Esperimenti nazisti: la versione del DOE (Dipartimento USA dell'Energia)

-DOE_DATE- 02/09/1995
-DOE_SITE- HUMAN RADIATION EXPERIMENTS: The Department of Energy Roadmap to the Story and the Records
-DOE_DOC_TYPE- HUMAN_RADIATION_EXPERIMENTS (DOE/EH-0445)
-DOE_SECTION- DOE Predecessor Agencies and Human Radiation Experiments: A Headquarters Overview
-DOE_TEXT-

 TABLE OF CONTENTS
 Chapter 2: Narratives and Records Series Description Institutional Areas

DOE Predecessor Agencies and Human Radiation Experiments:

A Headquarters Overview
 
Introduction

DOE inherited a legacy of human radiation experiments from predecessor agencies, including the Manhattan Engineer District (MED) and the Atomic Energy Commission (AEC). The Manhattan Project engaged in human radiation experimentation as part of its mission to build the atomic bomb. This mission included studying the health effects and hazards posed by nuclear energy. The AEC, postwar successor to the MED, had jurisdiction over both peaceful and military nuclear development and investigated related biomedical issues.

[Figure 9. Donner Laboratory carbon-14 metabolic study apparatus]

Shortly after the war's end, cancer research assumed a prominent place on the national agenda. At the direction of Congress, the AEC funded considerable research into cancer diagnosis and therapy. After the AEC was abolished in 1975, the Energy Research and Development Administration (ERDA) briefly had responsibility for all AEC functions except those related to nuclear regulation, which devolved upon the Nuclear Regulatory Commission (NRC). DOE came into existence in 1977 and in turn assumed responsibility for nuclear biomedical research and weapons production.

The Manhattan Project engaged in human radiation experimentation as part of its mission to build the atomic bomb.

Attempts to understand radiation and its impact on the human body began shortly after the discovery of x rays in 1895. The Federal government, however, did not sponsor human radiation experimentation until the Manhattan Project was on the verge of building the atomic bomb. This project required development of a new industry that created hazardous radioactive materials, some of which did not exist until the war effort. MED biomedical researchers began research and experimentation with animals to establish exposure standards for the workers. Yet animal experimentation proved incapable of providing all needed data. The Manhattan Project leadership therefore authorized studies with radioactive materials in human subjects.

Origins of the Manhattan Project

In December 1938, while conducting experiments in their Berlin laboratory, German scientists Otto Hahn and Fritz Strassman discovered that uranium could be broken into two lighter elements while releasing energy. Scientists soon realized that this "fission" process could release enormous amounts of energy, providing the basis for a weapon of unprecedented explosive power.

American scientists quickly grasped this possibility when news of the discovery of fission crossed the Atlantic. A month after Nazi Germany invaded Poland, Albert Einstein wrote President Roosevelt urging the President to launch a program to build atomic weapons. Spurred by the possibility that the Germans could already be working on an atomic bomb, Roosevelt organized an advisory committee that began considering how to separate the fissionable isotope of uranium from uranium ore. Soon after Glenn Seaborg of the University of California and his colleagues discovered plutonium in 1941, the committee expanded its scope to explore the feasibility of large-scale production of this second fissionable metal.

The uranium and plutonium projects began slowly due to the great technical and logistical problems involved. In June 1942, Vannevar Bush and James B. Conant, who led the bomb project, recommended that the country commit all possible resources to production of an atomic bomb. Bush and Conant further suggested that the Army run the project. Roosevelt agreed, and in August 1942 the Army Corps of Engineers established the Manhattan Project to build an atomic bomb as quickly as possible.

Creating a New Industry

The task called for creation of an enterprise greater in scope and complexity than any single contemporary private industry on "a pressing, almost desperate time schedule." Moreover, the project would incorporate new industrial processes and would have to deal with radioactivity on a previously unknown scale. Nevertheless, given the exigencies of wartime, the leader of the Manhattan Engineer District, General Leslie Groves, decided to bypass pilot plant stage and go directly to full production.

The task called for the creation of an enterprise greater in scope and complexity than any single contemporary private industry on "a pressing, almost desperate time schedule."

Unsure which (if any) would succeed, the Manhattan Project simultaneously pursued three methods to produce the fissionable isotope of uranium: electromagnetic separation, gaseous diffusion, and thermal diffusion. Plants for all three were built at Oak Ridge, a thinly settled area in eastern Tennessee selected by the Government as an atomic reservation. Hanford, a large arid tract in eastern Washington bounded by the Columbia River, was selected for the plutonium project. Nuclear reactors, a plutonium separation plant, and a variety of associated facilities were constructed there. These sites were chosen for their access to water and power and for their remoteness, which enhanced security. Virtual armies of workers moved into Oak Ridge and Hanford to construct and operate plants. To design a weapon, the Manhattan Project built a separate research laboratory at Los Alamos, NM.

Wartime Medical Problems

Creating the atomic bomb involved many unique and little-understood health hazards. The most novel was radiation. Scientists knew that radiation was hazardous; for example, the health effects suffered by radium dial painters earlier in the century had been well documented. What was not known was how much radiation would harm workers.

But the plutonium work, which produced highly radioactive and toxic materials, presented the greatest hazards.

Other hazards included chemical agents, high-voltage electricity, and the potential for explosions in experimental work that involved the use of gas and liquids under great pressure. To protect workers from these hazards, the Manhattan Project organized a Medical Section.

The Medical Section's most immediate problem was to identify and control the hazards associated with the various production processes. Data were collected on the potentially damaging effects of radioactive and toxic materials. The medical personnel provided advice on the design of plants and production processes and prepared to treat cases of radiation and chemical poisoning. Because the Manhattan Project oversaw entire communities at Oak Ridge, Hanford and Los Alamos, the Medical Section also ran clinical medicine programs to treat a variety of routine health problems. But the plutonium work, which produced highly radioactive and toxic materials, presented the greatest hazards.

The Plutonium Injection Experiments

Most project medical research involved experimentation with animals through programs established at the University of Rochester and elsewhere. Manhattan Project researchers, however, also used humans as research subjects; the most widely known example of this is the plutonium injection experiments.

As early as January 1944, Glenn Seaborg warned that "the physiological hazards" of plutonium might "be very great" and suggested that" a program to trace the course of plutonium in the body should begin as soon as possible." Animal studies had shown plutonium to be toxic and that different species excreted it from the body at different rates. Project physicians therefore wanted human data to obtain reliable information for the establishment of exposure levels for workers. In presenting these considerations to Los Alamos laboratory director J. Robert Oppenheimer on March 26, 1945, Louis Hempelmann asked that the MED "help make arrangements for a human tracer experiment." Such arrangements were made, and a series of human experiments began in 1945. (See the section, "Human Plutonium Injection Experiments," under Topical Areas later in this chapter.)

Other human radiation experimentation was conducted under the Manhattan Project. In the mid-1940s, University of Rochester researchers gave five patients radioactive polonium to obtain excretion data. Rochester researchers also injected six patients with uranium salts to investigate the metabolism of uranium by the body and to observe its effect on kidney function. To detect radiation skin effects, MED contractor researchers in Tennessee also exposed 10 subjects to beta radiation. (Individual experiments are detailed in Chapter 3.)

Distribution of Radioisotopes

The Manhattan Project also assisted postwar radiation experiments by non-Government physicians and researchers. In 1946, Oak Ridge began shipping radioisotopes to private physicians and other researchers. This distribution made radioisotopes available in far greater quantities and at much lower cost than previously. The isotope distribution program was the earliest, and for many years the most successful, aspect of the postwar promotion of "the peaceful atom." Researchers used isotopes to study the body's metabolic processes and to conduct experimental treatments for diseases, principally cancer. Some of this work involved experimentation with human subjects. The same distribution program provided isotopes to agency and contractor researchers.

[Figure 10. Oak Ridge National Laboratory workers checking for radioactive contaminations (circa 1950)]

Creation of the Atomic Energy Commission

Because the atomic bomb was a wartime military project, the Manhattan Project had built its facilities behind a curtain of secrecy. It was only with the bombing of Japan that the American public learned about the project. After the war, President Truman submitted legislation to Congress to set up a permanent atomic energy program under military control. After vigorous debate, however, Congress decided to charge a civilian agency with atomic energy and weapons development. The Atomic Energy Act of 1946 created the Atomic Energy Commission (AEC) to oversee both peaceful and military development of the atom. The law also created the Joint Committee on Atomic Energy to provide congressional oversight. Reflecting increasing tensions with the Soviet Union, the Atomic Energy Act ordered the AEC to develop atomic energy "subject at all times to the paramount objective of ensuring  the common defense and security." In its early years, the AEC's overriding task was the development of a nuclear weapons arsenal.

In January 1947, the AEC inherited the programs of the Manhattan Project. Coming to the agency were 254 officers; 1,688 enlisted men; 3,950 Government workers; 37,800 contractor employees; and plants and laboratories worth over $1 billion. The major facilities included the Los Alamos laboratory, the Oak Ridge enriched-uranium production plants, and the Hanford plutonium production complex. The AEC also assumed responsibility for uranium mining and refining activities. In addition, nonmilitary atomic research laboratories were under development at Argonne, near Chicago; Brookhaven on Long Island; and Oak Ridge.

Some information, such as medical research and treatment with radioisotopes, was openly available. Despite these exceptions, most atomic energy activities remained behind a congressionally mandated wall of secrecy.

The Atomic Energy Act of 1946 gave the agency responsibility for atomic energy activities from weapons production to scientific and medical research. The act also placed security restrictions on most information pertinent to atomic-energy development. Legally mandated classification restrictions applied to biomedical information associated with uranium or plutonium production, weapons production, or weapons design. Some information, such as medical research and treatment with radioisotopes, was openly available. Despite these exceptions, most atomic energy activities remained behind a congressionally mandated wall of secrecy. The Manhattan Project had used a small headquarters staff to oversee the operation of atomic energy facilities throughout the country. The AEC continued this practice, leaving substantial responsibility with agency and contractor field facilities. In some areas, such as weapons research and development, the AEC commissioners maintained central management control. In other areas, such as biomedical research, the AEC exercised less management`oversight.

Medical Problems Facing the AEC

During the war, the Manhattan Project medical program gained only preliminary information about the hazards of radioactive substances. There was a desire to find out much more about how uranium, plutonium, and other fission products acted in the human body: What amounts of radioactive dusts and gases were harmful to man? Exactly how toxic were uranium, plutonium, and their compounds? What was the most hazardous means by which radioactive substances were introduced into the body by ingestion, by inhalation, or by skin absorption? Physicians had no means available to stop or delay radiation injuries, nor did they possess therapeutic measures to treat injury from radioactive substances. To address these issues, an organizational unit to do the work was required.

The AEC and Human Radiation Experimentation, 1940s 1950s

The Atomic Energy Act mandated four AEC program divisions: military applications, production, research, and engineering. This arrangement left the agency temporarily without an organization to oversee biomedical research, but the AEC extended ongoing research on an interim basis. An Advisory Committee on Biology and Medicine was established in 1947, and a Division of Biology and Medicine in 1948. The AEC charged the new division with overseeing biomedical research programs, including human experimentation. Until the closed communities of Los Alamos, Oak Ridge, and Hanford were opened, the division also supervised clinical medicine programs for the treatment of resident workers and their families. By fiscal year 1949, the division was managing an operating budget of $14.6 million. Although the AEC biomedical division was charged with protecting the public from the hazards of atomic energy, its initial focus continued to be upon atomic workers. Thus, one area of human subject research in which the AEC built upon precedents was investigation of the biomedical hazards of uranium, plutonium, and fission products. Biomedical research projects devoted to investigating these hazards were authorized at the Argonne, Brookhaven, and Los Alamos Laboratories, and at the University of Rochester, the University of California (Berkeley and Los Angeles), Columbia University, and Case Western Reserve University. Most of these research projects involved experimentation with animals.

Another area in which the AEC built upon Manhattan Project foundations was isotope distribution, headquartered in Oak Ridge. The AEC stimulated private research with radioisotopes by providing funding to private physicians and researchers. The isotope distribution program was the AEC's first significant peaceful application of nuclear science, and the agency vigorously promoted it. By the end of 1954, Oak Ridge had made 64,202 shipments of radioisotopes, most to non-Government institutions. Some of this research involved human subjects.

Popular and scientific interest in the potential uses for radiation in cancer treatment was growing.

In other areas, the AEC broke new ground. Perhaps, the most visible of these was the use of radiation in cancer therapy. Popular and scientific interest in the potential uses for radiation in cancer treatment was growing as the AEC came into being. In 1948, Congress gave the AEC $5 million for the express purpose of developing a cancer research program. With the funds, the AEC built cancer research hospitals at the University of Chicago, Brookhaven Laboratory, and the Oak Ridge Institute of Nuclear Studies.

Cancer therapy was not the only new area of AEC sponsored or supported human radiation studies in the late 1940s and 1950s. Calibration of improved radiation measuring equipment involved volunteers ingesting small amounts of radioactive material. The AEC also sponsored human x-ray tests and studies of skin absorption of radioactive substances, and also began studying radium dial painters and other groups who ingested radium before World War II.

The AEC and Human Subject Consent, 1940s 1950s

To establish guidance for private research using radioisotopes on people, the AEC looked to its Subcommittee on Human Applications. The subcommittee, part of the larger Committee on Isotope Distribution, drew up a list of radioisotopes deemed safe for use in humans. The subcommittee also compiled lists of medical schools, hospitals, clinics, and other institutions qualified to conduct human radioisotope research. After the subcommittee reviewed an institution's qualifications and granted approval for use of an isotope in human research, the subcommittee expected each institution to form a local use committee to monitor individual research projects. This procedure limited AEC oversight of the clinical procedures and ethical practices of individual private physicians who used radioisotopes for human subject research. There was no requirement imposed by the AEC that private researchers obtain consent from subjects.

[Figure 11. Oak Ridge technicians measuring air monitor samples for radiation.]

Ethical issues were, however, considered in the context of research performed directly by AEC employees or in AEC-owned, contractor-operated facilities. In an April 1947 letter to Stafford Warren, chairman of the Interim Medical Advisory Committee, AEC General Manager Carroll Wilson stated that radiation should not be administered to medical patients unless there was "expectation that it may have therapeutic effect." Any human experimentation would have to be susceptible of proof from official records that the patient was "in an understanding state of mind, was clearly informed of the nature of the treatment and its possible effects, and expressed his willingness to receive the treatment."

While written consent from the patient was not required, doctors were instructed to attest that the subject had willingly consented. Wilson's directive applied to AEC officials and to employees of its contractor- operated facilities.

The record does not show that the AEC distributed or enforced Wilson's policy. Indeed, the directive was quickly superseded. During March 1951, Shields Warren, the first director of the AEC Division of Biology and Medicine, listed "guiding principles" for human experimentation for a Los Alamos Laboratory official. Warren drew upon another Wilson letter, a report from the AEC's Medical Board of Review, minutes of the September 1948 meeting of the Advisory Committee on Biology and Medicine, and his own experiences. Warren did not mention or refer to Wilson's April 1947 directive. Warren's principles for human subject research included five requirements:

1.   There must be hope of therapeutic benefit;

2.   There must be a provision
     requiring written informed
     consent;

3.   The subject would have the
     right to revoke consent at
     any time during an experiment;

4.   The research must require
     only limited use of classification or secrecy; and

5.   Any experimental work involving humans, including
     self-experimentation, would
     have to be supervised by a
     physician.

Figure 12. Brookhaven National Laboratory used "phantoms" such as the mannequin on wheeled table to approximate human radiation exposures.

Charles Dunham, who replaced Warren as Division of Biology and Medicine head, modified this policy. Thomas Shipman, the Los Alamos Health Division leader, wrote Dunham in 1956, noting widespread ignorance of Warren's human experimentation policy. Shipman, who was proposing research on normal  volunteers, confessed that he had heard about the policy but had never seen it in writing. In his response to Shipman's request for guidance, Dunham did not require that experiments carry some prospect of therapeutic benefit for the subject, but did mandate that all subjects provide informed consent. Dunham also added two provisions:

1.   Radioactive substances must be used in amounts judged small enough to avoid harming subjects; and

2.   Approval for human experimentation must be obtained by a senior medical officer.

Like Warren before him, Dunham did not refer to Wilson's April 1947 directive.

These letters suggest that the AEC lacked a firmly established policy regarding human radiation experiments during the 1940s and 1950s and used different policies at different times. On their face, these policies appear to be strict regarding both expected therapeutic benefit and written consent. What is not clear, except by negative inference, is whether any effort was made to widely distribute and enforce the policies. No documents have been found indicating that the AEC did either.

There was no requirement imposed by the AEC that private researchers obtain consent from subjects.

The Impact of the Cold War

The five AEC commissioners devoted most of their attention to problems other than human radiation experiments. Throughout the agency's first years, the commissioners attended mostly to military applications, particularly weapons development. Increasing Cold War tensions spurred the nuclear arms race, and by 1949 the agency was on the front line of the Cold War. The international event having the greatest impact on AEC activities was Soviet detonation of a nuclear device in August 1949. This occurred before it was expected and caused a secret Government debate over whether to develop a hydrogen, or "super," bomb. Truman concluded the debate during January 1950, when he ordered the AEC to build the super bomb, whose explosive power promised a "quantum jump" over atomic bombs. To produce the tritium required for the hydrogen bomb program, the AEC built a new production reactor facility near Aiken, SC, known as the Savannah River plant. In response to debates over the adequacy of the scientific resources devoted to hydrogen weapons development, the AEC also built a second weapons research laboratory at Livermore, CA, which, like Los Alamos, was administered by the University of California.

The Cold War spurred other AEC activities, including those related to radiological warfare. Unlike atomic bombs, which achieve their destructive power from explosive effect, radiological warfare would cause damage by the direct dispersal of radioactive material on a targeted area. By 1951, the agency had concluded that the limitations of such weapons outweighed their usefulness; this decision was based partially on field tests. Cold War competition with the Soviet Union also contributed to the agency's decision to conduct the Green Run test at Hanford in 1949. The Green Run, occurring soon after the first Soviet atomic detonation, was an intentional release of radioactive material to test methods for monitoring the Soviet nuclear program.

The Korean War

International tensions increased when the Korean War broke out in June 1950. This conflict spurred the first deployment of nuclear weapons overseas, vast expansion of AEC production facilities, and establishment of a continental nuclear weapons testing facility at the Nevada Test Site. By the mid-1950s, the AEC operated 13 nuclear production reactors and 12 gaseous diffusion plants for producing fissionable uranium. Both the Hanford and Oak Ridge plants were enlarged and new production complexes were constructed at Paducah, KY, and Portsmouth, OH.

The Hydrogen Bomb

The Korean war ended in July 1953, but the AEC's intensive programs to refine nuclear weapons continued. Atmospheric nuclear tests were conducted in Nevada during 1951, 1952, 1953, 1955, 1957, and 1958; and at the Pacific proving grounds during 1951, 1952, 1954, 1956, and 1958. The most important tests were the Castle series of 1954, which took place in the Pacific. Soon after the series, the AEC possessed a hydrogen weapon and a new plan to produce mass quantities of a few weapons types. Bravo, the first Castle shot, also ultimately affected agency biomedical programs.

The Cold War spurred other AEC activities, including those related to radiological warfare.

Los Alamos scientists fired the Bravo shot during March 1954. The blast size and amount of radioactive fallout were far greater than planned for: Bravo fallout contaminated 7,000 square miles, some of it with very high radiation. Fallout descended upon the military and scientific task force conducting the test series, Marshallese islanders, and the crew of a Japanese fishing vessel, the Lucky Dragon.

The Test Ban Debate

These fallout incidents, combined with the large number of atmospheric weapons tests conducted by both the United States and the Soviet Union, sparked public debate in the United States over a proposed test ban. A closely related debate also followed over the health hazards posed to the public by atmospheric nuclear testing. AEC assertions that fallout posed little threat to Americans were challenged, and public controversy raged until President Kennedy signed a limited test-ban agreement with the Soviet Union in August 1963. The treaty prohibited testing in the atmosphere, underwater, and in outer space.

The Impact of the Fallout Controversy

The fallout debate had caught the AEC unprepared and the Division of Biology and Medicine in a difficult position. Biomedical research into the hazards of fallout would take years to bear fruit, yet there was an urgent demand for information. To provide answers, the division gathered data from all relevant ongoing research projects, including one called Project Sunshine. This project had begun as an evaluation of the hazards associated with nuclear war and grew into a worldwide investigation of radioactive fallout levels in the environment and in human beings. Work in this area included collecting human tissues and samples of plants and animals from around the world.

Figure 13. A Brookhaven technician demonstrating fast-neutron detection equipment.

The fallout controversy compelled the AEC to focus more attention on questions related to public protection. It also gave greater public visibility to AEC biomedical research. The Joint Committee on Atomic Energy pushed the agency to place greater resources into investigating the health effects of fallout. As a result, in 1958, the AEC nearly doubled its prior level of spending on biomedical programs over a 5-year period.

The director of the Division of Biology and Medicine, Charles Dunham, stated that this effort would require "studies on human subjects," because data from animal experiments could not be applied directly to human experience. Dunham stated that human experiments were safe because of technical advances that allowed the use of radioactivity in very small amounts. These experiments required special equipment found in hospitals or large medical centers. Dunham urged the agency to expand its contractual support for human experiments at such institutions and increase funding for work in AEC-owned clinical facilities. The director of the Division of Biology and Medicine stated that this effort would require "studies on human subjects," because data from animal experiments could not be applied directly to human experience. During the 1950s, AEC contractor researchers participated in work in which subjects were injected with small amounts of radioactive strontium, calcium, or other substances to help determine the efficiency of chelating agents in removing radiation from the body. The fallout controversy imparted greater urgency to other AEC-sponsored research efforts to learn about human retention and excretion of radioactive materials. In the 1960s, the agency conducted tests in which human subjects were exposed to environmental releases of radioiodine to provide data on its absorption by the human body.

The AEC in Transition

By the time the United States signed the Limited Test Ban Treaty in 1963, the AEC's production and research efforts had created a nuclear weapons stockpile that met the military's needs. Accordingly, President Johnson in 1964 instructed the AEC to reduce production activities. This resulted in the gradual shutdown of eight Hanford production reactors, two Savannah River production reactors, and two Oak Ridge gaseous diffusion plants. The remaining gaseous diffusion plants were run at a reduced rate. Weapons research did not cease, but both the Los Alamos and the Livermore Laboratories diversified some of their effort into other activities. Nuclear weapon testing, although now performed underground, continued at a steady pace. The AEC reached a crossroads in 1963. Up to that time, the problems of the military atom had commanded the most time, attention, and energy from agency leaders. Over the next 10 years, the problems of the peaceful atom drew increasing negative attention to the AEC.

Atoms for Peace

Always anxious to promote the peaceful atom, the AEC was unable to do so effectively until after Congress amended the Atomic Energy Act in 1954. The 1954 Act encouraged private participation in atomic energy development, giving the AEC authority to remove entire topical areas of nuclear science and technology from secrecy restrictions. This law permitted the agency to foster a commercial nuclear power industry and to participate in international peaceful atomic energy activities. Both meshed with President Eisenhower's desire to reap practical benefits from America's lead in nuclear technology. Eisenhower proposed atomic energy development under United Nations auspices in his heralded "Atoms for Peace" speech. As a result, the AEC actively participated in the creation of the International Atomic Energy Agency, helped build research reactors abroad and, over a 10-year period, helped to organize three international peaceful atomic energy conferences in Geneva, Switzerland.

The 1954 Act gave the Atomic Energy Commission authority to remove entire topical areas of nuclear science and technology from secrecy restrictions.

At home, the AEC also promoted potential peaceful atomic energy applications. Among them were medical uses of radioactive tracers, fusion research, nuclear-powered rockets, nuclear batteries, and nuclear canal excavation. Many of these ambitious ideas never came to fruition. The largest single effort, however, was the push to develop a commercial nuclear power infrastructure.

Building a Commercial Nuclear Power Industry

In 1955, the AEC launched the Power Demonstration Reactor Program, designed to transform nuclear reactors into commercial electric power generators. Offering private industry financial and other assistance to design and build power reactors, the AEC attracted cooperation in building first-generation experimental power reactors, all of which were more expensive than comparable fossil-fuel-fired electric generating plants. In the expectation that power reactors would soon become economically competitive and that the utility industry would invest heavily in the new technology, the agency geared up its staff to license private utilities to construct and operate nuclear power reactors, a mission mandated by the 1954 Atomic Energy Act.
 
By 1965, however, the program was languishing. Only 12 power reactors were then in operation in the country, and of those, industry had built only three with wholly private funds. All others had required substantial governmental financial assistance to attract industry participation. The goal of making reactors economically competitive with fossil-fuel-fired power plants had not yet been realized, 10 years after initiation of the program. In 1966 1967, however, industry suddenly ordered 50 nuclear power plants, and commercial nuclear power continued to grow robustly for another decade.

The AEC and Human Radiation Experiments, 1960 1970s

As the AEC devoted more time to the peaceful atom, its biomedical research program continued along lines set earlier. This included substantial research into fallout and the occupational hazards of atomic energy. During the 1960s, the Division of Biology and Medicine gradually devoted greater resources to the hazards of the peaceful atom. Some of this research involved human radiation experiments.

[Figure 14. Brookhaven Low-level Whole Body Counting Facility (circa 1968)]

In the 1960s and 1970s, researchers in AEC-owned and private facilities expanded into new areas. The AEC funded experimentation in which prisoners in Oregon and Washington were  administered radiation from x rays to obtain data on radiation effects upon testicular cells. Contractor researchers used particle accelerator beams and total body neutron activation analysis in other human radiation experiments.

Radioisotopes and Nuclear Medicine

The direct applications of nuclear science and technology to medicine grew rapidly after World War II. By the early 1960s, the Government had made one-half million shipments of radioisotopes to physicians and other users. Nuclear medicine had become an accepted field of specialty and most human radiation experimentation was, in fact, being conducted by private physicians and private hospitals. The agency placed radioisotope licensing activities under its regulatory staff. All other radioisotope programs were the responsibility of officials charged with overseeing promotional activities.

The Atomic Energy Commission funded experimentation in which prisoners in Oregon and Washington were administered radiation from x rays to obtain data on radiation effects upon testicular cells.

Biomedical Research and Institutional Decision Making

By the 1960s, the Division of Biology and Medicine had systematized a decision-making process for biomedical research projects and proposals, including those which involved human subject research. The Division of Biology and Medicine approved most biomedical research through an annual budget cycle. Proposals for new research originated with doctors and scientists in AEC contractor laboratories or in AEC-funded university research projects. The proposals were drafted on a Proposal and Authorization for Research or Development form, also known as Form 189, which contained project descriptions, justifications, and cost estimates. After laboratory directors and university project leaders approved them, completed Form 189s were forwarded to the Division of Biology and Medicine, where they were reviewed by the branch chief who oversaw research in that discipline. Costs were then rolled into a consolidated division budget request. At that level, individual projects were no longer identified.

By 1970, the Atomic Energy Commission encouraged its sites to form institutional review boards to review human subject research projects.

When the division director and his senior managers approved the consolidated budget and the research that it would fund, the budget went to the AEC general manager and commissioners for approval. Approval at this stage was given for spending levels, not for individual research projects, or even for groups of them. By approving the Division of Biology and Medicine budget, and incorporating it into the agency budget submitted to Congress, the AEC general manager and commissioners authorized the biomedical research that it would fund.

The agency used the Advisory Committee on Biology and Medicine to provide advice on general biomedical research and health policies and programs. Except for a short period in the early years of the agency, the committee did not review individual research projects. Although the committee in theory presented its recommendations to the AEC commissioners, in practice the committee functioned as an advisor to the division director.

Occasionally, the agency did consider biomedical research programs or projects outside the budget review process. This was generally limited to programs or projects considered controversial or unusually expensive. For these projects, the division director would incorporate project proposals and recommendations into an agency decision paper and seek approval of the paper through the agency's formal policy decision process.

The AEC and Subject Consent, 1960s 1970s

The U.S. National Institutes of Health (NIH) adopted formal guidelines for the protection of human subjects in 1966. The Division of Biology and Medicine informed AEC facilities of this and some sites chose to apply elements of the guidelines, although there was not yet a requirement to do so. By 1970, the AEC encouraged its sites to form institutional review boards to review human subject research projects. The NIH guidelines required informed consent from subjects before experimentation and required that subjects be told that they could withdraw consent to experimentation at any time. Many local institutional review boards formed at AEC laboratories did require written consent from subjects.

Controversies Over Radioactive Effluents, Thermal Pollution, and Reactor Safety

The quieting of the fallout issue caused by the cessation of atmospheric nuclear testing in 1963 did not end the debate over the health effects of radiation. By the late 1960s, issues were raised about the potential environmental impacts of radioactive emissions from nuclear power plants. The agency maintained, however, that its authority did not extend to environmental impacts. The AEC was eventually directed by court order to consider the full range of environmental impacts of nuclear power plants during the licensing process. Compelled by this decision to strengthen its environmental assessment capability, the agency renamed the Division of Biology and Medicine the Division of Biomedical and Environmental Research and channeled more funds and scientific effort into environmental research.

Another public controversy erupted during the early 1970s, again over nuclear power plants. Critics charged that plant safety devices would not prevent a catastrophic meltdown of a nuclear reactor core, which could spread radioactive contamination over hundreds of square miles. The AEC was unable to provide conclusive proof of the adequacy of safety systems. A formal hearing on this subject gave national publicity to critics of the agency, raised significant questions about nuclear reactor safety, and revealed that the AEC had been less than forthcoming about reactor safety problems.

By 1973, the AEC was severely buffeted by controversy. Critics asserted that the agency had sacrificed its responsibility to regulate the atom in the public interest to its desire to promote nuclear science and technology. Many charged that the agency faced an inherent conflict of interest between its roles of regulating and promoting the atom. Sentiment grew for abolishing the agency and vesting protection of public safety in an independent regulatory agency.

Impact of the Energy Crisis

The AEC faced credibility problems as the country faced an energy crisis. Energy problems had started with the northeast power blackout of 1965, which had interrupted electric power for nearly 30 million people. Over the next 2 years, 20 other major power failures occurred across the nation. By decade's end, many sensed that an energy crisis was approaching and expected greater Federal action to solve the problem. The oil embargo of 1973 1974 deepened the sense of crisis.

[Figure 15. patient prepared for treatment with charge atomic particles at lawrence Radiation Laboratory (now Lawrence Berkeley Laboratory)]

One result of the energy crisis was a movement to unify scattered Federal energy programs under a single organization. In 1973, President Nixon unsuccessfully proposed a Department of Energy and Natural Resources. Then, in late 1974, Congress passed the Energy Reorganization Act of 1974, which abolished the AEC and established the Energy Research and Development Administration (ERDA), a single energy research agency, and another agency, the Nuclear Regulatory Commission, which was given the AEC's regulatory functions. ERDA also inherited the nuclear development and weapons-related programs of the AEC.

The Energy Research and Development Administration

ERDA had a much broader energy mission than did the AEC. The new agency conducted energy research and development in wind, solar, geothermal, and fossil-fuel energy technologies as well as nuclear energy technologies. ERDA also began comprehensive Federal energy research and development planning, publishing annual research and development plans. In addition, the agency created a new solar energy research institute. The bulk of ERDA's facilities, personnel, and contractors, however, came from the AEC.

In 1974, the Government adopted uniform regulations requiring independent institutional review boards to approve all experiments and requiring written informed consent.

ERDA inherited the AEC biomedical research programs, facilities, and its Division of Biomedical and Environmental Research, as well as its weapons research and production missions. In 1974, the Government adopted uniform regulations for all Federal agencies involved in human experimentation, including ERDA. These regulations required independent institutional review boards to approve all experiments before they took place. All subjects also had to provide written evidence of informed consent.

The most controversial biomedical problem ERDA inherited involved the wartime plutonium injection experiments. By now, documents related to the experiments had been declassified, although knowledge about them was largely confined to biomedical circles. In 1967, Patricia Durbin, a radiobiologist at the Lawrence Radiation Laboratory, learned that several patients injected in 1945 were still alive. She urged that the AEC examine them to obtain additional data about the retention and excretion of plutonium.

The University of Rochester, which still operated under an AEC biomedical research contract, was authorized in 1973 to conduct medical examinations of three of the four surviving subjects. While official agency policy mandated full disclosure, the three were not told that they had been injected with plutonium nor was the reason for their reexamination revealed. After learning of this, the AEC commissioners ordered an investigation and directed that full disclosure be made to the subjects. The AEC did not, however, reveal the experiments to the public. ERDA officials later published detailed information about the experiments in 1976.

The U.S. Department of Energy

ERDA had little time to build energy research and development programs. The perceptions that the Nation was in an energy crisis deepened, fueled by a natural gas shortage that closed plants, businesses, and schools in New England during the severe winter of 1976 1977. Spurred by the crisis, President Carter sent a proposal to Congress in 1977 to unify Federal energy policy planning and research and development units in one Cabinet-level department. Congress acted on the proposal promptly, and the Department of Energy (DOE) came into existence in October 1977.

The Department of Energy absorbed the Federal Power Commission, the Federal Energy Administration, and other smaller energy programs as well as all ERDA facilities, laboratories, production plants, and its division of biomedical and environmental research. The Department also became responsible for nuclear and other energy technology development, for nuclear weapons development, and for energy-related biomedical and environmental research, including human radiation experimentation activities. DOE inherited ERDA's radiation research activities and the regulations that the agency had promulgated to protect human subjects. Biomedical research activities were assigned to the office of energy research. By this time, predecessor agencies had established a legacy of research in biomedical research, including human radiation experiments.

Headquarters Records Collections

DOE headquarters records are rich and comparatively easy to find and use. The Department has custody of most AEC and ERDA headquarters records, while nearly all Manhattan Project headquarters records have been transferred to the National Archives and Records Administration. AEC records are extraordinarily valuable, covering agency activities in a breadth and depth seldom found in government records collections. All records for AEC regulatory activities are in the custody of the Nuclear Regulatory Commission.

For material pertinent to human radiation experiments, the records of the AEC Secretary (1958 1975) and of its Division of Biology and Medicine are the most valuable. Both document AEC decision-making on biomedical issues and agency oversight over biomedical programs. Beyond the institutional context of human radiation experiments, both collections contain some documentation about individual clinical experiments and both contain crucial documentation about the AEC's 1974 investigation of the plutonium injection experiments.

Most AEC headquarters records are in the custody of archivists or historians and are preserved either in the DOE History Division or Office of Human Radiation Experiments. Recently DOE has transferred some important AEC records to the National Archives, including portions of the AEC Secretary's files (1946 1958) and of the Division of Biology and Medicine files. DOE will transfer additional AEC records to the National Archives in the future. More recent records are in the custody of DOE program offices and are, at this time, more difficult to access. The agency is, however, working to bring these records under intellectual control.

There are limitations on documentary access due to classification and privacy. Although most AEC biomedical program data including information about human radiation experiments was never classified, it may be intermixed with other information or documents which were, or are, classified. DOE has recently devoted substantial resources to declassifying AEC records, but researchers may still encounter classified headquarters documentation. Researchers may request declassification reviews of collections, or portions of them. Few headquarters records have privacy restrictions. Researchers can also request that such documents be released to them, with the deletion of information which would identify individuals.

Department of Energy headquarters records are rich and comparatively easy to find and use.

AEC headquarters records are divided between National Archives and DOE custody. Because some AEC headquarters units operated out of Oak Ridge in the agency's early days, some AEC headquarters records are stored in Oak Ridge in DOE custody or in Atlanta in National Archives custody. The series described in the portion of Chapter 2 dealing with Oak Ridge, contain some headquarters records.