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Past Interpretations of the TCPS

Subject REB Membership and Decision-making: TCPS Articles 1.3 and 1.7
Keywords REB membership, REB composition, REB review
TCPS Articles 1.3, 1.7
Date July 2003

PDF REB_Membership_&_Decision_making_TCPS_Articles_1_3_&_1_7-July_2003.pdf

1. Thank you for your recent inquiry regarding Research Ethics Board (REB) composition and the use of a consultant for particular types of research and REB decision-making. Your query has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1.

2. Your first question concerns whether the current composition of your REB conforms to the standards of article 1.3 of the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998 (with 2000, 2002 amendments). The composition standards are intended to enable the REB to identify the scientific issues, risks and benefits of proposed research, as an integral part of the ethical review process.

3. The commentary to article 1.3 states that " the event that the REB is reviewing... a project that requires specific expertise not available from its regular members, the REB Chair should nominate appropriate ad hoc members for the duration of the review." We understand the commentary to 1.3 to refer to additional expert advice outside of the REB membership to assist in a particular proposal, while maintaining the REB composition and representation as outlined. As such, we agree with your analysis. That is, an REB is duly constituted when at least two members of the board understand the general approach being used in the protocols, and the risks that may be associated with those protocols as identified by medical and other approved consultants; and when issues arise that require expertise in the specific protocols, the REB may utilize consultants for advice.

4. You also inquire whether members should be present at an REB meeting to provide their input, or whether it is acceptable for a report or analysis to be given in writing. It is not clear from your correspondence whether the written report would be from a regular REB member who temporarily acts as a consultant, or a report from an external consultant other than an REB member.

5. Article 1.7 states that "When there is less than full attendance, decisions requiring full review should be adopted only if the members attending the meeting possess the range of background and expertise stipulated in Article 1.3." Article 1.3.a indicates that among the minimum membership requirements are two members with broad expertise.

6. The provision does not specify further what kinds of members participate in the approval, rejection or modification of proposed research. Do ad hoc members, invited to participate in REB deliberations because of their expertise, participate as full voting members for final decision-making under the TCPS?

7. The question underlines the nature of the role that ad hoc members are to play. Ad hoc members' expertise complements that of the REB. Their contribution of experience and expertise serves as a form of consultation, which may influence the final decision of an REB. On the one hand, if ad hoc members were to have full voting rights, it might facilitate matters of quorum. On the other, their ad hoc involvement means that beyond their expertise, they are unlikely to have the knowledge and experience that full members acquire from regularly reviewing applications. The term of appointment of full members is partly intended to ensure REB experience and continuity. This is the logic underlying the provision of article 1.7: that there must be at least two members with broad expertise present at REB meetings. A consultant's report may well help to inform REB deliberations, but it should not replace basic membership standards.

We hope that you will find these thoughts helpful to your human research ethics deliberations.


Secretariat on Research Ethics
on behalf of
The Interagency Advisory Panel on Research Ethics

  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.