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 women and men.
NIH has a rich history of inclusion. Factors such as sex/gender, race/ethnicity, age, and access to care 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 NIH's inclusion policies when planning clinical research studies and submitting an application for NIH funding.
- ORWH National Women’s Health Week 2015 Panel Event: Meet the Faces of Clinical Research — Beyond Inclusion. View Resources: Recorded Video | NIH Record Article | Agenda | Speaker Bios
- Highlighted Clinical Trial Participation and Inclusion, Resources from Across NIH
- 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
- ORWH Director’s Blog: Considering Sex as a Biological Variable: in the NIH Guide
- NIH Guide Notice: Consideration of Sex as a Biological Variable in NIH-funded Research
- NIH Guide Notice: Enhancing Reproducibility through Rigor and Transparency
- Consideration of Sex as a Biological Variable in Biomedical Research: Analysis of Public Comments , Request for Information (RFI) Report
- Hey, Medicine: Stop Ignoring the Existence of Women, External Web Site Policy, OZY
- Video: Expert Interviews
- Top-to-Bottom Sex Bias in Labs Skews Results, Top 100 Stories of 2014, Discover magazine
- Learn more! Methods and Techniques for Integrating the Biological Variable Sex in Preclinical Research
- New course offering! Learn about sex and gender’s role in health care with no-cost CME/CNE/CPE courses
- Questions & Answers
- Nature Comment: NIH to balance sex in cell and animal studies
- ORWH Communications