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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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E
Committee Biographies

Ruth Faden, Ph.D., M.P.H., is Professor and Director of the Program in Law, Ethics, and Health at the Johns Hopkins University School of Hygiene and Public Health. She is also Senior Research Scholar at the Kennedy Institute of Ethics at Georgetown University. Dr. Faden received her Ph.D. in 1976 and her M.P.H. in 1973, both from the University of California at Berkeley. She is a member of the American Association of Bioethics and the American Psychological Association, and has served on the Governing Council of the American Public Health Association. Dr. Faden has also served on a number of advisory committees, including those for the National Academy of Sciences, Social Science Research Council, Office of Technology Assessment, National Institutes of Health, Centers for Disease Control, and as a consultant to the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research and the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. She has authored numerous articles and books, including AIDS, Women and the Next Generation and A History and Theory of Informed Consent (Oxford University Press, 1986 and 1991)

Daniel Federman, M.D., was graduated from Harvard College and Harvard Medical School and had his internship and residency at Massachusetts General Hospital. He conducted research and trained in endocrinology at the National Institutes of Health, the University College Hospital Medical School in London, and Massachusetts General Hospital. He has served as Physi-

Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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cian, Chief of the Endocrine Unit, and Associate Chief of Medical Services at the Massachusetts General Hospital and was later Arthur F. Bloomfield Professor of Medicine and Chairman of the Department of Medicine at Stanford University Medical School. Since 1977 Dr. Federman has served as Dean for Students and Alumni and Professor of Medicine at Harvard Medical School. He is currently Dean for Medical Education and the Carl W. Walter Professor of Medicine and Medical Education. Dr. Federman has served as Chairman of the Board of Internal Medicine and President of the American College of Physicians. He is a member of the Institute of Medicine.

Anita Allen, J.D., Ph.D., is Professor of Law at the Georgetown University Law Center. She received her J.D. from Harvard Law School in 1984 and her Ph.D. in philosophy from the University of Michigan in 1979. She has also served as Visiting Professor of Law at Harvard Law School and Distinguished Visiting Adjunct Professor of Philosophy and Women's Studies at the University of Pennsylvania. Professor Allen is a member of several professional organizations, including the American Association of Law School Teachers, the American Association of University Professors, the American Bar Association, and the American Society for Political and Legal Philosophy. She has published several book chapters and articles and has spoken at numerous conferences and seminars. Professor Allen is admitted to the bar in New York and Pennsylvania.

Hortensia Amaro, Ph.D., is Professor of Social and Behavioral Sciences in the School of Public Health at Boston University. She received her doctorate in developmental and social psychology in 1982 from the University of California at Los Angeles. She has served as a consultant and in various advisory roles to the Surgeon General's Agenda on Hispanic Health, the Centers for Disease Control, the National Institutes of Health, the National Institute on Drug Abuse, and the Center for Substance Abuse Prevention, as well as to foundations and community-based organizations. She is founder and past president of the Latino Health Institute of Massachusetts and founder of the Multicultural AIDS Coalition and the National Hispanic Psychological Association. She has received numerous awards including the Alfred Frechette Award from the Massachusetts Public Health Association, and the American Psychological Association's Early Career Award for Contributions to Psychology in the Public Interest. She serves as associate editor for the Psychology of Women Quarterly and on the editorial board of the American Journal of Public Health. Dr. Amaro's research has focused on epidemiological studies and community-based interventions for substance abuse and HIV among women, and on Hispanic health issues.

Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Karen H. Antman, M.D., is Professor of Medicine and Chief, Division of Medical Oncology, Columbia University. Dr. Antman received her M.D. from Columbia University's College of Physicians and Surgeons. She joined the Harvard Medical School faculty in 1979 and served as the Clinical Director of the Dana-Farber Cancer Institute and Beth Israel Hospital Solid Tumor Autologous Marrow Program and coordinated the sarcoma and mesothelioma clinical research and treatment programs at the Dana-Farber Cancer Institute until 1993. She is an Associate Editor of the New England Journal of Medicine and is on the editorial board of Annals of Internal Medicine. She has consulted for the U.S. Department of Justice on asbestos related malignancies and has served on the Health and Human Services Advisory Board, Study of Coverage for Investigational Therapy and the Physicians Payment Review Commission/American Medical Association Consensus Panel for Evaluation and Management of Services (both in 1989), and on the Harvard Resources Based Relative Value Scale Technical Consulting Panel from 1989 to 1990. She has served on the Board of Directors of the American Society of Clinical Oncology (ASCO) and was Chairman of the Public Issues Committee for the past four years, repeatedly testifying before congressional committees. She is currently President-elect of ASCO. She is an author on more than 100 original reports, 5 editorials, 67 review articles or textbook chapters, and has edited or written 3 textbooks and monographs.

Lionel D. Edwards, MBBS, FFPM, DObst, RCOG, graduated from Guy's Hospital Medical School, London University, and worked in Family Practice, with part-time appointments in Rheumatology and Obstetrics. After 7 years of clinical practice, he joined the pharmaceutical industry, where over the last 19 years he has held various international and U.S. director positions in Clinical Research operations at Roussel, Upjohn, Abbott, Schering Plough Research Institute, and Hoffmann-La Roche. He has been heavily involved in contributing key studies to the Food and Drug Administration and international regulatory authorities on allergy, antibiotic, oncology, cardiovascular, and OTC products. He is Assistant Vice President, International Clinical Research, Hoffmann-La Roche. He is Chairman of the Pharmaceutical Manufacturers Association (PMA) Special Populations Committee and teaches in three different courses for PMA/PERI, and is the PMA ICH representative for the Orlando ICH II meeting for workshop topic 5—Ethnic Factors in the Acceptability of Foreign Data.

Ann Barry Flood, Ph.D., is Director of Policy Studies and Associate Professor at the Center for the Evaluative Clinical Sciences at Dartmouth Medical School. She received her doctorate in Organizational Sociology from Stanford University in 1977. She also served on the staff of the U.S.

Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Senate Finance Committee during 1989 as a Robert Wood Johnson Health Policy Fellow. Dr. Flood's areas of theoretical and policy expertise involve understanding the professional and organizational factors that influence physicians' styles of practice, patients' outcomes, and the costs of health care.

Shiriki K. Kumanyika, Ph.D., M.P.H., is Professor of Epidemiology and Associate Director for Epidemiology at the Pennsylvania State University College of Medicine (Milton S. Hershey Medical Center). She earned her M.S. (1969) in Social Work from Columbia University, a Ph.D. (1978) in Human Nutrition from Cornell University, and an M.P.H. (1984) in Epidemiology from Johns Hopkins University. Before coming to Penn State in 1989 with a primary appointment in nutrition (1989-1992), Dr. Kumanyika held faculty positions in Nutrition and Epidemiology, respectively, at Cornell University and Johns Hopkins University. She is currently principal investigator of a National Institutes of Health (NIH) grant to develop cardiovascular education materials for black American adults with low literacy skills and is a co-investigator on two multicenter trials for hypertension prevention or treatment. Her publications reflect 16 years of research-related to cardiovascular diseases, obesity, nutritional epidemiology, and the health of minority populations, older populations, and women. Dr. Kumanyika currently chairs the National Nutrition Monitoring Advisory Council and serves or has served on several other national task forces and advisory committees, including the NIH Behavioral Medicine Study Section, the NIH Epidemiology and Disease Control Study Section, the NIH Office of Women's Health Research Task Forces on Opportunities for Research in Women's Health and on the Recruitment and Retention of Women in Clinical Studies (which she co-chairs), and the Women's Health Initiative Policy Advisory Committee.

Ruth Macklin, Ph.D. is a Professor in the Department of Epidemiology and Social Medicine at Albert Einstein College of Medicine. She received a B.A. with distinction from Cornell University, and her M.A. and Ph.D. in philosophy from Case Western Reserve University. She has had more than 120 publications in professional journals and scholarly books in philosophy, bioethics, and law and medicine, in addition to articles in magazines and newspapers for general audiences. She is author or editor of seven books, including Mortal Choices, published by Houghton Mifflin in 1988 and Enemies of Patients, published by Oxford University Press in 1993. Her writings explore ethical issues in the clinical practice of medicine, biomedical and behavioral research involving human subjects, health policy, and health law. She is a member of the Institute of Medicine of the National Academy of Sciences, and is a consultant to and board member of several national and international organizations, including the National Institutes of Health, the National Research Council, and the World Health Organization.

Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Donald R. Mattison, M.D. is Dean of the Graduate School of Public Health and Professor of Environmental and Occupational Health and Obstetrics and Gynecology at the University of Pittsburgh. Dr. Mattison received his undergraduate education at Augsburg College, where he majored in Chemistry and Mathematics, and an M.S. in Chemistry from the Massachusetts Institute of Technology. He received his M.D. from The College of Physicians and Surgeons, Columbia University, and clinical training in obstetrics and gynecology at Sloane Hospital for Women, Columbia Presbyterian Medical Center, in New York. Dr. Mattison obtained postgraduate research training at the National Institutes of Health. From 1978 to 1984 Dr. Mattison was director of the Reproductive Toxicology Program in the Pregnancy Research Branch, National Institute of Child Health and Human Development, National Institutes of Health. From 1984 to 1990 he was Professor of Obstetrics and Gynecology and Toxicology at the University of Arkansas for Medical Sciences. During this period he was also Acting Director of the Human Risk Assessment Program at the National Center for Toxicological Research, a component of the Food and Drug Administration. Dr. Mattison has been at the University of Pittsburgh since August of 1990. Dr. Mattison is a member of many local and national boards. He has published more than 140 papers, chapters, and reviews in the areas of reproductive and developmental toxicology, risk assessment, and clinical obstetrics and gynecology.

Charles R. McCarthy, Ph.D., is Senior Research Fellow, Kennedy Institute of Ethics, Georgetown University. Trained in philosophy and political science at the University of Toronto, Dr. McCarthy taught at The Catholic University of America and George Washington University. Employed by the National Institutes of Health (NIH) in 1971, he functioned as Chief of the Legislative Development Branch and Executive Secretary of the NIH Director's Advisory Committee. In 1978 he was appointed Staff Director of the Secretary's Ethics Advisory Board. For the final 14 years of his career at the NIH he served as Director of the Office for Protection from Research Risks. In this capacity he was responsible for providing protection for human research subjects throughout the United States and in 80 nations worldwide, and for the humane care and use of laboratory animals. Dr. McCarthy has written many articles and received a number of honors including the Outstanding Achievement Award from the Secretary of Health and Human Services. Currently he is a member of the Board of Directors of Public Responsibility in Medicine and Research, of the Board of Directors of the Scientists Center for Animal Welfare, of the Ethics Committee of the American Fertility Society, and serves as Ethics Staff Consultant to the Acadia Institute.

Curtis L. Meinert, Ph.D., is Director of the Center for Clinical Trials

Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

at the Johns Hopkins University School of Hygiene and Public Health, where he is also a Professor of Epidemiology and Biostatistics. He received his Ph.D. in Biostatistics from the University of Minnesota in 1964. Throughout his career he has been involved in the design and conduct of more than 20 clinical trials, starting with the University Group Diabetes Program in the 1960s. Recently, he has served as Director of the Coordinating Centers for the Glaucoma Laser Trial and the Hypertension Prevention Trial. He currently heads the Coordinating Center for Studies of Ocular Complications of AIDS. He was a founding member of the Society for Clinical Trials, served on its first Board of Directors, and has been editor of its journal, Controlled Clinical Trials, since its inception in 1980. Dr. Meinert is the Director of the Clinical Trial Training Program and is the co-author of a textbook, Clinical Trials: Design, Conduct, and Analysis (1986, Oxford University Press). His teaching activities include a basic course on the design, conduct, and analysis of clinical trials and numerous intensive, short courses given both on the Johns Hopkins campuses and off campus at governmental agencies located in the Washington, D.C., area. He has been active on the Institutional Review Boards for both the Johns Hopkins Medical School and the School of Hygiene and Public Health and is currently Chair of the Committee on Human Research for the latter. In addition, he has served on advisory review committees and treatment effects monitoring committees for numerous trials both in this country and internationally. Dr. Meinert has also served on numerous National Academy of Science committees. He was also a member of the National Institutes of Health Task Force on Population-Based Research Training. Dr. Meinert has served as a consultant to governmental agencies and private industry and recently was an expert witness for the Federal Trade Commission.

Karen H. Rothenberg, J.D., M.P.A., is Professor of Law, the M. Jacqueline McCurdy Scholar, and Director of the Law and Health Care Program at the University of Maryland School of Law. She received her B.A., magna cum laude, and her M.P.A. from Princeton University, and a J.D. from the University of Virginia. She formerly practiced with the D.C. Law firm of Covington and Burling and has worked a variety of health and medical organizations including serving as legal counsel to the American College of Nurse-Midwives and on a number of National Institutes of Health panels. She is 19931994 president of the American Society of Law, Medicine and Ethics. Professor Rothenberg has written numerous articles on AIDS, women's health, genetic testing, the right to forego treatment, emergency care, and surrogacy, and lectures extensively on legal issues in health care.

Anthony R. Scialli, M.D., is Director of the Residency Program in Obstetrics and Gynecology at Georgetown University Medical Center and is

Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×

Director of the Reproductive Toxicology Center at Columbia Hospital for Women Medical Center, Washington, D.C. He received his M.D. at Albany Medical College and completed a residency in obstetrics and gynecology at George Washington University, following which he took a fellowship in reproductive toxicology with the late Sergio Fabro. Dr. Scialli is the founder and editor-in-chief of the journal Reproductive Toxicology and author of A Clinical Guide to Reproductive and Developmental Toxicology. He has served as a consultant to several government and private organizations on the effects of chemical and physical agents on reproduction, and is an active teacher and researcher in the field of teratology and reproductive toxicology.

Sheldon J. Segal, Ph.D., is a Distinguished Scientist at the Population Council in New York City and was Director for Population Sciences at the Rockefeller Foundation from 1978 through 1991. A Dartmouth graduate, he received his Ph.D. in Embryology and Biochemistry from the University of Iowa and is the recipient of honorary M.D. degrees from the University of Uppsala, Sweden, and the University of Tampere, Finland. Dr. Segal is a senior member of the Institute of Medicine and an honorary member of the Mexican Academy of Medicine and of the Chinese Academy of Sciences. The 1984 Laureate of the United Nations Population Award, he is a leading authority on global population issues, family planning, and contraceptive technology. Dr. Segal serves as advisor to the World Health Organization's Safe Motherhood Programme and is an Adjunct Professor, Department of Pharmacology, Cornell University Medical College. He is Chairman of the Board of Trustees, Marine Biological Laboratory, Woods Hole, Massachusetts, and a Director of the Center for Reproductive Law and Policy.

Walter J. Wadlington, LL.B. is James Madison Professor of Law at the University of Virginia School of Law and Professor of Legal Medicine at the University of Virginia School of Medicine. He was the Program Director of the Robert Wood Johnson Foundation Medical Malpractice Program. He is a member of the Institute of Medicine, the American Law Institute, and the Advisory Committee of the Robert Wood Johnson Clinical Scholars Program. Mr. Wadlington teaches in the areas of law and medicine, family law, and children's health care.

Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
×
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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Page 259
Suggested Citation:"Appendix E: Committee Biographies." Institute of Medicine. 1994. Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1. Washington, DC: The National Academies Press. doi: 10.17226/2304.
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Women and Health Research: Ethical and Legal Issues of Including Women in Clinical Studies, Volume 1 Get This Book
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In the nineteenth century some scientists argued that women should not be educated because thinking would use energy needed by the uterus for reproduction. The proof? Educated women had a lower birth rate. Today's researchers can only shake their heads at such reasoning. Yet professional journals and the popular press are increasingly criticizing medical research for ignoring women's health issues.

Women and Health Research examines the facts behind the public's perceptions about women participating as subjects in medical research. With the goal of increasing researchers' awareness of this important topic, the book explores issues related to maintaining justice (in its ethical sense) in clinical studies.

Leading experts present general principles for the ethical conduct of research on women--principles that are especially important in the light of recent changes in federal policy on the inclusion of women in clinical research.

Women and Health Research documents the historical shift from a paternalistic approach by researchers toward women and a disproportionate reliance on certain groups for research to one that emphasizes proper access for women as subjects in clinical studies in order to ensure that women receive the benefits of research.

The book addresses present-day challenges to equity in four areas:

  • Scientific--Do practical aspects of scientific research work at cross-purposes to gender equity? Focusing on drug trials, the authors identify rationales for excluding people from research based on demographics.
  • Social and Ethical--The authors offer compelling discussions on subjectivity in science, the evidence for male bias, and issues related to race and ethnicity, as well as the recruitment, retention, and protection of research participants.
  • Legal--Women and Health Research reviews federal research policies that affect the inclusion of women and evaluates the basis for researchers' fears about liability, citing court cases.
  • Risk--The authors focus on risks to reproduction and offspring in clinical drug trials, exploring how risks can be identified for study participants, who should make the assessment of risk and benefit for participation in a clinical study, and how legal implications could be addressed.

This landmark study will be of immediate use to the research community, policymakers, women's health advocates, attorneys, and individuals.

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