Prior Approval NIH Definitions
Types of Proposed Research
UL1 Pilot Project
A UL1 Pilot Project is used to support clinical and translational research. The UL1 can be administratively linked to another project or projects. A UL1 award may only be disaggregated from a U54 application and organizations may not apply for a UL1, Linked Specialized Center Cooperative Agreement. The UL 1 activity code is used in lieu of the U54 for those programs that offer linked awards.
KL2 Scholar Project
A KL2 Scholar Project is used to support newly trained clinicians appointed by an institution for activities related to the development of a successful clinical and translational research career. The award is administratively linked to another project or projects. A KL2 award may only be disaggregated from a U54 application and organizations may not apply for a KL2, Mentored Career Development Award. The KL2 is used in lieu of the K12 for those programs that offer linked awards.
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
NIH Decision Tool
The NIH Office of Extramural Research (OER) has developed a quick decision-making tool that should assist you with determining if your research involves human subjects, may be considered exempt from Federal regulations, or is not considered human subjects research. This tool should not be used as the sole determination of exemption.
Foreign Component
In accordance with the NIH Grants Policy Statement, a foreign component is defined as the performance of any significant element or segment of the project outside the United States, either by the recipient or by a researcher employed by a foreign organization, whether grant funds are expended.
New Project with Human Subjects Research Addendum
