Member Knowledgeable in Ethics (TCPS2, 2022)
"Knowledge of ethics of research involving humans is key within the REB membership as a whole. A member knowledgeable in ethics (Article 6.4[b]) needs to have sufficient knowledge to guide an REB in identifying and addressing ethics issues. A balance of ethics theory, practice and experience offers the most effective path to knowledge in ethics for REB membership. The kind and level of knowledge or expertise needed on the REB will be commensurate with the types and complexities of research the REB reviews. For example, a member knowledgeable in ethics serving on a social sciences and humanities REB may need to have different contextual and disciplinary knowledge in ethics than a member knowledgeable in ethics serving on a biomedical REB."
Member Knowledgeable in the Law (TCPS2, 2022)
"The role of the member knowledgeable in the law (Article 6.4[c]) is to alert REBs to legal issues and their implications (e.g., privacy issues), not to provide formal legal opinions or to serve as legal counsel for the REB. To avoid undermining the independence and credibility of the REB, the institution's legal counsel or risk manager should not be a member of the REB. In-house legal counsel might be seen to identify too closely with the institution's financial interest in having research go forward or, conversely, may be unduly concerned with protecting the institution from potential liability. Any external legal counsel hired on a case-by-case basis by the institution should not serve as a member of that institution's REBs while working for the institution.
An understanding of relevant legal issues and contexts is advisable for all REBs, although for non-biomedical research such insights may be sought from an ad hoc advisor whom the REB consults only for specific research projects. Where REBs review research on complex topics that regularly require advice on legal issues, they should appoint a member knowledgeable in the relevant law. In some instances, the legal issues that may be identified by the REB will necessitate further scrutiny and even formal legal advice by the legal counsel to the institution. Legal liability is a separate issue for institutions to handle through mechanisms other than the REB."
Relevant Expertise in Research Content and Methodology (TCPS2, 2022)
"At least two members should have the relevant knowledge and expertise to understand the content area and methodology of the proposed or ongoing research, and to assess the risks and potential benefits that may be associated with the research (Article 6.4[a]). For example, REBs reviewing oncology research, population and public health research, research involving First Nations, Inuit or Métis peoples, or research using qualitative methodologies, should have members that are knowledgeable and competent to address those fields of research, disciplines, and methodologies."
Community Member (TCPS2, 2022)
"The community member shall not be affiliated with the institution. The community member requirement (Article 6.4[d]) is essential to help broaden the perspective and value base of the REB, and thus advances dialogue with, and accountability to, relevant communities. In addition to a broad-based representation from the community, it is highly desirable that institutions seek to appoint former participants on REBs. Their experience as participants provides the REB with a vital perspective and an important contribution to the research ethics review process. It is advisable that members are not currently engaged in research or legal work as their principal activities.
The role of community members on REBs during the ethics review process is unique and at arm's length from the institution. Their primary role is to reflect the perspective of the participant. This is particularly important when participants are vulnerable and/or risks to participants are high.
To maintain effective community representation, the number of community members should be commensurate with the size of an REB and should increase as the size of an REB increases. Institutions should provide training opportunities to community members (Article 6.7)."
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