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The Air Force Health Study Assets Research Program (2015)

Chapter: Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study

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Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
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B


Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study

Public Law 108-183
Veterans Benefits Act of 2003

SEC. 602. STUDY ON DISPOSITION OF AIR FORCE HEALTH STUDY.

(a) Study Required.—The Secretary of Veterans Affairs shall, in accordance with this section, carry out a study to determine the appropriate disposition of the Air Force Health Study, an epidemiologic study of Air Force personnel who were responsible for conducting aerial spray missions of herbicides during the Vietnam era.

(b) Study Through National Academy of Sciences.—Not later than 60 days after the date of the enactment of this Act, the Secretary shall seek to enter into an agreement with the National Academy of Sciences, or another appropriate scientific organization, to carry out the study required by subsection (a).

(c) Elements.—Under the study under subsection (a), the National Academy of Sciences, or other appropriate scientific organization, shall address 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.

Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×

(2) Whether or not any obstacles exist to retaining and maintaining the medical records, other study data, and laboratory specimens referred to in paragraph (1), including privacy concerns.

(3) The advisability of providing independent oversight of the medical records, other study data, and laboratory specimens referred to in paragraph (1), and of any further study of such records, data, and specimens, and, if so, the mechanism for providing such oversight.

(4) The advisability of extending the Air Force Health Study, including the potential value and relevance of extending the study, the potential cost of extending the study, and the Federal or non-Federal entity best suited to continue the study if extended.

(5) The advisability of making the laboratory specimens of the Air Force Health Study available for independent research, including the potential value and relevance of such research, and the potential cost of such research.

(d) Report.—Not later than 120 days after entering into an agreement under subsection (b), the National Academy of Sciences, or other appropriate scientific organization, shall submit to the Secretary and Congress a report on the results of the study under subsection (a). The report shall include the results of the study, including the matters addressed under subsection (c), and such other recommendations as the Academy, or other appropriate scientific organization, considers appropriate as a result of the study.

Public Law 109-364
John Warner National Defense Authorization Act for Fiscal Year 2007

SEC. 714. TRANSFER OF CUSTODY OF THE AIR FORCE HEALTH STUDY ASSETS TO MEDICAL FOLLOW-UP AGENCY.

(a) Transfer.—

(1) Notification of participants.—The Secretary of the Air Force shall notify the participants of the Air Force Health Study that the study as currently constituted is ending as of September 30, 2006. In consultation with the Medical Follow-up Agency (in this section referred to as the “Agency”) of the Institute of Medicine of the National Academy of Sciences, the Secretary of the Air Force shall request the written consent of the participants to transfer their data and biological specimens

Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×

to the Agency during fiscal year 2007 and written consent for the Agency to maintain the data and specimens and make them available for additional studies.

(2) Completion of transfer.—

Custodianship of the Air Force Health Study shall be completely transferred to the Agency on or before September 30, 2007. Assets to be transferred shall include electronic data files and biological specimens of all the study participants.

(3) Copies to archives.—The Air Force shall send paper copies of all study documents to the National Archives.

(b) Report on Transfer.—

(1) Requirement.—Not later than 30 days after completion of the transfer of the assets of the Air Force Health Study under subsection (a), the Secretary of the Air Force shall submit to the Committees on Armed Services of the Senate and the House of Representatives a report on the transfer.

(2) Matters covered.—At a minimum, the report shall include information on the number of study participants whose data and biological specimens were not transferred, the efforts that were taken to contact such participants, and the reasons why the transfer of their data and specimens did not occur.

(c) Disposition of Assets Not Transferred.—The Secretary of the Air Force may not destroy any data or biological specimens not transferred under subsection (a) until the expiration of the one-year period following submission of the report under subsection (b).

(d) Funding.—

(1) Costs of transfer.—The Secretary of Defense shall make available to the Air Force $850,000 for preparation, transfer of the assets of the Air Force Health Study, and shipment of data and specimens to the Medical Follow-up Agency and the National Archives during fiscal year 2007 from amounts available from the Department of Defense for that fiscal year. The Secretary of Defense is authorized to transfer the freezers and other physical assets assigned to the Air Force Health Study to the Agency without charge.

(2) Costs of collaboration.—The Secretary of Defense may reimburse the National Academy of Sciences up to $200,000 for costs of the Medical Follow-up Agency to collaborate with the Air Force in the transfer and receipt of the assets of the Air Force Health Study to the Agency during fiscal year 2007 from

Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×

amounts available from the Department of Defense for that fiscal year.

Public Law 110-389
Veterans’ Benefits Improvement Act of 2008

SEC. 803. MAINTENANCE, MANAGEMENT, AND AVAILABILITY FOR RESEARCH OF ASSETS OF AIR FORCE HEALTH STUDY.

(a) Purpose.—The purpose of this section is to ensure that the assets transferred to the Medical Follow-Up Agency from the Air Force Health Study are maintained, managed, and made available as a resource for future research for the benefit of veterans and their families, and for other humanitarian purposes.

(b) Assets From Air Force Health Study.—For purposes of this section, the assets transferred to the Medical Follow-Up Agency from the Air Force Health Study are the assets of the Air Force Health Study transferred to the Medical Follow-Up Agency under section 714 of the John Warner National Defense Authorization Act for Fiscal Year 2007 (Public Law 109-364; 120 Stat. 2290), including electronic data files and biological specimens on all participants in the study (including control subjects).

(c) Maintenance and Management of Transferred Assets.—The Medical Follow-Up Agency shall maintain and manage the assets transferred to the Agency from the Air Force Health Study.

(d) Additional Near-Term Research.—

(1) In general.—The Medical Follow-Up Agency may, during the period beginning on October 1, 2008, and ending on September 30, 2012, conduct such additional research on the assets transferred to the Agency from the Air Force Health Study as the Agency considers appropriate toward the goal of understanding the determinants of health, and promoting wellness, in veterans.

(2) Research.—In carrying out research authorized by this subsection, the Medical Follow-Up Agency may, utilizing amounts available under subsection (f)(1)(B), make grants for such pilot studies for or in connection with such research as the Agency considers appropriate.

(e) Additional Medium-Term Research.—

(1) Report.—Not later than March 31, 2012, the Medical

Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×

Follow-Up Agency shall submit to Congress a report assessing the feasibility and advisability of conducting additional research on the assets transferred to the Agency from the Air Force Health Study after September 30, 2012.

(2) Disposition of assets.—If the report required by paragraph (1) includes an assessment that the research described in that paragraph would be feasible and advisable, the Agency shall, utilizing amounts available under subsection (f)(2), make any disposition of the assets transferred to the Agency from the Air Force Health Study as the Agency considers appropriate in preparation for such research.

(f) Funding.—

(1) In general.—From amounts available for each of fiscal years 2009 through 2012 for the Department of Veterans Affairs for Medical and Prosthetic Research, amounts shall be available as follows:

(A) $1,200,000 shall be available in each such fiscal year for maintenance, management, and operation (including maintenance of biological specimens) of the assets transferred to the Medical Follow-Up Agency from the Air Force Health Study.

(B) $250,000 shall be available in each such fiscal year for the conduct of additional research authorized by subsection (d), including the funding of pilot studies authorized by paragraph (2) of that subsection.

(2) Medium-term research.—From amounts available for fiscal year 2012 for the Department of Veterans Affairs for Medical and Prosthetic Research, $200,000 shall be available for the preparation of the report required by subsection (e)(1) and for the disposition, if any, of assets authorized by subsection (e)(2).

Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×

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Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×
Page 105
Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×
Page 106
Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×
Page 107
Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×
Page 108
Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×
Page 109
Suggested Citation:"Appendix B: Excerpts of Public Laws Regarding the National Academy of Sciences and the Air Force Health Study." Institute of Medicine. 2015. The Air Force Health Study Assets Research Program. Washington, DC: The National Academies Press. doi: 10.17226/20219.
×
Page 110
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 The Air Force Health Study Assets Research Program
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The Air Force Health Study (AFHS) is a longitudinal, prospective epidemiologic study of more than 2,700 men followed for approximately 20 years. This cohort participated in up to six intensive physical examinations with high rates of compliance. In addition to a complete record of clinical measurements and observations collected at these exams, serum and other biological samples were obtained and preserved. Extensive questionnaires addressing health, lifestyle, and socioeconomic status were administered during each exam, and other information was obtained about the participants' employment, families and offspring, and potential sources of environmental exposures. While the study was completed in 2006, the extensive health data linked to several types of longitudinally collected biologic specimens - some 91,000 serum, whole blood, urine, semen, and adipose tissue specimens - remain a resource for additional research. The AFHS assets are exceptional in the sheer multitude and range of types of information available for each participant. 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. Currently, the Institute of Medicine is the custodian of these assets.

The Air Force Health Study Assets Research Program outlines the feasibility and advisability of maintaining the biospecimens based on interest generated from the general scientific community and results of pilot projects and other research projects using the AFHS assets. According to this report, sustaining access to the AFHS biospecimens and data benefits the veterans community and the public at large, who will gain from the information derived from studies of the assets. . This report discusses the scientific value of the AFHS data and biospecimens and the lessons learned in managing access to the assets.

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