In keeping with a proportionate approach to research ethics review, as per Article 6.12 of the TCPS 2, the selection of the level of REB review shall be determined by the level of foreseeable risks to participants: the lower the level of risk, the lower the level of scrutiny (minimal risk review); the higher the level of risk, the higher the level of scrutiny (full REB review).
A proportionate approach to assessing the ethical acceptability of the research, at either level of review, involves consideration of the foreseeable risks, the potential benefits and the ethical implications of the research.
Full REB Review
It is the default procedure for all research projects involving human participants. The following are examples of research projects that may require a Full REB review:
- Projects involving any moderate to serious physical, emotional, psychological, legal, social, or economic risk to participants.
- Projects involving sensitive questions or invasive procedures.
- Projects involving vulnerable populations where participants’ capacity to consent may be affected (e.g., individuals with cognitive or intellectual disabilities).
- Projects where there is a possibility of coercion (e.g., studies involving "captive" groups such as employees, students, members of the military, prisoners).
- Projects involving partial disclosure or deception (e.g., some information which may affect participants’ decision to participate is withheld at time of initial consent).
Minimal Risk Review
Minimal risk review is intended for studies which pose minimal risk to the participants' rights and welfare and comply with the relevant standards relating to such matters as free and informed consent, privacy and confidentiality and appropriate balance of risks and benefits.
The term "risk" is interpreted broadly to include, among others, physical, psychological, economic and social risks. Recognizing that the TCPS 2 focuses on a participants-centered perspective, risks to others, such as those conducting the study and their organizations and third parties, may also be considered in the determination of whether or not an ethics submission may be considered through a minimal risk review process.
Expedited review is intended for projects that:
- Are not above minimal risk and have been already approved by the REB of a Canadian university or Canadian hospital compliant with the TCPS 2 and applicable legislation; or
- Have been approved by the REB of a University of Ottawa affiliated hospital (The Ottawa Hospital, CHEO, The Royal, Hôpital Montfort and Bruyère Continuing Care); or
- Involve secondary use of research data (no ethics review is required for the use of previously collected, publicly available, anonymously collected data)
- Are undertaken by students as part of an undergraduate or graduate course requirement (directed studies)
Note: The REB Chair, at his or her sole discretion, may refer the ethics submission to full board, minimal risk, or expedited review.