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
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
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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 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.
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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 Department of Defense Joint Pathology Center Biorepository. Washington, DC: The National Academies Press.
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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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
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
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
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
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, University 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 Registry; Professor of Pathology and Human Anatomy, Loma Linda University and Medical Center
Ellen Wright Clayton, Craig Weaver Professor of Pediatrics and Professor of Law, Center for Biomedical Ethics and Society, Vanderbilt University
Bernard Lo, Professor Emeritus of Medicine; Director Emeritus, Program in Medical Ethics, University of California, San Francisco
Timothy O’Leary, Director of Clinical Research and Development, Cooperative Studies Program, Department of Veterans Affairs
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 Diagnostics, Vanderbilt University Medical Center; Professor of Pathology, Microbiology and Immunology; Professor of Cancer Biology; Louise B. McGavock Chair, Department of Pathology, Microbiology & 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 conclusions 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 Institute 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.
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 committee 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 convened on April 21, July 11, and September 8, 2011. The intent of the workshops was to gather information regarding issues related to the topics 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 additional 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 hardworking 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.
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The State of the Biorepository’s Collection
Conclusions and Recommendations
Establishment and History of the Armed Forces Institute of Pathology and the Joint Pathology Center
The Joint Pathology Center Biorepository
Origin of the Study and Statement of Task
The Committee’s Approach to Its Task
Earlier Reports Addressing Armed Forces Institute of Pathology and Joint Pathology Center Operations
National Academy of Sciences Reports Addressing Related Topics
2 DETERMINANTS OF THE RESEARCH VALUE OF BIOSPECIMENS
Collection and Preservation of Biospecimens
Technologies Used to Manage Specimen Acquisition and Management
Technologies Used to Analyze Specimens
Limitations in the Use of Pathologic Samples in Research
3 ETHICAL, LEGAL, AND REGULATORY CONSIDERATIONS
The Changing Ethical, Legal, and Regulatory Landscape of Biorepositories
Considerations Regarding the Source of Specimens
Considerations Regarding Research on Diagnostic Specimens and Associated Data
4 FINDINGS, CONCLUSIONS, AND RECOMMENDATIONS
Opening Observations and General Recommendations
Retention and Maintenance of Biospecimens
Use of Biospecimens in Clinical Care, Education, and Research
B Contributor’s Consultation Request Form Joint Pathology Center
C DoD Instruction 3216.02 Protection of Human Subjects and Adherence to Ethical Standards in DoD-Supported Research
D Biographic Sketches of Committee Members, Consultants, and Staff