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Inclusion of Special Populations—Women, Minorities, and All Ages

Your human subjects research plans must include women, minorities, and participants of all ages unless you can justify their exclusion. Follow NIH’s inclusion policies on special populations:

  • 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.

As you develop a plan for recruitment and retention of study participants, consider how the age range could affect your plans.

In your application, provide inclusion information about your participants and justify their age range. If you plan to exclude some age groups or populations, fully justify why.

Reviewers will check whether you adequately justified your proposed plans for the inclusion (or exclusion) of participants based on your scientific 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. Learn more about progress reports in Reporting Requirements During Your Grant.

To change the involvement of human subjects in an active award, you must request prior approval. If applicable, include documentation of new or revised inclusion plans in your written request. Follow instructions in the Prior Approvals for Post-Award Grant Actions SOP.
 

Investigating Foreign Populations

For foreign awards, the NIH policy on inclusion in research is the same as that for the United States.

For both foreign awards and domestic awards with foreign components, report on planned study populations using the Planned Enrollment Report.

If there is scientific rationale for examining subpopulation group differences in a foreign population, consider designing your study to accommodate those differences, and discuss this in your application.

Outreach plan. You will need a culturally sensitive outreach plan. Build trust by involving relevant parties, such as family, religious organizations, and community leaders, when developing the plan.

In some cases, conducting a community consultation may benefit potential participants and your study. Although not required, NIH supports and encourages community consultations for many types of research. To learn more, read NIH Points to Consider When Planning a Genetic Study That Involves Members of Named Populations.

Regulatory oversight. You must obtain regulatory oversight by either the Food and Drug Administration (under an investigational new drug or investigational device exemption) or the regulatory body of the country where the research is to be conducted. Send NIAID written documentation from a foreign regulatory body showing you are in compliance with local laws.

Country-specific protections. See HHS International Compilation of Human Subjects Research Protections. Scroll to your country of interest.

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