Reporting to NIH on Race and Ethnicity of Clinical Research Participants


The inclusion of women, different racial and ethnic groups, and children is extremely important in clinical research to understand who is affected by a given disease or condition and to develop the appropriate treatments. To that end, we have long-standing inclusion policies to assure that research participant demographics — sex/gender, race, ethnicity and representation of those under age 21 — appropriately address the scientific question at hand. As in the past, this policy continues to apply to all projects meeting the NIH definition for clinical research, not just clinical trials. However, I’m bringing this topic to your attention because there has been some confusion about the distinction between race and ethnicity and how to report this information to the NIH.

Researchers are asked to report to NIH on the planned and actual enrollment of clinical research participants by sex/gender, race, and ethnicity. The racial and ethnic standards we use are set by the Office of Management and Budget (OMB). When enrolling research participants, researchers should ask participants to self-identify both their ethnicity and their race. The participant should also be given the option to select more than one racial category, or to decline providing their sex/gender, race, and ethnicity. When reporting on actual enrollment to NIH, researchers use the participants’ data to complete our forms. In an effort to clarify this policy and streamline our implementation, we’ve recently modified the layout of the reporting forms to clarify the need for collecting race and ethnicity information separately (for more on the distinction between race and ethnicity, check out this recent All About Grants podcast). We’ve also added the ability for researchers to indicate how many individuals identifying with more than one racial category they plan to enroll.

Note that these changes are to the forms researchers use in reporting to NIH. These forms should not be used for data collection from the research participants themselves.

We have created additional resources to help researchers report inclusion information to NIH including a new frequently asked questions page and narrated slide deck on race and ethnicity reporting — visit this recently-updated NIH inclusion policy website for these resources and more information about the inclusion policy and reporting.

We’re transitioning to the modified layout in phases, starting with competing applications that have receipt dates on or after September 25, 2013. We will be transitioning the progress reports for non-competing awards in the near future — see this NIH Guide Notice for more details.

We are continuing to make our policies clearer and make it easier for the community to report on their clinical studies, so that we can see this important research reach successful conclusions and provide the information needed to reduce illness and disability.


  1. I am preparing a code book for my study and would like to reference that I have adopted the NIH way of reporting race and ethnicity. Is there a specific form instructions form you have which I can link as a reference .

    1. The racial and ethnic standards are set by the Office of Management and Budget (OMB). The racial and ethnic categories are defined in terms of geographic origins. For more information on the categories and their definitions, information can be found here. In addition to the link above to the OMB description, information about the race and ethnicity categories and use of the NIH forms is available in the SF424 R&R and other NIH application forms available at

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