In another blow to Johns Hopkins University, Maryland's top appeals court on 16 August issued a scathing indictment of a study involving children exposed to lead-based paint in their homes. The ruling compared the study to the infamous Tuskegee syphilis experiments, in which African Americans with syphilis were monitored but not treated. Stunned health researchers say the study was important and did not differ much from previous lead-poisoning studies.
In the mid-1990s, the Kennedy Krieger Institute, a Hopkins affiliate, launched the "Repair and Maintenance Study," which aimed to evaluate low-cost lead abatement in old homes with peeling paint. Some of the 108 homes were occupied when the study began; in other cases, landlords were encouraged to rent to families with young children. Investigators then measured lead levels in dust and children's blood for 2 years. Families were offered incentives to participate, such as $15 payments for answering questionnaires. Johns Hopkins's institutional review board approved the protocol.
Now, one mother in the study charges that researchers waited 9 months to share test results showing high levels of lead dust in her house. By that time, her child had developed a blood lead level of 32 micrograms per deciliter (ug/dL)--"highly elevated," according to Centers for Disease Control and Prevention standards. Her lawyer, Kenneth Strong, says that the child now has learning disabilities. A second mother charges that she was given test results showing that lead dust levels in her home were low, but not results collected by a different, experimental method showing higher levels. Her child had blood lead levels as high as 21 µg/dL.
Although lower courts found that Kennedy Krieger had no legal obligation to notify the families, the appeals court last week disagreed. It also faulted the study because it "enticed" families to "potentially lead-tainted housing." "It can be argued that the researchers intended that the children be the canaries in the mines," wrote Dale Cathell and five other judges. In Maryland, the decision says, parents should not be allowed to let their children participate in "nontherapeutic research or studies in which there is any risk of injury or damage" to the child's health.
The lead investigator of the lead paint study, Marc Farfel, and Kennedy Krieger president Gary Goldstein vehemently defend the study as ethical. The ruling also surprised other lead-poisoning researchers. The neurotoxic metal is "already out there in hundreds of thousands of older homes," notes Bruce Lanphear of the University of Cincinnati. "We don't really have any other system" besides testing blood lead levels in children to evaluate the effectiveness of abatement techniques, Lanphear says.
Others are troubled by the court's conclusion that children should not be included in trials that don't have a therapeutic benefit. "The court didn't quite get how research works," says University of Kansas Medical Center bioethicist Mary Faith Marshall, who argues that nontherapeutic research can have indirect benefits, and that the U.S. human subject protections system seeks to balance all risks and benefits.
The Department of Health and Human Services' Office for Human Research Protections is now investigating the study. The decision is the latest of several problems with trials at Hopkins, including the death this spring of a volunteer in an asthma study (ScienceNOW, 19 July) and controversy over a cancer drug trial it sponsored in India (Science, 10 August, p. 1024).