Study Categories
Clinical Trial
A Clinical Trial is a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. A "health-related biomedical or behavioral outcome" is defined as the pre-specified goal(s) or condition(s) that reflect the effect of one or more interventions on human subjects’ biomedical or behavioral status or quality of life.
Greater Than Minimal Risk
Greater than minimal risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research risks are more than minimal risk, but not significantly greater. Studies that fall under this category will range in their probability of a moderate-severity event occurring because of study participation (and the level of safety monitoring will depend on that probability) but there are adequate surveillance and protections in place to identify adverse events promptly and to minimize harm.
Minimal Risk
Minimal Risk to subjects means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical and psychological examinations or tests and that confidentiality is adequately protected.
Exempt
Human subjects research that is classified as “exempt” means that the research qualifies as no risk or minimal risk to subjects and is exempt from most of the requirements of the Federal Policy for the Protection of Human Subjects but is still considered research requiring an IRB review for an exemption determination.
Exempt studies involve human subjects’ research that is research involving a living individual about whom data or biospecimens are obtained/used/studied/analyzed through interaction or intervention, or identifiable, private information is used, studied, analyzed, or generated.
Please review this document to see whether your study meets the criteria of one of the eight following exemptions: NIH Exempt Human Subjects Research Categories PDF