The Bureau of Medicine and Surgery Supplemental Report of Human Radiation Experiments, 31 March 1994

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THE BUREAU OF MEDICINE AND SURGERY SUPPLEMENTAL REPORT OF HUMAN RADIATION EXPERIMENTS the Secretary of Defense (Atomic Energy) request for a DOD-wide review of Human Radiation Experiments This review identifies medical department activities that might have conducted or sponsored human radiation experiments Identified are the archives and record centers where records concerning such experiments might exist and a description of the steps taken to search those records All efforts have been taken to include any studies which may involve exposure to ionizing radiation As such, studies are included where exposure was received as part of, but not for the purpose of the study The information in this report incorporates data available as of March 23, 1994 Additional information and details of individual studies continues to arrive and will be consolidated into future reports This is a supplemental report to the February 28, 1994 response to the Assistant to reporting all records of The Assistant to the Secretary ofDefense (Atomic Energy) directed locating and ( 1 ) Experiments on individuals involving intentional exposure to ionizing radiation This category does not include common and routine clinical practices, such as established diagnosis and treatment methods, involving incidental exposures to ionizing radiation ( 2 ) Experiments involving intentional releases of radiation that (a) Were designed to test human health effects of ionizing radiation (b) Were designed to test the extent of human exposure to ionizing The scope of this guidance was interpreted to include research involving human test subjects in which the subjects receive exposure to ionizing radiation which they would not receive if they were not part of a study Consequently this definition includes clinical research protocols where the patient receives exposure from diagnostic tests which are incidental but integral to the study The following summarizes searches conducted, record retention policies and administrative controls for use of human test subjects

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retention and disposal requirements Guidance prior to 1985 has yet to be reviewed Briefly, present guidance states SECNAVINST 5212.5C, 1 1 JULY 85, provides current guidance for records ( 1 ) Medical and dental research and development project files as well as preliminary, interim, and final reports are to be retained permanently They are to be transferred to the nearest Federal Records Center after 5 years and offered to the National Archives Regional Administrator after 20 years. (2) Supporting records (excluding reports) are to be transferred to the nearest Federal Records Center after 5 years After being held for 10 years they are to be destroyed by the Federal Records Centers. These copies are to be destroyed after 5 years, or upon project completion/termination, whichever is later Non-record copies of research project files are to be retained on board B A search for instructions governing human use testing was conducted The Na\., hlanual of the Medical Department in 1951 provided formal guidance for conducting. experiments using human use test subjects. Human Use Test protocols were to be reviewed and approved bv the Secretary of the Navy. Further guidance was issued in DOD and BURIED instructions in 1964,1982, 1983. 1984, 1988 and -1989 In addition, from 1963 to 1975 the Nuclear Regulatory Commission reviewed and approved or disapproved all human uses of investigational radiopharmaceuticals in humans and all human use testing with radioactive material C Key researchers, both active duty and retired, were questioned concerning research activities at various commands and documentation practices from 1944 to the present They identified approximately seventeen activities where humans may ha\.e been exposed as pan of a study D The reports at the Defense Technical Information Center (DTIC) were searched to identi@ applicable studies Copies of research reports hnded under a specific contract or budget line are supposed to be forwarded to DTIC upon completion of work The DTIC computerized Title Index contains all reports (700,000) provided to DTIC since 1972 (Some of the reports reflect research performed prior to 1972, e g work performed in the 1940's and 1950's, but not submitted to DTIC until after 1972) Reports provided to DTIC prior to 1972 are maintained on index cards DTIC performed a search by key words of their computerized and card indexes. The search identified over 3,600 Titles representing Army, Navy, Air Force, Defense Nuclear Agency, Defense Atomic Suppon Agency, Atomic Energy and other US Agency work, and translations of foreign work Review of the Titles, Abstracts and Reports identified six sponsored by the Navy Search

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Radioactive Material Use Permits, was asked tq review Nuclear Regulatory Commission Licenses and Permits to identify activities authorized to use radioactivity on human test subjects, and provide an estimate of the time periods when various commands had active programs In addition, copies of any curriculum vitae (CV) containing publications of studies on humans were requested Search is complete. The Naval Environmental Health Center, manager of the medical department's licenses and protocols used in investigational radiopharmaceuticals From 1963 to 1975 NRC reviewed and approved all protocols using investigational radiopharmaceuticals in humans Search is pending The Nuclear Regulatory Commission (NRC) was asked via the Chief of Naval records from activities suspected of having performed studies All of the Regional Archives and Federal Records Centers have conducted searches for records from actiL-itiessuspected of having performed studies which exposed personnel Records are taken care of as follows Federal Records Centers and National Archives were queried to identi@ any ( I ) Personnel, medical, and clinical records go to the National Records Center In St Louis Clinical charts and personnel medical records are retained for 75 years Records are filed by Service Number or Serial Number St. Louis estimates approximatelv 28 million Navy medical records are held for the 1943-1994 time (2) Research and administrative records held at the Federal Records Centers are transferred to the National Archives after 25 years, where a decision is made to either purge or retain them Information protected by the Privacy Act is purged, e g names of individuals Only about 1-2 percent o f all records sent to the Reeional Records Centers eo into National Archives (legal cases, deeds, titles, etc ) The rest are experiments or clinical trials that involved exposure to human test subjects Searches completed at all but two activities (NMRI and NMRU-2). Each BUMED activity was tasked to search their records and report any at various activities Search is pending. CVs were requested from researchers to identify publications of work performed publications by author Search is pending A list of possible researchers was compiled to allow a literature search for L Records maintained at the Federal Records Center and National Archives, San Bruno, California of work performed by the Naval Radiological Defense Laboratory, 1955- 1969, were physically reviewed by BUMED representatives

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111. Findings The results of the Bureau of Medicine and Surgery's review are provided A Part I describes by activity the efforts to locate records, individuals consulted, records found and a list of studies by title Included are studies involving human use test subjects, clinical protocols, prospective and retrospective clinical studies, and clinical case reports Studies were included if it was not clear if the subjects would have been exposed if not part of the study. B Activities and studies listed on previous reports which hrther review indicated did not involve human testing have been deleted C Previously reported Titles of studies identified from CV but still pending review are D Part I1 provides Information found in the course of our searches concerning studies at E Part 111 includes Detailed information pertaining to each study identified in Parts I and

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Study #NRDL -01: Decontamination of Synthetic Radioactive Fallout From Intact Location: Naval Radiological Defense Laboratory Purpose: Abstract not available at this time. Records: The National Archives, San Bruno, CA

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Study #NRDL -02: Protecting and Cleaning Hands Contaminated By Synthetic Fallout Under Field Conditions Location: Naval Radiological Defense Laboratory Purpose: Abstract not available at this time. Records: The National Archives, San Bruno, CA

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Studs #NRDL -03: Some Aspects of Recent Findings Pertaining to the Body Composition of Athletes, Obese Individuals and Patients Location: Naval Radiological Defense Laboratory Purpose: To analyze the gross composition of the human body . Procedures included determinations of whole-bodj density and the use of dilution techniques involving the use of Category: Research, diagnostic tracer study. Records: The National Archives, San Bruno, CA

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Study #NRDL -05: Rapid Assay Procedures for Tritium Labeled Water in Body Fluids Location: Naval Radiological Defense Laboratory Subjects: 12 active healthy men. Purpose: To test two new methods (rapid vacuum sublimination and simplified internal standardization) for tritiated water radioassay with an application to body water determination in active and healthy humans. Category: Research, diagnostic tracer study. Records: The National Archives, San Bruno, CA

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Stud\ # NhlR1-01: Tracer Gas Kinetic Studies for Dccomprcssion Table Design. Location: Na\,al Medical Research Institute and Lawrence Livermore National Laboraton Sponsors: NMRl and Lawrence Livermore National Laboratory Su t).iccts: Dixrs stationcd at NpI.IRI. Volunteers. Purposc: To study gas behavior dunng diving operations Fbdioactlve gases including \cnon-l33. argon-41. and nitrogen-13 \\ere used to stud) gas uptakc and elimination i n Category: Orher research, radioactive tracer study

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Stud\ # NMRJ-03: Nitrogen Gas Exchange in the Human Knee Location: Naval Medical Research Institute and Lawrence Livennore National Laboraton, Subjects: Nine male volunteers ranging in age from 24 to 41 y/o who pro\.ided infornied Purpose: Symptoms of human decompression sickness occur in man!' organ s! stems. bui most notabl! i n skeletal joints This study was designed to obtain quantitati1.e nicasures of niirogcn exchange rates in human knees using a radioacti1.e isotope of nitrogen Category: Other research. diagnostic tracer stud!

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Study # NMRl-02: Decreased Free Fraction 01 Thyroid Hormones After Prolongcd Ant arctic Exposure Location: NMRI, Port Hueneme, CA, and McMurdo Sound. Antarctica. Date: August 1983 - September 1984 Sponsors: National Science Foundation and NMRl Subjects: Fifieen healthy euthyroid male volunteers. All members of the US Na\?r 1983-81 Purposc: To measure the role of Antarctic residence in modifiing hormonal and ph! siological responses to cold air. This was an iodine-125 thyroid function stud! Catcgory Other research, diagnostic tracer stud!,.

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Studv #SMRLOI: Aerotitis Media in Submariners Location: Submarine Medical Research Laboratory Sponsors: Sound Laboratory, Medical Research Dept., US Subrnarinc Base. Subjects: 6.119 young healthy male submariners (732 were treated mith standard radiation Purposc: To identify the optimal treatment for middle ear barotrauma &no\\n then as aerotitis media. \j.hich is a rupture of the inner-ear due to inability to equalize pressure because of blocked eustachian tube). Five groups were given different opes of treatments (which were common practice in the civilian community) as follows: 1) psychological; 2) topical; 3) x-ray; 4) radium; and 5 ) dental. The types of treatment were based on some rationale designed to assist the men in accommodating pressure changes without developing acrotitis nicdia. Thirty pcrcent of the submarine applicants \\.ere failing thc pressurc lest Ninct! pcrcent of the those that failed the test were able to sustain pressurc following trcatmcnt with radium without dc\vloping aerotitis media. Category: Therapeutic research invol\.ing radiation.

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Stud\ #ShlRL42: Radium Therapy in Aerotitis Media Location: Submarine Medical Research Laboratory Researchers: Page Northington. CAPT.MC, USNR Purpose: Preventive treatment of aerotitis media, the most common physical ailmenr among Category Therapeutic rcscarch in\.olving radiation

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Nonrandomlj Selected Personnel Location: Submarine Medical Research Laboratory Subjects: 931 US Na\y divers Purpose: 931 US Na\y divers were selected and surveyed radiographically using standard rcchniques (s rays) developed for detecting aseptic bone necrosis (ABN) Cat ego ry :