National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

WOMEN AND HEALTH RESEARCH

ETHICAL AND LEGAL ISSUES OF INCLUDING WOMEN IN CLINICAL STUDIES

VOLUME 2

Workshop and Commissioned Papers

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

NATIONAL ACADEMY PRESS
Washington, D.C. 1994

Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

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.

Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

COMMITTEE ON THE ETHICAL AND LEGAL ISSUES RELATING TO THE INCLUSION OF WOMEN IN CLINICAL STUDIES

RUTH FADEN, Ph.D., M.P.H. (Co-chair), Professor and Director,

Program in Law, Ethics, and Health, School of Hygiene and Public Health, The Johns Hopkins University, and

Senior Research Scholar,

Kennedy Institute of Ethics, Georgetown University

DANIEL FEDERMAN, M.D.* (Co-chair), Professor of Medicine, Dean of Medical Education,

Harvard Medical School

ANITA ALLEN, J.D., Ph.D., Professor of Law,

Georgetown University Law Center

HORTENSIA AMARO, Ph.D., Professor of Social and Behavioral Sciences,

School of Public Health, Boston University School of Medicine

KAREN H. ANTMAN, M.D., Chief,

Division of Medical Oncology, Columbia-Presbyterian Medical Center, New York

LIONEL D. EDWARDS, M.D., Assistant Vice President and Senior Director of Therapeutic Research Operations II,

Hoffmann-La Roche, Inc., Nutley, New Jersey

ANN BARRY FLOOD, Ph.D., Director of Policy Studies and Associate Professor of the Center for the Evaluative Clinical Sciences,

Dartmouth Medical School

SHIRIKI K. KUMANYIKA, Ph.D., M.P.H., Professor of Epidemiology,

Center for Biostatistics and Epidemiology, Pennsylvania State College of Medicine

RUTH MACKLIN, Ph.D.,* Professor of Epidemiology and Social Medicine,

Albert Einstein College of Medicine

DONALD R. MATTISON, M.D., Dean,

Graduate School of Public Health, University of Pittsburgh

CHARLES R. McCARTHY, Ph.D., Senior Research Fellow,

Kennedy Institute of Ethics, Georgetown University, and

Retired Director of the Office of Protection from Research Risks,

National Institutes of Health, Richmond, Virginia

CURTIS MEINERT, Ph.D., Director,

Center for Clinical Trials, and

Professor of Epidemiology and Biostatistics,

School of Hygiene and Public Health, The Johns Hopkins University

KAREN H. ROTHENBERG, J.D., M.P.A., Professor of Law, Director,

Law and Healthcare Programs, University of Maryland School of Law

*  

Member, Institute of Medicine

Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

ANTHONY R. SCIALLI, M.D., Director,

Residency Program, Georgetown University Medical Center, and

Director,

Reproductive Toxicology Center,

Columbia Hospital for Women Medical Center, Washington, D.C.

SHELDON J. SEGAL, Ph.D., Distinguished Scientist,

The Population Council, New York

WALTER J. WADLINGTON, LL.B.,* Professor of Law and of Legal Medicine,

University of Virginia Law School

Study Staff

ANNA C. MASTROIANNI, Study Director

RUTH ELLEN BULGER, Division Director (until August 1993)

VALERIE P. SETLOW, Division Director (from August 1993)

ELIZABETH MEYER BOBBY, Research Associate

THELMA L. COX, Project Assistant

PHILOMINA MAMMEN, Administrative Assistant

*  

Member, Institute of Medicine

Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

Preface

In the fall of 1992, at the request of the National Institutes of Health's (NIH) Office of Research on Women's Health, the Institute of Medicine formed a committee to study the ethical and legal issues relating to the inclusion of women in clinical studies. The NIH's request was coincident with a growing perception that biomedical research had 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. With pressure from women's health advocates mounting and legislative change on the horizon, NIH requested that the committee (1) consider the ethical and legal implications of including pregnant women and women of childbearing potential in clinical studies; (2) provide practical advice for consideration by NIH, institutional review boards, and clinical investigators; and (3) examine known instances of litigation regarding injuries to research subjects and describe issues of legal liability and possible protections. Comprised of sixteen members with expertise in bioethics, law, epidemiology and biostatistics, public health policy, obstetrics and gynecology, clinical research, pharmaceutical development, social and behavioral sciences, and clinical evaluative sciences, the committee held five meetings during the one-year study. Volume 1, Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, contains the committee's final report.

The committee's report begins with an assessment of the claims regarding women's participation in clinical trials; this introduction is followed by a summary of the history of women's participation in clinical research so that readers may gain an understanding of the origins of controversy and concern

Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

surrounding this issue. An analysis of the principles of justice makes up the central chapter of the report. The committee chose to shape its report around considerations of justice in light of its understanding that calls to rectify women's alleged "underrepresentation" in clinical studies are based on concerns about the unequal distribution of the benefits of biomedical research. Subsequent chapters address the various challenges—scientific, social, ethical, and legal—to achieving justice in clinical studies. Each of the recommendations developed in these chapters flows from the central presumption embraced by the committee: that women and men should have the opportunity to participate equally in the benefits and burdens of research.

In an effort to solicit outside expertise on specific issues as well as gather input from interested individuals, the committee held an invitational workshop at the Georgetown University Conference Center on March 24–25, 1993. Speakers were invited by the committee to address such issues as recruitment and retention, liability, compensation, federal regulations, health consequences, and justice as they pertain to women's participation in clinical studies. Each speaker answered questions from the audience—a group of more than forty people from academia, industry, federal health agencies, and Congress.

This volume contains the text of the presentations given at the workshop. The presentation, Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework, by Professor Debra DeBruin, was expanded at the request of the committee, as this issue took on considerable importance in the committee's deliberations and final report. It is noteworthy that on the second day of the workshop, the Food and Drug Administration (FDA) announced its intention to reverse its 1977 guideline recommended the exclusion of women from early phases (Phase I and early Phase II) of drug development. Given the date of this announcement and of the formal issuance of new guidelines (July 22, 1993), the changes in FDA policy are not reflected in the presentations. Nor do the presentations take into account the June 10, 1993, passage of the NIH Revitalization Act, which also effected changes in federal policies regarding the inclusion of women in clinical studies.

Also included in this volume are additional papers commissioned by the committee. These papers address issues that were introduced at the workshop, but about which the committee felt the need for more in-depth analysis. Four of these papers focus on the research participation of women from specific racial and ethnic groups—American Indians, Alaskan Natives, Asian/Pacific Islanders, Blacks, and Latinos. In the fifth paper, the author attempts to answer the question, "Have women been 'underrepresented' in biomedical research?" through a systematic survey of clinical studies reported in the Journal of the American Medical Association.

The committee is indebted to the writers of this volume for their thought-provoking insights and scholarly presentation of opinions and ideas. Their work

Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

stimulated thoughtful discussion, heated debate, and sometimes even consensus. It is the committee's hope that this volume, on its own and in conjunction with Volume 1, proves to be a valuable resource to policymakers, clinical investigators, and subjects alike.

Ruth Faden, Co-chair

Daniel Federman, Co-chair

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
This page in the original is blank.
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
This page in the original is blank.
Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×

WOMEN AND HEALTH RESEARCH

Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
This page in the original is blank.
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R1
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R2
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R3
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R4
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R5
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R6
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R8
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R9
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R10
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R11
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R12
Page xiii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R13
Suggested Citation:"Front Matter." Institute of Medicine. 1999. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers. Washington, DC: The National Academies Press. doi: 10.17226/2343.
×
Page R14
Next: 1 Women's Participation in Clinical Research: From Protectionism to Access »
Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2, Workshop and Commissioned Papers Get This Book
×
Buy Paperback | $55.00 Buy Ebook | $43.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!