1. Which institutional body should establish the REB(s)?
TCPS 2 requires that the highest governing body of the institution establish the REB (or REBs), define an appropriate reporting relationship with the REB (or REBs), and ensure that REBs have the necessary financial and administrative resources to fulfil their duties. TCPS 2 does not specify which body within an institution meets this description, as the governance structures of institutions vary. However, in the application to Article 6.2, TCPS 2 provides a range of possibilities as to who could fill this role, with a focus on the one that holds the highest administrative rather than academic responsibility. Institutions determine the highest governing body based on their individual governance structures and taking into consideration whether other responsibilities of those bodies may conflict with the responsibility for establishing an REB.
2. What is the rationale for not permitting external legal counsel from serving on an REB of an institution for which the counsel provides service?
The rationale for excluding external legal counsel from serving on a research ethics board (REB) of the institution, regardless of the type of legal advice he/she provides to the institution, is the same rationale for excluding in-house legal counsel from serving on the REB. There is a danger that the lawyer's role as a legal adviser and as an REB member will become confused. The external legal counsel, even if retained by the institution only on a case-by-case basis is not immune from the pressures of being identified too closely with the institution's interests – whether its financial interest in having research go forward or its interest in protecting itself from potential liability. This presents a potential source of conflicts of interest that may undermine the independence and credibility of the REB.
For a research ethics board (REB) to function optimally, it is important that its members, including the member knowledgeable in law, understand the role of the REB as described in Article 6.3, as well as the specific role of the member knowledgeable in law "to alert REBs to legal issues and their implications (e.g. privacy issues), not to provide formal legal opinions or serve as legal counsel for the REB." (Application of Article 6.4)
3. Can an external legal counsel, who is not currently providing legal services for the institution, serve on that institution's REB?
While not ideal, it is possible for an external legal counsel to serve as the member knowledgeable in law on the research ethics board (REB) when he/she is no longer providing legal services for the institution. (See application of Article 6.4 for a description of the role of the member knowledgeable in law). In making a decision to appoint a former external legal counsel to the REB, the institution should take into account the following considerations:
- The amount of time lapsed since the external legal counsel last provided legal services for the institution.
- Whether other alternatives are available to the REB for obtaining the same knowledge/expertise.
- Whether the legal firm to which the external legal counsel is affiliated has an active business relation with the institution (that is, whether other lawyers from that counsel's firm are providing legal services to the institution).
- Whether the external legal counsel has an interest in getting future business from that institution.
It is prudent to keep a written record of steps taken to reach the decision to appoint this member.
4. Where an individual working under the auspices of an institution is involved in research solely as a service provider to researchers in other institutions, should the REB of that institution review the research?
The individual in question would not be required to submit the research for research ethics board (REB) review within his/her institution so long as
- the individual is not a member of the research team,
- he/she does not benefit from authorship on publications, and
- his/her contribution is limited in nature to a service that does not in and of itself constitute research involving humans as defined in TCPS 2 (see application of Article 2.1).
If the service provider meets the above criteria, or falls within an exception set out in his/her institution's policy, it would be sufficient for the individual to get confirmation from the principal investigator (PI) that this research has been reviewed by the PI's institutional REB so long as it is compliant with TCPS 2. Alternatively, the individual can make the provision of his/her services conditional on receiving evidence of an REB review and approval in accordance with TCPS 2.
5. Should institutions make REB minutes publicly available?
There is no general requirement in TCPS 2 regarding public accessibility of REB minutes. What TCPS 2 advises in the application of Article 6.17 is that files, minutes and other relevant documentation must be accessible to the authorized representatives of the institution, researchers, sponsors and funders under certain circumstances "when necessary to assist internal and external audits, or research monitoring, and to facilitate reconsideration or appeals." (Application of Article 6.17)
While not specific to public sharing of minutes, it should be noted that guidance in TCPS 2 encourages institutions' transparency to demonstrate their accountability while maintaining researchers' confidentiality (see Application of Article 6.1).
6. In the case of a strike at an institution that disables the REB's ability to conduct ethics reviews, must all research stop?
This issue is not addressed in TCPS 2, but institutions should try to anticipate the impact and the demands of a strike on the functioning of the research ethics board. Institutions are encouraged to develop mechanisms to permit the continuity of research ethics review and initiate them in case of a strike that involves the REB. In particular, institutions are encouraged to take measures to ensure that delays do not impact the welfare of participants, in particular by increasing risks or adding new risks.
Institutions may consider developing agreements with other institutions to assume responsibility for its research ethics review in the event of a strike (see Application of Article 8.1 for guidance on agreements). In developing their procedures, institutions may consider following relevant guidance in Section D, Chapter 6 of the Policy on research ethics review during publicly declared emergencies. While a strike is not a publicly declared emergency, it raises similar challenges for research ethics review in that it has a temporary impact on the normal procedures of an REB.
7. If a researcher transfers his/her research from one institution (where the REB initially approved an ongoing research project) to a second institution, is the researcher required to seek REB review at the second institution?
As the research involving humans is still ongoing, REB review is required at the second institution, unless an ethics review agreement exists between the two institutions (Application of Article 8.1). Each institution is accountable for the ethical acceptability of research involving humans carried out within its jurisdiction or under its auspices, "that is, by their faculty, staff or students, regardless of where the research is conducted" (Article 6.1). When a researcher transfers his/her research from one institution to another, s/he in effect transfers the research from the auspices of one institution to the other.
To facilitate the review, the researcher may provide the REB at the second institution with contact information for the REB at the first institution. The REB at the second institution may request documentation to facilitate and inform its review of the ethical acceptability of the research; for example, a copy of the consent documentation, evidence of ethics approval from the first institution, or a copy of the original research proposal. The level of REB review should be guided by the proportionate approach to research ethics review (Article 6.12).
8. Do course-based research activities intended for pedagogical purposes fall within the jurisdiction of the REB? New
Course-based research activities intended primarily for pedagogical purposes fall within the jurisdiction of the REB (Application of Article 2.1 and Article 6.12). Such research activities are assigned to students for the purpose of teaching them how to conduct research in a structured educational context. This includes, for example, asking students to conduct interviews to collect data to be used in a course assignment, or to practice interviewing techniques. Participants in the activities may be exposed to risks (normally minimal risk) as a result of their participation, and may not distinguish these activities from others that meet the definition of research in TCPS 2 (Application of Article 2.1).
In keeping with a proportionate approach to research ethics review, course-based research activities of minimal risk are generally eligible for delegated review. Course-based research activities of minimal risk are unique in that TCPS 2 allows them to be reviewed by delegates of the REB at the department, faculty or equivalent level, if authorized by the institution (Application of Article 6.12). Typically, the course instructor, as the contact person for the REB, submits an application for ethics review describing the course-based research activities, how the data will be managed, and whether the data will be used for any purpose beyond the course assignment. This would eliminate the requirement for each student or student group to submit individual applications for ethics review.
An REB that implements a delegated review process for course-based research activities “shall require that the actions and decisions of the delegated reviewer(s) be well documented and formally reported to the full REB… Accountability requires that, regardless of the review strategy, the REB continues to be responsible for the ethics of all research involving humans within its jurisdiction” (Application of Article 6.12).
Where course-based research activities pose more than minimal risk to those involved in the activities, or if the activities are later used for the purpose of research (e.g., as part of a researcher’s own research program), they shall be submitted for review under the secondary use provisions following the regular institutional REB process (Article 6.12). Student theses or other equivalent research projects involving humans typically meet the TCPS 2 definition of research (Application of Article 2.1) See also TCPS 2 Interpretations, REB Review #1. They are not considered course-based activities even if they are associated with a course number. They should be reviewed by the REB following a proportionate approach.
9. According to the TCPS 2, what makes a research ethics board (REB) independent? New
The TCPS 2 states that “REBs are independent in their decision making and are accountable to the highest body that established them for the process of research ethics review” (Article 6.2). Independence of an REB means independence in its ability to review and make decisions on the ethical acceptability of research without undue influence or interference.
Institutions must ensure that the governance and necessary supports are in place to ensure that REB independence is established and maintained. Operationally, “the highest body within an institution shall establish the REB or REBs, define an appropriate reporting relationship with the REBs” [see Article 6.2; also see Governance #1 for guidance on which institutional body should establish the REB]. The highest body of the institution must also secure necessary financial and administrative resources for the effective and continuous operation of the REB without interfering with, or influencing its independence in its decision-making on the ethical acceptability of research. To maintain the independence of the REB in its ethics review and decision-making, ‘institutional senior administrators’ must not serve on the REB nor should they interfere with the REB deliberations and decisions (Article 6.4). Their intervention or their presence in a room where the REB is making decisions can influence the decision-making process, and undermine the independence of the REB in fulfilling its role.
While the REB should be independent in its decision-making on the ethical acceptability of research, this does not mean that it is independent from the institution. The REB is created by the institution, draws its authority and resources from the institution, and is accountable for the integrity of its processes to the institution. Operationally, the institution “should establish a mechanism to coordinate the operations of all its REBs, and clarify their relationship…with other relevant bodies or authorities” (Application of Article 6.3). While research ethics administration staff are dedicated to supporting the functions of the REB, they are also accountable to the institution on administrative and operational matters.
To balance the independence of the REB in its decision-making with its accountability to the institution, TCPS 2 states that “Institutions shall have in place written procedures for the appointment, renewal and removal of REB members, including Chairs” (Application of Article 6.2). Ideally, such procedures should be developed in consultation with those affected by, or involved in, its implementation. In addition, TCPS 2 encourages effective communication processes to be established between REBs and relevant officers of their institutions. In managing this communication, “REBs and senior administrators should consider other venues [other than REB meetings] to discuss policy issues, general issues arising from the REB’s activities, or training and education needs, to the benefit of the overall operation and mandate of the REB” (Application of Article 7.3).
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