Throughout this paper I shall talk about women as a group. I realize that the group of women is not a homogeneous one; there are many subgroups, created by the multiple group memberships of individual women (e.g., memberships in a particular race, economic class, etc.). 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 24–25, 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).

I shall use the terms "clinical research" and "clinical studies" interchangeably. The Institute of Medicine Committee on the Legal and Ethical Issues Relating to the Inclusion of Women in Clinical Studies defines the term "clinical studies'' broadly to include, among other things, "epidemiological studies, health services research and outcomes research, as well as randomized clinical trials" (letter from Anna Mastroianni, Study Director, on file with author). Hence, I, too, shall use the term broadly.

See, for example, Rebecca Dresser, "Wanted: Single, White Male for Medical Research," Hastings Center Report, January—February 1992; Paul Cotton, "Examples Abound of Gaps in Medical Knowledge Because of Groups Excluded from Scientific Study," Journal of the American Medical Association, vol. 263, no. 8, Feb. 23, 1990; and Paul Cotton, "Is There Still Too Much Extrapolation From Data on Middle-aged White Men," Journal of the American Medical Association, vol. 263, no. 8, Feb. 23, 1990.

See Ruth Faden, Nancy Kass, and Deven McGraw, "Women as Vessels and Vectors: Lessons from the HIV Epidemic" (in press), for an excellent discussion of this problem.

See NIH/ADAMHA Inclusion of Minorities and Women as Subjects in Research: Grants and Cooperative Agreement Applications, 1992.

Cotton, "Is There Still Too Much Extrapolation From Data on Middle-aged White Men?" p. 1049; the quotation is from a letter to the General Accounting Office from Rep. Olympia Snowe and Rep. Patricia Schroeder (co-chairs of the Congressional Caucus on Women's Issues), which Cotton quotes.

See General Considerations for the Clinical Evaluation of Drugs, U.S. Food and Drug Administration, 1977. On March 24, 1993, the FDA announced a change in policy concerning the inclusion of women of childbearing potential in drug trials. This change in policy is an attempt to switch the presumption from one of exclusion to one of inclusion.

E.L. Kinney et al., "Underrepresentation of Women in New Drug Trials," Annals of Internal Medicine, vol. 95, no. 4, 1981.