Glossary Term

Minimal Risk

Glossary Term:

Minimal Risk


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 (45 CFR 46.102(i)). For example, the risk of drawing a small amount of blood from a healthy individual for research purposes is no greater than the risk of doing so as part of routine physical examination.  This is not interpreted to include the inherent risks certain categories of human subjects face in their everyday lives. For example, the risks imposed in research focused on a special population should not be evaluated against the inherent risks encountered in their work environment (e.g., emergency responder, pilot, soldier in a combat zone).

In addition, the IRB generally subscribes to the recommendations related to 45 CFR 46.404 from SACHRP regarding research involving children.

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