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Ethics of research with human volunteers and the College Ethics Review Board Justin H G Williams University of Aberdeen.

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Presentation on theme: "Ethics of research with human volunteers and the College Ethics Review Board Justin H G Williams University of Aberdeen."— Presentation transcript:

1 Ethics of research with human volunteers and the College Ethics Review Board Justin H G Williams University of Aberdeen

2 History Late 19 th century trials being carried out on hospital patients Late 19 th century trials being carried out on hospital patients E.g.transplant of tumour tissue from one patient to another E.g.transplant of tumour tissue from one patient to another Albert Neisser (a Jew) went into dermatology – discovered gonococci and Neisser stain. Albert Neisser (a Jew) went into dermatology – discovered gonococci and Neisser stain. Developed cell-free serum to use as vaccine against syphilis Developed cell-free serum to use as vaccine against syphilis 1892: Administered it to young women prostitutes in hospital 1892: Administered it to young women prostitutes in hospital

3 Some of the women developed syphilis. Some of the women developed syphilis. Neisser blamed patients occupation (prostitution) and concluded his serum to be ineffective but harmless. Neisser blamed patients occupation (prostitution) and concluded his serum to be ineffective but harmless. Media accused him of giving syphilis to children and destroying their lives Media accused him of giving syphilis to children and destroying their lives Much debate in Prussian parliament Much debate in Prussian parliament Found to have harmed patients and was fined. Found to have harmed patients and was fined. Judgement and politics very much influenced by anti-semitic, anti-immunization creeds amongst professionals and the media. Judgement and politics very much influenced by anti-semitic, anti-immunization creeds amongst professionals and the media.

4 Prussian parliament issued the first directive governing medical research, stating that all research should require Prussian parliament issued the first directive governing medical research, stating that all research should require A competent subject A competent subject Explicit consent Explicit consent A proper explanation of the possible negative consequences A proper explanation of the possible negative consequences 1920s Criticism of medical research in collaboration with creative chemical industry (soon to produce sulphonamides) 1920s Criticism of medical research in collaboration with creative chemical industry (soon to produce sulphonamides) 1931: Reich issued guidelines 1931: Reich issued guidelines 1946: Nuremburg issued code good for Barbarians but unnecessary for ordinary doctor- scientists 1946: Nuremburg issued code good for Barbarians but unnecessary for ordinary doctor- scientists WMA agreed Declaration of Helsinki in 1964 WMA agreed Declaration of Helsinki in 1964 Not binding in UK Not binding in UK

5 1967; Royal College of Physicians advises that a group of doctors should supervise the ethics of research 1967; Royal College of Physicians advises that a group of doctors should supervise the ethics of research BMA argue for self-autonomy and remain sceptical BMA argue for self-autonomy and remain sceptical Further report from RCP in 1973 Further report from RCP in 1973 RECs developed RECs developed 1990: first National Training Conference in Swansea 1990: first National Training Conference in Swansea 1991 Local Research Ethics Committees 1991 Local Research Ethics Committees 1997 Multi-centre Research Ethics Committees 1997 Multi-centre Research Ethics Committees 2001 GAfREC 2001 GAfREC 2003: EC directive 2003: EC directive

6 Context 1 Governance – insurance, resources management (NHS or University R&D) Governance – insurance, resources management (NHS or University R&D) Legality e.g. Data protection, human tissue act, radiation protection, Legality e.g. Data protection, human tissue act, radiation protection, Other regulation e.g. MHRA, Other regulation e.g. MHRA, Good science – peer review by funding agency or colleagues Good science – peer review by funding agency or colleagues The primary job of the ethics committee is to ask if research is ethical not if it is legal. The primary job of the ethics committee is to ask if research is ethical not if it is legal.

7 Context 2 An ethical obligation to do good science An ethical obligation to do good science If you do not know you need to find out! If you do not know you need to find out! Vulnerable populations have an equal right to research that will benefit them e.g. prisoners, elderly, children and learning disabled. Vulnerable populations have an equal right to research that will benefit them e.g. prisoners, elderly, children and learning disabled. Mutual trust between committee and scientist is necessary Mutual trust between committee and scientist is necessary Need to assume best motive on either side. Need to assume best motive on either side. Ethics committee should act as a critical friend Ethics committee should act as a critical friend Strict rules on conflicts of interest – a need to be open and transparent Strict rules on conflicts of interest – a need to be open and transparent Not a matter of getting it past the ethics committee. Not a matter of getting it past the ethics committee.

8 Ethics is about: ValiditySafetyDignity

9 Validity Is this research or audit? Is this research or audit? Research is a venture designed to obtain new knowledge that is generalisable. Research is a venture designed to obtain new knowledge that is generalisable. Is this a genuine question to which we really do not know the answer? Is this a genuine question to which we really do not know the answer? Invalid science is not ethical (Where there is an educational objective? ) Invalid science is not ethical (Where there is an educational objective? ) Equipoise in trials: 2 balanced arms where you really do not know which arm is preferable. Therefore randomisation is the only ethical choice. Equipoise in trials: 2 balanced arms where you really do not know which arm is preferable. Therefore randomisation is the only ethical choice. Is it statistically sound? Is an expert required? Is it statistically sound? Is an expert required?

10 Safety Minimal risk must be achieved. Minimal risk must be achieved. Is there any danger to participants? Is there any danger to participants? Are procedures being carried out correctly? Are procedures being carried out correctly? Are researchers adequately trained? Are researchers adequately trained? Are facilities well managed and safe? Are facilities well managed and safe? Does the sponsor have adequate insurance? Does the sponsor have adequate insurance?

11 Dignity Are patients needs and rights being respected? Are patients needs and rights being respected? Consent a) to be screened b) to take part Consent a) to be screened b) to take part Confidentiality Confidentiality Human beings not human guinea pigs Human beings not human guinea pigs Are they from vulnerable groups? Are they from vulnerable groups? Do they require renumeration? Do they require renumeration? Do they require follow-up? Do they require follow-up? ? Compensation? Insurance? ? Compensation? Insurance?

12 Consent By definition it is informed By definition it is informed Do your volunteers have the capacity? Do your volunteers have the capacity? To make a free decision after weighing up the advantages and disadvantages To make a free decision after weighing up the advantages and disadvantages Been provided with the information? Been provided with the information? Do they comprehend the information? Do they comprehend the information? Do they remember it? Do they remember it? Can they weigh it up? Can they weigh it up? Can they communicate their intention? Can they communicate their intention? Consent vs assent Consent vs assent

13 How much information should you provide? Patient must be informed of material risk What amounts to material risk? Shifting sands: 1957: what other practitioners would do in that position 1957: what other practitioners would do in that position 1985: what the reasonable doctor should do 1985: what the reasonable doctor should do 1999: what the reasonable patient should expect 1999: what the reasonable patient should expect 2004: what the reasonable patient should expect in light of their situation and circumstances. 2004: what the reasonable patient should expect in light of their situation and circumstances. Reflects increasing respect for autonomy and dignity of patients

14 Consent (contd) The consent form only provides evidence of consent The consent form only provides evidence of consent Patient needs to have been given the information and understood it. Patient needs to have been given the information and understood it. Information sheet should contain as much information as possible about risks that the participant can understand. Information sheet should contain as much information as possible about risks that the participant can understand. Exception: information may not be given if it would be therapeutically disadvantageous to do so (but only a let out clause to be used very carefully) Exception: information may not be given if it would be therapeutically disadvantageous to do so (but only a let out clause to be used very carefully)

15 Providing Information Who is your audience? Who is your audience? Young, old, learning disabled? Young, old, learning disabled? Normal IQ? Reading Age? Normal IQ? Reading Age? Comprehensive vs comprehendable Comprehensive vs comprehendable Your volunteers do not have all day! Your volunteers do not have all day! Consider getting help from your secretary. Consider getting help from your secretary.

16 Providing information (contd) What is going to happen? What is going to happen? What are the benefits (self and others)? What are the benefits (self and others)? What will be required of me? What will be required of me? What are the possible risks, costs, benefits? What are the possible risks, costs, benefits? Anticipate and allay anxieties (if appropriate) Anticipate and allay anxieties (if appropriate)

17 Providing information contd Be truthful but do not create anxiety Be truthful but do not create anxiety Anticipate and allay anxieties (if appropriate) Anticipate and allay anxieties (if appropriate) Provide an appropriate amount of information for the demands of the experiment. Provide an appropriate amount of information for the demands of the experiment. Consider pictures and other aids to comprehension Consider pictures and other aids to comprehension

18 What does he or she need to know? What is going to happen in the experiment? What is going to happen in the experiment? What are the benefits What are the benefits For the population in general For the population in general For me personally For me personally

19 Problems with the discovery of unwanted information Growing problem in neuroimaging and genetic studies on healthy people. Growing problem in neuroimaging and genetic studies on healthy people. Problems on brain scans and genetic susceptibilities Problems on brain scans and genetic susceptibilities Responses on questionnaires Responses on questionnaires Do you tell the patient? Do you tell the patient? Need to prepare for unexpected findings Need to prepare for unexpected findings Volunteer needs to be prepared beforehand Volunteer needs to be prepared beforehand Should you systematically look for abnormalities? Should you systematically look for abnormalities?

20 Insurance Genetic Insurance Advisory Committee Genetic Insurance Advisory Committee Diagnosis of Huntingtons may be used to load premiums Diagnosis of Huntingtons may be used to load premiums No other tests are currently used No other tests are currently used British Insurers have stated that they will not use the results of research to load premiums British Insurers have stated that they will not use the results of research to load premiums

21 Rewards and coercion Should people be paid for participating? Should people be paid for participating? When does payment mean the decision to participate is no longer free? Could the payment be considered coercive? When does payment mean the decision to participate is no longer free? Could the payment be considered coercive? Means of payment: Means of payment: Reimbursed expenses Reimbursed expenses Tokens of thanks Tokens of thanks Small salary (£5/hr) Small salary (£5/hr) (free medical treatment in the U.S.) (free medical treatment in the U.S.)

22 Payment (contd) Reflects inconvenience and disruption. Reflects inconvenience and disruption. Also reflects discomfort (e.g. due to pain or collecting samples) Also reflects discomfort (e.g. due to pain or collecting samples) Payment should not be paid for perceived risk. Payment should not be paid for perceived risk. Do not state what payment is in advertisement Do not state what payment is in advertisement

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36 Summary Validity, Safety, Dignity Validity, Safety, Dignity Ethical obligation to do good, productive research as well as to prevent harm Ethical obligation to do good, productive research as well as to prevent harm Occurs in a context of societal values, legal frameworks, research governance and peer review Occurs in a context of societal values, legal frameworks, research governance and peer review Thank you for your attention.


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