What is “minimal risk”?
A. According to the federal regulations, 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.
The federal guidelines define minimal risk as “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)). Minimal risk indicates that risks are designated as minor impositions on the participant. The IRB considers both the magnitude and likelihood of risk. For example, driving or being a passenger in a car carries a risk of injury or death, but it occurs relatively infrequently for most drivers and passengers. Significant risks include all risks that are of greater consequence. Any study involving significant risk must be reviewed at the Full Board level.
