1. Does TCPS 2 specify an age of consent for children?
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 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?
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?
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?
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?
The response to this interpretation has been superseded by new articles in TCPS 2 (2014). See Articles 3.7A and 3.7B for guidance on this topic.
6. Are all models of incentives for recruitment and participation in research ethically acceptable?
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?
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.)
8. Is it ethically acceptable to require prospective participants to consent to making their de-identified data available for future, unspecified research, as a condition of participation? New
It is a relatively common practice for researchers to require prospective participants to consent to making their de-identified data available to people outside the research team (e.g. a clinical trial sponsor, an auditor) for the purposes of verification and quality control. This is considered an ethically acceptable practice.
However, on occasion, Research Ethics Boards (REBs) are asked to permit researchers to make it a mandatory condition of participation in a study that the prospective participant consent to making their de-identified personal data available for use in future unspecified research. An example would be requiring the provision of de-identified participant data to a clinical trial sponsor for placement in the sponsor’s databanks and use in accordance with the sponsor’s data governance policies. This request to allow mandatory consent for unspecified future uses is based on the premise that there will be no future possibility to inform participants of how their data would be used.
The principle of Concern for Welfare as it relates to the welfare of society is often mentioned when advocating for the re-use of de-identified data for the purposes of future unspecified research. TCPS 2 acknowledges (Chapter 5, Section D) the benefits of re-using de-identified data which includes:
avoidance of duplication in primary collection and the associated reduction of burdens on participants; corroboration or criticism of the conclusions of the original project; comparison of change in a research sample over time; application of new tests of hypotheses that were not available at the time of original data collection...
However, when considering the potential benefit of making de-identified data available for future research, it is important to remember that “the welfare of a group should not be given priority over the welfare of individuals.” (Chapter 1B, Core Principles)
The Panel on Research Ethics is of the view that a mandatory condition of this nature is not consistent with TCPS 2, for a couple of reasons:
Risk of coercion
There is a risk of coercion when requiring prospective participants to consent to the sharing of their de-identified data for future unspecified research as a condition of participation in the study. This risk may be increased when, for example, in clinical trials, the experimental therapy has the potential to be of significant benefit to the participant. In such cases, the prospect of possible access to the trial may lead the prospective participant to agree to share their de-identified data when they otherwise would not have done so.
Inclusion/Exclusion and the core principle of Justice
Excluding individuals from a research study that could benefit them, solely on the basis that they refuse additional consent to storage of their data for future use, would contravene the core principle of Justice. The principle of Justice holds that individuals, groups or communities should not be unfairly excluded from the potential benefits of research participation, and that the criteria for inclusion in research must be relevant to answering the research question (Chapter 4).
Article 4.1 of TCPS 2 notes that “Taking into account the scope and objectives of their research, researchers should be inclusive in selecting participants.” The principle of Justice (Chapter 1) notes that participation in research “...should be based on inclusion criteria that are justified by the research question. Inequity is created when particular groups fail to receive fair benefits of research or when groups, or their data or their biological materials,are excluded from research arbitrarily or for reasons unrelated to the research question.”
For this reason, when researchers seek participants’ consent, they must separate the consent to participate in a specific research project from the consent to make their data available for future unspecified research. In practice, this would mean a) providing information relevant to both their participation in research and making their de-identified study data available for future unspecified uses, and b) providing an option to consent to each separately, either through separate consent forms or separate sections on the same form.
In seeking the consent of participants or their authorized third party, researchers must adhere to the core principle of Respect for Persons - that individuals who participate in research should do so voluntarily, based on as full an understanding as possible of the research, its risks, and potential benefits (See Article 1.1, and Chapter 3).
For research involving distinct communities, researchers may be required to adhere to community data management principles, where they exist, or the consent process may include additional requirements to maintain respectful relationships and engagement between researchers and participants. Researchers and research ethics boards can draw on relevant guidance in Chapter 9 of TCPS 2.
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