Research ethics review is a process of initial and ongoing review and monitoring of research involving human participants.
The process requires the evaluation of all proposed research by an independent committee (REB) of experts which examines the research study through the lens of prospective participants. The REB's assessment of a proposed study's ethical acceptability is guided by the core principles of research ethics (i.e., respect for persons, concern for welfare, and justice).
The underlying value of research ethics review is respect for human dignity. The review process ensures that research involving humans is sensitive to the inherent worth of all human beings and the respect and consideration they are due.
There are two categories of research ethics review (Behavioural and Clinical), each with different application processes. The difference between Clinical and Behavioural studies is not always clear. The final decision about which type of REB will review your study is at the discretion of the Boards. Please reach out to your REB if you have any questions about which study type should be selected in Box 4.1.
Behavioural and social sciences projects study the relationship between people and their surroundings, including how people interact with each other, their communities, and institutional systems. They include psychological phenomena such as emotions, biases, and motivations. Psychological therapy and counselling studies fall under behavioural research. Emergent design and community-based studies are considered social science and behavioural research unless a clinical intervention is involved. Common methods include, but are not limited to, interviews, focus groups, surveys, questionnaires, behavioural therapy workshops, experimental coaching, observations, and secondary use of data.
Behavioural and social sciences studies can be about health and include health care providers and patients, where the goal is not to modify direct patient clinical care (i.e., do not involve diagnosis, medication, or treatment). When clinical charts are being accessed for a behavioural study, full patient consent is required.
Retrospective medical chart review projects should be submitted using the Clinical application form.
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.
A Combined Metrics Report for all UBC Affiliated REBs is created annually to reflect review trends. The reports started in 2015 (which covers 2012 - 2015).