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Likening a Johns Hopkins University study that used healthy children to test the effectiveness of lead paint abatement measures to the Tuskegee Syphilis Study and Nazi medical experiments, the Maryland Court of Appeals, the state’s highest tribunal, blazed new paths in the law governing medical research on Aug. 16. The decision has already attracted the attention of the U.S. Department of Health and Human Services, which announced last Wednesday that it would be conducting an investigation into the federally funded study. Writing for a nearly unanimous court in Grimes v. Kennedy Krieger Institute, Nos. 128/129, Judge Dale R. Cathell told Maryland parents they will not be allowed to enroll their children in studies that carry risks but offer no therapeutic benefit. More significantly, Cathell told researchers who conduct nontherapeutic studies that they almost always have a duty of care toward participants and may have to pay tort damages if they carry out those duties negligently. Of the seven judges who heard the case, only one dissented in part, though the judge agreed with the conclusion that the university cannot escape trial on its liability. “Because there is a dearth of case law on the duties of medical researchers toward their subjects, this is one of the most significant cases of the decade,” said Michele Russell-Einhorn, formerly director of regulatory affairs in the National Institutes of Health’s Office for Protection from Research Risks and now director of PricewaterhouseCoopers’ Clinical Research Consulting Team. The study — conducted by the university’s Kennedy Krieger Institute (KKI) under grants provided by the Environmental Protection Agency (EPA) and several Maryland agencies — was designed to see if less than total abatement of lead paint would still reduce levels of lead poisoning in children. If partial abatement proved effective, researchers ultimately hoped that owners of low-rent housing, who often abandon their buildings rather than conduct full-scale abatement, would take more modest protective steps. Researchers approached the owners of 125 houses with varying degrees of lead paint contamination and abatement and encouraged them to rent to families with healthy children, the court said. They then periodically tested the children’s blood over the course of two years, using the children as “canaries in the mines” and “measuring tools,” in Cathell’s words. Ironically, KKI has been in the forefront of those sounding the alarm about lead paint. One of the directors of the study, J. Julian Chisholm Jr., was widely eulogized as the inventor of the only treatment for lead poisoning when he died in June. Baltimore attorney Suzanne Shapiro said that KKI’s reputation for good works lulled her client, Catrina Higgins, into thinking that no harm would come to her son, who lived in a house with partial abatement when he was 3 years old. Because KKI did not give full and timely information about lead levels, the boy suffered permanent neuropsychological deficits, she claims. The same fate befell the other plaintiff in this consolidated appeal, Ericka Grimes, according to her attorney, Kenneth Strong of Baltimore. Grimes, 10 months old when she entered the study, lived in a control house that had undergone complete abatement, Strong said. During testing, KKI discovered that in fact the house still had elevated levels of lead dust, but KKI failed to notify Grimes’ family for nine months, he added. In pleadings, the Rockville, Md., firm Godard, West & Adelman argued on KKI’s behalf that it had no duty to make houses safe or to warn Grimes and Higgins about the dangers they faced because the institute was not a landlord and never promised to provide medical care, an argument that persuaded the trial judge that KKI did not have to stand trial. KKI also maintained that Higgins and Grimes benefited, since they received frequent screenings for lead. KKI Chief Executive Gary Goldstein told The Associated Press on Aug. 22 that children in the study ran a high risk of being exposed to lead paint anyway. Cathell showed little patience for KKI’s attempts to paint the study in a benign light, noting that the children were required to have low levels of lead before entering the study. He also suggested that KKI’s research goals gave it an incentive to keep children in their contaminated houses for the full two years of the study and stated that KKI’s consent forms did not give adequate warnings. He also accused the university’s Institutional Review Board of purposely mischaracterizing the study as therapeutic to win approval from the EPA. Cathell and his colleagues wrote on a clean slate in ruling that KKI and other researchers who conduct nontherapeutic studies may have a duty to their subjects under any one of several legal theories, according to Kendra L. Dimond, a partner at Arent Fox Kintner Plotkin & Kahn in Washington, D.C., who represents institutions and researchers. Cathell said that agreements between subjects (or their parents) and researchers may, and in most cases do, create a “special relationship” with attendant duties and potential tort liability. Furthermore, when money changes hands, as it did here, and both researcher and subject take on obligations, a contract may be created and damages imposed for its breach. Finally, duties can be created by regulations, like those of the EPA, requiring researchers to meet certain standards as a prerequisite to obtaining federal grants. Cathell went on to suggest that international standards such as the Nuremberg Code may bind KKI and other researchers. On remand, the trial court will have to determine if duties were created on the facts in these cases, whether KKI breached those duties and the extent of damages. In an Aug. 22 press release, KKI pointed to its leadership in researching and treating lead poisoning, but it did not comment on this particular study. In an Aug. 17 interview with the Baltimore Sun, a second director of the study, Mark Farfel, defended the study by saying, “Society was already doing a Tuskegee experiment. Very little if anything was happening to remove lead while children were being poisoned.” The Associated Press contributed to this article.

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