The Arctic Aeromedical Laboratory's Thyroid Function Study A Radiological Risk and Ethical Analysis (1996) / Chapter Skim
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3 The Ethics of Human Subjects Research
3 The Ethics of Human Subjects Research
Pages 43-61
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From page 43... ...
To determine whether the AAL thyroid function research followed "generally accepted guidelines," the Committee had to consider both principles and practices. If only the principles of research ethics were considered, then virtually all research would be unethical, as principles can only rarely be employed in a manner that raises no questions at all.
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From page 44... ...
These issues are discussed at length in A History and Theory of Informed Consent (Faden and Beauchamp, with King, 1986) , which is drawn upon heavily here.
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From page 45... ...
It is essential to understand that the Nuremberg Code was intended, and was understood at the tine, to be an expression of existing and universal moral principles governing research with human subjects (Advisory Committee
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From page 46... ...
Dr. Ivy served as the AMA's official consultant to the Nuremberg prosecutors and played a significant role in the development of the Nuremberg Code (Advisory Committee on Human Radiation Experiments, 1995~.
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From page 47... ...
The Ethics of Human Subjects Research 47
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From page 48... ...
(The policy remained classified until 1975.) The Atomic Energy Commission discussed informed consent issues in a series of letters dating back to 1947 and developed subject consent requirements for the use of radioisotopes it supplied to medical researchers, but did not systematically promulgate or enforce them (Advisory Committee on Human Radiation Experiments, 1995~.
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From page 49... ...
The Belmont Report sets forth the same three basic ethical principles governing human subjects research that were outlined early in this chapter and that underlie the Nuremberg Code: respect for persons, beneficence, and justice. The report points out that respect for persons demands the informed and voluntary consent of the subjects; beneficence demands an assessment of the relative probability and magnitude of risks to subjects against benefits expected from the results; and justice demands equitable selection of subjects and equitable distribution of the research's benefits and burdens between research subjects and the population at large.
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From page 50... ...
RodahI, when asked directly over the telephone during the public hearing in Fairbanks if he had any guidelines similar to the Nuremberg Code for obtaining informed consent, told the Committee that he did not, but that he had approvals from his supervisors and if there was anything wrong with the research it would not have been approved, and he would not have been allowed to publish his study results. However, the Nuremberg Code itself, in its own language and as set forth in the medical and scientific literature of the times, is unqualified in its application to "the human subject." The Code was developed to be an expression of universal moral principles governing research with human subjects it was considered to represent current research ethics, acceptable and accepted at the time rather than new terrain.
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From page 51... ...
Subjects, both Alaska Natives and Air Force personnel, were given some information and an attempt at obtaining informed consent was made. The radioactive tracer was administered in doses believed to be harmless, and the purpose of the research was not to determine the effects of radiation in the human body7.
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From page 52... ...
125) , the elements that define consent in the Nuremberg Code correspond well to the Committee's contemporary concept of "informed consent," and so that term is used here for convenience.
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From page 53... ...
. The AAL research took place within a general context that included multiple visits by a variety of authority figures to Alaska Natives, for study, treatment, and other reasons.
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The Committee's criticism of the AAL researchers is based on their lack of efforts to attend to, or reduce, linguistic and cultural barriers- not on their failure to succeed. In the Committee's opinion, what the researchers obtained was closer to mere cooperation than informed consent.
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From page 55... ...
that health services were provided to Alaska Natives by the U.S. Department of Education before the Bureau of Indian Affairs took on that function.
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The notion of seeking informed consent from individuals was certainly not foreign to Alaska Natives at the time. Although Native peoples, including Alaska Natives, emphasize cooperation and community, individuals still have important rights and interests (see, for instance, Tjsselmuiden and Faden, 1992~.
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From page 57... ...
Although the principle of justice had been invoked in connection with human subjects research prior to the 1950s, at the time of the AAL research the perception of injustice resulting from social biases against minority populations was not well developed. In retrospect, a variety of activities over many decades seem to have made use of the lands and peoples of Alaska as means to the ends of others, with insufficient consideration of Alaska Natives as autonomous persons with interests of their own.
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From page 58... ...
In weighing the risks and benefits of this study, it is necessary to look at one a~sproport~onate~y nigh numbers or Alaska Natives selected to participate. The AAL research was performed to help prepare Air Force personnel to fight and survive in a possible future war fought in the Arctic.
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From page 59... ...
This reinforces the impression that the Alaska Natives represented a subject population of convenience. The Committee recognizes that Alaska Natives were needed as subjects to answer the research question; however, their disproportionate numbers by comparison with military personnel, and the researchers' failure to seek out indigenous non-Native subjects, emphasizes that their relative lack of understanding may have made Alaska Natives easier to recruit.
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From page 60... ...
Few of the Alaska Native subjects understood that they were participating in research. None of the subjects, neither Alaska Natives nor military personnel, were informed that they were taking a radioactive tracer.
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From page 61... ...
Although the Alaska Natives brought special physiological characteristics because of their long-term adaptation to the climate, Tong-term white Alaska residents were not sought. The AAL researchers held a genuine belief, justifiable at the time, that the research they were conducting was both harmless and necessary.
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