published in late 2001. Nelson addressed three basic considerations relating to the use of children as vulnerable populations in research: (1) whether or not “the interventions or procedures of the research offered the prospect of direct benefit to enrolled children”; (2) whether or not the “interventions or procedures involved in the research provided greater-than-minimal risk”; and (3) whether or not the parents of the children were properly informed of the potential risks of the study. On each of these issues Nelson argued that the court had acted properly in remanding the case to trial. With regard to the first question, for half of the children (those already living in housing that was to be abated as part of the study) the study “offered the prospect of direct benefit,” he said. But this was not true for those children who were moved into potentially more dangerous situations. Ethically, the partially abated home was a potential danger and therefore moving a child into it could not be considered a direct benefit. This was related to the second issue, whether the study presented these children with greater than minimal risk. Addressing this question was critical because the Belmont Report in 1977 argued, according to Nelson, “that a parent lacks the moral authority to expose a healthy child to more than minimal risk research.” Because the KKI researchers did not know for certain how partial lead abatement would affect the blood lead levels of the children, “the risk of continued lead exposure compared to the standard or full lead abatement procedure is more than minimal.” In addition, Nelson maintained, intentionally exposing children to lead by moving them into partially abated homes “cannot be considered as minimal risk” because “a ‘reasonable parent’ would not intentionally expose a child to environmental lead without making every effort to reduce or eliminate the lead exposure.”55
Were the parents properly informed about the critical matters that might concern a parent of a young child exposed to lead? The KKI study consent forms offered to the parents, Nelson said, “did not contain information that the ‘reasonable parent’ would want to know,” specifically, that the aim of the study was to evaluate “the effectiveness of three different methods of lead abatement,” what the impact on young children would be of the resulting lead exposure, and what the risks were “of inadequate lead abatement.”56 Further, what action was reasonable to expect from public health and housing officials in this conservative political era?
In the end, Nelson concluded, the court of appeals’s decision was consistent with the recommendations of the Belmont Report that “parents do not have the moral or legal authority to enroll healthy children in research that does not offer the prospect of direct benefit unless the risks of that research are no greater than the ordinary risks of daily life—a standard referred to as ‘minimal risks.’”57 In short, healthy children should not be encouraged to move into potentially dangerous situations.
Following the court’s decision, the critical issue that emerged for researchers, policy makers, and the public alike was the meaning of “minimal risk” and, more specifically, the relationship between socioeconomic inequality and the everyday risks of being poor in American society. The KKI study and the court’s response to it begged the question of whose life should be the standard of “the ordinary risks of daily life.” Did the dangers inherent in being poor mean, for example, that the children in the KKI study, because their everyday experience carried with it greater potential for harm, could be exposed to greater danger than average middle-class children who lived in a safer environment?
“Two entirely different standards emerge [in interpreting the meaning of ‘minimal risk’] depending upon whether researchers consider the daily or routine risks of harm encountered by some or all children,” wrote Loretta Kopelman, a professor at the Brody School of Medicine of East Carolina University and a member of the Institute of Medicine’s Committee on Research on Children. “With the first interpretation, or relative standard, the upper limit of harm would vary according to the particular group of subjects; with the second, or absolute standard, the upper limit would be the risks of harm encountered by all children, even wealthy and healthy children.” Kopelman reminded readers of the terrible consequences and ethical quandaries of such interpretative variation. In the 1960s and 1970s, for example, mentally retarded children had been used as subjects in the infamous Willowbrook hepatitis studies in which children were given hepatitis using the rationale that the “disease was endemic to the institution [and thus] the children would eventually have gotten hepatitis.”58
As the court of appeals’s ruling sank in, its implications appeared more profound and troubling. In an article titled “Canaries in the Mines,” Merle Spriggs, a medical ethicist at the University of Melbourne’s Murdoch Children’s Research Institute, gave perhaps the most cutting critique of the Johns Hopkins research: “The argument that the [KKI] families benefitted because they were not worse off can be compared with the arguments used in the infamous, widely discussed mother-child HIV transmission prevention trials in developing countries,” Spriggs said, referring to medical trials sponsored in the previous decade by the U.S. government in which researchers, seeking an inexpensive, effective way of reducing HIV transmission between mothers and children in African countries, provided AZT treatments to some mothers while comparing them with untreated “controls” who received only a placebo. Some argued that the research was justified in part because the African women who received the placebo would not normally have received any treatment at all, though ethical concerns would have precluded the research from being conducted in the United States. Both the HIV transmission prevention trials and the KKI research, Spriggs pointed out, “involved the problematic idea of a local standard of care,” an underlying assumption that “risky research is less ethically problematic among people who are already disadvantaged.” If this “relativistic interpretation of minimal risk” was considered acceptable, it opened a Pandora’s box of deeply disturbing issues and could virtually unleash the research community on poor people. She warned that such a stance “could allow children living in hazardous environments or who faced danger on a daily basis to be the subject of high risk studies.”59
Above all, what the KKI research effort exposed was a fault line that divides poor people from the rest of Americans and extends far beyond the ethics of occasional research. No one would suggest that a middle-class family allow their children to be knowingly exposed to a toxin that could be removed from their immediate environment. But for decades, as a society we have accepted that poor children can be treated differently. We have watched for over a century as children have, in effect, been treated as research subjects in a grand experiment without purpose. How much lead is too much lead? What are the limits of our responsibility as a society to protect those without the resources to protect themselves? As we confront new information about environmental toxins like mercury, bisphenol A, phthalates, and a host of new chemicals that are introduced every year into the air, water, and soil, whose reach extends beyond the poor, the issues raised by the KKI story—and by the modern history of the lead wars more generally—are issues that, by our responses, will define us all.
The history of lead poisoning and lead research is paradigmatic of the developing controversies over a range of toxins and other health-related issues now being debated in the popular press, the courts, and among environmental activists and consumer organizations, as well as within the public health profession itself. Public health officials struggle mightily with declining budgets, a conservative political climate, and a host of challenging and new health-related problems. Today, the public health community continues to have the responsibility to prevent disease. But it has neither the resources, the political mandate, nor the authority to accomplish this task, certainly not by itself. It is an open question whether it has the vision to help lead the effort, or to inspire the efforts needed.
Whatever the limitations of the bacteriological and laboratory-based model that public health developed in the early part of the twentieth century in response to the crises of infectious disease, there is no arguing that this model provided a coherent and unifying rationale for the profession. But, as we witness the emergence of chronic illnesses linked to low levels of toxic exposures, no powerful unifying paradigm has replaced bacteriology. Some suggest that the “precautionary principle” can serve as an overall guide, arguing that it is the responsibility
