Vaccine Safety Research, Data Access, and Public Trust (2005)

John C. Bailar III (Committee Chair), M.D, Ph.D., is Professor Emeritus in the Department of Health Studies at the University of Chicago. He is a retired commissioned officer of the U.S. Public Health Service, and worked for the National Cancer Institute for 22 years. He has also held academic appointments at Harvard University and McGill University. He was editor-in-chief of the Journal of the National Cancer Institute for six years, and was a statistical consultant and member of the editorial board for the New England Journal of Medicine. Dr. Bailar is a member of the International Statistical Institute. He has been the chair of several Institute of Medicine (IOM) and National Research Council (NRC) committees. Dr. Bailar’s research interests include interpreting statistical evidence in medicine, with special emphasis on cancer. He received his M.D. from Yale University and his Ph.D. in statistics from American University. Dr. Bailar is a member of the IOM.

Garnet L. Anderson, Ph.D., is the Co-Principal Investigator of the Women’s Health Initiative Clinical Coordinating Center. She is also a member of the Public Health Sciences Division, the associate program head of the Gynecologic Cancer Program at the Fred Hutchinson Cancer Research Center, and affiliate associate professor in the Department of

Biostatistics at the University of Washington. Dr. Anderson has been affiliated with the Women’s Health Initiative in numerous capacities since 1993. She has served as associate editor of Controlled Clinical Trials and Clinical Journal of Women’s Health. Dr. Anderson’s research interests include the design, analysis, and conduct of clinical trials, data monitoring, survival analysis, women’s health, and ovarian cancer. She received her Ph.D. in biostatistics from the University of Washington.

Stephen E. Fienberg, Ph.D., is Maurice Falk University Professor of Statistics and Social Science at Carnegie Mellon University. He previously was Professor of Statistics and Law at York University. Dr. Fienberg is a fellow of the American Association for the Advancement of Science, the American Academy of Political and Social Science, the American Statistical Association, the Institute of Mathematical Statistics, and the Royal Statistical Society. He has chaired and served on several IOM and NRC committees, including serving as chair of the CNSTAT Subcommittee on Data Sharing that produced the NRC report “Sharing Research Data” in 1985. Dr. Fienberg’s research interests include the development of statistical methodology, especially for problems involving categorical variables; disclosure limitation for statistical databases; statistical methods for large-scale sample surveys, such as those carried out by the federal government; the study of nonsampling errors; and formal parallels in the design and analysis of sample surveys and randomized experiments. He received his Ph.D. in statistics from Harvard University. Dr. Fienberg is a member of the National Academy of Sciences and a fellow of the Royal Society of Canada.

Debra R. Lappin, J.D., is Senior Advisor to B&D Sagamore, a Washington, DC-based public policy firm. Ms. Lappin serves as a consultant to industry, academic research institutions, nonprofit entities, and government on the structure and execution of collaborative cross-sector partnerships, on the development and implementation of public health initiatives, and on mechanisms for public engagement in science and enhancing public trust as an institutional asset. From 1996 to 1998, Ms. Lappin was the Chair of the Arthritis Foundation. She was a charter member of the National Institutes of Health (NIH) Director’s Council of Public Representatives from 1999 to 2003, and chaired its working group on Human Research Protections. Ms. Lappin lectures as an adjunct faculty member in the Department of Medicine, University of Colorado Health Sciences Center, chairs the Ethics Committee at National Jewish Medical and Research Center in Denver, and speaks often on the subject of the new partnership between the public and the scientific enterprise. Ms. Lappin has served on the IOM Committee on the Organizational Structure of the

National Institutes of Health and the Committee on Changing Health Care Systems and Rheumatic Disease. Ms. Lappin received her J.D. from the University of Denver.

Myron M. Levine, M.D., D.T.P.H., is Professor and Director of the Center for Vaccine Development at the University of Maryland School of Medicine. During his 34 years at the University, he has fostered the discipline of vaccinology, focusing on basic research on the pathogenesis of bacterial enteric infections and on the construction of vaccine candidates; clinical research to assess the safety and immunogenicity of candidate vaccines in adult and pediatric populations; and epidemiological field research. Dr. Levine has served on the IOM Committee on the Review of the USDA E. coli 0157:H7 Farm-to-Table Process Risk Assessment, the Steering Committee for the Study on the U.S. Capacity to Address Tropical Disease Problems, and is a member of the Board of the Medical Follow-Up Agency. He received his M.D. from the Medical College of Virginia and completed a pediatric residency and pediatric infectious disease fellowship at the Albert Einstein College of Medicine. Dr. Levine received his D.T.P.H. from the London School of Hygiene and Tropical Medicine. Dr. Levine is a member of the IOM.

Anna C. Mastroianni, J.D., M.P.H., is an Assistant Professor at the School of Law and at the Institute for Public Health Genetics at the University of Washington. Previously, Professor Mastroianni was a practicing health care attorney, Associate Director of the White House Advisory Committee on Human Radiation Experiments, and a study director for the IOM Committee to Study the Legal and Ethical Issues Relating to the Inclusion of Women in Clinical Studies. Her research and teaching focus on health law and bioethics, with specific interests in the legal, ethical, and policy issues related to the responsible conduct of research, human subjects research, public health, the use of genetic technologies, and women’s health. Professor Mastroianni is a fellow of the American Association for the Advancement of Science. She has served on the NRC Committee on Institutional Review Boards, Surveys, and Social Science Research. Professor Mastroianni received her J.D. from the University of Pennsylvania Law School and her M.P.H. from the University of Washington School of Public Health and Community Medicine. She is the author and coauthor of numerous publications on law, ethics, and public health policy.

Colin L. Soskolne, Ph.D., is Professor of Epidemiology in the Department of Public Health Sciences at the University of Alberta, where he has been based since 1985. Following graduate studies, he was Director of the Epi-

demiology Research Unit of the Ontario Cancer Treatment and Research Foundation at the University of Toronto. In 1999, he completed a sabbatical year as Visiting Scientist with the World Health Organization’s European Centre for Environment and Health in Rome, Italy. Dr. Soskolne spearheaded efforts to bring the question of professional ethics into focus for epidemiologists world wide. He was the first to call for ethics guidelines for epidemiologists in his paper in the Journal of Public Health Policy in 1985, and has jointly published ethics guidelines for environmental epidemiologists. He is a fellow and an elected officer in the American College of Epidemiology. Dr. Soskolne’s research interests include professional ethics in epidemiology, the health effects of occupational exposure to acid mists, and ecological disintegrity in relation to human health and well-being. Dr. Soskolne received his Ph.D. in epidemiology from the University of Pennsylvania. He won the Society for Epidemiologic Research annual student prize in 1983 for his Ph.D. thesis.

Elaine Vaughan, Ph.D., is Associate Professor of Psychology in the Department of Psychology and Social Behavior at the University of California, Irvine. She currently is involved in a longitudinal field experiment assessing the effects of participatory decision strategies for high-priority waste sites on social conflict and community response to risk. Her research interests include public understanding and use of scientific risk information, the interplay among cultural values/beliefs and emotional or cognitive response to risk, socioeconomic context of exposure and response to environmental risk, risk communication, risk perceptions of culturally diverse populations, and measurement and statistical issues that arise when studying psychosocial phenomena across diverse populations. Recently, she has published articles on risk communication and individual and community response to bioterrorism. Dr. Vaughan has served on the NRC Panel on Public Participation in Environmental Assessment and Decision Making, the IOM Committee on Strategies to Protect the Health of Deployed U.S. Forces, and the NRC Committee on Risk Characterization. Dr. Vaughan received her Ph.D. in social psychology from Stanford University.