 CHAPTER XVII. 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 policies underlay human experiments in these programs or whether such policies included national security exceptions. FINDING IX. IXA. 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. IXB. 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 IXA, 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 cataloged. Finding X 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 Essex 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 when 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 non-therapeutic 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 where 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. 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 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 blame-worthy 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. Non-therapeutic 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 blame-worthy 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 blame-worthy 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 blame-worthy 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 accord 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, and 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 blame-worthiness 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 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 towards the ends of others. We also note that at its 1947 beginning, officials of and biomedical advisors to the AEC were clearly aware of the issues raised when patients, as well as healthy people, were used as subjects in non-therapeutic 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 non-experimental 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 in 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 effects on humans. The advisory committee's charter identified 13 releases, one related to the testing of intelligence equipment, the green run, eight radiological warfare tests, and four releases of radioactive lanthanum, re-la, to test the mechanism of the atomic bomb. The advisory committee received information on more than 60 radiological warfare releases that took place in the period 1949-1952, and on the nearly 250 re-la 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 re-la 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 one 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. End of Section 82 Section 83 of Final Report of the Advisory Committee on Human Radiation Experiments This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org. Final Report of the Advisory Committee on Human Radiation Experiments Coming to Terms with the Past Looking Ahead to the Future Chapter 17 Part 3 Finding Fifteen 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 Sixteen 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 reduce 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 Rangrik et al., 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 SEVENTEEN 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 to 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, where 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 advisors publicly urged that biomedical research be kept secret only where required by national security. At the same time, AEC officials and advisors 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 advisors 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 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 did not appear to have been informed of the full scope of the program until 1994. Documentation on these mid-century 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 surface 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 surface personnel exposed to radiation, records relating to the secret program of experimentation conducted by the CIA, MKUltra, non-classified records of VA hospitals regarding the thousands of experiments that the VA told the advisory committee were conducted there, and non-classified 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 roadmaps 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 for both employees and subjects. Research in 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 non-radiation, 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. 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 40-50% 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 born 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 document 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 appear 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. End of Section 83 Section 84 of Final Report of the Advisory Committee on Human Radiation Experiments This is a LibreVox recording. All LibreVox recordings are in the public domain. For more information or to volunteer please visit LibreVox.org Final Report of the Advisory Committee on Human Radiation Experiments Coming to Terms of the Past Looking Ahead to the Future Chapter 18 Part 1 Recommendations Recommendations for remedies pertaining to experiments and exposures during the period 1944 to 1974 Biomedical Experiments Recommendation 1 The Advisory Committee recommends to the Human Radiation Interagency Working Group that the government deliver a personal, individualized apology and provide financial compensation to the subjects or their next of kin of Human Radiation Experiments in which efforts were made by the government to keep information secret from these individuals or their families or from the public for the purpose of avoiding embarrassment or potential legal liability or both, and where this secrecy had the effect of denying individuals the opportunity to pursue potential grievances. The Advisory Committee has found three cases to which the above applies. These are the surviving family members of 1. The 18 subjects of the Plutonium Injection Experiments 2. The subject of a Zirconium Injection Experiment known only as CAL-Z and 3. Several subjects of Total Body Irradiation Experiments conducted during World War II Deliberate attempts by public officials entrusted in often sensitive government positions to conceal the fact of participation from subjects or their families, particularly in the absence of sufficient national security justification, and for the declared purpose of avoiding potential liability and public embarrassment, are assaults upon the foundations of individual privacy and self-determination. Such actions violate an individual's right to information about him or herself and must be taken with the utmost seriousness. In the cases listed above, this secrecy served to prevent people who may have been wronged from seeking redress within their lifetimes. Secrecy regarding the participation of particular subjects was maintained until as late as 1974. Documents showing that the government kept information secret about particular 1940s experiments on grounds of potential liability and embarrassment remained secret until retrieved by the Committee in 1994. Even though, at the time, justice might not have required financial compensation for the failure to disclose information in the absence of direct physical harm, the fact that the government's actions limited the opportunity of these subjects to seek justice is undeniable. Because of the offensiveness of the government's actions, justice today warrants a remedy of financial compensation. Moreover, efforts to cover up governmental wrongdoing are assaults upon the polity itself and not just upon the directly affected individual, because such efforts undermine the ability of a civil society to ensure that the government and its agents act within the rule of law. Such a situation warrants the extension of compensation to the next generation. Implementation Congress may need to consider legislation to provide compensation for the immediate families of the subjects in the plutonium injection experiments whose identities are known. The identities of the subject known as Cal-Z, as well as the subjects in the wartime total body irradiation experiments, are not now known. Should their identities come to light, they or their families also should be compensated. In addition, should additional cases be identified that satisfy the criteria outlined above, further legislation should be enacted or other steps taken to provide those individuals or their family members with similar compensation. Recommendation 2 The advisory committee recommends to the Human Radiation Interagency Working Group that for subjects of human radiation experiments that did not involve a prospect of direct medical benefit to the subjects or in which interventions considered to be controversial at the time were presented as conventional or standard practice and physical injury attributable to the experiment resulted. The government should deliver a personal, individualized apology and provide financial compensation to cover relevant medical expenses and associated harms, pain, suffering, loss of income, disability, to the subjects or their surviving immediate family members. The advisory committee has identified several experiments that are candidates for remedies to former subjects under this recommendation. These are described below in the section on implementation. When the government puts an individual at risk in order to serve some collective national interest, it must take steps to ensure that the rights and interests of the individual are adequately protected. The advisory committee presumes, however, based on our understanding of the historical context, that such steps were not uniformly undertaken. As a consequence, it is possible that a citizen who was harmed as a result of participation in non-therapeutic research did not adequately consent to this use of his or her person. That the government did not have a system in place to ensure that individuals were not wronged by their use's research subjects in non-therapeutic research without their adequate consent when that use resulted in harm warrants a personal, individualized apology and financial compensation to subjects or to their surviving immediate family members. Analogous cases exist to support this recommendation. In awarding substantial compensation to victims or their families of the CIA's MK-ULTRA experiments who were killed or suffered other serious harm, Congress and the courts recognized that individuals used for government purpose without direct benefit to the experimental subject and without their consent deserved substantial awards. Nothing in this recommendation should be taken as having implications for how future policies governing compensation for research injuries should be constructed. Implementation Of the experiments that the advisory committee studied in detail, we have identified several that are candidates for remedies under this recommendation. These are as follows. The total body irradiation, TBI, experiments, should it be determined that TBI was considered at the time to be a controversial treatment for patients with radio-resistant tumors and it was not presented as such to potential subjects and should a determination of harm attributable to the experiments be made. The testicular irradiation experiments using prisoners as subjects should a determination of harm attributable to the experiments be made. The uranium injection experiments at Rochester and Boston should a determination of harm attributable to the experiments be made. And some of the iodine-131 experiments involving children should a determination of harm attributable to the experiments be made. Because of the scope of the advisory committee's charge and our limited tenure, we were not in a position to undertake the individualized and detailed fact-finding required to resolve the uncertainties in each of these cases, including the evaluation of medical and research records of all the patients or subjects involved. In addition, two experiments that the committee did not study in detail, the iodine-131 experiment in Alaska and the Vanderbilt Radio-Iron Nutrition Experiments are currently in legal proceedings in which claims of harm have been made. If an appropriate forum, such as the courts or a properly constituted review committee, determines that subjects were harmed as a consequence of non-therapeutic research or as a consequence of research in which controversial treatments were presented to patients as conventional or standard therapy, it is the advisory committee's view that the government should take steps to ensure that the remedies of apology and financial compensation are awarded. The question of causation is key to any such determination. The advisory committee has heard from many public witnesses regarding the standards of proof and presumptions involved in the administration of existing radiation compensation statutes, which cover atomic bomb testing and uranium mining. In those cases, the nature of the exposure for all applicants is relatively uniform and well-defined, and the exposures have been the subject of a relatively large amount of study. By contrast, in the case of human radiation experiments, each experiment may present a different set of circumstances. In some cases, as in the administration of iodine-131, there is considerable knowledge of the relation between exposure and subsequent injury. In many other situations, less is known. A decision should be made about how strict a causal association ought to be required, with a more strict standard making financial compensation available to fewer individuals. Whether the standard for presuming causation should be strict or loose is a policy decision that depends on values, not science. The standards-values problem speaks both to what should be done about whether the illness should be treated as experiment-related for purposes of compensation, if, one, it is impossible to determine the likely range of association between the exposure and the illness because the facts about dose or method of exposure are not available, and, two, the likely range of association is broad, where the probability of association between the exposure and the illness is low. To determine reasonable medical expenses, a schedule of projected medical costs appropriate for reimbursement could be created for specific diagnoses, rather than compensating for actual costs incurred. This approach would relieve the burden on the subject or immediate family members to prove actual costs, streamline the process for determining level of compensation, and allow for compensation for costs not yet incurred. Recommendation 3 The advisory committee recommends to the Human Radiation Interagency Working Group that for subjects who were used in experiments for which there was no prospect of medical benefit to them, and there is evidence specific to the experiment in which the subjects were involved that, one, no consent or inadequate consent was obtained, or, two, their selection of subjects constituted in injustice, or both, the government should offer a personal, individualized apology to each subject. The committee believes that people who were used as research subjects without their consent were wronged even if they were not harmed, although it is surely worse, from an ethical standpoint, to have been both harmed and wronged than to have been used as an unwitting subject of experiments and suffered no harm, it is still a moral wrong to use people as a mere means without their consent. Although what we know about the practices of the time suggests it is likely that many people who were subjects in non-therapeutic research were used without their consent, or with what today we would consider inadequate consent, in most of these cases we have almost no information about whether or how consent was obtained. Moreover, in most of these cases the identities of the subjects are not currently known, even if considerable resources were expended, it is likely that most of their identities would remain unknown. The committee is not persuaded that, even where the facts are clear and the identities of subjects known, financial compensation is necessarily a fitting remedy when people have been used as subjects without their knowledge or consent but suffered no material harm as a consequence. The remedy that emerged as most fitting was an apology from the government. The committee struggled with the issue of whether to recommend that the government extend such an apology. Our deliberations were complicated by what we all agreed was a murky historical record. In the case of some experiments there was evidence of some disclosure or some attempt to obtain consent and the issue emerged as to how poor these attempts must be for an apology still to be in order. In the great majority of cases there was simply too little documentary evidence to draw any conclusions about disclosure or consent. In most cases, as noted above, the identities of subjects are unknown and are unlikely to be uncovered even with a substantial expenditure of resources. What kind of evidence is necessary to determine that an apology is warranted? In the preceding recommendation the remedy is linked to evidence of harm to particular individuals. While requiring evidence of harm specific to individuals, we did not require such specific evidence of lack of consent. Rather, in that recommendation, we presumed that the government did not uniformly undertake steps to ensure that the rights and interests of individual subjects were adequately protected, and thus that it is possible that people who were harmed as a result of participation in research did not adequately consent to this use of their person. In this recommendation, by contrast, a remedy is linked to a showing that people were wronged, not harmed. Thus the committee believes that an apology should be offered only where there is evidence specific to an experiment or subject that no consent or inadequate consent was obtained, or the subject's selection constituted an injustice, or both. The committee believes that among those experiments we have had the opportunity to review in depth, there is sufficient evidence that wrongs were committed against the children who participated in the experiments at the Fernald School. This case is discussed in detail in Chapter 7. In recommending an apology to individuals who were subjects of these experiments, the committee wishes to emphasize that there are likely many other instances in which an apology is warranted, but for which experiment-specific factual support is not currently available. Recommendation 4 In the research that we reviewed for this recommendation, the advisory committee has found no subjects of biomedical experiments for whom there is a need to provide notification and medical follow-up for the purpose of protecting their health. In the event that other experiments of concern come to light in the future, we recommend to the Human Radiation Interagency Working Group that subsequent decisions for notification be based on evaluation of both the level of risk from radiation exposure and the potential medical benefit from medical follow-up in exposed individuals. Additionally, the advisory committee has found no evidence to indicate that the subjects of human radiation experiments we reviewed would have had greater likelihood of incurring inheritable genetic effects than the general population, and thus does not recommend notification or medical follow-up for descendants of subjects of human radiation experiments. In formulating this recommendation, the advisory committee considered those subjects for whom there is a significant risk of developing a radiation-related disease that has not yet occurred, or has occurred but may still be undetected or untreated, and in whom there might be an opportunity to prevent or minimize potential health risks through detection and treatment. In considering notification, we focused only on biomedical experiments, as stated in our charter. The advisory committee based its present recommendation on the specific guidelines stated below, and recommends that future decisions from medical notification and follow-up of subjects of government-sponsored human radiation experiments not examined by the committee, or that have not yet come to light, be based on these same guidelines, as follows. 1. The subject was placed at an increased lifetime risk for development of a fatal radiation-induced malignancy. The level of increased risk was set by the advisory committee at 1 per 1,000 remaining lifetime risk and at an excess relative risk of greater than 10 percent, organ-specific. This level of risk was arbitrarily chosen by the advisory committee. When compared with the normal risk of dying of cancer, 220 out of 1,000, this level of risk is small. The advisory committee chose this small remaining lifetime risk as a reasonable initial criterion to decide if an analysis of the utility of screening and intervention, criterion 2 below, was needed. 2. There is a recognized medical benefit from early detection and treatment of the cancer, which outweighs whatever medical risks are associated with detection and treatment interventions. In addition, the government should consider the public health and financial costs, as well as the potential benefits, before making a decision to offer such a notification and screening program. Eligible subjects for whom medical follow-up to protect health is recommended should be notified of their participation in a human radiation experiment and voluntary screening programs offered to them. Such a program should include adequate disclosure of both the nature of the potential benefits as well as the potential risks of medical follow-up, which might include some of the following aspects. Medical harm, discomfort, inconvenience, or anxiety from the screening test itself or subsequent follow-up exams. The possibility of incorrect test results, either false positive or false negative. The possibility of stigmatization by friends, family, employers, or life health insurance carriers. The costs to themselves of the screening program, if any, and subsequent medical tests and treatments. Thus, the advisory committee's recommendations for notification and medical follow-ups of individuals who were subjects of a human radiation experiment depend equally on risk estimates and the medical utility of early detection and treatment for changing the course of disease or the quality or length of life in such an exposed individual, as shown in the accompanying table. The advisory committee database includes articles and other documents describing approximately 4,000 government-sponsored human radiation experiments. Because of the limited data available on most of these and the advisory committee's limited resources, it has not been feasible for the advisory committee to systematically apply the two criteria described above to the majority of experiments identified within its database. The advisory committee therefore selected for review types of experiments that seemed most likely to include subjects who might still be alive and meet the risk criteria chosen by the committee and who might medically benefit from notification and medical follow-up. Table. Determination of the need for notification and medical follow-up. Medical benefit from early detection and treatment. Yes. Risk analysis for development of fatal cancer, remaining lifetime risk greater than or equal to 1 in 1,000 and relative risk greater than or equal to 10%, recommend notification and medical follow-up. Remaining lifetime risk less than 1 in 1,000 or relative risk less than 10%, no notification. Medical benefit from early detection and treatment. No. Remaining lifetime risk at greater than or equal to 1 in 1,000 and relative risk greater than or equal to 10%, no notification. Remaining lifetime risk less than 1 in 1,000 or relative risk less than 10%, no notification. Specifically, the advisory committee has reviewed 21 studies involving three types of experiments. One, children who received iodine-131. Two, prisoners subjected to testicular irradiation. And three, children and military personnel exposed to nasal pharyngeal radium treatments. Following this detailed analysis, the advisory committee concluded that none of the experiments examined satisfied both of the guidelines identified in this recommendation. If in the future new methods of screening are developed or new information about increased risk is discovered, then these experiments should be reevaluated to assess whether they meet the criteria. For a full discussion, see the Addendum on Medical Notification and follow-up at the end of this chapter. Though it was beyond the scope of the advisory committee to evaluate individually all the experiments in our database, the results of our review of these carefully selected studies suggest that the remaining experiments would be unlikely to meet the proposed criteria for notification and medical follow-up. However, another important group of studies not considered in detail by the advisory committee were tracer studies in pregnant and nursing women. It is possible that experiments that would satisfy the committee's criteria for notification and medical follow-up will be identified. Implementation of a notification and medical follow-up program would have to be done carefully if a follow-up program is to provide former research subjects with greater health benefits. Considerable effort would be needed to educate both subjects and physicians about the realistic benefits and the possible harms of medical follow-up as well as the specific screening modalities and follow-up care that would be indicated. It is particularly important to distinguish follow-up that is intended to benefit medical science from follow-up that is intended to medically benefit patients. An additional concern is that, for most experiments, no list of subjects exists. Performing screening tests in people who are incorrectly identified as having an increased risk is unlikely to result in any benefit and may result in harm. The advisory committee also recognizes that individuals who have received therapeutic radiation treatments, either in a purely clinical setting or research setting, may have been exposed to substantially higher doses of radiation and should seek medical follow-up pursuant to the advice of their treating physician. With regard to the need to notify descendants of subjects of human radiation experiments of potential genetic effects, it is likely that the risk of radiation-induced mutations is small in relation to natural rates. Thus it would be impossible to distinguish whether the condition was caused by the parent's radiation exposure or by other factors. Based on these considerations, the advisory committee does not recommend notification and medical follow-up for descendants of subjects of radiation experiments. In the event that specific genetic effects attributable to radiation exposure could be identified in a particular population of descendants at some future time, the guidelines would be the same as those previously outlined for subject populations. There would need to be evidence to indicate that early intervention would change the course of a particular disease before notification and follow-up would be recommended. Population Exposures In recent years, Congress has enacted a body of laws to provide relief to service personnel exposed to radiation in connection with atmospheric nuclear tests, citizens who live downwind from these tests, and workers who mind uranium to be used by the government in nuclear weapons production. These include the Veterans' Dioxin and Radiation Exposure Compensation Standards Act of 1984, the Radiation Exposed Veterans Compensation Act of 1988, and the Radiation Exposure Compensation Act of 1990. In the committee's view, these existing laws provide the framework on which to base continued provision for relief. In the interim since these laws were passed, experience with the laws and more current scientific knowledge strongly suggest the need for revisiting the laws and their administration and for extending their coverage to similarly situated groups such as those exposed to intentional releases who are not now covered. The following recommendations address the circumstances of groups exposed to intentional releases, service personnel who were exposed in connection with nuclear weapons tests, and workers who mind uranium for use in government programs. We also address the circumstance of the citizens of the Republic of the Marshall Islands, for whom a different framework of remedies has been fashioned. End of Section 84 Section 85 of Final Report of the Advisory Committee on Human Radiation Experiments This is a LibriVox recording. All LibriVox recordings are in the public domain. For more information or to volunteer, please visit LibriVox.org Final Report of the Advisory Committee on Human Radiation Experiments Coming to Terms of the Past Looking Ahead to the Future Chapter 18 Part 2 Recommendation 5 The Advisory Committee recommends to the Human Radiation Interagency Working Group that it, together with Congress, gives serious consideration to amending the provisions of the Radiation Exposure Compensation Act of 1990 to encompass other populations environmentally exposed to radiation from government operations in support of the Nuclear Weapons Program. Should information become available, it shows that areas not covered by the legislation were sufficiently exposed that a cancer burden comparable to that found in populations currently covered by the law may have resulted. The Advisory Committee did not have the time or resources to undertake our own epidemiologic studies of the cancer burden surrounding the Hanford facility in Washington State where the Green Run took place. The preliminary radioiodine dose estimates, now available, raised the issue of whether the releases from Hanford may have caused cancers. The Advisory Committee found that the Green Run itself contributed only a very small portion of that cancer burden, so small that it would be impossible to attribute any cancers to the Green Run as opposed to other sources, including routine Hanford releases. The Advisory Committee believes that, in addressing the Green Run intentional release, the appropriate response is to redress injury without regard to whether exposures were in the course of routine or research activities. There would be no practical way to make this distinction if it were desired. We also note that the Radiation Exposure Compensation Act provides relief for downwinders and uranium miners without regard for whether they were subjects of research, and in many cases they were not. Recommendation 6. The Advisory Committee recommends to the Human Radiation Interagency Working Group that it, together with Congress, gives serious consideration to reviewing and updating epidemiological tables that are relied upon to determine whether relief is appropriate for veterans who participated in atomic testing so that all cancers or other diseases for which there is a reasonable probability of causation by radiation exposure during active military service are clearly and unequivocally covered by the statutes. Congress has provided for compensation for veterans who participated in atmospheric atomic tests or the American occupation of Hiroshima or Nagasaki, Japan. The provision of compensation depends on evidence that the veteran has sustained disability from a disease that may be related to radiation exposure. The Veterans Dioxin and Radiation Exposure Compensation Standards Act of 1984 required the Veterans Administration to write a rule governing entitlement to compensation for radiation-related disabilities. The resulting regulation contains criteria for adjudicating radiation claims, including consideration of a radiation dose estimate and a determination as to whether it is at least as likely as not that the claim disease resulted from radiation exposure. The Radiation Exposed Veterans Compensation Act of 1988 provides that a veteran who was present at a designated event and subsequently develops a designated radiogenic disease may be entitled to benefits without having to prove causation. The committee recommends that the radio epidemiological tables prepared by the National Institutes of Health in 1985 which identify diseases that may be causally connected to radiation exposures be updated. The committee understands that the Department of Veteran Affairs agrees with this recommendation. The advisory committee further recommends to the Human Radiation Interagency Working Group that it review whether existing laws governing the compensation of atomic veterans are now administered in ways that best balance allocation of resources between financial compensation to eligible atomic veterans and administrative costs, including the costs and scientific credibility of dose reconstruction. While the committee's inquiry focused on participants at atmospheric testing who were subjects of experimentation, the committee found that the risks to which experimental subjects were exposed were typically similar to those to which many other test participants were subjected. Those service members who were participants in the experiments reviewed by the advisory committee would, as veterans of atmospheric atomic tests, be eligible for relief under the laws enacted in 1984 and 1988 as amended concerning radiation exposed veterans. The committee found that the government did not create or maintain adequate records regarding the exposures of all participants, the identity and test locale of all participants, and the follow-up to the extent it took place of test participants. Witnesses before the advisory committee and others who communicated with us by mail, telephone, and personal visit expressed strong concerns about the adequacy and operation of the current laws, including, specifically, record-keeping practices. Although the committee did not have the time or resources to pursue these concerns to the degree they merit, we believe that the concerns expressed by the veterans and their family members deserve attention, and we urge the Human Radiation Interagency Working Group, in conjunction with Congress, to address these concerns promptly. The concerns reported to us include the following. 1. The listing of diseases for which relief is automatically provided. The presumptive diseases provided for in the 1988 law is incomplete and inadequate. 2. The standard of proof for those without a presumptive disease is impossible to meet, and, given the questionable condition of the exposure records retained by the government, inappropriate. 3. The statutes are limited and inequitable in their coverage. For example, the inclusion of those exposed at atmospheric tests does not protect those who are exposed to equal amounts of radiation in activities such as cleanup at Inuitak at all. 4. The time and expense needed to prosecute a claim is too great. For example, veterans whose claims are initially denied at the VA regional offices and are seeking appeal of the initial decision receive a form letter stating that it will take at least 24 months to process their appeal. 5. Time and money spent on contractors and consultants in administering the program would be better spent on directly aiding veterans and their survivors. 7. The advisory committee recommends to the Human Radiation Interagency Working Group that it, together with Congress, gives serious consideration to amending the provisions of the Radiation Exposure Compensation Act of 1990 relating to uranium minors in order to provide compensation to all minors who develop lung cancer after some minimal duration of employment underground, such as one year. Without requiring a specific level of exposure. The act should also be reviewed to determine whether the documentation standards for compensation should be liberalized. The uranium minors were exposed to extremely high levels of radon daughters, which were recognized at the time to be hazardous, yet were not controlled by the government, despite the availability of feasible means to ventilate the mines. Furthermore, the government studied the minors without disclosing the purposes of the examinations or warning them of the hazards to which they were exposed. As a result of their continued exposure, hundreds of minors developed lung cancer or non-malignant respiratory diseases that could have been prevented and many of them have died. In recognition of this tragedy, Congress included provisions for compensating certain uranium minors in the Radiation Exposure Compensation Act of 1990, RECA. However, the criteria for compensation set in this act were far more stringent than for the two other groups, atomic veterans and downwinders of the Nevada test site, for which compensation was provided despite the fact that the risks were far higher for the uranium minors. Since 1990, additional scientific information has become available to support the view that radon exposure is responsible for a much higher proportion of the lung cancer cases among the minors than had been previously thought. In particular, the act's current requirement of a minimum of 200 WLM, working level months, exposure for non-smokers, or 300 to 500 WLM, depending on age, for smokers, translates to quite large probabilities of causation, according to a recent report by the National Cancer Institute. That analysis finds little evidence to support a distinction between smokers and non-smokers, and suggests that a majority of lung cancer deaths among Colorado white minors and New Mexico Navajo minors are attributable to radon exposure. Furthermore, it finds that the lung cancer risk is strongly modified by a number of factors and uncertainties that are not accounted for in the total dose. Thus, for many minors, the level of exposure that would merit compensation on the basis of the principle of balance of probabilities might be far lower than the present criteria. In particular, no exposure measurements are available for 90% of the years in most mines, so that any requirement to reconstruct exposure histories is likely to require some degree of extrapolation or estimation, and be quite uncertain. Furthermore, many mines have since gone out of business, so that records needed to establish an exposure history are simply unavailable. Also since 1990, there has been considerable experience with the administration of the Act, and apparently much of it has been negative. The advisory committee took extensive testimony regarding the difficulties faced by minors in meeting the documentation requirements, particularly those related to the requirement to provide a reconstruction of their radon dose. For these practical reasons, and in light of the additional information, we suggest that the requirement that a miner demonstrate that he had been exposed to a certain minimum cumulative dose be replaced by a simple requirement that he worked underground for a certain minimum length of time. Since more than half the lung cancer deaths in the cohort who worked at least one month underground appear to be attributable to radon, we suggest that minimum length of service be set quite low, preferably not more than a year. At most this should then lead to compensation being awarded to twice as many minors as would be entitled to it under the balance of probabilities principle, while not denying it to any who are entitled to it. The grave injustice that the government did to the uranium miners by failing to take action to control the hazard and by failing to warn the miners of the hazard should not be compounded by unreasonable barriers to receiving the compensation the miners deserve for the wrongs and harms afflicted upon them as they serve their country. Recommendation 8 The advisory committee supports the Department of Energy's program of medical monitoring and treatment for the exposed inhabitants of the Marshall Island atolls of Rongelab and Eutrick, and recommends that this program be continued as long as any member of the exposed population remains alive. Furthermore, the advisory committee recommends that the program be reviewed to determine if it is appropriate to add to the program the population of other atolls to the south and east of the blast, whose inhabitants may have received exposure sufficient to cause excess thyroid abnormalities. The advisory committee also recommends that consideration be given to the involvement of the Marshall Islanders in the design of any further medical research to be conducted upon them, and the advisory committee recommends that the Human Radiation Interagency Working Group consider establishing an independent panel to review the status and adequacy of the current program of medical monitoring and medical care provided by the United States to the exposed population of the Marshall Islanders. The 1954 Bravo Hydrogen Bomb Test caused the populations of several Marshall Islands atolls to be exposed to hazardous levels of radiation. The United States has provided a medical follow-up program that combines research on radiation effects with treatment for radiation-related illnesses. It is noteworthy that, as a result of the ongoing program to study radiation effects, many cases of thyroid disease were detected and treated, but not all exposed Marshallese received the benefits of the program. The people of Eiluk, for example, who according to early reports received about the same exposure as the people of Utrecht, were never evacuated from their atoll and were not followed up medically, even though they received a radiation dose of more than six runtkins. Moreover, an epidemiological study reported in the Journal of the American Medical Association in 1987 demonstrated that inhabitants of several atolls to the east and south of Bikini had elevated levels of thyroid disease and that there was a strong inverse linear relationship between the incidence of thyroid nodules and distance from the blast. It should also be noted that the exposed populations received additional doses of radiation over the years from later bomb tests and residual radiation on the atolls. The medical program is ongoing, but Congress has the authority to reduce or eliminate funding. Available evidence indicates that many Marshallese, it is impossible to identify specific individuals, were not adequately informed about the purposes of the medical tests to which they were subjected. There is also evidence in the documentary record that the Marshallese often did not understand the relationship between the research and medical care components of the medical follow-up program. For example, Dr. Robert A. Conard headed the program, and according to his report on 20 years of medical treatment and monitoring, the people did not always understand the need for the examinations or their results. Although this situation has improved in recent years, it would nevertheless be appropriate to consult with the Marshallese in the design and implementation of further medical research so as to minimize any possibility of misunderstanding and to ensure that the priorities of the Marshallese are a consideration in the planning of such research. The advisory committee supports the continuation of the Department of Energy's program of medical monitoring and medical care for the exposed inhabitants of the Marshall Islands. Questions have been raised during the course of our deliberations as to whether this program is running as well as it should, both with respect to the research and monitoring activities conducted by Brookhaven National Laboratory, BNL, and with respect to the medical care provided. In particular, the issue has emerged whether the medical care ought to be expanded to include treatment for conditions that are not radiogenic as a further remedy to Marshallese people who were exposed, however inadvertently, as a result of weapons tests. The advisory committee did not have the resources to pursue these issues, but we believe that they deserve serious consideration. One mechanism through which this could be accomplished is the establishment of an independent panel to review the program with input from the Marshallese as to the panel's composition. Recommendations for the protection of the rights and interests of human subjects in the future. While we were constituted to consider issues related to human radiation experiments, in critical, but not all respects, the government regulations that apply to human radiation research do not differ from those that govern other kinds of research. 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. These advances initiated primarily in the 1970s and 1980s, culminated in the adoption of the common rule throughout the federal government in 1991. Although the common rule now affords all human subjects of research, funded or conducted by the federal government, the same basic regulatory protections, the work of the advisory committee suggests that there are serious deficiencies in some parts of the current system. These deficiencies are of a magnitude warranting immediate attention. The committee was not able to address the extent to which these deficiencies are a function of inadequacies to the common rule, inadequacies in the implementation and oversight of the common rule, or inadequacies in the awareness of and commitment to the ethics of human subject research on the part of physician, investigators, and other scientists. We urge that in formulating responses to the recommendations that follow, the Human Radiation Interagency Working Group consider each of these factors and subject them to careful review. Recommendation 9. The advisory committee recommends to the Human Radiation Interagency Working Group that efforts be undertaken on a national scale to ensure the centrality of ethics in the conduct of scientists whose research involves human subjects. A national understanding of the ethical principles underlying research and agreement about their importance is essential to the research enterprise and the advancement of the health of the nation. The historical record makes clear that the rights and interests of research subjects cannot be protected if researchers fail to appreciate sufficiently the moral aspects of human subject research and the value of institutional oversight. It is not clear to the advisory committee that scientists whose research involves human subjects are any more familiar with the Belmont report today than their colleagues were with the Nuremberg Code 40 years ago. The historical record and the results of our contemporary projects indicate that the distinction between the ethics of research and the ethics of clinical medicine was and is unclear. It is possible that many of the problems of the past and some of the issues identified in the present stem from this failure to distinguish between the two. The necessary changes are unlikely to occur solely through the strengthening of federal rules and regulations or the development of harsher penalties. The experience of the advisory committee illustrates that rules and regulations are no guarantee of ethical conduct. The advisory committee has also learned in responses to our query of institutional review board, IRB, chairs, that many of them perceive researchers and administrators as having an insufficient appreciation for the ethical dimensions of research involving human subjects and the importance of the work of IRBs. The federal government must work in concert with the biomedical research community to exert leadership that alters the way in which research with human subjects is conceived and conducted so that no one in the scientific community should be able to say I didn't know or nobody told me about the substance or importance of research ethics. The advisory committee recommends that the Human Radiation Interagency Working Group institute, in conjunction with the biomedical community, a commitment to the centrality of ethics in the conduct of research involving human subjects. We urge that careful consideration be given to the development of effective strategies for achieving this change in the culture of human subjects research, including, specifically, how best to balance policies that mandate the teaching of research ethics with policies that encourage and support private sector initiatives. It may be useful to commission a study or convene an advisory panel charged with developing and perhaps implementing recommendations on how best to approach this challenge for the research community. The committee suggests that such an examination include consideration of the following. Extending to all federal grant recipient institutions and all students and trainees involved or likely to be involved in human subject research, the current federal requirement that institutions receiving NIH National Research Service Award training grants offer programs in the responsible conduct of research. The role of accrediting bodies, such as the Joint Commission on Accreditation of Healthcare Organizations, J-C-A-H-O. Establishing competency in research ethics as a condition of receipt of federal research grants, both for institutions and individual investigators. Incorporating of research ethics and the differences between the ethics of research involving human subjects and the ethics of clinical medical care into curricular for medical students, house staff, and fellows. Encouraging the nation's leaders in biomedical research to spearhead efforts to elevate the importance of research ethics in science.