Last November, the White House announced its Initiative on Women’s Health Research to “fundamentally change how we approach and fund women’s health research, and pioneer the next generation of discoveries in women’s health.” Relatedly, the NIH Director has emphasized the importance of ensuring proper inclusion of participants in NIH-supported clinical research (see her opening remarks at December’s Advisory Committee to the NIH Director meeting and a National Academies meeting in May). We, as part of this wider effort, want to remind the research community about relevant NIH inclusion policies and resources, as well as where inclusion data can be found.
As we have said before, appropriate inclusion of research participants ensures that NIH supports science that will inform clinical practice to benefit all who are affected by the disease or condition under study. We have had policies in place for over three decades to ensure appropriate inclusion of women and members of racial and ethnic minority groups in NIH-supported clinical research. And, our Inclusion Across the Lifespan policy (effective January 2019) requires individuals of all ages (including children and older adults) be included in clinical research studies unless there are scientific or ethical reasons to exclude them. Since these policies have been in effect, they have required, among other things, that recipients report to NIH on the sex or gender, race, and ethnicity, and more recently age of enrolled participants (in .csv format). These NIH All About Grants podcasts share helpful advice related to inclusion policies when planning and reporting on your study.
These inclusion data allow us to report the breakdown of participants in NIH-funded clinical research, so that the public has a better understanding of who is enrolled in our supported studies. For instance, in fiscal year 2023:
- Women represented 57 percent of participants in all NIH-supported clinical research (55 percent for U.S. participants).
- 44 percent of participants identified as members of racial or ethnic minority groups (31 percent for U.S. participants).
- 9 percent of participants were children under 18 years of age and 13 percent were adults older than 65 years (7 percent children and 15 percent older adults for U.S. participants).
Inclusion data are publicly available for many different research areas that NIH supports. Data broken down by NIH Research, Condition, and Disease Classification (RCDC) categories for women and members of racial and ethnic minority populations were first announced in 2019 and by age in 2022. Up until now, these data were only publicly updated once every three years. Going forward, we will produce inclusion by RCDC data annually to allow better insight into the demographics of participants in clinical research more often.
Finally, we sought public input on how common data elements may be used in NIH-supported clinical research. One area in particular focused on what demographic characteristics common data elements should collect. Although the comment period is now closed, we still encourage you to stay tuned for more information to come.
We appreciate the research community’s continued efforts to ensure proper inclusion of participants in NIH-funded research and in publications. We will continue providing resources and other educational materials (e.g. allowable costs for participant enrollment, reports on women’s health research, and NIH Institute and Center’s participant inclusion), so that we support science that will ultimately inform clinical practice to benefit all who are affected by the disease or condition under study.
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