How is minimal risk defined?
A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed 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 [Federal Policy 45 CFR 46.102(i)] and [21CFR50.3(k)]. 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 a routine physical examination.The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. Per 45 CFR 46.303, when prisoners are subjects in research, “minimal risk” is 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 ofhealthypersons.
A risk is minimal when the probability and magnitude of harm or discomfort anticipated in the proposed 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 [Federal Policy 45 CFR 46.102(i)] and [21CFR50.3(k)]. 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 a routine physical examination. The definition of minimal risk for research involving prisoners differs somewhat from that given for non-institutionalized adults. Per 45 CFR 46.303, when prisoners are subjects in research, “minimal risk” is 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.
