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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 for the report were chosen for their special competencies and with regard for appropriate balance.

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.

This project was funded by the Office of Research on Women's Health of the National Institutes of Health (Contract No. NOI-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.

Library of Congress Cataloging-in-Publication Data

Women and health research : ethical and legal issues of including women in clinical studies / Anna C. Mastroianni, Ruth Faden, and Daniel Federman, editors ; Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies, Division of Health Sciences Policy, Institute of Medicine.

p. cm.

Includes bibliographical references and index.

ISBN 0-309-04992-X

1. Women—Health and hygiene—Research—Moral and ethical aspects. 2. Human experimentation in medicine—Moral and ethical aspects. 3. Human experimentation in medicine—Law and legislation. 4. United States. National Institutes of Health Revitalization Act of 1993. I. Mastroianni, Anna C. II. Faden, Ruth R. III. Federman, Daniel D., 1928- . IV. Institute of Medicine (U.S.). Committee on the Ethical and Legal Issues Relating to the Inclusion of Women in Clinical Studies.

[DNLM: 1. Ethics, Medical. 2. Clinical Protocols. 3. Women's Health. 4. Research—United States—legislation. W 20.5 W872 1994]

R853.H8W66 1994

174'.28—dc20

DNLM/DLC

for Library of Congress 93-50549

CIP

Copyright 1994 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America.

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The image adopted as a logotype by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staalichemuseen in Berlin.



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