NIH Grant Application and Proposal Considerations for Human Subjects Research

If you are proposing human subjects research, learn how to prepare for the different human subjects protection requirements depending on how your study is classified. Learn about the specific considerations for exempt and non-exempt human subjects research in preparation for your NIH grant application or proposal.

Does your study involve human subjects research?

For further assistance determining if your research involves human subjects research, may be considered exempt from Federal regulations, or is not considered human subjects research, please visit our human subjects research and resources pages.

You may also visit the tools and resources on the Office for Human Research Protections (OHRP) website, including the guidance to determine if your institution is engaged in non-exempt human subjects research

NIH Specific Considerations

Exempt Human Subjects Research

Investigators and all key personnel involved in research considered exempt from the regulatory requirements in 45 CFR 46 must still meet the protection of human subjects education requirement. See the NIH Guide Notices of June 5, 2000 and September 5, 2001, or check out our Frequently Asked Questions for additional information.

Non-Exempt Human Subjects Research

Investigators involved in non-exempt human subjects research must meet the following requirements:

An Institutional Federal-Wide Assurance (FWA) with the Office for Human Research Protections (OHRP)
Institutional Review Board (IRB) Review and Approval
Education in the Protection of Human Research Participants

Check out the additional considerations for:

Developing the Human Subjects Sections of Your Application and Justifying Use of Human Materials:

All projects proposing human subjects research, either exempt or non-exempt, including those proposing clinical trials, must complete the PHS Human Subjects and Clinical Trials Information form as part of their grant application or contract proposal.

Applications must address the following elements on the Protection of Human Subjects section of the form:

Risks to the subjects
Adequacy of protection against these risks
Potential benefits of the research to the subjects and others
Importance of the knowledge gained or to be gained

To find details on the elements above and other aspects of the form, check the funding opportunity and carefully follow the instructions:

For grants: NIH Application Guide and the PHS Human Subjects and Clinical Trials Information form instructions
For contracts: Contract Attachment Files – Section J

Additional key resources:

Video orientation to the PHS Human Subjects and Clinical Trial Information Form

Presentation on preparing the NIH protection of human subjects section of the form (October 2018)

Click below to learn more about considerations for human subjects research in the next phase of the grants process: