1. INFORMED CONSENT Some Philosophical Puzzles Professor David Archard d.archard@lancaster.ac.uk

2. GENERAL BACKGROUND Sane competent adults should be free to make their own decisions Sane competent adults should be free to make their own decisions ‘…this doctrine is meant to apply only to human beings in the maturity of their faculties’ ‘…this doctrine is meant to apply only to human beings in the maturity of their faculties’

3. Informed Consent: Background A requirement of informed consent as a key principle of medical research and practice A requirement of informed consent as a key principle of medical research and practice Nothing shall be done to an individual without that individual’s consent Nothing shall be done to an individual without that individual’s consent Negatively: revulsion at abuse of medical practices during World War II Negatively: revulsion at abuse of medical practices during World War II Positively: reflecting an underlying view of the sovereign individual as final and authoritative source of an decision of what shall be done to her. Positively: reflecting an underlying view of the sovereign individual as final and authoritative source of an decision of what shall be done to her.

4. Principles of consent Nothing shall be done to a person without that person’s consent Nothing shall be done to a person without that person’s consent Something done to a person with her consent is morally permissible Something done to a person with her consent is morally permissible ‘Moral magic’: consent is a basic normative power to transform the moral relationships in which individuals stand to one another ‘Moral magic’: consent is a basic normative power to transform the moral relationships in which individuals stand to one another

5. From assault to sport…..

6. International Codes of Bioethics 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be situated as to be able to exercise free power of choice, …..and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. (Nuremberg Code, a ten point statement delimiting permissible medical experimentation on human subjects). 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be situated as to be able to exercise free power of choice, …..and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. (Nuremberg Code, a ten point statement delimiting permissible medical experimentation on human subjects). The subjects must be volunteers and informed participants in the research project. ([World Medical Association] Helsinki Declaration, 1964) The subjects must be volunteers and informed participants in the research project. ([World Medical Association] Helsinki Declaration, 1964) For all biomedical research involving humans the investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the permission of a legally authorized representative in accordance with applicable law. Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an ethical review committee. (CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, Guidline 4) For all biomedical research involving humans the investigator must obtain the voluntary informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the permission of a legally authorized representative in accordance with applicable law. Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an ethical review committee. (CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, Guidline 4)

7. The ‘triumph of autonomy’ Autonomy as one principle amongst others (beneficence, non-maleficence, justice) Autonomy as one principle amongst others (beneficence, non-maleficence, justice) ‘For better or for worse …autonomy has emerged as the most powerful principle in American bioethics, the basis of much theory and much regulation, and has become the “default” principle.’ ‘For better or for worse …autonomy has emerged as the most powerful principle in American bioethics, the basis of much theory and much regulation, and has become the “default” principle.’

8. The Roots of Consent The ideal of self- ownership (John Locke) The ideal of self- ownership (John Locke) The ideal of (rational) autonomy (Immanuel Kant) The ideal of (rational) autonomy (Immanuel Kant)

9. Two Very Different Kinds of Claim It’s my body and you can’t do that to me It’s my body and you can’t do that to me It’s my life and I’ll lead it as I choose It’s my life and I’ll lead it as I choose

10. Conditions of Consent Voluntary: given freely and not, e.g., as a result of coercive pressure. Voluntary: given freely and not, e.g., as a result of coercive pressure. Informed: given in possession and understanding of the principal, relevant information. Informed: given in possession and understanding of the principal, relevant information. Competent: given by somebody able, in virtue of their age and maturity, of making a free, considered choice. Competent: given by somebody able, in virtue of their age and maturity, of making a free, considered choice.

11. Challenges to the Principles within Medical Research and Practice Is it necessary to obtain consent to what will only minimally affect the individual but will be productive of great good? Is it necessary to obtain consent to what will only minimally affect the individual but will be productive of great good? The good could be for the individual. Or The good could be for the individual. Or For society For society Consider the painless, relatively costless obtaining (and use) of some kinds of very important information without consent Consider the painless, relatively costless obtaining (and use) of some kinds of very important information without consent

12. The autonomy of the patient/subject? Decisions made under conditions of considerable personal stress and short time scale Decisions made under conditions of considerable personal stress and short time scale The influence of doctors (as authority figures or as sources of inducement) The influence of doctors (as authority figures or as sources of inducement) The influence of family and loved ones The influence of family and loved ones

13. Informed? Much medical information is surely too complex for ordinary individuals to understand Much medical information is surely too complex for ordinary individuals to understand Is this a problem of the information as such or the manner in which doctors choose to communicate it? Is this a problem of the information as such or the manner in which doctors choose to communicate it? Some features of information – e.g. risk – may be impossible successfully to communicate Some features of information – e.g. risk – may be impossible successfully to communicate

14. Understanding Risk ‘This experimental drug will reduce your chances of contracting a certain fatal disease by a 100. But there is a 1 in 5 chance of some unpleasant side effects’ Take it? ‘This experimental drug will reduce your chances of contracting a certain fatal disease by a 100. But there is a 1 in 5 chance of some unpleasant side effects’ Take it? Your initial chances of contracting the disease are 1 in 1,000,000 Your initial chances of contracting the disease are 1 in 1,000,000

15. The scope of consent Opacity: consent to something under one description need not be consent to that same thing under another description (a life-saving operation v. an excruciatingly painful procedure) Opacity: consent to something under one description need not be consent to that same thing under another description (a life-saving operation v. an excruciatingly painful procedure) Consequential uncertainty: consent to something may not be consent to what might follow from it (an operation and its possible side-effects) Consequential uncertainty: consent to something may not be consent to what might follow from it (an operation and its possible side-effects)

16. The subjects of consent A (Western?) presumption that the subjects of consent are individuals A (Western?) presumption that the subjects of consent are individuals But we are relational subjects defined by our membership of, e.g., families But we are relational subjects defined by our membership of, e.g., families Who then should be the author of consent: the individual or her family? Who then should be the author of consent: the individual or her family?

17. Trust and Autonomy Trust (between professional and client) involves the confident reliance upon the professional to act in the client’s best interests Trust (between professional and client) involves the confident reliance upon the professional to act in the client’s best interests Such trust may be in tension with the demand for information that is a condition of consent Such trust may be in tension with the demand for information that is a condition of consent

18. Slippery Slopes The more information we demand the less we trust our informant (and vice versa) The more information we demand the less we trust our informant (and vice versa) Abandoning informed consent could lead to greater abuses Abandoning informed consent could lead to greater abuses

19. The future of consent Should a principle of informed consent remain a fundamental, basic principle of medical practice and research? Should a principle of informed consent remain a fundamental, basic principle of medical practice and research? Or should we use a principle of restricted scope and limited weight? Or should we use a principle of restricted scope and limited weight? Or should medical practice and research be regulated by other principles? Or should medical practice and research be regulated by other principles?