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Executive Summary
Pages 1-14

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From page 1...
... From 1962 to 1971, Operation Ranch Hand disseminated over 19 million gallons of herbicides in Vietnam, of which at least 12 million gallons were Agent Orange, the name given to a 50:50 mixture of the herbicides 2,4-D and 2,4,5-T. Health concerns over Agent Orange exposure have centered on a contaminant of 2,4,5-T: 2,3,7,8-tetrachlorodibenzo-p-dioxin; often abbreviated as TCDD and colloquially referred to as dioxin.
From page 2...
... of the law charged the NAS to evaluate the following: (1) The scientific merit of retaining and maintaining the medical records, other study data, and laboratory specimens collected in the course of the Air Force Health Study after the currently scheduled termination date of the study in 2006.
From page 3...
... In 1982, 1,046 of the so-called Ranch Hands and 1,223 comparison subjects participated in the first of the physical exam cycles. Twenty years later, 777 Ranch Hands and 1,174 comparison subjects completed the sixth cycle.
From page 4...
... The committee cannot offer a specific recommendation on the federal or nonfederal entity best suited to continue the study of the AFHS data assets but has identified a number of options that could be pursued successfully. Independent oversight of future research using the AFHS data assets is advisable, and should be provided through the review of proposals for scientific merit and adherence to ethical, legal, and related considerations by an Institutional Review Board and, separately, an advisory and over sight board.
From page 5...
... The committee recommended that action be taken prior to the currently scheduled termination date to reorganize and document the study's medical records, other study data, and laboratory specimens in a form and format that allows them to be easily understood, evaluated, managed, or analyzed by persons outside of the AFHS. Several specific actions to address the shortcomings are detailed in these chapters.
From page 6...
... The potential value and relevance of extending the study of the AFHS data assets rest in taking full advantage of the available information and in the application of the results of future research on the assets. This research could encompass • reanalysis of outcomes examined by the AFHS using different assumptions and approaches than have been applied to date, • new analyses of the medical records and other study data that examine questions that were not addressed in the AFHS, • new studies of the collected biospecimens that take advantage of advances in technology and science to conduct analyses that were not contemplated in the AFHS protocol, • expansion of the study's period of analysis through follow-up of the cohorts using publicly available information, and • additional follow-up of health outcomes in AFHS participants.
From page 7...
... In brief, the committee believes that such data assets should be written to electronic form where a mature technology exists to do so and where the assets have future research value. The X-ray films can be readily converted to digital format -- this should be done with acceptable quality control, the resource properly documented, and thereafter the original films disposed of according to standard practices.
From page 8...
... If these assets, along with the study's biospecimen collection, are transferred to a new custodian, other alternatives that would enhance access to the assets would be possible. A custodian could offer research support of various forms that would facilitate their use; or the custodian or outside researchers could supplement the assets with data from publicly available sources or the study participants themselves.
From page 9...
... This notification should offer the participants the opportunity to decide that information and specimens relating to them should not be transferred. The committee also recommends that the successor custodian obtain new informed consent that includes • their identity; • notice of the types of participant data and samples that will be maintained by the custodian; • the procedural protections that will be provided for the data and specimens, including access policies, and oversight; • the specific privacy and security protections that will protect the data and specimens; • the types of studies that the participant is willing to have his data and specimens used for; • whether the participant is willing to be approached in the future by investigators to seek participation in additional studies, including information regarding notice and recontact criteria; and • which individual study results the participant will and will not receive.
From page 10...
... Specifically, it recommends that the successor custodian of the AFHS data and biospecimens should commit to reviews of future research involving the assets by an Institutional Review Board constituted in accordance with the Common Rule, create and maintain an independent advisory and oversight board to provide guidance on the conduct of future research and to review and evaluate proposals for use of the data and biologic samples, and develop and implement strategies for apprising the research subjects about the ways in which their information is used and the scientific discoveries that result. These commitments should be a prerequisite to the transfer of the assets.
From page 11...
... 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 veteran health issues as the central focus of their operations, but also conduct other types of studies with their data assets.
From page 12...
... 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 collecting additional data and specimens could potentially cost millions of dollars. However, with the exception of the program proposed below, these costs will be the responsibility of prospective researchers, who will need to obtain their own support from funding sources.
From page 13...
... 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.


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