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

INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS
Washington, D.C.
www.nap.edu



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Vaccine Safety Research, Data Access, and Public Trust 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 INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES THE NATIONAL ACADEMIES PRESS Washington, D.C. www.nap.edu

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Vaccine Safety Research, Data Access, and Public Trust 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. RA638.I555 2005 614.4′7—dc22 2005007271 Additional copies of this report are available from the National Academies Press, 500 Fifth Street, N.W., Lockbox 285, Washington, DC 20055; (800) 624-6242 or (202) 334-3313 (in the Washington metropolitan area); Internet, http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2005 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 serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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Vaccine Safety Research, Data Access, and Public Trust “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE OF THE NATIONAL ACADEMIES Adviser to the Nation to Improve Health

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Vaccine Safety Research, Data Access, and Public Trust 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. The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Wm. A. Wulf is president of the National Academy of Engineering. 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. www.national-academies.org

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Vaccine Safety Research, Data Access, and Public Trust 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 Study Staff 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

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Vaccine Safety Research, Data Access, and Public Trust Reviewers 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

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Vaccine Safety Research, Data Access, and Public Trust 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.

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Vaccine Safety Research, Data Access, and Public Trust Contents     EXECUTIVE SUMMARY   1 1   STUDY BACKGROUND AND CONTEXTUAL ISSUES   13      Charge to the Committee,   14      Study Process,   16      Context of This Study,   17      Issues Framing the Committee’s Deliberations,   19      Previous Release of Preliminary Findings from the Vaccine Safety Datalink,   20      How Trust Affects the Vaccine Safety Datalink,   21      Overarching Principles,   23 2   DESCRIPTION OF THE VACCINE SAFETY DATALINK   25      Role of FDA and CDC in Assessing Vaccine Safety,   25      Development of the Vaccine Safety Datalink,   28      Complexity and Limitations of the Vaccine Safety Datalink Database,   29      The Shelby Amendment and the Information Quality Act,   31 3   THE VACCINE SAFETY DATALINK DATA SHARING PROGRAM   33      Design and Implementation to Date of the Vaccine Safety Datalink Data Sharing Program,   33      The Vaccine Safety Datalink Data Sharing Program’s Ability to Share Data,   35

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Vaccine Safety Research, Data Access, and Public Trust      Current Standards of Practice of Similar Data Sharing Programs,   37      Framework of Recommendations on Access to Vaccine Safety Datalink Data,   58      Limitations of Data Available Through the Vaccine Safety Datalink Data Sharing Program,   59      Specific Components of the Vaccine Safety Datalink Data Sharing Program Guidelines,   65 4   THE VACCINE SAFETY DATALINK RESEARCH PROCESS AND THE RELEASE OF PRELIMINARY FINDINGS   76      Review of Iterative Analysis Approaches Used for Vaccine Safety Datalink Studies,   76      Vaccine Safety Datalink Research Plan,   80      Sharing Vaccine Safety Datalink Program Information,   83      The Role of Peer Review,   85      Release of Preliminary Findings,   87 5   INDEPENDENT REVIEW OF VACCINE SAFETY DATALINK ACTIVITIES   96      NVAC Subcommittee to Review and Provide Advice on the Vaccine Safety Datalink Research Plan,   97      Independent Committee to Review Vaccine Safety Datalink Research Proposals and Provide Advice on the Release of Preliminary Findings,   99     CONCLUDING REMARKS   104     REFERENCES   105     APPENDIXES     A   Committee Biographies   111 B   Glossary   115 C   Acronyms   117 D   Meeting One—Agenda   119 E   Meeting Two—Agenda   123 F   Summary of Public Submissions   127 G   Notice and Request for Comment on Procedures and Costs for Use of the Research Data Center   132