technologies.
- Maintaining brand consistency throughout the web experience per client.
- Finding a balance between aesthetic design, functional design, speed, and scalability.
- Ability to apply ADA requirements to user interface.
- Collaborate with back-end developers to best implement individual features.
- Write and maintain functional requirements, guides, and technical documentation
- Collaborate with a multidisciplinary team of Designers, Solution Architects, Project Managers, Product Managers, and Stakeholders to complete projects
- Apply best practices for user input validation.
- Capable of handling multiple projects at once
REQUIREMENTS
- 5+ years of experience in a similar role
- Proven work experience as a front-end developer
- Proficiency in CSS Flexbox and CSS grid.
- Object oriented approach to UI design.
- Understanding of responsive design.
- Understanding of key design principles.
- Excellent verbal and written communication skills
- Good interpersonal skills. | https://catapultrecruiting.com/jobs/sr-front-end-engineer-remote/ |
Study: Organic Foods Might Not Be More Nutritious
[4]Organic foods aren't generally more nutritious than those grown conventionally, according to a research review published in the Annals of Internal Medicine.The review, which looked at 17 original studies on nutrient and contaminant levels, also found that there's a 30% lower risk of pesticide contamination in organic produce than conventionally grown produce. According to the analysis, 7% of organic produce samples were contaminated with pesticide compared to 38% of conventional produce samples. The study authors wrote that this difference may not be clinically relevant because the risks of exceeding maximum allowed pesticide exposure for both types of produce was small.The only nutrient found to be significantly higher in organic food was phosphorus, but this may not be a clinically relevant difference because phosphorus deficiency is unlikely. Other nutrients found in higher levels in organic foods were phenols in produce and omega-3 fatty acids in milk and chicken.There were no differences in bacterial contamination between organic and conventional produce and animal products, although bacterial contamination was common in both types of animal products. However, conventional chicken and pork were 33% more likely to contain antibiotic resistant bacteria.“What this study did is look at a large number of previous studies, which is one of the most powerful types of research you can do because you’re analyzing the results of hundreds of studies and not just one, so I do think it’s a good study,” says Liz Applegate, Ph.D., Runner's World nutrition columnist and director of sports nutrition at the University of California at Davis.Applegate says what's more important than how produce is grown is how much of it you eat.“We all need to eat more fruits and vegetables, whether they are conventionally grown or organic," says Applegate. "Some people make a choice between the two based on cost or based on benefits to the environment.”And, notes Applegate, there are reasons other than nutrition to consider organically grown and raised foods.“Is an organic strawberry more nutritious than a conventionally grown one? Sometimes maybe, sometimes no," she says. "It’s not consistent and it’s not a black-and-white science. But that doesn’t negate the benefit of choosing organic to help the environment. And perhaps as more soil improvements happen through organic farming we’ll start to see more changes in nutrient content of organic foods.”
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The Senate is expected to pass a temporary funding bill, known as a Continuing Resolution (CR), to fund the government through December 11th, avoiding a government shutdown which would have taken place October 1st. The House passed the CR last week by a 359-57 vote. Congress has not passed any of the 12 regular appropriations bills for Fiscal Year 2021 and will leave that work until after the elections. The CR would continue the current funding levels for federal agencies through December 11th.
CMS Launches New Quality Reporting Site
In early September, the Centers for Medicare and Medicaid Services announced the new Care Compare, a redesigned public facing resource of eight existing CMS healthcare compare tools available to beneficiaries. Care Compare provides a single user-friendly interface that patients and caregivers can use to make informed decisions about healthcare based on cost, quality of care, volume of services, and other data. The new site compiles eight existing quality reporting sites, including rehabilitation, into one site allowing beneficiates access to all quality reporting simultaneously.
CMS Administrator Seema Verma announced the new site saying, “By aggregating all eight of CMS’ quality tools into a single interface, patients can easily research different providers and facilities before they entrust themselves to their care. Today’s launch of Care Compare is the next step in fulfilling our eMedicare promise. Our Administration is committed to ensuring our tools are robust and beneficial to patients.”
While the measures and data used for Care Compare have not changed, the way information is displayed is now different. During a transition period, consumers and other stakeholders will be able to use the original eight compare tools while CMS continues to gather feedback and considers additional improvements to the tool. As new information about quality and cost are added to the compare tools, Care Compare will be updated to reflect that information. | https://www.aapadvocacy.com/post/october-2020-update |
DESCRIPTION (provided by investigator): The proposed research begins with the hypothesis that the importance of self-esteem lies not just in whether it is high or low (i.e., level of self-esteem), but also in people's preoccupation with seeking self-esteem - pursuing the goal to validate the self in domains of self-worth contingency. In the short term, successful pursuit of self-esteem relieves anxiety and increases feelings of safety, security, and superiority. These benefits, however, are short-lived and may come at a high price to the self and to others. The proposed studies explore the following hypotheses 1) threats in domains of contingent self-worth trigger the goal of self-validation, which in turn triggers reactions (thoughts, emotions, and behaviors) that undermine learning, autonomy, and relatedness, and self-regulation; 2) these reactions threats in domains of contingent self-worth trigger self-validation goals in others; 3) learning goals (in which performance outcomes are viewed as a means to learning), and goals that include what is good for the other as well as the self can undo or diminish the effects of threats in domains of contingent self-worth on learning, relatedness, autonomy, and self-regulation; 4) over time, self-validation goals trigger by actual or anticipated threats in domains of self-worth contingency undermine mental health, leading to increases in symptoms of depression, anxiety, disordered eating, and narcissism. Seventeen laboratory experiments examine the effects of actual and anticipated threats in domains of contingent self-worth on self-validation goals and thoughts, emotions, and behavior. Two daily report studies examine how threats in domains of self-worth affect self-validation goals and learning, relatedness, autonomy, and self-regulation in daily life, and also examine in students at risk (mildly depressed, anxious, eating disordered, and narcissistic students) whether threats in domains of contingent self-worth lead to a spiraling of symptoms over time. A 4-year longitudinal survey examines the long-term costs of self-validation goals in domains of contingent self-worth for the mental health of college students. This research has the potential to transform our understanding of the importance of self-esteem in daily life, and for mental health; if the predictions are confirmed, it will show that the importance of self-esteem lies not (only) in whether we have it or not, but in how the pursuit of self-esteem, by attempting to prove our worth and value in domains of contingency, undermines the fundamental human needs for learning, relatedness, autonomy and self-regulation, and ultimately mental health. [unreadable] [unreadable]
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This course is for students who have been learning English for two years or more. At this stage in their learning, students are starting to use English in a more abstract way.
Sample ‘can do’ statements
- I can make notes while talking on the phone
- I can give information about tourist sites
- I can make complaints and suggest solutions
- I can discuss options and help make a group decision
- I can talk about feelings related to music
Why choose this course?
This course gives learners the opportunity and freedom to apply their language skills in new and exciting ways. There is a strong focus on British culture and the course provides a wide range of activities that encourage learners to experiment and become more creative in their English use.
learning activities include:
- Flashcard games
- Role plays
- Board games and dice games
- Question and answer games
- Ordering activities
- Blind tasting
- Surveys
- Word races
- Discussions
- Drawing games
- Code breaking
- Interviews
CORE WORKBOOK LESSONS
- Making introductions and giving information
- Places to stay,
- Things to do and what to take when travelling
- Giving and taking down directions over the telephone
- The language of board games
- Age and family stereotypes
- Surveying healthy eating habits
- English sports and annual events
- Asking for information and making decisions
- Making and resolving complaints
- Giving opinions and making group decisions
- Ice breakers and small talk
- Keeping a conversation going
- Reported speech
GENERAL ENGLISH COURSES – WEEKLY PROGRAMMES OF STUDY
|Monday||Tuesday||Wednesday||Thursday||Friday|
|Lesson 1||Hello!||Nessie||Dream Team||What should
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we do now? | https://englishinaction.com/threshold.php |
Online Workshop in Normative Ethics
This annual Arizona Workshop features new work in normative ethical theory broadly construed, to include not only issues about the right and the good, but meta-theoretical questions about the project of developing and defending normative ethical theories.
Normative ethical theory addresses general questions about the right and the good and attempts to answer such questions as: What sorts of actions are right or wrong and why? What sort of person ought one to become and why? Normative ethical theories, including, for instance, versions of consequentialism, deontology, contractualism, natural law theory, and virtue ethics address such questions.
For more information, please visit: | https://philosophy.arizona.edu/events/online-workshop-normative-ethics |
Q:
How to determine $\prod_{g\in G}g$ in all generality
This question is based on another question that is closed as a duplicate:How to determine $\prod_{g\in G}g$?, which was in the reopening queue but is removed again, so I decided to ask myself. ("This question has been asked before and already has an answer. If those answers do not fully address your question, please ask a new question.") So the question was
Let $G$ be a finite Abelian group, then determine
$\prod\limits_{g\in G}g.$
This question has answers in the original post and here. I reasoned as follows:
If there is no element of order 2, every element and its inverse appear in the product, and the identity $e$ appears once, such that the product equals $e$. By Cauchy's theorem, this is the case when $\mathrm{order}(G)$ is odd.
If $\mathrm{order}(G)$ is even, again by Cauchy's theorem, there is an element of order $2$. Suppose there are $k$ elements of order $2$ and denote these by $g_1,g_2,\ldots,g_k$. Then, because $G$ is abelian by assumption, $\{e,g_1,g_2,\ldots,g_k\}\subset G$ is a subgroup (verify this). Then by Cauchy's theorem again, the order of this subgroup must be even, thus $k$ is odd. If we write out $\prod_{g\in G}g$ now, we observe that for all $g\not\in\{e,g_1,g_2,\ldots,g_k\}$, both the element and its inverse appear exactly once in the product, thereby yielding the identity element. Thus the product reduces to $\prod_{i=1}^{k}g_i$. For $k=1$, it's simple, $\prod_{g\in G}g=g_1$, for $k=3$ also: $\prod_{g\in G}g=g_1\circ g_2\circ g_3=g_3^2=e$, since $g_1\circ g_2\not\in \{e,g_1,g_2\}$. For any $k>3$ (the general case) the product reduces to exactly one element in $\{e,g_1,g_2,\ldots,g_k\}$ but to be honest I don't see how to infer anything about this.
So this is not a duplicate of the linked questions, the way I see it, because you are asked to determine the product in all generality. Maybe someone else knows how to calculate the product for $k>3$.
Question: for the case described above, how do I determine $\prod\limits_{g\in G}g$? This case is not treated in the other answers. Obviously the product reduces to exactly one element in $\{e,g_1,g_2,\ldots,g_k\}$, but can we say for which values of $k$ the product equals $e$ and when it equals a non-identity element from $\{e,g_1,g_2,\ldots,g_k\}$?
And please, don't close again unless there is a good reason. Also, if I'm missing something and I'm asking something that is totally trivial, please explain! Thanks in advance!
A:
In the general case you always get the identity. First note that the elements of order $2$ don't just have the structure of an abelian group, but also of a vector space over $\mathbb{F}_2$.
You are then just asking what the sum of every element in a finite dimensional vector space over $\mathbb{F}_2$ is. The answer is of $0$ unless the dimension is $1$ in which case it's the nonzero element. To see this either use induction starting at the 2-dimensional case or just note that the answer must be invariant under the action of $GL_n(\mathbb{F}_2)$, which acts transitively on the non-zero vectors.
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Over the years, I have often been asked to define what makes a good leader. Most working professionals have a strong opinion about this topic, or at the very least a personal view. I have come to realise that it is not so much the qualities of the leader that make a difference, but the effect the leader has on a company’s culture, and the engagement and determination this leadership inspires in all teams.
Leadership is the art of motivating a group of people to achieve common goals. It is about sharing a clear vision, set a steady direction and make all individuals and teams understand the important role they all play in moving the company forward. Today companies are diverse and people have different needs and expectations of their job and the company they work for. Several studies show that the levels of disengagement among employees in many countries are high and increasing. The loyalty that defined previous generations’ relationship to their employer has changed drastically. Today, people need to find a sense of purpose in their job. They also need to feel that they are part of a community, that they have a clear role to play, are recognised for their contribution and that they can leave their own marks. People want to work for an organisation that represents their own values. If they experience a mismatch, they are likely to disengage, lose motivation and often end up leaving.
I believe that a good leader can change this trend. Leadership is about seeing everyone’s potential and empowering your teams to use their entire skillset, give them room to express their ideas and creativity, and work to the best of their ability. This is not only positive for the employee, but highly beneficial for the company as well. Good leadership is fundamental in creating a culture where employees feel empowered to do their very best, think out of the box and dare to speak up when there is a problem.
As leaders, I believe we cannot succeed without the support of our teams. We are a lot stronger and more prone to success when we have their support because they believe in our vision and feel part of it, than if they only follow instructions from their hierarchy. This is why empathy is as important as drive, the ability to listen as crucial as the skill to communicate our own convictions, and the power to learn from failures as essential as celebrating major victories. Authority is not leadership. Leadership is about empowering teams to succeed and creating velocity for growth by capturing the team’s collective IQ, EQ, and their individual capacity to drive outcomes.
I also think that a leader that is passionate about his or her vision and goals makes a real difference. There is a saying that states that, “People with great passion can make the impossible happen”, and this is true also in a corporate setting. Inspirational leaders are passionate people who move beyond the reality of limited thinking. When you are working with someone who has a passion for what he or she does and believes in the goals he or she is trying to achieve, the feeling is extremely contagious. It makes people around them believe that they can achieve anything as well, and the more people that are engaged in their job and enthusiastic about what they are working to accomplish, the stronger and healthier the organisation will be. As Steve Jobs was quoted as saying: “If you’re working on something exciting that you really care about, you don’t have to be pushed. The vision pulls you”.
Women leaders are better at creating a sense of purpose
The important word here is “working”, which is different from thinking, wishing, hoping and believing. If you work towards something, it means that you have passed the initial motivational and awareness stage and you are actually implementing concrete steps and putting real and measurable effort into making a change. Motivation alone will not yield results, just as the ability to motivate people is not in itself enough – leaders need to be empathetic and connect with others to be successful. Passion goes hand in hand with purpose, and both come from within and are defined on a personal level. That’s why it is so important for a leader to be authentic and true to himself or herself. Only then can a leader inspire real change and passion in others.
According to a recent survey on leadership led by employee engagement platform Peakon, women leaders are more successful in creating a sense of purpose within their organisations and are better at communicating their organisation’s strategic goals internally. The differences seen between female and male-led companies could be due to the fact that industries that promote female leaders or attract top female talent might already be higher-performers when it comes to strategy and autonomy. Interestingly, the survey suggests that female leadership might not be the cause of these findings, but the result.
I believe that we need diverse leaders to reach our common goals and create a better work environment and society, with equal opportunities. With more women leaders, we would be able to fight the disengagement among employees in many industries. Women are often driven by a strong purpose, we promote teamwork, we are inclusive and we often put people first. However, women cannot succeed in a world without men; it is the diversity in perspectives that lead to success.
I am very proud to be part of the jury of WFE’s Women Leader’s List 2021, and I encourage women across the WFE member organisations to dream big and set high ambitions for themselves and their teams. | https://focus.world-exchanges.org/articles/leadership-passion-becker |
Aadhaar number is a 12-digit random number issued by the Unique Identification Authority of India (UIDAI) to the residents of India after satisfying the verification process laid down by it. The Aadhaar number is a proof of identity and does not confer any right of citizenship or domicile. Aadhaar has become very important now keeping in view the fact that the number has been made compulsory by the government for many financial transactions as well as a host of social schemes. However, the involvement of third-party agencies in data collection for Aadhaar has also left a lot of people worried over the safety and protection of their personal information and biometric data.
UIDAI, however, says that there is no need to worry as protection of an individual and safeguarding his/her information is inherent in the design of the UID project. UIDAI also has the obligation to ensure the security and confidentiality of the data collected.
1. What are the privacy protections in place to protect the right to privacy of the resident?
Protection of an individual and safeguarding his/her information is inherent in the design of the UID project. From having a random number which does not reveal anything about the individual to many other features, the UID project keeps the interest of the resident at the core of its purpose and objectives.
The UIDAI ( is collecting only basic data fields – Name, Date of Birth, Gender, Address, Parent/ Guardian’s (name essential for children but not for others) photo, 10 finger prints and IRIS scan.
The UIDAI policy bars it from collecting sensitive personal information such as religion, caste, community, class, ethnicity, income and health. The profiling of individuals is, therefore, not possible through the UID system.
UIDAI does not reveal personal information in the Aadhaar database – the only response is a ‘yes’ or ‘no’ to requests to verify an identity.
The UID database is not linked to any other databases, or to information held in other databases. Its only purpose is to verify a person’s identity at the point of receiving a service, and that too with the consent of the Aadhaar number holder.
The UID database is guarded both physically and electronically by a few select individuals with high clearance. The data is secured with the best encryption features, and in a highly secure data vault. All access details are properly logged.
2. What are the Data protection and privacy measures taken by UIDAI?
The UIDAI has the obligation to ensure the security and confidentiality of the data collected. The data will be collected on software provided by the UIDAI and encrypted to prevent leaks in transit. The UIDAI has a comprehensive security policy to ensure the safety and integrity of its data. There are security and storage protocols in place. UIDAI guidelines are available on its website.
Penalties for any security violation will be severe, and include penalties for disclosing identity information. There will also be penal consequences for unauthorised access to CIDR – including hacking, and penalties for tampering with data in the CIDR.
3. What are the possible criminal penalties envisaged against the fraud or unauthorized access to data?
# Impersonation by providing false demographic or biometric information is an offence – imprisonment for 3 years and a of fine Rs 10,000.
# Appropriating the identity of an Aadhaar number holder by changing or attempting to change the demographic and biometric information of an Aadhaar number holder is an offence – imprisonment for 3 years and a fine of Rs 10,000.
# Pretending to be an agency authorized to collect Identity information of a resident is an offence – imprisonment for 3 years and a fine of Rs 10,000 for a person, and Rs 1 lakh for a company.
# Intentionally transmitting information collected during enrolment and authentication to an unauthorized person is an offence – imprisonment for 3 years and a fine of Rs 10,000 for a person, and Rs 1 lakh for a company.
# Unauthorized access to the central identities data repository (CIDR) and hacking is an offence – imprisonment for 3 years and a fine of Rs 1 crore.
# Tampering with the central identities data repository is an offence – imprisonment for 3 years and a fine of Rs 10,000.
# Providing biometrics that is not one’s own is an offence – imprisonment for 3 years and of Rs 10,000.
Despite these security systems and criminal penalties, some security concerns remain as third-party agencies are involved for collecting data for Aadhaar. A majority of experts, however, say that the UIDAI itself has clarified that the usage of private agencies is commonplace in most government systems, including the Passport system of India, which also collects demographic and biometrics data. From this perspective, usage of private agencies/companies in itself is not against any government practices. Moreover, there are legal statutes in place that prevent third parties from holding the Aadhaar data. They are only allowed to collect and transmit the encrypted data to the UIDAI servers and receive acknowledgements. Also, UIDAI has implemented strong security and data protection measures, which makes it impossible to steal data.
Some experts, however, say that ultimately every system (including social security no in the US) is prone to some or other risk of error or mischief, and Aadhaar is no exception. Hence, be it a government agency or a third party managing it, there will always be a risk of human error or mischief. | http://www.aadhaarsolutions.com/news/safe-aadhaar-data-security-measures-taken-uidai-heres-need-know/ |
3 Mathematical Laws Data Scientists Need To Know
Machine learning and data science are founded on important mathematics in statistics and probability. A few interesting mathematical laws you should understand will especially help you perform better as a Data Scientist, including Benford's Law, the Law of Large Numbers, and Zipf's Law.
By Cornellius Yudha Wijaya, Data Scientist | Lecturer | Biologist | Writer | Podcaster.
Photo by Jeswin Thomas on Unsplash.
While a Data Scientist works with data as their main activity, it doesn't mean that mathematical knowledge is something we do not need. Data scientists need to learn and understand the mathematical theory behind machine learning to efficiently solving business problems.
The mathematics behind machine learning is not just a random notation thrown here and there, but it consists of many theories and thoughts. This thought creates a lot of mathematical laws that contribute to the machine learning we can use right now. Although you could use the mathematics in any way you want to solve the problem, mathematical laws are not limited to machine learning after all.
In this article, I want to outline some of the interesting mathematical laws that could help you as a Data Scientist. Let’s get into it.
Benford's Law
Benford’s law, also called the Newcomb–Benford law, the law of anomalous numbers, or the first-digit law, is a mathematical law about the leading digit number in a real-world dataset.
When we think about the first digit of the numbers, it should be distributed uniformly when we randomly took a number. Intuitively, the random number leading digit 1 should have the same probability as leading digit 9, which is ~11.1%. Surprisingly, this is not what happens.
Benford’s law states that the leading digit is likely to be small in many naturally occurring collections of numbers. A leading digit of 1 happens more often than 2, a leading digit of 2 occurs more often than 3, and so on.
Let’s try using a real-world dataset to see how this law is applicable. For this article, I use the data from Kaggle regarding Spotify Track songs from 1921–2020. From the data, I take the leading digit of the song durations.
Image created by Author.
From the image above, we can see that the leading digit 1 occurs the most, then it is decreasing following the higher number. This is what Benford’s Law state above.
If we talk about the proper definition, Benford law state that a set of numbers is said to satisfy Benford’s law if the leading digit d (𝑑 ∈ 1, …, 9) occurs with the equation,
Image created by Author.
From this equation, we acquire the leading digit with the following distribution,
Image created by Author.
With this distribution, we can predict that 1 as the leading digit is 30% likely to occur more than the other leading digit.
Many applications for this law exist, for example, in fraud detection on tax forms, election results, economic numbers, and accounting figures.
Law of Large Numbers (LLN)
The Law of Large Numbers states that as the number of trials of a random process increases, the results' average get closer to the expected values or theoretical values.
For example, when rolling dice, the possibilities for a 6-sided die are 1, 2, 3, 4, 5, and 6. The mean for the 6-side dice would be 3.5. As we roll the die, the number we get is random from 1 to 6, but as we keep rolling the dice, the results' average get closer to the expected value, which is 3.5. This is what the Law of Large Numbers denote.
While it is useful, but the tricky part here is that you need many experiments or occurrences. However, having a large number required means that it is good for predicting long-term stability.
The Law of Large Numbers is different than the Law of Averages used to express a belief that outcomes of a random event will “even out” within a small sample. This is what we called “Gambler’s Fallacy,” where we expect the expected value occurs in a smaller sample.
Zipf's Law
Zipf’s law was created for quantitative linguistics and states that given some natural language dataset corpus, any word's frequency is inversely proportional to its frequency table rank. Thus the most frequent word occurs approximately twice as often as the second most frequent word and three times as often as the third most frequent word.
For example, in the previous Spotify dataset, I split all the words and punctuation to count them. Below is the top 12 of the most common words and their frequency.
Image Created by Author.
When I sum all the words that exist in the Spotify corpus, the total is 759,389. We can see if Zipf’s law applies to this dataset by counting the probabilities when they occur. The first most occurring word or punctuation is ‘-’ with 32,258, which has the probability of ~4%, followed by ‘the,’ which has the probability of ~2%.
Faithful to the law, the probability keeps going down in some of the words. Of course, there is a little deviation, but the probability goes down most of the time following the frequency rank increase.
Original. Reposted with permission.
Related:
- How Much Math do you need in Data Science? | https://www.kdnuggets.com/2021/03/3-mathematical-laws.html |
1. Introduction {#sec1-ijms-20-00081}
===============
Alzheimer's disease (AD) is the leading cause of dementia worldwide and accounts for 60--80% of all cases \[[@B1-ijms-20-00081]\]. AD is characterized by senile plaques made of β-amyloid peptide (Aβ) and neurofibrillary tangles of hyperphosphorylated tau protein. There are two types of AD: Early-onset familial AD, and late-onset AD (LOAD); LOAD accounting for approximately 95% of all AD cases \[[@B2-ijms-20-00081],[@B3-ijms-20-00081]\]. Familial AD accounts for a small percentage of all cases and occurs exclusively through gene mutations in amyloid precursor protein (APP), or presenilins (PSEN1, PSEN2) that increase the production of Aβ \[[@B2-ijms-20-00081],[@B3-ijms-20-00081]\], or the ratio between longer (Aβ42) and shorter Aβ peptides. These mutations follow a pattern of Mendelian inheritance and result in symptom manifestation before the age of 65 \[[@B4-ijms-20-00081]\]. In contrast, LOAD has no known causative gene mutations, however, genome-wide association studies (GWAS), and whole exome sequencing have identified over 30 AD risk loci \[[@B5-ijms-20-00081]\]. Over half of those have been implicated in innate immune response including Apolipoprotein E (APOE) and triggering receptor expressed on myeloid cells 2 (TREM2) \[[@B6-ijms-20-00081],[@B7-ijms-20-00081],[@B8-ijms-20-00081],[@B9-ijms-20-00081]\].
In humans, the *APOE* gene resides on chromosome 19 and has three alleles with different allele frequencies: *APOEε2*, 5--10%; *APOEε3*, 65--70%; and *APOEε4*, 15--20% \[[@B10-ijms-20-00081]\]. APOE is a 299 amino acid protein, is a major cholesterol carrier in the circulation and the only cholesterol transporter in the brain \[[@B11-ijms-20-00081]\]. In mouse models for AD, the human isoforms APOE2 and APOE3 have the ability to bind and clear Aβ more efficiently compared to APOE4 \[[@B12-ijms-20-00081]\]. The physiological role of APOE in lipid trafficking is crucial as lipids play an essential role in immune regulation through cell signaling, membrane fluidity, and serve as ligands for a number of immune receptors \[[@B13-ijms-20-00081]\]. TREM2 is a cell surface receptor on myeloid cells, and through its interaction with protein tyrosine kinase binding protein (TYROBP), TREM2 activation initiates a multitude of pathways that promote cell survival \[[@B14-ijms-20-00081],[@B15-ijms-20-00081]\], proliferation \[[@B16-ijms-20-00081]\], chemotaxis, and phagocytosis \[[@B15-ijms-20-00081],[@B16-ijms-20-00081],[@B17-ijms-20-00081],[@B18-ijms-20-00081],[@B19-ijms-20-00081],[@B20-ijms-20-00081],[@B21-ijms-20-00081]\], making it vital for normal immune function. The most common TREM2 variant, R47H (arginine to histidine at position 47), impairs ligand binding and increases the risk of developing AD by approximately 4-fold \[[@B6-ijms-20-00081],[@B8-ijms-20-00081]\]. TREM2 has the ability to recognize a variety of ligands, many of them on the surface of apoptotic cells, phospholipids, glycolipids, and lipoproteins including low-density lipoprotein (LDL) and high-density lipoproteins (HDL), Clusterin (APOJ) and APOE \[[@B22-ijms-20-00081],[@B23-ijms-20-00081],[@B24-ijms-20-00081]\]. Emerging evidence suggests that TREM2 can bind to and is a putative receptor for APOE \[[@B22-ijms-20-00081],[@B23-ijms-20-00081],[@B24-ijms-20-00081]\], thus raising the possibility of an APOE-TREM2 interaction modulating AD pathogenesis. This review focuses on the interplay between APOE isoform and TREM2 and their association with AD.
2. APOE {#sec2-ijms-20-00081}
=======
2.1. APOE Structure and Isoforms {#sec2dot1-ijms-20-00081}
--------------------------------
In the brain, APOE is secreted by glia, mainly astrocytes, and is lipidated by adenosine triphosphate-binding cassette transporters A1 (ABCA1) and G1 (ABCG1) ([Figure 1](#ijms-20-00081-f001){ref-type="fig"}). ABCA1 transports cholesterol and phospholipids to lipid-free APOE, thus forming discoidal HDL particles (reviewed in \[[@B25-ijms-20-00081],[@B26-ijms-20-00081]\]). The discoidal HDL particles are composed of 100 to 200 lipid molecules that are surrounded by two apolipoprotein molecules \[[@B27-ijms-20-00081]\]. Once sufficient cholesterol and phospholipids are available to ABCA1, it undergoes a conformation change and forms a dimer. The lipidated dimers interact with actin filaments on the plasma membrane, thereby immobilizing them until lipid-free apolipoprotein directly binds to the ABCA1 dimer. Upon binding, the apolipoprotein accepts the lipids presented by ABCA1 and forms a discoidal HDL particle leaving the ABCA1 dimer to dissociate back to a monomer and begin the process again \[[@B27-ijms-20-00081]\]. In the brain, APOE is primarily synthesized de novo and there is a limited exchange between APOE circulating in the blood and the brain \[[@B28-ijms-20-00081],[@B29-ijms-20-00081]\]. In humans, APOE isoforms differ at either position 112 or 158 ([Figure 1](#ijms-20-00081-f001){ref-type="fig"}). APOE2 has cysteine (Cys) residues at both positions 112 and 158, APOE3 has a Cys residue at 112 and an arginine (Arg) residue at 158, and APOE4 has Arg residues at both positions \[[@B30-ijms-20-00081]\]. All other mammals investigated so far have a single APOE isoform with Arg at the residue equivalent to human APOE 112 \[[@B31-ijms-20-00081]\].
APOE has two functional domains: An N-terminal domain, residues 136--150, and a C-terminal lipid-binding domain, residues 244--272 \[[@B10-ijms-20-00081],[@B11-ijms-20-00081]\]). The N-terminal domain forms a four-helix bundle \[[@B32-ijms-20-00081]\] and the amino acid differences between isoforms alter the protein structure, thus leading to differential lipid and receptor binding. With a Cys residue at position 112, both APOE2 and APOE3 have the ability to form disulfide-linked hetero- and homodimers, while Arg at position 112 of APOE4 significantly impedes the binding \[[@B33-ijms-20-00081]\]. The structural variation between isoforms due to amino acid Cys/Arg at position 158 impacts the receptor-binding domain of APOE and thus, the binding affinity to APOE receptors. The variation at position 112 plays a role in domain--domain interaction and affects lipid binding properties of APOE \[[@B34-ijms-20-00081]\], thus explaining the binding preference of APOE4 for very low-density lipoproteins (VLDL) and APOE3 to HDL \[[@B35-ijms-20-00081]\]. Therefore, the stability and functional role of APOE is largely dependent on its ability to interact with lipids and its receptor binding properties.
2.2. APOE Receptors {#sec2dot2-ijms-20-00081}
-------------------
APOE predominantly binds to receptors of LDL receptor family, which includes low-density lipoprotein receptor (LDLR), LDLR-related receptor 1 (LRP1), very-low-density lipoprotein receptor (VLDLR), and APOE receptor 2 (APOER2) \[[@B36-ijms-20-00081],[@B37-ijms-20-00081],[@B38-ijms-20-00081]\] ([Figure 1](#ijms-20-00081-f001){ref-type="fig"}). The members of the LDL receptor family share structural properties consisting of a short intracellular domain, a transmembrane domain, and a large extracellular domain with a varying number of complement-type repeats, which allow them to interact with APOE \[[@B38-ijms-20-00081]\]. The first identified key member of this family of receptors was LDLR, which is the main receptor for LDL and VLDL. LDLR preferentially binds to lipidated APOE particles, and its deficiency leads to severe hypercholesterolemia and premature atherosclerosis \[[@B39-ijms-20-00081]\]. LRP1 binds to APOE aggregates and is essential for early development, as the deletion of the *Lrp1* gene in mice results in embryonic lethality \[[@B40-ijms-20-00081]\], while the brain-specific knockdown of *Lrp1* inhibits synaptic transmission and motor function \[[@B41-ijms-20-00081]\]. LDLR and LRP1 are the main APOE receptors in the brain, and deletion of *Ldlr* increases APOE levels \[[@B42-ijms-20-00081],[@B43-ijms-20-00081]\]. Both APOER2 and VLDLR are almost exclusively expressed in the brain, are structurally very similar to each other, bind to lipid-free APOE, and are dependent on the extracellular ligand Reelin \[[@B44-ijms-20-00081]\]. In mice deletion of both *Apoer2* and *Vldlr* leads to defective lamination of the cerebellum, cortex, and hippocampus, as well as a reduction in cerebellum volume and impaired motor function \[[@B44-ijms-20-00081]\].
Activation of APOE receptors by Reelin initiates a signaling cascade through the initiation of Src family kinases (SFKs). The activation includes PI3 kinase and Protein kinase B (Akt), which result in reduced phosphorylation of the microtubule stabilizing protein tau, and regulation of microtubule dynamics \[[@B45-ijms-20-00081],[@B46-ijms-20-00081]\]. As noted above, due to the amino acid substitution of Arg with Cys at 158 leading to conformational differences, APOE2 exhibits a severely decreased binding affinity to LDLR (1--2% of APOE3) \[[@B47-ijms-20-00081]\], a significantly decreased affinity to bind LRP1 (40% of APOE3) \[[@B47-ijms-20-00081]\], but similar affinity to VLDLR \[[@B48-ijms-20-00081]\]. The receptors from the LDL receptor family have distinct physiological roles due in part to their affinity to ligands, signaling potency, cellular localization, expression pattern, and endocytosis rate \[[@B36-ijms-20-00081]\].
2.3. APOE Function in the CNS {#sec2dot3-ijms-20-00081}
-----------------------------
The human brain accounts for approximately 2% of the weight of the body but contains over 20% of its total cholesterol \[[@B49-ijms-20-00081]\]. In the brain, cholesterol is necessary for the formation and maintenance of synapses, and APOE plays a major role in cholesterol homeostasis. The blood--brain barrier (BBB) prevents the exchange between the brain and plasma cholesterol and lipids transported by HDL, LDL, and VLDL \[[@B28-ijms-20-00081]\]. APOE as the major lipid carrier in the brain and has an important role in the transport of cholesterol and other lipids from astrocytes to neurons, where they are needed to maintain synaptic plasticity \[[@B50-ijms-20-00081]\]. The important role of APOE in synaptic integrity and plasticity, as well as dendritic complexity, has been demonstrated by experiments in APOE knockout mice \[[@B29-ijms-20-00081],[@B51-ijms-20-00081]\].
Disruptions in synaptic function such as decreased synaptic density, and alterations in autophagy, are pathological features of neurodegenerative disorders, including AD \[[@B52-ijms-20-00081],[@B53-ijms-20-00081],[@B54-ijms-20-00081],[@B55-ijms-20-00081]\]. There is increasing evidence that APOE isoforms differentially impact synaptic integrity and plasticity \[[@B56-ijms-20-00081],[@B57-ijms-20-00081],[@B58-ijms-20-00081],[@B59-ijms-20-00081]\]. In mice and humans, APOE4 correlates inversely with dendritic spine density \[[@B56-ijms-20-00081],[@B60-ijms-20-00081]\], and synaptic proteins PSD-95, synaptophysin, and syntaxin 1 are altered in an APOE isoform-specific manner (APOE4 \< APOE3 \< APOE2) \[[@B57-ijms-20-00081]\]. It has been shown that in targeted replacement mice expressing human APOE, APOE4 isoform has a differential effect on neuronal signaling in young and aged mice indicated by the expression level of proteins in NMDAR-dependent ERK/CREB pathway, reduced expression of APOE receptor LRP1 and lower NR2A phosphorylation \[[@B59-ijms-20-00081]\]. Other studies demonstrated that in APOE4 expressing mice, dendritic spine density and complexity, as well as glutamate receptor function, and synaptic plasticity are impaired \[[@B61-ijms-20-00081],[@B62-ijms-20-00081]\]. Meta-analyses addressing the differential effect of APOE isoforms in cognitively healthy adults over the age of 60 suggest that *APOEε4* carriers exhibit impaired episodic memory, executive function, and global cognition, with no impact on primary memory, verbal ability, or attention \[[@B63-ijms-20-00081],[@B64-ijms-20-00081]\]. Studies utilizing the same cognitive tests and similar in size patient cohorts are rare, thus making the findings inconsistent between groups \[[@B65-ijms-20-00081]\]. Whether or not memory and cognitive impairments in humans, carriers of *APOEε4* allele, are associated with a disturbed neuronal signaling and the level of NR2A phosphorylation, as in APOE4 expressing mice, is not known.
3. TREM2 {#sec3-ijms-20-00081}
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3.1. TREM2 Structure and Expression {#sec3dot1-ijms-20-00081}
-----------------------------------
TREM2 is a transmembrane receptor of the immunoglobulin superfamily expressed on the plasma membrane of myeloid cells and microglia, and is active in the innate immune response \[[@B66-ijms-20-00081]\]. TREM2 protein consists of an extracellular Ig-like domain, a transmembrane domain, and a small cytoplasmic tail. In the CNS, TREM2 expression is strongest in the basal ganglia, corpus callosum, spinal cord, and medulla oblongata \[[@B67-ijms-20-00081]\]. Human *TREM2* is located on chromosome 6p21.1 in the *TREM* gene cluster near other TREM and TREM-like genes: *TREML1*, *TREM2*, *TREML2*, *TREML3*, *TREML4*, and *TREM1* \[[@B68-ijms-20-00081],[@B69-ijms-20-00081]\]. Many of these genes are conserved in mice and humans with only *Trem3* and *Trem6* unique to mice and *TREML3* to humans. Both TREM2 and TREM1 interact with TYROBP to initiate pathways involved in cell activation and phagocytosis \[[@B16-ijms-20-00081],[@B69-ijms-20-00081]\]. TREMs proteins are implicated in the clearance of extracellular debris \[[@B70-ijms-20-00081]\].
The proteolytic cleavage of TREM2 ectodomain generates soluble TREM2 (sTREM2) \[[@B71-ijms-20-00081]\] ([Figure 2](#ijms-20-00081-f002){ref-type="fig"}). sTREM2 has the ability to passes the Brain---cerebral spinal fluid (CSF) barrier and can be detected in CSF \[[@B72-ijms-20-00081]\].
3.2. TREM2 Function {#sec3dot2-ijms-20-00081}
-------------------
TREM2 binds Lipopolysaccharides (LPS) \[[@B73-ijms-20-00081]\], phospholipids \[[@B15-ijms-20-00081]\], HDL \[[@B24-ijms-20-00081]\], LDL, APOE \[[@B22-ijms-20-00081],[@B23-ijms-20-00081],[@B24-ijms-20-00081]\], APOJ \[[@B24-ijms-20-00081]\], apoptotic neurons \[[@B18-ijms-20-00081]\], and Aβ \[[@B74-ijms-20-00081]\] all of which activate signaling pathways ([Figure 2](#ijms-20-00081-f002){ref-type="fig"}). TREM2 conveys intracellular signals through TYROBP, an adaptor protein that contains functional docking sites known as ITAMs. Upon TREM2 activation through ligand binding, the ITAMs on TYROBP are phosphorylated and recruit SYK. SYK activates the PI3K--AKT pathway and phosphorylates the adaptor LAT (linker for activation of T-cells family member 1), which recruits other signaling adaptors including PLCγ. PLCγ degrades PIP3 into IP3, which creates an efflux of Ca^2+^ \[[@B15-ijms-20-00081],[@B66-ijms-20-00081],[@B75-ijms-20-00081]\] ([Figure 2](#ijms-20-00081-f002){ref-type="fig"}).
Unlike the signaling cascade triggered by ligand-activated TREM2 ([Figure 2](#ijms-20-00081-f002){ref-type="fig"}), the biological role of sTREM2 is not well understood. It has been proposed, however, that it either acts as a decoy receptor opposing full-length TREM2 \[[@B76-ijms-20-00081]\] or has another still unidentified function. In cell culture, at least, sTREM2 promoted survival of bone marrow-derived macrophages (BMDM) \[[@B77-ijms-20-00081]\], yet failed to rescue phagocytosis in TREM2-deficient BMDM cells \[[@B78-ijms-20-00081]\].
A well-established function of *TREM2* is the regulation of cell proliferation. Knockdown of *TREM2* in primary microglia leads to a reduction in cell number \[[@B79-ijms-20-00081]\] and TREM2 deficiency inhibits myeloid cell population growth in response to traumatic brain injury \[[@B80-ijms-20-00081]\] and aging \[[@B16-ijms-20-00081]\]. Expression of *TREM2*, even at a normal level, may also impact the proliferation of endothelial cells. Recently, Carbajosa et al. investigated the impact of TREM2 deficiency, in the brain of young and aged mice using RNA-seq and found a disruption of gene networks related to endothelial cells that is more apparent in younger than in older mice. They suggested that the absence of TREM2 in microglia influences endothelial gene expression, which may link immune response and brain vascular disease as an underlying factor in AD pathogenesis \[[@B81-ijms-20-00081]\]. Microglia survival in the context of TREM2 expression has been also linked to the CSF-1-CSF-1R pathway, which is primarily active in conditions of reactive microgliosis \[[@B82-ijms-20-00081]\] and affects Aβ clearance \[[@B83-ijms-20-00081]\]. Since it has been demonstrated that TREM2 signaling, via TYROBOP, synergizes with CSF-1R signaling to promote survival of macrophages \[[@B84-ijms-20-00081]\], a similar mechanism can be involved in microglial survival as well. A recent study by Wang et al. demonstrating that TREM2-deficient microglia exhibited reduced survival at low CSF-1 concentrations support the role of CSF-1R signaling in microglia survival \[[@B15-ijms-20-00081]\]. In conjunction with decreased survival, TREM2-deficient microglia demonstrate a reduced chemotactic capacity. Migration of microglia towards injected apoptotic neurons as well as towards sites of laser-induced damage was also reduced in *Trem2*^−/−^ mice \[[@B20-ijms-20-00081]\].
3.3. TREM2 Variants and Neurodegeneration {#sec3dot3-ijms-20-00081}
-----------------------------------------
Rare biallelic mutations that result in loss of function of TREM2 cause Nasu--Hakola disease \[[@B67-ijms-20-00081]\] (NHD) and in some cases Frontotemporal dementia (FTD) \[[@B68-ijms-20-00081],[@B85-ijms-20-00081]\]. NHD is manifested with bone cysts and early onset of neurodegeneration. Brain pathology is comprised of axonal degeneration, white matter loss, cortical atrophy, increased microglia density, and astrogliosis \[[@B86-ijms-20-00081],[@B87-ijms-20-00081],[@B88-ijms-20-00081]\]. The variants associated with NHD and FTD can be a result of coding mutations in the transmembrane domain (D134G, K186N) \[[@B67-ijms-20-00081]\], ectodomain (Y38C, T66M) \[[@B68-ijms-20-00081],[@B89-ijms-20-00081],[@B90-ijms-20-00081]\], early stop codons \[[@B91-ijms-20-00081],[@B92-ijms-20-00081]\], or mutations in a splice site \[[@B93-ijms-20-00081],[@B94-ijms-20-00081]\]. Considering the role of *TREM2* in microglial function, variants in *TREM2* can be part of functional networks involved in multiple neurodegenerative disorders. Numerous studies have evaluated the effect of TREM2 on risk for AD (discussed in [Section 4.2](#sec4dot2-ijms-20-00081){ref-type="sec"}), frontotemporal dementia (FTD) \[[@B95-ijms-20-00081]\], amyotrophic lateral sclerosis (ALS) \[[@B96-ijms-20-00081],[@B97-ijms-20-00081],[@B98-ijms-20-00081]\], Lewy body dementia \[[@B99-ijms-20-00081]\], posterior cortical atrophy \[[@B100-ijms-20-00081]\], Creutzfeldt-Jakob disease \[[@B101-ijms-20-00081]\], progressive supranuclear palsy \[[@B96-ijms-20-00081]\], Parkinson′s disease \[[@B96-ijms-20-00081]\], ischemic stroke \[[@B96-ijms-20-00081]\], and multiple system atrophy \[[@B102-ijms-20-00081]\].
TREM2 R47H variant was identified as a risk factor for AD independently by two groups that analyzed European and North American \[[@B8-ijms-20-00081]\], and Icelandic cohorts \[[@B6-ijms-20-00081]\]. Later in the same year, Cruchaga et al. demonstrated that TREM2-R47H variant is associated with a higher level of tau and phospho-tau in CSF \[[@B103-ijms-20-00081]\]. The initial findings for the TREM2-R47H variant were confirmed by other groups \[[@B104-ijms-20-00081],[@B105-ijms-20-00081]\]. In addition, Sims et al. reported a significant association of TREM2-R47H and -R62H variants with LOAD and showed that even after removing these variants from the analysis the association remained significant suggesting the presence of other *TREM2* risk variants \[[@B106-ijms-20-00081]\]. *TREM2 pW191X* and *pL211P* variants were recently identified associated with LOAD in African American cohort but the variants shown to confer AD risk in Caucasians were extremely rare \[[@B107-ijms-20-00081]\]. Similarly, Yu et al. reported several new TREM2 variants in the Han Chinese population, however, none of them was significantly associated with AD risk and the TREM2 R47H variant was not detected in this population \[[@B108-ijms-20-00081]\].
In addition to *TREM2*, another gene in the same cluster---*TREML2* was also examined for association with LOAD. In a meta-analysis study of 36,306 human CSF samples, the missense variant rs3747742 of *TREML2* seemed to confer a protective effect against AD \[[@B109-ijms-20-00081]\]. A complete list of so far identified TREM2 variants---can be found on the ALZ forum website <https://www.alzforum.org/>.
Recently, Kober et al. demonstrated that NHD variants impact protein stability and decrease TREM2 cell surface expression, while AD variants impact TREM2 ligand binding \[[@B110-ijms-20-00081]\] ([Figure 2](#ijms-20-00081-f002){ref-type="fig"}). When mapping the electrostatic surface of TREM2, Kober et al. identified a large basic patch that was not present in other members of the TREM family \[[@B111-ijms-20-00081],[@B112-ijms-20-00081]\] indicating a unique role for this domain in TREM2 function. Many of the AD-related mutations can be found near or within this basic region of TREM2. Both R47H and R62H decrease the size of the basic patch and reduce binding properties resulting in a loss of function, while T96K increases the size corresponding to a gain of function \[[@B110-ijms-20-00081]\].
4. APOE, TREM2, and AD {#sec4-ijms-20-00081}
======================
4.1. APOE and AD {#sec4dot1-ijms-20-00081}
----------------
Studies in mice have suggested that a relationship between APOE isoform and Aβ metabolism was involved in AD pathogenesis. Considering APOE as an Aβ binding protein \[[@B113-ijms-20-00081]\], many of the early in vitro studies tested Aβ binding to APOE and other apolipoproteins \[[@B114-ijms-20-00081],[@B115-ijms-20-00081],[@B116-ijms-20-00081],[@B117-ijms-20-00081],[@B118-ijms-20-00081]\]. While the binding was repeatedly confirmed, none of those studies provided any indication that the risk for AD was dependent on differences in APOE-Aβ binding.
*APOEε4* is the major genetic risk factor for LOAD \[[@B119-ijms-20-00081],[@B120-ijms-20-00081]\]. Inheritance of a single copy of *APOEε4* increased AD risk by \~3-fold, and the inheritance of two copies increases risk by \~12-fold \[[@B121-ijms-20-00081]\]. Compared to AD patients who are not *APOEε4* carriers, AD patients who carry at least one *APOEε4* allele exhibit an earlier disease onset, faster disease progression, and increased brain atrophy \[[@B119-ijms-20-00081],[@B122-ijms-20-00081],[@B123-ijms-20-00081]\]. Importantly, however, homozygous *APOEε3* AD patients still account for the majority of LOAD cases, suggesting that additional genetic or environmental factors are relevant to disease progression. The question, however, if the APOE4 isoform is deleterious or less protective, remains unanswered, with evidence supporting both claims \[[@B124-ijms-20-00081]\]. While the global deletion of APOE is associated with a drastic reduction of compact amyloid plaques in the brain of APP expressing mice \[[@B51-ijms-20-00081],[@B125-ijms-20-00081],[@B126-ijms-20-00081],[@B127-ijms-20-00081]\] the phenotypes of those mice have not been extensively examined to improve our understanding of the role of APOE in the development of AD. Recent studies provided new insight on the role of microglia in the phenotype of APP expressing mice with global deletion of mouse *Apoe*---their reduced microglia recruitment and altered plaque morphology indicated a role beyond APP processing and deposition \[[@B128-ijms-20-00081]\].
Using mouse models for AD, it has been established that human APOE differentially impacts Aβ deposition in a dose-dependent, as well as isoform-specific manner, with APOE4 \> APOE3 \> APOE2 \[[@B12-ijms-20-00081],[@B129-ijms-20-00081],[@B130-ijms-20-00081],[@B131-ijms-20-00081]\]. Interestingly, recent publications implicated APOE as essential for plaque formation during early seeding stages of Aβ deposition \[[@B132-ijms-20-00081],[@B133-ijms-20-00081]\]. Utilizing APOE3 and APOE4 inducible mice Liu et al. have shown that APOE4 but not APOE3 increases amyloid pathology when expressed during the early seeding stages of amyloid deposition \[[@B132-ijms-20-00081]\]. This impact was not seen in APOE3 mice and was lost when APOE4 was expressed only in later stages of plaque development, indicating APOE4 has the greatest impact on amyloid deposition during the initial seeding stages \[[@B132-ijms-20-00081]\]. By dosing with anti-sense oligonucleotides from birth, Huynh et al. showed a reduction in Aβ deposition in APOE4 mice, whereas there was no effect when the treatment began after the onset of Aβ plaque formation \[[@B133-ijms-20-00081]\].
Data from animal models suggest that APOE affects also Aβ clearance in an isoform-dependent manner \[[@B12-ijms-20-00081],[@B130-ijms-20-00081]\], and the lipidation of the protein seems to be of importance \[[@B134-ijms-20-00081]\]. There are two major Aβ clearance pathways in the brain: Receptor-mediated clearance via microglia \[[@B135-ijms-20-00081]\], and astrocytes \[[@B136-ijms-20-00081]\], BBB \[[@B137-ijms-20-00081]\], or through interstitial fluid drainage pathways \[[@B138-ijms-20-00081]\]. Cell facilitated clearance mechanisms are likely to be, in part, mediated by APOE and APOE receptors. APOE receptor-mediated internalization of Aβ seems to be most functional in microglia \[[@B139-ijms-20-00081]\] and astrocytes \[[@B140-ijms-20-00081]\]. ABCA1 functions to alter the lipidation state of APOE in the brain, which consequently impacts Aβ fibrillization (reviewed in \[[@B25-ijms-20-00081],[@B26-ijms-20-00081]\]). In APP transgenic mice, targeted disruption of *Abca1* decreases APOE lipidation and increases amyloid deposition \[[@B141-ijms-20-00081],[@B142-ijms-20-00081],[@B143-ijms-20-00081]\]. Conversely, overexpression of *Abca1* increases APOE lipidation and decreases amyloid deposition \[[@B144-ijms-20-00081]\].
The second hallmark of AD, aside from Aβ deposition, is the formation of tau tangles. Early studies demonstrated isoform-specific binding of APOE to human tau in vitro, suggesting an isoform-specific impact on tau pathology \[[@B145-ijms-20-00081],[@B146-ijms-20-00081]\]. Recently, APOE4 has been shown to exacerbate tau-mediated neurodegeneration, while the absence of APOE altogether is protective \[[@B147-ijms-20-00081]\]. Using a P301S tauopathy mouse model on human APOE KI or APOE KO background Shi et al. found no changes at 3 months, but by 9 months the P301S/E4 mice had significantly more brain atrophy than P301S/E2, or P301S/E3, and that APOE KO mice were largely protected from this effect \[[@B147-ijms-20-00081]\].
As a result of the relationship between APOE and AD, it has been suggested that targeting APOE may have a therapeutic potential for AD (reviewed in \[[@B148-ijms-20-00081]\]). There are two potential therapeutic interventions: Regulation of APOE quantity and modification of APOE properties. The former entails the upregulation of APOE levels via liver X receptor (LXR) and PPARγ agonists \[[@B149-ijms-20-00081],[@B150-ijms-20-00081],[@B151-ijms-20-00081],[@B152-ijms-20-00081],[@B153-ijms-20-00081]\]. The administrations of retinoid X receptor (RXR) agonist, bexarotene, was shown to increase APOE level and its lipidation resulting in a reversal of cognitive deficits observed in APP mouse models \[[@B60-ijms-20-00081],[@B154-ijms-20-00081],[@B155-ijms-20-00081],[@B156-ijms-20-00081]\]. However, bexarotene effect on Aβ deposition in AD mouse models is controversial \[[@B157-ijms-20-00081],[@B158-ijms-20-00081],[@B159-ijms-20-00081]\]. Another therapeutic approach is the use of specific antibodies to alter the protein levels of APOE \[[@B160-ijms-20-00081]\]. A recent study demonstrated that using an anti-APOE antibody that recognizes human APOE isoforms, targets, and specifically binds to non-lipidated forms making it effective in reducing amyloid burden in APP transgenic mice \[[@B134-ijms-20-00081]\]. The modulation of APOE properties by structural modification through small molecule correctors \[[@B161-ijms-20-00081],[@B162-ijms-20-00081]\], or by inhibiting APOE-Aβ interactions with small molecule inhibitors \[[@B163-ijms-20-00081],[@B164-ijms-20-00081]\], have also been proposed for therapeutic interventions in AD.
4.2. TREM2 and Alzheimer's Disease {#sec4dot2-ijms-20-00081}
----------------------------------
As the resident immune cells of the brain, microglia continuously monitor the brain and respond to damage-related signals that perturb the environment, (reviewed in \[[@B165-ijms-20-00081]\]). The proposed function of microglial recruitment is to form a physical barrier that encapsulates neurotoxic Aβ, thereby restricting plaque growth and containing any neurotoxic effects \[[@B166-ijms-20-00081],[@B167-ijms-20-00081]\]. Deficiency in TREM2 or its adaptor protein TYROBP prevents myeloid cell accumulation around Aβ plaques in a dose-dependent manner \[[@B15-ijms-20-00081],[@B166-ijms-20-00081],[@B167-ijms-20-00081],[@B168-ijms-20-00081],[@B169-ijms-20-00081]\]. In AD patients, heterozygous for the R47H or R62H variants, there are fewer plaque-associated microglia than in those with nonmutant TREM2 \[[@B170-ijms-20-00081]\]. This lack of microglial response in R47H carrying patients has also been shown to increase plaque-associated neuronal dystrophy and reduced microglial coverage \[[@B166-ijms-20-00081]\].
Multiple groups have examined the effects of Trem2 deficiency on amyloid pathology with different results based on the mouse model used, as well as the stage of amyloid pathology. Wang et al. examined the effect of TREM2 deficiency in 5XFAD and found that at 8.5 months there was a significant increase of amyloid load in the hippocampus but not in the cortex \[[@B15-ijms-20-00081]\]. Using 5XFAD mice at an earlier age (4 months) the same group found that Aβ accumulation was similar in TREM2 deficient and TREM2-WT 5XFAD mice \[[@B167-ijms-20-00081]\]. Likewise, Jay et al. utilizing APPPS1-21 mice found no change in the amyloid pathology in the cortex and a significant decrease in the hippocampus in *Trem2*^−/−^ mice at 4 months \[[@B169-ijms-20-00081]\]. Interestingly, the same AD mouse model, when examined at 8 months, showed an increased Aβ staining in the cortex and no changes in the hippocampus of *Trem2*^−/−^ mice \[[@B171-ijms-20-00081]\]. Jay et al. concluded that in the early stages of amyloid deposition (2-month cortex, 4-month hippocampus) TREM2 deficiency reduces both plaque number and size, and at later stages (8-month cortex) it increases plaque size and area. Yuan et al. showed that TREM2 deficiency resulted in an increase of diffuse amyloid plaques with longer and more branched amyloid fibrils thus, covering a larger surface area \[[@B166-ijms-20-00081]\]. They conclude that lack of TREM2 may disrupt the microglia barrier around the plaques that regulates amyloid compaction and has a protective role ([Figure 3](#ijms-20-00081-f003){ref-type="fig"}).
Recently transgenic mouse models expressing TREM2 R47H variant have been generated that demonstrate a diminished response to amyloid deposition exemplified by the reduced cell number and activation of microglia surrounding the plaques \[[@B172-ijms-20-00081],[@B173-ijms-20-00081]\]. These data suggest that TREM2 R47H is a loss of function variant.
In regard to sTREM2, an early study demonstrated that sTREM2 levels were reduced in the CSF of AD patients \[[@B19-ijms-20-00081]\]. However, emerging evidence suggests the opposite: sTREM2 is increased in AD and is positively correlated with tau but not Aβ42 levels \[[@B174-ijms-20-00081],[@B175-ijms-20-00081],[@B176-ijms-20-00081],[@B177-ijms-20-00081]\]. sTREM2 has also been shown to be impacted by TREM2 variants, in which R47H carriers had significantly higher, and T96K, L211P, as well as W199X had significantly lower sTREM2 levels than TREM2 WT controls \[[@B176-ijms-20-00081]\]. A recent meta-analysis study comprising of 17 reports and 1593 patients found sTREM2 levels increased in the early course of AD progression, indicating its potential use as a biomarker for AD progression \[[@B72-ijms-20-00081]\].
4.3. APOE, TREM2, and AD {#sec4dot3-ijms-20-00081}
------------------------
APOEε4 and TREM2-R47H variant were identified as independent risk factors for LOAD \[[@B6-ijms-20-00081],[@B119-ijms-20-00081],[@B120-ijms-20-00081],[@B178-ijms-20-00081]\]. Interestingly both *APOE* and *TREM2* are part of a large group of genes associated with LOAD risk that are expressed in glia cells and related immune response \[[@B179-ijms-20-00081]\]. Several groups have shown that TREM2 binds to APOE using TREM2-Fc fusion pulldown \[[@B23-ijms-20-00081]\], dot blot assays \[[@B22-ijms-20-00081]\], and high throughput protein microarrays \[[@B24-ijms-20-00081]\] ([Figure 3](#ijms-20-00081-f003){ref-type="fig"}). Atagi et al. showed that APOE increases the phagocytosis of apoptotic neurons via the TREM2 pathway and that TREM2 R47H variant was shown to reduce TREM2 affinity to bind APOE \[[@B22-ijms-20-00081]\]. Interestingly APOE lipidation appears to enhance its binding to TREM2 and microglia are more efficient at Aβ uptake when Aβ forms a complex with LDL, APOE, or CLU \[[@B24-ijms-20-00081]\]. In contrast, the same study showed that *TREM2*-deficient microglia have a reduced uptake of Aβ-APOE or Aβ-LDL complexes \[[@B24-ijms-20-00081]\]. A recent study by Jendresen et al. suggests that amino acids 130--149 of human APOE contain the binding site for TREM2, and that there is an APOE-isoform-dependent binding to TREM2 \[[@B180-ijms-20-00081]\]. Although other groups have shown no APOE isoform differences in binding \[[@B22-ijms-20-00081],[@B23-ijms-20-00081]\], possibly due to the sensitivity of binding assays and the lipidation state of APOE.
Microglia as resident macrophages in CNS account for the immune response in the brain, therefore impaired microglia function through either TREM2 deficiency or APOE isoform-specific differences have significant implications. Consistently TREM2 haplodeficient, knockout, or the TREM2 R47H variant, have shown a dose-dependent reduction in microglial activation surrounding amyloid plaques resulting in more diffuse and less compact amyloid plaques. In agreement with these results, overexpression of *TREM2* and increasing TREM2 protein level cause a significant reduction in plaque area, plaque-associated neuronal dystrophy, and amelioration of cognitive deficit in 5xFAD mice \[[@B181-ijms-20-00081]\]. Recent reports identified novel microglia type associated with neurodegenerative diseases (also called disease associated microglia or DAM) characterized by a specific transcriptional profile with both Apoe and Trem2 as part of this program \[[@B170-ijms-20-00081],[@B182-ijms-20-00081]\]. Accordingly, during the progression of neurodegeneration in APP transgenic mice and possible AD brain microglia transcriptome convert from a homeostatic to a disease associated profile. Interestingly, in APP mice that are either TREM2 or APOE deficient microglia fail to convert from a homeostatic into a fully activated state \[[@B170-ijms-20-00081],[@B182-ijms-20-00081]\]. One explanation for these findings may be the significantly decreased plaque load observed in APP transgenic and APOE or TREM2 knockout mice reported by Krasemann et al. \[[@B170-ijms-20-00081]\]. Another explanation is that TREM2 and possibly APOE deficiency prevent microglia conversion from homeostatic to disease-oriented state thus impairing essential defense functions such as chemotaxis, proliferation, phagocytosis, and survival \[[@B15-ijms-20-00081],[@B20-ijms-20-00081],[@B128-ijms-20-00081],[@B170-ijms-20-00081],[@B182-ijms-20-00081]\].
In the end, we can conclude that during the last decade significant progress has been made towards understanding the biology of APOE and TREM2, as well as the biochemical aspects of their interactions and their impact on AD pathogenesis. And although there are still many unanswered questions our knowledge of the most significant risk factors of AD will be soon implemented in successful diagnostic and therapeutic strategies against this devastating disease.
Conceptualization, C.W., I.L., and R.K.; writing---original draft preparation, C.W.; writing---review and editing, C.W., R.K., I.L., N.F., K.N.; visualization, C.W.
This research was funded by the National institute of Health, grant number ES024233, AG056371, AG057565, K01AG044490, the Alzheimer's Association, grant number, AARF-16-443213, and the U.S. Department of Defense, grant number, W81XWH-13-1-0384
The authors declare no conflict of interest.
AD
Alzheimer's disease
APOE
Apolipoprotein E
LOAD
Late Onset AD
TREM2
Triggering receptor expressed on myeloid cells 2
Aβ
β-amyloid peptide
EOAD
Early-onset AD
APP
Amyloid precursor protein
PSEN1
Presenilin 1
PSEN2
Presenilin 2
GWAS
Genome-wide association studies
TYROBP
Tyro protein tyrosine kinase binding protein
R47H
Arginine to histidine at position 47
LDL
Low-density lipoprotein
HDL
High-density lipoproteins
APOJ
Clusterin
ABCA1
Adenosine triphosphate-binding cassette transporters A1
ABCG1
Adenosine triphosphate-binding cassette transporters G1
Cys
Cysteine
Arg
Arginine
LDLR
Low-density lipoprotein receptor
LRP1
LDLR-related receptor 1
VLDLR
Very-low-density lipoprotein receptor
APOER2
APOE receptor 2
SFKs
Src family kinases
AKT
Protein kinase B
BBB
Blood--brain barrier
sTREM2
Soluble TREM2
CFS
Cerebral spinal fluid
NHD
Nasu--Hakola disease
FTD
Frontotemporal dementia
ALS
Amyotrophic lateral sclerosis
LPS
Lipopolysaccharide
ITAMs
Immunoreceptor tyrosine-based activation motifs
SYK
Spleen tyrosine kinase
PI3K
Phosphoinositide 3-kinase
PLCγ
Phospholipase Cγ
PIP3
Phosphatidylinositol-3,4,5-trisphosphate
IP3
Inositol trisphosphate
ASO
Anti-sense oligonucleotides
ADSP
Alzheimer's Disease Sequencing Project
{#ijms-20-00081-f001}
{#ijms-20-00081-f002}
{#ijms-20-00081-f003}
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Electronic Banking Compliance is for the compliance officer, internal auditor, or other banking personnel responsible for monitoring, reviewing, and satisfying the requirements of federal laws, regulations, and bankcard association and clearinghouse rules associated with electronic payments.
There are many existing regulations and other rules governing electronic payment systems with which financial institutions must comply. Undoubtedly there will be regulatory changes and additional guidance as more institutions and their customers adopt the new products and services offered to them by new electronic applications.
Besides ensuring compliance with specific laws and regulations pertinent to retail payment systems, financial institutions should ensure compliance with general consumer protection rules that distribute the responsibility and minimum procedural measures that must be fulfilled before shifting the responsibility to another party.
The regulators require financial institutions to comply with their statutory or regulatory obligations. They remind institutions that they must also comply with the bylaws and contractual agreements established with the bankcard associations, clearinghouses and other parties that participate in the processing, clearing, and settling of retail payment transactions. Most significantly, financial institutions and third-party service providers must comply with the appropriate bylaws and agreements of bankcard associations and clearinghouses or they risk being fined or losing their memberships.
Subscribers will receive access to a downloadable file containing editable forms. | https://store.lexisnexis.com/products/electronic-banking-compliance-skuusSku19870343 |
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In our previous studies using combined radioisotopes with chemotherapeutic liposomal drugs (i.e., (111)In-labeled polyethylene glycol (PEG)ylated liposomal vinorelbine) we have reported possible therapeutic efficiency in tumor growth suppression. Nevertheless, the challenge remains as to whether this chemotherapy has a therapeutic effect as good as that of combination therapy. The goal of this study was to investigate the real therapeutic effectiveness of 6 mol% PEG (111)In-vinorelbine liposomes via the elevation of the radiation dosage and reduction in the concentration of chemotherapeutic agents.
Murine colon carcinoma cells transfected with dual-reporter genes (CT-26/tk-luc) were xenografted into BALB/c mice. The biodistribution was estimated to determine the drug profile and targeting efficiency of (111)In-vinorelbine liposomes. Bioluminescence imaging and (18)F-FDG small-animal PET were applied to monitor the therapeutic response after drug administration. The survival in vivo was estimated and linked with the toxicologic and histopathologic analyses to determine the preclinical safety and feasibility of the nanomedicine.
Effective long-term circulation of radioactivity in the plasma was achieved by 6 mol% PEG (111)In-vinorelbine liposomes, and this dose showed significantly lower uptake in the reticuloendothelial system than that of 0.9 mol% PEG (111)In-vinorelbine liposomes. Selective tumor uptake was represented by cumulative deposition, and the maximum accumulation was at 48 h after injection. The combination therapy exhibited an additive effect for tumor growth suppression as tracked by caliper measurement, bioluminescence imaging, and small-animal PET. Furthermore, an improved survival rate and reduced tissue toxicity were closely correlated with the toxicologic and histopathologic results.
The results demonstrated that the use of 6 mol% PEG (111)In-vinorelbine liposomes for passively targeted tumor therapy displayed an additive effect with combined therapy, not only by prolonging the circulation rate because of a reduction in the phagocytic effect of the reticuloendothelial system but also by enhancing tumor uptake. Thus, this preclinical study suggests that 6 mol% PEG (111)In-vinorelbine liposomes have the potential to increase the therapeutic index and reduce the toxicity of the passively nanotargeted chemoradiotherapies.
National Center for
Biotechnology Information, | https://www.ncbi.nlm.nih.gov/pubmed?cmd=Search&doptcmdl=Citation&defaultField=Title%20Word&term=Chow%20TH%5Bauthor%5D%20AND%20Therapeutic%20efficacy%20evaluation%20of%20111In-labeled%20PEGylated%20liposomal%20vinorelbine%20in%20murine%20colon%20carcinoma%20with%20multimodalities%20of%20molecular%20imaging |
BY ELEANOR PARK
Culture is an integral aspect of who someone is, and it inevitably influences their life and work even if they don’t realize it. Some may even choose to hide from their cultural heritage or pretend that it has no influence on them. However, rather than hiding from cultural identity, it is always better to embrace it and let it empower you.
A great story of a renowned and influential individual who realized that her culture could not be hidden from her work is acclaimed artist and architect, Maya Lin. Once she embraced her culture, it allowed her to be even more self-expressive in her art. After she accepted her culture and acknowledged it as a part of her, she felt truly herself.
Maya Lin’s East Asian heritage permeated her world through her parents' upbringing. She grew up as a second generation immigrant, born in the United States after her parents immigrated from China in the 1940s. The Lins had always been an artistic family. Lin’s mother wrote Taoist poetry, and her father was a craftsman who made furniture, pots, and other similar items. Her childhood home in Athens, Ohio was built in the Chinese 50’s modernist style and decorated with many of her father’s works. Although he was Chinese, her father’s artistic style was very Japanese. As a result, Maya Lin’s childhood home was laid out like a traditional Japanese house, and the decorations included Japanese style and motifs.
Like many second-generation immigrants, Lin struggled with her identity while growing up. She was facing American culture at school and in the community, but a greatly contrasting East Asian lifestyle at home. In an interview, Lin talked about growing up, saying, “I had a really hard time with my identity. I think I wanted to fit in, I wanted to be American.” Because she tried to be more “American,” she often rejected her family culture. For example, when recruited by the Asian American Society in college at Yale University, Lin felt uncomfortable being a part of it and chose not to join. This wasn’t the first time she felt awkward in all-Asian groups. Lin has also expressed that while growing up, it felt strange for her to hang out with groups of all Chinese Americans or all Asian Americans. In fact, she considered herself more as a typical American midwesterner rather than a Chinese American.
Even when Lin wasn’t consciously embracing her culture, however, her East Asian upbringing infused her art. This influence was particularly prevalent while she was in college. The 50s Chinese Modernist house she grew up in affected her architectural style, and even some of her artworks. Her well-known simple and direct artistic style can also be traced back to a home influence. Her mother wrote poetry in the Taoist philosophical tradition that emphasizes simplicity, balance, and spiritual harmony.
Her most famous work, the Vietnam Veterans Memorial in Washington, D.C., in fact, displays Taoist influence. This memorial is a wide V-shaped walkway surrounded on both sides by walls. These walls display 58,318 names of Americans who fought and gave their lives in the Vietnam War. Her design is simple but conveys a powerful message, and her parents believe that this style was subconsciously derived from Taoist philosophy. As her father explained, “[The memorial’s] simplicity is like Taoism: simple yet very direct. I'm not saying we have directly influenced it, but indirectly by the way we live, the way we brought [our children] up. The quietness and the directness really is an Eastern influence."
Maya Lin is also well-known for her other installations, designs, and artwork, all of which draw inspiration from her cultural background. Two of these famous works are:
Groundswell - Displayed at the Wexner Center for the Arts in Columbus, Ohio, this piece is created from pieces of recycled glass that emulate natural groundswells in the sea or ground caused by storms or seismic activity. Groundswell is one of Lin’s pieces that drew from her cultural heritage. As she noted, "The piece is a conscious effort on my part to combine my Eastern and Western cultural heritage—namely, mixing my affinity for the southeastern Ohio terrain and its regional burial mounds with my love for the raked-sand gardens of Japan."
Wavefields: These are a series of three fields patterned to resemble waves, located in Ann Arbor, Michigan; Miami, Florida (called Flutter); and Mountainville, New York. In their creation, Lin drew influence from Native American effigy mounds, which are common in her home state. While these wavefields don’t represent her East Asian heritage, they were inspired by the American cultural surroundings in Ohio, where she grew up.
After years of denying her heritage, Maya Lin discovered her culture had always been ingrained in her. With this discovery, she was able to acknowledge and even treasure, the legacy that had been passed down to her from her parents and from previous generations of influential Chinese artists, architects, writers, and scholars.
he now openly talks about the influence her cultural heritage has on her work. When discussing the Vietnam Veterans Memorial, for example, she stated that her East Asian cultural influence "is there. You can see it . . . the sensitivity to the landscape . . . the simplicity and the basic philosophy of the design. It's a memorial that does not force or dictate how you should think. It asks and provokes you to think whatever you should think. In that sense it's very Eastern -- it says, 'This is what happened, these are the people.' It wants you to . . . come to your own personal resolution. It has a lot of hidden philosophy. It reflects me and my parents."
Maya Lin is an example of a successful, talented, and well-known minority in the art field. Incorporating her cultural heritage into her work has driven her success. Her story shows others that one’s cultural identity and heritage can be a source of inspiration and empowerment. It can also drive others to embrace their own cultures as well.
Sources Referenced: | https://www.thediversitystory.org/post/maya-lin-the-influence-of-asian-american-heritage-on-artistic-identity |
Griha Pravesh is also called Vastu. The complete ritual takes six to seven hours. Early in the morning, Vastu pooja for Vastu devata is performed outside the house before the actual entry into the house.
During Vastu puja, a kumbh (copper pot, as in the Bhoomi puja) is consecrated through worship out side the house. The Vastu pooja is undertaken to expiate the sins that could have been committed by the owners of the house during construction.
After completing the Vastu and Kumbh pooja, the copper pot is taken inside the house by the husband and wife to a place where havan and various poojas take place. In the ritual inside the house different poojas like, pooja of sun, pooja of lamp, Ganpathi pooja, Pooja of the Kul devta, pooja of four directions, showering (abhishek) of the couple with water, Lakshmi pooja and Homa are all done.
This pooja is concluded by distributing peanuts, dry fruits and pede- a kind of sweet made of milk, as prasad. Finally the guests are fed. On the eve of the graha pravesh, vastubali is performed inside the house.
This is a pooja performed by a priest who is not a member of the family. It consists of Ganapathi pooja, Punyaha and Vastubali homa. These are done to appease the gods and propitiate them.
Every Pooja begins with invoking Lord Ganesha and then the specialized moola mantra japam and other rituals help the Vedic Bramhin assigned the task to achieve your hearts desire through your sankalpam (your wish is conveyed at the fire ritual ceremony).
Purity of panchang (almanac) and auspicioustime (muhurat) must be considered during the griha pravesh.
Apoorva: First entry to newly constructed house on a newly selected land is called apoorva (new) griha pravesh.
Sapoorva: Entry into an already existing house after travelling abroad or migration elsewhere is called sapoorva griha pravesh.
Dwandwah: Entry into a house to after reconstruction or renovation subsequent to damage due to fire, flood or earthquake, is termed as dwandwah (old) griha pravesh.
For apoorva griha pravesh, the exact auspicious time need to be adhered to. For sapoorva griha pravesh or dwandwah griha pravesh, the purity of the panchang should be given due consideration.
This entry was posted in Bhopal, Delhi, Ghaziabad, Gujrat, Gurgaon, Haryana, Indore, Jaipur, Jharkhand, Jodhpur, Maharashtra, Mumbai, Noida, Pandits, Pandits For Havan, Pandits For Marriage, Pandits For New Business, Pandits For Puja, Punjab, Rajasthan, Uttrakhand, Vivah and tagged Griha Pravesh Pooja, Vastu for Griha Pravesh, Vastu Pooja India on January 12, 2013 by admin.
The Upnayan sanskar (Yahyopavit Sanskar) denotes the rising of Man’s consciousness towards God.The sacred thread ceremony is very significant in the life of a Hindu man.In Indian culture its an taking pledge to lead disciplines, dignified spiritual life.
After Yagyopaveet , the child left his Home saying goodbye to all relatives who had gathered for this Goodbye.It indeed gives “new birth” to a person.His life would change. Discipline would then become the center point of his life.The child went to his Guru’s place and learn the art of living and develop vision to see things in a proper way and to know what is ‘wrong’ and what is ‘right’. Therefore, Upnayan is essential to handle household life.
The twist in the thread symbolizes strength and honesty. Gayatri Mantra is given to the child who promises to lead a good human life as per the rules of Vedas.This shikha is placed at a point, which is very important for positive impact of yoga and meditation.
This entry was posted in Arya Samaj Pandits, Bhopal, Delhi, Ghaziabad, Gujrat, Gurgaon, Indore, Jaipur, Jharkhand, Jodhpur, Maharashtra, Mumbai, New Delhi, Noida, Pandits, Pandits For Havan, Pandits For Marriage, Pandits For New Business, Pandits For Puja, Punjab, Rajasthan, Udaipur and tagged Yagyopavit Sanskar, Yagyopavit Upanayan Sanskar New Delhi, Yagyopavit Upanayana Sanskar on January 9, 2013 by admin. | http://www.aryasamajmarriagemumbai.com/category/pandits-for-new-business |
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Todd Clark became President/CEO of CO-OP Financial Services on June 27, 2016, bringing with him a 25-year career featuring a unique mix of start-up and corporate experience in the payments industry. Insight Vault sat down with him recently to get an inside look at his career, his vision for the future of the company and thoughts on the industry, including his focus on putting the client first and staying in front of new technology through an entrepreneurial mindset.
Insight Vault: Can you tell us a little about yourself and your background?
Clark: I’m originally a tech guy – a coder and a technologist. I studied math and economics in college, and engineering is in my family’s blood. I learned to write code in college as a hobby.
I’ve been an entrepreneur, co-founding a start-up, Core Data, and I’ve worked at First Data, a company with 29,000 employees, and succeeded at both.
We sold Core Data to Concord EFS, which later merged with First Data. At the time of sale, Core Data had grown to a $20 million organization and the second largest ATM processor in the country.
While at First Data, I served as SVP/Head of STAR Network and Debit Processing, where I was responsible for the business unit’s profit/loss and led a large team of product, strategy, communications, strategic sales, technology, operations and support personnel. Previously, I led the Community Financial Institution group at the company and led the team managing the relationship with Bank of America.
Working for business partners of CO-OP – including First Data and Cardtronics – has given me a strong appreciation of CO-OP’s essential role in the financial success of its credit union clients and their members. The relationship with the customer has always been first and foremost in my world.
I believe one of my main strengths is that I am able to identify technology gaps in the market quickly. In addition, I specialize in determining how emerging technology can fill those gaps, all with an aim of uncovering efficiencies for smaller financial institutions.
Insight Vault: What is your vision for the company in the months and years ahead?
Clark: CO-OP is in the midst of building out the full vision of CO-OP’s next phase of leadership in the payments and financial technology space.
Credit union member interaction and engagement, based on user behavior around new technologies, will be at the center of our strategy – all leveraging the scale of our current platforms. We will not only layer member-centric digital design over our card payments, digital/mobile delivery, branch/ATM/self-service and call center systems, we will also continue to build upon our comprehensive security and fraud detection platforms to make sure our credit unions are always the strongest link in the payments chain.
Insight Vault: How are you looking to further innovation in the credit union industry?
Clark: There is a fascinating synergy at work today between consumer demands and fintech innovation. Steve Jobs famously said, “A lot of times, people don’t know what they want until you show it to them.” It is certainly true today that fintech companies such as CO-OP are in a position to drive consumer demands as often as we are driven.
CO-OP sees at least four key consumer trends in payments technology – frictionless speed, digital/mobile first, product intelligence and customization, and security innovation.
Innovation begins, though, by listening to our clients and working closely with them to ensure that their needs are anticipated. I plan to leverage my background in both the start-up space and with large corporations to find innovative solutions for our credit unions in an era of unprecedented transformation.
Insight Vault: What do you think should be the biggest priority for credit unions?
Clark: Consumers have no problem switching to another institution today if their needs are not met – in fact, they are increasingly willing to bank with non-traditional players. This means that credit unions must provide the secure, convenient payment technology that they demand. Credit unions need to continue to evolve with the market and CO-OP needs to be the provider that helps them make that happen.
We have a particular responsibility to our clients and their members to help them provide the latest in data protection capabilities in an environment where payment is becoming more convenient for members – but fraudsters can all too easily take advantage.
Insight Vault: What are some examples of how CO-OP can help credit unions thrive in today’s market?
Clark: Consumers today demand superior, relentless service across all channels. They dictate how, when and where they want to interact. Digital is the future, yet branches remain popular. In a phrase – consumers want it all. CO-OP strives to have it all – we can help credit unions master both digital and physical member interactions; we offer the real-time, the 24/7 and personalized services needed to attract and keep members; and, we offer the control and security members want through payment apps such as CardNav by CO-OP.
Data itself is not the solution – it’s what you do with the analytics, and the financial world is unlocking this power to shape the future of global commerce. Winning the data game for credit unions – in terms of collection, analytics and security – will be even more of a priority for CO-OP going forward. | https://blog.co-opfs.org/meet-todd-clark-qa-new-presidentceo-co-op/ |
Global humanitarian crises – and the aid systems that respond to them – are undergoing massive change. More people are in crisis than ever before. In 2016, 65 million people were displaced by conflict and another 22.5 million were affected by weather-related disasters.
Meanwhile, the humanitarian sector is transforming how it responds to crises. It’s increasingly moving away from a traditional, commodities-based approach toward cash-based assistance. What was until recently a fringe tactic in the overall aid assistance toolkit has come of age. Ahead of the World Humanitarian Summit in June 2016, the U.N. Secretary General Ban Ki-Moon supported the transformation by calling for cash to become the go-to mechanism for distributing humanitarian aid.
The key to adapting to the new reality lies in tapping new approaches and new technologies that allow the sector to respond faster and better.
Digitizing cash payments through digital financial services (DFS) can provide heightened security, increased accountability and transparency, faster distribution and a scalable transfer model – all currently cruxes for the physical delivery of cash. Early examples of digital cash payments include supporting Ebola response workers in Sierra Leone and monthly aid stipends to refugees in Dadaab refugee camp in Kenya.
In addition, DFS can open a pathway to greater financial inclusion and resilience for crisis-affected populations. This not only helps poor and affected households access aid during crises, but it also gives people the tools they need to better manage future risk and shocks.
This means that DFS builds bridges between the humanitarian and development sectors, which has been a long-desired development goal. This goal motivated the Barcelona Principles for Digital Payments in Humanitarian Response, which was co-created in 2016 by 25 of the largest humanitarian responders.
Unfortunately, despite the enthusiasm and promise, progress has been slow. Many solutions employed by humanitarian agencies today remain one-off, fragmented solutions. Few of these solutions are shared across agencies and fewer utilize shared, standards-based systems such as commercially available, off-the-shelf DFS products.
So, what is preventing humanitarian agencies from leveraging these DFS systems for cash-based aid disbursement, and what might we do to remove those obstacles? A new report by the Bill & Melinda Gates Foundation sheds new light on this question.
First, the challenge is not the technology: Existing DFS systems meet the core payment needs of humanitarian agencies. However, four non-technical barriers stand in the way.
- Regulations that require personal identification documents that often aren’t possessed by crisis-affected people;
- Strict donor-imposed reporting requirements for tracing funds that limit the ability to provide a single, secure, general purpose account that beneficiaries control;
- Damaged or insufficient wireless network infrastructure; and
- Inadequate access to the local agents and merchants needed to process digital payments in crisis-affected geographies.
To be fair, humanitarian responders must choose approaches and tools that work within the constraints present in a crisis and cannot alone address these barriers. The barriers are the result of complex local circumstances across the public, private and nonprofit sectors, and they need a multi-sector approach to unlock the potential of DFS.
There are four specific areas where more work is required:
- Standardizing the approach to beneficiary data collection. There is a wide spectrum of beneficiary registration processes, systems and tools across humanitarian agencies, and the lack of standardization weakens the ability of regulators and DFS providers to coordinate with the sector. If the humanitarian community agreed to a common, minimum data set for collection and format of beneficiary registration data, it could enable regulators to better structure regulation that allows for flexibility in crises, reduces the need for solution customization, and supports existing national and global digital identity programs.
- Agreeing in advance on how to adjust the rules. Identifying, negotiating and enacting key DFS regulations after a crisis can significantly delay or prohibit a rapid response by agencies. Identification and negotiation needs to happen before a crisis. Emergency DFS regulatory templates could facilitate this preparedness activity by providing a standard, structured approach to negotiating, modifying and enacting time-bound regulations to address the barriers that prohibit the use of DFS in a crisis such as “know your customer” (KYC) and agent and merchant regulation.
- Rethinking donor reporting and control over the cash. To leverage DFS to drive financial inclusion and resilience objectives, donors must rethink reporting requirements so that agencies can more easily use standards-based systems that provide an enduring financial account for the beneficiary. Although a change to the status quo is required, mobile wallet systems may offer new monitoring opportunities. More collaboration between donors and agencies is needed to explore how DFS can even offer new possibilities for innovative metrics, processes and approaches to M&E.
- Experimenting for impact and culture change. The viability and utility of DFS will vary by crisis type (slow vs. rapid onset) and crisis phase (response vs. recovery vs. reconstruction). We need to better understand when, where and how to best leverage DFS in crises to effectively demonstrate the value of commercially available DFS systems in the short and long term. This will be critical for motivating additional private sector investment, as well as policy and systems change within agencies and donors.
Defining the role of DFS in humanitarian response is still very much a work in progress. The recommendations above will not solve all challenges in all contexts but are steps toward a vision where DFS positions the humanitarian sector and all those who engage with it to respond more effectively. This is why on March 21st, over 175 humanitarian and technology leaders will convene at Google Headquarters to discuss the most pressing needs and the role of technology in moving towards solutions, among them digital payments. The global humanitarian need is increasing and there is no time to lose.
Dr. Valerie Ngamkang Bemo is a senior program officer (Emergency Response) and Dilwonberish Aberra is an associate program officer (Financial Services for the Poor) at the Bill & Melinda Gates Foundation. Jamie M. Zimmerman is a senior associate for BFA.
This post reflects the findings just published by the Bill & Melinda Gates Foundation from their Emergency Mobile Wallet project, conducted in partnership with Ericsson in 2016. These findings reflect the analysis and outcomes of that project and do not necessarily indicate the strategic direction of the Emergency Response or Financial Services for the Poor team. | https://nextbillion.net/unlocking-the-power-of-digital-financial-services-for-humanitarian-response/ |
Risk selection in the German public health insurance system.
The German statutory health insurance market was exposed to competition in 1996. To limit direct risk selection the regulator required open enrollment. As the risk compensation scheme, introduced in 1994, is highly incomplete, substantial incentives for risk selection exist. Due to their low premiums, company-based sickness funds have been able to attract a lot of new members. We analyze, using data from the German Socio-Economic Panel, the determinants of switching behavior from 1995 to 2000. There is no evidence for selection by funds. The success of the company-based sickness funds originates in incomplete risk adjustment together with the negative correlation between health status and switching costs.
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The broad aim of this project is to elucidate the transcription factors that control chondrocyte differentiation during vertebrate development. Prior work in my lab has established that Sonic Hedgehog (Shh) and Wnt signals pattern somitic cell fate. We have recently found that one of the genes induced by Shh, Nkx3.2, confers competence for subsequent BMP signals to induce chondrogenesis. Activation of somitic chondrogenesis by Nkx3.2 requires BMP signaling and correlates with the ability of this regulator to induce the expression of another chondrocyte transcription factor, Sox-9. We have found that the transcriptional repressor activity of Nkx3.2 requires interaction of Nkx3.2 with both BMP-dependent Smads and histone deacetylases and is necessary for Nkx3.2 to induce both somitic chondrogenesis and Sox-9 gene expression. Forced expression of Sox-9 in somites can similarly induce competence for subsequent BMP signals to induce chondrogenesis. Together, these findings suggest that Nkx3.2 induces a prochondrogenic state in somites by repressing the transcription of an inhibitor of Sox-9 expression. Later in development Nkx3.2 is specifically expressed in immature cartilage in the developing limb bud and is excluded from regions of chondrocyte hypertrophy. Forced expression of Nkx3.2 throughout the limb bud blocks chondrocyte maturation and chondrocyte hypertrophy. The transcriptional repressor activity of Nkx3.2 is necessary for this transcription factor to block cartilage maturation, and suggests that Nkx3.2 blocks the transcription of a factor(s) required for cartilage maturation. Our findings indicate that Nkx3.2 plays a role in the generation and maturation of cartilage cells. In this proposal I outline a series of experiments to address the following specific aims. (1) Determine how BMP-dependent SMADs promote chondrogenesis. (2) Determine if GATA genes repress a chondrogenic response to BMP signaling (3) Determine how Nkx3.2 represses chondrocyte maturation. (4) Determine if other Nkx family members expressed in the developing bones act together with Nkx3.2 to repress chondrocyte maturation.
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Covid -19 Updates (Febbruary 2022)
The Organizing Committee of ICoNSoM 2022 has the main priority of safeguarding the health of each participant. ICoNSoM conferences are thought of and organized as full face-to-face conferences. To make this possible, strict safety rules and procedures will be implemented.
The Organization Committee of ICoNSoM 2022 is working to ensure a smooth process, in correspondence to the current health regulations. The Committee is monitoring the COVID-19 requirements and will be updating the information and safety guidelines regularly with alignment to the situation.
Safety rules for participants
To guarantee the highest safety standard, all participants ICoNSoM 2022 are kindly invited to follow the guidelines below:
- To remain home and avoid travel if experiencing any COVID symptoms.
- To wear a mask ffp2 that covers the mouth and nose at all times while attending the events.
- To keep the safety distance.
- To perform a health status self-check every day for any onset of COVID symptoms, as defined by the CDC
To ensure the conference takes place in conditions of maximum security for each participant, social distancing as required will be ensure during plenary lectures, poster sessions, and the other activities. Social events will be organized according to rules existing in June, 2022.
Travelling to/from Italy
We invite all attendes to regularly visit the official Italian government web-page to know about the travel conditions pertaining to their region and country.
Participants should also regularly consult the equivalent websites in their own countries.
In the meantime we advice participants to follow the latest updates here: | http://www.memocsevents.eu/iconsom2022/covid-19-updates/ |
Each EPActive 1000 mg softgel contains 800 mg of omerga-3 EPA in the triglyceride form from fish oil that has been ultra-purified and concentrated in Germany by molecular distillation. EPActive meets the stringent proposed USP monograph for purity to remove environmental contaminants, heavy metals, such as mercury, and organic toxins, such as dioxins and PCBs. Natural mixed tocopherols are used as antioxidants to protect against lipid peroxidation.
- Helps maintain healthy balance of cytokines that play key roles in the body’s metabolic responses.
- Supports cardiovascular health and helps maintain triglyceride levels that are within the normal range.
- Promotes mental well-being and positive mood.
- Promotes healthy skin. | https://expertnutrition.com/product/epactive-120-sftgels/ |
BACKGROUND OF THE INVENTION
SUMMARY OF THE INVENTION
DETAILED DESCRIPTION
1. Field of the Invention
The invention relates to a method and an apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal.
2. Related Technology
In an amplitude modulated receiver—AM receiver—the level of an amplitude modulated receiving signal is controlled by means of an automatic gain control (AGC) for adapting the receiving signal to the predetermined signal range in the signal path.
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FIG. 1
The receiving signal is fed through a (pre-)amplifier according to . The level of the (pre-) amplified receiving signal is measured by a subsequent RF level detector . The automatic gain control determines the suitable attenuation value for the radio-frequency receiving signal. Adjusted by means of the automatic gain control the radio-frequency-attenuator (RF attenuator) attenuates the receiving signal for ensuring a suitable signal level at the broadband mixer input.
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The mixer supplied with a carrier signal from a local oscillator converts the receiving radio frequency signal to intermediate-frequency (IF) range. The intermediate-frequency signal is bandpass filtered for a subsequent narrowband analog-digital-converter by means of an intermediate-frequency filter .
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The level of the intermediate-frequency receiving signal is measured by a subsequent IF level detector . The automatic gain control determines the suitable attenuation value for the intermediate-frequency receiving signal. Receiving the determined attenuation value from the automatic gain control the intermediate-frequency-attenuator (IF attenuator) attenuates the receiving signal for ensuring a suitable signal level at the (narrowband) analog-digital-converter input.
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After analog-digital-converting the attenuated digital receiving signal is frequency shifted to the baseband by means of a digital-down-converter sourced with a carrier signal from a numerically controlled oscillator . Finally the baseband receiving signal is filtered and demodulated in an AM demodulator . In the AM demodulator the time average DC(m(n)) of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) is determined by lowpass filtering of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) in a lowpass infinite-impulse-response filter .
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In a subtracting unit the difference between the amplitude m(n) of the complex attenuated baseband receiving signal x(n) and the time average DC(m(n)) of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) is calculated, which is scaled with the time average DC(m(n)) of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) in a subsequent scaler for generating the AM demodulated receiving signal y(n) corresponding to equation (1).
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For cost and performance reasons the RF and IF attenuator and are usually realized as step attenuators exhibiting only discrete levels of attenuation, for example 1-12 dB in 1 dB steps as in curve of .
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A RF receiving signal with an increasing and/or decreasing slope—curve in FIG. —is transformed by such an attenuation to an attenuated RF receiving signal with smaller increasing and/or decreasing slope segments connected each other by step segments. Curve in shows the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at the output of the digital-down-converter .
The subsequent AM demodulator creates the demodulated signal y(n) from the attenuated baseband receiving signal x(n). In principle the AM demodulation is performed corresponding to equation (1) by determining the time average DC(m(n)) of the amplitude m(n), subtracting the time average DC(m(n)) from the amplitude m(n) and normalizing the difference by dividing through the time average DC(m(n)) of the amplitude m(n).
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The time average DC(m(n)) of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) is determined by means of a lowpass infinite-impulse-response filter. The order of the lowpass infinite-impulse-response filter is normally at least two—typically four—and therefore the lowpass infinite-impulse-response filter, if activated by an step in the signal at its input, generates oscillations. The signal at the output of the lowpass infinite-impulse-response filter representing the time average DC(m(n)) of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) is characterized by oscillations in case of steps in the amplitude m(n) of the complex attenuated baseband receiving signal x(n), as can be seen in curve of .
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These oscillations are transferred to the output signal y(n) of the AM demodulation (curve of ). In case of a audio signal as receiving signal the oscillations in the output signal y(n) can be heard as unwanted clicks.
A receiver with an AGC-controller and a predictive offset correction is known from U.S. Pat. No. 6,240,100 B1 referred to as background art.
The invention provides a method and an apparatus, which level an increasing or decreasing slope of an AM modulated receiving signal and which avoid oscillations—heard as unwanted clicks—in the signal after demodulation of the AM modulated receiving signal.
According to the invention, a method for leveling an increasing or decreasing slope of an AM modulated receiving signal includes the steps of: attenuating the AM modulated receiving signal with an attenuation curve with a stepwise slope corresponding to the increasing or decreasing slope of the AM modulated receiving signal, filtering the attenuated AM modulated receiving signal with a lowpass filter having at least one delay unit within AM-demodulation, and increasing the level of the output signal of each delay unit of the lowpass filter each time a step in said attenuated AM modulated receiving signal arrives at the input of the lowpass filter and modulating the steps of leveling comprising increasing the level of each output signal in an amount of the step in the attenuation curve causing said step in said attenuated AM modulated receiving signal arriving at the input of said lowpass filter.
Also according to the invention, an apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal includes an attenuator for attenuating the receiving signal corresponding to an attenuation curve, an automatic gain control measuring the receiving signal control and generating the attenuation curve with a stepwise slope to the increasing or decreasing slope of the receiving signal, a lowpass filter within an AM-demodulator filtering the attenuated receiving signal, and a delay buffer for delaying a control signal signaling each step in the attenuated receiving signal for the delay time of the attenuated receiving signal from the attenuator to the lowpass filter.
According to the invention, the signals at the output of each delay-unit of the lowpass infinite-impulse-response filter are increased each time a step in the amplitude m(n) of the complex attenuated baseband receiving signal x(n) arriving at the input of the lowpass infinite-impulse-response filter. The increasing of each of these delay-unit output signals is dependent on the respective step in the attenuation curve causing the step in the amplitude m(n) of the complex attenuated baseband receiving signal x(n).
The increasing of each of these delay-unit output signals for one sampling instance guarantees a negative feedback in the canonical structure of the lowpass infinite-impulse-response filter and thus oscillations in the feedback structure of the lowpass infinite-impulse-response filter can be avoided.
The lowpass infinite-impulse-response filter is informed about the time occurring a step in the attenuated receiving signal using a control signal sc generated from the automatic gain control being responsible for the attenuation of the receiving signal. The delay time between the stepwise attenuation of the receiving signal in the attenuator and the compensation of the steps in the attenuated receiving signal in the lowpass infinite-impulse-response filter caused by means of processing units between the attenuator and the lowpass infinite-impulse-response filter, i.e. the delay caused by an analog-digital-converter and a digital-down-converter, is taken into account by a delay buffer delaying the control signal generated from the automatic gain control.
FIG. 6 to 9
Before describing the inventive apparatus and the inventive method for leveling an increasing or decreasing slope of an AM modulated receiving signal according to , the principle of function of an IIR filter of fourth order in case of a negative step in the attenuated receiving signal entering the IIR filter is presented in the state of the art in comparison with the invention.
FIG. 4
A lowpass infinite-impulse-response filter of fourth order in canonical structure is presented in .
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The feedback signal f(n) is subtracted from the amplitude m(n) of the complex attenuated baseband receiving signal x(n) in a subtracting unit . The feedback signal f(n) comprises the output signal V(n) of the first delay unit , which is weighted with the filter coefficient −a1 in the multiplier , the output signal V(n) of the second delay unit , which is weighted with the filter coefficient −a2 in the multiplier , the output signal V(n) of the third delay unit , which is weighted with the filter coefficient −a3 in the multiplier , and the output signal V(n) of the fourth delay unit , which is weighted with the filter coefficient −a4 in the multiplier .
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The output signal V(n) of the subtracting unit is fed to the input of the first delay unit and also to the multiplier for weighting with the filter coefficient b0. In the summing unit the signal V(n) weighted with the filter coefficient b0 is added to the output signal V(n) of the first delay unit , which is weighted with the filter coefficient bin the multiplier , to the output signal V(n) of the second delay unit , which is weighted with the filter coefficient bin the multiplier , to the output signal V(n) of the third delay unit , which is weighted with the filter coefficient bin the multiplier , and to the output signal V(n) of the fourth delay unit , which is weighted with the filter coefficient bin the multiplier .
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The filter coefficients a, a, a, a, b, b, b, b, and bof the IIR filter in are parameterized for a lowpass characteristic. Therefore the signal DC(m(n)) at the output of the IIR filter—at the output of the summing unit —represents the time average of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at the input of the IIR filter.
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FIG. 5A
The behavior of such an IIR filter as state of the art in case of an increasing slope segment in the amplitude m(n) of the complex attenuated baseband receiving signal x(n) followed by a negative step segment corresponding to curve of is presented in .
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At time t=n−1 the level of the signal Vat the input of the first delay unit , of the signal Vat the output of the first delay unit , of the signal Vat the output of the second delay unit , of the signal Vat the output of the third unit , of the signal Vat the output of the fourth unit and of the feedback signal f(n) increases slightly in comparison with the respective Level at the former time t=n−2.
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At time t=n the level of the signal V0 decreases significantly depending on the negative step segment in the amplitude m(n) of the complex attenuated baseband receiving signal x(n). The level of the signals V, V, V, and Vat the output of the respective delay unit , , , and overtake the level of the signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n−1. Therefore the level of the signals V, V, V, and Vincreases slightly in comparison with former time t=n−1. The level of the feedback signal f(n) as the sum of the levels of signals V, V, V, and Vweighted with the corresponding filter coefficient a, a, a, and aincreases slightly in the same manner.
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At time t=n+1 the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) increases slightly from the lowest level. Therefore the level of the signal V0 at the input of the delay unit as difference between the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) and the level of the feedback signal f(n) at former time t=n increases or decreases slightly or remains constantly independent from the values of the filter coefficients a, a, aand a. The level of signals V, V, V, and Vat the output of the respective delay unit , , , and overtakes the level of the signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n. The decreasing of the level of signal Vis significantly larger than the increasing of the level of each signal V, Vand V. Therefore the level of feedback signal f(n) decreases significantly independently of the values of the filter coefficients a, a, a, and a.
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At time t=n+2 the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) increases slightly, whereas the level of feedback signal f(n) at former time t=n+1 decreases significantly. Therefore the level of signal Vat the input of the delay unit as difference between the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at time t=n+2 and the feedback signal f(n) at former time t=n+1 increases significantly. The level of signals V, V, V, and Vat the output of the respective delay unit , , , and overtakes the level of signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n+1. The level of feedback signal f(n) increases or decreases slightly or remains constantly in comparison with the respective level at former time t=n+1, because the sum of increases and decreases of signals V, V, V, and V—especially with respect to the size of their slopes—weighted with the corresponding filter coefficients a, a, a, and a4 is not significantly different between time t=n+1 and t=n+2 independently of the values of the filter coefficients a, a, a, and a.
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At time t=n+3 the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) increases slightly, whereas the level of feedback signal f(n) at former time t=n+2 increases or decreases slightly or remains constantly. Therefore the level of signal V0 at the input of the delay unit as difference between the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at time t=n+3 and the feedback signal f(n) at former time t=n+2 increases or decreases significantly or remains constantly. The level of signals V, V, V, and Vat the output of the respective delay unit , , , and overtakes the levels of signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n+2. The level of feedback signal f(n) increases significantly in comparison with the respective level at former time t=n+2 independent from the values of the filter coefficients a, a, a, and a, because the sum of increases and decreases of signals V, V, V, and V—especially with respect to the size of their slopes—contains at time t=n+3 one significantly increasing of one of signals V, V, V, and Vmore than the sum of increases and decreases of signals V, V, V, and V—especially with respect to the size of their slopes—at time t=n+2.
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At time t=n+4 the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) increases slightly, whereas the level of feedback signal f(n) at former time t=n+3 increases significantly. Therefore the level of signal Vat the input of the delay unit as difference between the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at time t=n+4 and the feedback signal f(n) at former time t=n+3 decreases significantly. The level of signals V, V, V, and Vat the output of the respective delay unit , , , and overtakes the levels of signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n+3. The level of feedback signal f(n) increases or decreases slightly or remains constantly in comparison with the respective level at former time t=n+3, because the sum of increases and decreases of signals V, V, V, and V—especially with respect to the size of their slopes—weighted with the corresponding filter coefficients a, a, aand ais not significantly different between time t=n+4 and t=n+3 independently of the values of the filter coefficients a1, a, a, and a.
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The positive feedback—significant decreasing of feedback signal f(n) at time t=n+1—resulting from the negative step in the amplitude m(n) of the complex attenuated baseband receiving signal x(n) produces a continuous decreasing or increasing of the level of signals V, V, V, V, and Vat the input and also at the output of each delay unit , , , and of the IIR filter. These oscillations in signals V, V, V, V, and Vcan be identified in in column 1 for signal V, in column 2 for signal Vand in column 3 for signal V.
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FIG. 5B
The behavior of an IIR filter in an inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal in case of an increasing slope segment in the amplitude m(n) of the complex attenuated baseband receiving signal x(n) followed by a negative step segment corresponding to curve of is presented in .
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The levels of signals V, V, V, V, and Vand their slopes at time t=n−1 and time t=n are identical to those in the IIR filter of the state of the art.
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4
1
2
3
4
1
2
3
4
At time t=n+1 the levels of signals V, V, V, and Vare increased significantly corresponding to the step in the attenuation curve causing the step in the attenuated receiving signal arriving at the input of the IIR filter. Therefore the level of feedback signal f(n) as sum of the levels of signals V, V, V, and Vweighted with the corresponding filter coefficients a, a, a, and aincreases significantly.
0
1
2
3
4
0
1
2
3
1
2
3
4
1
2
3
4
21
21
23
25
27
21
23
25
27
At time t=n+2 the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) increases slightly, whereas the level of feedback signal f(n) at former time t=n+1 increases significantly. Therefore the level of signal Vat the input of the delay unit as difference between the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at time t=n+2 and the feedback signal f(n) at former time t=n+1 decreases significantly. The level of signals V, V, V, and Vat the output of the respective delay unit , , , and overtakes the level of the signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n+1. Therefore the level of signal Vincreases or decreases slightly or remains constantly, whereas the level of signal V, V, and Vincreases moderate. The level of feedback signal f(n) increases slightly or moderately or decreases slightly or remains constantly in comparison with the respective level at the former time t=n+1 dependent from the values of the filter coefficients a, a, a, and a.
0
1
2
3
4
0
1
2
3
1
2
3
4
1
2
3
4
1
2
3
4
21
21
23
25
27
21
23
25
27
At time t=n+3 the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) increases slightly, whereas the level of feedback signal f(n) at former time t=n+2 increases slightly or moderately or decreases slightly or remains constantly. Therefore the level of signal Vat the input of the delay unit as difference between the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at time t=n+3 and the feedback signal f(n) at former time t=n+2 increases slightly or decreases slightly or moderately or remains constantly. The level of signals V, V, V, and Vat the output of the respective delay unit , , , and overtakes the level of signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n+2. The level of feedback signal f(n) as sum of the levels of signals V, V, V, and Vweighted with the corresponding filter coefficients a, a, a, and aincreases or decreases slightly or moderately or remains constantly in comparison with the respective level at former time t=n+2 dependent from the values of the filter coefficients a, a, a, and a.
0
1
2
3
4
0
1
2
3
1
2
3
4
1
2
3
4
1
2
3
4
21
21
23
25
27
21
23
25
27
At time t=n+4 the level of the amplitude m(n) of the complex attenuated baseband receiving signal x(n) increases slightly, whereas the level of feedback signal f(n) at former time t=n+3 increases or decreases slightly or moderately or remains constantly. Therefore the level of signal Vat the input of the delay unit as difference between the amplitude m(n) of the complex attenuated baseband receiving signal x(n) at time t=n+4 and the feedback signal f(n) at former time t=n+3 increases slightly or decreases slightly or moderately or remains constantly. The level of signals V, V, V, and Vat the output of the respective delay unit , , , and overtakes the levels of signals V, V, V, and Vat the input of the respective delay unit , , , and from time t=n+3. The level of feedback signal f(n) as sum of the levels of signals V, V, V, and Vweighted with the corresponding filter coefficients a, a, a, and aincreases or decreases slightly or remains constantly in comparison with the respective level at former time t=n+3 dependent from the values of the filter coefficients a, a, a, and a.
1
2
3
4
0
1
2
3
4
0
1
14
14
The negative feedback—significant increasing of feedback signal f(n) at time t=n+1—resulting from the inventive increasing of the signals V, V, V, and Vat time t=n+1 in consequence of the step in the amplitude m(n) of the complex attenuated receiving signal x(n) at the input of the IIR filter at time t=n guarantees a stabilization of the IIR filter without oscillations. The behavior of the signals V, V, V, V, V, and f(n) is approximately smooth and is characterized only by slight or moderate increases or decreases or constancy (see especially the behavior of the signal V, V, and f at time t=n+3, t=n+4).
FIG. 6
In the inventive method for leveling an increasing or decreasing slope of an AM modulated receiving signal is shown.
10
2
8
In step S the level of the radio-frequency AM modulated receiving signal is measured by the RF level detector and the level of the intermediate-frequency AM modulated receiving signal is measured by the IF level detector .
20
3
3
In the following step S the automatic gain control determines based on the detected level of the RF receiving signal the corresponding RF attenuation value. Based on the detected level of the IF receiving signal, the automatic gain control determines the corresponding IF attenuation value.
30
4
9
In the following step S the RF modulated receiving signal is attenuated with the determined RF attenuation value by the RF attenuator , and the IF AM modulated receiving signal is attenuated with the determined IF attenuation value the IF attenuator .
40
3
3
14
13
In case of an increasing or decreasing AM modulated receiving signal—an approximating or departing mobile radio unit to or from the basestation, respectively—the time of a step in the attenuation is identified in the following step S by the automatic gain control . The automatic gain control generates a control signal sc signaling a step in the attenuated RF or IF receiving signal for the IIR filter in the AM demodulator ′.
50
17
14
13
17
9
14
13
In the following step S the control signal sc is delayed by a delay buffer corresponding to the delay time of the attenuated RF receiving signal between the RF attenuator and the lowpass IIR filter in the AM demodulator ′. The control signal sc is also delayed by the delay buffer corresponding to the delay time of the IF receiving signal between the the IF attenuator and the lowpass IIR filter in the AM demodulator ′.
1
2
3
4
14
13
60
Depending on the information in the delayed control signal sc signaling a step in the attenuated RF receiving signal or the IF receiving signal the level of each delay unit's output signal V, V, V, and Vof the lowpass IIR filter in the AM demodulator ′ is increased in the last step S corresponding to equation (2).
<math overflow="scroll"><mtable><mtr><mtd><mrow><mrow><mrow><msub><mi>V</mi><mi>k</mi></msub><mo></mo><mrow><mo>(</mo><mi>n</mi><mo>)</mo></mrow></mrow><mo>=</mo><mrow><mrow><mrow><mrow><msub><mi>V</mi><mi>k</mi></msub><mo></mo><mrow><mo>(</mo><mrow><mi>n</mi><mo>-</mo><mn>1</mn></mrow><mo>)</mo></mrow></mrow><mo>·</mo><msup><mn>10</mn><mfrac><mrow><mrow><mi>A</mi><mo></mo><mrow><mo>(</mo><mi>n</mi><mo>)</mo></mrow></mrow><mo>-</mo><mrow><mi>A</mi><mo></mo><mrow><mo>(</mo><mrow><mi>n</mi><mo>-</mo><mn>1</mn></mrow><mo>)</mo></mrow></mrow></mrow><mn>20</mn></mfrac></msup></mrow><mo></mo><mi>k</mi></mrow><mo>=</mo><mn>1</mn></mrow></mrow><mo>,</mo><mi>…</mi><mo></mo><mstyle><mspace width="0.3em" height="0.3ex" /></mstyle><mo>,</mo><mn>4</mn></mrow></mtd><mtd><mrow><mo>(</mo><mn>2</mn><mo>)</mo></mrow></mtd></mtr></mtable></math>
Here the variable A(n−1) is the value of the attenuation curve before the step and A(n) is the value of the attenuation curve after the step.
FIG. 7
The inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal is shown in .
FIG. 7
FIG. 1
Identical features of the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal in and of the apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal of state of the art in have identical reference numbers and are not described repetitively.
3
17
4
9
14
In the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal the automatic gain control generates a control signal sc signaling a step in the attenuated RF AM modulated receiving signal or the IF AM modulated receiving signal. The control signal sc signaling a step in the attenuated RF or IF AM modulated receiving signal is delayed in the delay buffer corresponding to the delay time of the attenuated RF or IF AM modulated receiving signal between the RF attenuator or the IF attenuator , respectively, and the lowpass IIR filter .
13
18
c
1
2
3
4
c
In the inventive AM demodulator ′ a control unit receives the delay control signal sand increases the signals V, V, V, and Vat the output of the respective delay unit each time the delayed control signal scontains an information signaling a step in the attenuated RF or IF AM modulated receiving signal.
14
13
1
2
14
13
FIG. 8
For comparison with the state of the art the time average DC(m(n)) of the amplitude m(n) of the complex baseband AM modulated receiving signal x(n) at the output of the lowpass IIR filter and the signal y(n) at the output of the AM demodulator ′ of the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal is displayed in curve and of . After appearing a step in the attenuated RF or IF receiving signal no or minimal oscillations can be identified in the time average DC(m(n)) of the amplitude m(n) of the complex baseband AM modulated receiving signal x(n) at the output of the lowpass IIR filter and in the signal y(n) at the output of the AM demodulator ′ of the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal.
FIG. 9
1
2
13
In more detail shows in curve a negative step in the attenuation curve and in curve the resulting signal y(n) at the output of the AM demodulator ′. A superposition of a further oscillation to the AM demodulated signal y(n) cannot be detected.
The invention is not limited to the described embodiment. Especially a separated increasing of each signal at the respective delay unit's output in case of arriving of the step in the attenuated receiving signal at the respective delay unit of the IIR filter is covered by the invention.
BRIEF DESCRIPTION OF THE DRAWINGS
An embodiment of the invention is shown in the drawings and is consecutively described in detail. In the drawings:
FIG. 1
shows a diagram of an apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal of the prior art.
FIG. 2
shows a time diagram of the stepwise attenuation curve, of the RF receiving signal and of the amplitude of the complex attenuated baseband receiving signal.
FIG. 3
shows a time diagram of the signal at the output of a lowpass infinite-impulse-response filter of state of the art representing the time average of the amplitude of the complex attenuated baseband receiving signal and of the signal at the output of an AM demodulator of the prior art.
FIG. 4
shows a diagram of a lowpass infinite-impulse-response filter of fourth order in canonical structure of the prior art.
FIGS. 5A and 5B
show a table of the level transition of several signals in the lowpass IIR-filter of state of the art and the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal.
FIG. 6
shows a flowchart of the inventive method for leveling an increasing or decreasing slope of an AM modulated receiving signal.
FIG. 7
shows a diagram of the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal.
FIG. 8
shows a time diagram of the signal at the output of the lowpass IIR filter and at the output of the AM demodulator of the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal.
FIG. 9
shows a time diagram of the stepwise attenuation curve and of the signal at the output of the AM demodulator of the inventive apparatus for leveling an increasing or decreasing slope of an AM modulated receiving signal. | |
There was a time in Western music that most music was sacred music. European monarchs commissioned favored musicians to create the tapestry of tunes to be played in the greatest cathedrals and their smallest private chapels. Folk tunes also were incorporated into this growing body of sacred songs.
But during the pandemic today, authorities discourage choirs, singing and such musical celebrations.
What’s a church to do?
If that church is Galveston’s First Lutheran, the answer is to invite the Bach Society to play an all-instrumental concert for the island, based on, of course, Bach.
You may never meet a musicologist, but Christopher Holman is just such a person. Based at the prestigious University of Oxford in the United Kingdom, he’s also attached to the Bach Society and will be our guide for Saturday’s concert at 3:30 p.m. at First Lutheran, 2415 Winnie St. in Galveston.
Saturday’s presentation is “Bach: Complete Sonatas and Partitas for Unaccompanied Violin, Part III with Bach Orchestra members Maria Lin and Kurt Johnson.”
The pieces are considered technically demanding and were, in part, derived from existing German dances circa the 17th century.
“In Bach’s day, there was no separation between church and state, and in his role as cantor, director of music at St. Thomas Church in Leipzig, plus teaching and composing duties, Bach was a government official, and thus had to compose music for the church, university and state occasions,” Holman said. “There are very few musical differences between works with secular, sacred, or no text in 18th century Saxony; many composers, including Bach, reused the same musical themes and ideas in both instrumental works and vocal compositions with sacred texts.”
Musical detectives like Holman also have uncovered what inspired Bach to constantly compose his timeless works.
“The many annotations, marginalia and underlined passages in Johann Sebastian’s copy of the Bible leave no doubt: composing and performing for him, regardless of context, was an act of faith,” Holman said. “He often signed his manuscripts, regardless of instrumentation or nature of the text, with ‘SDG,’ that is, ‘Soli Deo Gloria’, or ‘To the glory of God alone.’”
Trond Saeverud is the director of the Galveston Symphony and also is a fan of Bach.
“I play Bach’s harmonized Lutheran chorales every day,” he said. “It is the only music I play regularly just for my own enjoyment.”
As for the master, Saeverud said, “Bach was himself a virtuoso violinist. Today, he is mostly imagined at the keyboard, but his first instrument was actually the violin, and he often led ensembles while playing violin. His mastery of that instrument is evident in these incredibly intricate and virtuoso works. All the pieces are informed by Bach’s deep and sincere faith.”
The concert is open to the public with a suggested freewill offering of $5 to $10. The church phone number is 409-762-8477.
Next week in Our Faith: We’ll profile a priest, new to the island. | https://www.galvnews.com/faith/free/article_dcbc862d-7816-5b9d-b0a5-be55cca9cd48.html |
G. Wallner, S. Kriglstein:
"An Introduction to Gameplay Data Visualization";
in: "Game Research Methods: An Overview", P. Lankoski, S. Björk (ed.); ETC Press, 2015, ISBN: 9781312884731, 231 - 250.
The prevalence of internet-enabled gaming devices nowadays enables game developers to remotely and unobtrusively monitor every aspect of a game, allowing them to accumulate large amounts of data of the player-game interaction over extended time periods. This data has become a viable source for developers to guide decision-making throughout the game design process and even after the game has been released, for example, to identify balancing issues (Kim, et al., 2008; Zoeller, 2010), to understand player movement (Moura, El-Nasr and Shaw, 2011), to reduce production costs (Hullett, et al., 2011), or to uncover bugs (Zoeller, 2010), to name but a few. At the same time, the increasing popularity of online multiplayer gaming has attached great importance to in-game statistics to allow players to recap their performance and to compare it with others. This growing interest in game telemetry data is reflected by the emergence of the new field of game analytics - concerned with the discovery and communication of meaningful patterns in data as applied in the context of game development and game research (cf. El-Nasr, Drachen and Canossa, 2013). Game analytics heavily relies on visualization techniques to assist developers and players alike to understand, analyze, and explore the data (cf. Wallner and Kriglstein, 2013). Visualizations in game research can be helpful to discover unexpected paths which have been taken by the players, to identify possible design and balancing problems, or to find common patterns in the behavior of the players. Moreover, since the rich interaction possibilities provided by a game can give rise to emergent behavior which is hard to anticipate, visualizations can assist in exploratory data analysis helping the analyst to discover potentially interesting structures, trends, and anomalies not thought of beforehand. | https://publik.tuwien.ac.at/showentry.php?ID=238203&lang=6 |
Ottawa forms advisory committee to get more people into trades
HALIFAX — A new advisory committee will help promote apprenticeships and skilled trades across Canada, Prime Minister Justin Trudeau said Friday.
Trudeau made the announcement prior to a roundtable meeting focused on promoting trades for women at a Nova Scotia Community College campus in Dartmouth, N.S.
In brief opening remarks before the closed-door session, Trudeau said trades should be seen as a viable option at a time when there's "a lot of uncertainty" about where the jobs of the future will come from.
"We know that trades are a great career that offers professional development, continued advancement, and a level of satisfaction that is remarkable," he said.
The Liberal government announced $6 million over two years in the 2019 budget to create a national campaign to promote skilled trades to young people.
However, Trudeau acknowledged that breaking into trades isn't an easy proposition for many in the job market.
"There can be challenges for certain people to get into trades, particularly minority groups, or women, or marginalized communities. That's why talking about how important trades are is important . . . for everyone."
The advisory committee is to lay the groundwork for a national campaign to encourage apprenticeships and promote the skilled trades as a career. It will lead consultations, explore partnerships, and provide advice to the minister of employment, workforce development and labour.
Members named to the committee so far are the three co-chairs Mandy Rennehan, founder and CEO of Freshco, Jamie McMillan, ironworker and founder of Kickass Careers, and Matt Wayland, executive assistant with the International Brotherhood of Electrical Workers. More members are to be named later.
According to the federal government Canada will need 67,000 new journeypersons to sustain the country's workforce in the 10 largest standardized trades by 2023.
However, the number of young women in particular who are considering a career as a skilled tradesperson, continues to be low. The government points to an OECD survey that found only two per cent of 15-year-old female students were planning to pursue a career in the skilled trades.
Rennehan, said it's a trend that has to change given that women represent just four per cent of the skilled trades workforce.
"Everybody needs to understand that four per cent needs to shoot to 40 per cent, and then we will be the front-runner in the world," she said.
Emily Boucher, of the Nova Scotia-based nonprofit group Techsploration, said her group has been working through a mentoring program to introduce girls in Grades 9 through 12 to in-demand careers in science, engineering, trades and technology since 1998.
Boucher said nearly one-fifth of the program's graduates have found careers in construction trades.
She said there has been a "significant shift" over the past five to 10 years in how employers in the trades have come to see women as a potential source of labour.
Boucher welcomed the renewed emphasis by the federal and provincial governments on promoting the trades and women's place in them. "A diverse workforce is a more productive workforce, so it directly impacts innovation and bottom line in Canada," she said.
Ottawa forms advisory committee to get more people into trades
The skilled trades need more workers, but how to get them? Ottawa has set up and group to advise.
News06:56 PMby
Keith Doucette
The Canadian Press
HALIFAX — A new advisory committee will help promote apprenticeships and skilled trades across Canada, Prime Minister Justin Trudeau said Friday.
Trudeau made the announcement prior to a roundtable meeting focused on promoting trades for women at a Nova Scotia Community College campus in Dartmouth, N.S.
In brief opening remarks before the closed-door session, Trudeau said trades should be seen as a viable option at a time when there's "a lot of uncertainty" about where the jobs of the future will come from.
"We know that trades are a great career that offers professional development, continued advancement, and a level of satisfaction that is remarkable," he said.
The Liberal government announced $6 million over two years in the 2019 budget to create a national campaign to promote skilled trades to young people.
However, Trudeau acknowledged that breaking into trades isn't an easy proposition for many in the job market.
"There can be challenges for certain people to get into trades, particularly minority groups, or women, or marginalized communities. That's why talking about how important trades are is important . . . for everyone."
The advisory committee is to lay the groundwork for a national campaign to encourage apprenticeships and promote the skilled trades as a career. It will lead consultations, explore partnerships, and provide advice to the minister of employment, workforce development and labour.
Members named to the committee so far are the three co-chairs Mandy Rennehan, founder and CEO of Freshco, Jamie McMillan, ironworker and founder of Kickass Careers, and Matt Wayland, executive assistant with the International Brotherhood of Electrical Workers. More members are to be named later.
According to the federal government Canada will need 67,000 new journeypersons to sustain the country's workforce in the 10 largest standardized trades by 2023.
However, the number of young women in particular who are considering a career as a skilled tradesperson, continues to be low. The government points to an OECD survey that found only two per cent of 15-year-old female students were planning to pursue a career in the skilled trades.
Rennehan, said it's a trend that has to change given that women represent just four per cent of the skilled trades workforce.
"Everybody needs to understand that four per cent needs to shoot to 40 per cent, and then we will be the front-runner in the world," she said.
Emily Boucher, of the Nova Scotia-based nonprofit group Techsploration, said her group has been working through a mentoring program to introduce girls in Grades 9 through 12 to in-demand careers in science, engineering, trades and technology since 1998.
Boucher said nearly one-fifth of the program's graduates have found careers in construction trades.
She said there has been a "significant shift" over the past five to 10 years in how employers in the trades have come to see women as a potential source of labour.
Boucher welcomed the renewed emphasis by the federal and provincial governments on promoting the trades and women's place in them. "A diverse workforce is a more productive workforce, so it directly impacts innovation and bottom line in Canada," she said.
Top Stories
Ottawa forms advisory committee to get more people into trades
The skilled trades need more workers, but how to get them? Ottawa has set up and group to advise.
News06:56 PMby
Keith Doucette
The Canadian Press
HALIFAX — A new advisory committee will help promote apprenticeships and skilled trades across Canada, Prime Minister Justin Trudeau said Friday.
Trudeau made the announcement prior to a roundtable meeting focused on promoting trades for women at a Nova Scotia Community College campus in Dartmouth, N.S.
In brief opening remarks before the closed-door session, Trudeau said trades should be seen as a viable option at a time when there's "a lot of uncertainty" about where the jobs of the future will come from.
"We know that trades are a great career that offers professional development, continued advancement, and a level of satisfaction that is remarkable," he said.
The Liberal government announced $6 million over two years in the 2019 budget to create a national campaign to promote skilled trades to young people.
However, Trudeau acknowledged that breaking into trades isn't an easy proposition for many in the job market.
"There can be challenges for certain people to get into trades, particularly minority groups, or women, or marginalized communities. That's why talking about how important trades are is important . . . for everyone."
The advisory committee is to lay the groundwork for a national campaign to encourage apprenticeships and promote the skilled trades as a career. It will lead consultations, explore partnerships, and provide advice to the minister of employment, workforce development and labour.
Members named to the committee so far are the three co-chairs Mandy Rennehan, founder and CEO of Freshco, Jamie McMillan, ironworker and founder of Kickass Careers, and Matt Wayland, executive assistant with the International Brotherhood of Electrical Workers. More members are to be named later.
According to the federal government Canada will need 67,000 new journeypersons to sustain the country's workforce in the 10 largest standardized trades by 2023.
However, the number of young women in particular who are considering a career as a skilled tradesperson, continues to be low. The government points to an OECD survey that found only two per cent of 15-year-old female students were planning to pursue a career in the skilled trades.
Rennehan, said it's a trend that has to change given that women represent just four per cent of the skilled trades workforce.
"Everybody needs to understand that four per cent needs to shoot to 40 per cent, and then we will be the front-runner in the world," she said.
Emily Boucher, of the Nova Scotia-based nonprofit group Techsploration, said her group has been working through a mentoring program to introduce girls in Grades 9 through 12 to in-demand careers in science, engineering, trades and technology since 1998.
Boucher said nearly one-fifth of the program's graduates have found careers in construction trades.
She said there has been a "significant shift" over the past five to 10 years in how employers in the trades have come to see women as a potential source of labour.
Boucher welcomed the renewed emphasis by the federal and provincial governments on promoting the trades and women's place in them. "A diverse workforce is a more productive workforce, so it directly impacts innovation and bottom line in Canada," she said. |
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