Include Special Populations in Your Human Subjects Research

Funding News Edition: June 16, 2021
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Investigators, if you are proposing human subjects research, be sure to follow NIH’s inclusion policies on special populations, i.e., women, minorities, and all ages. See the following for complete details, including implementation, progress reports, and more.

  • Inclusion of Women and Minorities as Participants in Research Involving Human Subjects—You must provide a planned enrollment report (or cumulative report if participants have been enrolled in the study or you are proposing a new study using an existing dataset/resource where the participants have already been enrolled) breaking down the sample by sex/gender, race, and ethnicity, and report at least annually on inclusion enrollment progress.
  • Inclusion Across the Lifespan—In your application, use the PHS Human Subjects and Clinical Trials Information Section 2 (Study Population Characteristics) form to provide participant information and rationale for the selected age range. Note that if you are planning to leave out some age groups or populations, you must justify why. Examples of acceptable reasons for excluding people based on age include the following (see the policy for others):
    • The disease or condition does not occur in the excluded age group, or the research topic is not relevant to the excluded age group.
    • The knowledge being sought in the research is already available for the excluded age group or will be obtained from another ongoing study, and an additional study will be redundant.
    • There are laws or regulations barring the inclusion of individuals in a specific age group in research.

Be sure to read General Instructions for NIH and Other PHS Agencies (currently for Forms Version F series) for human subjects- and inclusion-related items.

Keep in mind that peer reviewers will check whether your justifications for including or excluding participants is adequate based on your project’s goals and research strategy.

After Submitting

In the event your application is likely to be funded, NIAID will send you a just-in-time (JIT) request, which includes sending certification that you and anyone identified as senior/key personnel involved in human subjects research has completed an education program in the protection of human subjects. See NIAID Request for Just-in-Time Information for details.

If you receive an award, you will submit updated information in the cumulative report as part of your annual progress report. Go to Reporting Requirements During Your Grant to learn more about progress reports.

Foreign Awards

For foreign awards, the NIH policy on inclusion in research is the same as that for the United States. Learn more in the section Investigating Foreign Populations of our Inclusion of Special Populations—Women, Minorities, and All Ages webpage.

Additional Resources

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