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Women and Health Research

Ethical and Legal Issues of Including Women in Clinical Studies

Volume 2

Workshop and Commissioned Papers

; Editors: Anna C. Mastroianni, Ruth Faden, and Daniel Federman.

Washington (DC): National Academies Press (US); .
ISBN-10: 0-309-05040-5

There is a growing perception that biomedical research has focused more on the health problems of men relative to those of women and that women have been denied access to advances in medical diagnosis and therapy as a result of being excluded from clinical studies.

Women and Health Research, Volume 2, addresses issues connected with women's participation in clinical studies: ethical issues related to recruitment, retention, and the inclusion of pregnant women and other women of childbearing age; legal issues such as liability, compensation for injury, constitutional concerns, and federal regulations; and health consequences associated with exclusion or underrepresentation.

The commissioned papers focus on the research participation of women from specific racial and ethnic groups and on whether women have been underrepresented in biomedical research, based on a systematic survey of clinical studies reported in a prominent medical journal.


This project was funded by the Office of Research on Women's Health of the National Institutes of Health (Contract No. N01-OD-2-2119) with supplemental support provided by the Ford Foundation (Grant No. 935-1335). Syntex (U.S.A.), Inc., and the Institute of Medicine also provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible

This report has been reviewed by a group other than the authors according to procedures approved by a Report Review Committee consisting of members of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

The Institute of Medicine was chartered in 1970 by the National Academy of Sciences to enlist distinguished members of the appropriate professions in the examination of policy matters pertaining to the health of the public. In this, the Institute acts under both the Academy's 1863 congressional charter responsibility to be an adviser to the federal government and its own initiative in identifying issues of medical care, research, and education. Dr. Kenneth I. Shine is president of the Institute of Medicine.

Copyright 1994 by the National Academy of Sciences. All rights reserved.
Bookshelf ID: NBK236574PMID: 25144106DOI: 10.17226/2343


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