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Past Interpretations of the TCPS

Subject REB Role in Reviewing the Safety of Researchers
Keywords Roles and responsibilities of REBs, risks to human participants, safety of researchers, research in other jurisdictions, institutional liability
TCPS Articles 1.1, 1.14, page 1.3
Date December 2007

PDF REB_Role_in_Reviewing_the_Safety_of_Researchers _Dec_2007.pdf

1. Thank you for your request for interpretation of the role your research ethics board (REB), versus the institution, in assessing the safety of researchers conducting research in other countries in accordance with commentary to Article 1.14 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)1. Given the controversial nature of the environment where the proposed research would be conducted, you expressed concern about the risks to research subjects and the safety of researchers. You also raised concerns about the capacity of your REB to make an appropriate determination on the safety of researchers, and about potential liability issues. Your questions have been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice2.

2. The REB’s responsibility is focused on research subject protection by virtue of its role in the ethics review of research involving humans. The role of the REB is clearly outlined in commentary to Article 1.1 of the TCPS: “The REB is established to help ensure that ethical principles are applied to research involving human subjects. The REB, therefore, has both educational and review roles. The REB serves the research community as a consultative body and thus contributes to education in research ethics; it also has responsibility for independent, multidisciplinary review of the ethics of research to determine whether the research should be permitted to start or to continue.” It is our understanding that the REB’s concern about risks for research subjects resulting from their participation in the proposed research has been appropriately addressed.

3. The only TCPS reference to the REB’s role with regard to the safety of researchers is made in commentary to Article 1.14, page 1.12: “REBs should, therefore, not veto research about authoritarian or dictatorial countries on the grounds that the regime or its agents have not given approval for the research project or have expressed a dislike of the researchers. They should, however, legitimately concern themselves about the safety of research subjects and indeed of the researchers, and the security of research materials” (Emphasis added). The commentary says that the REB should concern itself, and clearly does not indicate that the REB is responsible for assessment of researchers’ safety.

4. In fulfilling its review role, the REB has access to the details of the context within which the research takes place, and which may expose researchers to controversial environments in other jurisdictions. REBs should therefore legitimately raise such concerns as part of its communication of the results of the ethics review. Depending on the potential risk involved, and in the absence of appropriate expertise on the REB, the REB may exercise due diligence and decide to approve the ethics of the research conditional on the researcher obtaining a safety assessment by an appropriate entity deemed to have the necessary expertise, responsibility and mandate by the institution.

5. It is the institution and not the REB that should concern itself about liability issues. TCPS page 1.3 indicates that “Each institution is accountable for the research carried out in its own jurisdiction or under its auspices”. In light of this accountability, “Institutions may refuse to allow certain research within its jurisdiction, even though the REB has found it ethically acceptable.”

We hope you will find this information helpful to your human research ethics deliberations.

Sincerely,

Secretariat on Research Ethics
On behalf of the Interagency Advisory Panel on Research Ethics
pre.ethics.gc.ca


  1. Official version of the TCPS on PRE’s website at: http://ger.ethique.gc.ca/fra/archives/tcps-eptc/
  2. 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