The Air Force Health Study
ASSETS RESEARCH PROGRAM
Committee on the Management of the Air Force Health Study
Data and Specimens—Report to Congress
Board on the Health of Select Populations
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
THE NATIONAL ACADEMIES PRESS
Washington, D.C.
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 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 competencies and with regard for appropriate balance.
This study was supported by Grant No. HT9404-12-1-0028 between the National Academy of Sciences and the Department of Veterans Affairs. 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: 978-0-309-33914-8
International Standard Book Number-10: 0-309-33914-6
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Suggested citation: IOM (Institute of Medicine). 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press.
“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe
INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
Advising the Nation. Improving Health.
THE NATIONAL ACADEMIES
Advisers to the Nation on Science, Engineering, and Medicine
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. C. D. Mote, Jr., 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. Victor J. Dzau 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. C. D. Mote, Jr., are chair and vice chair, respectively, of the National Research Council.
COMMITTEE ON THE MANAGEMENT OF
THE AIR FORCE HEALTH STUDY DATA AND SPECIMENS—
REPORT TO CONGRESS
DAVID J. TOLLERUD (Chair), Professor and Chair, Department of Environmental and Occupational Health Sciences, University of Louisville
MARY N. HAAN, Professor and Vice Chair, Department of Epidemiology and Biostatistics, University of California, San Francisco
KENNETH W. KIZER, Distinguished Professor, University of California, Davis, School of Medicine, and Betty Irene Moore School of Nursing; Director, Institute for Population Health Improvement, UC Davis Health System
DIANE LEONG, Director, Biobanking and Human Biological Sample Management, Research Biology Department, Gilead Sciences, Inc.
BRADLEY MALIN, Associate Professor and Vice Chair, Biomedical Informatics, Vanderbilt University
LISA M. McSHANE, Mathematical Statistician, Biometric Research Branch, National Cancer Institute
F. JAVIER NIETO, Professor and Chair, Department of Population Health Sciences; Helfaer Professor of Public Health, School of Medicine and Public Health, University of Wisconsin–Madison
MICHAEL A. STOTO, Professor of Health Systems Administration and Population Health, Georgetown University
LINDA D. YOUNGMAN, Branch Chief, Community Grants and Program Development Center for Substance Abuse Prevention, Substance Abuse and Mental Health Services Administration
Study Staff
ANNE STYKA, Study Director
DAVID A. BUTLER, Scholar
HARRIET CRAWFORD, Data Operations Manager
VICTORIA KING, Senior Programmer/Analyst
DWAYNE BELL, Programmer/Analyst
SULVIA DOJA, Senior Program Assistant
JULIE WILTSHIRE, Financial Associate
FREDERICK ERDTMANN, Director, Board on the Health of Select Populations
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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 Report Review Committee. The purposes of this independent review are 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:
Garnet L. Anderson, Fred Hutchinson Cancer Research Center
Linda M. Bartoshuk, University of Florida
Carolyn C. Compton, Arizona State University
Helena J. Ellis, Duke University
Kelly Edwards, University of Washington
David A. Kalman, University of Washington
James W. McNally, University of Michigan
Michael D. Parkinson, University of Pittsburgh Medical Center
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 the report was overseen by Dan G. Blazer, Duke University Medical Center, and Mark R. Cullen, Stanford University. Appointed by the National
Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of the report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of the report rests entirely with the authoring committee and the institution.
Preface
Well designed, longitudinal prospective epidemiologic studies that follow a population for many years and that include the collection and storage of biospecimens for use in current and future research are relatively rare. Such epidemiologic studies, such as the Framingham Heart Study, have gained fame because they are relatively few in number and are associated with vast amounts of data useful for many types of research. Another member of this select group is the Air Force Health Study (AFHS), which is not well recognized outside of the veterans health research community. The extensive data and associated biospecimens collected during its 20-year course have been preserved and continue to be valuable for many types of research and many scientific disciplines.
The 2007 National Defense Authorization Act directed the Air Force to transfer custody of the AFHS assets to the Medical Follow-Up Agency of the Institute of Medicine (IOM). With the passage of the Veterans’ Benefits Improvement Act in 2008, the IOM was directed to undertake a program of research using the data and biospecimens to better understand the determinants of health and promote wellness in veterans and the general population. Because the AFHS has only been accessible to the scientific community for research for less than 3 years, the vast majority of its potential is yet to be realized.
The committee gratefully acknowledges the many individuals and groups that generously shared their time, expertise, and insights with the committee. Among these numerous people, the committee would like to acknowledge the veterans who continue to allow their materials to be used for research, the investigators who have demonstrated the value and some of the many uses of the AFHS assets in cutting-edge research, the potential researchers, the Department of Veterans
Affairs who sponsored this program and continues to publicize its availability, persons from the many national professional organizations who have promoted the availability of the AFHS assets for research, and the Air Force Research Laboratory staff who have maintained the biospecimens. The committee is also grateful for the service and insight provided by Dr. Marie A. Bernard, Deputy Director of the National Institute on Aging of the National Institutes of Health, and Dr. Richard J. Jackson, Professor and Chair of Environmental Health Sciences at the Fielding School of Public Health at the University of California, Los Angeles, who served on the advisory committee but rotated off before the initiation of the consensus committee.
I would especially like to acknowledge the tremendous work of the IOM staff who have worked tirelessly with the veterans, researchers, and committee to make the AFHS Assets Research Program a successful pilot research program. The committee is grateful to Anne Styka, who served as study director for this project, and to the IOM staff members who contributed to the project: David Butler, Harriet Crawford, Victoria King, Dwayne Bell, and Sulvia Doja.
David J. Tollerud, Chair
Committee on the Management of the Air Force Health Study
Data and Specimens—Report to Congress
3 MANAGEMENT OF THE AFHS ASSETS RESEARCH PROGRAM
Transfer Activities of the AFHS Assets
Detemining the Content and Value of the Transferred AFHS Assets for Research
Biospecimen Quality and Usability
Summary of the Application Process to Access the AFHS Assets
Research Approved for the Use of the AFHS Assets
Investigator Experience Using the AFHS Assets
4 CONTINUED MANAGEMENT AND USE OF THE AFHS ASSETS
Options for Continued Management and Use of the AFHS Assets
Retain Custody and Management Under the IOM
Considerations for Custodians or Stewards of the AFHS Assets
Storage, Data Curation, and Privacy Protection
Federal Policies Related to Management and Dissemination of the AFHS Assets
Opportunities for Continued Research
5 FINDINGS, CONCLUSIONS, AND RECOMMENDATIONS
Overview of the Committee’s Approach and Findings
A Committee Member Biographies
B Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study
AFHS |
Air Force Health Study |
AFRL |
Air Force Research Laboratory |
CDC |
Centers for Disease Control and Prevention |
CI |
confidence interval |
CRADA |
cooperative research and development agreement |
ECG |
electrocardiogram |
GAO |
Government Accountability Office |
ICD-9 |
International Classification of Diseases, Ninth Revision |
ICPSR |
Inter-university Consortium for Political and Social Research |
IOM |
Institute of Medicine |
IRB |
institutional review board |
MFUA |
Medical Follow-Up Agency |
MGUS |
monoclonal gammopathy of undetermined significance |
NCI |
National Cancer Institute |
NHLBI |
National Heart, Lung, and Blood Institute |
NIH |
National Institutes of Health |
OSTP |
Office of Science and Technology Policy |
RFP |
request for proposals |
RR |
relative risk |
SAIC |
Science Applications International Corporation |
SAS |
Statistical Analysis System |
TCDD |
2,3,7,8-tetrachlorodibenzo-p-dioxin |
VA |
Department of Veterans Affairs |
WPAFB |
Wright-Patterson Air Force Base |