DEPARTMENT OF ENERGY SUMMARY OF RECORDS SEARCH ON HUMAN RADIATION EXPERIMENTS DEPARTMENT OF ENERGY COMMITMENT Department of Energy Secretary Hazel O'Leary pledged in December 1993 a full review of the scope of experiments using radiation on human subjects conducted or sponsored by the Department and its predecessor agencies. The Department of Energy is committed to maintaining as a top priority its documents search and records dissemination to the Advisory Committee, Congress, and the public. DEPARTMENT OF ENERGY STRATEGY In December 1993, Department of Energy personnel were directed by Secretary O'Leary to cease routine and non-routine destruction of documents and to identify all pertinent records and information relating to human radiation experiments in the Department's possession and in the possession of our laboratories and contractors. The records retrieval effort is managed by Assistant Secretary for Environment, Safety and Health Dr. Tara O'Toole. An Office of Human Radiation Experiments and Information Center has been established to guide and oversee record retrieval activities by the field and by Headquarters. Personnel for this Office are varied in discipline: records managers, archivists, historians, health physicists, and security evaluation specialists among others. The Office is currently headed by Glenn S. Podonsky, Deputy Assistant Secretary for Security Evaluations. DEPARTMENT OF ENERGY RECORDS SEARCH Small multidisciplinary teams began travelling to field locations on April 4, 1994 to review field record collection activities. The teams will make two visits to each major location that may have participated in, performed, or sponsored radiation experiments involving humans. The teams will also retrieve documents that have been previously identified and placed in public reading rooms. Team members have visited the Albuquerque Operations Office, the Los Alamos National Laboratory, and Oak Ridge Operations Office, Oak Ridge Associated Universities and other Oak Ridge sites. These two visits resulted in the collection of over 1,000 documents pertaining to human radiation experiments. The Headquarters Information Center has over 1,300 documents as a result of this retrieval effort. Field offices and Department of Energy contractors have been directed to retrieve all documentation on experiments using radiation on human subjects. Departmental offices have identified approximately 2,500 records of human radiation experiments and placed them in public reading rooms throughout the country. The field thoroughly records the origins of the documents and keeps a detailed account of the records searched and the location of the records. Pertinent records are then shipped to Nevada for additional processing and dissemination. The Department's Coordination and Information Center (CIC) at the Nevada Operations Office is the central repository for information related to nuclear weapons production and testing. Copies of all relevant Department of Energy documents are being sent to the CIC, who ensure the security of the records and scan them for computerization. The Headquarters Information Center then receives the records for dissemination to the Advisory Committee, Congress, and public. GUIDANCE REQUESTED OF THE ADVISORY COMMITTEE Department of Energy records pertaining to human radiation research are spread throughout the country and in the possession of not only the Department and its current contractors, but also in the possession of universities and former contractors and employees. Current Department personnel may not be familiar with the circumstances surrounding certain events of the Cold War. The Department would value the guidance of the Advisory Committee in helping focus the records search activities on specific experiments or groups of experiments. An increase in the specificity of the definition of experiments that qualify under the Executive Order is critical in ensuring a complete inventory of appropriate records. DEPARTMENT OF DEFENSE ACTIVITIES ON HUMAN RADIATION EXPERIMENTS REVIEW Under the direction of Secretary Perry, the Assistant to the Secretary of Defense (Atomic Energy), Dr. Harold P. Smith, leads the DOD's efforts to discover and disclose to interested parties the nature and extent of the Department's involvement in human radiation experimentation. A Department of Defense Steering Committee, chaired by Dr. Smith, composed of high-level Department officials and supported by scores of DOD personnel, has met regularly to structure and guide the Department's efforts. A 31 January 1994 memorandum from Dr. Smith to all DOD components provided detailed guidance on locating, identifying, reviewing and declassifying records pertaining to human radiation experiments. This guidance instructed DoD components to preserve existing records; manage records in accordance with Freedom of information Act, Privacy Act and security classification procedures, directing that records were to be declassified to the maximum extent; and, if there were a question on an experiment, to err on of the side of inclusion in the initial identification of a possible experiment. To assure the quality, comprehensiveness and integrity of the search process, components were directed to submit a report, consisting of two parts. In Part 1 the agency was required to report: each organization under its control that may have it conducted or sponsored experiments; the locations(s) where records might be stored; a description of the efforts undertaken to confirm if records were at the location(s) identified; and if records were found. Part II required a description of each experiment identified as a result of activities described in Part l. Each experiment was to be described a follows: identification of experiment or possible experiment; where and when it took place; name of primary researchers; DoD organizations grantees, or contractors involved in the experiment, number of human subjects (including available information on subjects); summary of experiment; records location; estimated nature and quantity of records; and whether the records are classified, and, if so, what actions have been or will be taken to review the classification. A massive search effort has ensued. Following the dictum to err on the side of inclusion, reports thus far have identified approximately 1 ,760 DOD conducted or supported activities from 1944 to present that possibly fall within the scope of the Interagency Working Group definition of human radiation experiments. It appears that the overwhelming majority of these are clinical research activities conducted by DOD medical components since 1974, involving therapeutic investigations in which radiation was used solely in accordance with established, non-experimental diagnostic procedures. These activities will be further reviewed and analyzed and eventually categorized as either clinical procedures, therapeutic programs, research protocols, etc. Additionally, some components reported file volumes in the hundreds of feet, and that there are millions of individual service records at the Military Personnel Records Center in St. Louis, Missouri for personnel that served during the last 50 years. To coordinate the Department's efforts, a Radiation Experiments Command Center (RECC) was established. The RECC is the Department's central repository and point of contact for matters related to human radiation experiments. The RECC has developed an automated database for information on the status of ongoing actions that respond to inquiries from the public, other Federal agencies, and Congress, and analyze information received from these, and other, sources. A second RECC automated database is the "event file," to capture information on each experiment identified by DoD records search. This will allow reviewers to expeditiously match experiments with inquiries from the Advisory Committee, Congress or the public. DoD's efforts to date have highlighted several issues on which guidance from the Advisory Committee would be helpful. The major issue is the prioritization of records retrieval and review of the large number of possible experiments that.have been preliminarily identified. Dad suggests that pre-1974 experiments not clearly outside the scope of interest be considered for high priority attention. Guidance is also needed on identifying lead responsibility for resolving inquiries from individuals that fall within multiple agency jurisdictions. Finally, we suggest the need for a uniform, responsive, integrated and cost-effective approach to satisfy the Advisory Committee, the Congress, human subjects or their next-of-kin, and the public. DoD is fully committed to the task of discovering and documenting the extent of its participation in human radiation experimentation over the last 50 years. Carrying out this task will remain a high priority of Secretary Perry and the Department of Defense. U.S. Department of Justice Office of Public Affairs Washington, D.C 2053O HUMAN RADIATION EXPERIMENTS HUMAN RADIATION INTERAGENCY WORKING GROUP DEPARTMENT OF JUSTICE SUMMARY The Department of Justice did not conduct nor sponsor human radiation experiments. Nevertheless, it is participating in the work of the subcommittees of the Human Radiation Interagency Working Group. The Department shares the Administration's commitment to conduct an open and thorough inquiry of Cold War- era government sponsored human radiation experiments. The Department provides the Working Group with legal advice and counsel on a broad range of issues. That counsel rests on the Administration's commitment to make public the greatest amount of information at the earliest possible time, while mindful of the personal privacy of those involved in the experiments and their families. The Working Group is developing a broad range of potential responses for those who may have been affected by human radiation experiments. It is reviewing existing compensation programs as potential models, including several administered by the Department, in the event legislation is proposed after the facts have been determined. The Department's current programs include the Radiation Exposure Compensation Act, the National Vaccine Injury Compensation Program, and the Civil Liberties Act of 1988. It should be emphasized that each of these programs was carefully designed and tailored to provide efficient, appropriate compensation for the carefully defined injuries Congress intended to address. Great attention was paid to defining an appropriate recipient population, setting eligibility standards, assessing the availability of relevant evidence, and determining the propriety of monetary and other forms of compensation. The Department, with the same attention to detail, is approaching the challenge of crafting an appropriate framework for the Administration's response to the subjects of human radiation experiments should it become appropriate to consider compensation. The Department will join its fellow members on the Working Group in making recommendations to the president and the Congress regarding these matters. Component Contact: J. Patrick Glynn (501-7040) Central Intelligence Agency Washington, D. C. 20505 13 April 1994 The Central intelligence Agency's Search for Records on Human Radiation Testing On 4 January 1994 the Central Intelligence Agency began searching for records relating to any experiments that used ionizing radiation on human subjects. As this search nears completion, CIA has found no evidence that the Agency ever deliberately exposed anyone to toxic radiation. The Agency's search took its initial guidance from statements made in the reports of two probes of CIA conducted in the 1970s. The Rockefeller Commission (1975) and the Church Committee (1976) discussed the Agency's testing of drugs on unwitting subjects in the 1950s and 1960s, particularly the MKULTRA program. MKULTRA, according to the investigators, authorized Agency officials to explore "additional avenues to the control of human behavior," including "radiation, electroshock, various fields of psychology, psychiatry, sociology, and anthropology, graphology, harassment substances, and paramilitary devices and materials" (emphasis added). Agency officials tried to determine whether MKULTRA researchers actually experimented with radiation. No one associated with MKULTRA or the investigations of the 1970s recalled why the word "radiation" was used by the Rockefeller and Church reports. We found no documents indicating MKULTRA researchers used ionizing radiation on human subjects (most MKULTRA documents have been in the public domain for over a decade). Both reports used language from the CIA Inspector General's 1963 investigation of MKULTRA, and we believe the language might have originated in early documents mentioning radiation as a potential research field for Technical Services Division (which ran the MKULTRA program). CIA officers in all the directorates are searching relevant Agency records for any evidence of radiation experiments. Throughout this search, CIA has based its inquiries on the broadest usage of the term "radiation." CIA officials have queried dozens of current and former employees, ranging from former DCIs to scientists and medical personnel most likely to have conducted or been aware of radiation testing, if it occurred. Without exception, Agency veterans knew of no such experiments or operations. No documents found to date suggest that CIA conducted experiments or operations using ionizing radiation on human subjects. Since the 1970s, all Agency research involving human subjects has been conducted in accordance with all relevant guidelines issued by the Department of Health, Education and Welfare and the Department of Health and Human Services. DEPARTMENT OF VETERANS AFFAIRS Radiation Research in the Department of Veterans Affairs Issue: This briefing paper describes actions taken by the Department of Veterans Affairs (VA) in response to reports that government-sponsored research involving radioactive materials many years ago may have been conducted in an inappropriate manner. Discussion: Immediately following the publication of reports that questioned the conduct of radiation research involving human subjects sponsored by federal government agencies in the 40's and 50's, Secretary of Veterans Affairs Jesse Brown pledged a full review and disclosure of all such VA research. On January 6, 1994, he sent a message to all VA medical center directors to conduct an energetic and accurate review of all records relating to radiation research. As a part of the process, VA officials in the Central Office reviewed the Administrator's Annual Reports as well as the annual reports of Medical Research in the Veterans Administration for information on specific radiation research. The only information obtained from these sources related to radioisotope research which began with the Chief Medical Director's establishment in 1947 of a committee to advise him on matters of atomic medicine. That committee recommended that a radioisotope division be set up to support the broader atomic medicine program. The radioisotope program, later known as Nuclear Medicine, was very active both clinically and in research. During the early years, VA was recognized as a leader in nuclear medicine. One of the VA pioneers in Nuclear Medicine, Dr. Rosalyn Yalow, was awarded a Nobel Prize for her work at the Bronx VA Medicine Center. The first radioisotope laboratory was established in 1948 and at one time ten percent of all VA research was related to radioisotopes. The annual research reports from those years contain brief summaries of the activities at each of the involved medical centers. These summaries describe studies directed to thyroid function, diseases of the thyroid gland, metabolism, cardiac function, peripheral vascular disease, blood volume determinations, hemodynamics of the cardiovascular system, diagnosis and localization of brain tumors, and treatments for leukemia and cancer. Because the review of centrally held records revealed little specific information, a search for nuclear medicine research records at all facilities was ordered. This search recently has been extended to include radiotherapy research although there is little evidence of significant research activity in this area. Additionally medical centers have been asked to query their affiliated academic institutions for any information of research done by non-VA investigators but involving VA patients as subjects. The search of nuclear medicine research revealed that of the 137 VA facilities having nuclear medicine capability: 49 have located some protocols used during that period for radioisotope research, 24 have names of patients who participated in at least some research projects, and 54 have some publications available on specific research projects done during that period. No VAMCs found any evidence of research involving Plutonium and none had contracted out any research. A directive was issued to all VA facilities to preserve all existing records page 2. Radiation Research in the Department of Veterans Affairs of research involving human subjects. A review of records disposal requirements has also been done and revealed that a variety of retention rules apply to the files which might have relevance to radiation research and that these rules have changed over time. The majority now require a retention period of ten years so that many records relating to the 1940s, 50s, and even the 60s may have been destroyed already. Individuals' medical records files are maintained for a total of 75 years following the last episode of care. During most of that time the records will be held at the Federal Records Center. Research Projects Files which contain records of research projects including results, worksheets, questionnaires, progress reports, etc., are maintained for five years after completion of the project and preparation of the final report. A copy of the final report is then supposed to be maintained to document research activities. However, this policy was not instituted until 1960 and not incorporated into a manual until 1970. Therefore, it is possible that records from the 1940s and 50s were not retained. The process of inventorying the existing records is beginning in April using a prototype form developed by DOD in preparation for making them available to the Advisory Committee on Human Radiation Experiments. A rigorous "chain of custody" is being established. In addition to the searches going on, the Nuclear Medicine Services is investigating the licenses issued for radionuclides by the Atomic Energy Commission (ABC), now the Nuclear Regulatory Commission (NPC), for cross referencing with research information. The Office of Research and Development has reviewed protection of human subjects in VA research and reinforced the vigorous enforcement of policies and procedures in place to assure that all VA patients who participate in research are fully informed, consenting subjects. In the early days of VA research, nuclear medicine research studies were reviewed locally by the Radioisotope Committee which included individuals from outside VA. The committees also had access to radiation experts of international stature who served as consultants to the Central Advisory Committee on Radioisotopes. Research projects were not reviewed at the Central Office until the 1960s. A separate review by a human subjects subcommittee did not become a practice until about 1962. In order to be responsive to the public's need to know and the concerns of individual veterans, guidance has been issued to enable field facilities to respond to Freedom of Information requests in timely manner and procedures to respond to both the DOE Hotline, the VA Radiation Helpline, and similar inquiries are being developed. As of April 11, 1994, the Department of Energy had forwarded some 800 inquiries from their toll free hotline. Of these, approximately 650 related to exposure to ionizing radiation during military service and 150 related to possible research, diagnosis, or treatment involving ionizing radiation at a VA medical facility. Since mid-January 1994, VA Regional offices have taken 8,117 calls from individuals concerned about radiation exposure while on active duty or at a VA medical center. Approximately 800 callers were concerned about possible radiation exposures at a VA facility. VA is reviewing these cases and will contact each individual. page 3. Radiation search in the Department of Veterans Affairs Inquiries related to radiation exposure during military service will be referred to the Department of Defense and/or will be handled by VA. Veterans claiming exposure to ionizing radiation in the military from the detonation of a nuclear device in connection with nuclear tests or with the American occupation of Hiroshima and Nagasaki, Japan,between September 11, 1945 and July 1, 1946 are provided with free comprehensive health examinations, including base-line laboratory tests and other tests determined necessary by the examining physician to evaluate current health status. This is a part of the Ionizing Radiation Registry program. Priority health care services are also available at VA facilities to these veterans. Assistance in filing claims for service-connected disability compensation is available at VA Medical Centers and Regional Offices. Department of Health and Human Services Search for Records of Human Radiation Experiments Summary ORGANIZATION AND STRATEGY The Department of Health and Human Services (DHHS) is actively participating with the other Agencies of government in the search to. discover all instances in which human subjects have been experimentally exposed to ionizing radiation. The identification of all relevant documents and their public dissemination has been given high priority. On January 27, 1994, Secretary Shalala instructed all components of the Department of Health and Human Services to identify all records related to experimental human exposure to ionizing radiation conducted between 1944 and 1974. Because most experimental medical procedures are either conducted or funded by the Public Health Service (PHS), PHS established a working group to coordinate the DHHS records retrieval effort. This working group is co-chaired by Dr. D.A. Henderson, Deputy Assistant Secretary for Health Science, and Dr. Wendy Baldwin, Deputy Director for Extramural Research, National Institutes of Health (NIH). The group includes representatives from the NIH, the Centers for Disease Control and Prevention, the Indian Health Service, and the Food and Drug Administration. The working group is responsible for providing ongoing guidance and oversight for the search activities to assure the quality, comprehensiveness, and integrity of the records collection process. The working group is pursuing several strategies to identify relevant records, including: 1) All records of all PHS agencies are being carefully and systematically scrutinized for relevant information. 2) Past and present PHS employees are being interviewed for their recollections of this 1 type of experimentation. 3) National Library of Medicine staff are searching the medical and scientific literature for articles involving the experimental use of ionizing radiation on humans. 4) PHS staff are contacting people who have either written the government or called the toll-free hotline with information related to possible PHS funded studies. RECORDS SEARCH When DHHS records are retired to the Federal Records Center or the National Archives, a subject index for each set of records is created. These indices are known as Records Transmittal and Receipt Forms (SF 135). Virtually all of these forms have now been examined for the appearance of certain key words which would suggest that the files have some information pertaining to ionizing radiation. This search generated a list representing more than 1,000 cubic feet of possibly relevant records. The list is now being screened to identify which boxes of records should be searched individually. In addition to the systematic review of SF 135 forms, each of the principal PHS agencies has established its own search strategy tailored to the types of research activities and records maintained by each agency. For those experiments conducted by PHS employees, the records that exist are likely to be found within agency files. One important center for experimental studies in medicine is the NIH clinical center. It has been ascertained that all the medical records of all experimental subjects ever seen at the NIH clinical center are on file. NIH is currently reviewing protocols of experiments conducted at the clinical center. When specific studies are identified, the medical files will be available. However, most of the research supported by the PHS is conducted by research institutions located throughout the United States. Thus, most records of special interest-- research protocols, documents related to informed consent, and identities of research subjects-- will be 2 located at awardee institutions. On March 7, 1994, HHS sent a letter to 27,000 research institutions asking that they take special measures to ensure that all records related to human exposure to ionizing radiation are conserved. Several approaches are now being followed to identify specific instances in which PHS has funded relevant experimental human studies. The search for such studies is proving more difficult than had been expected. Available information about grants prior to the early 1960s consists solely of the study title, investigator's name and institution, and the amount of the award. For most grants, the very brief titles provide little information regarding the nature of the experimental work. Additional approaches are now being explored utilizing information from literature searches as well as special reviews of information pertaining to scientific groups identified with other studies. GUIDANCE NEEDED FROM THE ADVISORY COMMITTEE DHHS would value the guidance of the Advisory Committee on a number of points including the priorities for search and the nature and extent of materials desired. For example, might the search efforts be selectively directed to identify experiments having particular characteristics of greatest interest or concern to the committee. The committee could likewise provide useful on- going guidance with respect to the definition of experiments which are intended to by captured in the review. There are a variety of experimental and quasi-experimental projects which have proven difficult to know how to define, i.e. whether they represent forms of routing diagnostic or therapeutic modalities or whether they should be classified as experiments. 3 FACT SHEET FOR ADVISORY COMMITTEE ON HUMAN RADIATION EXPERIMENTS: NASA REVIEW OF HUMAN RADIATION EXPERIMENTS 13 APRIL 1994 NASA is continuing its review of human radiation experiments involving NASA investigations or NASA funding. Dr. Harry C. Holloway, Associate Administrator, Life and Microgravity Sciences and Applications, has been appointed to oversee this review. Dr. Earl W. Ferguson, Director, Aerospace Medicine and Occupational Health, will provide coordination of the review at NASA Headquarters. Dr. Donald E. Robbins, Acting Director, Space and Life Sciences, Johnson Space Center, is leading the team conducting this review. Daniel Goldin, Administrator, and Dr. Holloway have each issued guidance to Directors of NASA field centers instructing them to direct all NASA employees to take all necessary steps to locate, safeguard and report all records and other documentation related to human radiation experimentation. Dr. Robbins and his team are conducting a search of NASA records concerning human experiments involving radiation. This search includes a search of the Federal Records Centers databases. The team has also contacted current and retired investigators, research managers, and program managers at NASA Headquarters and NASA field centers who would have knowledge about previous radiation research and radiation research funding. The latter efforts are particularly important because most official documents covering research efforts during and prior to the 1970s have been retired and destroyed in the normal course of documents management. An independent computer search of published scientific literature and a manual scanning of biographic databases and other pertinent databases related to radiation research is also underway. As of 13 April 1994, this search has identified 2,407 literature citations for initial screening. 1,016 of the citations were selected for further review and 213 publications have been selected for detailed analysis. NASA has thus far received fewer than 20 Helpline calls, FOIA requests and other inquiries related to its radiation review. Our review is ongoing, but thus far the following studies which fall under the purview of this review have been clearly identified as involving NASA: 1. Oak Ridge Institute for Nuclear Studies (ORINS): ORINS began studies of the effects of whole body radiation on leukemia and other cancers in the late 1950s. From 1964 to 1974, NASA contributed to the funding of both a retrospective study and a prospective study at ORINS of the effects of radiation exposure in individuals who were exposed to whole body radiation for medical treatment or who were accidentally exposed. NASA provided less than 10% of the funding for these Atomic Energy Commission studies. The data on approximately 3,000 human subjects from 45 different institutions were reviewed (approximately 100 subjects from the prospective study at Oak Ridge itself). 2. Two studies (1968-1982) involving low levels of whole body radiation in experiments to measure total body calcium. 3. Studies (late 1960s to 1970s) in which investigators put their own heads in high energy particle beams to observe visual light flashes like those experienced by astronauts. A NASA Headquarters evaluation of the review process being conducted by Dr. Robbins and his team at Johnson Space Center is being conducted on 15 April 1994. Members of this review team include Dr. Holloway, Dr. Ferguson, and a representative from the NASA General Counsel's Office. The purpose of this review is to evaluate the quality, comprehensiveness, and integrity of the records collection process. In addition, NASA is establishing an internal, Independent Oversight Committee, chaired by the Associate Administrator for Safety and Mission Assurance, to oversee the search process. NASA is conducting its review using a definition of human radiation experiments that is more comprehensive than the definition used by the Human Radiation Interagency Working Group and established by the President's Executive Order of 18 January 1994. This is to assure that all research involving use of ionizing radiation in human research is adequately reviewed. NASA would like the Advisory Committee to provide additional clarification, guidance and definition regarding which type of human radiation experiments that are of interest and which are not.