Comments – Dawson College, Research Ethics Board
Comments are posted in the language in which they were received.
Proposed Guidance for the Review of Multi-Jurisdictional Research
Michael Nafi, PhD
Chair of the REB
Cégep Dawson College
A Welcome Change to Foster Consistency and Collaboration between REBs The proposed guidance is a welcome change to the TCPS2.
Dawson College belongs to a network of public colleges (Cégeps) in the province of Québec. It might be worth noting that the Féderation des Cégeps passed a motion inviting its members to enact procedures for the review of minimal-risk multi-jurisdictional research deployed under their auspices or within their jurisdictions. Our REB was working on a draft procedure when this TCPS2 consultation was launched. The proposed guidance has the great merit of offering specific elements that can serve as a basis for new institutional procedures regarding the review of multi-jurisdictional research.
Hopefully, this new guidance will increase the consistency of ethics reviews for multi-jurisdictional research.
Since any substantive issue missed during the review must be flagged to the REB of record and not to the applicant, the new guidance will foster consultations and exchanges between REBs based in different institutions. This is good news for the REBs and a welcome relief for research applicants.
The New Guidance for Multi-Jurisdiction Research Might Not Lead to Considerably Faster Review Processes in Small Institutions
We reckon that the implementation of this new guidance will not necessarily decrease the workload of REBs or speed up the review process to any considerable extent, for small institutions such as ours. Small institutions do not necessarily have a large REB office with a number of experienced ethics administrators. The responsibility of consideration and acknowledgement of the review of the REB of record will most likely and ultimately fall on the volunteer Chair. Our members, especially disciplinary specialists, are already over-solicited throughout the year for delegated reviews.
Some Considerations Regarding the Documentation To Be Made Available by the REB of Record
Section 3.2 of the new proposed guidance provides that:
“(the) decision and reasons (of the REB of record), along with the final study materials, would then be available to the REBs of all sites, for acknowledgment”.
This will require of change of practices. Most REBs provide a certificate which simply confirm their ethics approval of the research project. It is essential that multi-jurisdictional certificates include a brief but clear comment on the reasons for the approval, including a justification of the risk-assessment.
We recommend that the provisions of section 3.3 of the proposed guidance include issues related to the risk-assessment.
Our REB, has always required a copy of the application submitted to the REB of record as well as a copy of the application submitted to the granting agency for all multi-jurisdictional research. It is not uncommon to see discrepancies between all these applications. These can sometimes be justified as projects may evolve even over a short period of time. However, we have seen projects under the same title that were modified after the approval of the REB of record.
To safeguard the integrity of the review process under this new guidance, we would recommend that all these documents be sent directly from the REB of record to all the REBs of the institutions listed in the original application.
We recommend that the final changes to the TCPS2 be more specific about examples of what should be made available by the REB of record to the other REBs.
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