Office of Research on Women’s Health (ORWH)
History of Inclusion
Sex is a fundamental biological variable in biomedical research that must be considered from the very start. Rigorous science that produces key findings on the influence of sex in preclinical research can guide clinical studies, and ultimately, inform clinical practice for men and women.
NIH has a rich history of inclusion. Factors such as sex/gender, race/ethnicity, and age all affect health. Including women and diverse populations in research (referred to as “inclusion”) is not just a matter of enrolling women and diverse populations in clinical studies, but requires changing norms of how research is designed, long before a volunteer signs up for a study. Learn more about the history of inclusion at NIH.
- Background: A historical overview of the inclusion of women in clinical research at NIH.
- Comprehensive Reports: Full reports on NIH's accomplishments and continuous efforts in monitoring the inclusion of women and minorities as participants in clinical research. The reports, beginning with the 1997 report, include narrative information, aggregate extramural and intramural data tables as well as additional policy information.
- Policy Documents and Reference Materials: This listing provides current policy documents and references related to the inclusion of women in clinical research.
- Outreach Documents: Information on the inclusion, recruitment and retention of women, men and minorities as participants in clinical research. The documents help investigators to understand and comply with the NIH's inclusion policies when planning clinical research studies and submitting an application for NIH funding.
- Notice of Revised NIH Definition of “Clinical Trial”
- New System for Reporting Inclusion Data
- Inclusion of Women and Minorities as Participants in Research Involving Human Subjects – Policy Implementation Page
- Videocast: Clinical Research, Inclusion and You—A Scientific Seminar
- Clinical Trials and You
- Finding a Clinical Trial
- New Funding Opportunity: Administrative Supplements
- News Release: New supplemental awards apply sex and gender lens to NIH-funded research
- Stepping Stones to the Future, ORWH Director’s Blog
- A Conversation Worth Having, ORWH Director’s Blog
- Rock Talk: Considering Sex as a Biological Variable in Research – Your Input is Requested, OER Director’s Blog
- NIH Takes Steps to Address Sex Differences in Preclinical Research, NIH Director’s Statement
- Anne Rancourt, M.P.S.