| In 1994 the National Institutes of Health
revised and extended their guidelines on the inclusion of women and
minorities as subjects in clinical research. In 1995, the Food
and Drug Administration proposed parallel guidelines. Since a primary
aim of research is to provide scientific evidence leading to a change in
health policy or a standard of care, it is imperative to determine whether
the intervention or therapy being studied affects women or men or members
of minority groups and their subpopulations differently.
The revised guidelines are intended to ensure that all future NIH-supported
biomedical and behavioral research involving human subjects will elicit
information about individuals of both genders and of diverse racial and
ethnic groups and, in the case of clinical trials, to examine differential
effects on such groups.
The new guidelines continue the previous ones, with three major additions.
The new policy requires that, in addition to the continuing inclusion of
women and members of minority groups in all NIH-supported biomedical and
behavioral research, researchers must:
- for Phase III clinical trials, ensure that women and
minorities and their subpopulations are included such that valid analyses
of differences in intervention effect can be accomplished;
- not allow cost as an acceptable reason for excluding these groups;
and,
- initiate programs and support for outreach efforts to recruit
these groups into clinical studies.
Researchers in the Cook County Health system have for some time
been working towards these ends. These new guidelines should lead to increased
opportunities for collaborations between County researchers and those from
academic institutions.
See Also:
NIH:
Guidelines on Inclusion of Women and Minorities in Research
Gender
Differences in the Clinical Evaluation of Drugs (OPRR/FDA)
Inclusion
of Women in Clinical Trials: FDA Guidance
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