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Past Interpretations of the TCPS

Subject REB Membership—Individuals Knowledgeable in Ethics
Keywords REB membership, ethics knowledge
TCPS Articles 1.3
Date December 2004

PDF REB Membership-Individuals Knowledgeable in Ethics_Dec 2004.pdf

1. This is in response to your question regarding the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS). You ask about the TCPS norm that Research Ethics Board (REB) membership include a person “knowledgeable in ethics.” Your inquiry has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1.

2. As elaborated below, the absence of a detailed TCPS definition of “knowledgeable in ethics” gives institutions reasonable flexibility in bringing research ethics expertise to the membership of an REB. The key consideration is whether an individual has ample experiential or academic knowledge in ethics to provide reasonable REB guidance in identifying and addressing TCPS research ethics issues.

An REB Member “Knowledgeable in Ethics”—Why?

3. The TCPS indicates that the REB membership standards are “designed to ensure the expertise, multidisciplinarity and independence essential to competent research ethics review by REBs."2 Thus, REB members bring diverse perspectives and understanding in their complementary roles in the ethics review process. Knowledge of ethics of research involving humans is key within the REB membership as a whole.

4. Article 1.3(b) of the TCPS indicates that REB membership should include at least one member who is “knowledgeable in ethics."3 In fact, often more than one REB member will have ethics knowledge that contributes to the review of ethical norms and concepts of the TCPS. Still, the TCPS standard enables the REB to have sufficient ethics perspective, understanding, and know-how from at least one member to be able to identify, analyze and address ethics issues and options through the interdisciplinary dialogue in the research ethics review process.

Who is Knowledgeable in Ethics?

5. You ask who qualifies as one “knowledgeable in ethics” for REB membership. You wonder whether a member who has served on an REB for several years, and who has demonstrated an understanding of ethical principles, can be considered “knowledgeable in ethics.”

6. The lack of definition of a “knowledgeable in ethics” in the TCPS gives REBs reasonable flexibility in interpreting this standard, in a manner that reflects both context and the REB’s needs. Context includes such factors as the nature of research normally reviewed, the nature of the ethics issues, and local resources. For example, a member knowledgeable in ethics serving on a social sciences and humanities REB may have different contextual and disciplinary knowledge in ethics than has a member of a biomedical REB. The kind and level of knowledge or expertise essential to a particular REB should be proportionate to the kind and complexity of ethics issues it deals with.

7. Your question also probes the various paths toward becoming knowledgeable in ethics for REB purposes. Such knowledge may come from diverse and significant experiential learning, training, studies, and exposure to ethics issues relevant to REB analysis. Because knowledge and experience are often imparted through cultural frameworks, the values, perspectives and presumptions of relevant cultures will shape “ethics knowledge” and understanding for research ethics review. In a formal institutional educational model, for example, one may acquire “knowledge in ethics” through formal specialization in ethics in academia or formal professional training. Canada has an increasing number of university and professional study programs in ethics for such disciplines and professions as philosophy, theology, anthropology, law, medicine, engineering and health sciences. The TCPS does not, however, currently require a degree or certificate in ethics for an REB member to be considered “knowledgeable in ethics.”

8. Still, under the TCPS, REBs and institutions share important responsibilities for ensuring relevant and effective knowledge in ethics for the research ethics review process. A key consideration should be whether one has sufficient knowledge to guide an REB in identifying and addressing ethics issues in cases that require nuanced analysis. Perhaps a balance of ethics theory, practice and experience offers the most effective path to knowledge in ethics for REB membership. Such different paths to the acquisition of this knowledge enable institutions to responsibly translate the TCPS norm to their context and circumstances. Institutions should also be guided by relevant standards or competencies in ethics, as they evolve.

9. Finally, please note that operational issues for REB membership are under consideration for potential development by PRE.

We hope you find this information useful in your deliberation of research ethics.

Sincerely,

Secretariat on Research Ethics,
on behalf of
The Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. PRE provides advice on such interpretation questions to assist the research ethics community in applying the TCPS to the ethical issues it faces. While responses to TCPS interpretation questions may address ethical dimensions of legal issues in research ethics, PRE does not provide legal advice. Nor does it act as an appeal body on REB or institutional decisions.
  2. TCPS, commentary to article 1.3.
  3. The standard of “knowledgeable in ethics” has also been incorporated into the membership requirements for research ethics committees that review experimental drugs in human research under the 2001 revision of federal regulations in Canada. See Health Canada, Regulations Amending the Food and Drug Regulations: 1024, 2001, art. C.05.001; available at http://www.hc-sc.gc.ca/dhp-mps/compli-conform/clini-pract-prat/reg/1024_tc-tm_e.html