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ACHRE Report

Final Report

Executive Summary

Preface

Introduction

Part I

Part II

Part III

Discussion: Part III

Part IV

Part II: Overview

When we began our work, the Advisory Committee was aware of several dozen human radiation experiments and the thirteen intentional releases in our charter. Soon, however, we found that these represented a fraction of the several thousand government-sponsored human radiation experiments and hundreds of intentional releases conducted from 1944 to 1974.

It was clear that the Committee would have to decide how to proceed in examining the experiments. Our ability to review all of the experiments and releases in detail was limited not only by time and resources, but even more so by the information available. For the majority of experiments identified, only the barest descriptions remained. It appeared that the vast majority of experiments involved trace amounts of radioisotopes, as are routinely used today for the study of bodily processes and the diagnosis of disease. However, where reports or other data were available, they did not routinely provide information needed to assess the precise risks to which subjects were exposed. These reports were even less likely to identify what kinds of people were chosen as subjects and why and how they were selected.

Since the Committee could not review all experiments, we decided to prepare a series of case studies focused on groups of experiments. We quickly found that there was no one right way to organize the experiments for purpose of case study. For example, the case studies could have been defined by the type of radiation to which subjects were exposed. This would likely have yielded groupings of experiments with differing purposes, differing populations, and differing risks and benefits. Likewise, grouping all experiments according to the characteristics of the people who were the subjects of the research would have lumped together experiments with differing purposes, risks, and scientific procedures.


The ACHRE Experiments Database

By Cabinet directive on January 19, 1994, federal agencies were ordered to "establish forthwith an initial procedure for locating records of human radiation experiments conducted by the Agency or under a contract or grant of the Agency." The agencies most closely associated with these activities--the DOD, DOE, DHHS, NASA, CIA, and VA (and later the NRC)--in cooperation with Advisory Committee staff, identified record collections of importance and provided ACHRE with copies of documents potentially containing information on human radiation experiments. The documents were analyzed to identify individual experiments, which were then described according to a protocol developed by ACHRE members and staff, given unique identifiers, and recorded in an electronic database. Experiments were also identified by Advisory Committee staff in the published literature, discovered through a search of the National Library of Medicine databases and bibliographies, and documented by individuals who came forward with information for the Advisory Committee.

The database contains records for approximately 4,000 human radiation experiments. Information was collected, to the extent it was available, on the identity of the experiment (including investigators, location, dates, title, and documentation); funding, program approval and classification; the type and dose of radiation used; various characteristics of the experimental subjects; and the nature of the consent obtained. The experiments were in addition categorized by various themes and characteristics developed by Advisory Committee members and staff to reflect ACHRE research interests.

Documentation for individual experiments varies widely, sometimes including significant primary protocol documentation, often including only a journal article or abstract and, for the greatest number, just an investigator's name, a location, a date, and a title. As a result, although the database and the records it abstracts constitute an impressive and unique collection of information on human radiation experiments, that collection is not a comprehensive information resource on human radiation experiments but really just the best place to start to look for information.

The supplemental volume titled Sources and Documentation contains a more extensive and detailed description of the database and its sources.


After extensive deliberation, the Committee settled on eight case studies, which together address the charges to and priorities of the Committee. For example, we were charged to consider both intentional releases of radiation into the environment and the question of whether any former subjects of human radiation experiments would benefit medically from notification of their involvement. In addition, the Committee saw a responsibility to address those experiments that had received significant public attention at the time of the Committee's creation as well as those brought to our attention by members of the public. These experiments either offered no prospect of medical benefit to subjects or they involved interventions alleged to be controversial at the time. We also, however, recognized the importance of considering the far larger group of experiments that received no such attention but that also may have involved no prospect of benefit to subjects. We also placed a priority on experiments that were conducted on behalf of secret programs and for national security reasons; experiments that posed the greatest risk of harm; and experiments in which the subjects selected for experimentation were particularly powerless to resist or exercise independent judgment about participation. Together, these considerations formed the basis for the selection of the case studies.

In chapter 5, we look at the Manhattan Project plutonium-injection experiments and related experimentation. Sick patients were used in sometimes secret experimentation to develop data needed to protect the health and safety of nuclear weapons workers. The experiments raise questions of the use of sick patients for purposes that are not of benefit to them, the role of national security in permitting conduct that might not otherwise be justified, and the use of secrecy for the purpose of protecting the government from embarrassment and potential liability.

In contrast to the plutonium injections, the vast majority of human radiation experiments were not conducted in secret. Indeed, the use of radioisotopes in biomedical research was publicly and actively promoted by the Atomic Energy Commission. Among the several thousand experiments about which little information is currently available, most fall into this category. The Committee adopted a two-pronged strategy to study this phenomenon. In chapter 6, we describe the system the AEC developed for the distribution of isotopes to be used in human research. This system was the primary provider of the source material for human experimentation in the postwar period. In studying the operation of the radioisotope distribution system, and the related "human use" committees at local institutions, we sought to learn the ground rules that governed the conduct of the majority of human radiation experiments, most of which have received little or no public attention. Also in this chapter we review how research with radioisotopes has contributed to advances in medicine.

The Committee then selected for particular consideration, in chapter 7, radioisotope research that used children as subjects. We determined to focus on children for several reasons. First, at low levels of radiation exposure, children are at greater risk of harm than adults. Second, children were the most appropriate group in which to pursue the Committee's mandate with respect to notification of former subjects for medical reasons. They are the group most likely to have been harmed by their participation in research, and they are more likely than other former subjects still to be alive. Third, when the Committee considered how best to study subject populations that were most likely to be exploited because of their relative dependency or powerlessness, children were the only subjects who could readily be identified in the meager documentation available. By contrast, characteristics such as gender, ethnicity, and social class were rarely noted in research reports of the day.

Moving from case studies focused on the injection or ingestion of radioisotopes, chapter 8 shifts to experimentation in which sick patients were subjected to externally administered total-body irradiation (TBI). The Committee discovered that the highly publicized TBI experiments conducted at the University of Cincinnati were only the last of a series in which the government sought to use data from patients undergoing TBI treatment to gain information for nuclear weapons development and use. This experimentation spanned the period from World War II to the early 1970s, during which the ethics of experimentation became increasingly subject to public debate and government regulation. In contrast with the experiments that flowed from the AEC's radioisotope program, the use of external radiation such as TBI did not in its earlier years involve a government requirement of prior review for risk. The TBI experimentation raises basic questions about the responsibility of the government when it seeks to gather research data in conjunction with medical interventions of debatable benefit to sick patients.

In chapter 9 we examine experimentation on healthy subjects, specifically prisoners, for the purpose of learning the effects of external irradiation on the testes, such as might be experienced by astronauts in space. The prisoner experiments were studied because they received significant public attention and because a literally captive population was chosen to bear risks to which no other group of experimental subjects had been exposed or has been exposed since. This research took place during a period in which the once-commonly accepted practice of nontherapeutic experimentation on prisoners was increasingly subject to public criticism and moral outrage.

Chapter 10 also explores research involving healthy subjects: human experimentation conducted in conjunction with atomic bomb tests. More than 200,000 service personnel--now known as atomic veterans--participated at atomic bomb test sites, mostly for training and test-management purposes. A small number also were used as subjects of experimentation. The Committee heard from many atomic veterans and their family members who were concerned about both the long-term health effects of these exposures and the government's conduct. This case study provided the opportunity to examine the meaning of human experimentation in an occupational setting where risk is the norm.

In chapter 11 we address the thirteen intentional releases of radiation into the environment specified in the Committee's charter, as well as additional releases identified during the life of the Committee. In contrast with biomedical experimentation, individuals and communities were not typically the subject of study in these intentional releases. Rather, the releases were to test intelligence equipment, the potential of radiological warfare, and the mechanism of the atomic bomb. While the risk posed by intentional releases was relatively small, the releases often took place in secret and remained secret for years.

The final case study, in chapter 12, looks at two groups that were put at risk by nuclear weapons development and testing programs and as a consequence became the subjects of observational research: workers who mined uranium for the Atomic Energy Commission in the western United States from the 1940s to 1960s and residents of the Marshall Islands, whose Pacific homeland was irradiated as a consequence of a hydrogen bomb test in 1954. While these observational studies do not fit the classic definition of an experiment, in which the investigator controls the variable under study (in this case radiation exposure), they are instances of research involving human subjects. The Committee elected to examine the experiences of the uranium miners and Marshallese because they raise important issues in the ethics of human research not illustrated in the previous case studies and because numerous public witnesses impressed on the Committee the significance of the lessons to be learned from their histories.

Part II concludes with an exploration of an important theme common to many of the case studies--openness and secrecy in the government's conduct concerning human radiation research and intentional releases. In chapter 13 we step back and look at what rules governed what the public was told about the topics under the Committee's purview, whether these rules were publicly known, and whether they were followed.

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