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 Aboriginal peoples or other ethnic communities, groups or individuals
- 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