The Air Force Health Study Assets Research Program (2015) / Chapter Skim
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4 Continued Management and Use of the AFHS Assets
4 Continued Management and Use of the AFHS Assets
Pages 65-84
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From page 65... ...
OPTIONS FOR CONTINUED MANAGEMENT AND USE OF THE AFHS ASSETS The committee strongly believes that it is feasible and appropriate to maintain the AFHS data and biospecimens as their value and usefulness for research have been confirmed (as discussed in Chapter 3)
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From page 66... ...
of conducting epidemiologic studies of military and veterans' health; its experience maintaining data collections, including managing, analyzing, and disseminating data, protecting participants' privacy and confidentiality; and its independence, objectivity, and thorough review and oversight processes. The Disposition of the Air Force Health Study report identified several characteristics of a good custodian for the AFHS assets.
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From page 67... ...
In addition, the IOM provides all documentation, including vial labels and chain of custody forms for sample dissemination, as well as updates the electronic database with biospecimen sample locations and amounts. The Disposition of the Air Force Health Study report recommended that any custodian meet four guidelines pertaining to the storage and maintenance of the biospecimens: have a secure facility with controlled access and redundant power supplies to house freezers that are maintained at least –70°C, establish protocols for continuous monitoring of freezer function and other quality control and assurance practices for long-term biospecimen preservation, have appropriate local and remote alarm systems in place to ensure the preservation, viability, and integrity of the biospecimens, and have staff trained to respond to freezer breakdowns, power outages, or other emergencies at any hour (IOM, 2006)
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From page 68... ...
When samples of adipose tissue and semen are requested, the amount requested is removed and the rest of it refrozen without separation into additional aliquots. The committee finds the storage, monitoring, and emergency response guidelines recommended by the Disposition of the Air Force Health Study report have been met by AFRL and has no concerns about the maintenance of the biospecimens.
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From page 69... ...
Therefore, although much of the Framingham Heart Study data and biospecimens are maintained and made available by other entities, the stewards continue to maintain overall control of the assets, and such an arrangement may be possible for the AFHS data and biospecimens. Certain organizations have experience in the management of broader data repositories, such as the Inter-university Consortium for Political and Social Research (ICPSR)
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From page 70... ...
As was noted above, funding would need to be provided to support the staff needed to prepare assets for the transfer and assure that it was successfully completed. Regardless of which custodial option is ultimately selected by Congress, a number of aspects need to be considered and accounted for to ensure continued successful use of the AFHS data and biospecimens for new and innovative research.
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From page 71... ...
Considerations related to allowing broader access to existing scientific data include adequate preparation of data and its associated documentation, protection of human subjects, formation and use of data management plans, and appropriate attribution of the data source. An important component of any strategic plan concerning the maintenance of the AFHS data and its wide scientific use is long-term curation plans that align with best practices BOX 4-1 Considerations for Allowing Broader Access of Datasets to the Scientific Community 1.
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From page 72... ...
While not an insurmountable issue, it has and continues to require substantial efforts to integrate and process data over time. Based on the IOM's experience of working with the AFHS data and biospecimens for the past 3 years, additional issues have been identified that have affected the information available for research and timeliness of fulfilling data requests, such as the lack of standardization between examination cycles and the inability to abstract information from some types of files.
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From page 73... ...
Such an inventory is important to good management practices and an exercise that will be valuable for continued use of the biospecimens in research. The Disposition of the Air Force Health Study report also called for a plan detailing biospecimen access and residual return policies, including clear documentation of the entire biospecimen access application process, the review process, decision-making criteria, biospecimen processing and shipping costs, and final disposition of biospecimens (IOM, 2006)
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From page 74... ...
before posting the dataset to their website, within a few months the dataset had to be removed due to concerns about insecure data sharing practices and violations of participant privacy because the small size and special nature of the cohort led to the identification of individual participants. Therefore, any custodian must consider what other publicly available data might exist that would allow individuals with knowledge of both datasets to identify particular AFHS study participants.
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From page 75... ...
The Disposition of the Air Force Health Study report identified several ways in which these responsibilities could be addressed. The review process for access to the AFHS assets and the subsequent data use and asset transfer agreement stipulates that researchers must meet and comply with several criteria to ensure the privacy and confidentiality of the indi viduals who have provided data and biospecimens for their use.
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From page 76... ...
. Therefore, as long as personally identifiable information is removed from the biospecimen samples and associated data before they are provided to researchers, such that the individuals cannot be readily identified by the researchers, research conducted using these biospecimens or data would not constitute human subjects research under the Common Rule.
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From page 77... ...
If data sharing could not be performed then investigators would need to provide an explanation. The IOM's AFHS Assets Research Program has already implemented measures that align with the NIH policy to prevent identification of any individual (see Privacy Protection section on page 74)
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From page 78... ...
The data use agreement specifies that investigator-derived data does not need to be returned to MFUA until 3 years from the end of the project to allow adequate time for research results to be published. Because the AFHS Assets Research Program has only been distributing data to investigators for just over 2 years, no derivative data from researchers has been returned to MFUA or incorporated with the AFHS data files.
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From page 79... ...
For example, the IOM staff have presented updates of the program and approved research to the Ranch Hand Vietnam Association (a veteran organization composed of former participants in Operation Ranch Hand) at their annual meetings to update them on the types of research questions that have been approved for use of the AFHS data and biospecimens.
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From page 80... ...
Effectiveness can be measured by number and variety of biospecimens or datasets provided, number of researchers served, the number of difficult to obtain biospecimens or data provided, affordability, rate of repeat requests, number of research publications generated, and usability of the provided data and biopecimens. Metrics for impact of the scientific studies conducted using the s resource data and biospecimens include importance of published studies, prestige of journals, and rate of citation; role of the study in furthering useful research techniques or technologies; and whether the study led to a regulatory approval or commercialization of a product (e.g., an in vitro diagnostic or a drug)
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From page 81... ...
Opportunities for Continued Research The longitudinal nature of the AFHS -- with its extended follow-up, high rates of retention, and repeat biological samples -- provides a valuable opportunity for research beyond the original aims of the study. As the AFHS research program moves forward, it can draw upon the experiences of other data resources and biorepositories to ensure success, such as the Armed Forces Institute of Pathology's tissue repository, the Atherosclerosis Risk in Communities Study, the Cardio vascular Heart Study, and the Framingham Heart Study.
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From page 82... ...
2012. Air Force Health Study Quality Assurance Program.
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From page 83... ...
2006. Disposition of the Air Force Health Study.
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