The Air Force Health Study Assets Research Program (2015) / Chapter Skim
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3 Management of the AFHS Assets Research Program
3 Management of the AFHS Assets Research Program
Pages 43-64
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From page 43... ...
The second half of the chapter describes the research program's infrastructure, including development and implementation of the proposal and review process to allow qualified researchers access to the data and the biospecimens. The last section discusses examples of approved research studies, preliminary findings, and a summary of researchers' experience using the IOM's AFHS Assets Research Program.
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From page 44... ...
The IOM and VA entered into a separate s CRADA. It took approximately 3 years for a final agreement to be reached and for VA to provide funding to conduct the IOM's work on the AFHS data and to provide AFRL with funds for the maintenance of the biospecimens.
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From page 45... ...
DETERMINING THE CONTENT AND VALUE OF THE TRANSFERRED AFHS ASSETS FOR RESEARCH The AFHS data and biospecimens have long been recognized as valuable because of the availability of voluminous and detailed longitudinal data linked to numerous and unique biospecimens collected from a large sample of diverse men who were followed for more than 20 years. In addition to the contributions the AFHS assets have made to the scientific literature, it is their potential for use in research beyond the scope of the original study through the use of new assays, technologies, and methods developed since the samples were collected that continues to make the AFHS a valuable and useful resource.
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From page 46... ...
Once the data and biospecimens were transferred to IOM custody, additional consent was required to enable the AFHS data and biospecimens to be used for research other than studies pertaining to herbicide exposure or military health. Participants were informed that future research would likely involve a broad range of subject matter, including studies of health and well-being not directly related to military health or herbicide exposure.
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From page 47... ...
For the next 3 years, in addition to continuing to read in the text files, much time and effort was spent on file integration, data cleaning, analyses required to create researcher data requests, and quality checks. Although the AFHS data are in electronic form, the data are not standardized between cycles or in a database format.
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From page 48... ...
In these cases, the IOM program staff worked with the researchers, under guidance of the advisory committee, to refine the selection criteria for the study. Furthermore, some researchers requested all information available with the intent of "mining" the data for associations.
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From page 49... ...
Although this strategy of updating the biospecimen database works as an interim solution, the committee concurs with previous committees that an updated biospecimen inventory is critical to maximize the efficiency of the repository and better inform future research with the knowledge of what is actually available. The IOM program staff use the database to select the biospecimen samples that are to be processed and shipped to researchers requesting them.
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From page 50... ...
were randomly selected based on the 988 participants who met the following inclusion criteria: participated in all six physical examinations, had multiple 10 mL frozen serum specimens collected at each of the first five physical examinations, no history of cancer, had at least one quantifiable dioxin measurement, and signed an informed consent form. One 10 mL serum sample per examination per participant was selected from the first five exam cycles for a total of 25 serum samples.
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From page 51... ...
Similarities in results between the AFHS measurements taken at the time of collection and these later reanalyses of the same measurements were further evidence of the stability of the stored frozen serum samples. Although the AFHS samples are relatively old (from 32 years for cycle 1 to 12 years for cycle 6)
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From page 52... ...
Moreover, a broad array of other health information is available for each participant making it possible to explore new avenues of correlates to overall health. SUMMARY OF THE APPLICATION PROCESS TO ACCESS THE AFHS ASSETS The advisory committee was charged with fostering the use of the AFHS data and biospecimens in new research and reviewing research proposals.
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From page 53... ...
Researchers from the United States and abroad, from academic institutions, industry, and government organizations, were eligible to apply for a ccess to the AFHS assets. The RFP was publicized on the AFHS project page of the IOM website and initially sent to researchers and organizations that were familiar with the AFHS or had an interest in research related to herbicide exposure.
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From page 54... ...
Proposals that included requests for pilot funds were critically reviewed for both scientific merit and to ensure that awarded pilot funds were likely to facilitate generation of preliminary data or results that could then be used to apply for larger grants to further the research, instead of solely being a mechanism to support research projects without future planning. Committee members would
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From page 55... ...
If the researchers are requesting pilot funding: 1 The researchers demonstrate how the pilot funding will enable them 6. to prepare a compelling proposal for subsequent research using the AFHS data and/or biospecimens.
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From page 56... ...
Project staff made presentations about the AFHS research program at national meetings to encourage use in new research directions. The committee announced the availability of the data and biospecimens for use in research on several listservs, including the VA listserv of all chiefs of staff for research, listservs targeting aging and geriatrics research, and announcements to the toxicology-research community, all of which resulted in increased interest as demonstrated by many new queries and submitted letters of intent.
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From page 57... ...
Exposure–response relationship for Data only dioxin and cancer and noncancer health outcomes in the Air Force Health Study cohort using physiologically based pharmacokinetic modeling of exposure and updated mortality Knafl University of North Effects of dioxin exposure for male Air Data only Carolina at Chapel Force Vietnam veterans on reproductive Hill outcomes Mandel Exponent, Inc. The reanalysis of the Ranch Hand data Data only Mazur Syracuse University Testosterone changes Data only Mitchell Emory University Identifying novel biomarkers of Data and and Atlanta VA vulnerable coronary artery disease: The biospecimens Medical Center Air Force Health Study Ramosc University of Detection of L1 protein in Ranch Hand Data and Louisville biospecimens biospecimens Rossc Pacific Health Parkinson's disease and pre-motor Data only Research and features of Parkinson's disease in the Air Education Institute, Force Health Study VA Rothc VA San Diego Caveolin's role during healthy aging Data and Healthcare System biospecimens Seldinc Boston University Incidence of abnormal free light Data and chains and other markers of light chain biospecimens amyloidosis in veterans exposed to Agent Orange: A pilot study Shimc Centers for Disease Monoclonal gammopathy of Data and Control and undetermined significance (MGUS)
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From page 58... ...
RESEARCH APPROVED FOR THE USE OF THE AFHS ASSETS Although the Disposition Committee recommended that a 5-year commitment should be given to creating and operationalizing the new AFHS management program, and an evaluation of its success should not occur less than 2 years after the final pilot funding awards, the VA contract supported only a 4-year commitment with a report on the feasibility and advisability of maintaining the AFHS assets for future research required in the fourth year. The first proposals were approved in 2012.
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From page 59... ...
The first step was to provide 228 serum samples that had matching adipose tissue samples for the same year of collection. All serum samples were initially screened for abnormal levels of free immunoglobulin light chains, a biomarker of a plasma cell dyscrasia in the bone marrow due to amyloid light chain amyloidosis, multiple myeloma, or MGUS.
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From page 60... ...
Several of the earliest approved studies under the IOM's program focused on the health effects and potential biomarkers of dioxin and other herbicide contaminants that may provide further evidence of association and other occupational exposures or environment effects specific to individuals' service in the Air Force during Vietnam. The fact that these were among the first proposals is not surprising given that these investigators were already familiar with the "Ranch Hand Study" and its rich data and biospecimen resources and they were specifically made aware of the RFP.
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From page 61... ...
The committee asked these investigators to give specific examples of how the AFHS assets were unique for their research and any suggestions they could provide to make the AFHS Assets Research Program even more useful or valuable. Questions were primarily subjective and related to the overall application process, quality and completeness of the data received, quality and usefulness of the biospecimens, and future plans regarding the results and additional uses of the AFHS assets.
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From page 62... ...
The AFHS Assets Research Program began accepting applications in mid2012, and several of the research studies are still in process (especially for those studies approved in 2013 and 2014)
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From page 63... ...
2006. Testing the viability of stored frozen serum samples from the Air Force Health Study using human multi-analyte profiles (MAP)
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