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Machine-read from the scan, so expect some errors. Lines that couldn’t be read are left out.
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MEMORANDUM FOR Director, Radiation Experiments Command Center (ATTN: COL Clyde Bailey), 8 3 0 1 Greensboro Drive, Suite 630, SUBJECT: Report of Human Radiation Research Between 1 9 4 4 and 1 9 7 3 1. This letter responds to a telephonic request from COL Bailey on 23 September 1 9 9 4 for designation of human radiation exposure under research conditions between 1 9 4 4 and 1973, inclusive. This response pertains to the Clinical Investigation Program of the United States Army's Health Services Command (HSC), now known as the U.S. Army Medical Command (MEDCOM). MEDCOM is responsible for the delivery of health care to Armed Forces health-care beneficiaries at Army hospitals and clinics in the United States and Panama. The authority for and responsibilities of the Clinical Investigation Program is codified in Army Regulation 40-38. 2. Enclosed is the list of studies identified. They are listed in chronologic order, beginning in 1 9 5 4 and continuing through 1973. A code book is also provided to facilitate interpretation. Several tables summarizing the data are also provided for your use. These tables vary slightly from previous versions because of more specific data now available. 3. For many of the studies during this time interval, the only extant information is the title of the study, the site, and the approximate date. Information about source documents (including copies of many of the source documents) was provided to you in March 1994. 4. Additional information may be obtained by contacting MAJ John D. Grabenstein, Regulatory Affairs Pharmacist, at DSN 471-2511 or commercial 210CF: COL Erdtmann, OTSG Chief, Clinical Investigation Consultant to The Army Surgeon General for Clinical Investigation
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Facilities of U.S. Army Health Services Command at which investigational human exposures to ionizing radiation took place using health-care delivery resources (Major Defense Program 8) between 1944 and 1973, based on reports from that facility. We identified no evidence of impropriety in any study. Data as of: 2 8 September 1994 General Comment: Corporate policy in the U . S . Army required measures for the protection of human subjects (including informed consent) as early as 1962, two years before the oriqinal Helsinki declaration on human research ethics. This-policy was more respectful than the norm in comparable civilian IR - ionizing xadiation SE - projects involving radiopharmaceuticals licensed by the FDA at the time of study or investigational radiopharmaceuticals subsequently licensed as safe and affective. cancer or thyroid disease) used at a presumably safe and effective OG - projects involving collaborative Qncology groups [e.g., Cancer & Oncology Group (POG), Southwest Oncology Group (SWOG)]. These groups, often funded by the National Institutes of Health (NIH), offer the advantage of centralized review of the science and ethics of projects conducted at multiple civilian and federal hospitals around the DTSP - other projects involving the diagnosis or kreatment of sick geople to manage clinical disease. Excludes S E I RT, or OG categories.
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ISOTOPES USED IN RADIOPHARMACEUTICAL STUDIES Svmboa Isotope. Salt Au Gold, Unspecified (196?) Indeterminate or Unspecified Total Number of Studies * * - columns do not sum arithmetically, because some studies involved more than one isotope ONCOLOGY GROUP PROTOCOLS Gynecologic Oncology Group (GOG) Pediatric Oncology Group (POG) South Western Oncology Group (SWOG) Other Group Projects