Federal Regulation Of Human Experimentation 1975

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 activityâ€"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.

The EPA commissioned The National Academies to provide advice on the vexing question of whether and, if so, under what circumstances EPA should accept and consider intentional human dosing studies conducted by companies or other sources outside the agency (so-called third parties) to gather evidence relating to the risks of a chemical or the conditions under which exposure to it could be judged safe. This report recommends that such studies be conducted and used for regulatory purposes only if all of several strict conditions are met, including the following: The study is necessary and scientifically valid, meaning that it addresses an important regulatory question that can't be answered with animal studies or nondosing human studies; The societal benefits of the study outweigh any anticipated risks to participants. At no time, even when benefits beyond improved regulation exist, can a human dosing study be justified that is anticipated to cause lasting harm to study participants; and All recognized ethical standards and procedures for protecting the interests of study participants are observed. In addition, EPA should establish a Human Studies Review Board (HSRB) to evaluate all human dosing studiesâ€"both at the beginning and upon completion of the experimentsâ€"if they are carried out with the intent of affecting the agency's policy-making.

The law is a mandate and a mirror; it both commands and reflects. It should not come as a shock that scientists and physicians often prefer the mirror at times when society seems to be demanding a mandate. This may be especially true in the rapidly advancing field of medical genetics, where recent discoveries leading to potentially startling applications have raised old questions of law in a new light. Nevertheless, we believe that in general the conflict between the law and science, as illustrated in the field of genetics, is embroi dered with exaggeration. The Chief Justice of the United States Supreme Court, Warren Burger, has noted that "the prime function of the law is to protect basic human values--individual human values--sometimes even at the expense of scientific progress"; and that "it is not the function of the law to keep pace with science." While both of these statements are true as far as they go, we believe the law must make an affirmative effort to anticipate scientific developments so that those beneficial to society can be nurtured rather than stultified. It was to nurture cooperation and understanding that we brought together a distinguished faculty of internationally known experts on law and genetics to discuss their fields in 1975.