Women and Health Research Ethical and Legal Issues of Including Women in Clinical Studies: Volume 2: Workshop and Commissioned Papers (1994) / Chapter Skim
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16 Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework
16 Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework
Pages 127-150
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From page 127... ...
This is a worthy topic for study; the charge demands attention. However, our morel analysis of our practices concerning the inclusion of women in clinical research will fail to capture all that it should if we restrict our focus to the charge of exclusion and underrepresentation.
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From page 128... ...
Besides having these practices regarding research into conditions affecting both women and men, our hypothetical society pays relatively little attention to the study of health concerns that me specific to women. In general, then, this hypothetical society fails~ot completely, but to a significant extent-to study research questions appropriate for women.
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From page 129... ...
describe the following study as typical of AIDS research involving women: The study, begs in early 1990, is designed to assess whether the rate of HIV transmission from mother to infant can be reduced by contmnous oral AZI treatment to HIV-infected pregnant women, intravenous AZT durmg childbirth, and oral AZT treatment to the newborn infant. The shady also seeks to evah~ate the safety of AZT for both the pregnant woman and newborn infant.
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From page 130... ...
I shall also assume that these practices concerning the inclusion of women in clinical studies result in inequalities in the quality and availability of care, which have a detrimental impact on women's health. After a two-year study, the Public Health Service Task Force on Women's Health Issues concluded in its 1985 report that "[tithe historical lack of research focus on women's health
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From page 131... ...
THE INJUSTICE OF OUR PRACTICES Are our practices concerning the inclusion of women in clinical studies unjust? The answer, in a word, is yes.
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From page 132... ...
I suggest that we focus on particular considerations that might be offered in arguing for or against our practices concerning the inclusion of women in clinical studies and see why we must conclude, all things considered, that they are unjust. Let's begin by discussing considerations weighing against our practices concerning the inclusion of women.
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From page 133... ...
False universalism has two consequences. First, it makes women invisible in the following sense.
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From page 136... ...
Women must bear the costs of birth control: the inconvenience of acquiring it, which often requires a visit to her doctor for a prescription; the monetary cost of purchasing it; the psychological costs of bearing responsibility for its proper use, which are not inconsiderable especially since our gender norms frown on women who plan for sex; the physical costs of using it, from discomfort to serious health risks. Men needn't bear these costs, but they do reap the benefits of women's sacrifices.
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From page 137... ...
What considerations purport to weigh in favor of our practices concerning the inclusion of women in clinical studies? I shall focus on three such types of considerations.
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From page 138... ...
fetuses affected by the research. In the cases of both actually pregnant women and women of childbearing potential who are not pregnant, regulations deny (or, in the case of nonpregnant women, have until recently denied)
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From page 139... ...
Should we adopt (at least temporarily programs of preferential treatment which allocate a larger share of available resources to studies of women's health than would be allocated by a gender-neutral policy? I shall argue that we should, indeed, adopt a policy of preferential treatment as a remedy for the injustices involved in our practices concerning the inclusion of women in clinical studies.
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From page 140... ...
So we have no reason to believe that programs of preferential treatment are inherently unjust. But what reason do we have to believe that we would be justified in adopting such a program as a remedy for the injustices involved in our practices concerning the inclusion of women in clinical studies?
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From page 141... ...
JUSTICE AND 17IE INCLUSION OF WOMliNIN CLINICAL STUDIES 141
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From page 142... ...
After all, individual women suffer the injustices involved in our research practices not because they are He individuals they are but because they are women. Furthermore, all women just because they are women)
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From page 143... ...
The third reason why a gender-neutral policy cannot correct for the injustices involved in our practices concerning the inclusion of women in clinical studies is that gender-neutrality provides an unacceptable model of what constitutes justice. Gender-neutral policies are premised on the idea that a person's gender is irrelevant from the point of view of justice.
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From page 145... ...
In summary, then, gender-neutral policies fail to meet the demands of justice, while policies of preferential treatment succeed in doing so. Therefore, justice requires that we adopt a policy of preferential treatment in the allocation of resources for research, to remedy the injustices involved in the our practices concerning the inclusion of women in clinical studies.
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From page 146... ...
. we must be satisfied to indicate the troth with a rough and general sketch.39 Furthermore, to object to the adoption of programs of prefer-ential treatment on the grounds that we won't know exactly when those programs have completed their mission is to send the wrong message to society, especially to members of the group that has suffered the injustices in question.40 It is to say, "I know we cannot determine when we have doled out enough preferential treatment to correct for the injustices in question.
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From page 147... ...
However, it is beyond the scope of this paper to do a fine-grained analysis of the ways in which our practices concerning the inclusion of women in clinical studies has affected women of particular subgroups. For some comments on these issues, see Susan Sherwin, "Women in Clinical Studies: A Feminist View," in this volume, a presentation to the March 2~25, 1993, workshop sponsored by the Institute of Medicine Committee on the Legal and Ethical Issues Relating to the Inclusion of Women in Clinical Studies (hereafter, simply the IOM workshop)
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From page 148... ...
24. But notice that they specify different aspects of our social conception of men and women than does false universalism.
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From page 149... ...
However, at least until recently, similar regulations applied to women of childbearing potential who are not pregnant; see Vanessa Merton, "The Impact of Current Relevant Federal Regulations on the Inclusion of Female Subjects in Clinical Studies," a presentation for the above mentioned workshop, in this volume. On March 24, 1993, the FDA announced a change in policy concerning the inclusion of women of childbearing potential in drug trials.
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From page 150... ...
Instead, as I mentioned above, discussions of this "backward-looking" function of preferential treatment tend to characterize it as compensation to individuals for past injustices. As I also discussed above, I think it is more appropriate to frame the issue in terms of making amends to groups for past and present injustices.
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