Minimal risk

Minimal risk lets an IRB use expedited review and, in some cases, waive or alter informed consent requirements. It is a human subject protection concept and is separate from the significant risk or nonsignificant risk decision for device studies under the IDE rules.

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.

21 CFR, 50.3

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.

21 CFR, 56.102