APPENDIX E SUMMARY OF AGENCY RECORDS RETRIEVAL CENTRAL INTELLIGENCE AGENCY DEPARTMENT OF DEFENSE DEPARTMENT OF ENERGY DEPARTMENT OF HEALTH AND HUMAN SERVICES DEPARTMENT OF VETERAN AFFAIRS NATIONAL AERONAUTICS AND SPACE ADMINISTRATION CENTRAL INTELLIGENCE AGENCY History and Organization of the Central Intelligence Agency The Central Intelligence Agency (CIA) was created in 1947 by the National Security Act, which also established the Department of Defense (DOD) and the National Security Council (NSC). CIA was modeled largely after the Office of Strategic Services, which served as the principal U.S. intelligence organization during World War II. The newly created agency was authorized to engage in foreign intelligence collection (i.e., espionage), analysis, and covert actions; it was, however, prohibited from engaging in domestic police or internal security functions. Nonetheless, CIA engaged in a program of domestic human experimentation from the 1950s into the 1970s. CIA components most likely to have been associated with any experiment are the Office of Scientific Intelligence (OSI) in the Directorate of Intelligence; the Office of Security; the Technical Services Division (TSD) in the then-Directorate of Plans (DDP, now Directorate of Operations); and (at least from 1962) the Office of Research and Development (ORD) in the Directorate of Science and Technology. Beginning in the late 1940s, OSI analyzed and disseminated foreign scientific, and medical intelligence concerning the development and testing of atomic weapons and interacted with DOD and the Atomic Energy Commission (AEC) on these issues. TSD ran Project MKULTRA, discussed below. Human experimentation was done prior to MKULTRA by OSI and the Office of Security and, after MKULTRA, by ORD. Experiments To date, CIA has found no records or other information indicating that it conducted or sponsored human radiation experiments. Records Search In response to the January 1994 presidential directive, CIA conducted an agency-wide search for information about human radiation experiments that it may have conducted. [1] At the Committee's initial meeting in April 1994, CIA stated that the search encompassed an electronic review of approximately 34 million documents, a manual review of 480,300 documents, and nearly 50 interviews. CIA also stated that it had found no documents relating to experiments conducted by other agencies. The Committee, however, has since found records indicating that CIA officers did participate in DOD groups in which human radiation experiments, including those involving the placement of troops at atmospheric weapons tests, were discussed and planned. As discussed below, CIA is continuing to search for documents relating to these and other activities. Beginning in the early 1950s, CIA engaged in an extensive program of human experimentation, using drugs, psychological, and other means in search of techniques to control human behavior. CIA has so far found no evidence that radiation experiments on humans were part of this program. CIA documents and a 1963 CIA Inspector General (IG) report, however, state quite clearly that MKULTRA was a program "concerned with research and development of chemical, biological, and radiological materials capable of employment in clandestine operations to control human behavior." (emphasis added) The IG report states that "additional avenues to the control of human behavior had been designated . . . as appropriate to investigation under the MKULTRA charter, including radiation, electroshock, various fields of psychology, sociology, and anthropology, graphology, harassment substances, and paramilitary devices and materials." (emphasis added) [2] The program included unwitting experimentation on humans with LSD (lysergic acid diethylamide), brainwashing, and other interrogation methods. CIA's human behavior program originated in 1950 and was motivated by Soviet, Chinese, and North Korean use of mind control techniques. It began under the code name BLUEBIRD (and was later known as ARTICHOKE) and was operated by the Office of Security and OSI with support from other offices. MKULTRA formally began in April 1953 as a special, clandestine funding mechanism for DOD human behavior research. The program was the subject of investigations by the Rockefeller Commission in 1975, the Senate Church Committee in 1976, and hearings by Senator Kennedy in 1975 and 1977; however, these committees did not focus on radiation experiments, and no such information was found by them. CIA has told the Committee that MKULTRA involved human experimentation using every research "avenue" listed in the MKULTRA document except for radiation. [3] The agency also noted that most of the MKULTRA records were deliberately destroyed in 1973 by the order of then-Director of Central Intelligence Richard Helms. [4] In early September 1994, the agency found a document that summarized work done for ARTICHOKE, which states that "[i]n addition to hypnosis, chemical and psychiatric research, the following fields have been explored: . . . 7) other physical manifestations, including heat and cold, atmospheric pressure, radiation." (emphasis added) Although there is no indication from this document that radiation was explored on humans directly, it makes clear that CIA did "explore" radiation as a possibility for the defensive and offensive use of brainwashing and other interrogating techniques. [5] In another MKULTRA project, CIA secretly provided funding for the construction of a wing of Georgetown University Hospital in the 1950s so that it would have a locale to carry out clinical testing of its biological and chemical programs. Dr. Charles F. Geschickter, a Georgetown doctor who conducted cancer research and experimented with radiation therapy, acted as cover for CIA financing. [6] CIA also tried unsuccessfully to enlist AEC to cofund the project by appealing to its interest in Geschickter's radiation research. Geschickter testified before Congress in 1977 that CIA money helped fund his radioisotope lab and equipment. Thus, CIA money seems to have helped fund radiation- related medical research as a cover for the agency's real interest in chemical and biological research. Records obtained from DOD and the Department of Energy (DOE) and by Committee staff from the National Archives show that CIA was represented in key DOD biomedical groups in which both human experiments and experimental ethics policy were discussed and planned. At least three CIA officers were members of DOD's Committee on Medical Sciences (CMS) from 1948 to 1953 and attended meetings and received the "program guidance" of the DOD Joint Panel on the Medical Aspects of Atomic Warfare. As reported elsewhere, [7] the Joint Panel was the center for information gathering and planning for medical experimentation, including human experiments, relating to atomic warfare; for example, this panel helped coordinate the program of placing troops in the vicinity of atmospheric nuclear weapons tests. In 1948 CIA also participated in discussions regarding the proposed formation of an Armed Forces Medical Intelligence Organization, during which it was suggested that CIA would be in charge of foreign atomic, biological, and chemical intelligence from a medical sciences viewpoint. [8] CIA representatives on CMS worked for OSI (and its precursor, the Scientific Branch). This office had principal responsibility for analyzing and disseminating foreign atomic energy intelligence. It chaired the Joint Atomic Energy Intelligence Committee (JAEIC, also known as the Joint Nuclear Intelligence Committee), an interagency body that helped coordinate analyses and activities by Departments responsible for monitoring foreign nuclear weapons programs. It also chaired the interagency Scientific Intelligence Committee as well as the Joint Medical Sciences Intelligence Committee, both of which coordinated scientific and medical intelligence for the Government. These two committees provided medical intelligence to the Armed Forces Medical Policy Committee, which also played an active role in planning and overseeing radiation research and human experimentation for DOD. This office also worked on Projects BLUEBIRD and ARTICHOKE; at least one of the officers who attended CMS meetings also analyzed medical intelligence for the Office of Security's human experimentation activities under BLUEBIRD and ARTICHOKE. CIA historically has employed the facilities of other agencies, including DOD and DOE (and its predecessors) to assist in agency research. For example, in 1965 CIA entered into a Memorandum of Understanding with AEC's Lawrence Livermore Laboratory to perform a number of projects for CIA's Office of Scientific Intelligence. CIA has been asked to search for documents specifically related to the work performed under this agreement that might relate to human radiation experiments. With regard to the history of CIA's ethics policies, the MKULTRA experiment program gestated from 1951 to 1952. This was the very period in which DOD's CMS, with CIA participation, engaged in discussions that led to the Secretary of Defense's 1953 enactment of an ethics policy for human experiments based on the Nuremberg Code. The relationship between these Nuremberg Code discussions (and policy) and CIA's MKULTRA activities is a subject of the Committee's inquiry. Through the course of MKULTRA, CIA sponsored numerous experiments on unwitting humans. After the death of one such individual (Frank Olson, an army scientist who was given LSD in 1953 and committed suicide a week later), an internal CIA investigation warned about the dangers of such experimentation. Ten years later, a 1963 IG report recommended termination of unwitting testing; however, Deputy Director for Plans Richard Helms (who later became Director of Central Intelligence) continued to advocate covert testing on the ground that "positive operational capability to use drugs is diminishing, owing to a lack of realistic testing. With increasing knowledge of the state of the art, we are less capable of staying up with the Soviet advances in this field." The Church Committee noted that "Helms attributed the cessation of the unwitting testing to the high risk of embarrassment to the Agency as well as the 'moral problem.' He noted that no better covert situation had been devised than that which had been used, and that 'we have no answer to the moral issue.'" [9] Following revelations of MKULTRA and other unethical CIA practices, President Gerald Ford issued the first Executive Order on Intelligence Activities in 1976, which, among other matters, prohibited "experimentation with drugs on human subjects, except with the informed consent, in writing and witnessed by a disinterested third party, of each such human subject and in accordance with the guidelines issued by the National Commission for the Protection of Human Subjects for Biomedical and Behavioral Research." Subsequent Executive Orders by Presidents Jimmy Carter and Ronald Reagan expanded the directive to apply to any human experimentation: "No agency within the Intelligence Community shall sponsor, contract for, or conduct research on human subjects except in accordance with guidelines issued by the Department of Health, Education, and Welfare. The subject's informed consent shall be documented as required by those guidelines." [10] CIA has issued guidelines implementing the Executive Order and has provided them to the Committee. [11] Remaining Tasks The primary focus of CIA's initial search was records on the use of ionizing radiation on humans by the U.S. Government. The agency did not initially search specifically for information on such topics as the 1949 "Green Run" release (an intentional release of radiation in Hanford, Washington) or the activities of the JAEIC, CMS, or Joint Panel on the Medical Aspects of Atomic Warfare. Nor did CIA initially focus on activities of the Soviet Union and other countries that may have prompted U.S. agencies to consider human radiation experiments (e.g., when the Soviet Union sent approximately 40,000 troops to a test area to conduct military exercises 30 minutes after an atomic bomb test in Totsk, Kazakhstan, on September 14, 1954). In response to specific Committee queries, CIA has provided documents that describe activities of the OSI. CIA continues to search for records in light of five Committee requests. These requests include: (1) records on CMS, the Joint Panel on the Medical Aspects of Atomic Warfare, and other DOD and/or interagency medical intelligence organizations involving human experiments; (2) foreign medical intelligence records on human radiation experiments; (3) records on work done by other agencies; (4) records on ethics policies; and (5) records on the Green Run and other intentional releases. The Committee awaits completion of ongoing records searches that CIA has been conducting on the above and other topics raised by the Committee. ********** 1 In contrast to all other agencies, CIA maintains custody of virtually all of its records; only a small number have been transferred to the National Archives and none to any Federal Records Center. No publicly available index or inventory describes the size and organization of the records that CIA maintains. 2 A redacted version of the IG report was reprinted in Joint Hearings on Biomedical and Behavioral Research, 1975, before the Subcommittee on Health of the Senate Labor and Public Welfare Committee and the Subcommittee on Administrative Practice and Procedure of the Senate Judiciary Committee, 94th Cong., 1 st Sess., at 877 (the complete report is still classified); see also "Final Report of the Senate Select Committee to Study Governmental Operations with Respect to Governmental Operations, Book I" at 389-90, 94th Cong., 2d Sess., No. 94-755 (Apr. 26, 1976) ("Church Committee"). 3 CIA did investigate the use and effect of microwaves on humans in response to Soviet practice of beaming microwaves on the U.S. Embassy but determined that this was outside the scope of the Committee's purview. CIA also sponsored radioisotope tracer experiments involving irradiated LSD and other chemicals on laboratory animals as part of MKULTRA. The Army conducted similar tracer studies on humans at Edgewood Arsenal in Maryland during this period. Beginning in 1967, CIA's Office of Research and Development and the Edgewood Arsenal undertook a joint program for research in influencing human behavior with drugs, which included human experimentation (including on prison inmates) and was performed by the same University of Pennsylvania researchers who had performed the tracer studies. It is not know whether the joint program included radioisotope tracer studies on humans. 4 Helms testified in 1975 that he ordered the records destroyed because "there had been relationships with outsiders in government agencies and other organizations and that these would be sensitive in this kind of a thing but that since the program was over and finished and done with, we thought we would just get rid of the files as well, so that anybody who assisted us in the past would not be subject to follow-up questions, embarrassment, if you will." Church Committee, Book I, at 403-04. 5 CIA officials have suggested this reference to radiation might have meant "ultrasonic radiation" because they found another document in which the possibility of using "ultrasonics and other radiant energy" was proposed and rejected. This suggestion, however, seems unlikely because the summary document also lists "sound" as a field that was explored in addition to radiation. 6 The Geschickter Fund for Medical Research served as a principal "cut-out source" for CIA's secret funding of numerous MKULTRA human experiment projects. 7 See discussion in Part I of the Interim Report. 8 Although this organization apparently was never created, the basic division of labor between CIA and DOD suggested here seems to have been maintained by the Armed Forces Medical Policy Committee. 9 Church Committee, Book I, at 402. The Church Committee noted that "the project involving the surreptitious administration of LSD... was marked by a complete lack of screening, medical supervision, opportunity to observe, or medical or psychological followup. The intelligence agencies allowed individual researchers to design their project. Experiments sponsored by these researchers... call into question the decision by the agencies not to fix guidelines for the experiments." Id. 10 Executive Order 11905 (Feb. 19, 1976) (Ford); Executive Order 12036,  2-302 (Jan. 26, 1978) (Carter); Executive Order 12333,  2,10 (Dec. 4, 1981) (Reagan). 11 One section of the most recent guidelines originally was classified, i.e., HR 7-1a(6)(c)(4), but was declassified upon the request of the Committee. DEPARTMENT OF DEFENSE Five Components of the Department of Defense Five relevant components of the Department of Defense (DOD) have been involved in human radiation experiments: the Office of the Secretary of Defense (OSD), the Department of the Air Force (Air Force), the Department of the Army (Army), the Department of the Navy (Navy), and the Defense Nuclear Agency (DNA). The searches performed are described below. Office of the Secretary of Defense History and Organization DOD replaced the War and Navy Departments in 1947. OSD, established concurrently, consisted of the Secretary of Defense, his deputies and assistants, and various advisory boards and committees, including the Research and Development Board (RDB). Responsibilities of the RDB included preparing an integrated military research and development (R&D) program and coordinating R&D among the military services. Under the former War and Navy Departments, these tasks had been performed in part by the Office of Scientific Research and Development (1942-1945), National Research Council (1945-1946), and the Joint Research and Development Board (1946-1947). To accomplish its assigned responsibilities, RDB created numerous committees whose members included military personnel and civilians. There are at least three committees or panels whose work is particularly relevant: (1) Committee on Medical Sciences (CMS), (2) Joint Panel on the Medical Aspects of Atomic Warfare (which reported to both CMS and Committee on Atomic Energy), and (3) Committee on Human Resources. With the disestablishment of RDB in 1953, its responsibilities were apparently assigned to the newly created Assistant Secretary of Defense for R&D for several years and then to the Defense Director of Research & Engineering (DDR&E) in 1958. At least during the 1950s these offices had their own advisory committees and panels. The records of at least three such panels (i.e., CMS, Committee on General Sciences, and Committee on Atomic Energy) may be of interest. Another advisory board during this period, the Armed Forces Medical Policy Council (AFMPC), drafted and recommended to Defense Secretary Wilson the policy on consent for certain human experiments that he adopted in February 1953. AFMPC succeeded the Office of Medical Services in early 1951 but appears to have been disestablished in 1953. At some point thereafter, the office of the Assistant to the Secretary of Defense for Health was created, and it is believed that this office assumed some, if not all, of the functions of AFMPC. Experiments OSD reviewed and either approved or disapproved specific programs and projects of the four military services and the Defense Nuclear Agency and its predecessors (see below). Records Search The initial DOD search did not encompass OSD. DOD agreed to search OSD files at the Committee's request and has been engaged in an effort to locate and retrieve the files of relevant groups, as discussed above or further identified in the course of ongoing search. Most records of the RDB's CMS, Joint Panel on the Medical Aspects of Atomic Warfare, and Committee on Human Resources that are in the OSD collection (Record Group #330) at the National Archives (NARA) in Washington, D.C., have been examined. Some significant records, however, are not in this collection and may not exist. For example, although there are verbatim transcripts of the meetings of CMS and the Committee on Human Resources, only summary minutes exist for the meetings of the Joint Panel on the Medical Aspects of Atomic Warfare. Most records of AFMPC and its predecessors in this collection also have been reviewed. OSD has also started to identify and review pertinent collections in the OSD holdings at the Washington National Records Center (WNRC) (Record Group #330); these are estimated to comprise approximately 2000 boxes. Remaining Tasks Most records of two RDB predecessors, the Office of Scientific Research and Development (Record Group #227) and the Joint Research and Development Board (Record Group #330), are declassified and housed at NARA in Washington, D.C. The records of the committees with jurisdiction over biomedical research must be examined. Most of the records of the National Research Council are either unclassified or declassified and housed at the National Academy of Sciences in Washington, D.C. Similarly, the records of the committees with jurisdiction over biomedical research must be reviewed. With respect to the OSD records at NARA, the following remains to be done: 1) Committee Staff will complete the examination of the records of the CMS, Joint Panel on the Medical Aspects of Atomic Warfare, and Committee on Human Resources; (2) Committee staff will complete the examination of the monthly, quarterly, and annual progress reports submitted by the four military services and Armed Forces Special Weapons Project (AFSWP) to RDB; and (3) Committee staff will complete the review of the records of AFMPC and its predecessors. For the most part, these records are declassified. With respect to the OSD records at WNRC (Record Group #330), DOD must (1) complete the identification and review of any relevant RDB records (including, among other things, any correspondence files of the Joint Panel on the Medical Aspects of Atomic Warfare and any verbatim transcripts of its meetings), (2) complete the identification and examination of the pertinent records of the Assistant to the Secretary of Defense for R&D and DDR&E, (3) complete the identification and review of records of any other OSD office that had any role in human experiments, and (4) complete the identification and examination of any relevant records of AFMPC and its successor(s). Committee staff will assist OSD in this process. Most of the OSD records at WNRC are still classified. DOD must also identify and review any relevant OSD records still remaining. Department of the Air Force History and Organization The Air Force was established in 1947 under the new DOD. Prior to this it had been part of the U.S. Army under the War Department. Several Air Force components have been involved in biomedical research, including the Office of the Surgeon General (OSG), which has general oversight responsibilities. Another, the School of Aviation Medicine (SAM), was a subordinate command of the Air University in the 1950s and 1960s and is now part of the Human Systems Center. A third component is the Medical Centers attached to operational commands where clinical investigations are conducted. Experiments The Air Force provided a list of more than 600 human radiation experiments, approximately 90 of which predate 1975. Committee staff has asked the Air Force to provide available backup material it has identified regarding pre-1975 experiments. SAM was a primary sponsor of the majority of the pre-1975 experiments, and the Air Force has provided histories of SAM. The Air Force reports that additional material is warehoused at SAM's Texas facilities; however, records of many individual experiments appear to have been destroyed or taken by the investigators. Records Search With respect to headquarters documents, selected files in the Secretary of the Air Force (Record Group #340) and Headquarters, Air Force (Record Group #341) collections at NARA and WNRC have been examined. All periodic and programmatic histories of OSG have been examined, and pertinent portions provided (this effort extensively involved the U.S. Air Force Historical Research Agency). The minutes, agendas, and reports of the panels and committees of the Scientific Advisory Board (SAB) dealing with biomedical research in Record Group #341 at WNRC have been reviewed. SAB was established in 1947 and advises the Secretary of the Air Force and the Chief of Staff on research and development. In response to the DOD-wide January search directive, the Air Force sought to identify experiments (and related documentation) at field sites that may have conducted or sponsored experiments. This effort entailed several queries to all Air Force commands, including each individual clinical investigation facility (Travis AFB, Lackland AFB, Keesler AFB) and those conducting clinical investigation programs (Anderson AFB, Wright-Patterson AFB, Scott AFB). Command historians, as well as the Office of Air Force History, were also queried. The Air Force reports that over 6,000 person-hours have been spent reviewing selected files at the National Personnel Records Center in St. Louis; the holdings at Strughold Library at Brooks AFB; and the Geophysics Laboratory Library at Hanscom Field. Remaining Tasks Further review may be needed of selected files in Record Groups #340 and #341. The post-1953 records of OSG must be located and reviewed. Committee staff will continue to work with the Air Force to examine pertinent records of important nonheadquarters commands, particularly SAM. Although evidence exists that the Air Force received notice when the Secretary of Defense issued his Nuremberg Code directive in February 1953, little or no evidence exists of its implementation in specific cases. The Committee believes that the search will locate relevant materials on implementation. The Committee also has asked the Air Force to search for materials relating to (1) consent practices used for those involved in flash-blindness tests and atomic cloud air sampling activities conducted in connection with atomic bomb tests, and (2) the development and application of a 1958 Air Force policy regarding ultrahazardous research. Department of the Army History and Organization The Army was established in 1947 under the new DOD. Prior to this the Army was under the War Department, which DOD replaced. One component conducting biomedical research was the Office of the Surgeon General (OSG) and its many subordinate commands. These commands included hospitals (e.g., Letterman General Hospital in San Francisco) and research centers (e.g., the Medical Research Laboratory at Fort Knox). Beginning in the 1940s, OSG created a Medical Research and Development Board to review all biomedical research conducted by OSG and its many contractors. It is not known how long the board existed, but in 1958 OSG established the Army Medical Research and Development Command, which evidently had the same responsibilities. A second component conducting biomedical research is the Chemical Corps and its successor(s). The Chemical Corps replaced the Chemical Warfare Service in the mid-1940s, and it in turn was disestablished and had its responsibilities assigned to the Assistant Chief of Staff for Force Development in 1963. At least during the late 1940s and early 1950s, it appears that the majority of biomedical research was conducted by or for the Medical Division of the Army Chemical Center (one of three major centers in the Chemical Corps during this period). Another significant component might be the Scientific Advisory Panel and any successor(s). In 1951 this panel was established to advise the Secretary of the Army and the Chief of Staff on R&D the Army should undertake. Its responsibilities may have included R&D in the biomedical field. Experiments In September 1994 the Army provided the Committee with a listing of several hundred experiments. The Committee has asked the Army to identify all pre-1975 experiments and provide all available supporting documentation for each one. Records Search With respect to headquarters documents, the Army currently is reviewing the periodic and programmatic official histories of OSG and the Chemical Corps and its successor(s) at the Center for Military History. The tables of contents and relevant portions of any of interest will be provided to the Committee. All histories of the Chemical Corps and its successor(s) are classified. With the exception of records from 1952 to 1953, which could not be located, OSG records (Record Group #112) at WNRC for 1951 to 1958 have been reviewed. OSG records at WNRC for the years following 1958 currently are being examined. In response to the January 1994 DOD-wide search directive, the Army asked field sites that may have conducted or sponsored experiments to identify them and the location of related data. The Committee does not have a clear definition of the extent of this inquiry yet. Remaining Tasks The review of the histories of OSG and the Chemical Corps and its successor(s), as well as the remaining OSG records at WNRC, must be completed. Any OSG records at the National Archives or still housed at OSG must be identified and reviewed. The large collection of records of the Chemical Corps at WNRC (Record Group #175) and any possibly still with a successor must be identified and examined. (These include records related to radiation warfare experiments conducted at Dugway, Utah, or elsewhere.) The records of the Scientific Advisory Panel and any successor(s) must be located reviewed. In June 1953 the Secretary of the Army implemented in a separate order the Secretary of Defense's Nuremberg Code directive from earlier that year. A 1975 Army Inspector General report details the extent of its implementation in research involving psychoactive chemicals, but there is little documentation regarding its implementation in research involving ionizing radiation. The Committee has asked the Army to place a priority on locating this material. The Committee has also asked the Army (as well as other services) to provide all documents related to human experimentation planned or conducted in connection with atomic bomb tests, including documentation relating to the biomedical components of tests, and consent procedures for those involved in troop maneuvers, psychological observation, body fluid sampling, or other human subject tests. The Army has agreed to provide all such materials. Department of the Navy History and Organization The Department of the Navy (Navy) was established in 1947 under the new DOD. Prior to this the Navy was under the Navy Department, which DOD replaced. One component conducting biomedical research is the Bureau of Medicine (BUMED) and its many subordinate commands. BUMED through the years has conducted research at its own facilities and through contractors. A second component involved in biomedical research is the Office of Naval Research (ONR). Most of its research has been performed by contractors. BUMED and ONR existed at the time the Department of the Navy was established. A third component performing biomedical research was the Naval Radiological Defense Laboratory (NRDL) which existed from 1946 to 1969. NRDL was established in the aftermath of contamination problems experienced following the 1946 Bikini atomic bomb test Baker. A fourth possible important component is the Naval Research Advisory Committee. Established in 1946, its role has been to advise the Secretary of the Navy and Chief of Naval Operations on research and development. Its responsibilities may have included advising on biomedical research and development. Experiments The Navy has identified approximately 800 experiments, of which about 150 predate 1975. (Additional experiments are still being located.) The Navy provided the Committee with available documentation on these experiments, but in many cases, particularly for pre-1975 experiments, data are fragmentary. The Navy and the Committee will work to identify further data on selected experiments. Records Search The Navy reports that over 1,800 person-days have been expended in the records search. With respect to headquarters documents, relevant portions of the records of the Secretary of the Navy in Record Group #428 at NARA and WNRC, and at the Office of the Secretary of the Navy have been reviewed in part. Relevant portions of the records of BUMED at NARA (Record Group #52) and at BUMED have been reviewed in part. BUMED histories have been examined. Relevant portions of ONR records still housed at ONR have been reviewed. ONR records in Record Group #298 at NARA and WNRC are being examined. In response to the DOD-wide January search directive, the Navy sought to identify experiments and related records at numerous field sites. Selected files in the only known location of NRDL office files (the NARA and Federal Records Center in San Bruno, California) have been, or are being, examined. Certain technical reports from NRDL's library were sent to the Armed Forces Radiobiology Research Institute (AFRRI) and to the Naval Surface Weapons Center in White Oak, Maryland, and they have been reviewed. Unclassified NRDL histories have been provided. However, the Committee understands that many other NRDL records or reports were destroyed when NRDL was disestablished, and has requested a report on this matter. At the Federal Personnel Records Center in St. Louis, records were examined on the following commands: Naval Submarine Medical Research Center; Naval Hospital and Naval Submarine Base, Groton; Naval Hospital, Chelsea; Naval Hospital, St. Albans; and Naval Hospital and Naval Medical Research Institute, Taiwan. Remaining Tasks Further review of selected records of the Secretary of the Navy, BUMED, and NRDL may be necessary. Classified NRDL histories were once housed at the Naval Historical Center. Additionally, a review of the holdings of the Naval Historical Center should be made for other relevant periodic and programmatic histories, as well as relevant records collections. The records of the Naval Research Advisory Committee must be located and reviewed. The Navy has found evidence of consent policies dating to the 1930s. For the period through the mid-1960s, the Navy has located documentation of this process for some experiments. Only approximately six of these experiments involved ionizing radiation, however, while the Navy reported over 100 such experiments from this period. The Committee hopes that the Navy will be able to locate further information regarding these additional experiments, including information relating to any review process. Defense Nuclear Agency History and Organization DNA is the successor to the Armed Force Special Weapons Project (AFSWP) and the Defense Atomic Support Agency (DASA). Since the establishment of AFSWP in 1947, the responsibility for biomedical research conducted for AFSWP and its successors has lain primarily with a small medical division at the headquarters. The Armed Forces Radiobiology Research Institute (AFRRI, discussed below), has also had some responsibility in this area. Again, except for AFRRI, biomedical research of AFSWP, DASA, and DNA actually has been performed by a contractor or another Government agency. In the early 1960s. DASA assumed control of AFRRI from the Navy. AFRRI has conducted almost exclusively research at its own facilities. Experiments DNA initially identified approximately one dozen pre-1975 experiments. DNA's research has identified further experiments funded or organized by DNA. Records Search DNA has committed to reviewing all of its and its predecessors' records (Record Group #374) at NARA and WNRC, as well as those still housed at its headquarters and one field command. Apparently, these are the only four repositories that hold any such records, almost all of which are classified. A number of relevant documents have been and are being declassified and will be provided to Committee staff. Committee staff has asked DNA, and DNA has agreed, to include any documentation related to potential human experimentation connected with atomic bomb tests. DNA reports that some records have been destroyed. A key collection in this category is the contract files for the biomedical research sponsored by AFSWP and DASA during the 1950s and 1960s. Moreover, few records of some key offices (most notably the medical division at headquarters) have been located. DNA has examined all official periodic and programmatic histories of AFSWP, DASA, and DNA, all of which are classified. Tables of contents and pertinent portions have been declassified and furnished to Committee staff, who, after reviewing them, requested further portions. DNA has also provided the periodic histories of AFRRI, as well as the minutes of the meetings of its Board of Governors. All of these items were unclassified. DNA is reviewing selected classified materials it has collected that are connected to the histories of the nuclear weapons tests prepared for the Nuclear Test Personnel Review (NTPR) program. In conducting the DNA search, the Committee is mindful of previous DNA (and DOD) work connected with the NTPR program. That program sought, among other goals, to collect documentation on U.S. nuclear tests; it also prepared a series of test histories. Committee staff is availing itself of the public NTPR materials and has asked for declassification of many NTPR source documents that may remain classified. Remaining Tasks Committee staff has received significant documentation as a result of DNA's research, and, based on DNA's commitment, expects provision of the remaining information in the immediate future. DNA is preparing an index of the records at NARA, WNRC, and its headquarters and field command. Based on the materials provided from the search and this index, Committee staff will request further information. The areas of the requests will include specific biomedical experiments, intentional releases, and human experimentation connected with atomic bomb tests. DEPARTMENT OF ENERGY History and Organization of the Department of Energy The Department of Energy (DOE) is the successor to the Manhattan Engineer District (MED), Atomic Energy Commission (AEC), and Energy Research and Development Administration (ERDA). MED was established within the U.S. Army in 1942 to build the atomic bomb. Although biomedical research was conducted at individual project sites from the first days of MED, in August 1943 the Medical Section was created partly to coordinate such research. The biomedical research program was conducted both at Government-owned, contractor-operated laboratories (e.g., Clinton Laboratory, now Oak Ridge, and Los Alamos Laboratory) and by contractors (e.g., the University of Rochester and the University of California Radiation Laboratory). The Medical Advisory Committee was created in mid-1946 to advise MED on a number of issues, including future biomedical research programs that the atomic energy program might adopt. In 1946, MED began to distribute radioisotopes produced at Clinton Laboratory to researchers outside of its own laboratories and contractors. The Interim Advisory Committee on Isotope Distribution was set up to advise MED on policies and guidelines in this area, including the use of radioisotopes in humans. AEC came into existence as an independent agency within the executive branch on January 1, 1947. At the outset, AEC had no division or office responsible for biomedical research. Early in 1947 the Interim Medical Advisory Committee (IMAC) was created to advise AEC on its biomedical research effort, and most of the existing programs and contracts simply were continued. The Medical Board of Review, a successor to IMAC set up in mid-1947, recommended the creation of a division specifically responsible for biomedical research and a permanent advisory group of physicians from outside the Government to assist that division. Based on these recommendations, the Advisory Committee on Biology and Medicine (ACBM) was formed in September 1947, and the Division of Biology and Medicine (DBM) in early 1948. Under AEC, the biomedical research program increased dramatically both at Government-owned laboratories and at contractor sites. Virtually all of this effort was managed and directed by DBM, with the assistance of ACBM. The Division of Military Application (DMA) had substantial responsibilities involving the military use of atomic energy. During the late 1940s, and possibly later, DMA had a Radiological Branch that worked extensively in the radiological warfare field. DMA funded some biomedical research in the 1950s concerning fallout and also may have funded other biomedical research. The distribution of radioisotopes grew rapidly under AEC. Once production difficulties were overcome in 1947, distribution was expanded to users in industry and agriculture. The Isotopes Branch and its successors ran the isotope production and distribution program. The Advisory Committee on Isotope Distribution was created in 1948 to replace the interim committee of the same name, and the Subcommittee on Human Applications was established thereunder to set guidelines and policies for the Isotopes Branch governing use of AEC-supplied radioisotopes in humans. In 1958 the Advisory Committee on Medical Uses of Isotopes succeeded the Subcommittee on Human Applications. ERDA assumed most of the responsibilities of AEC in 1974; the civilian nuclear power and isotope distribution functions of AEC were transferred to the newly created Nuclear Regulatory Commission. The Biology and Environmental Research Division was established to continue the work of DBM. Experiments DOE-identified experiments include (1) experiments identified in the mid-1980s and included in the Markey report and (2) further experiments DOE identified in June 1994. Additional experiments are being identified by the DOE headquarters Office of Human Radiation Experiments (OHRE), to which DOE has given final responsibility for identifying experiments. OHRE works independently, and in conjunction with other DOE elements, to identify experiments. In mid-October, OHRE reported that it had identified information pertaining to over 80 separate human experiments. Further DOE experiments continue to be identified in documents provided by DOE and in other sources located by the Committee. Records Search In mid-October DOE reported that it had released approximately 115,000 pages of documents. DOE has issued written guidance to all DOE and contractor elements directing them to search for all records with information about human radiation experiments. The present aim of the search is to provide (1) inventories of relevant record collections ("series descriptions") and (2) copies of the documents. DOE created OHRE, among other matters, to serve as a central collection point and perform quality control. Series descriptions are complete for Lawrence Berkeley Laboratory, Argonne, and Oak Ridge; those for Los Alamos, Brookhaven, Hanford, and Idaho are being revised. The series descriptions indicate that approximately 75 percent of the relevant collections are unclassified or declassified. Committee staff has asked DOE to annotate series descriptions to indicate which records therein have been reviewed. In addition to MED and early AEC headquarters records at Oak Ridge, numerous headquarters records remain at various DOE headquarters offices and at the National Archives (NARA) and the Washington National Records Center (WNRC) in the Washington, D.C., area. [1] The relevant Oak Ridge and MED/early AEC headquarters records at the Atlanta NARA in Record Group # 326 have been reviewed by DOE and Committee staff. At the Committee's request, DOE is retrieving records related to human experimentation from the universities involved in the plutonium injection experiments (i.e., the University of Rochester, University of California, and University of Chicago). A number of records of interest remain classified. The Committee has sought to limit and prioritize declassification requests. Initially, the Committee asked DOE to locate and declassify relevant files of the AEC's Division of Intelligence, which were understood to include information on intentional releases and "work for others" (e.g., experiments performed for other agencies at DOE labs). Following an extensive search, DOE reported that these files--through the early 1970s--probably have been destroyed. At the Committee's request, DOE conducted an inquiry and prepared a report on this matter. Currently, the Committee has assigned priority to OHRE to declassify portions of the periodic reports of AEC to the Joint Committee on Atomic Energy (the congressional oversight committee) and portions of the periodic reports of AEC's divisions to the General Manager. A declassification request for selected files in the 1947-1951 and 1952-1958 Executive Secretariat files (i.e., the files of the five-member Commission) has been made to the DOE declassification team at NARA. Remaining Tasks With respect to headquarters materials, numerous collections in the Washington, D.C., area must be reviewed. Where detailed finding aids and inventories exist, individual files (instead of entire boxes or collections) often can be targeted for review. Committee staff will seek to work with DOE staff to assure the timely and efficient review and retrieval of documents. Specific collections of interest include the following: O Isotope Branch (and its successors) - Despite an extensive search by DOE staff, no collections of these records have been located. However, some documents have been found in other collections regarding the isotope production and distribution program. O Insurance Branch - Documents indicate that the Insurance Branch may have been a driving force in the development of rules relating to human experiments. Despite an extensive search by DOE, the records of this Branch have not been located. O Atomic Bomb Test Biomedical Planning Groups - DOE staff has located, and will soon provide, the files of these panels, which planned and reviewed biomedical research connected with atomic bomb tests. O Division of Military Application - Inventories for DMA collections at WNRC and DOE headquarters have been provided. Selected files in these collections must be reviewed and relevant individual documents declassified. O General Manager - The inventory for the General Manager collection at the History Division has been provided. Selected files in this collection must be reviewed and relevant individual documents declassified. O Office of General Counsel - Inventories have been furnished for collections at WNRC and NARA, but there appear to be no pertinent files there. The History Division has a large collection for which there is no inventory, but DOE staff's initial examination indicates that this collection contains relevant materials. Selected files must be examined and pertinent individual documents declassified. O Commission Minutes - Committee staff has examined the small collection of declassified minutes at the History Division. The much larger declassified collection in Record Group #326 at NARA must be reviewed. O General Advisory Committee - Committee staff has examined the small collection of declassified agendas, minutes, and reports at the History Division. The much larger declassified collection in Record Group #326 at NARA must be reviewed. O Division of Biology and Medicine - Committee staff has examined the declassified portions of the collections at the History Division and the collection on fallout in Record Group #326 at NARA. Both collections have files that must be declassified. Inventories have been provided for these and other DBM collections at NARA, WNRC, and DOE headquarters. All other collections are completely unclassified; selected files therein must be examined. O Advisory Committee on Biology and Medicine - Summary minutes of all ACBM meetings have been furnished, as well as some verbatim minutes. O Executive Secretariat Files - Committee staff has examined only a limited number of declassified files in the 1952-1958 collection in Record Group #326 at NARA. As noted above, a declassification request is pending for other files in this collection and the 1947-1951 collection at NARA. Inventories have been provided for the 1958-1974 collection, which is at the History Division; selected files must be reviewed, and relevant documents declassified. O Periodic Division Reports to the General Manager/Periodic AEC Reports to the Joint Committee on Atomic Energy - As noted above, these are being declassified by DOE and will be furnished shortly. O Individual Commissioner Files - These collections are at NARA, WNRC, and at DOE headquarters. A small number of selected files must be reviewed, and pertinent individual documents declassified. There are some indications that a significant percentage of the 1958-1974 records of the Isotopes Branch were transferred to the Nuclear Regulatory Commission. If true, these might be in Nuclear Regulatory Commission collections at a NARA or Federal Records Center or possibly still at the Nuclear Regulatory Commission. The Committee has requested the supporting documents used by the Division of the Inspector General in writing the 1974 report on the plutonium injections. DOE reports that it continues to search for these documents. While both headquarters and some laboratories had policies governing informed consent beginning in the late 1940s, few documents have been found thus far on the scope and implementation of these policies. Committee staff believes that DBM and Office of General Counsel collections, as well as those of the Insurance Branch, might have pertinent information. Finally, a number of unclassified periodic and nonperiodic AEC publications must be reviewed. These range from AEC semiannual and annual reports to congressional reports to annual reports of the Oak Ridge Institute of Nuclear Studies. In the field, series descriptions for several sites must be revised. The progress in examining records varies: some sites (e.g., Los Alamos and the Oak Ridge Operations Office) have completed or nearly completed the initial review, while others have not. Committee staff is working with DOE on targeted inquiries at several sites, including Brookhaven, Los Alamos, Oak Ridge, Richland, and the historic University of California contracts. DOE is seeking to locate and review records of several private and public institutions that performed important biomedical research for the AEC (e.g., the University of California at Los Angeles and San Francisco and the Universities of Chicago and Rochester). ********** 1 Records transferred to National Archives and Records Administration are no longer under agency control. However, DOE is committed to assisting the Committee in the identification and retrieval of relevant collections. DEPARTMENT OF HEALTH AND HUMAN SERVICES History and Organization of the Department of Health and Human Services The Department of Health and Human Services (HHS) is the Federal agency most directly concerned with public health and health-related research. The landmarks for the organization as a whole were the creation of the Federal Security Agency (FSA) in 1939, the establishment of the Department of Health, Education, and Welfare (HEW) in 1953, and HEW's reorganization into HHS in 1980. The U.S. Public Health Service (PHS), one of the five major operating divisions of HHS, has conducted and sponsored radiation research. From 1944 to 1967, PHS included the Office of the Surgeon General, the National Institutes of Health (NIH), the Bureau of State Services (BSS), and the Bureau of Medical Services. After reorganization in 1968, PHS--including NIH, the Food and Drug Administration (FDA), and the Health Services and Mental Health Administration--reported to the Assistant Secretary for Health and Scientific Affairs. Since 1973, HHS components relevant to the Committee's work have included the Office of the Assistant Secretary for Health (OASH), the Centers for Disease Control and Prevention (CDC), the FDA, the Indian Health Service (IHS), and NIH. The two historically significant agencies for radiation research within PHS are BSS and NIH. BSS, historically responsible for industrial and occupational health within PHS, began to study the biological effects of radiation as part of research on worker and public health. The studies were conducted by a component of BSS, the Bureau of Radiological Health (BRH), which also served as liaison to AEC and Department of Defense. BRH sponsored extramural research related to radiation and its public health hazards. BRH ran regional sampling and research labs, including the national monitoring network for radioactive fallout from the atmospheric testing of nuclear bombs, sampling and research laboratories in Nevada and Alabama, the bone strontium sampling program, and the national milk testing network. NIH has been the major Federal sponsor of biomedical research since the end of World War II and the dissolution of the War Department's Committee on Medical Research (CMR), which had previously sponsored such work. During the Korean War, representatives of PHS participated in interagency working groups that planned biomedical research of military relevance, including the Joint Panel on Medical Aspects of Atomic Warfare. Today NIH is one of the primary Federal sponsors for extramural biomedical radiation research. Most of the significant applications to NIH for radiation research funding were reviewed by the Radiobiology (later Radiation) Study Section of NIH. NIH's intramural research is conducted by various institutes. Those of interest to the Committee include the National Cancer Institute (NCI), which funded and conducted radiation research related to cancer; the National Heart Institute (now Heart, Lung, and Blood), and the National Institute of Arthritic and Metabolic Diseases (since reorganized into two separate Institutes). Moreover, in 1953 NIH created an intramural research hospital, the NIH Clinical Center, and centralized its intramural radiation research. The Clinical Center had a radiation wing, in which radiation research was conducted. Experiments NIH has sponsored a wide variety of radiation research involving human subjects, particularly relating to cancer therapy. Many of these research projects, probably including those of greatest interest to the Committee, were reviewed by the Radiation Study Section. There were also NIH satellite intramural programs involving radiation research, including a Laboratory for Experimental Oncology in northern California and work (likely involving animal and instrumentation research only) performed under a Memorandum of Understanding with the Clinton Laboratories of the Monsanto Chemical Company. The Bureau of Radiological Health also supported extramural radiation research by contracts and with grants. The FDA's Center for Devices and Radiological Health, the successor organization to BRH, identified 18 experiments funded by BRH that are relevant to the Committee's charge. Records Search The HHS records most relevant to the Committee's work comprise three sets of materials: (1) records of extramural research funded by NIH and BRH; (2) records of intramural research conducted by PHS components (most significantly, work done at the NIH Clinical Center); and (3) organization and policy documents relevant to program history, links with other Federal agencies interested in human radiation research, and the history of ethics guidelines for human subjects research generally. To date, NIH has in its computerized database only those extramural research grant records since 1962. It plans to computerize information on pre-1962 grants so that a specific set of data items can be provided for such awards. NIH also is developing a software program and creating electronic files that will permit the search by radiation keywords of its early grant awards. Another effort mounted by NIH involves matching names of researchers who received radioisotopes with names of investigators who received NIH research grants. NIH staff manually reviewed 1,200 boxes of records at the National Archives that may have contained information concerning its pre-1974 sponsored research; seven boxes were deemed potentially relevant. The Division of Research Grants (DRG) has searched all historical files of its Office of the Director and prepared an inventory of records found. Files of the NIH Director's Office also have been searched for research conducted by these investigators. NIH and PHS (with contractor support) also have conducted a targeted search of FSA, HEW, PHS, OASH, and NIH records at the National Archives and the Federal Records Center for any documents that may identify either pre-1974 research of particular interest to the Committee or evidence interagency radiation research with other federal agencies; this search is ongoing. During a reorganization in 1971, FDA received BRH's program and records related to its radiological public health responsibilities. FDA reports that it has not conducted or sponsored human radiation experiments, but FDA made approximately 26 boxes of BRH records available to the Committee. NIH currently is refining a list of all awards in which grant applications were reviewed by the Radiology Study Section and its successors. Experiments involving ionizing radiation and human subjects that were reviewed by other study sections before 1966 will not be included in this list. For those experiments conducted by NIH scientists, the Medical Records Department of the Clinical Center has records for the 245,000 patients admitted to the Clinical Center since it opened in 1953. Much of the Clinical Center's work is experimental, and this experimental work includes diagnostic/therapeutic procedures involving radiation. NIH staff reviewed the Medical Board minutes and the Radiation Safety Committee minutes from the Clinical Center. NIH staff is developing a database of human radiation experiments conducted in the NIH intramural program that will contain the protocols, titles, investigators, radiation usage, and so forth. This database will be provided to the Committee when it is complete. Although the history of ethics policy development at NIH was relatively well documented before the work of the Committee, HHS has recently found documents concerning the evolution of consent policy at the Clinical Center. These materials show the varying perspectives of legal counsel and the medical board in the 1950s concerning the need for formal consent documents for all patients admitted to the Clinical Center. In conjunction with the Committee's contemporary Research Proposal Review Project, Committee staff has been working with HHS staff to search the online CRISP (Computer Retrieval of Information on Scientific Projects) database for abstracts of extramural studies involving human subjects that were approved and funded in fiscal year 1993. From this search, HHS generated a preliminary printout of all fiscal year 1993 studies involving ionizing radiation and a sample of nonradiation studies. In addition, staff has received Request for Protocol Approval forms (including abstracts) for fiscal year 1993 intramural CDC human research studies, which are not available on CRISP. Abstracts of intramural human subjects research from other HHS entities (NIH, Agency for Health Care Policy and Research, and FDA) are currently "in process." Remaining Tasks NIH will continue to search and review its materials from the National Archives and the Federal Records Center. Various DOD documents from the 1950s indicate that the military consulted PHS on the health and biological effects of ionizing radiation (the contact points with the uniformed services appear to have been their respective Surgeons General offices); Committee staff will work with HHS to obtain memoranda and other correspondence between PHS and defense organizations that would clarify the nature of this consulting relationship. NIH and Committee staff will refine the Radiation Study Section and other experiment lists for both extramural and Clinical Center research and will explore search strategies to obtain the most useful, retrievable information on selected sets of experiments from the refined lists. With respect to contemporary human subjects research conducted or supported by HHS, Committee staff will work with HHS to review records of intramural research and facilitate review of records of extramural research funded by HHS. DEPARTMENT OF VETERANS AFFAIRS History and Organization of the Department of Veterans Affairs The Veterans Administration (VA) was established in 1930 through consolidation of the Veterans' Bureau, the Bureau of Pensions (under the Department of the Interior), and the National Homes for Disabled Volunteer Soldiers. In the immediate post- World War II era, VA's second Administrator, General Omar Bradley, launched a major expansion and reorganization of VA's medical services; this expansion included establishing the Department of Medicine & Surgery in 1946. At that time the director of medical programs, Major General Paul Hawley, instituted residency programs and teaching fellowships in VA hospitals and established the policy of locating VA hospitals adjacent to, and affiliating them with, leading medical schools. Hospital-based research began, increasing in scope during the next decade. In 1988 legislation was enacted to elevate VA to cabinet status; the Department of Veterans Affairs (also referred to as VA) was established on March 15, 1989. Today VA operates both nationwide health care and assistance programs for veterans and their families (e.g., pensions, disability compensation, vocational rehabilitation, education payments, and life insurance) and 113 national cemeteries. VA is divided into three main divisions: (1) the Veterans Health Administration (the linear successor to the Department of Medicine & Surgery); (2) the Veterans Benefits Administration; and (3) the National Cemetery System. The framework of VA's radioisotope/radiation research was developed in the fall of 1947 with the establishment of a five- member Central Advisory Committee on Radioisotopes that reported to General Hawley. At its first meeting, this advisory body recommended (1) the establishment of an Atomic Medicine Division within the Department of Medicine & Surgery, (2) the establishment of a Radioisotope Section within that Division, and (3) the designation of the Atomic Medicine Division as "confidential," directing attention instead to the existence of a radioisotope program within the Radioisotope Section. Following the adoption of these recommendations, the first radioisotope unit opened in Van Nuys, California in February 1948. Seven additional labs in Framingham, Massachusetts; Cleveland, Ohio; Minneapolis, Minnesota; Bronx, New York; Hines, Illinois; Dallas, Texas; and Los Angeles, California opened by year's end. That number grew to 14 by 1951, to 33 by the end of 1953, and to 48 by 1958. From the outset, VA used radioisotopes for diagnosis, treatment, and research. Experiments Based on information from VA and other sources (e.g., documents received from other agencies) and based on the Committee staff's independent research, staff thus far has identified approximately 60 VA human radiation experiments during the period from 1946 to 1974. In late September 1994, VA sent a list of approximately 3,500 potential human radiation experiments conducted by its researchers between 1956 and 1973; information on most of these potential experiments is limited to title, year, location, and (in some instances) name of investigator. In the absence of additional information, it is unclear how many of these 3,500 experiments actually are instances of human radiation research. (The list appears to include duplications, as well as some research involving animals.) VA experiments were conducted in several areas. Based on brief descriptions in the annual Medical Research in the Veterans Administration, much of VA's radioisotope research involving humans appears to have consisted of tracer studies (e.g., with Iodine-131). Documents received from HHS and reference materials on the history of nuclear medicine indicate that fallout research with cesium and strontium was conducted in Hines, Illinois, and (as part of Operation Sunshine) in Salt Lake City, Utah. AEC materials indicate that total body irradiation occurred at five VA sites. [1] As to the conduct of classified experiments, VA lacks original classification authority and VA staff has stated that it knows of no pertinent classified documents. However, VA apparently had such authority between 1951 and 1972 and could therefore have independently sponsored or conducted such research in the past. The West Los Angeles VA Medical Center was and still is affiliated with the University of California at Los Angeles' medical school, which has operated an Atomic Energy Project (now known as the Laboratory of Biomedical and Environmental Sciences) in conjunction with AEC/ERDA/DOE since 1947. The Committee has located documents that indicate that the Atomic Energy Project was engaged in some classified activities in the late 1940s and early 1950s; at present, it is unclear whether these activities included human radiation experimentation and to what extent (if any) VA may have participated in such activities. In addition to the above information about specific experiments, the Committee has lists of several hundred journal articles published by VA radioisotope/radiation researchers concerning research projects that may be characterized as human radiation experiments; these publications must be located and reviewed. Records Search VA records are maintained at VA medical centers throughout the country, at regional offices, at its headquarters (Central Office), and at Federal Records Centers and National Archives. VA's search for documentation of human radiation experiments began in early 1994 with a review of records then housed at the Central Office. Due to the paucity of responsive documentation at that site, the search was expanded to the field. A series of directives to the approximately 170 field locations requested (1) the completion of several surveys about radioisotope/radiation research and radiotherapy and (2) the location and retrieval of all pertinent records. The surveys did not expressly ask the field sites to identify and/or quantify their human radiation experiments; as a result, some responses merely included lists of radioisotopes employed, some appended lists of pertinent publications, and some attached descriptions of potentially relevant activities. Based on information contained in these survey responses and other sources, Committee staff identified an initial subset of field sites from which all records were requested. In August 1994, VA began to review approximately 1,800 boxes containing potentially relevant Central Office files that had been transferred to the Federal Records Center; it expects to complete its review of these materials no later than mid-November 1994. As of September 28, 1994, VA had transferred to Committee staff approximately 13.5 cubic feet of records. On October 7, 1994, VA's Chief of Staff requested the assistance of the Inspector General in the search for pertinent records. VA has produced little documentation regarding specific experiments. VA has produced policy manuals and annual reports dating back to the early 1950s, but it has provided little contemporary correspondence (e.g., to or from the Administrator or General Hawley) or other early materials that might provide context or information about actual implementation of policy. Additionally, VA's decentralization makes the location and retrieval of responsive documents difficult; many potentially responsive documents likely would be held in the field rather than in the Central Office, but retention policies suggest that such materials may long since have been destroyed. Records retention practices, however, may have varied among field sites, and some investigators may have retained some records. Remaining Tasks As discussed with VA, VA will follow several paths. First, VA will complete its review of potentially relevant Central Office materials now held at the Federal Records Center. Second, VA will continue to seek additional information about and locate documentation regarding its "confidential" Atomic Medicine Division, so that the nature and purpose of that entity can be understood. Third, based on an initial assessment by VA and Committee staff, VA will be asked to seek more detailed information about human radiation experimentation conducted at a selected subset of VA medical centers. Fourth, VA will locate documentation of its early ethics policies and practices regarding human subjects research in general, and human radiation experiments in particular. The Committee will continue to work with VA to quantify the universe of VA human radiation experiments. Further, Committee staff will continue its archival research to learn more about VA's work during the early years. ********** 1 Those sites were Long Beach, California; Denver, Colorado; New Orleans, Louisiana; Houston, Texas; and Wood, Wisconsin. NATIONAL AERONAUTICS AND SPACE ADMINISTRATION History and Organization of the National Aeronautics and Space Administration The National Aeronautics and Space Administration (NASA) was founded in 1958 as a civilian space agency, incorporating the older National Advisory Committee on Aeronautics (NACA) and some facilities and programs of the Department of Defense (DOD). NASA inherited no significant life science programs, and developed a centralized Office of Life Science Programs that operated briefly from 1960 to 1961. In 1962, NASA was reorganized along programmatic lines, and life sciences programs were divided among three main programs: the Office of Manned Space Flight, the Office of Space Science and Applications, and the Office of Advanced Research and Technology. The Office of Manned Space Flight was responsible for astronaut selection and training, including medical screening, and for biomedical studies on the effects of space flight on astronauts, primarily through the Manned Spacecraft Center in Houston, Texas (now the Johnson Space Center or JSC). The Office of Advanced Research and Technology included studies of astronaut life support systems. These life science studies were conducted mainly through the Ames Research Center (ARC) at Moffett Field, California. In many cases, particularly in its early years when it had limited intramural capabilities, NASA funded biomedical research through contracts and grants. NASA also funded research on radiobiology jointly with AEC and Air Force and, with some pressure from Congress, developed a coordinated program in space medicine with the Air Force. A reorganization in the early 1970s led to some consolidation of life science programs in the Life Sciences Programs Division of the Office of Manned Space Flight. These programs are now fully consolidated in the Office of Life and Microgravity Sciences and Applications, which is responsible for NASA's current review of records on human radiation research. Experiments NASA's initial document search identified 189 publications and reports describing human radiation experiments. From this list and from personal contacts, NASA has identified six human radiation studies--specific experiments or series of related experiments--undertaken before 1974, and three broad categories of research that it is now analyzing to identify individual experiments. A complete list or accounting of NASA-sponsored studies is not yet available. NASA was involved in two types of human radiation research: (1) studies to understand the effects of radiation in space on astronauts, and (2) studies of other effects of spaceflight that used radiation and radioisotope tracers as diagnostics. In the first category, NASA and AEC developed a joint research agenda on radiobiology, which included NASA support for total body irradiation studies at Oak Ridge as well as several studies that did not involve humans. NASA has also sponsored research on the effect of radiation on the human eye and collaborated with DOD in the study of space radiation hazards. NASA was interested in other physiological effects of space flight, particularly the effects of weightlessness. NASA conducted its own studies and sponsored studies by others on the effects of bed rest, which simulated some aspects of weightlessness. NASA also funded studies to develop radiation techniques to diagnose bone loss due to weightlessness in space. In addition to its simulations, NASA conducted numerous studies using astronauts themselves as subjects in order to observe the actual effects of space flight. In the area of intentional releases, NASA sponsored joint research with AEC on nuclear- powered rockets -- i.e., the Rover and NERVA projects. AEC conducted the Kiwi series of ground tests of nuclear-powered rockets, with some human exposures to the radioactivity released in these tests. It remains unclear which NASA offices were responsible for the nuclear rocket programs and what role, if any, NASA had in these field tests and associated human radiation exposures. Records Search NASA maintains records in a variety of forms. NASA's paper records may be located in any of its program offices and field installations, in internal records storage facilities, at Federal Records Centers (FRCs), or may have been transferred to the National Archives and Records Administration (NARA). NASA maintains comprehensive indexes of records transferred by any NASA installation to internal storage facilities, FRCs, and NARA, but not for documents that remain in NASA program offices. NASA has provided the Committee with complete listings of accessions to NARA. NASA plans to search its indexes of all stored and transferred records, identify potentially relevant records, and review those records by the end of November 1994. NASA has instructed officials throughout its organization to locate all records related to human radiation experiments and has requested employees, contractors, and grantees to do the same. NASA has also searched those offices for specific files (e.g., files relating to the Oak Ridge studies), and has identified and begun to search three specific collections: (1) a Space Life Sciences Archive in Houston, (2) a collection within NASA's History Office, and (3) a collection of files of the former chief radiation safety officer at the JSC. NASA's initial search included interviews, document searches, and electronic literature searches of several databases, including the RECON aerospace research database, the ARIN and NTIS databases of NASA documents, and other public databases. The database searches led NASA to identify more than 2,000 publications, from which 189 that were selected as relevant have provided the most valuable documentary source of information on NASA's human radiation experiments. Reviews of NASA records and interviews with over 20 current and former NASA employees have supplemented the literature search and provided additional leads on human radiation research. Further leads have come from responses to a letter sent to all current and former NASA employees, contractors, and grantees requesting information on possible human radiation experiments. NASA has provided summaries of the specific human radiation studies it identified, along with supporting documentation for some of those studies. This documentation includes reports and some correspondence regarding the Oak Ridge total body irradiation studies, supplemented by some contract and financial information provided by the Department of Energy. NASA reports that it destroyed most documents pertaining to the Oak Ridge studies in 1980, in accordance with standard records retention schedules. NASA has provided the Committee with secondary and some primary documents on its organization and history. These documents include one overall history of NASA, summary reviews and/or histories of NASA's life science programs and of the biomedical research programs for Projects Mercury, Gemini, Apollo, and Skylab. Primary documents include early plans and recommendations for NASA's life sciences program, several reports and reviews of those programs, and organizational charts. The earliest records received on NASA's ethics policies on the use of human subjects in research are from 1969. These records document the formation in 1969 of the Medical Isotopes Subcommittee of the Radiation Safety Committee at the Manned Spacecraft Center and the revision in 1969 of the Ames Management Manual for the operation of the Human Research Experiments Review Board. NASA has also provided some indications of earlier policies and practices, including references to consent procedures and radioisotope licenses at the Ames Research Center. In 1972, NASA established an overall policy on the use of human subjects in research conducted by NASA that established approval and oversight procedures and required written informed consent. This policy was revised and extended to grantees and contractors in 1986. NASA has provided some documents and other information that describes policies and practices involving the use of human subjects prior to the establishment of these official policies, and is attempting to reconstruct this information for each of the experiments it identifies. Remaining Tasks The Committee has asked NASA to complete its identification of individual experiments and provide a complete list with supporting documentation. The Committee also has requested additional information on biomedical studies involving astronauts as subjects and the rules that governed those studies, beyond what NASA has already provided. Once NASA completes its review of records indexes, it will begin to search selected paper records. This search will focus on the following four areas: (1) records pertaining to the cooperative agreement between NASA and AEC on radiobiology research, including the total body irradiation studies carried out at Oak Ridge; (2) records pertaining to joint research activities between NASA and Air Force on aerospace medicine; (3) records describing NASA's role with AEC in the Rover and NERVA nuclear-powered rocket programs, including any NASA participation in the Kiwi field test series; and (4) additional documents describing NASA's policies and practices for the use of human subjects in research. These would include documents describing policies in place at ARC and JSC prior to 1969, policies in place at other NASA field installations, any discussions of human use policies at NASA headquarters prior to the first agency-wide policy in 1972, and NASA licenses with AEC for the use of radioisotopes. Interim Report of the Advisory Committee on Human Radiation Experiments, October 21, 1994