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 examination or tests.” (45CFR46.102)

Studies involving treatments or procedures that are more invasive than a routine blood draw generally have more than minimal risks. Risks are also greater than minimal when identifiable information, if revealed outside the study, could be a risk to a subject’s employment, insurance, financial standing or reputation or put a subject at legal risk.