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Review of the Proposal for the Gulf Long- Term Follow-Up Study Highlights from the September 2010 Workshop Workshop Report Lynn Goldman, Abigail Mitchell, and Margie Patlak, Editors Committee to Review the Federal Response to the Health Effects Associated with the Gulf of Mexico Oil Spill Board on Population Health and Public Health Practice

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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. N01-OD-4-2139 between the National Academy of Sciences and the 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. International Standard Book Number-13: 978-0-309-16244-9 International Standard Book Number-10: 0-309-16244-0 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 2010 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. Suggested citation: IOM (Institute of Medicine). 2010. Review of the Proposal for the Gulf Long-Term Follow-Up Study: Highlights from the September 2010 Workshop: Workshop Report. Washington, DC: The National Academies Press.

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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. Ralph J. Cicerone 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. Charles M. Vest 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. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council. www.national-academies.org .

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COMMITTEE TO REVIEW THE FEDERAL RESPONSE TO THE HEALTH EFFECTS ASSOCIATED WITH THE GULF OF MEXICO OIL SPILL1 LYNN GOLDMAN, M.D., M.P.H. (Chair), Dean, George Washington University School of Public Health and Health Services DAVID E. COHEN, M.D., M.P.H., Vice Chair and Associate Professor of Dermatology, New York University School of Medicine FRANCESCA DOMINICI, Ph.D., Professor, Harvard University School of Public Health BERNARD GOLDSTEIN, M.D., Professor, University of Pittsburgh Graduate School of Public Health NANCY KASS, Sc.D., Phoebe R. Berman Professor of Bioethics and Public Health, Bloomberg School of Public Health, Johns Hopkins University MAI-NHUNG LE, Dr. P.H., M.P.H., Associate Professor, San Francisco State University GAIL A. MATTOX, M.D., F.A.A.C.A.P., Professor of Clinical Psychiatry and Chair, Morehouse School of Medicine LINDA A. MCCAULEY, Ph.D., F.A.A.N., R.N., Dean, Nell Hodgson Woodruff School of Nursing, Emory University ROBERTA B. NESS, M.D., M.P.H., Dean and M. David Low Chair in Public Health, University of Texas LAWRENCE A. PALINKAS, Ph.D., Albert G. and Frances Lomas Feldman Professor of Social Policy and Health, University of Southern California RUTH PARKER, M.D., Professor, Emory University School of Medicine SUSAN L. SANTOS, Ph.D., M.S., Assistant Professor, School of Public Health, University of Medicine and Dentistry of New Jersey NALINI SATHIAKUMAR, M.D., Dr.P.H., Associate Professor, School of Public Health, University of Alabama at Birmingham 1 The report summarizes the views expressed by workshop participants, and while the committee is responsible for the overall quality and accuracy of the report as a record of what transpired at the workshop, the views contained in the report are not necessarily those of the committee. v

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Study Staff ABIGAIL MITCHELL, Study Director MORGAN FORD, Program Officer CHINA DICKERSON, Senior Program Assistant TREVONNE WALFORD, Research Assistant ROSE MARIE MARTINEZ, Director, Board on Population Health and Public Health Practice HOPE HARE, Administrative Assistant vi

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REVIEWERS This report has been reviewed in draft form by persons 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: Tomás Aragón, University of California, Berkeley Rose Goldman, Harvard School of Public Health David Hoel, Medical University of South Carolina Maureen Lichtveld, Tulane University David Tollerud, University of Louisville Although the reviewers listed above have provided many constructive comments and suggestions, they did not see the final draft of the report before its release. The review of this report was overseen by Stephen Fienberg, Carnegie Mellon University and Jonathan Samet, University of Southern California. Appointed by the National Research Council and the Institute of Medicine, respectively, 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. vii

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CONTENTS Introduction......................................................................................................................................1 Gulf Study Design............................................................................................................................2 Tapping Existing Resources ............................................................................................................4 Administrative and Data Oversight Details .....................................................................................6 Exposure Assessment Challenges....................................................................................................6 Selecting Appropriate Controls........................................................................................................8 Predicting Outcomes........................................................................................................................9 Planning for Lower Enrollment .......................................................................................................9 Engaging the Local Community ......................................................................................................9 Establishing Referral Networks .....................................................................................................12 Planning for Legal Issues...............................................................................................................13 Additional Health Endpoints for Study..........................................................................................14 Final Remarks ................................................................................................................................15 APPENDIX....................................................................................................................................17 ix

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