PART II. THE AGENCY SEARCH PROCESS AND OTHER METHODS OF INQUIRY: THE HUNT FOR PIECES OF THE PUZZLE A. THE AGENCY SEARCH PROCESS When the President established the Advisory Committee on Human Radiation Experiments, he also directed Federal agencies to provide it with the documentary information it needed to do its job. The Interagency Working Group created a subgroup to focus on document location and retrieval. Committee staff works with this group, and its representatives from each agency. The Interagency Working Group has, collectively, devoted considerable time to these search efforts, which are ongoing. Numerous records collections, encompassing thousands of boxes of potentially relevant files in Federal Records Centers throughout the country, have been identified. Even where relevant collections are identified, however, the search process has been arduous; dozens of boxes may yield only a handful of relevant documents, yet these documents may be of great value. Overall, the level of effort expended by the agencies, and the yield, has been significant. 1. Initial Reports At the Committee's initial meeting, each agency reported on the status of their searches and invited Committee direction for continued search. o CIA told the Committee in April, 1994 that its search had not found evidence that either showed CIA sponsorship or funding of human radiation experiments or information on human radiation experiments conducted by others. o In January, DOD components had been charged to locate entities that conducted or sponsored experiments, and documents related to those experiments. DOD reported that many experiments had been identified. o DOE explained that the first phase of its search was an attempt to inventory all potentially relevant records possessed by the agency and current contractors, in order to identify specific experiments and collections that would merit further review. The second phase would be an attempt to focus, based on what had been found, on the policy or contextual documents surrounding the experiments. (DOE had previously provided documents relating to human radiation experimentation in response to congressional inquiry and other investigations. [15]) o HHS reported that data on the many thousands of grants for earlier years were limited to skeletal grant records, which did not always make clear whether research involved human subjects. HHS was working on targeted approaches to locate documents of relevance to the Committee and to develop more complete data on intramural research. o NASA's initial search resulted in the identification of about 200 reports and publications describing six specific studies and three large categories of research. o VA's initial search focused on a survey of 172 medical centers throughout the country and a review of reports at the central office. There was no formal effort to identify and list experiments. VA told the Committee it would search for further information on its confidential Atomic Medicine Division, which was created in 1947. In addition to document searches, a number of the agencies interviewed former officials who might have knowledge of experiments (or related records) and sought to make use of Radiation Helpline telephone information. 2. Committee Assessment In the first days and weeks of work, staff met with the search teams from each agency to learn of progress in and obstacles to the search. Search plans and status, as reported in detailed staff memoranda to the Committee, varied from agency to agency. In most cases, however, their progress demonstrated the inevitable difficulty of retrieving complete, detailed records on specific activities after the passage of up to half a century: o To the extent experiments had been identified, only fragmentary further information had been provided (or was available). o The volume of potentially relevant records is enormous, particularly because records often have been consigned to records centers or the National Archives with little useful indexing. o Agencies had not always searched for headquarters- related documents, including those showing the nature and development of research ethics policies. o Agencies had not always searched for documents retired to the National Archives (which are technically not within agency possession) and only sporadically searched for documents located in Federal Records Centers. o While the agency searches produced surprising new information on early ethics policies, there was much less information on the implementation of these policies in the case of particular experiments. o After the passage of many years, agency components responsible for human experimentation have been renamed, reorganized, or abolished, making it difficult to determine which records collections to search. 3. Committee Work with Agencies on Search Strategy The initial agency searches provided a start in identifying experiments and an appreciation for the difficulty in retrieving substantial data about the experiments. With this data and experience in hand, the Committee sought to determine how to assist agencies in directing the searches. The particulars of these activities are discussed in more detail in Appendix E and in staff memoranda and related Committee discussion concerning each agency. In general, agencies were asked to refocus their searches. From the "dragnet" searches to identify experiments, it was suggested that focus be placed on identifying and retrieving headquarters-level collections that could provide context for particular experiments. The Committee expected that once more was known about the planning, funding, and use of experiments, it would be able to better advise the agencies on the particular experiments (or groups of them) for which a more intense field- level search would be requested. (It was also expected that the higher-level documents would help identify further experiments.) Agencies also were asked to look for documentation of the development and implementation of ethics policies governing human experimentation. The Committee's archivists and historians, in conjunction with agency historians and records specialists, identified headquarters-level records collections to be searched and the likely location of these collections in the National Archives or Federal Records Centers. Agencies were also asked to give high priority to locating readily available documentation, such as agency histories, that could serve as guides to further searches. In summary, and with further detail provided in Appendix E, considerations that were raised with each agency are discussed below. a. CIA. Documentation provided by DOD and DOE, and located by staff in the National Archives, confirmed that CIA was a participant in the mid-century DOD groups at which biomedical human experimentation, among other matters, was discussed and planned. Other data obtained by the Committee from members of the public confirmed that CIA contracted for work with, at least, DOE radiation research facilities. As a consequence, the Committee has asked CIA to search for documentation related to further evidence of CIA's association with human radiation experimentation. b. DOD. The Committee proposed that DOD agencies [16] look for headquarters-level planning, programming, and budgeting documentation. The headquarters-level ethics and policy documentation located as a result of this effort did reveal important documentary trails. For example, the records of the Joint Panel on the Medical Aspects of Atomic Warfare include debate on the need for human experimentation, plans for experimentation, and digests of experiments. Similarly, the Armed Forces Medical Policy Council initiated discussions in 1951 that led to both the Secretary of Defense's February 1953 issuance of the top secret version of the Nuremberg Code for human experimentation and to the Joint Panel's consideration of experimentation in connection with atomic bomb tests. DOD will continue to search for the location and retrieval of the records of relevant headquarters-level groups (through at least 1974), and the location and retrieval of documents relating to the development and implementation of its 1953 Nuremberg Code policy. It is also refocusing field-level searches in light of the new understanding that has been gained. c. DOE. In initial discussions, DOE proposed to continue its Phase I effort to locate and provide a comprehensive inventory to all relevant record collections. This effort should yield a publicly available index to extensive and previously disorganized public records. In the course of this review, experiments would be identified and some records retrieved. The Committee agreed to this proposal, with the expectation that the inventories would be available in the timeframe required by the Committee to retrieve documents for its work. The Committee's initial review of DOE efforts led to specific Committee requests that DOE (l) locate the files of the AEC Intelligence Division, which may have contained data on work performed for other agencies and on intentional releases; (2) locate the collection of 250 documents that underlay DOE's 1974 reports on the plutonium injection experiments; and (3) arrange for the retrieval of documents from the three universities involved in the plutonium injections (University of Chicago, University of Rochester, and University of California-- San Francisco). DOE is currently retrieving materials from the universities, but it reported that the files of the AEC's Intelligence Division had been destroyed and that the collection associated with the 1974 report could not be located. As discussed in Appendix E, the volume of documents that remain to be examined is large. On an ongoing basis, DOE and Committee staff are working to identify headquarters and field collections for priority retrieval. d. HHS. Initial review by HHS produced a computer-generated list of experiments that apparently involved both ionizing radiation and human subjects, but only for research initiated in and after 1962. Although components of the agency and its predecessor conducted or funded numerous human radiation experiments before 1962, a complete review of potentially relevant records was determined not to be feasible, because the extant records of earlier research are fragmentary. Once a listing of experiments reviewed by the NIH Radiation Study Section was produced, the systematic search for early experiments focused on archival research into organizational, policy-related evidence, and project specific documentation when available. More recently, the Committee and HHS have agreed that the Radiation Study Section list, with completed project titles, could serve as a reasonable proxy for a comprehensive search of pre-1962 experiments. This approach is reasonable because many, if not most, of the experiments of interest likely were reviewed by this study section. This approach will be complemented by review of a more complete listing of intramural human radiation research conducted at the NIH Clinical Center. e. NASA. The Committee has asked NASA to provide a comprehensive inventory of potentially relevant record collections and locations. Several areas for focused inquiry have been identified: the development of NASA ethics practices; total body irradiation work conducted at Oak Ridge and supported by NASA; and space-related research performed in coordination with AEC and/or DOD. f. VA. VA's initial effort focused on a survey of field locations, in response to which some data were provided. There was only limited review of headquarters-related documents and no provision for the systematic identification of experiments conducted or sponsored by VA. Following review of the responses to the survey, the Committee and VA agreed to search headquarters records and, as that search proceeded, focus on a sample of field sites. In July, VA committed to a search of the approximately 1,800 Washington, D.C.-area record boxes that may contain relevant information. The present estimate is that the review will be completed by mid-November. The Committee simultaneously identified a number of field offices from which additional information was requested. As noted previously, VA intends to find the purpose of its Atomic Medicine Division, which apparently included confidential activities. In October, VA asked the Office of the Inspector General, because of its expertise in records examination and search, to assist in this search. 4. Classified Documents From the outset, the Committee was concerned about the limits that classification may put on its ability to review documents and to report on them to the American public. The Committee's policy is to seek declassification of relevant documents. In the cases of DOD, DOE, and CIA, while documents have been declassified, significant collections of relevant material are still classified. [17] The Committee sought, and received, written assurance that reasonably discrete requests for declassification would be acted upon within three weeks. Where large classified collections of documents remain to be searched, Committee and staff may review the collections to identify priorities for declassification requests. This process has been impeded because of delays in the receipt of security clearances. By mid-October, only the Chairperson and six staffers had received interim clearance. Agencies have stated that biomedical research materials should, in general, no longer be classified. However, they have also stated that some information of importance to the Committee, particularly that related to some intentional releases, will continue to require classification. [18] For example: o DOD has stated that information related to the planning and purpose of the Green Run intentional release must still remain classified; and o DOE has stated that much documentation related to the 250 radioactive lanthanum intentional releases conducted at Los Alamos must remain classified. B. ADDITIONAL METHODS OF INQUIRY In addition to documentation available from the agencies, the Committee seeks to locate information from all other feasible sources. Towards that end, it is conducting additional documentary searches, an interview project, and an oral history project. 1. Documentary Search This search for information includes: o Members of the public. Many members of the public have provided the Committee with important data, including documents gathered through personal research. o Published literature. As noted elsewhere, the Committee staff is assembling published material from a wide variety of sources. o Congressional materials. Staff has compiled a chronology of congressional hearings related to human research involving radiation going back to 1948. The materials are a valuable research tool. o Universities. The Committee is contacting universities that may house documents of relevance. With DOE's assistance, for example, the Committee is retrieving documents from universities where researchers participated in the plutonium injection experiments. The Committee is also working with universities that have undertaken to review human radiation research conducted at their institutions. As the Committee focuses on additional experiments, further inquiries will be made. o Collections. The Committee seeks to locate and review relevant collections of personal papers. For example, Committee members and staff have reviewed portions of papers of the medical director of the Manhattan Project (located at University of California - Los Angeles), the first head of the AEC Isotope Development Division (Texas A&M University), an early director of the AEC Division of Biology and Medicine (Boston University), the 1950-1951 chairman of the Armed Forces Medical Policy Council (Ohio State), the chairman of the DOD's Joint Panel on the Medical Aspects of Atomic Warfare (Harvard), and other members of mid-century radiation research review committees (University of California, Case Western Reserve University), as well as DOD-funded researchers at the Medical College of Virginia, the World War II Committee on Medical Research (University of Pennsylvania), and Henry Beecher, whose 1966 New England Journal of Medicine article was a watershed in the discussion of the ethics of biomedical research (Harvard University). 2. Ethics Oral History Project and Interview Project In addition to collecting documentation, the Committee has embarked upon an Ethics Oral History Project in order to understand the evolution of ethical norms and research practices in human experimentation from World War II onward. Oral histories are essential, since information from other primary and secondary sources will be incomplete. Approximately 10 to 25 senior research scientists active in both radiation and nonradiation research from 1944 to the present are being interviewed by experienced interviewers from the Advisory Committee and its staff. Interviewees are being selected from two age groups: (a) clinical researchers who began their careers in the 1940s or 1950s, and (b) those whose careers began in the early 1970s. In developing this project, the Committee has consulted with independent experts (ethicists and historians) concerning both whom to interview and how to conduct an oral history. Because the project involves the collection of information from human subjects, and the Committee seeks to draw generalizable conclusions from this information, the project was submitted to an institutional review board (IRB) from Pennsylvania State University College of Medicine (the home institution of the Committee member directing this effort). With IRB approval granted September 26, 1994, the Committee began interviewing on September 30, 1994. All interviews are being tape-recorded and transcribed; interviewees will be offered the opportunity to review transcripts before they are evaluated by the Committee. The Committee also is interviewing individuals connected with particular experiments that the Committee is studying, and the government programs related to the experiments. Those interviewed to date include individuals connected with the plutonium injection and Cincinnati TBI experiments, attorneys who worked in the AEC Office of General Counsel at its creation, the military assistant to Secretary of Defense Wilson, and Glenn Seaborg (discoverer of plutonium). Finally, the Committee is seeking transcripts of interviews conducted by others. For example, DOE provided the Committee with (DOE-funded) interviews conducted by J. Newell Stannard on behalf of his history of radiation research and the Committee has reviewed interviews conducted by the American Institute of Physics. ********** 15 These documents, along with materials collected by DOD relating to the Cincinnati total body irradiation experiments, were the bulk of documentation about specific experiments available at the onset of the Committee's work. 16 Including the Office of the Secretary of Defense and the Defense Nuclear Agency, as well as each of the military services. 17 HHS initially stated that it did not have classified documents. HHS subsequently reported that it reviewed classified documents still within its possession and did not find any of relevance. VA similarly reported that it lacked original classification authority and that it does not possess any relevant classified documents. More recently, VA has found that President Truman in 1951 gave VA original classification authority; VA lost this authority in 1972, apparently due to none-use. 18 The Committee will explore the further possibilities for declassification. Interim Report of the Advisory Committee on Human Radiation Experiments, October 21, 1994