Research Ethics BC is pleased to announce that a model for harmonized ethical review of clinical trials has been developed. The working group responsible for the model to be piloted was led by Sara O’Shaughnessy, PhD of Fraser Health Department of Evaluation and Research Services and included members from the research ethics offices of Interior Health, University of Victoria, BC Children’s and Women’s Hospitals, Providence Health Care, Island Health, BC Cancer, and UBC CREB.
The pilot is focused on investigator-led clinical trials that are not sponsored by a for-profit sponsor, such as a pharmaceutical or medical device company. We have had models for harmonized review for other types of studies, excluding sponsored clinical trials, since 2015 but this is a landmark accomplishment in furthering the collaborative model for ethical review in the province.
As with other harmonized ethical reviews in BC, researchers will be asked to submit their initial application via the Provincial Research Ethics Platform (PREP) housed within the RISe system owned by UBC. Researchers can find an Instruction document HERE, and the detailed Guidance Document for Research Ethics Board Administrators (REBA) is available on our website under Resources.
The Pilot phase is expected to run for 1 year at which time we will evaluate the process and adjust as necessary. Additionally, we are hopeful that this Pilot will lead to a harmonized ethical review process for sponsored clinical trials as well.
Should you have any questions or comments about the Pilot, please direct them to our Research Ethics Navigator, Paola Pinto Vidal via email: firstname.lastname@example.org .