Appeals Committee for Research Ethics Board Decisions on Proposals with Human Participants
Terms of Reference
Status and Purpose of the Committee
The University has a Research Ethics Board (REB) that approves, rejects, proposes modifications to, or terminates any proposed or ongoing research involving human participants which is conducted under the auspices of the institution, guided by the Tri-council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2 2022). The REB, in cases where the researcher disagrees with its decision, has the responsibility to reconsider, but if agreement cannot be reached between the REB and an applicant, the researcher may submit an appeal to the Vice President Research (VPR), who will appoint members to the Ad Hoc Research Ethics Appeal Committee. The role of the Research Ethics Appeal Committee is to review negative decisions made by the REB with authority to approve, reject or request modifications to the study. Decisions of the Appeal committee are final and will be communicated in writing to the applicant and the Research Ethics Board.
This committee is an independent Ad Hoc Appeal committee following the guidelines for reconsideration of Research Ethics Board decisions as per TCPS 2 2022, Article 6.19: “Institutions shall have an established mechanism and a procedure in place for promptly handling Appeal from researchers when, after reconsideration, the REB has refused ethics approval of the research”. It should be noted that the application of Article 6.19 stipulates that the appeal process should only be used when the researcher and the REB have “exhausted the reconsideration process and the REB must have issued a final decision before the researcher initiates an appeal.” The University, represented by the Vice President Research (VPR), acknowledges and respects the committee's autonomy and ensures that it has the appropriate financial and administrative support to independently conduct the Appeal process. The University must respect the authority delegated to the REB. The University may not override negative REB decisions reached on grounds of ethics without a formal appeal mechanism as set out below.
Principles of Governing the Committee
The role of the Research Ethics Appeal Committee is to hear Appeal of the decisions of the REB. As such, the Committee is presented with the positions and arguments of the researcher making the appeal and of the REB. Its task is to make an informed, fair, and just decision based upon the materials presented while ensuring that the principles and articles of the TCPS 2 and any other relevant guidelines, legislation, and policies are upheld.
Membership of the Committee
The Ad Hoc committee will be composed of a minimum of 5 members: two members have expertise in relevant research disciplines, fields and methodologies covered by the application under appeal; one member knowledgeable in ethics; one member knowledgeable in the relevant law (for biomedical research) and one community member with no affiliation with the institution, preferably one who is representative of the participant pool that would be included in the study under review.
When possible, the members of the committee should be chosen from past members of the Research Ethics Board or from active researchers sensitive to the ethical problems that arise in research with human participants. The VPR may determine that expertise from another institution is required. Efforts will be made to ensure that the committee represents the diversity of the university community and participant pool. The committee will elect a chair from its own members by a majority vote prior to the committee’s first meeting, this could be done by email.
Conflict of Interest
Potential members of the Appeal Committee shall disclose actual, perceived, or potential conflicts of interest to the VPR, as would members of the REB as per TCPS 2 2022, Article 7.3. The Appeal Committee should develop mechanisms to address and resolve conflicts of interest. To maintain the independence and integrity of the Appeal process, it is of the highest importance that members of the Appeal Committee avoid real or apparent conflicts of interest. For example, Appeal Committee members are in a clear conflict of interest when their own research projects are under appeal or when they have been in direct academic conflict or collaboration with the researcher whose proposal is under appeal. To manage such conflicts, Appeal Committee members must withdraw from the committee when such projects are under consideration.
In some instances, individual members of the Appeal Committee may also have a conflict of interest because of their role within the University. The Appeal Committee must act independently from the University. Situations may arise where the University has a strong interest in seeing a project approved before all ethical questions are resolved. As the body mandated to maintain high ethical standards, however, the public trust and integrity of the research process require that the Appeal Committee maintain an arms-length relationship with the University and avoid and manage real or apparent conflicts of interest.
Procedures
The Research Ethics Appeal process will proceed as follows:
The appeal begins when a researcher presents to the VPR a written statement stating the grounds and rationale for the appeal indicating any breaches to the research ethics review process or elements of the REB decision not supported by the TCPS 2. It will normally be expected that from the time of receiving the appeal to a point of a final decision on the part of the Appeal Committee, it should not take longer than six weeks (42 days). It should be recognized that there may be unusual circumstances that may affect this deadline but extension in time should be limited as far as possible.
The VPR notifies the Compliance Specialist and Chair of the REB that one of its decisions has been appealed and provides a copy of the appeal. The Compliance Specialist works with the VPR to identify potential Appeal Committee members. Normally, it would be expected that the Appeal Committee would be formed within 3 weeks (21 days) of the receipt of the appeal. The Office of Research Services will provide the Appeal Committee with a copy of the complete REB File including the review materials.
The Compliance Specialist will call a meeting of the Research Ethics Appeal Committee, providing the members with all the written material in advance, requesting both the researcher and the REB Chair and appointed delegates from the REB to be present and make oral presentations.
The Appeal Committee shall function impartially, provide a fair hearing to those involved, and provide copies of all the relevant meeting materials to those present. In conducting its hearing, the Appeal Committee shall accommodate reasonable requests of those appearing before it. The Researcher and the REB Chair and delegates shall not be present when the Committee is making its final decision.
The Research Ethics Appeal Committee shall notify the VPR, the Researcher and the REB Chair in writing of its decision with a rationale for that decision. The decisions of the Appeal Committee are final and cannot be appealed.
As must be evident from the above, the TCPS 2 2022 not only influenced the development of these terms of reference but also the operation of the Appeal Committee. The author of these terms of reference used the January 2022 updated version of TCPS 2 2022.