Comments – University of Waterloo, Research Ethics Board

More clarity is needed with specific examples referencing participant recruitment at more than one eligible institution. The current examples are focused on researcher affiliation and resources.

It would be helpful to provide relevant examples of “involvement” and “resources” to identify levels of collaboration covered by this guidance. For instance: “Noting that these examples are not exhaustive, researcher ‘involvement’ might include study design, collecting or analyzing data, and co-authoring papers, and ‘resources’ could include provision of funding, personnel, or access to participant populations.” If this recommendation is adopted, revising the first bullet point to say “research involving researchers” rather than “research conducted by researchers” would improve consistency.

This guidance also provides the opportunity to clarify the scope of multi-jurisdictional research and provide specific examples of what types of collaboration require multi-jurisdictional review at one or more institutions. A table or decision tree would be a helpful tool to outline specific examples of researcher collaboration and if local REB review is required. These tools would help researchers and REBs determine if this guidance applies or not. The examples currently used in the guidance are a bit too vague. Specific examples would provide greater clarity. For example, if a researcher is only receiving results and helping to write a paper is the local REB required to acknowledge the study? Does this change if the researcher is receiving and analyzing the data? Is there a consideration if institutional funding is supporting the research?

A clear and detailed chronological process outlining how REBs are expected to work collaboratively would be most helpful to ensure there are no barriers to implementing the REB of record review process. This outline should include an explanation of when the REB of record should provide approval and when the researchers could start the study (i.e., can they start the study after the REB issues clearance or to they need to wait until all acknowledgements are received). It would also be helpful to distinguish between the role and responsibilities of the REB of record and the local REBs. Are the steps for minimal risk research meant to be something like the following?

1. The REB of record is confirmed (by default at the institution of the project PI, unless the PI demonstrates that another REB is better suited because of their expertise).
2. The REB of record receives an ethics application and works with the lead researcher (i.e., PI) to address the ethical issues.
3. Researchers at other institutions provide their own local REBs the ethics clearance from the REB of record and the full study documentation.
4. An individual at each local REB reviews the materials to identify local or substantive issues and work with the REB of record to resolve these issues (if any) before the local REB sends an acknowledgement to the REB of record and the local researcher(s), recognizing its clearance.

Creation of a master REB of record application could support communication among REBs as well as outline the processes for communication and how acknowledgements will be shared with the local REBs.

It would be helpful if this section also provided guidance about processes that are to be followed post-approval. For example, what processes are researchers at the local site to follow if there needs to be an amendment to the study protocol, report an unanticipated problem, renew the study for another year (continuing review)? Are all such responsibilities handled by the REB of record?

The heading for this section indicates that this section pertains to greater than minimal risk research only and describes how local REBs may have an opportunity for local review. There does not seem to be a different process for minimal risk research other than the timeline of 3 weeks compared to 6 weeks for greater than minimal risk research.

Line 160 states “in situations where all local REBs have not completed their review....” which suggests the research may begin, and at the sites where the local REB has completed the review, but not at the sites where the local REB has not completed their review. It is unclear if this is only possible for research that is greater than minimal risk or if this same process can be applied to studies that are minimal risk. It might be helpful to note that regardless of the risk level, research can only begin at the sites where the researchers have obtained the necessary approvals to proceed.

As REBs may judge the risk level associated with a project differently, more information and guidance for REBs on how to address conflicting opinions on risk level is needed particularly when conducting research with vulnerable populations. Emphasizing clear communication between the REB of record and the local REBs may be a way to address these differences. This guidance would also create mutual understanding around issues such as the secure transmission of information or data. A master application held by the REB of record could be created for use by REBs who act as the REB of record and include a checklist or section for tracking multi-site/local REB approvals.