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Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
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Page 62
Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
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Page 63
Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
×
Page 64
Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
×
Page 65
Suggested Citation:"4 Conclusions and Recommendations." Institute of Medicine and National Research Council. 1996. The Arctic Aeromedical Laboratory's Thyroid Function Study: A Radiological Risk and Ethical Analysis. Washington, DC: The National Academies Press. doi: 10.17226/5106.
×
Page 66

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4 Conclusions and Recorrunendations After examining the records, analyzing the health risks, and talking with research participants as well as researchers, the Committee concludes that in all probability the AAL thyroid function study caused no physical harm to the subjects. As calculated in Chapter 2, the weighted average risk among the populations that participated in the AAL thyroid function study is about ~ In 3,000, a risk six times lower than the background thyroid cancer risk in the United States. The greatest risks (albeit small) of thyroid cancer appear in the people who received multiple }~3{ doses. In particular, the Anak~vuk Pass females and the Arctic Village females who received multiple doses have calculated risks of ~ in 800 and ~ In 700, respectively. Because thyroid cancer is rare (about 5 cases per 100,000 population annually), the additional radiological risk is extremely low, and radiation-induced thyroid cancers caused by the AAL study would not be expected in either the Alaska Native or white military personnel who participated as research subjects. Some health benefits may have been coincidentally provided because the researchers identified endemic goiter problems in Arctic Village and Anakcuvuk Pass. From an ethical perspective, the Committee concludes that the Alaska Natives who participated and, to a lesser extent, the military research subjects were wronged. Although the AAL thyroid function study was conducted according to generally accepted scientific and medical procedures of the tunes, there was a specific violation of existing ethical standards because information on the li3} tracer was not disclosed. Thus the Alaska Native and military subjects were not fully informed about the nature and risks of the research. This omission was wrong, even though the risk of harm was believed at the time to be nonexistent and has since been determined to be extremely low. The blurring of medical care and research activities, as well as cultural differences, compromised the ability of Alaska Native subjects to recognize not only that Hey were participating in research, but that refusal to participate would not harm their health. The language barrier between researchers and study subjects in the Native villages and the use of Native interpreters who were not scientifically trained prevented participants from gaining a complete understanding of the research and its risks. In addition, some study subjects should have been excluded on the basis on the basis of age or other physical conditions. 62

Conclusions and Recommendations 63 The study's flaws are not attributable solely to the AAL researchers in the field, but are shared by their superiors in the U.S. Air Force and the Department of Defense chain of command who approved the research or were aware of it. Indeed, what we today identify as inappropriate was common for the times. It should be noted that during the 1950s and later many researchers viewed obtaining consent as essential only for obviously risk-bearing research, because of the circumstances that produced the Nuremberg Code. However, neither the Code by its teens nor the American Medical Association (AMA) or DOD requirements hasec! on it . contain such a caveat. .. . . . . , _ _ _ ~ ~ .. It IS Important to emphasize that while the Committee believes it is inappropriate to place individual blame for the flaws of the AAL study, it is essential for the government to acknowledge that wrongs were done. The researchers were conscientious scientists who held genuine belief, justified at the time, that their research was both harmless and Important. The lack of emphasis on autonomy and infonned consent, and the lack of cultural sensitivity, were standard errors of the time. It is the Committee's hope that acknowledgment of these wrongs will reduce the likelihood of sunilar wrongs in the future. The Committee heard repeated concerns about the history of abuse of the Native people by the incoming white culture. In the Alaska Natives' view, the AAL study was a small but characteristic event in the ongoing tradition of using the Native peoples for the benefit of others with little regard for their interests. Although the Committee was limited by charge and resources from considering this wider context in any depth, its recommendations are not unrelated to this underlying concern. As explained in a review of the social and psychological stress faced by veterans of above-ground nuclear testing and similar nuclear weapons-connected events conducted by the government, there is a relationship between trust and acknowledgment elf error ((~.~rri~ 1q`~/I n Visa>. ''r~llrh ~rPt~r~n~1 V1 `_llV1 ~V"l~l"' $~' if. and. Lowell Vat . . . must deal with the possibility that their lives were undermined without apology, acknowledgment of error, or recognition of their service to their country." The Department of Energy, in a parallel activity investigating the use of human subjects in radiation research, acknowledges the importance of dealing with past wrongs directly and openly. As stated in a 1995 report (Deparunent of Energy, 1995~: Over the past several decades, the American people's trust in our institutions o government has greatly eroded. Many complex factors have contributed to this erosion, not least among them the secrecy associated with our Cold War nuclear competition with the Soviet Union. Without judging the historical necessity of secrecy, and in recognition that even today some activities require national security classification, it is a fact that the ability of the Government to perform its post-Cold War missions is greatly impeded by pervasive public distrust of its motives and competence. The commitment to openness, of which this project is a very visible element, is a deliberate effort to rebuild that basic level of trust between the American nec)nle and their government that is necessary for a democracy to function. ---I- r-~r~~ ~~ - ~~~~~~ The Alaska Natives who spoke to the Committee were clearly frustrated by the lack of communication and lack of acknowledgment. Until this Committee held its public meeting, beliefs about how the goverrunent conducted itself had not been given a forum for expression. As a result, Alaska Natives are dealing with unresolved burdens in regard to trust and justice. However belatedly, the Air Force, U.S. health organizations, or the Congress could redress the

64 The MAIN Thyroid Function Study wrong of failure to obtain informed consent during the AAI~ thyroid function study with information now. The ongoing provision of meaningful information could provide surviving subjects, their families, and their villages with better understanding of the true magnitude of the risks and possible consequences of the research. This demonstration of respect for their autonomy and concern for their well-being could help restore a sense of control to the Native populations over their own health decisions and hopefully increase the level of trust. The present inquiry affords the federal government a singular opportunity to give audience to urgent and long-held Native concerns. In this spirit, the Committee recommends the following: (A The government and the Air Force should acknowledge responsibility for wrongs done in the course of the ALL thyroidfunction study in the hopes of ensuring that similar problems do not occur in the future, and they should address these wrongs by undertaking the following actions: (aJ The Air Force should endeavor to contact all living sublects or their immediate families and provide records to them v ~ of their ALL research participation in the /~3] experiments. The Air Force should also continue to search for records of the ALL that would identify the six U. S. Army subjects and six Point Hope subjects who were not named in the Air Force report of the study, and to locate the Air Force and Army subjects named in the study. (bJ In the process of contacting subjects and subjects' families, the Air Force should disseminate the Committee's report and other available information on human medical experimentation conducted by the ALL in the period 1948-Z967 to appropriate health care providers, tribal governments, anal other key figures in the relevant Alaska Native villages. This dissemination of information could be accomplished in the six affected Native villages by having a group of medical and ethical experts provide a briefing on the Committee's report at a town meeting and answer questions related to the AAL research. A concise, readable summary of such information (preferably bilingual) also should be prepared. Even though material related to the AAL studies is available in larger Alaska public libraries, the lack of knowledge about studies, tests, and research conducted by that goverrunent facility has haunted participants and their families, some of whom took part in even the most benign of studies. (2) U.S. government and Alaska state health organizations, under U.S. government auspices, could complement the efforts of the Air Force by conducting related public health education programs facilitated by Native experts focused on conveying information about patients' rights in any therapeutic or research situation and medical information about exposure to radiation. Such a process will enable Native experts, clinics, and physicians to provide accurate information to their communities and ease fears.

Conclusions and Recommenciatior~s 65 (3) If Congress considers legislations to redress any wrongs or harms done to human subjects -of government radiation research where informed consent was not obtained, the Committee believes Congress should consider including the subjects of the CAL thyroid function study. The last question posed to the Committee was whether or not follow-up surveys should have been performed to ensure that the participants suffered no long-term ill effects from the experiments and whether medical care was needed. Extending that to the present, the Committee also considered whether medical follow-up is warranted today based on our current understanding of the risks involved. Such medical follow-up would focus on the major negative health effects associated with }~3} exposure disorders of the thyroid gland, including thyroid cancer and the development of thyroid nodules. (There is no evidence of a link between }~31 exposure and skin disorders, a concern raised by some study participants at the public hearing.) Because the dosages of radioactive iodine used in the AAL study were thought to be hanniess at the time and there were no guidelines requiring follow-up for diagnostic doses, no follow-up would have been indicated. In reexamining the doses of radioisotope ingested by the research subjects, the Committee concludes that there is no justification based on risk for medical follow-up. The risk, even among research subjects who received multiple doses, is substantially lower than the background incidence of thyroid cancer in the United States. (4) Although medicalfollow-up based on the calculated risk values is not warranted, the U.S. Air Force should provide medical follow-up to those participants who were under age 20 at the time of the ALL study since those participants will be at risk for the longest period of time. Such follow-up would provide assurance that these participants suffered no [ong-terrn physical ill elects. Various laws have some bearing on issues in this study. For instance, common law provides that governments cannot be sued by their subjects (Feres v. United States, 340 U.S.C. 135, 139 (19501~. The Federal Tort Claims Act (28 U.S.C. v§2674 et seq. (1988~) authorizes federal liability for compensatory damages in limited circumstances, but not when the injury results from the exercise of discretionary judgment bv government officials an exception that has barred recovery for uranium ~ J C7 -~ ~ C7 · ~ .~ · ~ ~ Or ·, ~ m~ ~ _ ~^ ~ ~ ~ 1 ^~^ ~^.1_ an- 1 ^~\ ___ ~ lo_ ~ _ ~ miners on-tne-~oo exposure <negary v. unllea elates, 1~ r.za 1~ born Air. low'' and for raulallon exposure at nuclear test sites (e.g. Prescott v. United States (D.Nev. July 21, 19941), and that seems clearly to apply in the case of medical and scientific research. Legislation exists to compensate some persons exposed to radiation by the government the Veterans Radiation Exposure Compensation Act (42 U.S.C. §2210nt), and the Compact of Free Association with the Marshall Islands (48 U.S.C. §168Int). However, none of these existing statutes addresses the subjects of the AAL study or, for that matter, of other Cold War-era radiation experiments under investigation by other bodies, notably the President's Advisory Committee on Human Radiation Experiments. If such legislation is considered, the language must be carefully chosen to ensure that it encompasses all of the human subjects who, in the eyes of Congress, deserve compensation for wrong and/or harms. Two related bills were considered in the 103rd Congress, but neither passed out of committee. As this report goes to publication, the Radiation Experimentation Compensation Act (H.R. 2463) had been reintroduced in the 104th Congress and referred to the Judiciary Committee; the Radiation Experimentation Victims Act was being redrafted, with plans to reintroduce it.

66 The AAL Thyroid Function Study Such follow-up should be at government expense. It might include a review of the subjects' medical history and a physical medical examination with special attention to physical complaints, ailments, or physiological changes or disease that could be related to the AAL thyroid injunction study, specifically assessment of the condition of the participants' thyroids for the occurrence of thyroid cancer or nodules. If a thyroid disease, including cancer, were to be found, there would be no way of determining whether participation in the AAL study had any role in causing it. Nonetheless, if thyroid disease were found the federal government should be responsible for all expenses associated with treatment. In the remote possibility that thyroid disease is found for those under 20, the Air Force should then reassess the issue and decide if more subjects should receive medical follow-up. The Committee recognizes that its basic conclusion-that the subjects of the AAL thyroid function study were wronged but not harmed-may prove controversial. Some will claim that the Committee's calculations are incorrect and that the risk is higher. Others will believe that the Committee failed to go far enough in suggesting ways to right the wrongs. Some will say that the Committee failed to understand the climate of the tunes the intensity of Cold War pressures and national security concerns and the fact that many researchers truly did not believe that the Nuremberg Code applied to benign human subjects research. They may claim that the Committee was swayed by the clarity that only hindsight brings. The Committee believes that these various perspectives arise from concern for the people involved, both the researchers and their superiors and the research subjects. It recognizes that some subjectivity is inherent in this type of analysis and that honest differences of opinion can occur. Still, the Committee is convinced that its position is defensible, sensible, and ethical. The risk analysis in this report is based on the best epidemiology and dosunetry available. It is, if anything, conservative; risks may actually be smaller than expressed. The Committee's position acknowledges the flaws of the AAL thyroid function study within the context of history' while not placing blame on those who conducted the research using what they perceived to be harmless methods in pursuit of justifiable goals.

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During the 1950s, with the Cold War looming, military planners sought to know more about how to keep fighting forces fit and capable in the harsh Alaskan environment. In 1956 and 1957, the U.S. Air Force's former Arctic Aeromedical Laboratory conducted a study of the role of the thyroid in human acclimatization to cold. To measure thyroid function under various conditions, the researchers administered a radioactive medical trace, Iodine-131, to Alaska Natives and white military personnel; based on the study results, the researchers determined that the thyroid did not play a significant role in human acclimatization to cold.

When this study of thyroid function was revisited at a 1993 conference on the Cold War legacy in the Arctic, serious questions were raised about the appropriateness of the activity--whether it posed risks to the people involved and whether the research had been conducted within the bounds of accepted guidelines for research using human participants. In particular, there was concern over the relatively large proportion of Alaska Natives used as subjects and whether they understood the nature of the study. This book evaluates the research in detail, looking at both the possible health effects of Iodine-131 administration in humans and the ethics of human subjects research. This book presents conclusions and recommendations and is a significant addition to the nation's current reevaluation of human radiation experiments conducted during the Cold War.

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