Women of childbearing potential in clinical research: perspectives on NIH policy and liability issues.

For many years there has been a presumption that women of childbearing age are to be automatically excluded from clinical studies. This approach has led to continued gaps in our scientific knowledge, as important information about metabolic activity and drug interactions in this group of subjects is not readily available. As a result, there is the possibility that drugs may be marketed with undetected side effects, or that the benefit of potential treatments may be delayed for women who may not have access to novel interventions as early in the research process as their male or infertile female counterparts. In the past government regulations have emphasized the ethical principles of beneficence and respect for persons in protecting subjects from risks and assuring their right NOT to participate in research studies.1 This has not changed. But we now also recognize the important ethical principle of justice with regard to who receives the benefits of clinical research and in assuring an individual's right TO participate in research. As a result, investigators are now encouraged to use fertile women earlier in clinical trials. Such a change in thinking represents a major landmark. The new NIH requirements to include women as research subjects reflect the most recent changes in accepted standards of practice. In this article, we describe the experience of the National Institutes' of Health (NIH) in developing and implementing its policy regarding the representation of women as research subjects, address the relevance of this policy to women of childbearing potential and pregnant women, and consider the liability implications of their inclusion in research studies.