IOM Makes Clinical Data Available for Research


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In 1979, Congress mandated that an epidemiologic study be launched to evaluate the frequency and type of adverse health conditions experienced by military personal as a result of their exposure to Agent Orange and other herbicides used during the Vietnam War. Called the Air Force Health Study (AFHS), data from a health questionnaire and physical examination and over 86,000 biospecimens were collected from 2,758 subjects over 20 years in six cycles—in 1982, 1985, 1987, 1992, 1997, and 2002—from airmen who participated in the spraying missions and were exposed to the herbicides and a comparison cohort of airmen who served in Southeast Asia, but were not involved in herbicide-spraying operations.

Once the study was completed in 2006, Congress directed that both the clinical data and biospecimens be transferred to the Institute of Medicine for safekeeping and to provide guidance on the future use of the information gathered. Now, the clinical data and biospecimens, which include serum, whole blood, adipose tissue, semen, stool smears, and urine, are being made available to researchers for further scientific study.

David Butler, PhD, Scholar and Director of the Medical Follow-up Agency at the IOM, said “For cancer research, some of the most fruitful uses might be in looking for biomarkers of susceptibility in the development of different cancers over time. These data give researchers an opportunity to look at health outcomes over 20 years and ask, is there something different about the specimens of people who developed a specific cancer from those who didn’t develop that cancer?”

To obtain access to the data and biospecimens, researchers must first submit a letter of intent to the IOM. A review committee will then evaluate the scientific merits of the proposal, and if accepted, investigators will be required to submit a formal proposal detailing specifically how the data and biospecimens will be used. All proposals will also have to be approved by both the investigator’s and the National Academies’ Institutional Review Boards.

Complete details of the AFHS study and the data and biospecimens collected can be found in the IOM report, Disposition of the Air Force Health Study.1

Reference

1. Institute of Medicine: Disposition of the Air Force Health Study. Released February 24, 2006. Available at www.iom.edu/Reports/2006/Disposition-of-the-Air-Force-Health-Study.aspx. Accessed December 11, 2013.



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