Office of Research on Women's Health (ORWH)
Inclusion of Women and Minorities in Clinical Research
How can we make sure that women and minorities are included in NIH research, as NIH policies and federal law require? What can be done to improve the speed of translating scientific findings into clinical practice, where people receive health care?
Factors such as sex/gender, race/ethnicity, age, and access to care are important in determining if populations may benefit from the results of clinical studies.
Including women and minorities in research (referred to as “inclusion”) is not just a matter of enrolling women and minorities in clinical studies, but requires changing norms of how research is designed, long before a volunteer signs up for a study.
ORWH helps the research community understand the scientific reasoning that underpins the NIH policies, and promotes the benefits of good clinical research practices.
ORWH also focuses on the importance of providing data that can inform both the research community and potential volunteer communities of the trends and shifts in including certain populations in clinical trials. NIH provides this information to Congress, the media, scientific organizations, advocacy groups, and individuals.
While there are a number of challenges—such as balancing scientific needs with the ethics of enrolling pregnant women in clinical research—ORWH and the NIH community stress the importance of including understudied populations and reporting analyses of differences and similarities between groups, as scientifically appropriate.
- Outreach Notebook for the Inclusion, Recruitment, and Retention of Women and Minority Subjects in Clinical Research : Outreach efforts for inclusion, recruitment, and retention of research subjects necessarily span the entire clinical research spectrum, from small observational studies to the largest Phase III clinical trials enrolling thousands. This notebook furnishes advice on inclusion criteria, provides an overview of key elements in recruitment and retention processes, and suggests a number of practical applications, including ethical considerations. Attention to these factors in the design of a research project will assist in the appropriate inclusion of women and minorities in clinical research studies.
- 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.
- 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