Past Interpretations of the TCPS

Subject	Quorum for Research Ethics Boards
Keywords	REB review, quorum, membership, representation, consultation
TCPS Articles	1.3, 1.7
Date	February 2003

Quorum_for_Research_Ethics_Boards_Feb_2003.pdf

1. This is in response to your questions on (a) the suggested quorum for Research Ethics Boards (REBs), and (b) whether ad hoc members of REBs should be considered in the quorum. Your message has been referred to the Interagency Advisory Panel on Research Ethics (PRE) for advice¹.

REB Quorum

2. The Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS) of 1998 (with 2000, 2002 amendments) deals with the question of "quorum" in the text following article 1.7. The TCPS states: "Institutions should also 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" [emphasis added for this interpretation].

3. Thus, the TCPS recommends that institutions adopt a representation-based quorum consistent with article 1.3. This article specifies that REB members play different but complementary roles and that among the members there should be at least:

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

4. The size of an REB may vary based on the size and needs of the various institutions. Institutions establishing quorum rules for REBs need to take into consideration the size of their REB. The quorum should be at least 50 percent of the REB voting members, including the representation set out in article 1.3.

5. National and international practices and guidelines on the quorum for REBs vary. Quorum has been defined as "majority of the members" in the United States, while it has been specified as "seven members" in the United Kingdom. In Canadian universities, the definition of quorum for an REB varies. Some define the quorum as 50 percent of appointed voting members plus one, or 60 percent of the committee; others define it as "at least two third of its members," or set it as "a minimum of five members."

6. Logistical difficulties in achieving quorum may occur, but these can be addressed at the institutional level. For example, in the terms of reference for their REBs, some institutions require members unable to attend specific meetings to provide, in advance, signed comments, written in a prescribed ethics review summary template and including a recommendation for a decision to be entered into the board's discussion.

Ad Hoc Members and the Quorum

7. The TCPS encourages the addition of ad hoc members to an REB, to provide particular community or research subject representation or for the purpose of a project that requires specific expertise not available among the REB's regular members. While an ad hoc member may complement the REB through his or her experience or expertise, his or her input is a form of consultation that may or may not be considered in the final decision of an REB. He or she is not an REB member and, as such, does not necessarily have the knowledge and experience gained from reviewing applications as a member whose term of appointment is specifically arranged to maintain continuity. Therefore, ad hoc members should not be counted in the quorum for an REB.

We hope you 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

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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.