You must justify including or excluding children, a gender, or minority populations. Find more information in Office of Human Research Protections (OHRP) Special Protections for Children as Research Subjects and NIH Inclusion of Women and Minorities as Participants in Research Involving Human Subjects.

After you get the award, you will submit updated information in the Cumulative Inclusion Enrollment 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 for women, children, and minorities in your written request.

Investigating Foreign Populations

For foreign awards, the NIH policy on inclusion of women and minority groups in research is the same as that for the United States, and the tables are based on U.S. minority populations.

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.

For more details, see NIH Policy and Guidelines on the Inclusion of Women and Minorities as Subjects in Clinical Research.

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.