Institutional Review Boards and Health Services Research Data Privacy

A Workshop Summary

Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection

Division of Health Care Services

INSTITUTE OF MEDICINE
Washington, D.C.



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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary Institutional Review Boards and Health Services Research Data Privacy A Workshop Summary Committee on the Role of Institutional Review Boards in Health Services Research Data Privacy Protection Division of Health Care Services INSTITUTE OF MEDICINE Washington, D.C.

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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary INSTITUTE OF MEDICINE 2101 Constitution Avenue, N.W. Washington, DC 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 for the report were chosen for their special competences and with regard for appropriate balance. Support for this study was provided by The Agency for Healthcare Research and Quality, and the Office of the Assistant Secretary for Planning and Evaluation, both of the Department of Health and Human Services (Contract No.282-99-0045, Task Order No.1). Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary is available in limited quantities from the Institute of Medicine , Division of Health Care Services, 2101 Constitution Avenue, N.W., Washington, DC 20418; (202) 334-2360. The full text of this workshop summary is available on line at www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at www.iom.edu. Copyright 2000 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 logo-type by the Institute of Medicine is based on a relief carving from ancient Greece, now held by the Staatliche Musseen in Berlin.

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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary “Knowing is not enough; we must apply. Willing is not enough; we must do.” —Goethe INSTITUTE OF MEDICINE Shaping the Future for Health

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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary THE NATIONAL ACADEMIES National Academy of Sciences National Academy of Engineering Institute of Medicine National Research Council 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. William 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. Kenneth I. Shine 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. William A. Wulf are chairman and vice chairman, respectively, of the National Research Council.

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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary COMMITTEE ON THE ROLE OF INSTITUTIONAL REVIEW BOARDS IN HEALTH SERVICES RESEARCH DATA PRIVACY PROTECTION BERNARD LO (Chair), Professor of Medicine, Director of Programs in Medical Ethics University of California, San Francisco ELIZABETH ANDREWS, Director, World Wide Epidemiology, Glaxo Wellcome JOHN COLMERS, Executive Director, Maryland Health Care Commission GEORGE DUNCAN, Professor of Statistics, Heinz School of Public Policy and Management, Carnegie Mellon University JANLORI GOLDMAN, Director, Health Privacy Project, Georgetown University, Institute for Health Care Research and Policy CRAIG W. HENDRIX, Associate Professor of Medicine, Johns Hopkins University MARK C. HORNBROOK, Associate Director, Center for Health Research, Kaiser Permanente, Northwest Division LISA IEZZONI, Professor of Medicine, Harvard Medical School, Beth Israel Deaconess Medical Center, Division of General Medicine and Primary Care DONALD KORNFELD, Associate Dean, Faculty of Medicine, Chairman, Institutional Review Board, Professor of Psychiatry, Columbia University College of Physicans and Surgeons, Presbyterian University ELLIOT STONE, Executive Director and Chief Executive Officer, Massachusetts Health Data Consortium, Inc. PETER SZOLOVITS, Professor, Massachusetts Institute of Technology, Department of Electrical Engineering and Computer Science ADELE WALLER, Partner, Bell, Boyd & Lloyd, Chicago Consultants BARTHA-MARIA KNOPPERS, Professor, Faculty of Law, Senior Researcher, C.R.D.P., Legal Counsel, McMaster Gervais, University of Montreal ROSS THOMPSON, Professor, Department of Psychology, University of Nebraska Staff LEE ZWANZIGER, Senior Program Officer RITA GASKINS, Senior Project Assistant

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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary BOARD ON HEALTH CARE SERVICES DON E. DETMER (Chair), Professor of Medical Education in Health Evaluation Sciences, University of Virginia BARBARA J. McNEIL (Vice Chair), Ridley Watts Professor, Department of Health Care Policy, Harvard Medical School LINDA AIKEN, Director, Center for Health Outcomes and Policy Research, Claire M. Fagin Leadership Professor of Nursing and Professor of Sociology, University of Pennsylvania STUART H. ALTMAN, Sol C. Chaikin Professor of National Health Policy, the Florence Heller Graduate School for Social Policy, Brandeis University HARRIS BERMAN, Chairman and Chief Executive Officer, Tufts Health Plan BRIAN BILES, Chair and Professor, Department of Health Services Management and Policy, School of Public Health and Health Services, George Washington University CHRISTINE CASSEL, Chairman, Henry L. Schwarz Department of Geriatrics and Adult Development, and Professor of Geriatrics and Internal Medicine, Mount Sinai Medical Center PAUL D. CLAYTON, Medical Informaticist, Intermountain Health Care, Salt Lake City, Utah PAUL F. GRINER, Vice President and Director, Center for the Assessment and Management of Change in Academic Medicine, Association of American Medical Colleges RUBY P. HEARN, Senior Vice President, Robert Wood Johnson Foundation PETER BARTON HUTT, Partner, Covington & Burling, Washington, D.C. ROBERT L. JOHNSON, Professor of Pediatrics and Clinical Psychiatry, and Director, Adolescent and Young Adult Medicine, University of Medicine and Dentistry of New Jersey, New Jersey Medical School JACQUELINE KOSECOFF, President and Co-Chief Executive Officer, Protocare SHEILA T. LEATHERMAN, Executive Vice President, United Healthcare Corporation, Center for Health Care Policy and Evaluation, Minneapolis UWE E. REINHARDT, James Madison Professor of Political Economy and Professor of Economics and Public Affairs, Princeton University SHOSHANNA SOFAER, Robert P. Luciano Professor of Health Care Policy, School of Public Affairs, Baruch College GAIL L. WARDEN, President and Chief Executive Officer, Henry Ford Health System JANET M. CORRIGAN, Director, Board on Health Care Services, Institute of Medicine

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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary Acknowledgments The workshop speakers, listed in the appendix, all were very helpful and generous with their time in preparing, attending, and participating in the workshop. The committee very much appreciates the information and insight they provided both in the workshop and in comments and suggestions afterwards. Many individuals assisted with helpful advice and suggestions for the planning of the workshop. The committee thanks Paul Clayton of Intermountain Health Care, Nancy Donovan of the General Accounting Office, Molly Greene of UTHSCSA, Erica Heath of IRC, Steve Heinig of AAMC, Andy Nelson of HealthPartners, Joan Rachlin of PRIM&R, Erica Rose of SmithKline Beecham, Ada Sue Selwitz of ARENA, and many others. The committee appreciates the support provided by the sponsors of the project, the Agency for Healthcare Research and Quality (AHRQ) and the office of the Assistant Secretary for Planning and Evaluation (ASPE), both of the Department of Health and Human Services. The individual representatives of the sponsoring agencies, Michael Fitzmaurice (AHRQ) and John Fanning (ASPE) were very helpful throughout the planning and execution of the workshop. 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 Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the Institute of Medicine in making the 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 the draft manuscript remain confidential to protect the integrity of the deliberative process. The committee wishes to thank the following individuals for their participation in the review of this report: Ruth Bulger, Uniformed Services University of Health Sciences; Donna Chen, Southeastern Rural Mental Health Research Center, University of Virginia; Joan Porter, Department of Veterans Affairs; and Hugh Tilson, University of North Carolina School of Public Health. Although the individuals acknowledged have provided valuable comments and suggestions, responsibility for the final content of the report rests solely with the authoring committee and the Institute of Medicine.

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Institutional Review Boards and Health Services Research Data Privacy: A Workshop Summary Although the individuals acknowledged have provided valuable comments and suggestions, responsibility for the final content of the report rests solely with the authoring committee and the Institute of Medicine.