Part 3: Righting Past Wrongs

The Committee recommended several steps that the government should take to make amends for the specific wrongs for which the government bears moral responsibility. This section of the report discusses ACHRE's findings and recom-mendations in the areas of notification, apology, and compensation and presents the Administration's response. Within the discussion of compensation, the report addresses individual cases, uranium miners, other populations covered under the Radiation Exposure Compensation Act, veterans, and Marshall Islanders.

The Advisory Committee recommended that (Recommendation 4):

• For any newly-discovered experiments the government should notify participants and provide medical follow-up for "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."
• The government need not notify subjects of experiments reviewed by ACHRE for public health reasons because they did not meet the recommended criteria for notification.

Beyond protecting public health, the government will seek to support as fully as possible an individual's right to know about actions that may have affected him/her. Therefore, the government will also notify an identified experimental subject if the subject requests the information; if the government determines that a subject is likely to fall within the criteria for government compensation; and, on a case-by-case basis, if there is uncertainty about the effects of the experiment and notification is necessary to investigate whether subjects were placed at significant risk and whether there is a potential benefit from treatment. The Administration believes that this approach fulfills the government's grave responsibility to inform subjects while maintaining respect for those people who would not want information that has no tangible benefit. It is important to be clear that notification is not simply the process of taking existing lists of names, current addresses, and phone numbers and contacting people. For most experiments, names are unavailable. Much of the information about past experiments comes from the published literature which does not generally include names. Even where more detailed records have survived, information about individuals is generally fragmentary and does not include anything about their current whereabouts. Much of the information about individuals is in the records of private hospitals and universities where confidentiality and privacy rules prohibit government access.

Notwithstanding the difficulties of undertaking individual notifica-tion, the government reaffirms its continuing commitment to openness. Where the government does not undertake individual notification, it will continue to make material relating to human radiation experiments available to the public, to respond to individual inquiries relating to these experiments, and to carefully review any newly identified experiments in the light of the Advisory Committee notification criteria.

ACHRE's recommendation on notification has generated controversy among stakeholders, including those who participated in the Stakeholders Workshop of February 26Ð 27, 1996, held by the Federal Departments. As the Advisory Committee detailed, many of the wrongs in experimentation involved the failure to obtain consent from subjects or to fully disclose risks and benefits (or lack of benefits) of the experiments, rather than actual adverse health effects from the testing. Some stakeholders believe the government has a responsibility to notify and provide medical follow-up to all who were wronged by the government; not only those who were physically harmed by the government's conduct. Although it is difficult to generalize about the diversity of views presented at the Workshop, the stakeholders generally advocate that the government pursue some form of notification, and fund medical care by individually chosen physicians. Many subjects and families of subjects do not have confidence that the government can honestly make a judgment about notification, or that the government can, without bias or intimidation of subjects, implement any needed medical follow-up. Others suggested that subjects would want to be notified, whether or not they were harmed.

The Administration agrees that the decision of when and how to notify experimental subjects requires a judgment about whether individuals would want to be notified even if there is no public health reason for notification.

Where the agencies discover new records containing information that would allow notification, the Administration will notify subjects that meet the ACHRE public health criteria, and will also notify those that meet any one of three additional criteria which are intended to shed light on the non-health benefits that may accrue to those who may be notified. As noted above, notification will take place if the subject requests the information; if the government determines that a subject is likely to fall within the criteria for government compensation; and, on a case-by-case basis, if there is uncertainty about the effects of the experiment and notification is necessary to understand whether subjects were placed at significant risk and whether there is a potential benefit from treatment. The Administration believes that these other benefits where they are present would cause most subjects to prefer notification.

Information requests: Where information is available, it will be provided to the possible experimental subject, if they so request. The government will use all reasonable means to let individuals know that they have the opportunity to ask questions about their own history and a choice about whether to pursue that information.

To make the choice meaningful, the government has provided widespread opportunities for individuals to seek information about their own involvement as subjects of research. Publicity about the existence of experiments, and the widespread availability of information about human radiation experiments, has generated thousands of inquiries from those who want to know whether they were experimental subjects. This response suggests that the government's outreach efforts allowed many possible subjects to choose whether to seek more information.

Based on the response so far, the Administration believes that continued publication of general information and follow-up of individual inquiries satisfies much of the government's obligation to notify experimental subjects.

As experiments are identified, there may be uncertainty about whether initial exposures to radiation significantly increased the risk to subjects. In at least one case, that of members of the armed services exposed to nasopharyngeal radiation, there may be a sufficient number of identifiable subjects to allow for a follow-up study. The follow-up study would be designed to identify any risk to subjects and whether medical follow-up could be beneficial. The Administration's policy does not preclude conducting such a study, even though the government cannot answer with certainty what level of risk is faced by former subjects and whether there is any prospect of medical or other benefit to subjects from a follow-up study. Any follow-up study should move forward only under the following conditions:

1. All care has been taken to minimize any harmful effects of participating in a study.
2. Members of the public have been consulted regarding the study and its fairness to individuals who will be notified of their prior participation in an experimental treatment.

Individual inquiries: Those who would like more information about their individual experience can obtain assistance by a phone call; the current number is (202) 586-8439. By calling this number, individuals who think they may have been involved in experiments can have their cases reviewed by the appropriate agency. As of December 1, 1996, DOE has answered over 20,000 information requests, and researched 3,000 cases; DOD has responded to ap-proximately 7,000 case inquiries of which approximately 800 are currently undergoing active research; VA has responded to approxi-mately 1,530 inquiries; and HHS, to approximately 90.

The Departments are continuing their efforts to research cases. There are several factors beyond the government's control that influence the ultimate success in each individual quest for informa-tion. For example, some government records are more complete than others and some individuals can provide more kinds of information (e. g., dates, place and researcher names, and other identifying information) upon which to base a search. In cases where the possible experiment took place in a non-governmental facility (e. g., a hospital or university), access to information may be limited.

Notification of NASA employees: Consistent with the effort to provide general information to the widest possible group of people, the National Aeronautics and Space Administration (NASA) has notified approximately 110,000 current and former NASA employees, con-tractors, and grantees about the human radiation research review. This notification included those universities and institutions at which human radiation research was performed through NASA grants.

Notification of veterans: VA convened an expert committee including specialists in nuclear medicine, radiation oncology, health physics, and radiation dosimetry to review information about certain projects, and to determine whether notification of known subjects was warranted. The VA focused its attention on early radiation research projects for which at least some of the names of research subjects were known. These studies were chosen because of the possibility of contacting veterans or family members to encourage medical surveillance or submission of a compensation claim, if warranted. The expert committee did not identify any veterans who required special follow-up actions specifically because of their radiation exposure.

Nasopharyngeal irradiation with radium (NP) during military service: DOD and VA are reviewing the records of hundreds of Service members who received NP irradiation during and immedi-ately following World War II. In April 1996, DOD discovered a Navy medical log book which lists the names of submariners who were given the NP treatment from 1945 to 1946 under an experimental protocol. Using the log book as the focal point, DOD and VA are conducting intensive research at the National Records Center and other repositories to identify other Service members who received NP treatment and, if feasible, to retrieve medical data for possible cohort or epidemiological studies to notify individuals as appropriate. NP treatment was a widely used conventional therapy, particularly for children, during the 1940s and 1950s. Therefore a study could be valuable to many civilians as well as veterans.

Alaskan natives: A number of Alaskan Natives were involved in the U. S. Air Force Arctic Aeromedical Laboratory Iodine-131 thyroid test, which took place in 1956 and 1957. Although both the Advisory Committee and the Institute of Medicine (IOM) determined that there was no evidence of lifetime risk to the participants in these tests, notification and follow-up of the juvenile participants was recommended by the latter as prudent. The Air Force and the Radiation Experiments Command Center (RECC) are following up on the recommendations of the IOM. Efforts are ongoing with representatives of the Native Alaskans to determine appropriate follow-up remedies.

Identifying additional subjects: DOE notified subjects of the pluto-nium and uranium injection experiments, or their next of kin, when these could be located. In addition, DOE asked all its facilities at which human radiation experiments were identified, to provide detailed information about the availability of data relating to individual subjects, the feasibility of notification, and whether any notification process had occurred. Where employees or former employees had been involved in experiments, notification generally had taken place. Otherwise, it was determined that the available data did not warrant notification in light of the Advisory Committee criteria. If new information or experiments come to light, the Department will review these according to the Advisory Committee criteria.

[T]he government sponsored . . . several thousand human radiation experiments. In the great majority of cases, the experiments were conducted to advance biomedical science; some experiments were conducted to advance national interests in defense or space exploration; and some experiments served both biomedical and defense or space exploration purposes. (Finding 1)

[P]eople who were used as research subjects without their consent were wronged even if they were not harmed." In addition, the Committee was "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. (Recommendation 3)

[S]ome government agencies required the consent of some research subjects well before 1944 . . . [and] government agencies did not generally take effective measures to implement their requirements and policies on consent to human radiation research. (Findings 4 and 5)

[T]he government and government officials are morally responsible in cases in which they did not take effective measures to implement the government's policies and requirements. . . .

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

[S]ince the end of the Manhattan Project in 1946 human radiation experiments (even where expressly conducted for military purposes) have typically not been classified as secret by the government. Nonetheless, important discussions of human experimentation took place in secret, and information was kept secret out of concern for embarrassment to the government, potential legal liability, and concern that public misunderstanding would jeopardize government programs. In some cases, deception was employed. In the case of the plutonium injection experiments, government officials and government-sponsored researchers continued to keep information secret from the subjects of several human radiation experiments and their families, including the fact that they had been used as subjects of such research. Some information about the plutonium injections, including documentation showing that data on these and related human experiments were kept secret out of concern for embarrassment and legal liability, was declassified and made public only during the life of the Advisory Committee. (Finding 17)

[f]or 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. (Recommendation 3)

So today, on behalf of another generation of American leaders and another generation of American citizens, the United States of America offers a sincere apology to those of our citizens who were subject to these experiments, to their families, and to their communities. When the government does wrong, we have a moral responsibility to admit it. The duty we owe to one another to tell the truth and to protect our fellow citizens from excesses like these is one we can never walk away from. Our government failed in that duty, and it offers an apology to the survivors and their families and to all the American people who must be able to rely upon the United States to keep its word, to tell the truth, and to do the right thing.

The Advisory Committee identified three sets of subjects that fit the first class of cases: one set of 18 whose identity is known, and two sets, totaling 52 people, whose identity is not known. The Advisory Committee did not make conclusive findings about which subjects fit the second class of cases. Instead, the committee identified several experiments that might fit the second class of cases, with the expectation that the government would consider the Committee's recommendation in deciding whether to compensate individuals. (Recommendations 1 and 2)

To date, DOE and DOJ have settled compensation claims with the 16 families of plutonium injection subjects who have come forward, representing compensation to the families of all known subjects recommended for compensation by the Advisory Committee.

The miners, who were the subject of government study as they mined uranium for use in weapons manufacturing, were subject to radon exposures well in excess of levels known to be hazardous. The government failed to act to require the reduction of the hazard by ventilating the mines, and it failed to adequately warn the miners of the hazard to which they were being exposed, even though such actions would likely have posed no threat to national security. (Finding 16)

The Advisory Committee recommended that the Administration,

together with Congress, give serious consideration to amending the provisions of the Radiation Exposure Compensation Act of 1990 relating to uranium miners in order to provide compensation to all miners who develop lung cancer after some minimal duration of employment underground (such as 1 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. (Recommendation 7)

Proposed legislative changes to RECA: Congress enacted RECA to provide compensation to certain groups of people who developed radiation-related diseases as a result of radiation exposure from the government's Cold War nuclear weapons program, including military and civilian nuclear weapons test participants, and people living "downwind" of the Nevada Test Site. In addition, the Act recognizes the tragedy created by the government's failure to use available resources to ensure that the companies and individuals operating uranium mines in Arizona, Colorado, New Mexico, Utah, and Wyoming between 1947 and 1971 provided adequate ventilation in the mines to reasonably reduce the risk of radon-induced lung cancer. The Act provides for compensation to some affected uranium miners, but ACHRE questioned whether the eligibility requirements for compensation were fair and reflected our present scientific knowledge about the effects of radon.

Proposed regulatory changes to RECA: ACHRE described concerns from many citizens regarding the administration of RECA. These concerns focussed on the difficulty of the documentation requirements and other burdens on those who seek compensation under the Act. The Administration has undertaken a thorough review of the regulations with the intention of making them fairer and more straightforward. While these are the paramount goals, the regula-tions must also effectively implement the limitations and requirements in RECA. The result of these efforts is a set of proposed changes to the rules that are designed to relieve some of the burden of those seeking compensation, without sacrificing the accuracy of the decision as to whether particular claimants qualify for compensation. These regulations will be published shortly. The Administration expects that, as a result of these legislative and regulatory changes, additional uranium miners and others will qualify for compensation.

The Advisory Committee recommended that the Administration,

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. (Recommendation 5)

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, appar-ently independently of the memorandum. The Committee also finds that the government did not create or maintain adequate records for both experimental and nonexperimental participants. (Finding 12)

The Advisory Committee also concluded that "although there was a real possibility that human subjects research had been conducted in conjunction with the bomb tests, the tests were not themselves experiments involving human subjects." The Advisory Committee further noted that "while the studies all took place in the context of the atomic bomb, and therefore involved some potential exposure to radiation, none of them were designed to measure the biological effects of radiation itself (as opposed to the levels of exposure)." The Advisory Committee recommended that the Administration, 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. (The Radiation-Exposed Veterans Compensation Act of 1988 and the Veterans Dioxin and Radiation Exposure Compensation Standards Act) (Recommendation 6)

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.

Hundreds of thousands of veterans were exposed to radiation- those who were present at atomic tests, those who were part of the American occupation of Hiroshima and Nagasaki, and many who were otherwise exposed to radiation in the course of their duties. The President has recognized the special obligation that we owe the men and women who have served their country in the Armed Forces. The President recently said

. . . [O] ur country can face up to the consequences of our actions . . . we will bear responsibility for the harm we do, even when the harm is unintended . . . we will continue to honor those who served our country and gave so much. Nothing we can do will ever fully repay the . . . veterans for all they gave and all they lost . . . but we must never stop trying.

Current law authorizes comprehensive VA health care for veterans who were either atomic test participants or who served in the postwar occupation of Hiroshima or Nagasaki, and who suffer from radiogenic diseases (diseases caused by radiation). This care is provided, free of charge, regardless of whether these veterans' diseases are determined to have resulted from radiation exposure during service. Veterans are also eligible for compensation based on their radiation exposure during their service if they have radiogenic diseases and their claims otherwise meet the criteria for benefits. In determining whether certain claimants qualify for compensation, VA uses radioepidemiological tables. The Advisory Committee recommended that these epidemiological tables be updated to reflect the latest scientific information. The government will contract with preeminent scientists to update the tables. The project is expected to take approximately 2 1 /2 years. The Departments are considering a proposal from the Institute of Medicine, part of the National Academy of Sciences, to accomplish this update. The updated tables will more accurately identify whether there is a reasonable probability that certain diseases were caused by radiation exposure.

First, reported concerns included whether the list of diseases for which compensation is available is fair. VA currently provides benefits for veterans exposed to radiation based on two separate statutory schemes. The Radiation-Exposed Veterans Compensation Act of 1988 provides that if a veteran has a disease listed in the statute, and meets the criteria for exposure, the veteran is entitled to benefits. Thus, for qualified veterans, the list of compensable diseases establishes a presumption of a service connection. This approach has the advantage of simplicity and goes as far as possible toward providing the benefit of doubt to the claimant. It does, however, qualify some people for benefits for whom there is a low probability of a connection between their in-service exposure to radiation and their disease.

Radiation-exposed veterans may also seek benefits under the Veterans Dioxin and Radiation Exposure Compensation Standards Act. Regulations issued pursuant to this Act require a determination that the disease is both radiogenic and connected to the type and amount of radiation the veteran was exposed to during service. The implementing regulations include a list of diseases that claimants do not have to prove were caused by radiation. HHS' epidemiological tables then provide additional information to help VA adjudicate claims and provide some measure of predictability for claimants. This approach has the potential to be scientifically more accurate in determining service connection. It has, however, been criticized for a variety of reasons, including that the epidemiological tables are out of date, the system creates a difficult burden of proof, and the process is expensive for claimants and the government.

ACHRE noted that complaints have been raised about the appeals process for radiation-related claims. VA recognizes it must do a better job to meet veterans' needs, and is taking steps to improve compensation claims processing. For example, VA is redesigning the claims process to provide a partnership among the veteran making a claim, the veteran's representative, and the VA employees processing the claim. VA will discuss the claim, issues that arise, and evidence needed. Once a decision is made, VA will discuss it with the veteran and the veteran's representative, and if necessary, will provide help framing the claim for any appellate review. VA believes that this personal interaction will lead to better and faster decisions and will provide a transparent claims process.

VA remains open to other reforms that will make the process of deciding claims fairer and more streamlined.

[a]s 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. (Finding 16)

The heads of delegations of the Government of RMI, the DOE, and the U. S. Departments of State and Interior held a meeting in May 1996. A Joint Communiqué was signed that outlined a path forward to address the basic ACHRE issues of concern to the Marshall Islands people. At a subsequent meeting on June 7, 1996, a 30-day action plan was mutually agreed upon. This action plan establishes objectives for eight working groups and a time table for achieving these defined objectives. These objectives include how best to include RMI in decisionmaking on future direction of programs and in evaluating the DOE Marshall Islands medical program.

The major outcome of the January Majuro meeting was the development of a joint USG/ RMI committee to deal collectively with the four working groups issues related to the redesign of the current medical delivery process for the Rongelap and Utirik exposed community. The Marshall Islands called for an open competitive process that would provide a more community-based medical delivery program on a more frequent basis than the current twice-yearly medical missions. The Committee set an accelerated time-table to have an instrument for open competition published in the Federal Register by mid-1997 with a new medical delivery process in place by the latter part of calendar year 1998.

An independent review of the DOE Marshall Islands Medical Program is still under discussion. At the request of the Government of RMI, the mechanism for such a review is being reevaluated. RMI has requested a broader historical review that might be done by the National Research Council/National Academy of Sciences. The Department is considering the use of a Blue Ribbon Panel as another possible mechanism for this review. DOE is also working with the RMI to systematically review and collect historical documents which will help to complete the record of U. S. atmospheric testing in the Marshall Islands and the impact on its people. As part of this effort, DOE is also providing support to facilitate Marshallese access to these and previously collected documents. Documents are being scanned into an electronic retrieval system available via the Internet that makes it possible to search many documents of direct pertinence to the RMI concerns.

As ACHRE recommended, the Administration plans to continue to support the current monitoring and treatment program. This program is an important element of our nation's commitment to those who were harmed by the atomic testing program.

As ACHRE recommended, the Administration has considered whether additional populations should be included in this program. Extensive analyses to date of radiation exposures in the Marshall Islands have indicated that the exposures to inhabitants of Ailuk and other northern Marshall Island atolls were a factor of 30 to 90 times less than at Rongelap and about 10 to 25 percent of those at Utirik, based upon external dose measurements and on estimates of thyroid doses. Consequently, the Administration does not believe that additional populations should be added to the medical surveillance program. The connection between radiation exposure and thyroid disease is the subject of several ongoing studies sponsored by DOE and managed by CDC. If these or other studies reveal new data to indicate that residents of atolls south and east of Bikini, other than Rongelap and Utirik, are at a significantly increased health risk, DOE will propose any needed expansion of the current medical surveillance program.