The federal Common Rule identifies categories of research eligible for exemption from IRB review. Although these categories involve research with human subjects, the research exposes subjects to minimal psychological, social, or physical risks. (Minimal risk is a risk of harm to the subject that is no greater than the risk encountered in normal, day-to-day activities or during routine physical or psychological examinations.)
According to federal regulations, the IRB, not investigators, determines whether the research is exempt from review. Investigators must submit protocols for potentially exempt research; and then the protocol is reviewed and a determination made as to whether the protocol meets the criteria for exempt status.