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.
The following are examples of research studies that are excluded from the minimal risk review process because they pose greater than minimal risk due to their intrinsic nature and/or use of a vulnerable population:
- Studies involving sensitive questions or invasive procedures;
- Studies involving vulnerable populations (e.g., individuals with cognitive or intellectual disabilities);
- Studies where there is a possibility of coercion (e.g., studies involving "captive" groups such as employees, students, members of the military, prisoners);
- Studies involving deception or partial disclosure.
Expedited review is intended for studies that:
- Are not above minimal risk and have been approved by the REB of a Canadian university or Canadian hospital compliant with the TCPS 2 and applicable legislation
- 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)
- Are a replication of a project that received ethics approval from a University of Ottawa REB
- Involve secondary use of research data (no ethics review is required for the use of previously collected, publicly available, anonymized data)
- Are undertaken by students as part of an undergraduate or graduate course requirement
Ethics submissions which may be eligible for expedited review will be reviewed by the REB Chair and the Protocol Officer to determine if the submission meets the University of Ottawa’s and other relevant ethical standards. Upon such positive determination, the REB Chair may, at his or her sole discretion, grant approval. Alternatively, the REB Chair, at his or her sole discretion, may refer the ethics submission to either full board or minimal risk review.