while the results are not yet available, it is expected that the level of women's participation in clinical studies will be significant.

The challenge for those involved in clinical research is how to achieve full implementation of these policies in a way that enhances the overall research enterprise, while simultaneously dealing with the apparent theoretical, methodological, and regulatory complications they pose for investigators, sponsors, peer review and regulatory bodies, and research participants. Of particular relevance to this report is the challenge of anticipating and resolving the social, ethical, and legal dilemmas that may arise in the attempt to achieve equity in our pluralistic society. For example, both the revised guidelines from NIH on the inclusion of subpopulations in research studies and the provisions of the NIH Revitalization Act of 1993 (the "Act") requiring that each NIH-funded study include representative samples of subpopulations unless their absence is justified, have caused concern among many people, including the members of this committee, about the feasibility and cost of conducting clinical studies in accordance with these new mandates.

An important consequence of implementing the demands of justice in the context of clinical research is the improvement of scientific knowledge and the ability to address the health problems of all peoples. The Act clearly is intended to promote this goal by changing the prevailing presumption to one of inclusion. The Act requires investigators to both justify any gender or racial or ethnic exclusions and identify and analyze gender differences. The committee fully endorses the spirit of these requirements. Investigators should be obligated to be inclusive in their recruitment practices and to justify any departure in the composition of their study populations from what might be expected given the characteristics of the problem under investigation. The committee is concerned, however, that if the act is too rigidly interpreted, it will make costly and undue demands on the scientific research process and impede the implementation of its noble goal. The committee has offered specific recommendations intended to ensure that questions of justice and inclusion are a top priority at every level of the research process. The committee does not believe that the interests of justice in advancing the health of all people are best served by a requirement that every clinical trial be large enough to conduct valid analyses of every relevant subgroup comparison. As reflected in the committee's guiding principles I and 2, (see Chapter 3), the ultimate burden for achieving justice falls on the national research agenda as a whole and cannot be implemented by a mechanical approach to the selection of subjects on a study-by-study basis.

The preceding chapters have laid out the rationale and guiding principles for including greater numbers of women in clinical studies; they also identified the considerations-ethical, scientific, social, and legal-that might impede the achievement of this goal. In the process of presenting this mate-



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