PART V. TAKING STOCK: SOME INITIAL OBSERVATIONS The Committee has accomplished a good deal. It has made significant progress towards identifying and organizing the world of past experiments and reconstructing the framework needed to evaluate them. It has sought and has begun to receive the advice and assistance of groups and individuals interested in its work. It has initiated projects to evaluate the conduct of experiments today. And, with the agency search teams, it is recovering documentation of our past, which is being archived for use following the conclusion of the Committee's work. A. OPENNESS The President's request that Federal agencies open their Cold War files to the Committee, and the public, was ambitious. There were many reasons for skepticism: the enormity of Federal records collections, the disorganization of many collections, the large number of classified records, and the potential for bureaucratic delay. These factors remain real, yet the Committee and the agency search teams have been able to locate significant collections of material. Of greater importance, the work has produced a road map that will permit the completion of a substantial search within the Committee's life, and will remain as a guide to national records that will serve public, Congress, the press, and Government agencies in years to come. For example: o At the Committee's request, the Defense Nuclear Agency has declassified the table of contents of its more than 500 histories, on the basis of which declassification of portions of these histories is being requested. The histories of this agency, which has been at the center of nuclear weapons research and development, had previously been available only on a limited basis. o The Committee is organizing the minutes and related records of the AEC Advisory Committee on Biology and Medicine and several DOD committees that were central to biomedical research related to atomic warfare. o The Committee has located and is assembling documentation of the mid- century relationship between the civilian health research agencies (predecessors to the current HHS) and defense agencies. o The Committee is assembling histories of military research organizations and activities. (DOD, for example, has provided multivolume histories of the Air Force's School of Aviation Medicine, the Naval Radiological Defense Laboratory, and a history of the Atomic Cloud Sampling Program.) B. ORGANIZING THE SECRET AND PUBLIC WORLDS OF HUMAN RADIATION EXPERIMENTS The Committee is learning that secrecy is not necessarily the primary bar to comprehending our past: a vast amount of relevant information is public but scattered. In tandem with the task of opening up that which was secret, the Committee places a premium on collecting and organizing that which is public. For example, the reconstruction of the story of human radiation experimentation in connection with the atomic bomb tests requires the piecing together of previously disconnected public and secret data, including: (1) facts that have, to some extent, long been public and relatively well known--such as the performance of psychological testing in connection with atomic bomb tests, or the manned flythrough of atomic clouds; (2) facts that were initially secret, had to some extent become public, but have not been relatively well known--such as the existence of the 1953 top secret Secretary of Defense ethics policy; and (3) facts that were initially secret, have been partially declassified, and are still being discovered, such as the biomedical planning related to atomic tests, and the relationship between this planning and DOD ethics policy and test activities. The lists of experiments provided by the agencies are forming the core of the Committee's database of experiments. This database, in turn, is the starting point for the addition of new experiments, new data, and new information from the further sources that are currently being canvassed. Following the Committee's expiration, this database will remain as a "living electronic document." C. HISTORICAL DISCOVERY The work of the Committee is the work of a national government looking into its own past. Among the most important findings and implications of this search have been the following: 1. Government Ethics Debate and Policy While full evaluation must await the final report, it already is clear that the information developed by the Committee should require a significant revision of our understanding of the history of research ethics. (This information is detailed in staff memoranda.) 2. Discovery of the Present in the Past When the Committee began its work six months ago, it might reasonably have been presumed that human experimentation conducted in the mid-century world was so different from current research that its relevance to the present day would be limited. The examination of the past was, and remains, an end in its own right. However, the story that is unfolding appears to have far greater relevance to the contemporary questions faced by the Committee than might have been expected. For example: o It might have been assumed that the mid-century was marked by the complete absence of debate on consent, much less formal consent policies. Documents now show that discussion took place and policy statements were issued. Then, as now, a key question is the way in which bureaucracies translate policies into practice and the extent to which policies that have been implemented are adhered to or enforced. o Similarly, it appears that the meaning and reach of policies that were intended to govern experimentation were then, as now, not always clear. Where policies did exist, what were they intended to cover? Did they cover sick patients undergoing experimental therapy, as well as healthy volunteers? What was the assumed boundary between experimentation with healthy volunteers and occupational safety monitoring? o Then, as now, questions include the assignment of responsibility for policies designed to ensure basic rights of subjects. Where experiments involved multiple agencies and institutions, how was responsibility for ensuring rights assigned? When the decisionmakers included medical professionals, government officials, military officers, and civilian administrators, what rules and expectations governed the conduct of the differing professions? o Documents show that, faced with critical decisions concerning the safety of workers, soldiers, and the public health, Cold War experts were eager for opportunities to gather data on radiation. Then, as today, there was tension between the role of the physician as healer and as seeker of new knowledge. What can the study of the resolution of this tension in the past tell us about its resolution in the present? o A conflict of interest may also exist within institutions that have dual responsibility for promoting human subject research and assuring health and safety. Biomedical offices or committees vested with responsibility for ensuring that health standards were met also promoted the exposures needed to learn about the appropriate standards. What can this experience tell us about the desired relation of promotional and regulatory roles today? What difference did it make when the promotion and regulation were conducted, at least in part, in secret? What can this experience tell us about the future organization of research that involves secret components? 3. Government Rediscovery of its Past The events that the Committee is studying often predate the working careers, even lives, of those now staffing the agencies. The search process has involved the continued discovery of a heritage that had been lost even to those to whom it had been bequeathed. Consequently, the search has been an opportunity to rediscover this past. For example, there was limited recollection of the extent to which the Cold War linked the activities of civilian and military agencies. The reconstruction of the intertwined Cold War roots of civilian and defense agencies requires the piecing together of documents and memories from many sources. D. PUBLIC ACCESS TO THE RECORDS OF OUR PAST As discussed above and in Appendix F, the Committee is devoting considerable resources to organizing important record collections so that they can be made available to the public during the Committee's lifetime. This effort includes the organization of collections (in paper form) and the development of databases for electronic access via Internet. E. CHALLENGES TO RECONSTRUCTING THE PAST The primary challenge to the Committee's task is its daunting nature. Agency searches are time consuming, data on experiments are fragmentary, some important document collections have been lost or destroyed, and declassification is slow and uncertain. 1. Agency Searches Are Time Consuming While the process of identifying and retrieving documents remains overwhelming, the basic contours of the search have been established. As discussed in detail in Appendix E, agency searches have now located many headquarters-level collections that are likely to contain relevant information. The effort is currently directed at the retrieval of these documents. At the same time, effort will be required to access field collections that appear most promising. These efforts will take more time, but they should be relatively well-defined tasks--the time should not be open-ended. 2. Data on Experiments are Fragmentary In the case of many experiments, only fragmentary data are available from government and public sources (e.g., journal articles). Data on key questions, such as consent practices and subject selection, are often lacking. Additional information may be available from the institutions that conducted the experiments, the investigators who conducted them, and the subjects themselves. The Committee will seek to focus its efforts on cases where access to additional information is more likely. However, the reconstruction of experiments will be time consuming and its success uncertain. The problem of fragmentary data also applies to intentional releases, where in some cases pertinent information remains classified. 3. Loss or Destruction of Important Document Collections Even when important document collections have been identified, they can rarely be recovered in toto. In some cases, significant collections appear to have been lost or destroyed. (The destruction may well have been in accord with standard records retention practices; however, at many years remove, it is often difficult to know the precise circumstances of destruction.) For example: o CIA acknowledged that the charter of its MKULTRA program of experiments included radiation research; however, as CIA previously reported, Director of Central Intelligence ordered MKULTRA files destroyed in 1973. o As noted above, documents provided by DOD and DOE, and/or located by staff in the National Archives (in the files of HHS predecessors) show that CIA played a role in the mid-century DOD committees that debated and planned for, among other things, human experimentation. CIA, however, has not yet located any materials related to these groups in its own files. o In issuing his Nuremberg Code directive in 1953, Secretary of Defense Wilson required the advance approval of covered human experimentation by the Service Secretaries. With limited exceptions, the files containing such approvals have not been located. o The Naval Radiological Defense Laboratory (NRDL) was established in 1947 to study contamination problems posed by the use of the atomic bomb. At the time of its "disestablishment" in 1969, its library of research reports was evidently dispersed, and basic records were apparently destroyed. The Navy continues, however, to search for surviving NRDL materials. o DOE was unable to locate the pre-1970s files of its Intelligence Division, which could have provided critical data on intentional releases and work done for others. In response to Committee request, a DOE investigation revealed that these files were substantially purged during the 1970s and as late as 1989. o In the early 1970s, DOE's predecessor (AEC) conducted an extensive inquiry into the plutonium injection experiments. The resulting reports referenced a collection of 250 documents that were gathered and used in the reports. DOE has not yet been able to locate this potentially important collection. o Requests for the use of isotopes for human experiments, as well as other purposes, required the approval of the AEC Isotope Development Division. However, DOE has been unable to locate much of the basic licensing documentation, which would provide fundamental data on human experimentation conducted with isotopes. o At the outset, HHS reported that, except for skeletal records of grants, there was a paucity of information on experiments for the years through the early 1960s. o In the 1960s, NASA contracted with DOE's Oak Ridge operations to perform a retrospective study of whole body irradiation. The study encompassed over 3,000 radiation exposures at over 40 institutions. If recoverable, the data would be an essential source on whole body irradiation. However, in 1981 congressional testimony, NASA stated that the data had been destroyed in the routine course of business. o At the time of the Committee's creation, VA announced its intent to learn about the purpose of a confidential "Atomic Medicine Division," that, according to a 1952 report, was created in 1947. VA has located only a handful of additional relevant documents that might shed light on any activities of this confidential division. However, as noted, VA has asked its Inspector General to assist in the search. 4. Classification As noted, a substantial amount of material of relevance to the Committee remains classified. The declassification process slows the document retrieval process. The Committee has sought and received written assurance that declassification decisions will be made within a short time frame. Possessed of security clearances, Committee and staff will be able to review documents and earmark those meriting speedy declassification. However, security clearances have been received only recently and on a limited basis. In addition, as noted earlier, agencies have stated that in some cases declassification requests will not be granted. Interim Report of the Advisory Committee on Human Radiation Experiments, October 21, 1994