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6 Options and Recommendations for Further Study of the AFHS Data Assets
Pages 122-174

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From page 122...
... In answering these questions, the committee took a broad view of what constituted extension of the AFHS. It thus considered a number of options for the future of the AFHS data assets, including rendering the assets to the National Archives, dissemination of the existing assets by a research entity, continuation of data collection through publicly available sources or from the study subjects, and the extension of the AFHS in its current form.
From page 123...
... . The two primary considerations in evaluating the disposition of the hard copy records are compliance with the Federal Records Act and retention for further research purposes.
From page 124...
... Further, assuming that the scanned images are of acceptable quality and that sufficient electronic backup procedures will be established to ensure the integrity of these electronic records, the committee does not 2AFHS research has been cited in the National Academy of Sciences' Veterans and Agent Orange series reports, which are in turn a source of information used by the Department of Veterans Affairs in making determinations of whether certain health outcomes are service connected for Vietnam veterans. 3Formally, the agency is known as the National Archives and Records Administration.
From page 125...
... video tapes collected during the cycle exams. If there is to be further study of the AFHS data assets, then the committee believes that consideration should be given to taking additional steps to render these assets in a form and format that facilitates their use in the future.
From page 126...
... The X-ray films could be housed in a repository, but the committee believes it makes more sense to convert them to digital format: this will allow them to be more compactly stored and more easily made available for research purposes. Conversion is a mature and widely available technology, and the committee estimates that the labor and materials cost to digitize the X-ray films is on the order of $35,000.6 The cost of proper disposal of the original films may be mitigated through silver recovery.
From page 127...
... The digitized records, if created, should be retained and handled in accordance with the recommendations for the disposition of the AFHS data assets. Concluding Remarks Concerning the AFHS Nonelectronic Data Assets In summary, the committee believes that the (nonbiologic)
From page 128...
... These assets must be stored in a manner that ensures their integrity and security, and protects the privacy of study subjects. ALTERNATIVES FOR THE FUTURE OF THE AFHS DATA ASSETS This section addresses two closely interrelated issues: the alternatives for administering the AFHS data assets and the parameters of future research using those assets.
From page 129...
... The data assets would then presumably be handled in accordance with one of the alternatives below. This option is separate from the others discussed in this section because it would involve no action on the part of the Congress and no additional funding.
From page 130...
... Parameters of Future Research on the AFHS Data Assets Means of Carrying out Future Research on the Data Assets There are two means of carrying out any of the research options listed above: through the work of a dedicated research staff, as the AFHS is currently conducted; or via a custodian that makes the assets available to independent research
From page 131...
... In addition to facilitating the work of others, the persons responsible for managing the assets may also seek funding for their own research on them. Scope of Future Research on the Data Assets Developing a future research agenda or setting research priorities for the AFHS data assets is beyond the charge of the committee.
From page 132...
... Other studies using cohorts of veterans have taken this broader view and done so in a manner that respects the study participants. The Normative Aging Study, for example, has recently addressed the relationship between lead exposure and changes in cognition (Weisskopf et al., 2004)
From page 133...
... Continuing communication with study subjects will help ensure that up-to-date contact information is available for the cohort for use in any data collection activities. Conclusions Regarding the Future of the AFHS Data Assets Given the discussions and findings presented above, the committee has reached the following conclusion: It is advisable to extend the study of the AFHS assets by making the database and associated biospecimen collection available for study via a custodian.
From page 134...
... offered several recommendations for organizing and documenting the AFHS medical records and other study data in ways that facilitates their management. If these are implemented, they will significantly ease the job of any custodian to supervise the data and share it with others.
From page 135...
... The committee also believes that the future custodian will need a mechanism for assessing requests to access these finite resources. This is taken up in a section on the oversight of the future uses of the AFHS data assets below.
From page 136...
... of 1966, the federal Privacy Act of 1974, and specific provisions of the Public Health Service Act.
From page 137...
... In all other situations, consent must be obtained before information can be disclosed. The Privacy Act also prohibits the maintenance of identifiable health information by a governmental agency that is not relevant to the agency's purposes, and requires agencies to publish notice about each record system, describing its purposes and identifying disclosures outside the agency.
From page 138...
... The HIPAA Privacy Rule, which had a compliance date of April 14, 2003, for most covered entities, protects most individually identifiable health information that is created or received by a covered entity (a health plan, health care clearinghouse, or health care provider that conducts transactions electronically, or others performing covered functions) (Hodge, 2004)
From page 139...
... Greater effort is required to protect such resources from outside hacking, but much progress has been made in developing strategies to provide the necessary security.12 The committee noted in its discussion of procedural limitations to retaining the AFHS database (Chapter 3) that the exceptionally large amount of information available on each subject may make it possible for their identities to be determined through triangulation of the data with public sources.
From page 140...
... of the Public Health Act. CONSENT ISSUES REGARDING FUTURE USES OF THE AFHS DATA ASSETS Respect for persons is the main ethical principle underlying the requirement of specific informed consent.
From page 141...
... No matter what you decide, your decision will not affect your participation in the Air Force Health Study. If you decide now that your samples can [be]
From page 142...
... . Among the issues that are often addressed in current consent forms are what types of research may be conducted; who is going to hold and have access to these resources; what privacy and security protections are going to be used; under what conditions, if any, individuals may be recontacted either to obtain further consent or to be provided specific health-related results; and the possibility that intellectual property may be developed.14 None of these matters were addressed in any depth in the consent document that the AFHS research participants received regarding future use.
From page 143...
... At the same time, it seems at best imprudent to let the current study expire and then have the new custodian approach the participants seemingly out of the blue. Recognizing that complexity can be confusing, the committee recommends the following two part process to ensure a smooth transfer: Prior to the end of the study, the Air Force Health Study should notify the participants of the following: • The study, as currently constituted, is ending.
From page 144...
... If health information regarding the wives and children of the AFHS re search participants is made available for future research, consent, and where appropriate, parental permission and assent, must be sought from these individuals. OVERSIGHT OF THE FUTURE USES OF THE AFHS DATA ASSETS To comply with the Common Rule and ethical precepts, research projects must be scientifically sound: that is, designed so that they can achieve valid results.
From page 145...
... The committee notes that future IRB review of research on the AFHS data assets is not guaranteed. According to recent guidance from the DHHS Office of Human Research Protections (OHRP)
From page 146...
... . An advisory and oversight board would provide several important benefits to the future custodian of the AFHS data assets.
From page 147...
... Two lay members, study subjects if possible, should be included to provide insights from the participant and veteran perspectives. The committee does not believe that a federally administered advisory committee like the RHAC is necessary to obtain independent advice on the future conduct of studies of the AFHS data assets and cohort.
From page 148...
... . The committee recommends that: The new custodian of the AFHS data and biospecimens should commit to developing and implementing strategies for apprising the research subjects about the ways in which their information is used and the scien tific discoveries that result.
From page 149...
... The Mechanism for Providing Independent Oversight of Future Research The sections above thus recommend a three-pronged approach to providing independent oversight for future research using the AFHS data assets: the review of proposals for scientific merit and adherence to ethical, legal, and related considerations by an IRB and, separately, an advisory and oversight board. In addition, the committee recommends that steps be taken to ensure that the research is carried out in a manner transparent to study subjects, through systematic communication of research plans and results.
From page 150...
... The primary advantages of having the National Archives as the custodian of the AFHS data are that they have the mission and -- unlike any other potential custodian -- the funding to act as a repository. The Archives manages access to other epidemiologic databases, and have legal mandates to protect privacy and provide security for the data.
From page 151...
... . DOD thus appears to have the capacity to serve as a manager and analyst of the AFHS data assets, and -- separately or in addition -- function as a repository for the specimens.
From page 152...
... and the Seattle Epidemiologic Research and Information Center (Seattle ERIC) -- manage data assets that are in some respects similar to AFHS's and make these assets available to independent, outside researchers under controlled circumstances.
From page 153...
... A MAVERIC collaborator is required to be among the investigators in order to both assure the appropriate use of the data assets and to facilitate access to them. The facility's core laboratory stores ~200,000 specimens from multiple collections -- including transferred archived collections -- comprising serum, plasma, urine, buffy coats, DNA, and immortalized cell lines (MAVERIC, 2005b)
From page 154...
... Issues Regarding VA and VA-Affiliated Epidemiologic Data Management and Distribution Mechanisms The VA Epidemiologic Research and Information Centers -- both the existing ERICs and the general ERIC concept -- have several attributes that are desirable in a future custodian of the AFHS data assets. The centers have mechanisms in place for the collection, management, analysis, and dissemination of veterans' health data.
From page 155...
... Both maintain biospecimens as part of their collections. However, it is uncertain whether the VA would want to establish a new ERIC or whether the existing centers would be interested in taking on responsibility for the AFHS data assets.
From page 156...
... and provides funding to researchers to study them. The cohort's past exposure to herbicides and experience as veterans does not present a barrier to studies of them via NIH or CDC research channels,23 and these bodies have considerable experience in managing, analyzing, and disseminating epidemiologic data and biologic specimens.
From page 157...
... Louis, Missouri, to facilitate research involving materials in the National Archives' primary repository for service, health, and medical information on discharged and deceased veterans. Established in 1946, MFUA has produced a number of National Academy of Sciences reports, and written or collaborated in over 460 papers published in the peer-reviewed scientific literature.
From page 158...
... Identify a New Custodian Through a Competitive Process The above described options for future access to and management of AFHS data assets all involve designating an existing institution as either the custodian itself or as the parent body for a new custodian established under its aegis. However, one could alternatively open up the management of the data assets to a competitive process wherein universities, nonprofit or private research entities, research consortia, and the like could submit proposals.
From page 159...
... Statutory constraints and agency practices would ensure that ethical, legal, and social issues in handling the AFHS data assets were taken into account. The major issue in the eyes of the committee is whether there is 28As compared to the data analysis operation that they currently conduct.
From page 160...
... MAVERIC, Seattle ERIC, and MFUA all have prior experience in veterans' health studies: collecting and storing epidemiologic data; disseminating it to independent researchers; fostering collaborations with those researchers; maintaining quality control over the studies that use their datasets; and publishing results in the peer-reviewed literature. All have military or veterans health issues as the central focus of their operations, but also conduct other types of studies with their data assets.
From page 161...
... The committee thus does not believe there is any clearly superior candidate(s) that it can recommend to be the future custodian of the AFHS data assets.
From page 162...
... Costs associated with conducting research on the data assets These categories are addressed in turn below. As the committee recommended that the AFHS be extended by making the database and associated biospecimen collection available for study via a custodian, potential costs are considered from this perspective.
From page 163...
... budget (DTIC, 2005) includes allocations to perform documentation and organization of the data assets in anticipation of their future disposition.
From page 164...
... Preparation of custom datasets allows for far greater flexibility in type and scope of available data at the expense of the time to assemble them.32 This approach used by Seattle ERIC, MAVERIC, and MFUA as a mechanism for data dissemination. Limited access data enclaves, which are discussed earlier in this chapter and in Appendix E, require staff time for supervision of researchers and secure space and equipment for their use.
From page 165...
... Details of the committee's observations on this topic are presented earlier in this chapter in a section entitled "Oversight of the Future Uses of the AFHS Data Assets." Expenses related to database management are best expressed in terms of workforce needs, as the allocations required to cover direct and indirect costs vary by location and type of institution (government, nonprofit, commercial) as well as over time.
From page 166...
... This would result in additional costs in the range of dollars per vial in the first year of the custodian's operation.34 It is not clear whether secure transfer of the biospecimen collection under cryogenic conditions is covered under AFHS funds allocated for the "turnover of archives/biological samples to designated agencies" (DTIC, 2005)
From page 167...
... Costs Associated with Conducting Research on the AFHS Data Assets The committee recommends that further study of the AFHS medical records, other study data, and laboratory specimens be accomplished by making these 36Table B-14 in Appendix B provides a partial list of the laboratory analyses coded in the database and which cycle(s) the specimens were collected in.
From page 168...
... Pilot studies and empirical analyses of the existing AFHS dataset could have relatively modest needs for support -- tens of thousands of dollars -- while investigations that include gathering additional data and specimens from all of the subjects in the cohort could easily cost millions of dollars. The studies that will be conducted on the data assets will depend on the initiative and imagination of prospective researchers, as tempered in the crucible of funding, institutional, and scientific review.
From page 169...
... The program should span the first three years after the successor custodian establishes operations. Other than the limited-life grant program figures, no estimate can be offered of the costs associated with conducting research on the AFHS data assets as these depend so heavily on the form of research contemplated.
From page 170...
... . Consent form provided to the Committee on the Disposition of the Air Force Health Study by the AFHS.
From page 171...
... 2001. US Army Chemical Corps Vietnam veterans health study: preliminary results.
From page 172...
... PowerPoint presentation before the Committee on the Disposition of the Air Force Health Study, Washing ton, DC. MMCS (The Multiethnic/Minority Cohort Study)
From page 173...
... . NHS (Nurses' Health Study)
From page 174...
... 2003. Effect of negative emotions on frequency of coronary heart disease (the Normative Aging Study)


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