Consent

1. Does TCPS specify an age of consent for children?

TCPS 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 Chapter 3, Section 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 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?

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?

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. 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. 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 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 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 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 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 plan, 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?

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, 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 research data repositories 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 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 1, Section B).

Key ethics issues to consider include the following:

  1. 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.

  2. 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 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 are strongly encouraged to 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 (See Article 3.13). Exceptions to this requirement may be considered by REBs on a case-by-case basis and at their discretion. The onus is on the researcher to justify that mandatory consent for future unspecified research use of the data and/or human biological materials is required, and that participant autonomy and privacy, as well as the Policy’s core principle of Justice are not impacted by this exception (see Consent #10, sub-question B).

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 REBs can draw on relevant guidance in Chapter 9 of TCPS.

9. What does the requirement for REBs to review the creation of a repository mean in practice?

Article 3.13 outlines the requirements for broad consent for the storage of data and human biological materials for future unspecified research as it relates to repositories. The TCPS defines a repository as “A data repository or biobank with a known governance framework that ‘must ensure safe storage, preservation and curation of the data’ and human biological materials” (see TCPS Glossary). The REB’s assessment of the consent form should be based on TCPS and include an ethics review to ensure that the applicable elements outlined in Article 3.13 are addressed.

The Application of Article 3.13 states that the “creation of a repository requires REB review and is subject to continuing research ethics review, in accordance with a proportionate approach to research ethics review (Article 6.14).” The REB is responsible for reviewing the ethical acceptability (see Article 6.3) of the repository’s plans for ensuring that the data and/or human biological materials will be obtained, stored and shared, in a manner that is consistent with TCPS, as outlined in the consent form. Therefore, the REB is only responsible for reviewing the ethical aspects, as outlined in the consent form of the repository, as they pertain to the TCPS (e.g., consent, privacy and confidentiality, and future research that will make use of the repositories).

The creation of a repository is not considered “research” as defined by the Policy. However, it is appropriate for the REB to review the ethical aspects of the repository’s consent form to ensure the data and human biological materials stored in the repository are fit for use in future research projects, which will later undergo REB review in accordance with the TCPS. The REB shall determine the appropriate submission requirements and process for the review of broad consent forms.

For the purpose of the TCPS, the term “governance” is intended to mean “Appropriate mechanisms and procedures […] to ensure that subsequent use of the data and human biological materials is in accordance with the original terms of participant consent” (Application of Article 3.13). The appropriate governance structure and management of a repository will vary depending on its size and usage. The broader policy and procedures necessary for the creation of a repository and, when relevant, ongoing review or accreditation, are outside both the scope of the TCPS and the responsibility of the REB.

10. How does Article 3.13 apply in specific contexts?

The purpose of the new guidance around broad consent is to formally introduce the concept and the elements it includes into the TCPS. It does not impact the application of already existing guidance on topics such as privacy and confidentiality.

  1. Is there a threshold between simply possessing one's own research data and the creation of a research data repository?

    The term biobank, as defined in the TCPS (see Chapter 12, Section D), ranges from small collections held by an individual to large collections held by institutions. The definitions of research data repository and biobank are intended to mirror one another. Therefore, similar to a biobank, research data repositories can have a wide range of possible characteristics, but the key characteristic is the intent to share data for specific or unspecified future research purposes. Repositories must have a known governance framework to ensure safe and responsible storage, preservation, and curation of data and/or human biological materials.

    While different disciplines may have their own definitions for research data repositories, the intent in the TCPS is to capture both the platform and the data archived/deposited therein. Therefore, the general principles outlined in Article 3.13 apply to all disciplines.

    Researchers who collect and store data and/or human biological materials for the sole purpose of using them in the context of a specific research project would not be considered to have created a repository, as per the TCPS.

    In general, data and/or human biological materials should be de-identified (coded or anonymized) prior to depositing in a repository and sharing for future research purposes. If this is not possible (e.g., where a repository may intentionally hold onto identifiable data, such as medical record numbers), additional steps should be taken to protect participants from identification ahead of sharing the data and/or human biological materials for future research purposes.

  2. How does a researcher manage consent when a participant only consents to participate in specific research, but not to the storage of their data and/or human biological materials in a repository?

    The guidance found in Article 3.13, and more specifically the requirement to seek separate consent for a) the specific research project and b) the storage of data and/or human biological materials for future unspecified research aligns with Consent #8. In practice, this means providing an option to consent to each separately, either through separate consent forms or separate sections on the same form. An iterative or phased consent process may be adopted (i.e., documented ongoing discussion with participants) where the research design would permit such an approach.

    Participant consent to participate in a specific research project entails the inclusion of their data and/or human biological materials in the analysis. However, if the participant does not consent to the storage of their data and/or human biological materials for future unspecified research, their data and/or human biological materials would not be placed in a repository for this purpose.

    In the rare situation where a participant may decline to consent to the storage of their data and/or human biological materials for future unspecified research, the participant should generally not be excluded from participating in the specific research project on that basis (Consent #8). Exceptions to this may be considered by REBs on a case-by-case basis and at their discretion. The onus is on the researcher to justify that mandatory consent for future unspecified research use of the data and/or human biological materials is required, and that participant autonomy and privacy, as well as the Policy’s core principle of Justice are not impacted by this exception.

  3. Does Article 3.13 apply in the context of open repositories and data sharing with journals for publication or for purposes of verification and error detection (e.g., peer review)?

    Article 3.13 applies to the storage and future unspecified use of data and human biological materials. Therefore, it does not specifically apply in the context of archiving data at the completion of a research project, depositing data in a shared/open repository or when sharing datasets in the context of journal publications for purposes of reproducibility/transparency, verification or error detection. These contexts do not necessarily imply that a new research project will be conducted using the shared data (i.e., not a situation of secondary use).

    There is a distinction to be made between the storage of data (e.g., archiving) following the completion of a research project and the storage of data for future unspecified use, and this should be clearly specified in both the consent process and in the materials that are submitted to the REB for ethics review and approval. For example, where a research participant has provided consent to participate in a specific research project, this consent extends to the storage of their data for a period of time following the completion of the project (see REB Review #5), as per the terms of the consent form. This could include securely archiving the data in an institutional repository. However, if the same research participant does not consent to the storage of their data for future unspecified use, their data should not be deposited in a research data repository that serves such a purpose. If seeking consent for the deposit of existing data was not part of the consent process, researchers may need to take additional steps to address such situations (see the Guidance on Depositing Existing Data in Public Repositories).

    The REB determines whether all elements listed in Article 3.13, or additional elements, are necessary to the consent process of a given research project. See sub-question B for considerations around exceptions to the requirement for participants to provide separate consent to participate in a specific research project and to the storage of their data and/or human biological materials for future unspecified research (either in separate consent forms or separate sections on the same form).

    Note that the new guidance on broad consent aligns with the Tri-Agency Research Data Management (RDM) Policy, which states that “the agencies expect researchers to provide appropriate access to the data where ethical, cultural, legal and commercial requirements allow, and in accordance with the FAIR principles and the standards of their disciplines.” The RDM Policy also “aligns with the CARE Principles for Indigenous Data Governance (Collective benefit, Authority to control, Responsibility, and Ethics), which reflect the crucial role of data in advancing Indigenous innovation and self-determination” (Section 2, Tri-Agency Research Data Management Policy – Frequently Asked Questions).

  4. Does the new guidance on broad consent apply to long-standing repositories or repositories that already exist?

    The guidance on broad consent applies to newly established repositories; therefore, REBs are not expected to retroactively review the ethical aspects, as outlined in the consent form, of long-standing repositories or repositories that already exist at an institution. However, it may be appropriate for REBs to review the ethical acceptability of an existing repository’s consent form to ensure that data and/or human biological materials have been obtained, stored, and shared in a manner that is consistent with TCPS. For example, this could be done during the continuing review of a research project that is using data and/or human biological materials from the existing repository. As with other areas of guidance, TCPS sets out core principles and general guidelines and it is up to each institution to establish its own policies or procedures that implement those guidelines in a manner that is suited to its own context.

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