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Appeals Committee for Research Proposals on Human Subjects

Terms of Reference

Status of the Committee

This committee is an independent standing appeals committee. In founding this committee, the University acknowledges and respects the committee's autonomy and ensures that it has appropriate financial and administrative independence from the University.

Purpose of the Committee

The University has already founded a Research Ethics Board (REB) that approves, rejects, proposes modifications to, or terminates any proposed or ongoing research involving human subjects which is conducted within, or by members of, the institution, using the considerations set forth in the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans. The REB, in cases where the researcher disagrees with its decision, has the responsibility to try to reach agreement through discussion and reconsideration, but if agreement cannot be reached between the REB and a particular researcher, the researcher may appeal to the Appeals Committee for Research Proposal on Human Subjects (the Appeals Committee). The goal of the Appeals Committee is to deal with such appeals guided by principles of natural and procedural justice. Such principles include providing a reasonable opportunity to be heard to both the researcher making the appeal and the REB whose decision is being appealed. Such an opportunity should consist in allowing both an opportunity to give an explanation of the reasons for or against the decision and also an opportunity for rebuttal. The Appeals Committee, in turn, will provide fair and impartial judgement with reasoned and written grounds for its decision.

Membership of the Committee

The standing committee will be composed of a minimum of 5 members who will serve a 3-year term on the committee. (When it is first formed, two members will serve 3-year terms, two, will serve two-year terms, and one, a one-year term. This is to ensure that there will be a regular turnover of members but only a small part of the committee ever changes.) At the same time, the committee has the power to add up to two additional members if an appeal requires specific expertise that its members do not have. What is important is that the committee has collectively the expertise to deal with all aspects of the appeal. If it is at all 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 on human subjects. The five members of the committee should fit, as far as possible, into the following categories:

Two members should be chosen from two different areas in which research in human subjects is done. It would be preferable that these two different areas be in different faculties of the University.

One member should be chosen because of expertise in ethical matters. One might reasonably expect someone from the Philosophy Department to have these skills, but one might find faculty who have developed this same expertise in other academic areas.

One member should be chosen because of expertise in legal matters pertaining to research on human subjects.

One member should be chosen from the community which the University serves (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans clearly states the importance of such a member). In order to make a contribution to the activities of the Appeals Committee, it is necessary to choose someone from outside the University Community who has expertise in ethical problems relevant to research on human subjects. For example, one might include a member from one of the local hospital Research Ethics Boards, as long as this hospital is not within the University.

The committee will elect a chair from its own members by a majority vote.

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Principles Governing the Committee

The Appeals Committee is concerned about the ethical implications of research proposals. It operates, as does the REB, based upon the familiar moral imperative of respect for human dignity. It is unacceptable to treat persons solely as means (mere objects or things) because doing so fails to respect their intrinsic human dignity and, thus, impoverishes all of humanity. The Appeals Committee must clearly keep in sight the requirement that the welfare and integrity of the individual remain paramount in human research (Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans devotes a very long passage to affirming these points).

At the same time, the role of the Appeals Committee is different from the REB. The job of the Appeals Committee is to hear appeals of the decisions of the REB. As such, the Appeals 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.

Procedures

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.

The Appeals Committee will proceed as follows:

  1. The appeal begins when a researcher presents to the chair a written statement stating the grounds and rationale for the appeal. 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 Appeals Committee, it should not take longer than one month (31 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.
  2. The Chair of the Appeals Committee notifies the Chair of the REB that one of its decisions has been appealed and provides the Chair with a copy of the appeal. The Chair of the REB is requested to provide the Appeal Committee with a written copy of the decision of the REB on this particular proposal.
  3. When the Chair of the Appeals Committee has the written statements of both the researcher who is appealing and of the REB, the chair will call a meeting of the Appeals Committee, providing the members with all the written material in advance, requesting both the researcher and the REB to be present and make oral presentations.
  4. The Appeals Committee shall function impartially, provide a fair hearing to those involved, and provide copies of all the relevant materials to those present. In conducting its hearing, the Appeals Committee shall accommodate reasonable requests of those appearing before it. The Researcher and the REB shall not be present when the Committee is making its final decision.
  5. The Appeals Committee shall notify both the Researcher and the REB in writing of its decision with a rationale for that decision.
  6. The decisions of the Appeals Committee cannot be further appealed within the University. In fact, the decisions cannot be appealed to any of the research councils.

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Conflict of Interest

The members of the Appeals Committee shall disclose actual, perceived, or potential conflicts of interest to the Committee. The Appeals Committee should develop mechanisms to address and resolve conflicts of interest. To maintain the independence and integrity of the appeals process, it is of the highest importance that members of the Appeals Committee avoid real or apparent conflicts of interest (see Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, Article 1.12). For example, Appeals 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, Appeals Committee members must withdraw from the committee when such projects are under consideration.

In some instances, individual members of the Appeals Committee may also have a conflict of interest because of their role within the University. The Appeals 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 Appeals Committee maintain an arms-length relationship with the University and avoid and manage real or apparent conflicts of interest.

Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans

As must be evident from the above, the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans not only influenced the development of these terms of reference but also the operation of the Appeals Committee. The author of these terms of reference used the February 25, 1999, Update. While this policy ought to have a guiding role on the Appeals Committee, it must be noted that this policy is clearly in the process of development. One should reasonably expect that the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans will undergo three or four substantive changes every year. The Appeals Committee should be governed by the latest update provided that the Tri-Council makes such updates available.

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