Guidance for Principal Investigators

When submitting a new or competing renewal application or proposal for NIH-supported clinical research, investigators should address plans for inclusion on the basis of sex/gender, age, race, and ethnicity and should complete the PHS Human Subjects and Clinical Trials Information Form. Investigators submitting a competing renewal application or conducting research with an existing cohort or data set should also complete the PHS Human Subjects and Clinical Trials Information Form to describe progress on inclusion from the previous funding period.

The inclusion plan should, at a minimum, describe the proposed sample distributions by sex/gender, race, and ethnicity. The Principal Investigator (PI) should justify the proposed sample in the context of the study’s scientific goals and the study population and should consider such factors as who is at risk for the disease or condition under study. If proposing to further limit the sample within a given study population, the PI should provide additional justification regarding the appropriateness of the sample, particularly if the data set does not reflect the population of the disease or condition under study. For example, justification might relate to the nature of the scientific question, a requirement for data provided by the cohort, or addressing a knowledge gap.

The financial cost of securing a clinical research study population that is distributed appropriately by sex/gender, race, and/or ethnicity is not an acceptable justification for excluding a particular group. If proposing multisite clinical research studies or trials, the PI should consider the appropriate distribution by sex/gender, race, and ethnicity across all sites. The NIH-funding Institute or Center and/or the PI/research team may decide to provide inclusion data individually by site or by overall study, but the PI should not provide the data both ways.

More detailed instructions for addressing inclusion in applications are provided in the application instruction guides available on the NIH Forms & Applications Web page. In addition, more detailed information and guidance on the subject of inclusion is provided on NIH’s Inclusion of Women and Minorities as Participants in Research Involving Human Subjects—Policy Implementation Page.