Chapter 7: IntroductionIn the late 1940s and again in the early 1950s, Massachusetts Institute of Technology scientists conducting research fed breakfast food containing minute amounts of radioactive iron and calcium to a number of students at the Walter E. Fernald School, a Massachusetts institution for "mentally retarded" children. The National Institutes of Health, the Atomic Energy Commission, and the Quaker Oats Company funded the research, which was designed to determine how the body absorbed iron, calcium, and other minerals from dietary sources and to explore the effect of various compounds in cereal on mineral absorption.
In 1961, researchers from Harvard Medical School, Massachusetts General Hospital, and Boston University School of Medicine administered small amounts of radioactive iodine to seventy children at the Wrentham State School, another Massachusetts facility for mentally retarded children. With funding from the Division of Radiologic Health of the U.S. Public Health Service, the scientists conducting this experiment used Wrentham students to test a proposed countermeasure to nuclear fallout. Specifically, the study was meant to determine the amount of nonradioactive iodine that would effectively block the uptake of radioactive iodine that would be released in a nuclear explosion.
Recently, these two studies have received considerable media attention, and an official Massachusetts state task force has reported on both episodes in some detail. Although they represent special cases because they involve institutionalized children, the Fernald and Wrentham experiments nonetheless are the most widely known examples of a category of research that raises particular concerns for the Committee: nontherapeutic experimentation on children.
Experiments involving children are important to the Committee for two reasons. First, children are more susceptible than adults to harm from low levels of radiation, and thus as a group they are more likely than adults to have been harmed as a consequence of their having been subjects of human radiation experiments. Second, an evaluation of research with children is critical to determining whether any former subjects of radiation experiments should be notified in order to protect their health, one of our specific charges. Subjects who were children at the time of their exposure are more likely than adults to be candidates for such notification, both because of their increased biological sensitivity and because they are more likely to still be alive. (See chapter 18 for the Committee's recommendations with respect to notification and follow-up.)
We elected to focus on pediatric research that offered subjects no prospect of medical benefit, so-called nontherapeutic research, because it is this kind of research that has generated the most public concern and is the most ethically problematic. This is not to say, however, that experiments on children in which the children stand to benefit medically never raise ethical issues; such research certainly can and does. But in deciding how to allocate our limited resources, we chose to concentrate where the issues are mostly sharply drawn. Also, because most nontherapeutic research with children involved tracer doses of radioisotopes, focusing on this work allowed us a window into radioisotope research generally.
We begin the chapter by setting the context for nontherapeutic radiation experiments on children. We review those factors that make nontherapeutic research on children ethically problematic and how such research has been viewed historically. We next consider what the practices and standards were for research on children in the 1940s, 1950s, and 1960s. This is a continuation of the discussion in chapter 2, which focused on professional standards and practices for human research.
The next three sections address human radiation experiments in terms of the central ethical issues raised by nontherapeutic research involving children--level of risk, authorization for the involvement of children, and selection of subjects. To address the question of risk, we analyzed twenty-one nontherapeutic radiation experiments with children conducted during the 1944-1974 period. The focus of this analysis is whether it is likely that any of the subjects of these experiments was harmed or remains at risk of harm attributable to research exposures. A table summarizing these experiments and our risk estimates can be found at the end of this chapter. The twenty-one experiments were selected from eighty-one pediatric radiation research projects identified by the Committee from government documents and the medical literature. Although these eighty-one by no means constitute all the pediatric radiation research conducted during this time, they include what are likely fairly typical examples of such research. Of the eighty-one, thirty-seven studies were judged to be nontherapeutic, and twenty-one of these were conducted or funded by the federal government and thus fell under the charge of the Committee. Included within these twenty-one studies were the two nutrition experiments conducted at the Fernald School and one fallout-related study conducted at the Wrentham School discussed in the introduction to this chapter. All twenty-one studies employed radioisotopes to explore human physiology and pathology.
We turn next to a consideration of how authorization for the inclusion of the children in these experiments was obtained and who these children were. Unfortunately, for most of these experiments, little is known about either of these issues. The last section of the chapter focuses specifically on the experiments at the Fernald School where, thanks to the work of the Massachusetts Task Force on Human Subject Research, relevant information is available. Throughout the chapter, we focus only on research in which children could not have benefited medically. The Committee did not have the resources to pursue two related areas of research--nontherapeutic research on pregnant women and therapeutic research on children. We include two capsule descriptions of examples of these types of research at the end of this chapter.