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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.