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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers (1999)
Institute of Medicine (IOM)

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers

National Academy Press
2101 Constitution Avenue, N.W. Washington, D.C. 20418

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.

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.

International Standard Book Number 0-309-05040-5

Volume 1 of Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies and additional copies of Volume 2 are available for sale from the
National Academy Press,
2101 Constitution Avenue, N.W., Box 285, Washington, D.C. 20055. Call 800-624-6242 or 202-334-3313 (in the Washington Metropolitan Area).

B313

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 Staatlichemuseen in Berlin.

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Front Matter (R1-R14)
1 Women's Participation in Clinical Research: From Protectionism to Access (1-10)
2 Women in Clinical Studies: A Feminist View (11-17)
3 Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (I) (18-22)
4 Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trial (II) (23-28)
5 Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials (29-34)
6 Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (I) (35-40)
7 Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (II) (41-44)
8 Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations (45-51)
9 Recruitment and Retention of Women of Color in Clinical Studies (52-56)
10 Recruitment and Retention of Women in Clinical Studies: Ethical Considerations (57-64)
11 Impact of Current Federal Regulations on the Inclusion of Female Subjects in Clinical Studies (65-83)
12 Brief Overvew of Constitutional Issues Raised by the Exclusion of Women from Research Trials (84-90)
13 Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies (91-102)
14 Liability Exposure When Offspring Are Injured Because of Their Parents' Participation in Clinical Trials (103-112)
15 Compensation for Research Injuries (113-126)
16 Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework (127-150)
17 Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992 (151-173)
18 Racial Differentials in Medical Care: Implications for Research on Women (174-191)
19 Health Status of American Indian and Alaska Native Women (192-215)
20 Ethical and Legal Issues Relating to the Inclusion of Asian/Pacific Islanders in Clinical Studies (216-231)
21 The Inclusion of Latino Women in Clinical and Research Studies: Scientific Suggestions for Assuring Legal and Ethical Integrity (232-240)
Appendix: Author Biographies (241-248)