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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12 Brief Overvew of Constitutional Issues Raised by the Exclusion of Women from Research Trials
12 Brief Overvew of Constitutional Issues Raised by the Exclusion of Women from Research Trials
Pages 84-90
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From page 84... ...
Whether the disparate treatment of these two classes raises constitutional issues depends upon a number of factors: 1. Does the disparate treatment result in any disparate benefits to the two classes?
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From page 85... ...
Robert Levine has amply demonstrated that there has been a paradigm shift in the way in which we view enrollment in research trials Levine, 1988~. While research on human subjects was first viewed as a necessary aspect of public health, and then viewed as a transgression of individual rights tantamount to torture, it has lately come to be viewed as an avenue of access to better medical care for oneself and one's cohort, 1991.
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From page 86... ...
The usual justifications for excluding fertile women from research trials include: male-only data are more homogeneous and therefore more useful; inclusion of women in trials will be unduly costly; government regulation requires the exclusion of women; and the threat to potential fetuses creates a legal and moral imperative to exclude all potentially pregnant women (Merton, V., "The Exclusion of Women from Research Trials," presentation at the Texas Journal of Women and the Law Symposium: New Perspectives on Women, Health and the Law, 5 - March 1993~. Each of these justifications, however, can be shown to be seriously flawed.
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From page 87... ...
Further, even the DHHS regulations, which purport to limit the autonomy of pregnant women on behalf of state interests in fetal outcome, are themselves subject to constitutional scrutiny, as they appear to elevate concerns for fetal well-being over concerns for maternal and female well-being. Although state interest in fetal well-being is certainly permissible (Planned Parenthood of Southeastern Pennsylvania vs.
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From page 88... ...
the policy is narrowly tailored to its goal, neither over- nor underinclusive. To the extent that excluding fertile women burdens the fundamental rights to life and liberty, these policies are subject to the strict scrutiny test.
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From page 89... ...
The question of whether discrimination based upon pregnancy or the capacity to become pregnant is tantamount to gender discrimination has occasioned significant hairsplitting controversy. If government action is gender neutral on its face, e.g., if discrimination based on the capacity to become pregnant is gender neutral because some women, as well as all men, are unable to become pregnant, then despite the discriminatory results of a policy's application, a constitutional violation is demonstrated only if the discrimination is intentional (Personnel Administrator of Massachusetts v.
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From page 90... ...
Thus, in the context of government controlled research, the Equal Protection Amendment would appear to preclude exclusionary policies because they unconstitutionally deny access to a possibly important benefit to many and possibly most women. Research funded entirely by private means is not similarly covered by the amendment, and even limited receipt of governmental Finds may not be sufficient to transform those actions into the sort of"state actions" subject to me amendment (Randall-Baker v.
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