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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
