PART I. AREAS OF INQUIRY: THE FRAMEWORK AND PIECES OF THE PUZZLE When the Committee began operations in late April 1994, it had limited information about the experiments it was to study and about the ethical and scientific standards of the past in which they were set. The Committee had not only to collect information scattered in files and warehouses throughout the country but, at the same time, to create and test the framework needed to ensure that there is a "big picture" into which pieces of the puzzle could be fit. In this section we discuss the components of the framework, and some of the pieces of the puzzle that have already been assembled. In Part II, we discuss the methods for locating the pieces, including the Committee's work with the Interagency Working Group search teams. While the framework and search method are discussed separately, in practice they are inseparable, and continually inform one another. A. THE PROBLEM: WIDELY DISPERSED AND FRAGMENTARY INFORMATION How many human radiation experiments were conducted prior to 1975? By whom? What were they about? In April, even the most approximate answers to such questions were guesswork. There was no known place or combination of locations to investigate that ensured the quick compilation of even a reasonably complete list of experiments. The Committee could begin with documents that were assembled during the 1980s and that underlay the "Markey report." [6] But review of the materials available for the Markey report confirmed that, even for that relatively well-known group of experiments, basic information was lacking. The Department of Health and Human Services (HHS) reported that its data on mid- century research grants was limited to capsule descriptions that often did not permit distinction of work performed on humans from that performed on other forms of life. Components of Department of Defense (DOD) and other agencies did provide lists of human experiments; in many cases, however, even when reports on the research were available they often lacked data on basic questions of concern (for example, who the subjects were and what they were told about the risks of the experiment). What codes of conduct, if any, existed to govern federally sponsored experiments? Who developed them? How were they put into effect? There was no readily identifiable body of ethics policies that governed human experimentation in the pre-1974 period. Indeed, the prevailing assumption was that until the mid-1960s Federal agencies, by and large, did not even possess such policies for their extramural research programs. [7] In order to evaluate experiments it also is necessary to understand the scientific or medical standards in effect during the period of their performance. What were they? How were they made known and put into effect? Where would information be found that would show whether experiments were conducted for military, scientific, or medical purposes, or some combination, and thus would reveal the considerations of public benefit that went into their conduct? Finally, when the facts and standards are assembled, by what factors is the past to be judged? By what criteria are wrongs to be assessed? In each of these areas of inquiry, the well-lit streets and well-known landmarks had long since been altered beyond recognition or demolished. Where agency organization charts or other road maps existed to guide the way, the fragments at hand were often blurred beyond recognition. B. BIOMEDICAL EXPERIMENTS: 1944-1974 1. Phase I: Mapping of Experiments and the World in Which They Were Set The Committee has tried simultaneously to recreate both the world of experiments and the basic framework in which they were set and must be understood. These efforts have involved trying to get the Committee's arms around a potentially huge number of experiments, retrieving the ethical and scientific norms that were prevalent during the time experiments were conducted, and identifying and reconstructing the institutions that planned, funded, set policy for, carried out, and used data from the experiments. a. Experiment Database The aim of this activity is to provide a living electronic document that will serve as a central record on the identity of many (but by no means all) Government-sponsored human radiation experiments, with basic information on each experiment and keys to permit further research. To this end, the Committee created a form to collect standard information regarding each biomedical experiment of which it became aware. [8] As of mid-October, the database comprised about 400 experiments that were conducted prior to 1975. In addition to the experiments in the database, the Committee has at least fragmentary data that may involve 1,000 or more further experiments. [9] The core of the database is the experiments identified by the agencies. [10] However, it is now clear that these comprise only a portion of the research conducted, albeit a significant portion. The Committee seeks further sources to identify additional experiments and to provide missing data on those already identified. These include the following: o Information provided by members of the public; o Biomedical textbooks, histories, and journal articles, and bibliographies of radiation research; o The Atomic Energy Commission (AEC, predecessor to the Department of Energy) listing of recipients of isotopes and other AEC reports; o Documents provided by the agencies or located by staff in public or private archives or records centers (including, for example, agency program and budget documents, agency histories, and the minutes of relevant committees); and o Presentations to Congress. The database includes many categories of data with provision for electronic sorting by category. It was quickly apparent that data on some key categories of information (e.g., whether or not consent was obtained, who the subjects were, how they were selected) are lacking for most experiments. Given the fragmentary data presently available on most experiments, the database will not itself be the basis for evaluating individual experiments, but it will provide a guide or index for further research. b. Ethics Policies and Practices The aim of this effort is to determine what Federal and private sector research ethics policies and practices were in use prior to 1975. Following its first meeting, the Committee asked the agencies to provide basic information on the development of their research ethics policies and regulations. The retrieval of agency information is ongoing. The Committee is simultaneously searching private archives and conducting an interview program to trace private sector, as well as public sector, policies and practices. It is now apparent that from the onset, the government engaged in high-level debates on human experimentation during the Cold War period. Committee staff, working with agency search staff, have attached high priority to tracing down the twists and turns in these debates and the development and implementation of policies that flowed from them. i. Department of Defense (DOD). In the case of the military, documentation of consent policies predates the 1947 creation of DOD. [11] In February 1953, the Secretary of Defense issued, as a top secret document, a policy adopting the Nuremberg Code "to govern the use of human volunteers by the Department of Defense in experimental research in the fields of atomic, biological and/or chemical warfare." [12] Research questions for the Committee include the following: o The extent to which the Secretary's policy, which was stamped "Top Secret", was known throughout DOD and by civilian researchers funded by DOD; o Whether and how the Armed Services implemented the Secretary's policy; o The extent to which implementing directives were actually applied to particular experiments; o How the 1953 policy was interpreted: what research activities were considered to be covered by the directive and which were not? For example, how was research distinguished from training maneuvers? Were activities conducted by DOD contractors, as well as DOD employees, covered?; and o The meaning of "human volunteers" in the context of military activities. ii. Central Intelligence Agency (CIA). The Committee is seeking information on the relation between early ethics policies in DOD, HHS, and AEC, and experiments conducted by the CIA. In the 1970s, public and congressional attention focused on MKULTRA, and other programs of CIA experiments on mind control (most famously involving LSD), at least some of which involved unknowing subjects, including members of the public. Documents show that CIA officials who were involved in the predecessors to MKULTRA also were members of the DOD Committee on Medical Science and probable participants in the DOD Joint Panel on the Medical Aspects of Atomic Warfare, groups at which human experimentation planning and policy, among other items, were discussed. iii. AEC/Department of Energy (DOE). At AEC, evidence for a consent policy dates to 1947, the year of AEC's creation. The Committee has been seeking to determine whether policies indicated in high-level documents were enacted as formal guidelines or rules, and whether these policies were put into practice by AEC-sponsored investigators. iv. Department of Health and Human Services (HHS). The initial HHS policy appears to have been that applied to the National Institutes of Health (NIH) Clinical Center, which opened in 1953. The Committee has been researching the development and application of that policy. Policies governing extramural research were initiated during the 1960s. v. National Aeronautics and Space Administration (NASA). NASA was created in 1958. The policies initially retrieved by NASA dated to 1972. At its birth, NASA drew upon the research work of other agencies, such as DOD. The Committee is researching how NASA developed these policies and the extent to which early NASA research relied upon ethics policies developed by others. vi. Department of Veterans Affairs (VA). The recovery of policies related to experiments sponsored by the then-Veterans Administration has been limited. However, it appears that work done under VA auspices was often performed in coordination with other agencies or by investigators who also worked under DOD, AEC, or HHS (its predecessor) funding. The relation between the policies and practices of VA and those found elsewhere should be of interest. In parallel with the reconstruction of Federal ethics policies and practices, the Committee is seeking to reconstruct the policies and practices that governed privately funded or performed biomedical research. This effort includes a search of relevant literature and records collections and an oral history project, described in more detail in Part II.B. below. c. Institutional Mapping The goal of this effort is to identify and understand the policies and programs in which experiments were set and to identify responsibility for these programs, policies, and ultimately experiments. A subsidiary goal is to provide the roadmap needed to ensure that as many experiments as possible can be identified, and to locate potential additional sources of information on those already known. The effort has already shown that headquarters-level records can aid in the reconstruction of the "big picture" in which experiments fit, as can be seen from the following examples. From its creation in 1947, AEC had components that funded human experimentation and provided needed experimental tools (radioisotopes as well as equipment grants). AEC's Division of Biology and Medicine, created in 1948, awarded grants for research and set the overall biomedical research program agenda. Its Isotope Development Division distributed radioisotopes to researchers throughout the country, and its Human Use Subcommittee of the Committee on Isotope Distribution reviewed applications for the use of isotopes in human subject research. Documents reveal early policy debates and declarations on human experimentation. But as discussed at Committee meetings (and in related staff memoranda), the scope of ethics policies and the way in which they were translated from headquarters to field application remains to be reconstructed. The Committee is also constructing a picture of DOD organizations, programs, and policies that provided high-level direction and oversight of human radiation experimentation. For example, in 1949, the Office of the Secretary of Defense created the Joint Panel on the Medical Aspects of Atomic Warfare. The Joint Panel included participation by private medical researchers and representatives of the AEC, Public Health Service (PHS), and probably the CIA. The Joint Panel served as a focal point for planning and information gathering on experimentation (including human experimentation) related to atomic warfare. At the same time, the Office of the Secretary of Defense also included the Armed Forces Medical Policy Council, whose work led the Secretary of Defense to issue DOD's Nuremberg Code policy and led the Joint Panel to consider human experimentation in connection with U.S. atomic bomb tests. The Committee has been following the trail of plans and policies formulated by these groups. Mid-century debates and sponsorship of human experimentation often involved participation by multiple agencies. It is therefore necessary to understand relationships among agencies, as well as within them. For example, AEC and DOD (and their consultants), engaged in vigorous discussion over the need for human experimentation in connection with the nuclear-powered airplane (which was never built). Civilian agencies or their representatives also were involved in defense-related discussion and planning. Following World War II, the National Institutes of Health (NIH) inherited many of the research grants and contracts of the World War II Committee on Medical Research, the medical research and development component of the military effort. During the Korean War period, representatives of VA, NIH, and PHS, as well as AEC and DOD, were involved in the discussions of the Joint Panel on the Medical Aspects of Atomic Warfare. PHS played an important role in monitoring bomb tests and conducting fallout measurement. When NASA was created in 1958, it was able to rely on a research heritage from agencies such as the Air Force and AEC. NASA established a joint research program in radiobiology with the AEC in the early 1960s. d. Scientific Standards Timeline The goal of this effort is to identify the scientific and medical standards that governed judgments about risks and potential benefits during the period in which experiments were undertaken. Areas of inquiry include the following: o Determining the radiation standards that existed at the dawn of the Cold War, the manner in which they were set, and their basis; o Examining the levels of risk developed and assumed by AEC's Isotope Development Division; o Determining the extent to which the early research now under study played a role in the development of standards; and o Identifying documents that contain key discussions of risks and potential benefits of human experimentation and reviewing risk/benefit discussions in contemporary literature. 2. Phase II: Focus on Specific Experiments and Their Context While the reconstruction of the world of experiments continues, the Committee at its September meeting adopted a particular analytic strategy for focusing its efforts. This strategy involves two overlapping approaches that together capture as complete a picture as is reasonably possible. These approaches are (1) examining groups of biomedical experiments; and (2) examining the institutions that conducted and sponsored them. The program is ambitious, and its success will depend critically on the ability to retrieve needed information, as well as staff and Committee resources. The first approach identifies for intensive study five groups of experiments (outlined below) covering the spectrum of human radiation research. Each group is anchored in one or more relatively well-publicized experiments. The second approach focuses on two institutions that were among several sites that were hubs of planning and research in human radiation research. Both approaches provide rich opportunities for exploring the nine overarching themes noted in the Introduction above. a. Biomedical Experiments i. Biodistribution. This group centers on the plutonium injection experiments. From those well-known experiments it reaches out to include (1) other experiments designed to test the biodistribution of isotopes with no clear immediate therapeutic or diagnostic potential; and (2) other experiments whose primary purpose was to advance the health and safety of those directly involved in weapons production, such as experiments related to toxicology or chelation therapy. ii. Total Body, Partial Body, and Local Irradiation. This group includes the Cincinnati whole body irradiation experiments and other external irradiation experiments where the subjects were predominately persons who were ill. iii. Research Involving or Affecting Children. This group is anchored in the Fernald School and Vanderbilt experiments. The Fernald School experiments were tracer studies using radioactive calcium in a population that included institutionalized mentally compromised children. Vanderbilt University conducted studies on pregnant women using radioactive iron to determine maternal-fetal iron exchange. iv. Radiation Research where Subjects were Predominately Healthy Adults. This group includes the testicular irradiation of prisoners and other experiments on healthy adults (such as flash-blindness studies and other experiments related to atomic bomb tests) in which external sources of energy were applied with no potential for therapeutic or diagnostic benefit for the experimental subject. v. Radioisotope Research. This group, which includes experiments at the Wrentham School, encompasses studies using radioisotopes that were products of the nuclear age and also had major medical applications in both diagnosis and therapy. Examples of these radioisotopes include iodine and iron. Unlike the biodistribution group, this group allows a purposive sampling of cases that include research on medical applications. It is hoped that these five groupings, although by no means mutually exclusive, will serve as useful devices for organizing research and analytic efforts. b. Institutional Case Studies It now appears that these experiments took place in a world in which there was official debate at the highest level about human experimentation and the policies that should govern it. The primary purpose of the institutional inquiry is to advance the theme of management responsibility (see Introduction) by adding to our understanding of how decisions to experiment (or not) were made, and to answer questions such as: o Where higher-level policies existed, how were they supposed to flow down from headquarters to research institutions and, ultimately, to investigators and subjects? o Where did responsibility lie for determining the formal and practical reach of policies and the requirements for implementation? o If policies were limited in coverage, or in their implementation, why was that the case? o Where did responsibility lie for failure to implement and/or enforce policies and was a policy oversight process either in place or considered? By focusing on institutions that sponsored or conducted many relevant experiments, the institutional case studies also should provide further basis for focusing on, and evaluating, particular groups of experiments, as well as other themes of interest to the Committee. Staff researched a number of institutions as candidates for case studies, including AEC sites that conducted or sponsored research, such as Oak Ridge and Los Alamos; key DOD organizations, including the School of Aviation Medicine; and research centers funded by multiple agencies (such as the UCLA complex, which included work funded by the AEC, DOD, and VA, and similar complexes in the Boston and San Francisco areas). The Committee has decided to pursue two institutional case studies: the Oak Ridge complex and the Bay Area components of the University of California. Research on sites not chosen for case studies nevertheless continues to be of value in providing data on individual experiments, and on prevailing ethics policies and scientific standards. C. INTENTIONAL RELEASES The Committee's Charter includes 13 intentional releases of radioactive material into the environment. [13] These releases were generally related to radiation warfare tests, the gathering of intelligence, and the development of instrumentation. The category of intentional releases is now known to be larger, in variety and quantity, than the 13 releases identified in the Charter. For example: o The Charter included 8 radiation warfare experiments; the number is at least 53. o The Charter includes 4 Los Alamos, New Mexico, implosion tests involving radiolanthanum. DOE reports that the number of such tests approximates 250. o The Charter includes one intentional release from a plutonium production facility (Green Run). Examples of further releases from nuclear production facilities have been found. In addition to the types of releases identified in the Charter, other intentional releases include: o Releases related to the development of nuclear rocket and nuclear aircraft technology; o One-point safety tests of fission warheads at the Nevada test site that were performed to determine whether the accidental detonation of the high explosive at one point in a warhead would produce a nuclear yield; o Radioecology tests, in which radioactive material was introduced into the environment to test for retention or transmission through the environment; and o Tests of reactor safety and simulated accidents, such as reported by DOE's Idaho National Engineering Laboratory. In addition to the intentional releases stipulated in its Charter, the Committee may also investigate examples of further intentional releases. In general, the focus of efforts will be (1) to locate and retrieve for public release (where possible) information that may shed light on the planning of, and responsibility for, the releases; and (2) to determine whether releases that took place in the past, typically shrouded in secrecy, could be conducted today. As a complement to the Committee's overarching themes, the following questions are being pursued: o What was the purpose of the release (e.g., bomb testing, reactor testing, long-range detection, environmental study)? o How much radioactivity was released and in what form? o Was radiation monitored on and off site? Who was responsible for the monitoring? o Were there human biomedical studies in connection with the releases? o Were participants and bystanders notified in advance of potential hazards? o What measures were recommended or taken to minimize risks to participants and bystanders? o What rules govern intentional releases today (for example, environmental impact regulations)? o How would the historical releases be conducted today? For example, would environmental impact statements be required? Would there be public notice? Could all or portions of the review process be kept secret? o What kind of releases are being conducted today, and what rules are being followed? D. A NOTE ON SCOPE At the outset, the Committee had to consider the scope of its activities. During its early meetings, the Committee heard public comments from veterans of the atomic bomb era and their families (military personnel exposed during atomic bomb tests), downwinders (for example, private citizens exposed to fallout from nuclear tests in Nevada), the Marshallese (inhabitants of the Marshall Islands, many of whom were exposed to radiation from bomb tests conducted in the Pacific), and representatives of uranium miners (who were exposed to radon as workers in AEC uranium mines). The Committee also received comments regarding once-common radium treatments and written communications or office visits from other individuals and groups. The question of the scope of the Committee's activities was assigned to a subcommittee that recommended, and the full Committee agreed, that for purposes of inquiry hard and fast lines should not be drawn. In the absence of some degree of inquiry, the facts may be insufficient to determine whether human experimentation took place. The Committee's inquiry has revealed that, both in the past and at present, the factual and conceptual boundaries separating an experiment from other kinds of data gathering are not always clear. Finally, analysis of activities that may not be deemed experimental may shed important light on the conduct of human experimentation by showing why experimental data were needed. In general, in cases of group exposure, the Committee directed the staff to review previously organized accounts, with an eye toward information that shows or suggests biomedical experimentation. Staff was also directed to focus on materials that have not previously been made public. In piecing together the records of DOD's 1949-1953 Joint Panel on the Medical Aspects of Atomic Warfare, the Committee found a trail of discussion and planning that appears to have led to the conduct of at least some biomedical human experiments in connection with atomic bomb tests. These experiments are being pursued as part of the group of biomedical experiments involving subjects who are predominately healthy adults. The Committee asked staff to pursue this trail of inquiry, and at the Committee's request, DOD and DOE have agreed to locate and retrieve documentation related to actual or potential human experimentation in connection with atomic bomb tests. The areas of inquiry include: o Documents related to the biomedical panels (or offices, committees, etc.) that planned the biomedical components of atomic bomb tests; o Documents related to human subject data-gathering activities that, according to available documentation, may have been experiments (including, for example, flash-blindness testing, psychological observation or testing, the measurement of radioisotopes in body fluids, and the measurement of radiation doses to certain ground or aircrews, all in connection with weapon tests); and o Documents related to DOD's ethics policies (particularly the 1953 Secretary of Defense Directive) to atomic bomb test activities. In agreeing to search for the information, the agencies and the Committee reserve for future discussion whether particular activities constitute experiments. In conducting the search, the Committee will work with the agencies to ensure that previously retrieved data (such as that assembled for DOD's Nuclear Test Personnel Review) are used efficiently. Public presentations also spurred Committee consideration of the concept of "experiment of opportunity," that is, situations in which the initial exposure to radiation may have been accidental (or, if premeditated, not for the primary purpose of human subject study), but the opportunity presented by the exposure led to an organized research effort. In discussing the concept, the Committee is mindful that, if only because of staff and resource limits, its mission cannot include the examination of human data gathering solely for safety monitoring purposes. However, the question of the boundary between such data gathering and experiments of opportunity is a focus of inquiry. E. THE CONTEMPORARY STORY As part of its mission, the Committee must establish the current status of the policies and practices related to human radiation research and make recommendations regarding future policies. In an effort to gain insight into this area, the Committee has undertaken three separate research projects aimed at describing contemporary practices related to the ethics of human subject research. The Subject Interview Study aims to discover the beliefs and attitudes of research subjects regarding their understanding and voluntary participation in research; the Research Proposal Review Project aims to discover the adequacy of current policies and practices in the protection of the rights of the subjects of research; and the Agency Oversight Review aims at assessing both the policies and practices of the agencies for oversight of the review and monitoring of human subject research supported or performed by them. The bulk of the work for these projects will be undertaken and completed during the remaining months of the Committee's term. Up to this point, work on the contemporary projects has consisted of seeking administrative approval (through the Office of Management and Budget), designing the projects, requesting the necessary information and materials from agencies, and preparing sufficient staff resources to successfully carry out the projects. 1. Subject Interview Study The purpose of this project is to collect data concerning (1) the extent to which patients of radiation oncology, medical oncology, and cardiology services at both major research institutions and community hospitals believe they are participants in research; (2) the perceived voluntariness of this participation; and (3) subjects' reasons for agreeing to participate. This project will enrich the deliberations of the Committee with direct information about the contemporary experiences of some research subjects. The project will proceed in three phases. Focus groups will be conducted (Phase I) to assist in development of a short survey, which will be administered to approximately 1,000 patients drawn from approximately 15 different institutions (Phase II), followed by a semi-structured interview to be administered to a subsample of approximately 150 subjects (Phase III). Phase I: Focus Groups. Focus groups comprised of patients from two different institutions will be conducted by a professional facilitator. Issues to be covered in focus groups include: o Voluntariness: did subjects feel as if they had a choice about whether to participate in an experimental protocol, and were others involved in the decision? o Reasons for participating, including whether participation had been recommended and, if so, by whom? o Understanding of what it means to participate, such as what it means for a drug or treatment to be experimental, and how being a patient in a research project differs from receiving regular medical care. Phase II: Short Survey. Based on the focus group responses, a short survey, anticipated to take 5-10 minutes to complete, will be designed by Committee staff in conjunction with survey research consultants. The survey instrument will be designed to capture the following topics, provided as potential examples: o Beliefs about being a research participant, such as whether the subject is currently receiving any treatments or drugs considered to be experimental, or participating in any research studies or proposals. o Voluntariness (to be asked of those who believe they are currently participants in research), such as whether he/she believes there was a choice about whether to participate in research or experimental therapies, and why or why not. o Reasons for participating, e.g., to receive state-of- the-art treatment; to help advance science; to receive compensation; because someone recommended they should, etc. o Understanding of what it means to participate in research, such as whether the subject understands what it means for radiation therapy to be experimental, the difference from regular medical care, whether everyone in their research proposal is getting the same therapy or treatment. Phase III: In-Depth Interviews. Semi-structured, in-depth personal interviews then will be conducted with 10-15 patients who are participants in research at each of the 15 institutions. An interview guide will be developed with the help of the focus groups, and the same issues covered in the survey will be included in the interviews, with questions posed in an open-ended fashion and followup questions asked based on the subject's responses. Through this process, considerably more attention can be given to the relevant topics, such as the meaning of research participation for subjects. 2. Research Proposal Review Project The project will evaluate the extent to which the rights and interests of persons currently involved as subjects of radiation research conducted or supported by the U.S. Government appear to be adequately protected in the proposal review process, and to compare this level of protection with that afforded the subjects of nonradiation research. The objectives of this project are (1) to determine, based on research proposal and IRB materials, whether harms and benefits, informed consent procedures, and selection of subjects appear to be appropriate; and (2) to determine whether research proposals and IRB materials provide sufficient information to make judgements about the protection of human subjects. This project involves collecting the necessary documents from agencies and grantee institutions. To achieve these objectives, listings of pertinent research projects will be obtained from the Departments of Defense, Energy, Health and Human Services, Veterans Affairs, and NASA, [14] including: o All human subject research proposals involving ionizing radiation that were newly approved and funded or renewed by the agency in fiscal year 1993, and a sample of such proposals from previous years. o Human subject research proposals not involving ionizing radiation that were newly approved and funded or renewed during the same period as the ionizing radiation proposals, for the purpose of creating a comparison group. Both intramural and extramural proposals in each category will be considered for review. Grantee institutions and the agencies will be asked to provide relevant documents for a sample of the radiation research proposals as well as a parallel sample of non-radiation research. A subset of Committee members and staff will review and evaluate the proposal materials based on evaluation criteria developed by Committee and staff. This team of evaluators will include persons with technical radiation risk and medical expertise, knowledge of the appropriate standards for informed consent and selection of human subjects, and any additional expertise necessary to address the objectives listed above. 3. Agency Oversight Review In an effort to assess both the status and efficacy of current policies regulating human subject research, Committee staff has requested that each of the six agencies identified above (CIA, DOD, DOE, HHS, NASA, and VA) provide information related to oversight of research involving human subjects that it either conducts or supports, including any special procedures for oversight of research involving ionizing radiation. This includes information and materials related to the roles and responsibility of the appropriate office, personnel, process, and authority for oversight of human subject research review in each agency, as well as any applicable rules, regulations, or policies for the conduct, funding, or oversight of human subject research. Agencies also will be asked what procedures would be followed should it be determined that there is a need to bypass applicable research policies or regulations in the conduct of specific research projects. This information will be compiled, analyzed, and recommendations for future policy will be made during the next months of the Committee's work. ********** 6. "American Nuclear Guinea Pigs: Three Decades of Radiation Experiments on U.S. Citizens," Report Prepared by the Subcommittee on Energy Conservation and Power of the Committee on Energy Commerce, U.S. House of Representative, November, 1986, chaired by Edward Markey (D-MA). 7 For example, in February 1991 the Congressional Research Service issued a report that fairly reflected prevailing understanding on the history of federal regulations for the protection of human subjects. The report begins the story of Executive Branch regulation in the 1960s, focusing on the activities at HHS' predecessor. "Protection of Human Subjects in Research, "Irene Stith-Coleman, CRS Report 94- 179 SPR, February 28, 1994. As discussed above, we now know the story starts far earlier, and involves DOD and the Department of Energy (DOE) predecessor, AEC, as well. 8. The form contains entries for the range of basic data that should be of importance to the Committee, the Interagency Working Group, and the public. For example, categories include (1) classification of the experiment by scientific and governmental purpose(s) (if any); (2) isotope and dosage; (3) source(s) of funding; (4) researcher(s) and institution(s); (5) provisions for consent, if any; (6) subject population and selection method; and (7) relevant publications. 9 As discussed in this report, intentional releases are being catalogued separately. 10 Appendix E discusses the number of experiments located in the case of each agency. 11 Most notably, Walter Reed employed a form of release in the turn of the century battle against yellow fever. The Navy has retrieved evidence of a relevant policy dating to the 1930"s. Documentation obtained by the Committee staff shows discussion of consent policy in the World War II Committee on Medical Research, which coordinated the wartime medical research effort. 12 The Nuremberg Code was the standard that was codified by the International Military Tribunal following the prosecution of Nazi doctors who engaged in human experimentation. 13 See Charter, section 3(2), Appendix B. 14 CIA maintains that it neither funded nor performed any human subject research involving ionizing radiation in fiscal year 1993. The Committee is currently determining whether CIA supported such research in 1990-1992. Interim Report of the Advisory Committee on Human Radiation Experiments, October 21, 1994