remedies for human subjects of cold‘war research: recommendations of the advisory committee

Remedies for Human Subjects of Cold 'war Research: Recommendations of the Advisory Committee -~ Anna Mastroianni,Jeffrey Kahn

t a White House ceremony in October 1995, the Advisory Committee on Human Radiation Experi- A ments prcsented its f ind Report to President Bill

Clinton. The 92S-page repon and the over 2,000 pages of supplemend volumes summarized eighteen months of in- vestigative research, debate, and deliberation on historical aiid contemporary issues in human subjects research. The Advisory Committee's effom were aided by unprecedented support from the highest levels of thc executive branch, including the heads of eight cabinet-level agencics and their departments' resources. The presidentially appointed committee and its staff delved into long-forgotten Cold War- era government archives, listened to hours of public testimony, interviewed key players in the development of medical therapies and nuclear weapons, and studied ethical is- siies arising in today's rcxarch.

In tiis article we focus on a critical, but narrowly de- fined, part of the Advisory Committee's Final Report: rem- edying harms or wrongs to subjects of human radiation experiments conducted or sponsored by the U.S. govern- mei,~ between 1944 and 1974. By providing focus and context to this issue through illumination of Committee delib- erations, we hope to advance understanding and provoke tholitiht about redress for governmrrrt wrongdoing.

Background The President established the Advisory Committee on Human Radiation Experiments in early 1994, following public revclations of secret government-sponsored radiation research performcd during the Cold War. In 1993, journalist Eileen Wclsome wrote a Pulitzer Prize-winning

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series of articles, "The Plutonium Injection Experiments," for the Afbuqumpe Tribune. She described personal histe ries of a number of hospitalized patients who allegedly had been injected with plutonium without their knowledge during the 19405 and 1950s. The secret experiments had been supported by the Atomic Energy Commission (AEC), a predecessor to the Department of Energy (DOE). The articles caught the attention of Secretary of Energy Hazel O'Leary who, as pan of thc Clinton administration's "open- ness initiative," made the issue 3 top priority and ordered archives rc, be searched for evidence of these and other radiation experiments. Prcss reports of other govemment- sponsored radiation experiments soon followed: instinr- tionalized children in Massachuserts had k e n fed oatmeal containing radioactive tracers PS part of "science club" ac- tivities; cancer patients in Ohio wcre exposcd to total body irradiation in research supported by the Department of Defense (DOD); and prisoners in Oregon and Washington correctional facilities were exposed to tcsticular irradiation. An overlooked 1986 report, prepared by a congressional subcommittee headed by US. Representative Ed- ward Markcy (D-MA), rcsurfaced in h e press. It docu- mented more experiments. At the same time, the General Accounting Office delivercd 3 report, requested by Senator John Glenn (D-OH), describing thirteen cases in which the federal government had released radiation into the environment without notifying thc potentially affected com- munities.

It becamc dear that human radiation experiments and intentional releascs of radiation were not performed or supported solely by DOE and its predecessors; rather, these actions wcre pan of a government-wide effort that perm- tially included DOD, the Department of Health and Hu- man Services (DHHS), Veterans Affairs (VA), the National Aeronautics and Space Administration (NASA), and the

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Ccntnl Intelligence Agency (CIA). Thewforc, President Clin- ton ordered thrsc federal agencies to scarch their archives for rclcvant documentation. He appointcd the Advisory Committcc to rrvicw and evaluate indepcndently the un- covcrcd documcntation, as well as to dircct the efforts of the agencies and to conduct its own investigation. He sc- lectcd a multidisciplinary group, composed of a citizcn rcp- rcscntative and thirtcen experts from thc ficlds of biocthics, radiation oncology, radiation biology, nitclcar mcdi- cine, epidcmiology, biostatistics, law, history of science and medicine, and public health.’ The expcrtise of a largc pro- fessional staff mirrored that of the Committcc.

By cxecutive order, the President charged the Advi- sory Committcc: ( I ) to uncovcr the history of human radiation experiments benvcen 1944 (the year that the fint- known human radiation cxperimcnt of interest was planned) and 1974 (the ycar that the Dcpanment of Health, Educa- tion and Welfarc (DHEW) adopted landmark regulations governing the conduct of human rcsearch); (2) to cxaminc specifically identificd cases of intentional releases of radiation into the environment for research purposcs; (3) to iden- tity ethical and scientific standards for evaluating these crrcntr; and (4) to make recommcndatiom to c m r e that what- ever wrongdoing might have omirrcd in the pas could not be repeatcd.l While not expressly charged with considering remcdies, the Committee members felt an obligation to address the appropriateness and the types of remedies that the government should provide to expcrimcntal subjects.”

A cabinet-lcvel group, established by President Clin- ton in advance of naming the Advisory Committce, is rc- spoirsible for responding to and implementing the Com- mittec’s recommendations, including the remedies for wrongs and harms resulting from human experimentation. This group, the Human Radiation Interagcncy Working Group (IWG), consists of the heads of all of thc agencics namcd above (thc secretaries of Energy, Defcnse, DHHS, and VA, the dircctor of the CIA, and the administrator of NASA), as well as the director of the Office of Manage- ment and Budget and the US. Attorney Gencral. A formal response regarding the implementation of the Advisory Committee’s recommendations is likely to be issued in the ncxt fcw months, indepcndent of the status of pending lawsuits and claims.

?he experiments Vhen the President established [lie Advisory Committec, only a handful of federally sponsored human radiation expcrimcnts had been identified as falling within its man- date. By the time the Committee’s offices closed, its data- L c e s contained information on approximately 4,000 such cxperimcnts, although information was frequently limited tu bare-bone descriptions of the mearch. Because of thc sheer number of experiments, limitations on resources and

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time, and limitations of the available information, it was impossible to investigate and make judgments about evcry expcrirnent in the database. A dccision was made to group the rxpcriments into five general categories, according to the priorities described below. Spccific investigations and judgments focused on detailed, repraentativc case studies within each category. The casc study method provided the opportunity to develop an evaluative structure for rem- edirs with the potcntial for broader applicability to spccific cxperimcnts not revicwcd by, or unknown to, thc Com- rnittcc.

In selecting experiment!! for review, the highest priority was placed on identifying and analyu’ng experiments that offcrcd no prospecr of medical benefit to the subject or involved novel *treatmcnrs” in which the potenrial for medical benefit to the subject was in dispute. This priority reflected thc compelling nature of thes= experiments, in which individuals wcre subjeacd to risk, sometimes of s c a t or unknown magnitudc, with little, if any, expectation of benefit to them. Thesc expcrirncna wcre all the more wor- thy of scrutiny because they appeared to have taken place without adequate consent. The experiments included many of those that were highly publicized whcn the Advisory Committee was created and those brought to the Com- mittee’s attention by members of the public. Arother large group of cxperimcnts did not receive public attention, but because they held no potential for direct medical benefit to mbjects, they were selected for priority attention. These expcriments werc pcrformcd for national security reawns or as part of secret research programs; they involved large risks of harm; or their subjects were relatively powerless to decline participation.’

Thc five ategories of biomedical radiation experiments on human subjects selmed for case study rcview include: (1) expcrimcnts with plutonium, uranium, polonium, and other atomic bomb-making elemenrs (typically through injection);’ (2) radioisotope tracer ucperimcnn;6 (3) unon- therapcutic” experiments on children;’ (4) rota! body irradiation (typically uscd on cancer patients);” and (5) testicular irradiation experiments on prisoner^.^ These casc studics reprcsenr a wide range of rcscarch: they involve injection, ingestion, and external exposures to ionizing radiation; research involving healthy subjects and sick pa- tienrs; and rescarch on adults and on children. The stated purposes of the experiments indudc the advancement of biorncdical science as well as issues of national defense and space exploration.

Moving from experiments to remedies Several steps had to be takcn to bridge the gap between information about experiments and any considcration of rcdras for wrong and harms. llresc indudcd (I) reviewing informarion on experiments and on governing policies in

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plncr at the timr to identify types of potential wrongs and harms; (2) comidcriry thc cvidcricc needed to support a claim of wrong o r harm; and (3) considering types of rcmcdics.

Identifying itrformutio,t otr rurongs and harms Potential wrongs and harms identified from available information concerned issues of sccri:cy, injury duc to research participation, potential for direct medical benefit to subjects, adequate consent of subjects, and subjcct selcction. Wrongs o r harms rclatcd to t lwe issiics, if identified in particular cxpcrimrnts, wvcrc dccincd to warrant a rcm- cdy. The qiicstion of adequate consent was particularly difficult to .assuss, becaiisc: it was influenccd both by practice in thc CI?SCS of specific experiments and by the policics at the time. Thcrcforc, both documcntary information on individual experiments, and the gcneral practices and gov- crning policirs of the day werc cxamincd.

In tcrms of policics of consent, by 1947 (and arguably carlicr), policy existed at ARC and, by 19.52 (if not wcll bcforc), at DOD. It appears, however, that thesc policies wcrc not widcly disserninatcd or applied. Thc first widely applied policies for rcscarch pcrformcd by thc fcderal gov- ernmcnt appcarcd in 1962, for research pcrformcd at the National Institutes of Health (NIH) Clinical Ccntcr. Pro- spcctivc rcvicw rcquiremcnts for thc protection of subjects wcrr instinitcd for all Public Hcalth Scrvicc g a m e institutions in 1966, and that policy was reviscd a number of times until the landmark CHEW policy of 1974 for all departmentally performcd or funded research. The Advi- sory Commiacc concluded that thc govcrnmcnt's failure to havc policies in place that adequately protcctcd the rights and interests of research subjccts at thc time of thc human radision cxpcrimcnts was onc for which the govcrnmcnt was blamcworthy.'"

Investigation rcvcalcd that diffrrcnt practiccs wcrc followed for rcsrarch on patients as compared with research on hcalthy subjects. This is undcrstandablc, because in the physician-patient rclationship of thc 1940s to 1 9 6 0 ~ ~ physicians wielded grcat authority ovcr treatment decisions for thcir paticnts, and patients largely acquiesced. In its orai history project, the Advisory Cornmittcc lcarncd that physician-rcscarchcrs thought it unnccemry to scek consent from patient-subjects as long as the patients wcre exposed to little risk, or the potcntial for paticnt benefit out- w:.:ighcd the risk of research. The stark reality was that rcscarch on hcultlty subjects could not proceed on such a model, in that hcalthy potential subjects would havc been unlikely to submit to research without some explanation and undcrstanding of what would be done to them. This mcailt that some level of consent was sought from healthy subiecn much before a similar level of conscnt was sought from patient-subjects. The Commitrce concluded that this unequal treatment was without moral basis, and hcld that

rcsearchcrs werc blamcworthy as a group for failing to haw adequate practices in placc for both categories of research subjects." Rescarchcrs may have actcd in ways consistent with existing policies and practices, but those policies and practices were found to protect inadequately the rights and wclfarc of research subjccts given what was then undcr- stood about thosc issues. Documentation, in fact, demon- strates an apprcciation of thc need for explicit policy to protect the rights and welfare of research subjects during thc Cold War period. This conclusion Icd to a presumption that adcquatc conscnt was not achicvcd in research during thc period of thc human radiation experiments, and this prcsumption was a consideration in crafting remedies rec- ommcndations, as is discusscd below.

Supporting a claim of wrong or harm Wrong can gcnerally be dcfincd as violations of the rights of individuals or groups. In the case of human radiation cxpcrimcnts, the Advisory Comrnittce idcntified wrongs in the arcas of no, or inadequate, consent, unjust subject sclcction, and secrecy in research participation. Subjcct selcction and sccrccy were considercd on a case-by-case b a k Inadequate consent, howcvcr, can be shown specifically or gmcrally, through documentation about a panicular experiment or by thc claim that the research policies and practices of the time were inadequate. As will be discussed in rclation to particular recommendations, the Committee rccornmended accepting both gcneral and spccific evidence of inadequate consent, dcpending on the remedy at issuc.

An individual making a claim of rcsearch harm con- tends that research participation caused injury. Support for such claims rcquires the resolution of issues of causation. The Advisory Cornmiace left this issuc to policy makcrs and the coum. Grouping the relevant experiments together for purposes of compensation is impossiblc because each cxperimcnt is diffcrent in terms of Icvcl of exposure, cur- rent state of knowledge about potential for injury, and other significant issues. The strictness or looseness of rcquire- ments for causal associations are policy dccisions rather than scientific questions with objcctivc answers. Dcvclop- mcnt of an appropriatc policy rcquircd consideration of situations whcrc, as the Cornmittcc stated, "(1) it is irnpos- siblc to determine thc likcly range of association bctween the exposure and the illness (bccausc the facts about dose or method of exposure are not available) and (2) the likely range of association is broad or thc probability of association betwecn the exposure and thc illness is Iow.~~* In each rcmedy recommendation below, the criteria required to satisfy claims of wrongs or harms are discussed.

Types of remedies Remedies servc different purposes. Broadly construed,

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monetary remedies either may be compcnsatory-including rcimbunement of medical costs, 1st earning, other real costs, and payment for pain and suffering-or they may be punitive. Rcmedia may be due to the injurcd individual or to the next of kin or other family members. Nonmon- etary remedies may include specific performance or apology. All these remedies may also serve a deterrent value, dcpcnding on the number of individualsto whom they apply and the visibility and publicity surrounding the award.

US. history provides examples of federal legislation granting apology only, compensation only, and compensation provided in conjunction with a broad govcrnmcnt apology. The federal government has extendcd apologies to those it admitted wronging andlor harming For example, through the vehicle of a public law, Congress, on behalf of the pcople of thc United States, apologized to Native Ha- waiians in 1994 for the 1893 overthrow of the Kingdom of Hawaii and the deprivation of their rights to self-dcter- mination." Congress also apologized in 1988 "on behalf of thc people of the United States for the evacuation, relo- cation, and internment"" of those of Japanese ancestry during World \%r IJ. In addition, in 1990 Congress apolo- giad to individuals through the Radiation Exposure Com- pensation Act (RECA).'" RCCA is a federal law that pro- vidcs for both a government apology and monetary compensation to individuals whose health suffered either by exposure to radioactive gases while mining uranium for production of U.S. atomic weapons or by exposure to fall- out from govcrnment-sponsored above-ground nuclear tests in Nevada, Utah, and Arizona.

Similarly, the fcderal government has financially com- pcnmtcd citizens who have been harmed as a result of govcrnmcnt action or omission. Compensation can be made through congressional appropriation or court order. For cxamplc, a S 1 .U billion trust fund was rsrablishcd to pay rcparations to Japancse-Americans, who were placed in internment camps during World War 11, and to their families. Monetary compensation has also hecn awarded to subjects of human experimentation. The government paid, under court ordcr and congressional action, some of the subjects (cnd their familics) of mind-contra1 cxpcriments that were part of the CIA program codc-named MKULTRA.IL These subjccts suffered serious harm or died as a result of their participation. In the notorious Tuskegee Syphilis Study, the guvcrnment agrced, in an out-of-court settlcmcnt, to provide cash paymcnts to former subjects or thcir heirs, to provide continuous lifetime medicdl care for subjecrs, their spouses, and offspring, and to provide death benefits for former subject^.'^

The Advisory Committee's remedies recommendations The rcmedia recommendations of the Advisory Commit-

tee enunciate three arcumstances in which apologies, financial compensation, or both should be provided by the government. The Committee did not limit itself to propos- ing only approaches currentty available under federal law. To the extent that proposed remedia were not currently possible, the Committee encouraged the Clinton administration and Congress to work to make them available by appropriate means.

All the Advisory Committee's recommendations were directed to WC, which was charged by the President with their review and implementation. The recommendations are discussed herc in terms of two categories of experiments: (1) experiments warranting apology only; and (2) experiments warranting apology and financial compensation. As is dimmed, some kind of specific evidence is required for each recommendation, whether it be evidence of inadequate consent, unjust subject selection, potential benefit of the research, research injury, or the secrccy of a research project. None of the recommendations is a "blan- ket" recommendation in which the conclusions of the Com- mittee warranted a remedy without requiring evidence. All claims, whether they be for wrongs, harms, or both, re- quire that individuals come forward with some evidence specific to thcir research participation. Below, the recommendations are reproduced and described, then the conceptual basis for each, along with details of experiments satisfying the recommendation's criteria, arc discussed.

Experiments warranting apology only: Recommendation A

Recommendation A'" The Advisory Committee rec- ommends ... that for subjects who were used in experiments for which thcre was no prospect of mcdi- cal benefit to them and there is evidence spccific to the experiment in which the subjects were involved that (1) no consent, or inadequate consent, was obtained, or (2) their stlcction as subjects constituted an injustice, or both, the government should offer a personal, individualized apology to each subject.'Y

The overriding goal in the Committee's recommendations was to 'bind the nation's wounds" from this period of U.S. history, and apology satisfies that goal in a number of ways. First, an apology carries with it an admission of wrongdoing. Many who gave testimony to the Committee during public meeting made it clear that an admission of wrongdoing was among the most important things the government could do for the subjects of research, their surviving families, and the country as a whole. This would begin the healing procas that motivated those who t d - fied and the Committee members. Second, an apology is public evidence that those affected were treated in unac- ceptable ways, c o n h i n g what some individuals had been

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unable to communicate for many years. Third, an apology carries with it a commitment to avoid similar wrongdoing in the future. Together, the meaning of an apology and its effects go a long way toward the sought after process of collective hcaling.

Apology, but no financial compensation, was tecorn- mended in cases where no injury was suffered from par. ticipation in research, and in which evidence could be produced showing that no, or inadequate, consent was obtained or that subject selection was unjust. Subjects in such research were considered wronged, but not harmed. I f such evidencc were produced, such individuals would dcserve a personal and individualized apology?” As discussed below in Recommendation B, cases of wrongs and harms (rcsearch injuries) were deemed to warrant both apology and financial compensation.

The Advisory Committee found sufficient evidence to support a remedy of a personal apology in response to wrongs against subjects in the nutritional absorption study performed during the late 1940s and early 1950s at the Fernald State School in Massachusetts, a state institution for children labeled as mentally retarded.z’ In research funded by NIH, AEC, and the Quaker Oats Company, researchers from the Massachusetts Institute of Technology fed breakfast cereal containing radioactive iron and cal- ciuili to members of the “science club.” Although the doses werr: low, and it is extremely unlikely that any of the children were harmed, this particufar group of studies was fouid to be morally troubling for at least two reasons: (1) available evidcncc indicates that parents were nor provided with adequate information about the studies, and (2) the studics raise serious questions of fairness in selecting insti- tutionalized children as the subject population. Poignant support for the second reason was provided by a rhetorical comment, made during one of thc Commirtce’s public meeting, as to why thosc doing the study did not “use the boys up the road at Choate instead.” Here, apology is rec- ommended because evidence indicate a wrong-that adequate consent was not obtained and that subject selection was unjust.

Experiments ruarranting apology and financial cornpensation: Recommendation B

Recommcndation B? The Advisory Committee rec- ommends ... that for subjects of human radiation expcrimcnts that did not involve a prospect of direct medical benefit to the subjects, or in which intervcn- tions 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, individu- alizcd apology and provide financial compensation to cover relevant medical expenses and associated

harms (pain, suffering, loss of income, disability) to thesubjects or their surviving immediate family members.”

As reflected in Recommendation B, the Advisory Com- mittee concluded that an apology plus compensation is due LO those who are both wronged and harmed, that is, those subjects who took pan in experiments that were without prospect of direct medical benefit (historically referred to as nontherapeutic research) and that resulted in physical injury from research participation. Unlike Recommenda- tion A, Recommendation B does not address consent issues directly, instead it relies on the presumption that adequate consent was not obtaincd given the practices of the time.2‘ This presumption was based on review of historical records, interviews, and oral histories of researchers who worked during this period, and the published histories of research ethics policies and practices.

To satisfy Recommendation B, evidence is required to support the claim that an individual was injured by participation in research that offered no prospcct of individual benefit or in controversial treatments that were presented to patients as conventional therapy. If such a claim is supported, by a finding of the courts or some other forum designated by the government, the subject would be due both financial compensation and a personal and individualized apology. Compensation in this instance means cov- ering “relevant medical expenses and associated harms (pain, suffering, loss of income, disability) to the subiccn or their surviving immediate family memben.”2s If the individual is unable to produce support for a claim of research injury but had sufficient evidence for a claim of no, or inadequate, consent or unjust subject selection in a particular experiment, they would only be eligible for an apology under Recommendation A.

Several experiments examined by the Advisory Com- mittee are potential candidates for compensation under Recommendadon B. These experiments include: uranium injections of six patient-subjects a t the University of Roch- ester during the 1940s and eleven patient-subjects a t Massachusetts General Hospital during the 1950s; some of the experiments involving injection of iodine-131 into children during the 1950s and 1960s; the administering of iodine-131 to Alaska Natives during the 1950s; and radioiron nutrition experiments involving 820 pregnant women at Vanderbilt University during the 1940s. Notable among the experiments reviewed in some detail by the Com- mince are the taticular irradiation experiments on prisoners and the total body irradiation experiments on cancer patients.

In a series of experiments on prisoners at state correctional facilities in Washington and Oregon bewecn 1963 and 1973, testes of healthy subjects were exposed to an x- ray source to assess the effect of irradiation on male f e d -

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ity. These studies, funded by AEC, were performed to un- derstand radiation effects on astronauts in space flight and on workers and military personnel in nuclear weapons development and testing. Today’s important ethical con- cerns-balancing risks and benefits, consent and subject selection-appear not to have been carefully addressed by those with oversight responsibility for the experiments. The evidence suggests that the volunteers, who were paid for their participation, were informed that no potential health benefits were expected, but they may not have been told what the potential acute effects of the experiments could be. In addition, many might not have understood the small risk of testicular cancer or the ramifications of agreeing to a vasectomy as a requirement of participation in the ex- perim ent.

In DOD-supported studies with both therapeutic and military research purposes, beginning during the 1940s and continuing through the early 1970s, cancer patients were exposed to total body doses of radiation. The most publicized of these experiments were conducted on patients at the University of Cincinnati during the 1960s and early 1970s. The therapeutic reasons offered for these experiments have proven to be controversial, because some ex- pens have seriously questioned whether ar that time any potential medical benefit could have been expected to ac- crue to these patients. A separate and stated goal of the research was to collect military information for nuclear weapons development and use-both in terms of battle- field effects of total body irradiation (as a result of nuclear attack) and the occupational hazards of accidental total body irradiation in weapons production. As concluded by the Advisory Committee, this comminglingof research goals called into question the quality of information given to patient-subjects, many of whom apparently believed they were receiving standard treatment for their cancers, and it might have also blurred the lines of responsibility for oversight and protection of patient-subjects. Because of the length of time since the experiments were undertaken and the dcarth of existing data and records, unresolved questions remain about the potential harm caused to the subjects.

Experiments warranting apology and financial compensation: Recommendation C

Rccomrnendation C:” The Advisory Committee rec- ommends ... 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 Recommendation C, even though those involved in secret experiments might not have experienced direct physical harm, the Advisory Committee felt it was appropriate to recommend both apology and compensation due to the seriousness of the wrong committed. Intentional deception at the hands of the government and insufficient justification are, in the Committee’s words, “assaults upon the foundations of individual privacy and self-determina- tion.”’ Added to the wrong committed against these subjects by the initial deception was the ongoing secrecy that prevented them from seeking justice within their lifetimes. The Cornmitree concluded that the offense of unjustified and continued deception warranted financial compensation. The Committee concluded that evidence of secrecy in research essentially trumps the cvidentiary requirements for inadequate consent or research injury seen in Recom- mendations A and B. Research performed under con& tions of secrecy without the subjects’ knowledge obviously mocks the consent process, warranting apology; and the overriding seriousness of the wrong warrants compensation without requiring proof of research injury.

Evidence indicated that some experiments had been secretly performed, prcsumably justified by national SKU-

rity considerations. However, previously classified and other publicly inaccessible documents indicate that the rationale for secrecy was far more mundane and less compelling: the federal government in some cases deliberately concealed participation in experiments from the subjects in order to avoid embarrassment or potential legal liability. The plutonium experiments, the cases that triggered the investigation leading to the formation of the Advisory Committee, were among such experiments.

In some experiments conducted during the 1940s and 1950s, sick patients were injected with radioisotopes that offered no potential for direct medical benefit, and secrecy was closely maintained. The radioisotopesselected for these experheits were substances used in nuclear weapons production (for example, plutonium, uranium, and polonium). I t was hoped that the experiments, which involved the col- lection of bone, urine, and feces from the injected patients, would aid in assessing the biological effects of radiation exposure of workers involved in weapons production.

In the plutonium injection series, eighteen patients at various institutions throughout the United States (including the University of Rochester, University of Chicago, and University of California at San Francisco) were injected with plutonium. All subjects were hospitalized patients: one was recovering from an automobile accident, some were cancer patients, and others were comatose or beliwed to be suffcring from trrmind or chronic illness All were expected to live ten years or fewer. The experiments are

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acknowledged in government documents to have offered no potential medical benefit for the patients, and, although not expected to cause acute effects, put the subjects at risk of developing cancer within ten or twenty years. In what appears to be an unexpected turn, some of the subjects lived for far longer than the predicted maximum of ten years. The Advisory Committee was unable to conclude whether any ir..’.vidual was physically harmcd as a result of the injections.

Available evidence suggests that the patient-subjects wcre never told that they were participants in an experiment. National security considerations may have required kceping secret the names of classified substances, but should not have required using subjects without their knowledge or deceiving them into believing that they were receiving treatmen; or benefit from the injections. In some cases, secrecy was carefully maintained until the mid 1970s.

Secrecy in this context has had the effect of limiting individuals’ opportunities to seek redress based on their research participation. The Committee viewed these kinds of behavior as among the most serious uncovered in its work. Efforts at cover-up are also an attack on the com- munity and on individual subjects, seriously undermining both public perception and the government’s ability to ensure that its agents act within the law. That this offense had far greater reach than individual subjects justified providing compensation for surviving family members of the subjects as well.

Follow-up to the recommendations and the Final Report By describing its conceptual approach to remedies, the Advisory Commince provided a basis for other former research subjccts, unknown today, to come forward in the fumre. In his remarks on accepting the Committee’s report, President Clinton offered a broad apology on behalf of the federal government to former subjects of human radiation experiments and their families, and he directed IWC to review the findings and recommendations of the Committee to determine the next steps to be taken, particularly in the area of compensation to subjects of radiation experiments and their families. The President’s remarks on Accepting the report underscore the significance of the Committee’s recommendations:

When the government docs wrong, we have a moral responsibility to admit it. The duty we owe to one another to tell the truth and to protect our fel- low 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. We know there are moments when words alone

are not enough. That’s why I am instructing my Cabi- net to use and build on these recommendations, to devise promptly a system of relief, including compensation, that meets the standards of justice and con- science.

When called for, we will work with C o n g a to serve the best needs of those who were harmed. Make no mistake, as the committee report says, there arc circumstances where compensation is appropriate as a matter of ethics and prinaple. I am committed to seeing to it that the United States of America lives up to its responsibility.’Y

As directed by the President, IWG is actively reviewing the Advisory Committee’s recommendations. Shortly after the release of the Final Report and the disbanding of the Committee, IWG met with a group of “stakeholder” representatives to discuss the Committee’s compensation recommendations and their implementation. Since then, the U.S. Senate Governmental Affairs Committee held a hearing on the subject of human radiation experiments.’”

Despite the Advisory Committee’s guidance on both individual experiments and in creating a general basis for remedies, difficult judgments remain in deriving a fair policy for how to determine eligibility for compensation in actual cases. Pending lawsuits and claims will have an impact on federal government direction or action on compensation in response to the Committee’s recommendations, but the impact is not yet predictable. More than a dozen cases and administrative actions have been brought against the federal government and other defendanrs These actions were filed before, during, and after the Committee’s term.” Plain- tiffs or claimants include subjects or representatives of the subjects of the plutonium injection experimenrs, the Cin- cinnati total body irradiation experiments, the testicular irradiation experiments on prisoners, the Fernald School nutrition experiments, and the iron absorption experiments on pregnant women at Vanderbilt University. Generally, these cases allege common law torts (for example, battery, negligence, negligent infliction of emotional distress, acd medical malpractice), wrongful death and survival claims, and deprivation of due prtress. The federal government is not named in all of the casts; some are restricted to claims against particular states or institutions. Given that govern- mcnt representatives are in discussion with plaintiffs’ coun- sels, formulation of any particular approach to remedies will take these negotiations into account. As this article goes to press, settlements in various lawsuits have already been proposed.lZ

President Clinton acknowledged the importance of the work the Advisory Committee undertook and completed in reviewing a chapter of U.S. history. He acknowledged as

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well the importance of the Committec's insights into thc protection of research subjects today'' by ordering the a- tablishmcnt of thc rcccntly appointed National Bioethics Advisory Commission. This commission will provide ad- vice and recornmendations on the appropriateness of cer- tain governmcnr policies and practices in biocthics, including principles for the ethical conduct of research.>' In assessing U.S. rcsrarch policies and practices during the Cold War and how that legacy can be understood both historically and presently, the Committee shed new light on our collcctive past and, we hope, will deter wrong of the past from recurring. The key to the success of this effort is the willingness of the government to admit its wrongdoing, which has implications for redressing w r o n g already com- mittcd and those that might be discovered in the future. The Clinton administration has made public statements signaling its commitment both to applying and creating the opcnness critical to making that application effective. The willingness of the government to a n on and imple- ment the finding and recommendations of the Advisory Committce will be a measure of that effectivcness.

Acknowledgment The Final Report of the Advisory Committee on Human Radiation Experiments is available from either the US. Government Printing Office (GPO) (no. 061-000-00-848- 9, $44.00; Executive Summary, no. 061-000-00849-7, $2.75) or The Human Radiation Experiments (Ncw York: Oxford University Press, 1996), $39.95 (including the text of the President Clinton's remarks and an index). The full text of the report and the summary are also available on the World Wide Web, at hnp://nattie.eh.doc.gov/systems/ hrad/report.html, and documentation from the Advisory Comrnittec at http://www.seas.gwu.edu/nsarchive/radiation. The supplemental volumes to the Final Report (nos. 061-000-00850-1,$42.00; 061-000-00851-9, $12.00; and 061-000-00852-7, $43.09) may be purchased from GPO.

References 1. The Advisory Committee mcmbcrs were: Ruth hden,

P1i.D.. M.P.H., Chair; Kenneth Fcinberg, J.D.; Eli Clatsrein, M.D.; j a y f f i q M.D.; Patricia King, J.D.; Suun Lederer, Ph.D.; Rwh Liacklin, Ph.D.; Lois Norris; Nancy Oleinick, Ph.D.; Henry Rnyal, M.D.; Philip Russcll, M.D.; Mary Ann Stevenson, M.D., Ph.D.; Duncan Thomas, Ph.D.; and Rred Tuckson, M.D. The staff effort WY directed by the te311t of: Daniel Gutunan, J.D.. Executive Director; Jeffrey M n , Ph.D., M.P.H., Associare Di- rector; and Anna Mmroianni, J.D., h i a r e Director.

2. Advisory Committee on Human Radiation Experiments, Exec. Order No. 12$91,59 Fcd. Reg. 2935 (1994).

3. Advisory Committee on Human Radiation Experiments, Final Reporf (Washington, D.C.: US. Government Printing Of- fice, 1995): at 54.

4. The focus on rcscarch that offered no or disputed potential benefit was not intcndcd to imply that a conclusion can

be dnwn that a11 research offering the prospect of medial benefit WY ethically performed during this time. Id. at 772.

5. From 1945 through 1947, Manhattan Project research- crs injected eighteen human subjects with plutonium, five with polonium, and six with unnium. Another KC of experiments took place between 1953 and 1957, in which eleven subjects were injected with unnium. Id. at 264,268.

6. The grn t majority the approximately 4,000 experiments in the Advisory Committee's database were tracer experiments, and little information is known about most of them. The Committec's analysis focused on the government's policies for distribution of radioisotopes and protecting subjects from risk. Id. at 229.

7, The Advisory Committee analyzed twenty-one %on- therapeutic" radiation experiments with children conducted between 1944 and 1974. These twenty-one were selected from eighty-one pediatric radiation experiments identified by the Committee from government documents and in the medical lit- erature. The eighty-one did not constitute all the pediatric radiation research conducted during the time, although the Corn- mince believed them to be fairly typical examples of such research. Of the eighty-one, thirty-scven were judged to be %on- therapeutic," and twenty-one of these were conducted or funded by the federal government and so fell under the charge of the Committee. Id. at 321.

8. The Advisory Committee's consideration of total body irradiation began by looking at a 1967 National Academy of Sciences "retrospective study" of total body irradiation exposures, which collected records on more than 2,000 exposures from forty-five U.S. and Canadian institutions. The Committee then focused on approximately twenty research studies published between 1940 and 1974 on the use of total body irradiation in thc United States. Id . at 368.

9. In a series of experiments carried out between 1963 and 1973,131 prisoners in Oregon and Washington submitted to experimental testicuhr irradiations. The cxpcriments had national security and other societal goals, but no potential for therapeutic benefit for the subjects. Id. at 421.

10. Id. at 786-88. 11. td. 12. Id. at 805.

14. Civil Libcrtics Act of 1988, Pub. h w h'o. 100-383,102 Stat. 903 (1988).

IS. Radiation Exposure Compensation Act, Pub. Law No. 101-426, 104 Stat. 920 (1990).

16. Thesc awards included $750,000 authorized by Con- gress in 1976 to bc paid to the family of Frank Olson because he died as a result of CIA-sponsored LSD experiment; $703,000 authorized by court order in 1987 to be paid to the family of Harold Blauer because he died Y a result of his part in a secret U.S. Army experiment involving mexaline; and $750,000 authorized by court order in 1988 to be paid to nine Gnadians for their participation in nonfatal CIA-sponsored brainwashing experiments.

17. See J.H. Jones, Bud Blood (New York Free P rey 2nd ed., 1993): at 217,277 citing to U.S. District Court in Ahbama, "Stipulation of Settlcmcnt," Chartes W: Pollard. et ul. v. United Sfures of America, ef al., No. 4126-N.

18. ?hi is Rccommendation 3 in the F i n d Report. See Ad- visory Committee, supra note 3, at 805-07. Rccommendaticns are renamed here for clarity.

19. Id. at 805. 20. The Advisory Committee intentionally settled on a "per-

sonal and individualized" apology after exploring three options:

13. Pub. L ~ w NO. 103-150, 107 Stat. 1510 (1993).

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(1) a general public apology; (2) a personalized form letter apology; and (3) a personal and individualized apology written specifically to address that person's experiences. 2 1. Some who bccamc residents of the Fernald School were

not diagnosed ;IS mcntally retarded but were labeled as such by virtue of having resided there.

22. This is Recommendation 2 in the final Report. See Ad- visory Committee, supra notc 3, at 803-05.

23. Id. at 803.

2.5. Id. at 803. 26. This is Rccomniendation 1 in the f i n d Report. See id.

27. ld. at 801. 28. Id, at 802. 29. Advisory Committee on Human Radiation Experiments,

The Humun Radiotion Experiments (NCW York: Oxford Univer- sity Press, 1996): at xviii-xix.

30. The hearing was chaired by Senator Ted Stevens (R-AK) on March 12,1996. Humon Radiation Weriments: Hearing of the Senate Governmenfal w/airs Committee, 104th Cong., 2d Sca. (1996).

3 1. See, for example, I n re Cincinrtafi Radiation fifigalion, 874 F. Supp. 796 (S.D. Ohio 1995) (total body irradiation experiments on cancer patients); Mowo u. Universify o/Roches- tcr, No. 95-CV-6288T (W.D.N.Y. filed June 16, 1995) (phto- nium injection experiments); Heinrich v. Sweet, No. CV95-3845 (E.D.N.Y. Bled Sept. 21, 1995) (uranium injection experiments on hospitalized patients); Bibeurr u. Pacific Northwest Research Foundorion, No. 95-006410-HO (D. Or. filed Dec. 4, 1995) (testicular irradiation experiments on prisoners); and Shuttrrck v. Massachusetts Institute ofTcchnology, No. 95-12605GAO (D. Mass. filed Dec. 18, 1995) (radioisotope experiments on insti- tutionalized children).

32. In August 1996, it WY reported that the parties in a 1994 clvs action lawsuit, concerning total body irradiation experiments, had reached a $4.25 million settlement. This action was brought by the families of the University of Cincinnati radiation experiment subieas against the University of Cincin- nati, the City of Cincinnati. federal project officers, and fifteen

24. Id. at 785-86.

at 801-02.

individual defendmts, including physicians and rcsesTchers. The settlement is subject to approval by the court. Associated Prey "Lawyers Gather Support for Settlement in Radiation Testing," Columbia Disputch, Aug. 30, 1996, at 7B. Also in Augusr 1996, it was reported that some of the defendants had agreed to a settlement in the case of experimenainvolving radioactive mcecs in over 800 pregnant women at Vandcrbilt University. Monsanto Company, who allegedly shipped the radioactive iron, and the federal government reportedly agreed to a $100,000 settlement. C. Trevison, "Radiation Settlement Sought; Would Allow Pay- ments by Momnto, Federal Government," 7he Tmnessurn,Aug. 10, 1996, at 4B. Two other defendants, the Tennessee Depart- ment of Health and the Nutrition Foundation in Washington, earlier reportedly paid $100,000 and $125,000 to settle claims against them. C. Miller, "40s W Tit Didn't Explain Risk: At- torneys," Nashville Banner, July 2, 1996, at 82. No settlement has been reached with Vanderbilt University, its m e d i d center, or the Rockefcller Foundation. See Trevison, id. at 4B.

33. To augment the lwons learned through its findings, the Advisory Committee also undertook three research projects on the state of contemporary human subjects research. These projects, their findings, and the Committee's recommendations that grew out of them a n be found in the Final Report. Advi- sory Committce, supra note 3, at chs. 14-18. Discussion of these projects can be found in N. K3ss and J. Sugrman, "Are Rc- search Subjects Adequately Protected? A Review and Discussion of Information Gathered by the Advisory Committee on Hu- man Radiation Experiments," Kennedy Institute o/ Erhics lour- nu/, 6 (1996): 271-82.

34. Protection of Human Research Subjects and Creation of National Bioethics Advisory Commission, Exec. Order No. 12,975,60 Fed. Reg. 52,063 (1995). Priority items for consideration by the National Bioethics Advisory Commission W A C ) are human subjects protection and genetic information. NBAC has a two-year term, subject to acns ion , and will operate in full public view under the Federal Advisory Committee Act. Although it will report to the National Science THhnology Coun-. cil, a body that advises the Office of Science and Technology Policy, it will be administered through DHHS. Appointment of fifteen of the eighteen members of NBAC was announced on July 19, 1996.

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