A Standing Appeal Board shall be established by the President to adjudicate any1 appeal of a decision reached by the McMaster University Research Ethics Board (MREB), or the joint Hamilton Health Sciences/McMaster Faculty of Health Sciences Research Ethics Board (HHS/FHS REB) or the St. Joseph’s Healthcare, Hamilton Research Ethics Board (SJHH 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.
The REBs are guided by principles of natural justice in their decision making. Such principles include providing a reasonable opportunity to the researcher to be heard, a written explanation of the reasons for opinions or decisions, an opportunity for rebuttal, fair and impartial judgment, and reasoned and written grounds for the decisions.
To this end, the REBs encourage ongoing discussion with researchers prior to the submission of new human ethics protocols and during the review process, with provision for reconsideration of a decision affecting a research project. When a researcher and the REB cannot reach agreement, the decision of the REB may be appealed by the researcher. Such appeals will be considered by an Appeal Panel, drawn from the membership of the Standing Appeal Board as defined below.
1 except for appeals of decisions rendered by Student Research Ethics Committees, in which case, the appeal will be considered by the MREB. The decision of the MREB will be final and binding.
Structure of Research Ethics Appeal Board
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:
- Three McMaster University faculty members with broad expertise in the methods or in the areas of research that are covered by the REB(s)
- one McMaster University faculty member knowledgeable in ethics;
- one member knowledgeable in the law relevant to biomedical research;
- a previous member of the MREB; and
- two members from the community external to the University.
For meetings of the Board, at least 50 per cent of the membership of the Board shall constitute a quorum.
- 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.
Terms of Reference
The mandate of the Appeal Board is:
- 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;
- to submit annually to the Vice President, Research & International Affairs a written report on the appeals received and considered by the Appeal Panel and
- to assess periodically the appeal process and to make recommendations to the President through the Vice President, Research & International Affairs, for modifications, as appropriate.
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:
- To review the decision made by the REB which has been appealed by a researcher;
- To conduct a full review of the application and associated documentation2 in order to reach an independent decision;
- To render a final and binding decision, by majority vote, which may either
- Uphold the original decision
- Modify the original decision or
- 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.
- 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
- 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.
2 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 (SJHH), 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 SJHH REB and to include appropriate representation from these REBs and from HHS and SJHH.
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.
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.
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.
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 previous member from the joint HHS/FHS REB and SJH REB;
- One member from each hospital and
- 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.
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:
The chairs of the MREB, the HHS/FHS REB and the SJH/REB
- 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
Guidelines for the Appeal of Research Ethics Boards’ Decisions
All decisions made by the REB are communicated in writing to the researcher via the REB Secretariat. Copies of all applications, associated correspondence and decisions are kept on file by the REB Chair and/or the REB Secretariat.
In the event that a researcher and the REB do not reach an agreement through discussion and reconsideration, the researcher may appeal the final decision of the Board. This may be an appeal against refusal to approve a protocol as submitted, or against amendments or additions required as a condition of approval.
Administrative support for the Appeal Board and Appeal Panel will be provided through the REB Secretariat.
- A written appeal of an REB decision, outlining the grounds for the appeal and accompanied by supporting documentation3 must be received by the REB’s Secretariat within thirty (30) days of receipt by the researcher of the final decision of the REB.
- The REB Secretariat will acknowledge receipt of the appeal in writing and forward a copy of the written appeal to the Chair of the Appeal Board and the Chair of the REB; with a request to the latter to provide to the REB Secretariat a written response to the appeal within ten (10) working days of receipt of the request.
- The Chair or, alternatively, the Vice Chair, where appropriate, of the Appeal Board will select four members, with a minimum of one and up to two McMaster University faculty members, from the Appeal Board membership and, together, these five will serve as the Appeal Panel.
- The REB Secretariat will assemble and distribute the supporting documentation to the Appeal Panel for review, with a copy to the researcher and the REB Chair.
- A meeting of the Appeal Panel, with provision for presentations by the researcher and the REB Chair, will be convened by the REB Secretariat, within thirty (30) days of receipt of the appeal by the Secretariat. Both parties may be accompanied by a colleague of their choice.
- Meetings of an Appeal Panel will be conducted in accordance with the principles of natural justice. Both parties have the right to speak to the issues raised in the documentation distributed in accordance with 4. above. The Appeal Panel is free to ask questions at any time during the presentations. The following procedure is a natural sequence, which any Appeal Panel may vary at its discretion.
- The researcher presents the reasons for the appeal and speaks to the issues.
- The REB Chair presents the reasons for the decision of the REB and speaks to the issues.
- The Appeal Panel, having heard the oral presentations of both parties and having reviewed the written, supporting documentation, shall be the sole judge of the facts and shall render a decision which is fair and just in the circumstances.
- The majority decision of the Appeal Panel will be final and binding and will be communicated within ten (10) working days of the meeting held in accordance with 5. above.
- The REB Secretariat will communicate the decision of the Appeal Panel in writing, including a summary of issues, factual findings, conclusions and reasons for the decision to the researcher, the Appeal Board, and the Chair of the REB. The REB Chair will be responsible for implementation and follow up through the REB, and such other parties as it deems appropriate.
3 may include the original ethics application, original REB decision, all subsequent written communications, documents and records, including REB Minutes pertaining to the submission, including 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.
A Collaboration of
Disclaimer: The Hamilton Integrated Research Ethics Board (HiREB) represents the institutions of Hamilton Health Sciences, St. Joseph’s Healthcare Hamilton, Research St. Joseph's-Hamilton, and the Faculty of Health Sciences at McMaster University and operates in compliance with and is constituted in accordance with the requirements of: The Tri-Council Policy Statement on Ethical Conduct of Research Involving Humans; The International Conference on Harmonization of Good Clinical Practices; Part C Division 5 of the Food and Drug Regulations of Health Canada, and the provisions of the Ontario Personal Health Information Protection Act 2004 and its applicable Regulations; For studies conducted at St. Joseph's Healthcare Hamilton, HiREB complies with the Health Ethics Guide of the Catholic Alliance of Canada