Ethics evaluation may be completed by a delegated reviewer (expedited review) or the whole ethics committee (full board review). This is dependent upon the risk level of a study.
Module 8: Ethics review
Minimal risk studies vs. More-than-minimal risk studies
‘Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.’
(Quoted from: Revised Common Rule (45 CFR 46), 2018) (4)
e-CFR (Revised Common Rule) [Internet]. United States Electronic Code of Federal Regulations. Sect. Part 46—Protection of Human Subjects Jul 19, 2018. Available from: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/index.html
Examples of ‘minimal risk’ studies:
- Retrospective studies using existing databases
- Questionnaire surveys
- Studies that involve only simple blood sampling
Examples of ‘more-than-minimal risk’ studies:
- clinical trials
- studies using stem cell or cell-based interventions
- studies that involve genetic testing
- studies that involve invasive procedures more than simple blood sampling
- studies that involve vulnerable populations (e.g. people who lack capacity)
The ultimate decision of whether a study is considered ‘minimal risk’ or ‘more-than-minimal risk’ lies with the ethics committee.