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Past Interpretations of the TCPS

Subject Status of REB Decisions in the Absence of an REB Quorum
Keywords REB membership, quorum in an REB, REB decision making, knowledgeable in law or ethics, ad hoc members of REBs
TCPS Articles 1.3, 1.6, 1.7
Date May 2006

PDF Status_of_REB_Decisions_in_the_Absence_of_an_REB_Quorum_May_2006.pdf

1. Thank you for your question regarding the validity of Research Ethics Boards’ (REBs) decisions on projects where the members knowledgeable in law and/or in ethics are not in attendance at the REB meeting. Your inquiry has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice1 based on the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS).

2. Your query raises procedural issues regarding quorum requirements for REBs as it relates to the REB membership and decision-making process. Our response is provided within the context of decisions on projects that require a full REB review. Given that TCPS quorum requirements apply to the entire REB, our response applies equally to all REB members (hence, it is not limited to the attendance of the person knowledgeable in law and/or in ethics.) As elaborated below, decisions regarding research for which a quorum of REB members is required should be made only when members attending the ethics review process meet the minimum representation of membership to ensure necessary multidisciplinary expertise for competent and effective REB decision making under the TCPS. This implies that attending members are available to provide the range of input for all reviews that might require it throughout the REB meeting.

REB Membership, Quorum and Decision Making

3. Under the TCPS, REBs and institutions share the responsibility for ensuring that the REB has “the expertise, multidisciplinarity and independence essential to competent research ethics review by REBs.2” REB members bring diverse perspectives and understanding in their complementary roles to the ethics review process. Accordingly, Article 1.3 of the TCPS specifies that:

The REB shall consist of at least five members, including both men and women, of whom:

  1. At least two members have broad expertise in the methods or in the areas of research that are covered by the REB;
  2. At least one member is knowledgeable in ethics;
  3. For biomedical research, at least one member is knowledgeable in the relevant law; this is advisable but not mandatory for other areas of research; and
  4. At least one member has no affiliation with the institution, but is recruited from the community served by the institution.

4. Each of the above minimum requirements brings the necessary basic background, expertise and perspectives to allow the REB to undertake informed multidisciplinary reflection towards sound judgments. While all research must be reviewed adequately, the minimum TCPS quorum requirements should be satisfied for a full REB review conducted in accordance with the proportionate approach to ethics assessment.3 Accordingly, institutions “should...establish quorum rules for REBs. 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 1.3.4 [Emphasis added.] Therefore, decisions made in the absence of a quorum would generally be inconsistent with the TCPS.

5. Even with the satisfaction of the minimum TCPS quorum requirements, REBs have a critical responsibility to determine whether members in attendance have the context-specific expertise for the soundness and integrity of the ethics review process. “For example, in the event that the REB is reviewing a project that requires particular community or research subject representation, or 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. Should this occur regularly, the membership of the REB should be modified.”5 This is also in keeping with the context-based ethics review outlined in the TCPS: “Good ethical reasoning requires thought, insight and sensitivity to context....”6

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

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, page 1.3.
  3. See TCPS article 1.6 on the proportionate approach to ethics assessment.
  4. TCPS, commentary to article 1.7, page 1.8.
  5. TCPS, commentary to article 1.3, page 1.4.
  6. TCPS, Context of an Ethics Framework, page i.9: G. Putting Principles into Practice.