The Doctrine of Informed Consent

The Doctrine of Informed Consent

The doctrine of informed consent is a moral and legal doctrine that is widely applied in medical and research ethics. Its ancestry is often traced to the Nuremberg Code, which was developed as a reaction to the non-consensual research practices that occurred in German concentration camps in the Second World War. Rule One of the Nuremberg Code states:

The voluntary consent of the human subject is absolutely essential. This means that the person involved should have the legal capacity to give consent; should be so situated as to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, over-reaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the subject matter involved as to enable him to make an understanding and enlightened decision. ( Nuremberg Code , 1949)

Originally developed as a constraint on research involving human subjects, the doctrine of informed consent has become the keystone of institutional ethical procedures in hospitals . These days, it is usual for medical professionals to obtain the explicit informed consent of patients before conducting an operation or prescribing a course of treatment. Obtaining a patient s informed consent involves advising the patient of the nature of the proposed procedure or course of treatment, together with its attendant risks and benefits. It also involves ensuring that the patient comprehends the disclosure. ^{[ 5]} It is often thought that the doctrine of informed consent is a doctrine that applies to medicine and research involving human subjects, but is not relevant to consideration of our consenting practices elsewhere. It is only in medicine and in research involving human subjects that we currently institute official procedures to ensure that informed consent is obtained. And in other areas of human activity, where consent is at issue, we do not normally talk of informed consent.

Although the doctrine of informed consent is associated almost exclusively with medicine and research involving human subjects, I have argued elsewhere (Clarke, 2001) that informedness is a necessary precondition for all effective acts of consent. When I consent to get married, I do so on the understanding that I have had a reasonable opportunity to gather information about the person I marry and that the information that they have provided is, by and large, accurate. If I subsequently find out that they have neglected to provide me with some important piece of relevant information, then I have grounds for a divorce or even an annulment.

Similarly, when I consent to buy a computer, I do so in the belief that I have had a reasonable opportunity to obtain relevant information about the computer from the vendor. If I find out that there was some important information about the computer that was withheld from me before purchase, then the contract of sale can be rendered null and void, and I may have the basis for a legal claim against the vendor. The opportunity to obtain relevant information is a necessary precondition of all effective consenting acts, so talk of informed consent is appropriate outside the domain of medical and research ethics.

^{[ 5]} The locus classicus of informed consent in medicine and research involving human subjects is Faden and Beauchamp (1986). Wear (1998) provides a very accessible account of the informed consent process that is broadly in line with Faden and Beauchamp s approach.