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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies
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Anna C. Mastroianni, Ruth Faden, and Daniel Federman; eds. 247 pages. Washington, D. C.: National Academy Press; 1994.
Historically, health care research has been largely directed by and done on men, and the knowledge gained has been extrapolated to and applied to women. Numerous examples of differences between men and women in the incidence of disease, biodisposition of drugs, and response to therapy show the shortcomings and contradictions of this well-intentioned but flawed practice. Women of childbearing age, in particular, have generally been excluded as research subjects by the government and the pharmaceutical industry, although for different reasons. Before 1993, guidelines from the National Institutes of Health (NIH) and the Food and Drug Administration (FDA) sought to protect women from exposure to potentially fetotoxic agents; the pharmaceutical industry shared this concern but was also motivated to avoid expensive reproductive toxicology studies—a usual prerequisite for including women of childbearing age in clinical trials. Thus, forces of exclusion were formidable, and ways to include women in health research safely and equitably has been the subject of recent public debate.
This book is a collection of papers by a distinguished group of scientists, ethicists, lawyers, and health care providers who participated in, or were invited to submit papers to, a workshop sponsored by the Institute of Medicine in March 1993. It follows an earlier Institute of Medicine report compiled by 16 experts. The strength of this publication, and presumably of the workshop, is the multidisciplinary depth of the participants and authors. Informative and insightful papers discuss the historical basis for excluding women from health research; the ethical issues related to inclusion of pregnant women and women of childbearing age; the recruitment and retention of women in clinical studies; the status of federal regulations pertaining to women as study participants; and particular issues that affect women from ethnic minorities. Several reviews are refreshingly outside the usual palaver of physicians, particularly those that address concepts of equity and social justice in modern society.
The common thread in nearly all of the position papers is that women, like men, should have the right to choose—to be given accurate information regarding potential risks and benefits of experimental treatment—to provide informed consent. The recommendations of this group and of the Institute of Medicine have already affected health research policy: new FDA and NIH guidelines issued after this symposium have encouraged and mandated wider participation of women in clinical studies.
As one author points out, equitably including women in health care research is like navigating between Scylla and Charybdis. On the one hand, it is not equitable to exclude women from the process; on the other, it may not be ethical to expose women to real biological risk. This book will provide a valuable framework to help policymakers and institutional review board members steer this delicate course.
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