On March 28, 2013, Réjean Hébert, the Minister of Health and Social Services and minister responsible for Seniors, introduced at the National Assembly Bill n° 30 aimed at amending certain provisions of the Civil Code of Québec (C.c.Q.) and An Act Respecting Health Services and Social Services (R.S.Q., c. S 4.2) (ARHSSS).

The Bill, entitled An Act to amend the Civil Code and other legislative provisions with respect to research (the Act) received assent and came into force on June 14, 2013. The Act, which was last modified in 1998, modernizes the legislative framework relating to research. More specifically, the Act modifies certain provisions of the Civil Code’s section on “care” (including sections 21 through 24), as well as section 34 of the ARHSSS regarding the complaints procedure related to institutions that carry on research activities in the Province of Quebec. The amendments made to the Civil Code. and the ARHSSS soften a number of measures pertaining to consent to research when health risks are minimal in order to facilitate the advancement of knowledge while fostering research development. Indeed, said legislative changes are part of a harmonization effort with nationally and internationally recognized ethical standards.

Replacement of the term “experiment” by the expression “research that could interfere with the integrity” (ss. 20, 21, 24 and 24 C.c.Q.)

The expression “research that could interfere with the integrity” was chosen in order to clarify as much as possible the scope of the targeted field of research, namely research that can undermine the physical or psychological integrity of the participants. It is to to be noted that the type of research concerned is not broadened by this amendment to the Civil Code.

Persons qualified to give consent for a minor older than 14 years of age

Section 21 had provided that it was necessary to obtain the consent of the person having parental authority or the tutor of a minor for the latter to participate in an experiment. Now, a minor fourteen years of age and over may give consent alone if, in the opinion of a designated research ethics committee (REC), the research involves only minimal health risk and the circumstances justify it. This is an exception to the general rule requiring the consent of the person having parental authority or the tutor.

Persons qualified to consent for the person of full age who is incapable of giving consent

The Act now provides that this type of consent may be given by a person qualified to consent to this care, if the person of full age is not legally represented. The research project must involve only minimal risk to the health of the person of full age, in the REC’s opinion.

The participation of a minor or person of full age who is incapable of giving consent to a research and the notion of “minimal risk”

The notion of “minimal risk” is introduced for the first time in the Civil Code at s. 21. The REC will have to determine whether the research involves a minimal risk and the circumstances justify it. This notion of “minimal risk” is already known and used by RECs, among other things, for research related to persons of full age who are capable of giving consent in accordance with the Tri-Council Policy Statement.

Replacement of the notion of “serious risk” by that of “proportionality”

At s. 21 of the Civil Code, the notion of “serious risk” is replaced by the notion of “proportionality”, which requires that the risk incurred not be disproportionate to the anticipated benefit. To that effect, the REC must consider, when evaluating the research, the state of health and personal condition of the minor or person of full age who is incapable of giving consent.

The notion of “proportionality” includes the notion of “serious risk”, meaning that research involving a serious risk must also entail an important anticipated benefit for the proportionality requirement to be satisfied. The protection given to minors and persons of full age who are incapable of giving consent is not reduced or modified by that legislative change given that, in practice, RECs already considers the state of health and personal condition of the person involved when assessing the seriousness of the risk.

Removal of the last paragraph of s. 21 C.c.Q. concerning innovative care

The last paragraph of former s. 21 provided that when the REC considered care to be innovative and required by the person’s state of health, this care was not overseen by the REC. This paragraph was removed from the Civil Code. Innovative care is now governed by the Civil Code’s provisions regarding care. The notion of innovative care refers to care that is not yet standardized, but whose efficacy has been proven.

Evaluation of research involving persons of full age who are capable of giving their consent by a REC

Section 20 now provides that research involving persons of full age who are capable of giving their consent must be analyzed by a REC. This requirement is in accordance with nationally and internationally recognized ethical standards.

Contrary to what applies to minors and persons of full age who are incapable of giving their consent, the Act does not require that the REC be designated by the Minister of Health and Social Services. Nevertheless, the composition and functioning of the REC must comply with the norms put forward in the Tri-Council Policy Statement, by Health Canada or any other organization, where applicable.

Consent to the use of a body part removed from a deceased for research purposes

Section 22 provides that consent to the use of a body part removed from a deceased for research purposes may be given by the person who could give or could have given consent to any care required by the deceased. Former s. 22 was silent with regard to the consent given in the name of the deceased, which caused confusion with regard to who could give consent for the deceased.

It must be noted that s. 24 does not allow a REC to authorize consent otherwise than in writing with regard to clinical trials related to drugs, natural health products or medical devices. Federal rules require written consent with regard to these matters.

Consent given otherwise than in writing

Section 24 now provides that consent to research may be given otherwise than in writing if a REC is of the opinion that the circumstances justify it. The latter must determine the proper manner, for evidentiary purposes, of obtaining consent.

It must be noted that s. 24 does not allow a REC to authorize consent otherwise than in writing with regard to clinical trials related to drugs, natural health products or medical devices. Federal rules require written consent with regard to these matters.