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Research in Emergency Health Situations

Article 21, paragraphe 2, Code civil du Québec:

"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."

However, when a previously incapacitated subject regains capacity, free and informed consent must be sought promptly for continuation in the project and for subsequent examinations or tests related to the study.

Below is article 21 of  the Code civil du Québec.:

"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, a. 1.)

 

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