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NIH and NIDCR Human Subjects Research & Clinical Trial Policies and Expectations

Am I Conducting Human Subjects Research?

The NIH Oﬀice of Extramural Research (OER) has developed a quick decision tool that can assist investigators with determining whether research involves human subjects, may be considered exempt from federal regulations, or is not considered human subjects research.

If you have questions about whether your application involves human subjects, consult with your NIH Program Oﬀicial or ask your institutional review board (IRB) or independent ethics committee (IEC).

Resources for NIH- and NIDCR-funded Human Subjects Research Additional Resources for NIH- and NIDCR-funded Clinical Trials