Bureau of Medicine and Surgery Supplemental Report of Human Radiation Experiments (Includes Case Studies)

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BUREAU OF MEDICINE AND SURGERY SUPPLEMENTAL REPORT OF HUMAN RADIATION EXPERlMENTS Assistant to the Secretary of Defense (Atomic Energy) request for a DOD-wide review of Human This is a supplemental report to the March 3 1, April 29 and 26 May 1994 responses to the B. This report summaries search activities for June and the first two weeks of July, reports documents identified, identifies an additional 24 studies, and provides missing information for studies previously reported . This brings the total to date of BUMED studies identified to 815. The vast majority are clinical research, i.e., clinical research directed toward advancing combat casualty care. Only 19 appear to be for direct military applications, e.g., improvement of diver decompression schedules, surveys for bone changes in saturation divers, evaluation of skin decontamination techniques, evaluation of normal body fat ranges for racial or sexual bias in Navy physical fitness standards, etc. C. Indexes of pertinent documents identified in the searches are provided. numbers are sequential beginning with the last number submitted in the March 3 1, April 29 and 26 May Abstracts of studies identified are sorted by activity in the same order and study identification IL Search. The following search activities have been completed since the last report: against results from our other searches is now complete. The search did not identify any activities or time periods for use of isotopes that were not already known. The search identified 39 individuals named as "Authorized Users" of isotopes not previously identified. Literature searches by author were initiated for The Nuclear Regulatory Commission's search of their license files to allow cross-checking The literature search by author is now complete. The 39 individuals identified by the Nuclear Regulatory Commission's licenses review brings the total of 117 individuals who may have performed research or been authorized to use radioisotopes. They represent researcher scientists, authorized users of radioisotopes, senior radiologists, nuclear medicine physicians, radiation therapists, radiation physicists, radiation health officers and other individuals that may have been involved in research using h4anual searches of MEDICUS INDICUS were performed for the above individuals who were on active duty prior to 1966. (Computerized indexes only go back to 1964-66 time-frame.) A computerized search utilizing MEDLINE was performed for publications by individuals on active duty after about 1964. Titles, abstracts and articles were reviewed to identify human radiation experiments. Two professional librarians, a Lieutenant junior grade, a Chief Hospital Corpsman and three petty officers conducted this search with guidance and oversight from a Navy Captain. Research and Development Command's records at the Suitland Federal Records Center and National Archives for policy documents and examples of human research protocols has been conducted. A 16 man-day manual search of the Bureau of Medicine and Surgery and Naval Medical Center and National Archives for a history of the Naval Radiological Defense Laboratory has been A 2 man-day manual search of the 12th Naval District records at the San Bruno Federal Records

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The following documents were found at the Federal Records Center and National Archives, Suitland Permission for the use of human subjects in investigation of mechanism of head injury and flight head protective processes; request for Permission for the use of human subjects in investigation of mechanism of head injury and flight head protective processes; supplementary information Use of human volunteers of subjects in research; request for Use of volunteer subjects in Project Alpha Assignment of enlisted personnel as research subjects for psychophysiological research during active sonar noise (Project PING); Permission to use human volunteers for ship slam studies Letter, BUMED, Research Division Second endorsement letter, BUPERS Permission for the use of human subjects in study of human exposures to FREON FE 1301 gas fireextinguishing agent at reduced atmospheric pressures; request for Authorization to use human volunteers as subjects in the testing of malaria Use of human volunteers in dental research work unit LHA embarked troop acclimatization study, Phase IV; request for assistance in obtaining research subjects for Use of human volunteers in connection with C-I-C-C study 2-48-202 entitled "Apneic oxygenation in anesthesia"; request for approval of Permission for the use of human subjects in development of a minimum envelope and weight ejection seat system; request for Permission for the use of human subjects in development of a minimum envelope and weight ejection seat system; request for Review of CP approved studies where human volunteers or experimental drugs are involved; procedures for

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Permission to utilize human volunteers in acceleratioddeceleration experiments; request for Human volunteer subjects at NAMRL, NADC, and Naval Aerospace Authorization for the use of human volunteer subjects in shallow saturation dives breathing air or mixed nitrogedoxygen gases; request for Information on human volunteers for technical coordinating paper Authorization for the use of human volunteer subjects in an oxygen tolerance study; request for The investigation of daily and seasonal cycles of physiological variables in man living and working in Barrow, Alaska Authorization for use of human volunteer subjects in an oxygen tolerance study; request for (Second Endorsement letter) Authorization for use of human volunteer subjects in an oxygen tolerance study; request for (Third Endorsement letter) Authorization to use human volunteers in simulated shallow saturation dives breathing compressed air; J.A.G. objection to consent for in the case The University of Michigan Policy on the use of humans as subjects in research and instructional investigations Letter, Honorable Marvin L. Esch Assignment of temporary active duty personnel as human volunteers; Authorization to use human volunteers in simulated shallow saturation dives breathing compressed air; revision of Assignment of temporary active duty personnel as human volunteers Research and development use of human subjects in research, Draft Permission for the use of human subjects to evaluate automobile occupant restraint systems; request for Authorization to use of human volunteer subjects to evaluate automobile occupant restraint systems Establishment of military billets in support of ADO 43-12Kand ADO 43Authorization for the use of human volunteer subjects in an oxygen

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tolerance study; request for Human use board; recommendations concerning Human volunteers; material on Senate health subcommittee staff review of DOD use of human subjects in Permission to utilize human volunteers in acceleratioddeceleration experiments; request for Authorization to use human volunteer subjects in vibration acceleration tests simulating dace effect ships operating environments Permission for the use of human subjects to evaluate an artificial atmosphere; request for Request for billets for human volunteers Permission for the use of human subjects to evaluate an artificial atmosphere; request for Permission for the use of human subjects to evaluate an artificial atmosphere; request for Information on use of human subjects Bodily intrusion in research on human volunteers Human volunteers; use of in NSMRL diving research Request for approval to use volunteers in hyperbaric research Test and evaluation of the portable life support stretcher unit (PLSSU) Navy Filing Manual, NAVEXOS P-20 Navy-Marine Corps standard subject classification system Declaration of Helsinki Protection of human subjects, notice of proposed rule making Untitled document for Federal Government "Risky experiments on humans scored", Washington Post Human experimentation, forum subject in February

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Proposed clinical evaluation of influenza antiserum, and messages concerning influenza virus specimens Atomic energy activities of the Navy Medical Department - Report of Van de Graf generator for installation at the Naval Radiological Defense Laboratory, San Francisco; comment concerning Cumulative bibliography of research reports and publications originating in US. Naval Medical Research Laboratory Utilization of radioactive iron powder particles for radiation therapy of cancer tumors;information pertaining thereto The relationship between the American and Japanese scientists during the Fukuryu Maru No. 5 incident Disposition of natives evacuated from Rongelap and Utirik Atolls The relationship between the American and Japanese scientists during the Fukuryu Maru No. 5 incident; final report of Personnel and training research needs related to atomic bomb operations; Bureau of Medicine and Surgery research projects Marshall Island resurvey report; submittal of copy of Armed Forces Epidemiological Board, Review of current status of projects Permission to use human volunteers; request for Minutes of the special session on radiation effects on infection and Air crew equipment laboratory bio-astronautics program Review of contract funding to military/civilian laboratories in support of Nuclear Weapons Effects Research (NWER) Study of the effects and evaluation of the use of radioisotopes and diagnosis and treatment Collection of blood from donors contaminated by radioactive fallout Nuclear radiation exposure limits for Marine Corps personnel involved in nuclear tactical exercises Technetium 99M: Evaluation of its use in brain scanning Nuclear weapons effects research long range biomedical requirements

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Authorization to use human volunteers in the Phase I1 evaluation of the British Mark MI submarine escape immersion equipment Annual audit and disposition of health and dental records Fractures of the ankle in a military population Cytosine araboside treatment of smallpox (variola minor); effects on the virus and the disease Approval of research proposal involving use of human subjects Approval for use of human volunteers as subjects in diving medical research and development project; request for DOD personnel participating in nuclear weapons testing Authorization to use human volunteers as subjects for impact of water balance in heat acclimatization study; request for Experimental stress duty billets; request for authorization Justifcation for retaining documents exceeding three years; forwarding of Rapid diagnosis and treatment of bacterial meningitis Recommendations of the Committee for Protection of Human Subjects MROOOO 101-507 1 entitled "Diagnostic aids aboard submarines; biochemical evaluation of acute myocardial infarction"; PHS application Analysis of adipose tissue as a key to the understanding of mechanism of body weight loss in the human

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The following documents were found at the Federal Records Center and National Archives, San Bruno, History of the United States Naval Radiological Defense Laboratory, 1946-1958 History of the United States Naval Radiological Defense Laboratory, 1959 History of the United States Naval Radiological Defense Laboratory, 1960 History of the United States Naval Radiological Defense Laboratory, 1961 History of the United States Naval Radiological Defense Laboratory, 1962 History of the United States Naval Radiological Defense Laboratory, 1963 History of the United States Naval Radiological Defense Laboratory, I964 History of the United States Naval Radiological Defense Laboratory, 1965 9900,930-85RHH/RC:as Itr to Chief, BUSHIPS, Subj: Strippable Protective Coating for Ship Weather Surfaces: evaluation of 5511,212-751,ADG:amj Itr to Director, AEC, Subj: Downgrading of Documents: 10330,730-58,ALS:jp Itr to AEC , Subj: Change of Status of Working Areas 3900,0030997,900-00535,KPC:ba endorsement on BUMED Itr, Subj: BUMED request for modification of shore (field) activity including command relationship; forwarding endorsement recommending disapproval 920-00520,ELA:eb, 0030804 Itr to Chief BUMED, Subj: Requirements for Radiobiological Research and Development; review of (Without enclosure) Incoming Mail Control Record, File 3900 with Air Force Itr RRFP of 18 Aug 67, Subj: Distribution of FY68 Project Plans @D Forms 1498) 3900,935,ECF:cs Itr to AEC, Subj: Proposed N 1968 Research Project for the U.S. Atomic Energy Commission; submission of 920-427,ELA/HW:eb Itr to Chief, BUMED, Subj NRDL RDT&E Five Year Plan for FY 1969-FY-1973for the Navy Medical Department; submission of 3900.920416 HW:eb Itr to Chief, BUMED, Subj: Research and Development Work Units; re orientation of Subj: USNRDL FY 1969 DASA Biomedical NWER Subtask Summaries (Proposals):

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23 Jan 1967 3900,920-376,HW:eb ltr to Chief, Bureau of Medicine and Surgery (Code 71), Subj: Annual Progress Reports for Calendar Year 1966; submission of

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The following abstracts represent new studies identified in the author search from the "Authorized Users" list compiled upon review of the Nuclear Regulatory Commission's license search. In addition, studies identified during the manual search at the national archives or other searches are abstracted. Abstracts of studies identified in previous reports where information was unknown or titles of papers which were know but the papers had not been reviewed are updated The abstracts are grouped by activity and numbered in the sequence found as was done in the two previous reports. No additional studies.

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Study # NHSTALB 11: Findings of Retrograde Femoral Arteriography in Location: Naval Hospital St. Albans, New York Purpose: Purpose was to follow a case of choriocarcinoma by means of percutaneous retrograde Category: Clinical research Records: American Journal of Obst. and Gynecology

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Studv # NHSTALB 12: Use of Femoral Arteriography in Assessment of Bleeding in Location: Naval Hospital St. Albans, New York Purpose: The problem of bleeding during pregnancy is one in which the eitiology is often obscure. The use of percutaneous retrograde femoralarteriography has been studied at the U.S. Naval Hosptial, St. Albans for the past 3 years. The value of this technique in bleeding in all stages of pregnancy was recognized. As a result, an intense survey of all cases of bleeding in pregnancy over a 6 month period was made. The details of this survey serve as the base of this Category: Clinical research Records: American Journal of Obst. and Gynecology

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Studv # NHSTALB 13: Extenal Recording Method for Estimating Hepatic Blood Flow with the Use of Radiogold Location: Naval Hospital St. Albans, New York Sponsors: U. S. Navy and M i c e of Naval Research to the State University of New York Purpose: This study was undertaken to find a simple percutaneous method of measuring hepatic blood flow that could be of clinical use. Category: Clinical research

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Studv # NHSTALB 14: Influence o f Chelates on the Metabolism of Radioyttrium (Y-90) Location: Naval Hospital St. Albans, New York and Division of Nuclear Medicine, The Long Island Jewish Hospital, New Hyde Park, N. Y. Sponsors: U. S. Navy and Joel Finkelstein Cancer Foundation Purpose: To study the delivery of high-energy betas of Y-90to neoplastic lesions in trabecular bone and stomach mucosa. The results of the autoradiographic study of the localization of Y-90 in normal and healing bone as well as the distribution of yttrium in 3 patients, utilizing Y-90as a tracer, as also presented. Category: Clinical research Records: Journal of Laboratory and Clinical Medicine

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C. Naval Medical Research Unit No. 3, Cairo, Egypt. No additional studies.

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D. National Naval Medical Center, Bethesda, MD. Studv # NNMC-138: Late Clinical Changes Following the Internal Deposition of Location: Naval Hosptial Bethesda Subjects: 50 radium medical patients; 28 luminous dial workers; 4,955 thorotrast patients Purpose: Reviewed patients at Bethesda and patients reported in the literature to study the late effects of internally deposited radioactive materials. He felt that: ( I ) the clinical information will serve 85 a guide for the diagnosis, management and treatment of patients who may ingest or receive harmful amounts of radioactive materials, (2) the radiobiologic data obtained by new and refined technics can give a better understanding of the manner in which changes are produced by internally deposited radioelements, (3) the information can be used to establish more accurately maximal permissible levels of body burden for these and other radio-elements in use today. Category: Clinical research Records: Ann. of Internal Medicine, 42, pp. 378-387

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Studv # NMC 139: Autoradiographic and Histopathological Studies of Thorium Dioxide Location: Naval Hosptial Bethesda, University of Utah, University of Copenhagen Subjects: Two thorium dioxide patients Purpose: To study the late effects of thorium dioxide (Thorotrast) to protect personnel that may be exposed to thorium. Material from patients who died 10 and 19 years afier thorotrast administration were studied by several techniques. Category: Clinical research Records: A.M.A. Archives of Pathology, 60: 173-178.

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Study # NNMC …