Scope
Note: This Procedure is consistent with the Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans, (“TCPS 2 (2022)”), Chapter 6 – Governance of Research Ethics Review.
This procedure forms part of JIBC’s Research Involving Human Participants Ethics Policy (the “Policy”) and should be followed and applied in relation to the free and informed consent of participants in research at JIBC under the Policy. Terms not otherwise defined in this procedure are as defined in the Policy.
Purpose
Where researchers do not receive ethics approval in accordance with Procedure 3404-004 Governance of Research Ethics Review, or receive approval conditional on revisions that they find compromise the feasibility or integrity of the proposed research, they are entitled to reconsideration by the REB. If that is not successful, they may appeal using the established appeal mechanism in accordance with JIBC’s procedures.
Procedural Guiding Principles
In situations where the Research Ethics Board (“REB”) rejects the original Request for Ethical Review, the Chair, REB will notify the Dean, Office of Applied Research & Graduate Studies (“OARGS”) of the decision. The Dean, OARGS will review the REB decision and notify the Researcher, in writing, within a reasonable time frame of receipt of the decision.
Reconsideration of REB Decisions (TCPS 2 (2022), Chapter 6, Article 6.18)
Researchers have a right to request, and the REB has an obligation to provide, prompt reconsideration of an REB decision.
Initial reconsideration may simply consist of informal discussions between the Researcher and the Chair, REB. If the matter is resolved through this process, the REB Chair will ensure the resolution is reflected in the application materials as appropriate.
If informal discussions do not lead to a resolution, the Researcher may request a formal reconsideration. The Researcher must provide a written Request for Reconsideration to the Chair, REB, outlining the concerns they have with the initial REB decision. When requesting a formal reconsideration, the onus is on the Researcher to justify the grounds on which the reconsideration is requested and to indicate any alleged breaches to the established research ethics review process, or any elements of the REB decision not supported by the Tri-Council Policy Statement.
The Researcher has a right to be heard and answer questions in a meeting with the REB to discuss the issues identified.
The Chair, REB will render a decision on the reconsideration in writing within a reasonable amount of time of the completion of the formal reconsideration process. The Chair, REB will provide a copy of the decision to the Researcher, with copies to the Dean, OARGS, within a reasonable amount of time.
Appeal of REB Decisions (TCPS 2 (2022), Chapter 6, Articles 6.19 and 6.20)
If, after having fully exhausted the reconsideration process, the Researcher continues to be dissatisfied with the REB decision, the Researcher may commence a formal appeal by submitting a written Notice of Appeal to the Vice-President, Academic (“VPA”), while copying the Dean, OARGS, within 20 working days of completion of the formal reconsideration process.
The onus is on the Researcher to justify the grounds on which the appeal is requested and to indicate any breaches to the review process or elements of the REB decision that are not supported by the Tri-Council Policy Statement. The Notice of Appeal must include:
- A copy of the decision by the REB;
- The Researcher’s reason(s) for challenging the decision of the REB must be based solely on:
- the criteria for ethical review;
- patently unreasonable decisions based on material fact; or
- want of procedural fairness in the ethical review process;
- the resolution being sought; and
- any additional relevant information, not previously submitted, that would help the VPA understand the matter at issue.
Within a reasonable time of receiving a Notice of Appeal, the VPA or delegate will establish a three-person appeal committee to hear the appeal (the “Appeal Committee”). The VPA will chair the Appeal Committee. The Appeal Committee will otherwise be comprised of individuals with similar background and qualifications as members of the REB, but who were not involved in making the original REB decision.
The Appeal Committee will review the Notice of Appeal and supporting documentation and respond to the Researcher within a reasonable time of receiving the Notice of Appeal. Both the Researcher and a representative of the REB whose decision is being appealed will be granted the opportunity to address the Appeal Committee, either in person or in writing, but neither will be present when the Appeal Committee makes its final decision.
The Appeal Committee may approve, reject, or request modifications to the proposed research project.
The Appeal Committee will render a decision with reasons in writing within a reasonable amount of time of the completion of the appeal process. The decision of the Appeal Committee is final and binding in all respects for any appeal lodged with respect to the original REB decision. The VPA will provide a copy of the Appeal Committee’s decision to the Researcher, with copies to the Dean, OARGS and the Chair, REB, within a reasonable amount of time.
Privacy and Confidentiality
The Dean, and the Administrative Assistant, OARGS will be responsible for keeping and controlling access to records. Such records will be kept in accordance with the Institute’s Policy 2105 Protection of Privacy and Access to Information.
The privacy of the Researcher and any associated colleagues, funding agencies or other organizations will be protected.
Related Policies and Procedures
- 2105 Protection of Privacy and Access to Information Policy
- 3404 Research Involving Human Participants Ethics Policy
- 3404-004 Governance of Research Ethics Review