6
Options and Recommendations for Further Study of the AFHS Data Assets

This final chapter of the report draws on the material presented previously to draw conclusions and recommendations regarding the disposition of the medical records, other study data, and laboratory specimens collected in the course of the Air Force Health Study (AFHS) after its currently scheduled termination date. The charge to the committee set forth a set of interrelated questions to be addressed in relation to future research using the AFHS data assets: in brief, whether—and if so in what form—the study should be extended, whether the data assets should be made available for independent research, and whether—and if so, in what form—independent oversight of these activities should be provided. The committee was also asked to evaluate the potential value and relevance of further research, and its potential cost. Assessing the potential value and relevance of future research is integral to the question of whether there is scientific merit to retaining and maintaining the data assets—this was addressed in Chapter 5. The remaining issues are dealt with here.

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.



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Disposition of the Air Force Health Study 6 Options and Recommendations for Further Study of the AFHS Data Assets This final chapter of the report draws on the material presented previously to draw conclusions and recommendations regarding the disposition of the medical records, other study data, and laboratory specimens collected in the course of the Air Force Health Study (AFHS) after its currently scheduled termination date. The charge to the committee set forth a set of interrelated questions to be addressed in relation to future research using the AFHS data assets: in brief, whether—and if so in what form—the study should be extended, whether the data assets should be made available for independent research, and whether—and if so, in what form—independent oversight of these activities should be provided. The committee was also asked to evaluate the potential value and relevance of further research, and its potential cost. Assessing the potential value and relevance of future research is integral to the question of whether there is scientific merit to retaining and maintaining the data assets—this was addressed in Chapter 5. The remaining issues are dealt with here. 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.

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Disposition of the Air Force Health Study DISPOSITION OF THE AFHS NONELECTRONIC DATA ASSETS Hard Copy Records The AFHS’s collection of hard copy originals of cycle physical exam reports and completed questionnaires; the subject’ medical, military administrative, and vital status records; research reference materials; and copies of the study’s reports and papers take up ~5,350 cubic feet of records storage systems space (AFHS, 2005b). All have been scanned and the images1 stored in electronic files in Portable Document Format (PDF). 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. These are addressed below. Compliance with Records Retention Requirements The U.S. Air Force (USAF) has regulations (termed instructions) defining records management responsibilities (USAF, 2003) and the proper disposition of records (USAF, 1994). The latter document directs that no records be disposed of “without the specific authority of the Archivist of the United States” (§ 1.1.1) and indicates that “valuable research records” are generally sent to the Archive’s Washington National Records Center for evaluation and either transfer to permanent storage or destruction (§ 2.12.2.6). A threshold issue is thus whether any of the resources of the AFHS are subject to the requirements of the Federal Records Act, which requires agencies to “make and preserve records containing adequate and proper documentation of the … decisions, procedures, and essential transactions of the agency … designed to furnish the information necessary to protect the legal and financial rights of the Government and of persons directly affected by the agency’s activities” (44 USC § 3101). As defined by the Act, records include the following: All books, papers, maps, photographs, machine-readable materials, or other documentary materials, regardless of physical form or characteristics, made or received by an agency of the United States Government under Federal law or in connection with the transaction of public business and preserved or appropriate for preservation by that agency or its legitimate successor as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities of the Government or because of the informational value of data in them. (44 USC § 3301) Using this definition, the biologic specimens collected during the AFHS are not subject to the Act and can be handled pursuant to the recommendations of- 1   The committee was told by AFHS staff that the text in these files is not, in general, searchable.

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Disposition of the Air Force Health Study fered later in this chapter. Because the findings of the AFHS have been a basis for certain disability determinations,2 an argument can be made that the data and supporting documentary materials created during the study (the medical records) are covered by the Act. If these resources are records within the statutory definition, the National Archivist must determine whether they “have sufficient administrative, legal, research, or other value to warrant their continued preservation by the Government” (44 USC § 3303a). If not, and the vast majority of materials are not judged worthy of retention, the Archivist may dispose of them following notice in the Federal Register and opportunity to comment. Separately, the AFHS must meet other applicable Department of Defense (DOD) and USAF records retention and disposal requirements. In the event that the Archivist concludes that the data and supporting documentary materials are records that should be retained, either the original hard copy documents or the PDF copies could be stored (NARA, 2006). Documents stored in the National Archives3 are subject to the requirements of the Federal Privacy Act of 1974, discussed below, as well as all the protections that were provided in the research protocol (36 CFR § 1228.274). Committing the records to the National Archives would not preclude using them for research in the future. The Archivist can—again, subject to Privacy Act requirements—make the PDFs, other electronic files, and the hard copy documents available to researchers at one of their facilities or via the World Wide Web. Alternatively, the Archivist can place the materials with another entity within or outside the federal government (44 USC § 2107(3)). The Federal Records Act does not preclude additional copies of the dataset being placed with, used by, or managed by other entities. Retention for Further Research Purposes The committee believes the major obstacles to retaining the AFHS hard copy records are the costs to securely store and manage the paper and the possibility that these records may be improperly disclosed to third persons. The committee has not explicitly estimated costs for hard copy records storage, as this varies considerably by location. 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 2   AFHS 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. 3   Formally, the agency is known as the National Archives and Records Administration.

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Disposition of the Air Force Health Study believe that it is necessary to retain hard copy records in order to conduct further research on the AFHS cohort. Modern privacy concerns suggest secure destruction of unnecessary medical records held by government bodies. Recommendations Regarding the AFHS Hard Copy Records Given the legal, regulatory, and logistic considerations discussed above, the committee recommends the following: All of the hard copy originals of AFHS documents that have been saved in electronic form should be destroyed unless the National Archivist concludes that these records must be maintained or they are subject to other records retention requirements. No matter what decision is made by the National Archives regarding the retention of the records produced during the AFHS, a separate complete set of electronic copies of these records should be kept for possible placement with another custodian. These recommendations are predicated on the assumption that the electronic images (PDFs) accurately represent the hard copy records. The committee was informed that the PDF files were subjected to quality control checks for readability, and that special attention was given to poor quality originals4 to try to enhance the scanned images (J. Robinson, Air Force Health Study, personal communication, January 10, 2006). Facilitating Future Use of Other Nonelectronic Assets The committee’s interim letter report (IOM, 2005a) offered several recommendations for organizing and documenting the serum, whole blood, urine, and semen specimens collected by the AFHS that would facilitate their future use. These recommendations are reiterated in Chapter 4 of this report. There are three other components of the AFHS data collection that are neither in traditional paper nor electronic form: the electrocardiogram (ECG) strips, X-ray films, and Super-VHS (SVHS) 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. ECG Strips and X-Ray Images As Chapter 3 notes, 12-lead, scalar, resting ECGs were obtained from subjects during all six physical exam cycles. The ECGs were evaluated and informa- 4   These include records dating from World War II and those printed on thermofax or other unstable media.

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Disposition of the Air Force Health Study tion regarding various parameters5 and evidence and type of prior myocardial infarction were coded and placed into the electronic database. There are also over 15,000 X rays, primarily chest films captured during Cycles 2–6. Chest X rays are objective evidence of lung pathology (at least by one measure), and ECGs serve the analogous function for cardiovascular pathology. Both of these could be important endpoints for herbicide or dioxin exposure, and both are likely to show findings well in advance of symptoms or medical diagnoses. Because these measures are largely standardized, in the sense that chest X rays and ECGs are taken in more or less the same way for everyone and have been for decades, they provide a potentially valuable resource defining preclinical health endpoints that may relate to subjects’ exposures. The serial nature of these data provides critical time-point information and allows for the analysis of changes over the 20 years in which data were taken. It also lessens concerns about confounding from intercurrent disease that might affect one cycle of measurements. The X-ray films and ECGs are thus valuable components of the database. The major obstacles to retaining these materials are the costs to index and store them and the possibility that these records may be inappropriately disclosed to third persons. Means exist for converting paper ECGs to digital format (Badilini et al., 2005; Moody, 2005) but the technologies are not widespread, and the committee cannot offer any observations on their utility or costs. 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. The committee thus recommends that: All electrocardiogram strips collected in the course of the AFHS should be retained; their documentation should be reviewed and, if needed, supplemented to ensure easy retrieval. All X-ray films collected in the course of the AFHS should be digitized with acceptable quality control, this resource properly documented, and thereafter the original films be disposed of according to standard practices. The digitized records should be retained and handled in accor- 5   Depending on the exam cycle, these parameters included ST-T, P, U, and Q wave morphology; QRS and QT interval; axis deviation; and evidence of bradycardia, tachycardia, arrhythmia, and abnormal sinus rhythm. 6   This estimate is based on information provided to the committee by the Vanderbilt University Medical Center Department of Radiology on September 8, 2005, and was calculated as follows: ((5 minutes labor/film × $10.15/hour) + ($1.31 materials/film)) × 15,400 films.  

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Disposition of the Air Force Health Study dance with the recommendations for the disposition of the AFHS data assets. SVHS Video Tapes There are 3,074 Super-VHS (SVHS) format video tapes in the AFHS data collection, comprising high-resolution images of subjects’ teeth taken during the Cycle 4 and 5 exams. The tapes were made as part of a National Institute of Dental and Craniofacial Research (NIDCR) adjunct to the study examining the association between exposure to elemental mercury via dental amalgams and measures of neurologic function (Kingman et al., 2005). The major obstacles to retaining these records are, again, the costs to index and store them and the possibility that any personal information on the tapes might be disclosed to third persons. The committee does not have any suggestions for future research employing the videos but understands that such material, in combination with other data on the subjects, can be useful in oral epidemiology studies. As this data asset was gathered under a contract with NIDCR and would be of primary interest to the oral epidemiology community, the committee suggests that the NIDCR be consulted on whether the tapes can be usefully exploited by the research community. If the decision is made to retain them, then their usefulness will depend on their linkage to the rest of the AFHS data assets, and it thus makes sense for them to be a part of the collection. In this circumstance, the SVHS tapes—which are in a little-used and largely-obsolete format—should be digitized and written to a medium such as DVD for ease of long-term storage. The cost of this would be ~$50,000, based on $15/tape for the conversion. Additional costs would be incurred in documenting and indexing the materials. The committee therefore recommends that: The AFHS should consult with the National Institute of Dental and Craniofacial Research on whether the video tapes of subjects’ teeth collected in the course of the study have future research value. If the tapes have value for future research, they should be digitized with appropriate quality control, written to an acceptable long-term storage medium, properly documented, and thereafter the original tapes be disposed of according to standard practices. 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) data assets of the AFHS that are not already in electronic form should be converted to this form

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Disposition of the Air Force Health Study where a mature technology exists to do so and where the assets have future research value. Federal regulations addressing the preparation of electronic records for transmittal to the National Archives (36 C.F.R. § 1228.270) contain specific information about file formats and media that are appropriate for long-term storage. 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. Five alternatives were identified for administering the assets after the currently scheduled termination date of the study in September 2006. The committee’s conclusions on the preferred means for carrying out future research on the assets and the scope of that work—including potential future data gathering—are in turn driven by their consideration of these alternatives. Alternatives for Administering the AFHS Data Assets Render the Data Assets to the National Archives for Evaluation and Possible Retention As noted above, federal law and USAF regulations require that the National Archives make a determination of whether it will retain the data collected in the course of the AFHS. Rendering the assets to the Archives is thus the default option. In this alternative, any further research on the assets would be dependent on the Archives deciding to preserve the data and make them available to the public—the latter decision subject to applicable privacy and other laws. It could choose to make the data accessible as it has for other epidemiologic datasets in its collection such as the Hill Air Force Base Study Files (NARA, 2000) which includes electronically encoded information on the health status of persons whose job at the base exposed them to hazardous substances and potential diseases (Blair et al., 1998). The Archives also holds data from the Vietnam Experience Study (VES), another study that included a medical examination, laboratory tests, and a psychologic evaluation of a cohort of Vietnam veterans. However, the Archives website indicates, without further explanation, that the VES records cannot be released (NARA, 2005). Privacy considerations might lead to a decision to restrict access to the AFHS data for an extended time period—possibly 75 years or more—intended to ensure that all study subjects are deceased before information on them is made public. Work on any publicly available materials would need to be done without any research support to investigators as the Archives does not provide this service.

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Disposition of the Air Force Health Study The Archives does not maintain biospecimens. A 2001 GAO congressional briefing (GAO, 2001) mentioned that the AFHS was considering transmitting biospecimens to the Armed Forces Institute of Pathology (AFIP), but it is not known whether this option was actively pursued or whether the AFIP would have an interest in the samples.7 The National Archives sometimes chooses to manage materials through disposal by donation, in which case they would be passed on to one or more entities that would assume responsibility for them. 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. The National Archives already has the mission to evaluate—and where appropriate to preserve and make publicly available—documents and materials created in the course of business conducted by the United States federal government. It does not, however, have exclusive rights to the data. No matter what the Archives decides, copies of the data can be made available through other channels. Identify or Establish a Research Entity for Dissemination of Existing Data Assets This alternative would require a research entity with the funding and mission to carry out responsible management of the assets. Management responsibilities would include the ability to securely store materials, to conduct or manage the appropriate review of requests for data access, and ensure that subjects’ privacy was maintained. It could also include aiding investigators in understanding and exploiting the assets, collaborating with outside investigators, and preparing custom data sets for analysis by those researchers. Specimens could be disposed of, maintained by the research entity, or stored by a separate entity. It should be noted, however, that the specimens have little value without the detailed medical and questionnaire data collected. Access and linkage to subjects’ data are thus necessary components to the retention of the specimens. Identify or Establish a Research Entity to Continue Passive Data Collection on AFHS Subjects Under this alternative, the activities described above would be expanded to include the collection of data on the AFHS morbidity or mortality cohort through publicly available sources such as the National Death Index. Such work could 7   It should also be noted that the AFIP was slated for closure as part of the DOD Base Realignment and Closure 2005 initiative (Kaiser, 2005). It is unclear how the specimens in its collection would be affected by this.

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Disposition of the Air Force Health Study take place under one or both of two circumstances. It could be part of an explicit research project conducted by the entity holding the existing data assets. Alternatively or additionally, one-time studies could be pursued by outside investigators. If the entity holding the data assets were to carry out this work, there would be the need for a specific research plan with a data manager or principal investigator and some assurance of research funding for the period covered by the plan. An outside investigator could carry out the same work, although there would be no assurance that data would be collected systematically or consistently over time. Identify or Establish a Research Entity to Maintain Contact with the AFHS Subjects and Conduct or Facilitate Further Active Data Collection This alternative would extend the passive data collection option above to also encompass active following of and contact with AFHS cohort participants. Active administration of an epidemiologic cohort entails far more effort and cost than the previously identified options. It would require regular communication with study subjects to ensure that contact information remained current and to ensure that they were vested members of the research team. Active data collection could take many forms, including questionnaires seeking self-reported health or sociodemographic data, or ascertaining vital status from all or parts of the cohort; as well as conducting limited physical examinations of subjects. New tests results could be obtained and medical imagery or specimens could be collected. Data gathering could be accomplished through outside investigator initiatives or through an explicit research plan carried out by the entity responsible for holding the assets. Extend the AFHS Extension of the AFHS would entail a decision by Congress to provide funds to continue the administration of periodic, extensive data and biospecimen gathering through cohort-wide physical examinations and questionnaires. Support for a dedicated staff to maintain contact with the cohort and manage and analyze these data assets would also be required. This alternative could be accomplished with the existing AFHS infrastructure or by assigning responsibility and funding to some other entity. 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-

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Disposition of the Air Force Health Study ers. The committee believes that the second of these options is more desirable because it taps the creativity, expertise, and motivation of the entire research community to pursue promising applications. This custodian should not act as a passive repository of the data but should play an active role in fostering its use. Such activities should at minimum include collaboration with outside researchers to ensure the assets are used effectively and with proper respect for the participants. Depending on the scope of future research, the custodian’s responsibilities could also include the preparation of restricted datasets or managing interactions between researchers and the study subjects for the collection of new data. Work done on behalf of outside investigators should be compensated, of course—a cost that these parties can factor into their requests for research support. 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. However, it is possible to talk about the scope of such work in general terms. In Chapter 5, the committee indicated that while AFHS analyses focused on the effects of herbicide or dioxin exposure, data were collected on a wide range of potential influences on disease and health status, and that a number of outcomes not addressed in the AFHS reports could potentially be studied with them. Given the nature of the cohort, all studies of the data assets are arguably studies of veterans’ health. It may, thus, be more appropriate to view the range of studies possible with the data as a function of how closely they conform to the original intent of the AFHS. Potential studies could be classified, for example, by whether they address the health consequences of wartime exposure to herbicides or dioxin, service in Vietnam, service in the military during the Vietnam era, aging in males, or general health and well-being. A less specific construction might define the Cycle 6 consent form term military health and add a category for all other studies. Depending on the objective of the specific investigation, the AFHS’s division of the cohort into Ranch Hand and comparison subjects might or might not be relevant—research might combine the two or only use one of the subcohorts. Other studies might need to identify a different comparison cohort because all of the subjects were in-theater veterans. Researchers conducting work under one of these rubrics would, of course, need to factor the relevant limitations of the cohort. The committee believes that the issues of military and veterans’ health should be paramount in future research but that other applications are also appropriate. Taking a broader view of applications for AFHS data assets will allow the study to generate results that could potentially inform a greater range of VA compensation and health delivery issues—not just those related to wartime exposure to

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Disposition of the Air Force Health Study herbicides. It may also allow a better understanding of health issues that can best be explored in a population for whom detailed longitudinal data are available. 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) and the effects of air pollution on heart rate variability (Park et al., 2005) while the Vietnam Era Twins (VET) Registry database has been used to examine the genetic and dietary influences on nephrolithiasis (Goldfarb et al., 2005) and the links between depression symptoms, hypertension, and heart disease (Scherrer et al., 2003). The decision on the scope of future research is ultimately in the hands of the participants who contributed the data—their informed consents will define the span of the work. It is important, then, that the consent request clearly communicate the options and what research might flow from them—a topic that is addressed below. Future Data Gathering The AFHS’s current collection of data and specimens is rich and could be a source for studies for several years. However, there are also options for supplementing the collection. One of these is for the custodian to collect or facilitate the collection of data from publicly available sources. Chapter 5 and Appendix D discuss the possibility of expanding the study’s period of analysis through a mortality follow-up of the cohorts using the National Death Index and other data sources. Rough estimates presented in the appendix suggest that, even in analyses limited to the subjects who participated in one or more cycle exams, the AFHS cohort is large enough to detect associations of realistic magnitude in future mortality analyses of health outcomes of potential interest to Vietnam veterans. The information needed to do such work could be obtained for no more than a few thousand dollars. A second, more detailed level of involvement is to engage in further data gathering from the participants. Questionnaires administered through the mail, over the phone, or even via the web could be used to obtain information from all or from subsets of the cohort. Third parties could be contracted to administer limited physical exams to selected participants via in-home visits, or centralized locations could be used in areas where there were concentrations of subjects. The committee believes that there is merit is keeping open the possibility of further data gathering, allowing future investigators to consider and pursue the additional avenues of research. As indicated above, compiling publicly available data is relatively straightforward and inexpensive, and serious consideration should be given to pursuing this. It is unclear whether further active data gathering efforts will be practicable—this will depend on whether enough study partici-

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Disposition of the Air Force Health Study Costs Associated with Managing the Database The primary costs of maintaining AFHS’s medical records and other study data are associated with storage and handling of the electronic materials. The custodian will need to have or obtain sufficient space on servers to contain at least ~525 GB of files. Software for database management and possibly analysis will be required and a modest amount of file cabinet space needed. If collaborating researchers are allowed direct access to the electronic files, a secure room will be needed for this purpose. There will also be some one-time costs associated with the start of the custodianship, including those connected with transferring files, setting up storage, creating protocols for managing the data, and obtaining new consent from the subjects for the continued use of the materials. Earlier in the chapter, the committee recommended that all of the hard copy records of the AFHS that have been saved in PDF form be destroyed unless the National Archivist concludes that these records must be maintained or they are subject to other records retention requirements. There is no need for the custodian to hold the hard copy versions of these materials. The primary means for providing data to researchers for studies are to create public use databases, prepare custom data sets for specific research projects, and supply access via a limited access data enclave mechanism. Chapter 3 notes that, for a time in the early 2000’s, deidentified data from physical examination Cycles 2–5 were available to the public. However, AFHS later withdrew access, owing to questions over whether the study subjects had given consent for the posting. Explicitly obtaining such consent would allow relatively limited amounts of data to be freely available for research without the need for staff time after the datasets and associated documentation were created. The limitations imposed by the need to protect the interests of subjects would, however, greatly limit the kind and scope of research that would be permitted with these data. 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. Generally speaking, the ease with which data can be retrieved and correspondingly the cost of pulling data for research purposes depends on the quality of the assets’ documentation. If the committee’s documentation recommendations are followed, there will be abundant information for prospective researchers 32   Only qualified researchers who execute privacy and confidentiality agreements and who conform to data security requirements would be able to request a dataset like this because it could contain information that could be used to discern subjects’ identities.

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Disposition of the Air Force Health Study to use in planning studies and for the custodian’s staff to use in facilitating that work. Less time and effort will be expended by both parties in the mechanics of getting research done, leading to lower labor costs per study. However, better documentation may well lead to more demand for the data assets and thus greater time commitments from the staff. The custodian will also incur costs associated with implementing the committee’s recommendations for providing independent oversight of future research. A three-pronged approach was put forward: 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, and systematic communication of research plans and results to study subjects. In brief, the boards will require time from the custodian’s staff for managing applications for data access and interactions with board members, while communications with subjects will involve the development and dissemination of newsletters, websites, or other media. 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. The committee spoke with investigators responsible for other epidemiologic datasets that permit public access. They indicated that typical needs would be for time from a principal investigator or project director, database manager, programmer(s), clerical personnel, and perhaps a webmaster or participant liaison. With the possible exception of a database manager, there would be no need to allocate an entire full-time equivalent (FTE)33 to any of these tasks. Roughly speaking, the committee estimates that $150,000–300,000 per year would be required to support a data management and access operation of the type proposed here. The actual amount would depend critically on the custodian chosen and the number and type of studies proposed for and conducted with the data assets (which would in turn influence the amount of staff time required to support those studies). At least some of these funds would presumably be derived from fees assessed to researchers seeking access to the resources. It is important, especially in the early years of this new phase in the life of the AFHS resources, that such fees be set a level that will facilitate use of the resource. Costs Associated with Managing the Biospecimen Collection The costs associated with the maintenance of the biospecimen collection are related to its physical maintenance and retrieval of materials for research purposes. 33   FTE is a standard means of characterizing personnel needs. One FTE is one job at 100% time.

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Disposition of the Air Force Health Study Physical Maintenance of the Collection The cost for physical maintenance of the AFHS biospecimens vary considerably depending upon the setting in which the collection is housed. A research university with a large capacity biospecimens repository may impose relatively modest costs to store materials for a project that has some affiliation with it. A government repository would incur costs in accepting and storing specimens, but there is no set means for factoring how this would be handled for budgeting purposes. Informal discussions with commercial repositories suggest that such institutions would charge $200,000 or more per year to house a collection the size of the AFHS’s. Biospecimens may need to undergo inventorying and labeling (barcoding, for example) upon receipt so that they can be integrated into a repository’s management system. 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). If the specimens are instead maintained by a freestanding entity that does not have oversight for other biologic materials, costs for establishing and maintaining the repository will be higher than if the materials are received and maintained by an entity with an existing repository. Expenses such as rental space for freezers will vary, depending upon where in the country35 and possibly the type of institution at which the specimens are maintained. Other expenditures related to the set-up of a new facility—the purchase or rental of laboratory-quality ultralow temperature freezers and creation of a specimen inventory management system, for example—will also be required. Regardless of where the specimens are housed, maintenance of the collection requires space for the 23 freezers currently used for specimen storage and backup freezers or the equivalent volume in comparable storage conditions, space for additional freezers for future aliquots, personnel to monitor freezer function, costs for preventive maintenance and repair when compressors fail, and electricity costs. An alarm system must also be used to monitor freezer function and alert personnel of problems whether or not they are on site. If the specimens were housed in a preexisting facility, then monitoring would be subsumed into the staff’s existing responsibilities and could be accomplished with only a nominal increase in existing overhead costs that would be covered in the storage fee. In a freestanding facility, sufficient staff to respond to failures at all times would be required. 34   Over 86,000 specimens have been collected over the course of the study. 35   State, local, and institutional regulations that affect biospecimens can be additional sources of regional variation in cost.

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Disposition of the Air Force Health Study Retrieval of Materials for Research Purposes Costs associated with the retrieval of biospecimens from storage may include those related to locating, pulling, realiquoting, packing, and proper shipping. In addition, time from a database manager may be needed to select the study subjects and exam cycles to be included in a specific project, identify locations of the specimens requested and to update the repository database when specimens are removed. If the custodian maintains its own repository, laboratory space will be required for the technical staff to work on dry ice to maintain the specimens during handling and do any realiquoting. Associated laboratory supplies (e.g., pipettes and tips, gloves) will also be needed. For specimens labeled with the subject’s name, it will be necessary to relabel or carefully delete the identifying information before shipment, if complete vials are being sent. A source of specimens for use in quality control for laboratory testing will also need to be identified. If new specimens are collected, additional freezers or space will be required. Realiquoting the specimens into smaller volume vials might result in some space saving, at the expense of a freeze-thaw cycle. Repositories do not, in general, publicly post the amount they charge for their services, making cost estimates difficult. Informal discussions with such organizations suggest it will cost between dollars and tens of dollars per specimen for samples to be extracted and shipped from a repository. Economies of scale may be realized with larger numbers of samples. Many, but not all, repositories can carry out in-house laboratory testing, obviating the need for shipment and lowering the access cost. Laboratory testing costs, which are in addition to retrieval fees, vary quite widely depending on the procedure. Simple clinical parameters—many of which, it should be noted, were already measured and coded in the AFHS database36—cost tens of dollars per sample; newer and more complex tests, hundreds of dollars per sample. University and government laboratories may have different cost structures for resident researchers; this also affects estimates. The committee assumes that the custodian would follow the practice of other repositories and impose fees for biospecimens access that would recover at least some their costs. As the committee noted in its discussion of database access management, it is important—especially in the early years of this new phase in the life of the AFHS resources—that such fees be set a level that will facilitate use of the resource. 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 36   Table 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.

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Disposition of the Air Force Health Study materials available for research via a custodian that takes an active role in fostering use of the assets. It does not propose that particular studies or type of studies be conducted nor does it put forward a research agenda. A number of possible topics for future work are listed in Chapter 5. The cost of conducting new studies will greatly depend on their scope and whether they need to use other databases, analyze biospecimens, or contact subjects. 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. The committee believes that funds are needed to establish the AFHS data assets as a resource for independent researchers. Its judgment is that a limited-life, small grant program is the best way to accomplish this goal. The committee anticipates that this program will stimulate prospective researchers to also seek external funding from other existing sources for further or more in-depth projects. Such an approach has been successfully used by the federal government in other circumstances. The committee therefore recommends that: The Congress should allocate a minimum of $250,000 per year of direct costs for three years for small grants for secondary data analysis or pilot projects using the data assets of the AFHS. These funds should be in addition to already-planned or contemplated support of Vietnam veterans’ health research—funding should not be diverted from other research efforts for this initiative. An allocation of at least $250,000 per year will provide at least partial support to one to three research projects. This seed money is intended to raise the visibility of the AFHS data assets in the research community and stimulate prospective researchers to seek additional sources of support. Such sources could include the National Institutes of Health, Centers for Disease Control and Prevention, Department of Veterans Affairs, and private foundations. MAVERIC provides a listing of these for prospective users of their assets (MAVERIC, 2006). The Seattle ERIC program has administered a pilot study grant program, details of which are available at their website (Seattle ERIC, 2006). It is the committee’s judgment that a 3-year trial will be sufficient to establish the AFHS assets as a research resource and that, thereafter, it is appropriate that research projects that propose to use them obtain support through customary funding channels. The committee has no recommendation regarding the mechanism by which the support proposed here should be administered. This could take place through a federal entity such as the NIH or VA, or the responsibility could be assigned to

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Disposition of the Air Force Health Study the custodian. Outreach activities by the custodian—conference presentations, articles in professional journals, or informational workshops, and the like—would help ensure that the scientific community is made aware of the small grant program and, more generally, the research possibilities presented by the data assets. Although the committee is enthusiastic about the potential for future studies of the AFHS data assets, it understands that the viability of such work is not assured. It therefore believes that it is appropriate to revisit the question of support for further work after the committee’s recommendations have been implemented and have had time to play out in the research realm. A 5-year commitment—that is, two years after the last small grants proposed above are made—should be sufficient to establish whether the AFHS resources have value and relevance as a resource. The committee therefore recommends that: Five years after the chosen custodian assumes responsibility, a committee should be convened to evaluate the potential value and relevance of extending further support to the maintenance of access to the data or the biospecimens collected in the course of the AFHS. Summary Remarks Regarding the Costs Associated with Extending the AFHS As the discussion above makes clear, there are a number of uncertainties and variables in the costs associated with extending the AFHS as a data resource managed by a custodian. It is therefore difficult for the committee to present a bottom-line estimate for the total cost of implementing its recommendations. The major fixed costs for the custodian are those related to the management of the database and biospecimens. Roughly speaking, the committee estimates that $150,000–300,000 per year would be required to support database management responsibilities and an additional $200,000 or more per year for proper maintenance of the biospecimens. First year costs would be higher because a number of one-time only tasks would have to be performed to set up the operation. Reinventorying of the biospecimens, if required, would be a major component of such start-up costs. Estimates of the fixed costs could be refined once a decision is made on the custodian. The committee also recommends that a minimum of $250,000 per year of direct costs be allocated to a limited-life small-grants program to stimulate interest in and awareness of the AFHS data assets within the research community. 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. However, these costs are the responsibility of prospective researchers, who will need to obtain their own support from funding sources.

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Disposition of the Air Force Health Study The committee believes that the costs of properly documenting the data assets, making them available to the research community, and implementing the proposed 5-year program to encourage their use are small in comparison with the government’s investment of ~$143 million to date. The potential benefits of these actions, while subject to considerable uncertainty, appear to greatly outweigh the costs. REFERENCES AFHS (Air Force Health Study). 1982. An Epidemiologic Investigation of Health Effects in Air Force Personnel Following Exposure to Herbicides: Study Protocol, Initial Report. Brooks AFB, TX: USAF School of Aerospace Medicine. SAM-TR-82-44. AFHS. 2005a (January 20). Air Force Health Study Post-End-of-Protocol Options. Memorandum to the Committee on the Disposition of the Air Force Health Study by the AFHS. AFHS. 2005b (January 28). Ranch Hand II Follow-On Effort. Spreadsheet provided to the Committee on the Disposition of the Air Force Health Study by the AFHS. AFHS. 2005c (January 26). Consent form provided to the Committee on the Disposition of the Air Force Health Study by the AFHS. AFIP (Armed Forces Institute of Pathology). 2005. National Pathology Repository. [Online]. Available: http://www.afip.org/Departments/repository/npr.html [accessed August 30, 2005]. Army Medical Surveillance Activity. 2005. The Department of Defense Serum Repository. [Online]. Available: http://amsa.army.mil/DoDSR_Items/DoDSR_Overview.htm [accessed August 29, 2005]. Badilini F, Erdem T, Zareba W, Moss AJ. 2005. ECGScan: a method for conversion of paper electrocardiographic printouts to digital electrocardiographic files. Journal of Electrocardiology 38(4):310–318. Berkowitz ED, Santangelo MJ, eds. 1999. The Medical Follow-Up Agency: The First Fifty Years 1946–1996. Washington, DC: National Academy Press. Blair A, Hartge P, Stewart PA, McAdams M, Lubin J. 1998. Mortality and cancer incidence of aircraft maintenance workers exposed to trichloroethylene and other organic solvents and chemicals: extended follow up. Occupational and Environmental Medicine 55(3):161–171. Cassano PA, Rosner B, Vokonas PS, Weiss ST. 1992. Obesity and body fat distribution in relation to the incidence of non-insulin-dependent diabetes mellitus. A prospective cohort study of men in the Normative Aging Study. American Journal of Epidemiology 136(12):1474–1486. CDC (Centers for Disease Control and Prevention). 2003. HIPAA Privacy Rule: guidance for public health. Morbidity and Mortality Weekly Report 52(1):1–24. CDC. 2004. Procedures and costs for use of the research data center: notice and request for action. Federal Register 69(222):67584–67592. Clayton EW. 2005. Informed consent and biobanks. Journal of Law, Medicine, and Ethics 33(1): 15–21. Clayton EW, Steinberg KK, Khoury MJ, Thomson E, Andrews L, Kahn MJ, Kopelman LM, Weiss JO. 1995. Informed consent for genetic research on stored tissue samples. Journal of the American Medical Association 274(22):1786–1792. Coene R, Deputy Director for Washington Operations, National Center for Toxicological Research, FDA. 2000. Statement at the March 15, 2000, hearing of the Subcommittee on National Security, Veterans Affairs, and International Relations Committee on Government Reform, U.S. House of Representatives. [Online]. Available: http://www.fda.gov/ola/2000/ranchhand.html [accessed November 28, 2005].

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