ACHRE Report

Part II

Chapter 7


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: Beyond Risk: Other Dimensions of the Ethics of Nontherapeutic Research on Children

The level of risk to which children are exposed is critical in evaluating the ethics of nontherapeutic research on children. Also important, however, is whether and how the authorization of parents was solicited, and also which children were selected to be so used. For nineteen of the twenty-one studies reviewed by the Committee, we know almost nothing about whether the permission of parents was sought or what the parents were told about their children's involvement. Two of the studies conducted at the Fernald School were the exceptions, as a result of extensive historical and archival research by the Massachusetts Task Force on Human Subjects Research.

There is a reference to parents in the published literature on only one of the remaining nineteen studies, a 1954 iodine uptake experiment at the University of Tennessee. This paper included the following line: "The procedure was described to the mothers of the infants studied, and the mothers gave consent for the study before the tests were made."[82] (The inclusion of this line is noteworthy for it suggests that at least some investigators thought parental permission was worth mentioning in published reports of their research.)

If the Committee had devoted extensive investigatory resources to these nineteen studies, it is likely we would have learned more about whether or how parental authorization was obtained in at least some cases. It is also almost certain that even the deepest archival digging would have produced no useful information about parental authorization for some of these experiments. The recent experience of the Massachusetts Task Force demonstrates the possibility of both outcomes: for some of the experiments conducted at the Fernald School, the task force's diligent historical research uncovered a variety of documents that shed important light on what both parents and children were told; for the experiments at Wrentham, similar efforts did not produce any significant information on questions of parental authorization.

Again with the exception of the experiments conducted at Fernald and Wrentham, we know almost nothing about who the children were who served as subjects in these experiments. The journal articles on these remaining studies do not describe the sociodemographic characteristics of the subjects. They do sometimes mention whether the subjects had relevant medical conditions and usually that the children, including the "control" subjects, were hospitalized patients. In some of the experiments reviewed by the Committee, the scientific research questions of interest could have been pursued only in children who were ill and hospitalized. In other instances, however, the hospitalized children were likely samples of convenience. This is particularly plausible in the case of control subjects, when a sample of healthy, nonhospitalized children might have made a better control group from a scientific perspective. As we saw in chapter 2, hospitalized patients were often viewed by physician-investigators as a convenient source of research subjects.

Because so little is known, the Committee cannot draw conclusions about the ethics of most of the nontherapeutic studies involving children we reviewed, apart from the important issue of risk of harm to the children involved. We turn now to an analysis of the studies where relevant information about parental authorization, disclosure, and subject selection is available: the studies conducted at the Fernald School.

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