PREGNANT WOMEN SHOULD BE ELIGIBLE FOR CLINICAL TRIALS

PREGNANT WOMEN SHOULD BE ELIGIBLE FOR CLINICAL TRIALS assuming that adequate information about the risks and benefits of participation is provided, the Institute of Medicine recommends in a Feb. 24 report entitled "Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies."

In a departure from current HHS policy regarding pregnant women and clinical trials, the IoM panel "was unanimous in the view that pregnant women should be presumed to be eligible for participation in clinical studies," the report says. The committee suggests that women should be "treated as competent adults capable of making their own decisions about participation in research." To facilitate the inclusion of pregnant women in trials, IoM asserts that a "strengthened informed consent process can address specific concerns" regarding their participation.

The IoM panel added that "it is not advocating active recruitment of pregnant women into each and every clinical study. Rather, it is urging that the prevailing presumption regarding the participation of pregnant women in clinical trials and other intervention studies be shifted from one of exclusion to one of inclusion." Furthering the committee's policy of inclusion, IoM recommends that both women of childbearing age and women who are lactating also be eligible for clinical study.

Pregnant women may be excluded from trials, the committee said, when the investigators and Institutional Review Boards determine "there is no prospect of medical benefit" and when a "risk of significant harm to potential offspring is known or can be plausibly inferred."

HHS regulations stipulate that pregnant women may not be research subjects except under limited circumstances. FDA recently proposed new guidelines that would lift the ban on inclusion of women of child bearing potential in clinical trials. The new guidelines leave unresolved the issue of inclusion of pregnant women ("The Pink Sheet" July 26, 1993, T&G-4).

The IoM report was requested by the National Institutes of Health's Office of Research on Women's Health. The 16-member committee began its deliberations in September 1992. The panel was chaired by Ruth Faden, PhD, Johns Hopkins and Daniel Federman, MD, Harvard Medical School. The committee was asked to consider the ethical and legal implications of broader policies governing women in clinical trials.

A more inclusive policy for women in clinical studies raises the potential for additional liability concerns. In the report, IoM "recommends that current and future initiatives toward general tort reform include attention to issues of research-related injury, including issues of proof of causation." The IoM report states: "On balance, however, the committee concludes that liability concerns should not represent an impediment to implementation of public policies that favor the broader inclusion of women in clinical studies."