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Part III

Chapter 18

Recommendations 1 - 6

Recommendations 7-12

Recommendations 13-16

Recommendations for Remedies Pertaining to Experiments and Exposures During the Period 1944-1974[*]

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.

*In preparing these recommendations, the Advisory Committee addressed only the question of whether the federal government owes remedies to subjects or their surviving immediate family members. The remedies identified below are not intended to preclude any remedies that subjects or their family members may otherwise be entitled to from nonfederal institutions or from individuals.

The Advisory Committee has found three cases to which the above applies. These are the surviving family members of:

  1. The eighteen 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.[1]

Deliberate attempts by public officials in trusted and 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.


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 was convened in response to concerns about human radiation experiments that offered no prospect of medical benefit to human subjects. In our historical analysis, the experiments we investigated either offered no prospect of medical benefit or they involved interventions alleged to be controversial at the time (see Overview to Part II). As a consequence, the Advisory Committee focused its consideration of remedies for subjects of human radiation experiments only on those experiments that fit these descriptions. The Committee makes no recommendations about whether, or under what conditions, remedies are appropriate for subjects of human radiation experiments that were considered at the time to offer a plausible prospect of medical benefit to subjects.

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 nontherapeutic 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 as research subjects in nontherapeutic 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 MKULTRA 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.[2]

Nothing in this recommendation should be taken as having implications for how future policies governing compensation for research injuries should be constructed.


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 "radioresistant'' 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 radioiron 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 nontherapeutic 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 (1) 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 (2) the likely range of association is broad or 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 (1) no consent, or inadequate consent, was obtained, or (2) their selection as subjects constituted an injustice, or both, the government should offer a personal, individualized apology to each subject.[*]

* For a discussion of the Committee's deliberations about this recommendation, see "Overview to Part IV."

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 nontherapeutic 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.[3]

* Several other experiments studied by the Committee are candidates for remedies under Recommendation 2. Where it is determined that subjects in these experiments were not harmed, they may be due an apology under this recommendation if it is determined that they were wronged.

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 heritable (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 for 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 increased lifetime risk for development of a fatal radiation-induced malignancy. The level of increased risk was set by the Advisory Committee at 1/1,000 remaining lifetime risk and 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-up 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.


  Risk Analysis (For Development of Fatal Cancer)
Remaining Lifetime Risk 1/1,000 AND RR 10% Remaining Lifetime Risk < 1/1,000 OR RR< 10%

Specifically, the Advisory Committee has reviewed twenty one studies involving three types of experiments:

  1. Children who received iodine 131;
  2. Prisoners subjected to testicular irradiation; and
  3. Children and military personnel exposed to nasopharyngeal 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 benefit than harm. 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 lived downwind from the tests, and workers who mined 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 mined 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.

Recommendation 5

The Advisory Committee recommends to the Human Radiation Interagency Working Group that it, together with Congress, give 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 that 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 raise 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, give 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 claimed 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.[4]

The Committee recommends that the radioepidemiological 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 Veterans 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 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 were exposed to equal amounts of radiation in activities such as cleanup at Enewetak atoll.

  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 twenty-four 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.

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