Executive Summary of Human Radiation Research Findings

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MEMORANDUM THRU COL Harrison, Chief, Clinical Investigation Regulatory Office FOR MG Moore, Commanding General, AMEDD Center & School SUBJECT: Executive Summary of Human Radiation Research Findings 1. Responding to the Secretary of the Defense, the Clinical Investigation Regulatory Office assembled research records of all experimental exposures of humans to ionizing research at Army hospitals between 1944 and 1994. This document summarizes those findings. The complete report weighs 12 pounds and occupies two 3-ring binders. 2. After two months of inquiry, 828 investigational studies of ionizing radiation were located. All but four of those studies involved the diagnosis or treatment of Army patients. Of the four non-therapeutic studies, two measured occupational exposure to X-rays among emergency room personnel and two were tests of new field X-ray equipment intended for combat hospitals. We identified no evidence of impropriety in any study at Army hospitals. 3. Among the 828 studies, 478 studies (58%) involved radiation therapy of 4. Among the 828 studies, 434 studies (52%) were part of larger cooperative oncology group protocols with civilian colleagues at major universities. These groups, often funded through the National Institutes of Health, offer the advantage of centralized expert review of the science and ethics of projects conducted at multiple civilian and federal hospitals across the country. 5. Among the 828 studies, 273 studies (33%) included radiopharmaceuticals, drugs that include a radioisotope. Most of these studies involved patient diagnosis, with exposure to less radiation than a chest X-ray, but a few involved larger therapeutic doses. The most common isotopes used were 99m-technetium, 1116. The remaining studies investigated a wide range of clinical problems, such as comparison of magnetic resonance imaging (MRI) versus computed tomography (CT) scans, comparison of brands of X-ray film, and the relative value of barium 7. CIRO has fulfilled all requests from the Human Radiation Interagency Working Group, coordinating the efforts of all federal departments, and the corresponding Department of Defense working group. We await further tasking from the Pentagon for other relevant information. If you have any questions on this topic, please do not hesitate to contact me (1-2511). Regulatory Affairs Pharmacist