Reversing the presumption: the IOM report on women in health research.

On February 24, 1994, the Institute of Medicine (IOM) released its report entitled Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies. That report highlighted principles of justice in calling for the inclusion of women in clinical studies. This article addresses one key feature of the report, the controversial recommendation that pregnant and lactating women be considered eligible for enrollment in clinical studies. This recommendation of the report effectively reverses the previously existing presumption that excluded pregnant women from most clinical studies and severely restricted enrollment of women of "childbearing potential." The committee explicitly rejected a view of pregnant women as "vulnerable," along with the paternalism inherent in denying women of childbearing potential the same autonomy granted to other competent adults enabling them to decide whether to volunteer as research subjects. The ethical principles used by the committee in reaching these conclusions are described.