Appeals Board Terms of Reference

Structure of Research Ethics Appeal Board

1. Research Ethics Appeal Board Membership

The Appeal Board, from which the Appeal Panel will be formed, shall consist of a minimum of eight (8) members, including both women and men, drawn from the broad range of disciplines and faculties in which research with human participants takes place. All members of the Appeal Board will have the appropriate background and be without conflict of interest. Membership will include at least:

1. three McMaster University faculty members with broad expertise in the methods or in the areas of research that are covered by the REB(s);
2. one McMaster University faculty member knowledgeable in ethics;
3. one member knowledgeable in the law relevant to biomedical research;
4. a previous member of the MREB; and
5. two members from the community external to the University.

Members shall be appointed by The President, upon the recommendation of the Vice President, Research and International Affairs, for staggered terms of three years, renewable.

2. Quorum

For meetings of the Board, at least 50 per cent of the membership of the Board shall constitute a quorum.

3. Chair and Vice-Chair

A Chair and a Vice Chair shall be appointed from the Board membership by the President, upon the recommendation of the Vice President, Research and International Affairs. These appointments will be for two years, renewable terms.

Appeal Board's Terms of Reference

The mandate of the Appeal Board is:

1. to hear, through an Appeal Panel, appeals of decisions reached by the MREB, HHS/FHS REB or the SJH REB, provided that decisions rendered by the latter two REBs are specific to an appeal by a McMaster University faculty member under the auspices of their University appointment;

2. to submit annually to the Vice President, Research & International Affairs a written report on the appeals received and considered by the Appeal Panel and

3. to assess periodically the appeal process and to make recommendations to the President through the Vice President, Research & International Affairs, for modifications, as appropriate.

Appeal Panel's Structure

To hear an appeal, the Chair or Vice-Chair shall select four members, including both women and men, with a minimum of one and up to two McMaster University appointed faculty members, from the Appeal Board membership and, together, these five shall constitute the Appeal Panel. Composition of the Appeal Panel shall meet the requirements of the Tri-Council Policy Statement. Chairs of the REBs may serve only on an Appeal Panel reviewing a decision not made by their respective REB.

The members of the Appeal Panel shall have appropriate background and be without conflict of interest. In the case of a conflict of interest or absence on the part of the Chair, the Vice Chair will chair the Appeal Panel.

Appeal Panel's Terms of Reference

The mandate of the Appeal Panel is:

1. to review the decision made by the REB which has been appealed by a researcher;

2. to conduct a full review of the application and associated documentation(1) in order to reach an independent decision;

3. to render a final and binding decision, by majority vote, which may either

a) uphold the original decision,
b) modify the original decision or
c) impose specific conditions for approval of the project.

In the event a majority vote is not rendered, the Chair or the Vice-Chair shall cast the deciding vote.

4. to communicate the decision, in writing and with reasons, to the researcher, Chair of the REB and to all members of the Appeal Board, and

5. to provide advice, in the event of 3.b) or 3.c) above, to the REB charged with the responsibility for implementing and monitoring the final decision of the Appeal Panel.

(1) may include the original ethics application, the original REB decision, all subsequent written communications, documents and records, including REB Minutes pertaining to the submission, a copy of a research proposal for funding of the proposed research, if applicable, relevant references or copies of pertinent guidelines, internal and external policies and legislation.


Single, Regional University/Hospital Appeal Process

Recognizing the merits of and mutual interest expressed in having a single, university/hospital appeal process for McMaster University, Hamilton Health Sciences (HHS) and St. Joseph's Healthcare, Hamilton (SJH), provision is made for McMaster University to broaden, through agreements with its affiliated hospitals, the mandate and structure of the Standing Appeal Board. Such agreements between McMaster University and its affiliated hospitals will enable the mandate and structure of and terms of reference for the Standing Appeal Board and Appeal Panel to be expanded to include the adjudication of any appeal of a decision reached by the joint HHS/FHS REB and the SJH REB and to include appropriate representation from these REBs and from HHS and SJH.

1. McMaster University and Affiliated Hospital Agreements

The agreement(s) between McMaster University and its affiliated hospital(s) shall define communication and repository procedures and designated administrative resources.

2. Ex-officio Members

Subject to the execution of agreement(s) with the affiliated hospital(s), the Chairs of the MREB, HHS/FHS REB and SJH REB will serve as ex-officio members on the Appeal Board. Chairs of the REBs may serve only on an Appeal Panel reviewing a decision not made by their respective REB.

3. Chair and Vice-Chair of Research Ethics Appeal Board

Subject to the execution of agreement(s) with the affiliated hospital(s), the Vice-President, Research and International Affairs shall consult with the heads of the affiliated hospitals prior to making appointment recommendations.

4. Affiliated Hospital Representation on the Research Ethics Appeal Board

Representation from affiliated hospitals will be added to the membership of the Appeal Board under separate agreements and will include at least:

a. a previous member from the joint HHS/FHS REB and SJH REB;
b. one member from each hospital and
c. the Chairs of the joint HHS/FHS and the SJH REBs, as per 2. Ex-officio Members above.

The members from the hospitals (item 4. above) will be appointed by their respective Trustees, upon the recommendation of their respective Chief of Staff.

5. Composition of the Complete Single Regional University / Hospital Appeal Board

Subject to the execution of agreements between McMaster University and its affiliated hospitals, the full composition of the Single Regional University / Hospital Appeal Board shall constitute at least the following 15 positions:

Ex-Officio Members:

The chairs of the MREB, the HHS/FHS REB and the SJH/REB

Appointed Members:

Three faculty members expert in methods of research
One faculty member knowledgeable in ethics
One faculty member knowledgeable in the law relevant to biomedical research
One previous member of the MREB
One previous member of the HHS/FHS REB
One previous member of the SJH REB
One faculty member from HHS
One faculty member from SJH
Two community members