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)
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)
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.
5. In research involving partial disclosure or deception, on what basis can REBs justify no debriefing for participants? (July 2012)
Article 3.7 (d) states that participants will be debriefed “whenever possible and appropriate, after participation, or at a later time during the study … ”. The intention of the phrase “whenever possible and appropriate” in Article 3.7 (d) is to acknowledge that there may be circumstances in which debriefing is not possible or would not be appropriate in research involving deception or partial disclosure. When identifying what types of research involving deception or partial disclosure justify no debriefing, REBs should consider the level of potential harm to the participant which the debrief itself may cause, the impact of the debriefing on the feasibility of the research, and whether a debriefing is even possible as a practical matter (e.g., an anonymous survey conducted in a public space). The onus is on the researcher to provide justification to the REB where s/he does not intend to debrief participants.
6. Are all models of incentives for recruitment and participation in research ethically acceptable? (July 2012)
TCPS 2 acknowledges the use of incentives as a legitimate way of encouraging participation in research, but neither discourages nor encourages their use. Incentives are an important consideration in assessing voluntariness to consent to participate in research. They should not be so large or attractive as to encourage reckless disregard of risks, or result in undue inducement (see Application of Article 3.1).
Incentives for participation in research may be monetary or may take other forms, for example lotteries, or bonus credits to students. TCPS 2 does not provide guidance on the ethical acceptability of specific incentive models. The onus is on the researcher to justify to the REB the use of a particular incentive model and the level of incentives in the research. It is the REB that makes the final determination on the appropriateness of the use of the proposed incentive from an ethics perspective, taking into consideration the context of the research, the economic circumstances of the pool of prospective participants, their age and capacity, and the customs and practices of the community (see Article 9.15). In their conduct of research and ethics review, researchers and REBs, respectively, should take into consideration TCPS 2 guidance as well as other applicable policies, rules and regulations (see Chapter 1, Research Ethics and Law).
7. Can incentives be offered as a recruitment strategy and paid regardless of whether individuals choose to become involved in the study? (March 2013) NEW
TCPS 2 acknowledges the use of incentives as a legitimate way of encouraging participation in research, but neither discourages nor encourages the use of incentives (see Application of Article 3.1). Ordinarily, incentives are given to participants after they have consented to participate in a study. It is, however, possible to provide incentives in advance of the decision to participate for recruitment purposes if the REB approves this incentive plan. For example, gift cards may be offered to a group with an invitation to participate in an online survey. In this scenario, the researcher is hoping that some portion of individuals who received the gift card will participate in the study but the payment is not dependent on participation. Individuals receive the payment regardless of whether they choose to participate in the study. The REB review should consider whether the incentive is appropriate to the participant population and whether those who do choose to participate are engaged in a study that meets all other criteria to be deemed ethically acceptable. See Consent #6 for guidance on models of incentives for recruitment and participation in research.
The financial obligations of submitting evidence of incentive distribution noted in Privacy and Confidentiality #1 apply regardless of the timing of the incentives. In situations such as the one described here where the researcher cannot be sure which individuals will become participants, and/or collects no identifying information from them (including initials on receipts), the researcher must still comply with any financial reporting requirements that apply (e.g., receipts for purchase of incentives, REB approval of incentive model, attestation by researcher and any others involved in incentive distribution.)