would continue to knowingly allow future generations of children to be exposed to lead. In contrast, those who have set their sights lower and labored to reduce rather than eliminate lead in children’s environment, believing this to be the only “practical” course, celebrate dramatic declines in both blood lead levels and symptomatic children as among the great successes in public health history.
THE KENNEDY KRIEGER CASE AND THE ETHICS OF LEAD RESEARCH
The lead researchers at Johns Hopkins’s Kennedy Krieger Institute faced a troubling dilemma in the midst of this history: children living in Baltimore, the epicenter of the lead-poisoning epidemic for almost a century, were being poisoned because their homes had been covered with lead paint, which, when it deteriorated, the children inhaled or ingested. Despite the CDC’s grand vision of eliminating lead from the home, it was highly unlikely that the money necessary for a dramatic federal detoxification program would be appropriated: during the Reagan and first Bush administrations, government social projects were defined as part of the problem, not a part of the solution. It was in this general context that the Environmental Protection Agency funded the Kennedy Krieger Institute: the federal government, and various lead researchers, were looking for relatively inexpensive, nonconfrontational, noncoercive methods of partial abatement so that landlords would reduce the lead hazard to children rather than either evade an abatement law or abandon their properties.47
“The purpose of the study,” wrote Mark Farfel, the co-principal investigator with Julian Chisolm, “is to characterize and compare the short and long-term efficacy of comprehensive lead-paint abatement and less costly and potentially more cost-effective Repair and Maintenance (R&M) interventions for reducing levels of lead in residential house dust which in turn should reduce lead in children’s blood.”48 “R&M,” as Farfel later put it in a grant renewal request, “may provide a practical means of reducing lead exposure for future generations of children who will continue to occupy older lead-painted housing which cannot be fully abated or rehabilitated without substantial subsidy.”49 In the struggle to prevent lead poisoning, there was no question in the researchers’ minds as to what was ultimately needed: the complete removal of lead paint. But “repair and maintenance” was a compromise they made in the hopes of doing at least some good in a difficult time.
The Farfel and Chisolm study was designed to test the efficacy of three different methods of lead reduction in older homes. The investigators then planned to contrast results with those of two control groups: one of children living in homes that had previously undergone what was thought to have been full lead abatement and the second of children living in homes built after 1978 and presumed to be lead free. For the study, more than a hundred parents with young children were recruited to live in the various partially lead-abated houses. The premise of the research was that children would now be in a safer environment, a home that was an improvement over the lead-covered homes that were generally available to poor residents of Baltimore. However, the blood lead levels of children in at least two of the homes rose over the course of the study.50 It was the two sets of parents of these children who filed the lawsuits alleging that they had not been properly informed of the risks their children faced while participating in the study.51
To some, the Johns Hopkins study was an attempt by dedicated researchers to address the discoveries about the effects of low-level lead exposure and determine the cost of reducing harm to children living in leaded environments. This was the view the Baltimore City Circuit Court took in granting KKI’s motion for summary judgment and dismissing the suit initially. But others, including the plaintiffs on appeal, clearly saw things in a different light. In reversing the lower court’s decision and ordering the lawsuits to proceed to trial, the Maryland Court of Appeals in 2001, quite aware that the subjects of the KKI study were African American children, saw the case through the lens of a long history of ethical and social debate over the use of vulnerable populations in human subjects research, as well as through the lens of the ongoing environmental justice movement that joined the civil rights and environmental movements of the previous three decades. Since the 1970s, and particularly following revelations about the Tuskegee experiments, in which an initial sample of 399 African American men with syphilis were “observed” over a forty-year period from the early 1930s through the early 1970s and to whom state-of-the-art treatments were denied, historians, ethicists, and others had explored instances where scientific research has crossed generally accepted ethical and social boundaries. They had detailed the evolution of standards for human subjects research, the importance of informed consent, and other ethical issues involved in nontherapeutic and sometimes harmful experimentation.
The Baltimore study was organized in the wake of a dramatic rethinking of the use of human subjects in scientific experiments. During the preceding two decades researchers had become acutely aware of the ethical dilemmas presented by human subjects research, especially when it involved “vulnerable populations.” The legacy of Nuremberg, the revelations about the Tuskegee experiments, and publication in the late 1970s of the “Belmont Report,” the landmark federal report that expanded and codified the principles of ethical research with human subjects, all combined to cast doubt on the morality and ethical basis of the KKI research.52 But this framework may be too simple, incapable of acknowledging the complexity of the issues at hand.
Two contending interpretations of the events in Baltimore indicate fissures in the public health community over the ethics and politics of the KKI study, echoing the debates over research on vulnerable populations that emerged in the 1970s, 1980s, and 1990s and the debates over what was feasible to accomplish in a conservative political environment. In one common interpretation, the KKI study was intrinsically unethical because the means of protecting children by complete abatement from lead poisoning were well known, and to knowingly subject children to lead by placing them in homes where only partial abatement had been performed put them needlessly at risk. In the main contending interpretation, research such as Farfel and Chisolm’s on incremental improvements that could lessen exposures was necessary and important because, in the context of the social realities of housing and income inequalities in America, complete abatement on a large scale was a utopian idea. As two subscribers to this general interpretation explained, “Powerfully appealing egalitarian principles cannot be regarded as a sufficiently compelling reason to totally shut down research that offers a realistic prospect of improving conditions [in this instance, complete abatement] or to what many might consider a minimally just standard of living. . . . We contend that it is the failure to conduct such research that causes the greater harm, because it limits health interventions to the status quo of those who can afford currently available options [complete abatement] and deprives disadvantaged populations of the benefits of imminent incremental improvements in their health conditions.”53
In this light, the history of the KKI research could be seen as a tragedy rather than a melodrama: a fight between two defensible conceptions of the public good rather than a fight between the forces of good and evil. Of course, this raises different questions: Are two defensible conceptions of the public good both ethically justifiable with respect to putting others knowingly in harm’s way? Could not valuable research be—and have been—done on levels of abatement without putting children in harm’s way, with a differently designed study? Lurking here, too, is another question that, as we will see, adds a further twist: was it justified to assume that partial and complete abatement could be conducted safely and effectively in the early 1990s?
The decision of the Maryland Court of Appeals to let the case go forward unleashed a storm of controversy and argument, not just about the KKI study but more generally about the ethics of what was called “nontherapeutic research” on children. Until the Maryland court decision, discussion about the use of children as research subjects, according to bioethicist Lainie Friedman Ross, had been largely “pragmatic.” She notes that “unless research is done with children the advances of modern medicine cannot accrue to them or to future generations of children.”54 Following the KKI decision, the questions became more complex as ethicists began weighing in.
The first article laying out the issues raised
