Mastroianni, Anna C. Faden, Ruth Federman, Daniel, eds., Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Report of the Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, Division of Health Sciences Policy, Institute of Medicine (Washington, D.C.: National Academy Press, Vol. I, 1994), p. 204.Google Scholar

Actually, two volumes. The IOM also published Volume II, a collection of the background papers commissioned by the IOM committee. It, too, is a handy reference tool. Although I have no reason to think that any reader of this review will care, in the interest of full disclosure I should add that I wrote and presented one such paper to the committee.Google Scholar

58 Fed. Reg. 39,406 (July 22, 1993).CrossRefGoogle Scholar

42 U.S.C.A. § 201 (West Supp. 1993).Google Scholar

59 Fed. Reg. 14508 (March 28, 1994), originally published at 59 Fed. Reg. 11146 (March 9, 1994).Google Scholar

Although technically outside its mandate, not least among the virtues of the report is its pervasive acknowledgment of the interplay of race and ethnicity, class, and economic status with the role of gender in the recruitment and retention of human subjects. Barriers to participation in clinical research by people of color have more often been implicit and circumstantial than the express exclusion of pregnable women, but the impact, in terms of lack of relevant research and access to enhanced care, is similar. The report points out that the Revitalization Act's strategy of aggregating all non-European-American people into one vast category of “minorities” is scientifically unsound and perpetuates a “white norm” as pernicious as the “male norm” discussed below. Mastroianni, Faden, and Federman, supra note 1, at 116–17.Google Scholar

Mastroianni, Faden, Federman, , supra note 1, at 136.Google Scholar

NIH Guidelines, supra note 5, at § V(C) and (D), 59 Fed. Reg. at 14511.Google Scholar

The FDA recognizes three stages of pre-approval clinical research: Phase I, in which a small number of healthy volunteers are challenged with varying doses of drug to establish safety and dosage ranges; Phase II, when a few hundred subjects receive the drug and begin to evaluate clinical efficacy and side-effects; and Phase III, large-scale trials in thousands of patients intended to demonstrate definitively therapeutic value and elicit longer-term adverse effects. See Kessler, David, “The Regulation of Investigational Drugs,” New Engl. J. Med., 320 (1989): 282–83; and Mastroianni, Faden, Federman, , supra note 1, at 30–34.CrossRefGoogle Scholar

NIH Guidelines, supra note 5, at § III(B), 59 Fed. Reg. at 14509. See also id. at § V(C) and (D), 59 Fed. Reg. at 14511.Google Scholar

Mastroianni, Faden, Federman, , supra note 1, at 104.Google Scholar

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Mastroianni, Faden, Federman, , supra note 1, at 105.Google Scholar

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See Eichler, Margaret Reisman, Anna Lisa Borins, Elaine Manace, “Gender Bias in Medical Research,” Women and Therapy, 12, no. 4 (1992): 61–71; Elks, Martha L., “The Right to Participate in Research Studies,” Journal of Laboratory and Clinical Medicine, 122, no. 2 (1993): 130-36; Williams, Karen Manace Borins, Elaine F., “Gender Bias in a Peer-Reviewed Medical Journal,” Journal of the American Medical Women's Association, 48, no. 5 (1993): 160-62; and Meinert, Curtis, “Memo to Co-Chairs of IOM Committee on the Legal and Ethical Issues Relating to the Inclusion of Women in Clinical Studies,” cited in Mastroianni, Faden, Federman, , supra note 1, at 58 and 73.CrossRefGoogle Scholar

One especially intriguing study of all articles reporting on clinical trials in two years' worth of JAMA found that single-gender clinical trials differed systematically by whether the reported reason for the single-gender design was actual disease prevalence or convenience for the researcher. In the case of protocols including only women, 75 percent were studying a medical condition that occurs only in women. Of the male-only protocols, 41 percent were studying a male-only condition, and 47 percent recruited only men because of their presence at convenient sites for recruitment. Convenience was the primary factor in only 8 percent of the female-only studies. Bird, Chloe E., “Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992,” in Mastroianni, Faden, Federman, , supra note 1, Vol. II, pp. 151–73.Google Scholar

I appreciate the political adroitness of this approach, but quibble with it on two grounds. First, it tends to undercut the appeal of claims for compensatory justice, affirmative action if you will, to rectify past abuse. Second, the psychodynamics of social change are accelerated by a sense of responsibility for an unsatisfactory status quo. As the report notes in an analogous context, “Knowledge of the history of health research in relevant racial and ethnic groups…will enable researchers to avoid perpetuating the problem.” Mastroianni, Faden, Federman, , supra note 1, at 125.Google Scholar

The historic neglect of questions important to women's health, whatever its provenance, cannot be fully alleviated by a new era of formal equality, especially one characterized by the lip-service compliance of resentful researchers doubtful that any inequity ever existed. Here the IOM committee and I part company; its Statement of Guiding Principles of Justice provides that, even if it can be demonstrated that specific groups have not received a fair share of research resources in the past, that fact may, but need not, dictate preferential consideration of the health needs of those groups in setting national research goals. The committee failed to articulate exactly why, once prior inequity is not just posited but also proven, catch-up resource allocation would be unfair or unwise.Google Scholar

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Id. at 88.Google Scholar

Id. at 93–94.Google Scholar

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Hamilton, Jean A., “How to Include Women in Clinical Trials: Debate in the U.S. and International Implications,” to appear in Sargent, C. Bretell, C., eds., Gender and Health: An International Perspective (1995).Google Scholar

See, e.g., Nadel, Mark V., “National Institutes of Health: Problems in Implementing Policy on Women in Study Populations” (Testimony before the House Subcommittee on Health and the Environment, General Accounting Office GAO/T-HRD-90-38, June 19, 1990).Google Scholar

See Merton, Vanessa, “The Exclusion of Pregnant, Pregnable, and Once-Pregnable People (a.k.a Women) from Biomedical Research,” Am. J. L. & Med., 19, no. 4 (1993): Note 15, at 373–74.Google Scholar

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Hamilton, , supra note 23, at 18.Google Scholar

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See FDA Guideline, supra note 3; Merton, supra note 25, at 394–96; and Mastroianni, Faden, and Federman, supra note 1, at 139–40.Google Scholar

Mastroianni, Faden, Federman, , supra note 1, at 104.Google Scholar

Id. at 113.Google Scholar

Id. at 110–11.Google Scholar

Id. at 110–13.Google Scholar

Which is not to suggest that I have a better idea. I commend the committee members for getting their hands dirty with an issue like “male bias” that they easily could have sidestepped. The problem has far more to do with real reform of the research enterprise than crunching the numbers of female and male enrollment. It is no surprise that the committee had trouble coming up with a convincing solution.Google Scholar

Merton, , supra note 25, at 396.Google Scholar

Mastroianni, Faden, Federman, , supra note 1, at 193.Google Scholar

Id. at 175.Google Scholar

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Id. at 200.Google Scholar

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Id. (emphasis added).Google Scholar

Id. at 198.Google Scholar

Id. at 152.Google Scholar

Id. at 150.Google Scholar

Id. at 169.Google Scholar

Id. at 81 (emphasis added).Google Scholar