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ACHRE Report

Part III

Chapter 17

Findings 1-7

Findings 8-14

Findings 15-23

Chapter 17: Findings 15-23

Finding 15

The Advisory Committee finds that during the period from 1944 to about 1970 there was no system of environmental laws and regulations governing the conduct of intentional releases analogous to that currently in place. However, those responsible for intentional releases during this period recognized the possible health risks from environmental releases and that risks had to be considered in making policy decisions about such releases.

In the case of the Green Run, guidelines existed for routine (or normal operating) environmental releases of radioactive iodine but were exceeded; in the case of radiological warfare tests, a safety panel was created. These and other releases specified in the Advisory Committee's charter were conducted in secret because of a combination of concerns about national security and public reaction. The Atomic Energy Act of 1954 began the formal public system of safety regulation of environmental releases of radiation. It was not until the National Environmental Policy Act of 1969 that public review of federal actions likely to have a significant impact on the environment was institutionalized.

Finding 16

The Committee finds that, as a consequence of exposure to radon and its daughter products in underground uranium mines, at least several hundred miners died of lung cancer and surviving miners remain at elevated risk. As a consequence of a U.S. hydrogen bomb test conducted in 1954, several hundred residents of the Marshall Islands and the crew of a Japanese fishing boat developed acute radiation effects. Some of the Marshall Islanders subsequently developed benign thyroid disorders and thyroid cancer as a result of the radiation exposure. Surviving Marshallese also may remain at elevated risk of thyroid abnormalities.

The miners, who were the subject of government study as they mined uranium for use in weapons manufacturing, were subject to radon exposures well in excess of levels known to be hazardous. The government failed to act to require the reduction of the hazard by ventilating the mines, and it failed to adequately warn the miners of the hazard to which they were being exposed, even though such actions would likely have posed no threat to the national security.

Some Marshallese exposed during the 1954 bomb test received radiation doses substantially in excess of those considered safe, both at the time and today. One Marshallese exposed as a baby died of leukemia in 1972, which may have been as a consequence of exposure during the test. In 1954, twenty-eight U.S. servicemen manning a weather station on Rongerik Atoll also received doses of radiation substantially in excess of those considered safe at the time and today. The Advisory Committee does not know whether any of the servicemen suffered long-term harm as a result of their exposure. Twenty-three Japanese fishermen were irradiated as a result of the fallout from the 1954 bomb test. The exposed Marshallese population received additional doses of radiation from later bomb tests and residual radiation in the food chain, which continues to this day. The U.S. government--initially the Navy and then the AEC and its successor agencies--has provided care to the Marshallese ever since for radiation-related illnesses while conducting research on this population to determine radiation effects. For many years the distinction between research and clinical care was not adequately explained to the Marshallese.

Finding 17

The Committee finds that since the end of the Manhattan Project in 1946 human radiation experiments (even where expressly conducted for military purposes) have typically not been classified as secret by the government. Nonetheless, important discussions of human experimentation took place in secret, and information was kept secret out of concern for embarrassment to the government, potential legal liability, and concern that public misunderstanding would jeopardize government programs. In some cases, deception was employed. In the case of the plutonium injection experiments, government officials and government-sponsored researchers continued to keep information secret from the subjects of several human radiation experiments and their families, including the fact that they had been used as subjects of such research. Some information about the plutonium injections, including documentation showing that data on these and related human experiments were kept secret out of concern for embarrassment and legal liability, was declassified and made public only during the life of the Advisory Committee.

Human experimentation conducted during the Manhattan Project was carried out in secret. Since 1947 (when the Atomic Energy Commission began operations and the military services were unified under a secretary of defense) human radiation experiments have rarely been protected as classified secrets. However:

In 1947 AEC biomedical advisers publicly urged that biomedical research be kept secret only where required by national security. At the same time, AEC officials and advisers secretly determined that reports on human radiation experiments should not be declassified where they contained information that was potentially embarrassing or a cause of legal liability. Upon requests for declassification, research reports involving human radiation experiments and other human radiation exposures were reviewed for their effects on public relations, labor relations, and potential legal claims.

In 1947 AEC officials and advisers conducted discussions about human subject research policy; some of these discussions were conducted in secret meetings, and the statements of requirements that were articulated, while not secret, evidently were little disseminated. Similarly, 1949-1950 AEC/DOD discussions of the terms on which human radiation experiments could be conducted were either secret or the substance of the discussions was given limited public distribution. In 1952, Department of Defense biomedical advisory groups also engaged in secret or restricted discussions of policy, which led to the 1953 issuance of the Wilson memorandum, which was itself issued in Top Secret.

Government officials and experts did not squarely and publicly address the existence and scope of government-supported human radiation experimentation. For example, in the late 1940s and early 1950s the AEC denied to the press and citizens that it engaged in human experimentation, even though the AEC's highly visible radioisotope distribution program had been created to provide the means for, among other things, human experimentation.

Project Sunshine, a worldwide program of data gathering, including human data gathering to measure the effects of fallout, was kept secret from its 1953 inception until 1956, and AEC officials and researchers employed deception in the solicitation of bones of deceased babies from intermediaries with access to human remains. It appears that concern for public relations played a key role in keeping the human data gathering, and the very existence of Project Sunshine, secret.

Finding 18

All the intentional releases identified in the Advisory Committee's charter, as well as the several hundred other releases that were essentially of the same types, were conducted in secret and remained secret for many years thereafter. All involved some stated national security purpose, which may have justified some degree of secrecy. Despite continued requests from the public that stretch back well over a decade, however, some information about intentional releases was declassified and made publicly available only during the life of the Advisory Committee.

The Committee's review indicates that internal proposals that the public be informed about the existence of the radiological warfare program were rebuffed on grounds that public misunderstanding might jeopardize the program.

Citizens learned of the 1949 Green Run in 1986, and then only following close review of documents requested from the government by members of the public. Portions of a key surviving report on the Green Run were not declassified until 1994. Similarly, although 250 intentional releases near the land of the Pueblo Indians in New Mexico took place between 1944 and 1961, the Pueblo do not appear to have been informed of the full scope of the program until 1994. Documentation on these midcentury tests is only now being declassified.

Finding 19

The Advisory Committee finds that the government did not routinely undertake to create records needed to ensure that secret programs could be understood and accounted for in later years and that it did not adequately maintain such records where they were created. The Committee further finds that many important record collections (including records that were not initially classified) have been maintained in a manner that renders them practically inaccessible to those who need them, thereby limiting the utility of the records to the government itself, as well as the public's rights under the Freedom of Information Act.

Where citizens are exposed to potential hazards for collective benefit, the government bears a burden of collecting data needed to measure risk, of maintaining records, and of providing the information to affected citizens and the public on a timely basis. The need to provide for ultimate public accounting, as was recognized by early AEC leadership, is particularly great where risk taking occurs in agencies that do much of their work in secret. The government did not routinely or adequately create and maintain such records for relevant human radiation experiments, intentional releases, and service personnel exposed in conjunction with atomic bomb tests.

Where records were initially created, important collections have been lost or destroyed over the years. These include the classified records of the Atomic Energy Commission's Intelligence Division; secret records that were kept in anticipation of potential liability claims from service personnel exposed to radiation;[2] records relating to the secret program of experimentation conducted by the CIA (MKULTRA); nonclassified records of VA hospitals regarding the thousands of experiments that, the VA told the Advisory Committee, were conducted there; and nonclassified files of the AEC's Isotope Distribution Program relating to the many licenses for "human use" it granted in the period 1947 to 1955. The Committee notes that laws governing government records provide for routine destruction of older records; however, we also found that some records documenting the destruction of records had been lost or destroyed.

Public witnesses and others repeatedly expressed doubt to the Advisory Committee about the credibility of the government's efforts to respond to requests for documents. The Advisory Committee's experience indicates that shortcomings in government response to Freedom of Information Act requests, which may be interpreted by citizens as deliberate nondisclosure, may often occur because the agencies themselves lack adequate road maps to the records that still exist and lack records needed to determine whether collections of importance to the public have been lost or destroyed. In the absence of the efforts put forth by the Human Radiation Interagency Working Group, thousands of documents that have now been made public would not have been located.

Findings for the Contemporary Period

Biomedical Experiments

Finding 20

The Advisory Committee finds that human research involving radioisotopes is currently subjected to more safeguards and levels of review than most other areas of research involving human subjects. The Advisory Committee further finds that there are no apparent differences between the treatment of human subjects of radiation research and human subjects of other biomedical research.

Today, research involving either external radiation or radioactive drugs usually undergoes an additional layer of review for safety and risk. Most medical institutions have a radiation safety committee (RSC) responsible for evaluating the risk of radiation research and other medical activities and limitation of radiation exposure of both employees and subjects. Research and medical institutions that perform basic research involving human subjects and radioactive drugs must also have studies reviewed and approved by a radioactive drug research committee (RDRC), a local institutional committee approved by the Food and Drug Administration, to ensure that safeguards in the use of such drugs are met. These steps are in addition to the review of risks and benefits undertaken for all research, whether radiation or nonradiation, by local institutional review boards.

In the Advisory Committee's two empirical projects examining current practices in human subject research, we found no meaningful differences between radiation research and human research in other fields.

Finding 21

The Advisory Committee finds that today research involving human subjects sponsored by the government may be classified and conducted in secret, but it must comply with the provisions of the Common Rule.

It is permissible today to perform classified research on human subjects, although it is our understanding that classified research occurs relatively rarely. Like unclassified research, such research is covered by the protections enunciated in the Common Rule. There may be significant problems in the application of the Common Rule to classified research, however. One problem concerns the possible need for security clearances if institutional review boards are to appropriately protect the interests of human subjects. Written guidance on this question differs among the agencies. Of particular concern is whether only those members of the IRB who are employees of the agency will possess security clearances and thus be able to participate in reviewing classified projects.

Another issue of concern is that for classified research involving no more than minimal risk, as with any such research, the Common Rule allows IRBs to waive any or all elements of informed consent if, among other things, it is not practicable for the research to be carried out without such a waiver.[*] The Committee believes, however, that research conducted in secret should never be permitted on human subjects without the subjects' informed consent. The question of what must be disclosed to potential subjects in order for them to make an informed decision about participating in classified research, including whether an adequate disclosure can be made to people who do not have security clearances, is an important issue not addressed in the Common Rule.

* Common Rule, __.116(d). Under the Common Rule, four requirements must be met for an IRB to waive the rule's informed consent requirements: "(1) the research involves no more than minimal risk; (2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; (3) the research could not practicably be carried out without the waiver or alteration; and (4) whenever appropriate, the subjects will be provided with additional pertinent information after participation."

Finding 22

The Advisory Committee finds that, in comparison with the practices and policies of the 1940s and 1950s, there have been significant advances in the protection of the rights and interests of human subjects of biomedical research. However, we also find that there is evidence of serious deficiencies in some parts of the current system for the protection of the rights and interests of human subjects.

Based on the Advisory Committee's review, it appears that about 40 to 50 percent of human subjects research poses no more than minimal risk of harm to subjects. In our review of research documents that bear on human subjects issues, we found no problems or only minor problems in most of the minimal-risk studies we examined. In our review of documents we also found examples of complicated, higher-risk studies in which human subjects issues were carefully and adequately addressed and that included excellent consent forms. In our interview project, there was little evidence that patient-subjects felt coerced or pressured by investigators to participate in research. We interviewed patients who had declined offers to become research subjects, reinforcing the impression that there are often contexts in which potential research subjects have a genuine choice.

At the same time, however, we also found in our review of documents examples in which human subjects issues were carelessly and inadequately addressed. These disparities suggest that there is substantial variation in the performance of institutional review boards.

We found serious deficiencies in our review of research proposal documents in several areas central to the ethics of research involving human subjects. Specifically, these documents often failed to provide sufficient information with which judgments could be made about the likely voluntariness of participation and about the characteristics of and justification for the subjects selected for study. It also was often difficult to assess, again because of insufficient information, whether the likely merits of the research warranted the imposition of risk or inconvenience on human subjects. We also found serious deficiencies in many of the consent forms we reviewed, including the consent forms of some minimal-risk studies.

Most of the Advisory Committee's concerns focus, however, on research that exposes subjects to greater than minimal risk. We found evidence of confusion over the distinction between research and therapy in interviews with patients, in the research documents reviewed, and in public testimony. This confusion appears to be borne out of a combination of trust in physicians and an inadequate understanding of the differences among innovative practice, therapeutic research, and accepted modes of therapy. The Advisory Committee's empirical studies suggest that there is reason to worry that patient-subjects who have serious illnesses may have unrealistic expectations both about the possibility that they will personally benefit by being a research subject and about the discomforts and hardships that sometimes accompany research.

The Advisory Committee is also concerned about research we reviewed involving adult subjects of questionable capacity. In the documents made available to the Advisory Committee, there was little discussion of the implications of diminished capacity for the process of consent and authorization to participate in research, even in studies that appeared to offer no prospect of medical benefit to subjects. In addition, the Advisory Committee is concerned about the failure of federal regulations to address the conduct of research involving institutionalized children.

Population Exposures

Finding 23

The Advisory Committee finds that events that raise the same concerns as the intentional releases in the Advisory Committee's charter could still take place in secret under current environmental laws and regulations.

Today the law provides that environmental reviews may be conducted in part or even in whole in secret, thereby eliminating provision for public notice and comment. In classified programs, the government must still comply with environmental standards, and the Environmental Protection Agency must oversee and review environmental compliance. However, the EPA has not maintained records of environmental releases where the reviews were conducted in whole or in part in secret. Environmental laws and regulations that limit quality or quantity of a release also contain provisions allowing exemptions for national security. In principle, the President or the secretary of energy (in the case of the Atomic Energy Act) could invoke these exemptions to permit releases that would otherwise exceed risk standards.

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