study populations” and it was “impossible to determine the impact of the policy.” The resulting public outrage and response by Congress led to many of the developments in the early 1990s discussed below (Carnes et al., 2008). Table 1-1 highlights some of the milestones in women’s health research at the federal level.

The National Institutes of Health Revitalization Act of 1993 (PL 103-43, Subtitle B, “Clinical Research Equity Regarding Women and Minorities”) required that NIH grantees include women and minority groups in human-subjects research and, for clinical trials, “ensure that the trial is designed and carried out in a manner sufficient to provide for a valid analysis of whether the variables being studied in the trial affect women or members of minority groups, as the case may be, differently than other subjects in the trial.”4 Cost was not allowed as an acceptable reason for exclusion. In addition, NIH developed a database to monitor compliance with the law. However, the law for clinical trials applied only to phase III trials.5 The act also formalized the NIH Office of Research on Women’s Health (ORWH), which was established in September 1990, and charged it with reporting on progress related to the law throughout NIH.6 Inclusion guidelines for complying with the law were published in 1994 and effectively stated that “that NIH could not and would not fund any grant, cooperative agreement or contract or support any intramural project … which did not comply with this policy” (NIH Tracking/Inclusion Committee, 2009).

In 2000, a second analysis by GAO documented that NIH had made significant progress toward the goal of including women and minorities in research.

4

The National Institutes of Health Revitalization Act of 1993 essentially reinforced the existing NIH policies but with four major differences: (1) that NIH ensure that women and minorities and their subpopulations be included in all clinical research, (2) that women and minorities and their subpopulations be included in phase III clinical trials in numbers adequate to allow valid analyses of differences in intervention effect, (3) that cost not be allowed as an acceptable reason for excluding these groups, and (4) that NIH initiate programs and support for outreach efforts to recruit and retain women and minorities and their subpopulations as participants in clinical studies (HHS, 2008).

5

According to NIH (2008), phase I trials are “initial studies to determine the metabolism and pharmacologic actions of drugs in humans, the side effects associated with increasing doses, and to gain early evidence of effectiveness; may include healthy participants and/or patients”; phase II trials are “controlled clinical studies conducted to evaluate the effectiveness of the drug for a particular indication or indications in patients with the disease or condition under study and to determine the common short-term side effects and risks”; and phase III trials are “expanded controlled and uncontrolled trials after preliminary evidence suggesting effectiveness of the drug has been obtained, and are intended to gather additional information to evaluate the overall benefit-risk relationship of the drug and provide an adequate basis for physician labeling.”

6

ORWH, in collaboration with the Office of Extramural Research and the Office of Intramural Research, monitors efforts for compliance, including convening a “trans-NIH” Tracking and Inclusion Committee. Inclusion of women and minorities in NIH-supported clinical research is documented by fiscal year in a series of reports, which are available to the public at http://orwh.od.nih.gov/inclusion/inclreports.html (accessed June 17, 2010). ORWH has also helped to develop outreach documents for investigators and study staff of NIH-supported research that include guidance on inclusion, recruitment, and retention of women and minorities in clinical research (ORWH, 2009).



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