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ACHRE Report

Part III

Chapter 17

Findings 1-7

Findings 8-14

Findings 15-23

Chapter 17: Findings 8-14

Finding 8

The Committee finds that for the period 1944 to 1974 there is no evidence that any government statement or policy on research involving human subjects contained a provision permitting a waiver of consent requirements for national security reasons.

Neither the AEC nor the DOD included national security exceptions in their written rules on human subjects research. For example, the 1953 Wilson memorandum adopting the Nuremberg Code was expressly applicable to human experimentation related to atomic, biological, and chemical warfare and did not provide for any "national security" exception.

The Committee notes that much documentation related to the CIA's program of secret experimentation, including MKULTRA, has long since been destroyed, and, therefore, we cannot state with certainty what policy(ies) underlay human experiments in these programs or whether such policies included national security exceptions.

Finding 9

9a. The Advisory Committee finds that government agencies had no requirements or policies to ensure equity in the selection of subjects for research conducted or funded by the federal government during the period 1944 through 1974.

The only reference during this period to issues of equity in the selection of subjects in agency documents reviewed by the Advisory Committee is in an influential DHEW guide to recipients of federal research funds published in 1971, popularly known as the Yellow Book. The Yellow Book notes a "particular concern" about research involving "groups with limited civil freedom."

9b. Because of the limited data available on the universe of experiments identified by the Committee, the Committee was unable to determine whether during the period 1944 through 1974 people who were socially disadvantaged were more likely than more socially advantaged people to be used as subjects in human radiation experiments generally or in those experiments that offered no prospect of medical benefit or posed greater risks. The Advisory Committee finds, however, that some of the biomedical experiments reviewed by the Committee that were ethically troubling were conducted on institutionalized children, seriously ill and sometimes comatose patients, African-Americans, and prisoners.

The Committee was troubled by the selection of subjects in many of the experiments we reviewed. These subjects often were drawn from relatively powerless, easily exploited groups, and many of them were hospitalized patients. As noted in Finding 9a, there were during this period no federal rules or policies directed at fairness in the selection of research subjects, and no norms or practices within the biomedical research community specifically addressing considerations of fairness. This silence on questions of justice in the conduct of human research was characteristic not only of radiation research but also of the entire research enterprise. While we note here cases that provoked concern, we were unable to determine the extent to which there were systemic injustices in the selection of research subjects in human radiation research because in most cases we were unable to determine any of the characteristics of the subjects involved in the experiments we catalogued.

Finding 10

The Advisory Committee finds that even as early as 1944 it was conventional for physicians and other biomedical scientists to obtain consent from healthy subjects of research. By contrast, during the 1944-1974 period but especially through the early 1960s, physicians engaged in clinical research generally did not obtain consent from patient-subjects for whom the research was intended to offer a prospect of medical benefit. Even where there was no such prospect, it was common for physicians to conduct research on patients without their consent. It also was common, however, for physicians to be concerned about risk in conducting research on patient-subjects and, in the absence of a prospect of offsetting medical benefit, to restrict research uses of patients to what were considered low- or minimal-risk interventions.

Perhaps the best-known example of the use of informed volunteers in research conducted at the turn of the century is the yellow fever research by military scientist Walter Reed. In the Advisory Committee's Ethics Oral History Project, several of Reed's military successors who were active in the 1940s and 1950s gave similar examples of voluntary consent from healthy subjects in the context of work on typhus and malaria. In 1946, the American Medical Association (AMA) articulated the principle that human subjects must give "voluntary consent." In 1947, the prosecution's expert witness at the Nuremberg Medical Trial, Dr. Andrew Ivy, who had helped shape the AMA principle in conjunction with his role at Nuremberg, asserted that this was a standard by which physicians were guided in the use of human beings in medical experiments and that this standard was in "common practice" prior to its articulation by the AMA in 1946. Precisely what Ivy meant by this claim is unclear. Although there are doubtless instances in which this standard of voluntary consent was not followed, it does seem to have been widely recognized and adhered to among investigators whose research involved healthy subjects.

By contrast, various sources confirm that it was not conventional to obtain consent from patient-subjects. These sources include documents from the period in which the conduct of clinical research was discussed as well as the Committee's Ethics Oral History Project, in which physicians active in research in the 1940s and 1950s agreed that consent played little or no role in research with patient-subjects, even where there was no expectation that the patient would benefit medically from the research. At the same time, however, there was also agreement that, where patients were used as subjects in nontherapeutic research, the research usually posed little or no risk to the patients.

Finding 11

11a. The Advisory Committee finds that the government and government officials are morally responsible in cases in which they did not take effective measures to implement the government's policies and requirements, and the medical profession and biomedical scientists are morally responsible for instances in which they failed to adhere to the professional norms and practices of the time.

The Advisory Committee was concerned that our conclusions about actions taken in the past be rendered fairly. Clearly, if government agencies had rules or requirements for the use of human subjects at the time, and if these requirements were sound from our point of view and consistent with basic moral principles, then agencies and agency officials had just as much moral responsibility to implement those requirements as those in analogous positions would have today, or in any day, with respect to current sound government requirements.[1] We have found that some government agencies did in fact have such requirements (see Findings 4 and 6).

Similarly, if the medical profession and the research community generally had recognized norms and practices for the conduct of research with human subjects, and if these norms and practices were sound, then physician-investigators and other scientists operating in the past had just as much responsibility to adhere to those norms and practices as those in analogous positions would have today with respect to current norms and practices that are morally sound. The Committee found evidence that the medical profession had such norms with respect to obtaining consent from healthy subjects, although physicians engaged in clinical research did not generally seek consent from patient-subjects. The Committee also found evidence of professional norms concerning acceptability of risk to subjects (see Finding 10).

11b. The Advisory Committee finds that by today's standards we consider it wrong that our government did not take effective measures to adequately protect the rights and interests of all human subjects of research. We also find that by today's standards we consider it wrong that medical and other professions engaged in human research did not have norms and practices of consent for all subjects of research.

There is today a well-established consensus about the basic principles that should govern the use of human subjects of research. There is also wide agreement that the government has an obligation to protect the rights and interests of all human research subjects and that the medical and other professions engaged in research are obligated to have norms and practices of consent for all human subjects of research. The failure to have such conditions in place would today be considered wrong.

11c. The Advisory Committee finds that government officials and investigators are blameworthy for not having had policies and practices in place to protect the rights and interests of human subjects who were used in research from which the subjects could not possibly derive medical benefits (nontherapeutic research in the strict sense). By contrast, to the extent that there was reason to believe that research might provide a direct medical benefit to subjects, government officials and biomedical professionals are less blameworthy for not having had such protections and practices.

We also find that, to the extent that research was thought to pose significant risk, government officials and investigators are more blameworthy for not having had such protections and practices in place. By contrast, to the extent that research was thought to pose little or no risk, government officials and biomedical professionals are less blameworthy for not having had such protections and practices.

Today we consider policies and practices to protect the rights and interests of human subjects to be as important in research that offers participants a prospect of medical benefit as in research that does not. Government regulations and the rules of professional and research ethics apply equally to both kinds of research. In the 1940s, 1950s, and 1960s, however, patients and society generally accorded doctors more authority to make decisions for their patients than they do today. It was both commonplace and considered appropriate for a physician to determine what treatments a patient should receive without necessarily consulting the patient, provided that the decision was based on the physician's judgment about what would be in the patient's best interest. This authority generally extended to decisions about whether a patient's interest would be served by being a subject in medical research. Judgments about the blameworthiness of officials and physician-investigators for not having had policies and practices to protect the rights of human subjects in research that offered a prospect of medical benefit, such as requirements of consent, are mitigated by this historical context.

However, even at the time, government officials and biomedical professionals should have recognized that when research offers no prospect of medical benefit, whether subjects are healthy or sick, research should not proceed without the person's consent. It should have been recognized that despite the significant decision-making authority ceded to the physician within the doctor-patient relationship, this authority did not extend to procedures conducted solely to advance science without a prospect of offsetting benefit to the person. This finding is supported by the moral principle, deeply embedded in the American experience, that individuals may not be used as mere means toward the ends of others. We also note that at its 1947 beginning, officials of and biomedical advisers to the AEC were clearly aware of the issues raised when patients, as well as healthy people, were used as subjects in nontherapeutic research without their consent.

The Advisory Committee has also determined that government officials and scientific investigators at the time recognized that research could put subjects at risk of harm, that they had an obligation to determine that the risks imposed were reasonable, and that research that posed greater or more uncertain risks was more problematic than research whose risks were lower. Sometimes government officials and investigators took steps to protect subjects from unnecessary or unacceptable risks. These steps included in some cases a requirement of group review of research proposals and the obtaining of consent of the subjects, particularly where risks were considered worrisome. But these steps were not consistently or uniformly taken.

Population Exposures

Finding 12

The Advisory Committee finds that some service personnel were used in human experiments in connection with tests of atomic bombs. The Committee finds that such personnel were typically exposed to no greater risks than the far greater number of service personnel engaged in similar activities for training or other purposes. The Committee further finds that there is little evidence that the 1953 secretary of defense Nuremberg Code memorandum was transmitted to those involved with human experiments conducted in conjunction with atomic testing. However, some of the requirements contained in the memorandum were implemented in the case of a few experiments, apparently independently of the memorandum. The Committee also finds that the government did not create or maintain adequate records for both experimental and nonexperimental participants.

More than 200,000 service personnel participated in nuclear weapons tests from 1946 to the early 1960s. The vast majority of those who participated were engaged in management of the tests, training maneuvers, or data-gathering activities. In the range of 2,000 to 3,000 of these participants were research subjects. In many cases these research subjects engaged in activities, and were subjected to risks, essentially identical to those engaged in by many more people who were not research subjects. The purpose of this human subject research was not to measure the biological effects of radiation. Rather, for example, researchers sought to measure the psychological and physiological effects of participation in bomb tests, the levels of radiation to which individuals who flew in and around atomic clouds were exposed, and the effects of intense light from the bomb blast on the eyes.

The Advisory Committee found little evidence that the 1953 Wilson memorandum on human experimentation in connection with atomic, biological, and chemical warfare (or an Army implementing document) was transmitted to those involved in bomb-test-related experimentation. In interviews with Committee staff, some of those involved in the experimentation stated that they were unaware of the memorandum. However, there is evidence that in some of the experiments consent was provided for, but this was likely independent of the 1953 policy.

The military took successful precautions against exposure to radiation levels that were likely to produce acute effects. However, bomb-test participants were exposed to lower levels of radiation, which might conceivably have effects on some participants over the longer term. The evidence shows that those who managed the tests were aware of the potential, however small, that injury might result years later from such exposures. In recent years, as the government and veterans have sought to reconstruct the extent of exposure and resulting injury, it has become apparent that the government did not uniformly create records that would permit all individuals to efficiently and confidently know the extent of their exposure, did not create records that would permit reconstruction of the identity and location of all those who participated at the tests, did not adequately undertake to link medical and exposure records, and did not adequately maintain those records that were initially created.

Finding 13

The Advisory Committee finds that during the 1944-1974 period the government intentionally released radiation into the environment for research purposes on several hundred occasions. In only a very few of these cases was radiation released for the purpose of studying its effect on humans.

The Advisory Committee's charter identified thirteen releases: one related to the testing of intelligence equipment (the "Green Run"), eight radiological warfare tests, and four releases of radioactive lanthanum ("RaLa") to test the mechanism of the atomic bomb. The Advisory Committee received information on more than sixty radiological warfare releases that took place in the period 1949-1952 and on the nearly 250 RaLa releases that took place in the period 1944-1961. We identified further intentional releases of a kind that were not described in the charter. These included the release of radiation to study its environmental pathways and the release of radiation in connection with outdoor safety tests and tests related to the development of nuclear reactors, as well as to the development of nuclear-powered rockets and airplanes.

Most releases took place in and around the sites that constitute the nation's nuclear weapons complex, notably Oak Ridge, Tennessee; Hanford, Washington; Los Alamos, New Mexico; the Nevada nuclear weapons test site; and the Idaho National Engineering Laboratory. Releases related to radiological warfare tests took place primarily at the Dugway Proving Ground in Utah. Radioactive material was also released into the environment for research purposes at other locations; for example, fallout from the Nevada Test Site was inserted into the tundra of Alaska.

Finding 14

The Advisory Committee finds that for both the Green Run (at Hanford) and the RaLa tests (at Los Alamos), where dose reconstructions have been undertaken, it is unlikely that members of the public were directly harmed solely as a consequence of these tests.

It is impossible to distinguish any harm due to these releases from other sources of exposure, particularly at Hanford, where the amount of radioactivity intentionally released by the Green Run was 1 percent of the amounts released by routine operations of the Hanford facility in the 1945-1947 period. The risks of thyroid disease from all past operations of the Hanford plant are currently under study; however, the Advisory Committee estimates that the contribution of the Green Run to any such risks amounts to substantially less than one case. No dose reconstruction has been undertaken for the radiological warfare field tests at the Dugway Proving Grounds. Most of the intentional releases the Advisory Committee has studied, including all those identified in our charter, involved radioactive materials with short-enough half-lives that they quickly decayed and therefore pose no risk to health from continuing exposure.

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