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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



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

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

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

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

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

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

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers Contents     WORKSHOP PAPERS         Women's Participation in Clinical Research: From Protectionism to Access Tracy Johnson and Elizabeth Fee   1     Women in Clinical Studies: A Feminist View Susan Sherwin   11     Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (I) John Robertson   18     Ethical Issues Related to the Inclusion of Pregnant Women in Clinical Trials (II) Bonnie Steinbock   23     Ethical Issues Related to the Inclusion of Women of Childbearing Age in Clinical Trials Jonathan D. Moreno   29

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers     Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (I) Carol S. Weisman and Sandra D. Cassard   35     Health Consequences of Exclusion or Underrepresentation of Women in Clinical Studies (II) Leslie Z. Benet   41     Recruitment and Retention of Women in Clinical Studies: Theoretical Perspectives and Methodological Considerations Diane B. Stoy   45     Recruitment and Retention of Women of Color in Clinical Studies Janet L. Mitchell   52     Recruitment and Retention of Women in Clinical Studies: Ethical Considerations Robert J. Levine   57     Impact of Current Federal Regulations on the Inclusion of Female Subjects in Clinical Studies Vanessa Merton   65     Brief Overview of Constitutional Issues Raised by the Exclusion of Women from Research Trials R. Alta Charo   84     Liability Exposure for Exclusion and Inclusion of Women as Subjects in Clinical Studies Ellen Flannery and Sanford N. Greenberg   91     Liability Exposure When Offspring Are Injured Because of Their Parents' Participation in Clinical Trials Ellen Wright Clayton   103     Compensation for Research Injuries Wendy K. Mariner   113

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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 2 - Workshop and Commissioned Papers     COMMISSIONED PAPERS         Justice and the Inclusion of Women in Clinical Studies: A Conceptual Framework Debra A. DeBruin   127     Women's Representation as Subjects in Clinical Studies: A Pilot Study of Research Published in JAMA in 1990 and 1992 Chloe E. Bird   151     Racial Differentials in Medical Care: Implications for Research on Women Vanessa Northington Gamble and Bonnie Ellen Blustein   174     Health Status of American Indian and Alaska Native Women Barbara W. Lex and Janice Racine Norris   192     Ethical and Legal Issues Relating to the Inclusion of Asian/Pacific Islanders in Clinical Studies Elena S. H. Yu   216     The Inclusion of Latino Women in Clinical and Research Studies: Scientific Suggestions for Assuring Legal and Ethical Integrity Ruth E. Zambrana   232     APPENDIX Author Biographies   241

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

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