Scope
Note: This Procedure is consistent with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (“TCPS 2 (2022)”), Chapter 3 – The Consent Process.
This procedure forms part of JIBC’s Research Involving Human Participants Ethics Policy (the “Policy”) and should be followed and applied in relation to the free and informed consent of participants in research at JIBC under the Policy. Terms not otherwise defined in this procedure are as defined in the Policy.
Purpose
The purpose of this procedure is to set out the ethical requirements for consent in research involving humans.
Procedural Guiding Principles
General Principles of Consent
Consent Shall be Given Voluntarily (TCPS 2 (2022), Chapter 3, Article 3.1)
- Consent shall be given voluntarily.
- Consent can be withdrawn at any time.
- If a participant withdraws consent, the participant can also request the withdrawal of their data or human biological materials.
Consent Shall be Informed (TCPS 2 (2022), Chapter 3, Article 3.2)
Researchers shall provide to prospective participants, or authorized third parties, full disclosure of all information necessary for making an informed decision to participate in a research project.
Consent Shall be an Ongoing Process (TCPS 2 (2022), Chapter 3, Article 3.3)
Consent shall be maintained throughout the research project. Researchers have an ongoing duty to provide participants with all information relevant to their ongoing consent to participate in the research.
Incidental Findings (TCPS 2 (2022), Chapter 3, Article 3.4)
Within the limits of consent provided by the participant, researchers shall disclose to the participant any material incidental findings discovered in the course of research.
Consent Shall Precede Collection of, or Access to, Research Data (TCPS 2 (2022), Chapter 3, Article 3.5)
Research shall begin only after the participants, or their authorized third parties, have provided their consent.
Critical Inquiry (TCPS 2 (2022), Chapter 3, Article 3.6)
In critical inquiry, permission is not required from an institution, organization or other group in order to conduct research on them. If a researcher engages the participation of members of any such group without the group’s permission, the researcher shall inform participants of any foreseeable risk that may be posed by their participation.
Departures from General Principles of Consent
Alterations to Consent Requirements (TCPS 2 (2022), Chapter 3, Article 3.7A)
The Research Ethics Board (“REB”) may approve research that involves an alteration to the requirements for consent if the REB is satisfied, and documents, that all of the following apply:
- the research involves no more than minimal risk to the participants;
- the alteration to consent requirements is unlikely to adversely affect the welfare of participants;
- it is impossible or impracticable to carry out the research and to address the research question properly, given the research design, if the prior consent of participants is required;
- in the case of a proposed alteration, the precise nature and extent of any proposed alteration is defined; and
- the plan to provide a debriefing (if any) that may also offer participants the possibility of refusing consent and/or withdrawing data and/or human biological materials.
Debriefing in the Context of Alterations to Consent Requirements (TCPS 2 (2022), Chapter 3, Article 3.7B)
Debriefing must be a part of all research involving an alteration to consent requirements whenever it is possible, practicable and appropriate.
Participants in such research must have the opportunity to refuse consent and request the withdrawal of their data and/or human biological materials whenever possible, practicable and appropriate.
Consent for Research in Individual Medical Emergencies (TCPS 2 (2022), Chapter 3, Article 3.8)
Subject to all applicable legal and regulatory requirements, research involving medical emergencies shall be conducted only if it addresses the emergency needs of the individuals involved, and then only in accordance with criteria established in advance of such research by the REB. The REB may allow research that involves medical emergencies to be carried out without the consent of participants, or of their authorized third party, if all of the following apply:
- A serious threat to the prospective participant requires immediate intervention.
- Either no standard efficacious care exists, or the research offers a realistic possibility of direct benefit to the participant in comparison with standard care.
- Either the risk is not greater than that involved in standard efficacious care, or it is clearly justified by the prospect for direct benefits to the participant.
- The prospective participant is unconscious or lacks capacity to understand the risks, methods and purposes of the research project.
- Third party authorization cannot be secured in sufficient time, despite diligent and documented efforts to do so.
- No relevant prior directive by the participant is known to exist.
When a previously incapacitated participant regains decision-making capacity, or when an authorized third party is found, consent shall be sought for continuation in the project, and for subsequent examinations or tests related to the research project.
Decision-Making Capacity (TCPS 2 (2022), Chapter 3, Articles 3.9 and 3.10)
For research involving individuals who lack the capacity, either permanently or temporarily, to decide for themselves whether to participate, the REB shall ensure that, as a minimum, the following conditions are met:
- The researcher involves participants who lack the capacity to decide on their own behalf to the greatest extent possible in the decision-making process.
- The researcher seeks and maintains consent from authorized third parties in accordance with the best interests of the persons concerned.
- The authorized third party is not the researcher or any other member of the research team.
- The researcher demonstrates that the research is being carried out for the participant’s direct benefit, or for the benefit of other persons in the same category. If the research does not have the potential for direct benefit to the participant but only for the benefit of the other persons in the same category, the researcher shall demonstrate that the research will expose the participant to only a minimal risk and minimal burden, and demonstrate how the participant’s welfare will be protected throughout the participation in research.
- When authorization for participation was granted by an authorized third party, and a participant acquires or regains decision-making capacity during the course of the research, the researcher shall promptly seek the participant’s consent as a condition of continuing participation.
Where an authorized third party has consented on behalf of an individual who lacks legal capacity, but that person has some ability to understand the significance of the research, the researcher shall ascertain the wishes of that individual with respect to participation. Prospective participants’ dissent will preclude their participation.
Research Directives (TCPS 2 (2022), Chapter 3, Article 3.11)
Where individuals have signed a research directive indicating their preferences about future participation in research in the event that they lose capacity or upon death, researchers and authorized third parties should be guided by these directives during the consent process.
Consent Shall be Documented (TCPS 2 (2022), Chapter 3, Article 3.12)
Evidence of consent shall be contained either in a signed consent form or in documentation by the researcher of another appropriate means of consent.
Broad Consent for storage and future unspecified use (TCPS 2 (2022), Chapter 3, Article 3.13)
To seek broad consent for the storage and future unspecified use of data and human biological materials, researchers shall provide prospective participants, or authorized third parties, with applicable information as set out in Articles 3.2 and 12.2, as well as the following details, as appropriate to the particular research project:
- the type, identifiability, and amount of data and human biological materials being collected and stored for re-use, and for what potential purpose.
- the voluntariness of the participant’s consent, including any limitations on the feasibility of withdrawal.
- a general description of the nature and types of future research that may be conducted, including whether the research might be conducted outside of Canada (if known).
- the risks and potential benefits of storage of data and human biological materials, and of their use in future unspecified research, including areas of uncertainty where risks cannot be estimated.
- access to a general description of the repository and its governance.
- a statement regarding participants’ preference to being recontacted for additional future research.
- whether the data or human biological materials could be shared with researchers who are not subject to the TCPS.
- whether the research will (if known) or might include whole genome sequencing or similar technologies that may pose a substantial risk of re-identification of the participant or identification of material incidental findings (when appropriate).
- whether linkage of data gathered in the research or derived from human biological materials with other data about participants – either contained in public or personal records – is anticipated (Article 5.3).
- separate options for consenting to participate in a specific research project and for consenting to the storage of data and human biological materials for future unspecified research.