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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.