research in women’s health. Women as advocates, research subjects, researchers, clinicians, administrators, and US representatives and senators played a major role in building a women’s health movement.

Government Activities

In 1986, NIH established a policy for the inclusion of women in clinical research;1 guidelines for the implementation of the policy were included in its 1987 Guide to Grants and Contracts. A similar policy encouraging enrollment of minority-group members was issued in 1987 (ORWH, 2009). Before that, little clinical research on women’s health was conducted, for reasons that included concern about ethical issues of possible fetal exposure to an experimental substance, the variability in hormonal status in women, comorbidities, the assumption that results of research on men could be extrapolated to women, and legal issues. Several developments led to a questioning of the exclusion of women from clinical trials: with the onset of the epidemic of the acquired immunodeficiency syndrome, clinical trials explicitly solicited only men, thereby denying to women the potential of a life-saving treatment; results of clinical trials in men were not being extrapolated to women, as seen in the initial unequal application of stents, beta blockers, and cholesterol-lowering drugs; and the male model did not always corresponds to health and disease status in women, especially with regard to cardiovascular disease (McCarthy, 1994; Merkatz and Junod, 1994). As a result of congressional inquiries, particularly from the bipartisan Congressional Caucus on Women’s Issues (Carnes et al., 2008), in the early 1990s the General Accounting Office2 (GAO) reviewed how well NIH had implemented its 1986 policy3 to encourage the inclusion of women in research study populations (GAO, 1990). GAO found that the policy was not well communicated within NIH or the research community; there were inconsistencies in application of the policy in the grant-review process; the policy applied only to extramural research, and the smaller intramural research program had no policy; and NIH officials took little action to encourage researchers to analyze results by sex. GAO also concluded that there was “no readily accessible source of data on the demographics of NIH

1

NIH definition of clinical research: “1. Patient-oriented research. Research conducted with human subjects (or on material of human origin such as tissues, specimens and cognitive phenomena) for which an investigator (or colleague) directly interacts with human subjects. Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual. Patient-oriented research includes: a. Mechanisms of human disease, b. Therapeutic interventions, c. Clinical trials, and d. Development of new technologies. 2. Epidemiologic and behavioral studies. 3. Outcomes research and health services research” (HHS, 2009).

2

In 2004, the agency name was changed to Government Accountability Office.

3

According to GAO (1990), “although the policy first was announced in October, 1986, guidance for implementation was not published until July, 1989, and the policy was not applied consistently before the 1990 grant review cycles.”



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