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Past Interpretations of the TCPS

Subject Member Knowledgeable in Law and REB Membership
Keywords Member knowledgeable in law, in-house vs. external legal counsel, potential conflict of interest, REB membership, role of REB members
TCPS Articles 1.1, 1.3, 1.12
Date December 2007

PDF Knowledgeable_in_Law_and_REB_Membership_Dec_07.pdf

1. Thank you for your request for interpretation of a statement in commentary to Article 1.3 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS)1 that states that “The institution’s legal counsel should not be a member of the REB”. You seek clarification on whether legal counsel refers to in-house institutional legal counsel, or if it also subsumes “external” legal counsel who may be hired on a project basis but has no employment relationship with the institution. Your question has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice2.

2. The TCPS is clear that in-house legal counsel should not serve as a member of the same institutional Research Ethics Board (REB). In-house legal counsel might be seen to identify too closely with the institutions’ financial interest in having research go forward or, conversely, may be unduly concerned with protecting the institution from potential liability. This presents a potential source of conflict of interest that may undermine the independence and credibility of the REB in assuming its role.

3. As with in-house legal counsel, external legal counsel (even on a project-basis) is retained by the institution, and thus is not ultimately immune from the same pressures. Ideally, to avoid any potential or perceived conflict of interest, external legal counsel hired on a project basis by the institution, as well as other members of the legal counsel’s law firm should not sit as members knowledgeable in law on the same institutional REB. However, it is understandable that in practice choices may be limited in recruiting members knowledgeable in law to serve on an REB; therefore, the following, while not ideal, may be considered. While the same person should not be selected to assume both roles as an external counsel for the institution as well as sit as the member knowledgeable in law on the REB concurrently, the institution may consider appointing to the REB another member from the same firm taking the following into consideration.

4. Some mechanisms can be put in place to address the participation of another member from the same law firm to serve on the REB. These include, but are not limited to, disclosure of potential conflict of interest for the REB’s discussion and decision, in conformity to Article 1.12 of the TCPS. Consideration should be given to the time lapsed since the external legal counsel of the same firm assumed this role for the institution as well as how the roles of the two members of the same law firm could be fire walled. It would also include an assessment of whether other alternatives are available for obtaining the same knowledge/expertise to the REB. It is prudent to keep a written record of steps taken to reach the decision whether or not to allow the participation a member from the same firm to participate on an REB.

5. For an REB to function optimally, it is important that its members, including the member knowledgeable in law understand the role of both the REB and that of the members. The role of the REB is described in the commentary to TCPS Article 1.1: “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. …it has responsibility for independent multidisciplinary review of the ethics of research…” (Emphasis added). The role of the member knowledgeable in law is also clear in the TCPS in commentary to Article 1.3: “Role of the member knowledgeable in the applicable law is to alert REBs to legal issues and their implications, not to provide formal legal opinions nor to serve as legal counsel for the REB.” And as you mention, the TCPS clearly indicates that “the institution’s legal counsel should not be a member of the REB.”

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://pre.ethics.gc.ca/eng/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