Appeal Process

The current Tri-Council Policy Statement requires the institution to have a process for reconsideration and appeals of the Carleton University Research Ethics Board (CUREB) decisions, but stresses that such a process is not to be considered a basis merely for seeking a second opinion. In all cases, the CUREB and researchers work together to ensure high-quality and ethical research. Therefore, dialogue and discussion should normally be expected to resolve any lack of agreement.

If a CUREB refuses to provide ethics clearance for a proposed research protocol, or if it requires amendment to the research protocol as a condition of approval, and the lead Carleton researcher for the project (hereafter referred to as “the researcher”) disagrees with the decision of the Board, this researcher may request that the CUREB reconsider its decision. An appeal can be requested for procedural or substantive reasons. The onus is on the researcher to justify the grounds for the appeal.

Upon receiving the written request for reconsideration, including the basis for the request, the CUREB involved will provide a prompt reconsideration and decision. The researcher may present to the Board, but will not be present for the Board decision making.

Should the researcher still not agree with the CUREB’s reconsideration decision, the researcher may appeal the CUREB’s decision to the Carleton University Research Ethics Appeals Committee (CUREAC) within 30 days of the communication of the reconsideration decision of the CUREB to the researcher. The onus is on the researcher to justify the grounds for the appeal. The CUREAC shall conduct an independent ethics review of the research protocol and the procedures followed by the CUREB in conducting its review. Decisions of the CUREAC are final and binding.

Terms of Reference

The Mandate of the CUREAC is to determine if there are sufficient procedural or substantive grounds for the appeal and, if so,

• Hear appeals of decisions reached by the CUREB-A and CUREB-B, provided that decisions rendered are specific to an appeal by a Carleton University researcher.
• Submit annually to the Vice-President (Research and International) a written report on the appeals received and considered and their disposition.
• Assess periodically the appeal process and make recommendations to the Vice-President (Research and International) for modifications, as appropriate.

Composition of the CUREAC

An appeal committee shall be appointed by the Vice-President (Research and International), ensuring that members of the appeal committee have expertise and knowledge to be able to competently judge the ethical acceptability of the research ethics protocol under review and have no real or perceived conflicts of interest.

The appeal committee will be composed of at least 6 members:

• At least 4 faculty members who have broad expertise in the areas of research involving human
  participants and who have served on a Research Ethics Board at Carleton University or another institution. Members should not be current members of the CUREB whose decision is
  being appealed.
• At least one community representative.
• An expert in law (but not the University legal counsel).
• Any other person who is believed to have expertise relevant to the particular case.

Quorum for all meetings of the committee includes all members of the committee.

Appeal Consideration Process

The CUREAC will act impartially and independently in its review of documentation provided by the CUREB, and the researcher and will consult with others as required, including but not limited to members of the CUREB and the researcher. The Committee will consider all materials relevant to the case, including the research protocol; the written appeal submitted by the researcher; the materials related to the decision; and the grounds for the decision of the CUREB. Both the researcher and a representative of the CUREB shall be granted the opportunity to address the CUREAC, but neither shall be present when the appeal committee deliberates and makes a decision.

Following a review of an appeal, CUREAC may:

1. Reject the appeal and affirm the original CUREB decision.
2. Modify the original decision concerning the specific conditions for clearance of the protocol.
3. Accept the appeal and clear the research protocol.

The majority decision of the CUREAC is final and will be communicated in writing (in print or by electronic means), normally within 60 days of receiving the appeal request, to the researcher and the CUREB whose decision was appealed.