21. A minor or a person of full age who is incapable of giving consent may participate in research that could interfere with the integrity of his person only if the risk incurred, taking into account his state of health and personal condition, is not disproportionate to the benefit that may reasonably be anticipated.
Moreover, a minor or a person of full age incapable of giving consent may participate in such research only if, where he is the only subject of the research, it has the potential to produce benefit to his health or only if, in the case of research on a group, it has the potential to produce results capable of conferring benefit to other persons in the same age category or having the same disease or handicap.
In all cases, a minor or a person of full age incapable of giving consent may not participate in such research where he understands the nature and consequences of the research and objects to participating in it.
The research project must be approved and monitored by a competent research ethics committee. Such a committee is formed by the Minister of Health and Social Services or designated by that Minister from among existing research ethics committees; the composition and operating conditions of such a committee are determined by the Minister and published in the Gazette officielle du Québec.
Consent to research that could interfere with the integrity of a minor may be given by the person having parental authority or the tutor. A minor 14 years of age or over, however, may give consent alone if, in the opinion of the competent research ethics committee, the research involves only minimal risk and the circumstances justify it.
Consent to research that could interfere with the integrity of a person of full age incapable of giving consent may be given by the mandatary, tutor or curator. However, where such a person of full age is not so represented and the research involves only minimal risk, consent may be given by the person qualified to consent to any care required by the state of health of the person of full age. Consent may also be given by such a qualified person where a person of full age suddenly becomes incapable of giving consent and the research, insofar as it must be undertaken promptly after the appearance of the condition giving rise to it, does not permit, for lack of time, the designation of a legal representative for the person of full age. In both cases, it is incumbent upon the competent research ethics committee to determine, when evaluating the research project, whether it meets the prescribed requirements.
1991, c. 64, a. 21; 1992, c. 57, s. 716; 1998, c. 32, s. 1; 2013, c. 17, s. 2.