Comments – British Columbia Institute of Technology, Research Ethics Board
Comments are posted in the language in which they were received.
RE: Ethics Review of Multijurisdictional Research – Proposed Revised Guidance
Dear Panel and Secretariat,
While it is important to simplify ethics review for researchers, the proposed guidance on review of multijurisdictional research will complicate and potentially slow review for many of the applications that are reviewed by our REB. While the proposed guidance may be “...based on confidence that a single, comprehensive ethics review of minimal risk studies should, in the vast majority of cases, be sufficient to provide the appropriate protection to participants,” it misses the reality of local issues that are not readily known by researchers or a board of record.
We suggest some changes to clarify collaboration between REBs that will keep reviews going smoothly for researchers. Potential edits to the guidance are included below the text of this reply.
1. Please highlight the need for REBs to review proposals collaboratively, in parallel.
The current proposal appears to take us back to the serial process the new guidance is written to avoid, where the board of record reviews the study and local boards are asked to acknowledge the approval. If the local board identifies an issue with the study, an amendment is required, revisions made, and re-approved, slowing approval for researchers.
We have adopted harmonized ethics review in BC through Research Ethics BC to facilitate collaborative review amongst boards before approval to avoid this conflict and provide researchers with one point of contact at the board of record. Adoption of such a harmonized review system across Canada would meet our dual goals of facilitating research and protecting participants.
2. Please consider assigning initiation of collaborative review on the board of record, rather than the researcher.
Ideally, a national harmonization system would be developed, similar to that in place in BC, to automate communication between boards and simplify the application process for researchers. Researchers are focused on their studies and rely on institutions to communicate with each other. With a list of REB contacts in Canada, preferably through a single email or phone number (e.g., firstname.lastname@example.org), the board of record can forward proposals to local boards and request acknowledgement or revisions before approval. A standard time limit (e.g., ten business days) can ensure that reviews and acknowledgements are collected and collated without significant delay. Where necessary, researchers can help facilitate communication between boards by making contact with the local boards, discussing the study, and confirming contact information is up to date.
3. Please reiterate the importance of considering local issues in ethics review.
As a polytechnic institution with a non-traditional blend of government and regulator oversight, as well as faculty, staff and students from all industries and walks of life, there is an interpersonal and multi-layered dynamic that is difficult for those outside the institution (and many within the institution) to appreciate. Recruitment of employees by managers or students by instructors creates coercion that prevents free consent. Knowledge of this structure and dynamic sits with the local board and most external (and some internal) researchers are unaware and often design studies without taking these into account.
Prior approval by an external board of record sets up a second dynamic where the local board is placed in the uncomfortable position of raising these important concerns and slowing the review, in the face of a potentially more experienced and influential institution. This dynamic occurs frequently during reviews at our institution where an employee is working towards a degree (PhD or Masters) at another institution and participants are recruited exclusively from their own department or school at BCIT. Issues that might be considered minor at some institutions—e.g., involvement of instructor, supervisor, gender questions on surveys, and arbitrary age restrictions on inclusion—loom large for many participants at our institution. Having more eyes on an application improves the research for both the researcher and the participant and should be encouraged.
Existing TCPS2 Chapter 8 does an excellent job of guiding researchers and institutions in the review of multijurisdictional research and we do not see the need for new proposed guidance, except to facilitate collaborative review by REBs in Canada before initial approval.
In particular, from 8.1: “Ethics review of the proposed research at each collaborating institution helps to ensure that local issues and values are taken into consideration. This approach may be particularly important, though often more challenging, when there are relevant social or cultural differences between the participating institutions. When several REBs consider the same proposal from their own institutional perspectives, they may reach different conclusions on one or more aspects of the proposed research, that reflect local issues and values. REBs may therefore wish to coordinate their ethics review of research projects requiring multiple REB involvement, including conducting their research ethics reviews in a timely manner and communicating any concerns that they may have with other REBs reviewing the same project. When multiple REBs are involved, the principal investigators should work with their REBs to formulate a strategy to address procedural inconsistencies or substantive disagreements that may arise among the participating REBs.
Where possible, researchers should provide their REBs with the name and contact information of the other REBs that will also review the project to facilitate direct communication between the REBs, and help resolve disagreements that may arise.”
From Article 8.2: “Sensitivity to context is a key issue in the application of the core principles of this Policy to the ethics review of research involving multiple institutions and/or REBs. Researchers should consider the alternative research ethics review models at the planning and design stage of their research, and should consult with their REBs to facilitate the selection and coordination of the appropriate review model. In choosing the appropriate research ethics review model, the researcher and the REB should pay attention to the research context and the characteristics of the populations targeted by the research. The final decision regarding the selection of the appropriate model is the responsibility of the principal REB.”
Articles 8.3 and 8.4 point out that human research should be reviewed by all institutions involved, including inside and outside Canada and conflicts resolved through collaboration.
Thank you for the opportunity to comment on the proposed guidance. We look forward to working with you in developing a more collaborative approach to ethical review of multijurisdictional research.
Province or territory: BC
Capacity in which you are submitting the comments: REB chair
Your main discipline: No speciality
Allison Kirschenmann, PhD (she/they) Faculty, Basic Health Sciences Chair, BCIT Research Ethics Board British Columbia Institute of Technology 3700 Willingdon Avenue, SW3-3090 Burnaby, B.C. V5G 3H2 Tel: 604-451-6917 or 1-800-663-6542 x6917
I acknowledge that BCIT campuses are located on unceded traditional territories of the Coast Salish peoples, including the territories of the xʷməθkwəy̓əm (Musqueam), Səlí lwətaʔ/Selilwitulh (Tsleil-Waututh) and Skwxwú7mesh (Squamish) Nations. I work remotely from the traditional territory of the Qayqayt First Nation.
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