Office of Research on Women's Health

Inclusion of Women in Research

The establishment and implementation of policies for the inclusion of women and minorities in clinical research funded by the National Institutes of Health (NIH) has its origins in the women's health movement. Following the issues of the report of the Public Health Service Task Force on Women's Health in 1985, the NIH established a policy in 1986, which urged the inclusion of women in clinical research. Later, in a later 1987 version of the NIH guide, a policy encouraging the inclusion of minorities in clinical studies was first published.

The Congress made what had previously been policy into public law through a section in the NIH Revitalization Act of 1993 (PL 103-43). The Revitalization Act essentially reinforced the existing NIH policies with four major differences:

  • NIH ensures that women and minorities are included in all human subject research;
  • Phase III clinical trials inclusion of Women and minorities in numbers adequate to allow for valid analyses of differences in intervention effect;
  • Cost is not allowed as an acceptable reason for excluding these groups; and,
  • NIH initiates programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as volunteers in clinical studies

This section provides links to the following information:

  • Background: This page provides an historical overview of the inclusion of women in clinical research at NIH
  • Comprehensive Reports (1997 - Present): This page contains the 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: A listing of current policy documents and references related to the inclusion of women in clinical research.
  • Outreach documents: This page provides 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.
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