NIH has examined and reported aggregate inclusion enrollment information for its portfolio of NIH-funded clinical research since fiscal year 1994. These reports are one component of NIH's policy on Inclusion of Women and Minorities as Subjects in Clinical Research.

Inclusion reports are produced with all NIH enrollment information and for each NIH Institute and Center (IC) that supports clinical research. Formally biennial, the 21st Century Cures Act changed the frequency of inclusion data reporting to triennial reporting. Each report provides some analysis of the data. FY 2018 inclusion data are also available by research, condition, and disease categories (RCDC) using the link below. However, caution should be used in interpreting these figures as analyses of aggregate data has limits.

  • Enrollment figures should not be compared directly to national census figures when considering inclusion data or evaluating policy implementation.
  • The goal of NIH's inclusion policy is not to endorse or enforce quotas for proportional representation based on census data, but rather to support biomedical and behavioral research that produces scientific knowledge that is generalizable to the population under study and ultimately applicable to the entire population of the United States.
  • The appropriate number of women, men, and/or representatives of racial/ethnic groups included in a particular study depends upon a number of factors, including but not limited to the scientific question(s) being addressed, the prevalence of the disease, disorder, or condition among women, men, and/or racial/ethnic groups, and potential gaps in scientific knowledge.
  • The scientific missions of different Institutes and Centers are distinct. This includes the amount of clinical research and NIH-defined Phase III clinical trials that are the IC portfolio. For example, some ICs support only a limited number of clinical trials, particularly late stage trials such as Phase III trials.
  • RCDC categories are not mutually exclusive; individual projects can be included in multiple categories.

NIH Reports

NIH RCDC Inclusion Statistics Report
This report displays the typical representation of the sex or gender, race, and ethnicity of participants in human subject studies enrolled in projects associated with the listed research, condition, or disease category. Data on enrollment by age are available below.

All Individual NIH Institute and Center reports, including previous triennial reports, are available in the Report Catalog