CCQ-1991 - Civil Code of Québec

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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.
21. A minor or a person of full age who is incapable of giving consent may not be submitted to an experiment if the experiment involves serious risk to his health or, where he understands the nature and consequences of the experiment, if he objects.
Moreover, a minor or a person of full age who is incapable of giving consent may be submitted to an experiment only if, where the person is the only subject of the experiment, it has the potential to produce benefit to the person’s health or only if, in the case of an experiment 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. Such an experiment must be part of a research project approved and monitored by an ethics committee. The competent ethics committees are formed by the Minister of Health and Social Services or designated by that Minister among existing research ethics committees; the composition and operating conditions of the committees are determined by the Minister and published in the Gazette officielle du Québec.
Consent to experimentation may be given, in the case of a minor, by the person having parental authority or the tutor and, in the case of a person of full age incapable of giving consent, by the mandatary, tutor or curator. Where a person of full age suddenly becomes incapable of consent and the experiment, 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, consent may be given by the person authorized to consent to any care the person requires; it is incumbent upon the competent ethics committee to determine, when examining the research project, whether the experiment meets that condition.
Care considered by the ethics committee to be innovative care required by the state of health of the person concerned does not constitute an experiment.
1991, c. 64, a. 21; 1992, c. 57, s. 716; 1998, c. 32, s. 1.
21. A minor or a person of full age who is incapable of giving his consent may be submitted to an experiment only in the absence of serious risk to his health and of objection on his part, provided that he understands the nature and consequences of the act; the consent of the person having parental authority or of the mandatary, tutor or curator is necessary.
An experiment may be carried out one person alone only if a benefit to the health of that person may be expected, and the authorization of the court is necessary.
An experiment on a group of minor persons or incapable persons of full age shall be carried out within the framework of a research project approved by the Minister of Health and Social Services, upon the advice of an ethics committee of the hospital designated by the Minister or of an ethics committee created by him for that purpose; in addition, such an experiment may be carried out only if a benefit to the health of persons of the same age group and having the same illness or handicap as the persons submitted to the experiment may be expected.
Care considered by the ethics committee of the hospital concerned to be innovative care required by the state of health of the person submitted to it is not an experiment.
1991, c. 64, a. 21; 1992, c. 57, s. 716.