Vaccine Safety Research, Data Access, AND Public Trust
THE NATIONAL ACADEMIES PRESS
THE NATIONAL ACADEMIES PRESS
500 Fifth Street, N.W. Washington, DC 20001
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 for the report were chosen for their special competences and with regard for appropriate balance.
This study was supported by Contract No. 200-2000-00629, Task Order No. 23 between the National Academy of Sciences and the Centers for Disease Control and Prevention, U.S. Department of Health and Human Services. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.
Library of Congress Cataloging-in-Publication Data
Institute of Medicine (U.S.). Committee on the Review of the National Immunization Program’s Research Procedures and Data Sharing Program.
Vaccine safety research, data access, and public trust / Committee on the Review of the National Immunization Program’s Research Procedures and Data Sharing Program, Board on Health Promotion and Disease Prevention.
p. ; cm.
Includes bibliographical references.
ISBN 0-309-09591-3 (pbk.)—ISBN 0-309-54874-8 (PDF)
1. Vaccination—United States—Safety measures—Databases. 2. Vaccines—United States—Safety measures—Databases.
[DNLM: 1. Vaccines—standards. 2. Access to Information. 3. Database Management Systems. 4. Public Opinion. 5. Safety—standards. 6. Trust—psychology. QW 805 I5914 2005] I. Title.
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THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Bruce M. Alberts is president of the National Academy of Sciences.
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The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.
The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Bruce M. Alberts and Dr. Wm. A. Wulf are chair and vice chair, respectively, of the National Research Council.
COMMITTEE ON THE REVIEW OF THE NATIONAL IMMUNIZATION PROGRAM’S RESEARCH PROCEDURES AND DATA SHARING PROGRAM
JOHN C. BAILAR III M.D., Ph.D. (Chair), Professor Emeritus,
University of Chicago, Washington, DC
GARNET L. ANDERSON, Ph.D., Co-Principal Investigator,
Women’s Health Initiative Clinical Coordinating Center, Fred Hutchinson Cancer Research Center, Seattle, WA
STEPHEN E. FIENBERG, Ph.D., Maurice Falk University Professor of Statistics and Social Science,
Carnegie Mellon University, Pittsburgh, PA
DEBRA R. LAPPIN, J.D., Senior Advisor,
B&D Sagamore, Public Health and Life Sciences Consulting, Washington, DC
MYRON M. LEVINE, M.D., D.T.P.H., Professor and Director,
Center for Vaccine Development, School of Medicine, University of Maryland at Baltimore
ANNA C. MASTROIANNI, J.D., M.P.H., Assistant Professor,
School of Law and Institute for Public Health Genetics, University of Washington, Seattle
COLIN L. SOSKOLNE, Ph.D., Professor,
Department of Public Health Sciences, University of Alberta, Edmonton, Canada
ELAINE VAUGHAN, Ph.D., Associate Professor,
Department of Psychology and Social Behavior, School of Social Ecology, University of California, Irvine
ANDREA PERNACK ANASON, M.P.H., Study Director
AMY GROSSMAN, Research Associate
RUTH KANTHULA, Senior Program Assistant
NORMAN GROSSBLATT, ELS (D), Senior Editor
ROSE MARIE MARTINEZ, Sc.D., Director, Board on Health Promotion and Disease Prevention
This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s (NRC’s) Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:
Alfred Berg, University of Washington, Seattle
Ann Bostrom, Georgia Institute of Technology, Atlanta
Alan Karr, National Institute of Statistical Sciences, Research Triangle Park, NC
Kristin Nichol, University of Minnesota, Minneapolis
Sarah Putney, Harvard University, Boston, MA
Jonathan Samet, Johns Hopkins University, Baltimore, MD
Brian Strom, University of Pennsylvania, Philadelphia
Frances Visco, National Breast Cancer Coalition, Washington, DC
Robert Woolson, Medical University of South Carolina, Charleston
Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations nor did they see the final draft of the report
before its release. The review of this report was overseen by Neal A. Vanselow, Tulane University, and Joseph P. Newhouse, Harvard University. Appointed by the NRC and Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.