BC Rapid Response Ethical Review Process for Clinical Research Pertaining to COVID-19
Researchers and REBs are dedicated to finding treatment options and vaccines for COVID-19 and BC research ethics professionals want to ensure that not only is there equity for patients and participants in studies, but also that there is the ability to get studies going quickly in an emergency such as the COVID-19 outbreak.
As part of the harmonized ethical review process in BC, Research Ethics BC together with the respective Health Authorities and their clinical Research Ethics Boards (REBs) have agreed to implement a rapid ethical review process for clinical studies (including Health Canada regulated clinical trials) pertaining to COVID-19. Using the already agreed upon reciprocity arrangement between Health Authorities in BC regarding research ethics and applying their emergency standard operating procedures, only one REB review will be required for the approval of a provincial clinical study pertaining to COVID-19. The review will be conducted within five (5) business days from submission.
Please note that this process pertains only to research ethics reviews. Operational/institutional approvals will still need to be sought and obtained by the researcher(s) involved.
Clinical research where there is a BC lead Investigator:
If your research proposal is for a clinical COVID-19 related study that is intended to be rolled out for all Health Authorities, the REB will review the study within five (5) days of receipt and provide ethics approval on behalf of Island Health, Northern Health, Interior Health, Providence Health, Vancouver Coastal Health, Fraser Health and, where relevant, Children’s and Women’s Hospitals.
If your proposal is initially not intended to be conducted at multiple provincial sites, a review by one REB will still occur within five (5) business days. Other locations may be added later if the study becomes feasible at additional sites.
Regulated Sponsored Clinical Trials where there are multiple investigators and sites in BC:
Research Ethics BC will help researchers and REBs to facilitate the rapid review process described above for COVID-19 clinical trials where there may be multiple distinct sites within BC.
This means that each Qualified Investigator will be added to a provincial level research ethics application rather than submitting individually. This is the most efficient process as it allows for a provincial approval of the protocol and informed consent forms and then addition of new sites to the original ethics application.
We are here to help researchers and study sponsors with either scenario described above, so please contact us directly at Research Ethics BC.
Prepared by: T. Fleming, Director, Research Ethics BC