The Context for Nontherapeutic Research with Children
Risk of Harm and Nontherapeutic Research with Children
Beyond Risk: Other Dimensions of the Ethics of Nontherapeutic Research on Children
The Studies at the Fernald School
Chapter 7: The Studies at the Fernald SchoolResearchers from the Massachusetts Institute of Technology, working in cooperation with senior members of the Fernald staff, carried out nontherapeutic nutritional studies with radioisotopes at the state school in the late 1940s and early 1950s. The subjects of these nutritional research studies were young male residents of Fernald, who were members of the school's "science club." In 1946, one study exposed seventeen subjects to radioactive iron. The second study, which involved a series of seventeen related subexperiments, exposed fifty-seven subjects to radioactive calcium between 1950 and 1953. It is clear that the doses involved were low and that it is extremely unlikely that any of the children who were used as subjects were harmed as a consequence. These studies remain morally troubling, however, for several reasons. First, although parents or guardians were asked for their permission to have their children involved in the research, the available evidence suggests that the information provided was, at best, incomplete. Second, there is the question of the fairness of selecting institutionalized children at all, children whose life circumstances were by any standard already heavily burdened.
Parental AuthorizationThe Massachusetts Task Force found two letters sent to parents describing the nutrition studies and seeking their permission. The first letter, a form letter signed by the superintendent of the school, is dated November 1949. The letter refers to a project in which children at the school will receive a special diet "rich" in various cereals, iron, and vitamins and for which "it will be necessary to make some blood tests at stated intervals, similar to those to which our patients are already accustomed, and which will cause no discomfort or change in their physical condition other than possibly improvement." The letter makes no mention of any risks or the use of a radioisotope. Parents or guardians are asked to indicate that they have no objection to their son's participation in the project by signing an enclosed form.
The second letter, dated May 1953, we quote in its entirety:
Again, there is no mention of any risks or the use of a radioisotope. It was believed then that the risks were minimal, as indeed they appear to have been, and as a consequence, school administrators and the investigators may have thought it unnecessary to raise the issue of risks with the parents. There was no basis, however, for the implication in both letters that the project was intended for the children's benefit or improvement. This was simply not true.
The conclusion of the Massachusetts Task Force was that these experiments were conducted in violation of the fundamental human rights of the subjects. This conclusion is based in part on the task force's assessment of these letters. Specifically, the task force found that
[t]he researchers failed to satisfactorily inform the subjects and their families that the nutritional research studies were non-therapeutic; that is, that the research studies were never intended to benefit the human subjects as individuals but were intended to enhance the body of scientific knowledge concerning nutrition.
Fairness and the Use of Institutionalized ChildrenThe Fernald experiments also raise quite starkly the particular ethical difficulties associated with conducting research on members of institutionalized populations--especially where some of the residents have mental impairments. Living conditions in most of these institutions (including Fernald and Wrentham) have improved considerably in recent years, and sensitivity toward people with cognitive impairments has likewise increased. As Fred Boyce, a subject in one of these experiments has put it, "Fernald is a much better place today, and in no way does it operate like it did then. That's very important to know that."
The Massachusetts Task Force describes conditions in state-operated facilities like Fernald, particularly as they bear on human experimentation, as follows:
Until the 1970s, the buildings were dirty and in disrepair, staff shortages were constant, brutality was often accepted, and programs were inadequate or nonexistent. There were no human rights committees or institutional review boards. If the Superintendent (in those days required to be a medical doctor) "cooperated" in an experiment and allowed residents to be subjects, few knew and no one protested. If nothing concerning the experiments appeared in the residents' medical records, if "request for consent" letters were less than forthright, or if no consent was obtained there was no one in a position of authority to halt or challenge such procedures.
Although public attitudes toward people who are institutionalized are admittedly different today than they were fifty years ago, it is likely that this state of affairs would have been troubling to most Americans even then. Historian Susan Lederer has revealed several episodes of experimentation with institutionalized children in America that caused considerable public outcry even before 1940, presaging the concern generated by Willowbrook when this research became a public issue in the 1960s.
The LMRI staff reported in the early 1960s that the pediatric researchers whom they had gathered agreed in principle that the convenience of conducting research on institutionalized children did not outweigh the moral problems associated with this practice:
Several investigators spoke about the practical advantages of using institutionalized children who are already assembled in one location and living within a standard, controlled environment. But the conferees agreed that there should be no differential recruitment of ward patients rather than private patients, of institutionalized children rather than children living in private homes, or of handicapped rather than healthy children.
A particularly poignant dimension of the unfairness of using institutionalized children as subjects of research is that it permits investigators to secure cooperation by offering as special treats what other, noninstitutionalized children would find far less exceptional. The extra attention of a "science club," a quart of milk, and an occasional outing were for the boys at Fernald extraordinary opportunities. As Mr. Boyce put it:
I won't tell you now about the severe physical and mental abuse, but I can assure you, it was no Boys' Town. The idea of getting consent for experiments under these conditions was not only cruel but hypocritical. They bribed us by offering us special privileges, knowing that we had so little that we would do practically anything for attention; and to say, I quote, "This is their debt to society," end quote, as if we were worth no more than laboratory mice, is unforgivable.
Even when a child was able to resist the offers of special attention and refused to participate in the experiment, the investigators seem to have been unwilling to respect the child's decision. One MIT researcher, Robert S. Harris, explicitly noted that "it seemed to [him] that the three subjects who objected to being included in the study [could] be induced to change their minds." Harris believed that the recalcitrant children could be "induced" to join in the study by emphasizing "the Fernald Science Club angle of our work."
From the perspective of the science, it was considered important to conduct the research in an environment in which the diet of the children-subjects could be easily controlled. From this standpoint, the institutional setting of Fernald was ideal. The institutional settings of the boarding schools in the Boston area, however, would have offered much the same opportunity. Although the risks were small, the "children of the elite" were rarely if ever selected for such research. It is not likely that these children would have been willing to submit to blood tests for extra milk or the chance to go to the beach.
The question of what is ethical in the context of unfair background conditions is always difficult. Perhaps the investigators, who were not responsible for the poor conditions at Fernald, believed that the opportunities provided to the members of the Science Club brightened the lives of these children, if only briefly. Reasoning of this sort, however, can all too easily lead to unjustifiable disregard of the equal worth of all people and to unfair treatment.
Today, fifty years after the Fernald experiments, there are still no federal regulations protecting institutionalized children from unfair treatment in research involving human subjects. The Committee strongly urges the federal government to fill this policy void by providing additional protections for institutionalized children.