Clinical Research Ethics

Clinical research evaluates the effects of one or more health-related interventions on health outcomes.  Investigations include, but are not restricted to, drug administration, surgical procedures, radiologic procedures, devices, genetic therapies, cells and other biological products, radiopharmaceuticals, natural health products (NHPs), process-of-care changes, preventive care, manual therapies, and psychotherapies.

Health Canada and US FDA regulated research, research evaluating human anatomy, physiological outcomes and processes, medical chart reviews, secondary analysis of clinical data, biobanks and clinical data registries should be submitted as a Clinical application.

A clinical research project that also includes questionnaires or interviews as part of its methodology should be submitted to a Clinical Research Ethics Board. 

The CREB reviews clinical research conducted at UBC's Vancouver campus and at Vancouver Coastal Health Authority sites (including UBC Hospital, Vancouver General Hospital, and GF Strong). It also reviews any clinical research that does not fall under the purview of site-specific REBs at BC Cancer, Children & Women’s Hospital or St. Paul's Hospital (Providence Health Care).

United States Federal Wide Assurance (FWA)

Under the United States Department of Health and Human Services (DHHS) Code of Federal Regulations 45: Part 46 A Protection of Human Subjects Section 46.103, every institution engaged in human subjects research supported or conducted by any United States Federal Department or Agency must have assurance of compliance approved by the United States Office for Human Research Protections (OHRP). The Assurance formalizes the institution’s commitment to protect human subjects.