What does minimal risk mean?

What does minimal risk mean?

Institutional Review Board (IRB) FAQs What does minimal risk mean?

What does minimal risk mean?

​The Common Rule defines minimum risk—for non-prisoners—as risk in which "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" (45 CFR 46.102).

For prisoners, minimal risk is defined as risk in which "the probability and magnitude of physical or psychological harm that is normally encountered in the daily lives, or in the routine medical, dental, or psychological examination of healthy persons" (45 CFR 46.303).

 
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