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Informed Consent: the Principle

Chapter Forty-Four

Syllabus topic 3, "Medicine and the Law"

Pages 256 to 260 of 951

In one line

The body is not the doctor's to treat, so the doctor needs permission, and permission given without understanding is not permission.

In the wording a student can write in an exam: informed consent is the requirement that a medical intervention be carried out only with the prior, free and informed agreement of the person concerned, based on adequate information; it rests on autonomy, the proposition that decisions about a person's body belong to that person, and it is enforced in two distinct ways, as a trespass to the person where there was no consent at all or where the procedure performed was not the one consented to, and as negligence where consent was given but the disclosure preceding it was inadequate.

Why the law has this at all

The requirement looks obvious and is not. Three arguments have been made against it, each with real force, and the law's answer to each is what gives the doctrine its shape.

"The doctor knows better." True, and irrelevant. Superior knowledge of what is medically advisable is not authority over another person's body. The doctrine of autonomy holds that the decision belongs to the patient even where the patient decides badly, because the alternative is that a person's body is at the disposal of anybody better informed than they are.

"Full disclosure will frighten patients out of necessary treatment." Also true, and the law accommodates it rather than dismissing it. The Indian standard, in the next chapter, expressly balances the need for adequate information against the risk of deterring a patient from necessary treatment or driving them to unnecessary treatment.

"There was no time to ask." Sometimes true, and answered by a narrow exception rather than by abandoning the rule: an unauthorised procedure is permissible where it is necessary to save the life or preserve the health of the patient and it would be unreasonable to delay until the patient regains consciousness and decides.

Autonomy, and where it comes from

The principle in this module has the same source as the principle in [Bodily Integrity and Intervention Without Consent], and a candidate should be able to move between them.

The Nuremberg Code 1947, point 1: the voluntary consent of the human subject is absolutely essential. It stands first of ten, before the points on the design of the experiment and the qualifications of the investigator. Point 9 adds that the subject should be at liberty to bring the experiment to an end.

ICCPR article 7: no torture or cruel, inhuman or degrading treatment, and in particular no one shall be subjected without his free consent to medical or scientific experimentation. There is no limitation clause.

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