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Future Uses of the Department of Defense Joint Pathology Center Biorepository Committee on the Review of the Appropriate Use of AFIP's Tissue Repository Following Its Transfer to the Joint Pathology Center Board on the Health of Select Populations

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THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001 NOTICE: The project that is the subject of this report was approved by the Govern- ing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineer- ing, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropri- ate balance. This study was supported by Contract Award W91YTZ-10-R-0177 between the National Academy of Sciences and the U.S. Department of Defense. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the authors and do not necessarily reflect the view of the organizations or agencies that provided support for this project. International Standard Book Number-13: 978-0-309-26065-7 International Standard Book Number-10: 0-309-26065-5 Additional copies of this report are available for sale from the National Academies Press, 500 Fifth Street NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu. For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu. Copyright 2012 by the National Academy of Sciences. All rights reserved. Printed in the United States of America Cover credit: Top: Karen Kasmauski/Corbis. Bottom: Karen Kasmauski/Science Faction/Corbis. 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). 2012. Future uses of the Depart ment of Defense Joint Pathology Center Biorepository. Washington, DC: The National Academies Press.

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"Knowing is not enough; we must apply. Willing is not enough; we must do." --Goethe Advising the Nation. Improving Health.

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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 Acad- emy 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 en- gineers. 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 engineer- ing programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is presi- dent 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 Insti- tute 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 S ciences 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 ON THE REVIEW OF THE APPROPRIATE USE OF AFIP'S TISSUE REPOSITORY FOLLOWING ITS TRANSFER TO THE JOINT PATHOLOGY CENTER JAMES F. CHILDRESS (Chair), University Professor and John Allen Hollingsworth Professor of Ethics; Director, Institute for Practical Ethics and Public Life; University of Virginia, Charlottesville ALEXANDER M. CAPRON, University Professor; Vice Dean for Faculty and Academic Affairs, Scott H. Bice Chair in Healthcare Law, Policy and Ethics, Gould School of Law; Professor of Law and Medicine, Keck School of Medicine; University of Southern California, Los Angeles CAROLYN C. COMPTON, President and CEO, Critical Path Institute, Tucson, Arizona KELLY EDWARDS, Associate Professor in the Department of Bioethics & Humanities and Adjunct Associate Professor in the Department of Environmental and Occupational Health; University of Washington, School of Medicine, Seattle BRADLEY A. MALIN, Associate Professor of Biomedical Informatics and Computer Science; Director of the Health Information Privacy Laboratory; Vanderbilt University, Nashville, Tennessee GUIDO MARCUCCI, Professor of Medicine; John B. and Jane T. McCoy Chair in Cancer Research; Director of the Comprehensive Cancer Center Leukemia Tissue Bank; Ohio State University, Columbus ROBERT L. REDDICK, Chair and Frank Townsend Professor of Pathology; Director of the Histology and Electron Microscopy Labs, University of Texas Health Science Center, San Antonio FREDERICK J. SCHOEN, Professor of Pathology and Health Sciences and Technology at Harvard Medical School; Director of Cardiac Pathology; Vice-Chairman in the Department of Pathology, Brigham and Women's Hospital, Boston, Massachusetts MICHAEL L. SHELANSKI, Delafield Professor and Chairman of the Department of Pathology and Cell Biology; Director of Pathology Service at New York Presbyterian Hospital, Columbia-Presbyterian Center; Columbia University, New York, New York ROBERT WEST, Associate Professor of Pathology and Codirector of the Immunodiagnosis Laboratory, Stanford University Medical Center; Stanford, California IGNACIO I. WISTUBA, Jay and Lori Eisenberg Professor in the Department of Pathology; University of Texas MD Anderson Cancer Center, Houston v

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SUSAN M. WOLF, McKnight Presidential Professor of Law, Medicine & Public Policy and the Faegre Baker Daniels Professor of Law, University of Minnesota Law School; Professor of Medicine, University of Minnesota Medical School, Minneapolis Consultants JEFFREY T. MASON, Director, Laboratory of Proteomics and Protein Science, Washington Veterans Affairs Medical Center PILAR OSSORIO, Associate Professor of Law and Bioethics, University of Wisconsin at Madison Program Staff DAVID A. BUTLER, Scholar; Director, Medical Follow-up Agency; Study Director LAUREN N. SAVAGLIO, Research Associate RACHEL S. BRIKS, Program Assistant LATARSHA CARITHERS, Christine Mirzayan Science and Technology Policy Fellow PAMELA McCRAY, Administrative Assistant NORMAN GROSSBLATT, Senior Editor FREDERICK (RICK) ERDTMANN, Director, Board on the Health of Select Populations vi

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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 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: Abul K. Abbas, Professor and Chair, Department of Pathology, Univer- sity of California, San Francisco, School of Medicine Wylie Burke, Professor and Chair, Department of Bioethics and Humanities, University of Washington Donald R. Chase, Executive Director, California Tumor Tissue R egistry; Professor of Pathology and Human Anatomy, Loma Linda Univer- sity and Medical Center Ellen Wright Clayton, Craig Weaver Professor of Pediatrics and Profes- sor of Law, Center for Biomedical Ethics and Society, Vanderbilt University Bernard Lo, Professor Emeritus of Medicine; Director Emeritus, Pro- gram in Medical Ethics, University of California, San Francisco Timothy O'Leary, Director of Clinical Research and Development, Cooperative Studies Program, Department of Veterans Affairs vii

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viiiREVIEWERS Rodney A. Schmidt, Professor of Pathology, University of Washington School of Medicine Jeffery K. Taubenberger, Chief, Viral Pathogenesis and Evolution Section, Laboratory of Infectious Diseases, National Institute of Allergy and Infectious Diseases, National Institutes of Health Mary M. Zutter, Assistant Vice-Chancellor for Integrative D iagnostics, Vanderbilt University Medical Center; Professor of Pathology, Micro biology and Immunology; Professor of Cancer Biology; Louise B. McGavock Chair, Department of Pathology, Microbiol- ogy & Immunology, Vanderbilt University School of Medicine Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclu- sions or recommendations nor did they see the final draft of the report before its release. The review of this report was overseen by Harold C. Sox, Professor of Medicine, Dartmouth Medical School and Associate Director for Faculty, The Dartmouth Institute, and Jeremy Sugarman, Harvey M. Meyerhoff Professor of Bioethics and Medicine, Berman Insti- tute of Bioethics and Department of Medicine, Johns Hopkins University School of Medicine. Appointed by the National Research Council 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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Acknowledgments This report could not have been prepared without the guidance and expertise of numerous persons. Although it is not possible to mention by name all those who contributed to the committee's work, the commit- tee wants to express its gratitude to a number of them for their special contributions. Sincere thanks go to all the participants at the public meetings con- vened on April 21, July 11, and September 8, 2011. The intent of the workshops was to gather information regarding issues related to the t opics addressed in the committee's statement of task. The speakers, who are listed in Appendix A, gave generously of their time and expertise to help to inform and guide the committee's work. Many of them also provided addi tional information in response to the committee's questions. Pilar Ossorio and Jeffrey Mason supplied important detail and insight on issues before the committee in their role as consultants. The committee extends special thanks to the dedicated and hard working staff of the Institute of Medicine's Board on the Health of Select Populations, who supported and facilitated its work. Board Director Rick Erdtmann helped to ensure that this report met the highest standards of quality. Finally, James Childress, chair, thanks David Butler, director of the study, for his fine work in drafting and editing materials for the report, and he thanks the members of the committee for their excellent ideas, helpful drafts, and vigorous and valuable participation in the deliberative process. He is also grateful to Alexander Capron for filling in as chair when he was unable to participate in committee meetings. ix

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Contents SUMMARY1 Framework and Organization, 3 The State of the Biorepository's Collection, 3 Conclusions and Recommendations, 5 References, 14 1 INTRODUCTION AND BACKGROUND 17 Establishment and History of the Armed Forces Institute of Pathology and the Joint Pathology Center, 17 The Joint Pathology Center Biorepository, 21 Origin of the Study and Statement of Task, 26 The Committee's Approach to Its Task, 27 Earlier Reports Addressing Armed Forces Institute of Pathology and Joint Pathology Center Operations, 28 National Academy of Sciences Reports Addressing Related Topics, 32 Organization of This Report, 33 References, 34 2DETERMINANTS OF THE RESEARCH VALUE OF BIOSPECIMENS37 Collection and Preservation of Biospecimens, 37 Uses of Biospecimens, 40 Technologies Used to Manage Specimen Acquisition and Management, 42 xi

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xiiCONTENTS Technologies Used to Analyze Specimens, 43 Limitations in the Use of Pathologic Samples in Research, 54 References, 60 3 ETHICAL, LEGAL, AND REGULATORY CONSIDERATIONS 65 The Changing Ethical, Legal, and Regulatory Landscape of Biorepositories, 65 Considerations Regarding the Source of Specimens, 78 Considerations Regarding Research on Diagnostic Specimens and Associated Data, 81 References, 104 4 FINDINGS, CONCLUSIONS, AND RECOMMENDATIONS 109 Opening Observations and General Recommendations, 109 Retention and Maintenance of Biospecimens, 112 Use of Biospecimens in Clinical Care, Education, and Research, 119 References, 132 APPENDIXES A Public Meeting Agendas 137 B Contributor's Consultation Request Form Joint Pathology Center 141 C DoD Instruction 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research 145 D Biographic Sketches of Committee Members, Consultants, and Staff 179