INFORMED CONSENTINFORMED CONSENTSome Philosophical PuzzlesSome Philosophical Puzzles

Professor David ArchardProfessor David Archard

d.archard@lancaster.ac.ukd.archard@lancaster.ac.uk

GENERAL BACKGROUNDGENERAL BACKGROUND

• Sane competent Sane competent adults should be adults should be free to make their free to make their own decisionsown decisions

• ‘…‘…this doctrine is this doctrine is meant to apply only meant to apply only to human beings in to human beings in the maturity of their the maturity of their faculties’faculties’

Informed Consent: Informed Consent: BackgroundBackground• A requirement of informed consent as a A requirement of informed consent as a

key principle of medical research and key principle of medical research and practicepractice

• Nothing shall be done to an individual Nothing shall be done to an individual without that individual’s consentwithout that individual’s consent

• Negatively: revulsion at abuse of medical Negatively: revulsion at abuse of medical practices during World War IIpractices during World War II

• Positively: reflecting an underlying view of Positively: reflecting an underlying view of the sovereign individual as final and the sovereign individual as final and authoritative source of an decision of what authoritative source of an decision of what shall be done to her.shall be done to her.

PrinciplePrincipless of consent of consent

• Nothing shall be done to Nothing shall be done to a person without that a person without that person’s consentperson’s consent

• Something done to a Something done to a person with her consent person with her consent is morally permissibleis morally permissible

• ‘‘Moral magic’: consent is Moral magic’: consent is a basic normative power a basic normative power to transform the moral to transform the moral relationships in which relationships in which individuals stand to one individuals stand to one anotheranother

From assault to sport…..From assault to sport…..

International Codes of International Codes of BioethicsBioethics• 1. The voluntary consent of the human subject is absolutely essential. This 1. The voluntary consent of the human subject is absolutely essential. This

means that the person involved should have legal capacity to give consent; 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 be situated as to be able to exercise free power of choice, …..and should have sufficient knowledge and comprehension of the elements of the should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and subject matter involved as to enable him to make an understanding and enlightened decision. (Nuremberg Code, a ten point statement delimiting enlightened decision. (Nuremberg Code, a ten point statement delimiting permissible medical experimentation on human subjects). permissible medical experimentation on human subjects).

• The subjects must be volunteers and informed participants in the research The subjects must be volunteers and informed participants in the research project. ([World Medical Association] Helsinki Declaration, 1964)project. ([World Medical Association] Helsinki Declaration, 1964)

• For all biomedical research involving humans the investigator must obtain For all biomedical research involving humans the investigator must obtain the voluntarythe voluntary informed consent of the prospective subject or, in the case of informed consent of the prospective subject or, in the case of an individual who is not capable of giving informed consent, the permission an individual who is not capable of giving informed consent, the permission of a legally authorized representative in accordance with applicable law. of a legally authorized representative in accordance with applicable law. Waiver of informed consent is to be regarded as uncommon and Waiver of informed consent is to be regarded as uncommon and exceptional, and must in all cases be approved by an ethical review exceptional, and must in all cases be approved by an ethical review committee. (CIOMS International Ethical Guidelines for Biomedical committee. (CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects, Guidline 4)Research Involving Human Subjects, Guidline 4)

The ‘triumph of autonomy’The ‘triumph of autonomy’

• Autonomy as one principle amongst Autonomy as one principle amongst others (beneficence, non-maleficence, others (beneficence, non-maleficence, justice)justice)

• ‘‘For better or for worse …autonomy has For better or for worse …autonomy has emerged as the most powerful principle emerged as the most powerful principle in American bioethics, the basis of much in American bioethics, the basis of much theory and much regulation, and has theory and much regulation, and has become the “default” principle.’become the “default” principle.’

The Roots of ConsentThe Roots of Consent

• The ideal of The ideal of self-self-ownershipownership (John (John Locke)Locke)

• The ideal of The ideal of (rational) (rational) autonomyautonomy (Immanuel Kant)(Immanuel Kant)

Two Very Different Kinds of Two Very Different Kinds of ClaimClaim

• It’s my body It’s my body and you can’t and you can’t do that to medo that to me

• It’s my life and It’s my life and I’ll lead it as I I’ll lead it as I choosechoose

Conditions of ConsentConditions of Consent

•VoluntaryVoluntary: given freely and not, : given freely and not, e.g., as a result of coercive pressure.e.g., as a result of coercive pressure.

• InformedInformed: given in possession and : given in possession and understanding of the principal, understanding of the principal, relevant information.relevant information.

•CompetentCompetent: given by somebody : given by somebody able, in virtue of their age and able, in virtue of their age and maturity, of making a free, maturity, of making a free, considered choice.considered choice.

Challenges to the Principles Challenges to the Principles within Medical Research and within Medical Research and

PracticePractice• Is it necessary to obtain consent to what Is it necessary to obtain consent to what

will only minimally affect the individual will only minimally affect the individual but will be productive of great good?but will be productive of great good?

• The good could be for the individual. OrThe good could be for the individual. Or• For societyFor society• Consider the painless, relatively costless Consider the painless, relatively costless

obtaining (and use) of some kinds of very obtaining (and use) of some kinds of very important information without consentimportant information without consent

The autonomy of the The autonomy of the patient/subject?patient/subject?

• Decisions made under Decisions made under conditions of conditions of considerable personal considerable personal stress and short time stress and short time scalescale

• The influence of The influence of doctors (as authority doctors (as authority figures or as sources figures or as sources of inducement)of inducement)

• The influence of family The influence of family and loved onesand loved ones

Informed?Informed?• Much medical information Much medical information

is surely too complex for is surely too complex for ordinary individuals to ordinary individuals to understandunderstand

• Is this a problem of the Is this a problem of the information as such or the information as such or the manner in which doctors manner in which doctors choose to communicate it?choose to communicate it?

• Some features of Some features of information – e.g. information – e.g. riskrisk – –may be impossible may be impossible successfully to successfully to communicatecommunicate

Understanding RiskUnderstanding Risk

• ‘‘This experimental This experimental drug will reduce your drug will reduce your chances of contracting chances of contracting a certain fatal disease a certain fatal disease by a 100. But there is by a 100. But there is a 1 in 5 chance of a 1 in 5 chance of some unpleasant side some unpleasant side effects’ Take it?effects’ Take it?

• Your initial chances of Your initial chances of contracting the contracting the disease are 1 in disease are 1 in 1,000,0001,000,000

The scope of consentThe scope of consent

• OpacityOpacity: consent to something under one : consent to something under one description need not be consent to that description need not be consent to that same thing under another description (a same thing under another description (a life-saving operation v. an excruciatingly life-saving operation v. an excruciatingly painful procedure)painful procedure)

• Consequential uncertaintyConsequential uncertainty: consent to : consent to something may not be consent to what something may not be consent to what might follow from it (an operation and its might follow from it (an operation and its possible side-effects)possible side-effects)

The subjects of consentThe subjects of consent

• A (Western?) A (Western?) presumption that the presumption that the subjects of consent are subjects of consent are individualsindividuals

• But we are But we are relational relational subjectssubjects defined by our defined by our membership of, e.g., membership of, e.g., familiesfamilies

• Who then should be the Who then should be the author of consent: the author of consent: the individualindividual or her or her family?family?

Trust and AutonomyTrust and Autonomy

• Trust (between Trust (between professional and client) professional and client) involves the confident involves the confident reliance upon the reliance upon the professional to act in the professional to act in the client’s best interestsclient’s best interests

• Such trust may be in Such trust may be in tension with the demand tension with the demand for information that is a for information that is a condition of consentcondition of consent

Slippery SlopesSlippery Slopes

• The more The more information we information we demand the less we demand the less we trust our informant trust our informant (and vice versa)(and vice versa)

• Abandoning Abandoning informed consent informed consent could lead to could lead to greater abusesgreater abuses

The future of consentThe future of consent

• Should a principle of informed consent Should a principle of informed consent remain a fundamental, basic principle remain a fundamental, basic principle of medical practice and research?of medical practice and research?

• Or should we use a principle of Or should we use a principle of restricted scope and limited weight?restricted scope and limited weight?

• Or should medical practice and Or should medical practice and research be regulated by other research be regulated by other principles?principles?