Consent

1. Does TCPS 2 specify an age of consent for children? (August, 2011)

TCPS 2 does not specify an age of consent for children. Seeking consent from children is not based on their age, but on whether they have the capacity to understand the significance of the research and the implications of the risk and benefits to themselves – as defined in TCPS 2 Section 3.C. Factors to consider in making the decision to seek consent from children as participants include, but are not limited to, the nature of the research, the research setting, the level of risk the research may pose to participants, provincial legislation and other applicable legal and regulatory requirements related to legal age of consent, and the characteristics of the intended research participants - who may differ in many aspects including their competence/cognitive capacity to make their own decisions. As no two research studies or research participants are identical, the decision to seek consent from children instead of an authorized third party should be considered on a case-by-case basis. In practice, the researcher plays a key role, sometimes in association with the parents, in determining whether the child is able to consent.

Children who lack capacity to consent may still be able to express their wishes in a meaningful way (assent or dissent), even if such expression may not be sufficient to fulfill the requirements for consent. Researchers must respect the decision of children who are capable of verbally or physically assenting to, or dissenting from, participation in research, even if the authorized third party has consented on their behalf (see Article 3.10).

2. How do researchers manage the consent process for post-secondary student participants who have not reached the age of majority? (August, 2011)

TCPS 2 does not rely on the concept of “age of majority” to determine whether people have the necessary capacity to consent to research. In the case of post-secondary students recruited as research participants, the relevant criterion is not their age, but rather whether these students have the capacity to consent on their own behalf in the context of the particular study (see Article 3.10). In their application for REB review and approval, researchers should point out the issue of consent, the age group of the prospective participants, and their plans to address the issue in light of the capacity of students to understand the particular research project. Do they understand the consequences of their participation in research i.e. their ability to assess the risks and potential research benefits of research. This will guide the REB’s decision on the consent process necessary for this research. Researchers and REBs must also be guided by applicable legal and regulatory requirements with respect to consent and capacity within their jurisdiction as well as institutional policy.

3.  Is the awarding of bonus credits to post-secondary students for their participation in research consistent with the guidance regarding consent in TCPS 2? (December, 2011) NEW

In some institutions, post-secondary students (mostly in first year psychology courses) participate in research to receive bonus credits over and above their normal grade in an academic course. In other institutions, students’ participation in research is part of the curriculum and the participation is reflected in the grade earned in the course. In both cases, to ensure that participation in research is voluntary and to minimize the risk of undue influence (Article 3.1), students should be given an alternative means of earning an equivalent participation credit. For example, instead of participating in a survey, students could submit a short written assignment about the uses of surveys or survey techniques. To maximize freedom of choice, the effort and time expended for the research and the offered alternative, as well as the potential rewards, should be comparable.

4.  Is penalizing post-secondary students for failing to fulfill all conditions of research participation for course credit consistent with TCPS 2? (December, 2011) NEW

Penalizing post-secondary students, who participate in research for course credit but who later decide to withdraw from participation in research, by refusing to award them the promised incentive, is a form of coercion (Application of Article 3.1). This is contrary to the principles of TCPS 2. The imposition of penalties runs directly contrary to a participant’s right to withdraw from participation in research at any time (Article 3.1(b)) without suffering any disadvantage or reprisal. If the incentive for participation is a lump-sum reward (Application of Article 3.1 (b)), student participants, like all participants, are entitled to the full amount of the reward for their participation even if they choose to withdraw at any point in time. If a schedule of incentives is used, student participants shall be awarded the incentive earned in proportion to the extent of their participation.  For example, a student who completes only one part of a three-part participation commitment in a research study is awarded course credits for one part only. As part of the consent process, researchers should provide participants the necessary information for making an informed decision to participate in research (Article 3.2), including an explanation of the responsibilities of participants, and assurances regarding their rights and freedom to withdraw at any time without prejudice to pre-existing entitlements.