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participation in a clinical trial has consequences beyond the denial of the specific treatment opportunity.8 For example, in the area of HIV research there are tangible advantages attached to participation as a research subject for members of the population likely to be at risk, advantages such as improved access to care. In some cases treatment modalities for those who have "failed" with standard medications have only been available within protocol.

In citing these advantages of participation in research for a specific subgroup of women of reproductive age, I open myself to the charge that I am inviting race, sex, and class-based exploitation. Yet it is a canon of research ethics that the benefits as well as the burdens of research should be equitably distributed. Further, the practical implications of exclusion of younger women from clinical trials help to highlight the import of my more general claim, that the class of women of reproductive potential should not be excluded from participation as subjects in research.

Here, then, is a summary of my conclusions:

  1. The class of women of reproductive age should be presumed as eligible for enrollment in research.

  2. The burden of argument in particular cases should rest on showing that the balance of risks and benefits is patently unacceptable, including harm to the subject's reproductive system without offsetting benefits to the subject.

  3. In all other cases the informed consent process should enable the woman to be the ultimate decision maker concerning the acceptability of risks.9

An important by-product of these considerations could be a more cautious approach to the investigation and use of drugs in males of reproductive potential.

NOTES

1.  

Levine, C. 1993. Women as research subjects: New priorities, new questions. In: Emerging Issues in Biomedical Policy: An Annual Review, R.H. Blank and A.L. Bonnicksen, eds. New York: Columbia University Press.

2.  

Dresser R. Wanted: Single, white male for medical research. Hastings Center Report 22(1):24–29.

3.  

National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report. Federal Register 44(76):23192–23197.

4.  

Levine R. 1986. Ethics and the Regulation of Clinical Research. New Haven: Yale University Press.

5.  

Soyka, L.F., and Joffe, J.M. 1980. Male-mediated drug effects on offspring. In: Drug and Chemical Risks in the Fetus and Newborn, R.H. Schwartz and S.J. Yaffe, eds. New York: Alan R. Liss. Uzych, L. 1985. Teratogenesis and mutagenesis associated with the exposure of human males to lead: A review. Yale Journal of Biology



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