Key Points to Remember About Human Subjects Exemptions

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Remember, most NIAID-funded research is either "human subjects" or "not human subjects" and is usually not exempt. To help determine which your research is, see the Office for Human Research Protections' decision chart Is an Activity Research Involving Human Subjects? For more details, visit Is Your Research Exempt?

If you still think your research may be exempt, talk to your program or project officer. If he or she agrees that an exemption applies, you must:

• Include a justification for the exemption in the human subjects section of your Research Plan, as follows.
  • For electronic applications, see the human subjects instructions in the Grant Application Guide for details. Provide the justification in sections 8-11 of the PHS 398 Research Plan component of the Grant Application Package.
  • For paper applications, see the human subjects instructions in the PHS 398 for details. Create a section called Protection of Human Subjects in the narrative part of your application and include your justification there.
• Resolve any concerns for human subjects protections to the satisfaction of NIH. Keep in mind:
• While you must justify the exemption in your application, you don't need official documentation from your institutional review board or independent ethics committee that your research is exempt.The peer review panel will assess your justification.

It is rare that NIAID will return your application if you claim an exemption and it is incorrect or improperly justified. However, the lack of information may negatively affect your score or result in it being unscored.

• If your research is exempt but you still have access to basic characteristics about your subject population, you should include that information. If basic characteristics are unknown for exemption 4, indicate that in your plan.
• For all exemptions, if you know the criteria for including or excluding any subpopulation, you must identify that in your plan.

To learn more about Research Plan requirements, see the following:

• Electronic applications. Look at the Grant Application Guide for your Grant Application Package.
• Paper applications. Go to the PHS 398 Preparing the Research Plan, the Checklist, and the Appendix, and scroll down to Content of Research Plan.

For exemptions other than exemption 4:

• Provide certification of human subjects education for key personnel.
• Submit completed Targeted/Planned Enrollment Tables and Inclusion Enrollment Report Tables when appropriate.

To learn about the different exemptions, visit Part III, Policies, Assurances, Definitions, and Other Information in the PHS 398 and scroll down to section 3, Definitions. Or see Part III, Policies, Assurances, Definitions, and Other Information, in the Grant Application Guide for your Grant Application Package, and scroll down to section 3, Definitions.

Additional Resources

• Code of Federal Regulations: Protection of Human Subjects OHRP Web site
• Human Subjects questions and answers page
• OHRP Human Subject Assurance Training
• Private Information or Biological Specimens in Human Subjects Research Questions and Answers

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