ANNAPOLIS – Research representatives told Maryland legislators Tuesday their institutions can and should continue research on humans without state intervention, despite recent revelations about research projects that led to the death of one subject and exposed nearly 200 children to lead poisoning.
The House Health and Human Resources Subcommittee heard testimony from an assistant state attorney general and several research directors to determine if “immediate legislative action” was needed to keep human subject research running in light of those incidents.
The briefing followed a Maryland Court of Appeals statement clarifying its Aug. 16 ruling that permitted subjects of a Baltimore lead paint study to sue researchers for failing to inform them of the study’s risks.
Between 1993 and 1995, the Kennedy Krieger Institute encouraged families to live in homes with varied lead levels to determine the level that posed a real poisoning risk for children.
Parents of some study subjects sued the institute, complaining researchers neither warned them about lead exposure nor adequately explained the risks of the study.
The original Court of Appeals ruling included language legislators feared would have “a chilling effect” on medical research in Maryland.
Assistant Attorney General Jack Schwartz assured the committee the court’s Oct. 11 statement did not impose any limits on human research beyond federal regulations already in place.
But Schwartz recommended the committee look into expanding current regulations to cover non-federally affiliated research groups involved in human studies. And he suggested the state work to improve the regulations already in place.
Representatives from Johns Hopkins University and the University of Maryland School of Medicine – both of which conduct federally regulated research – detailed their provisions to keep studies compliant with federal rules.
Johns Hopkins research was frozen last summer following the June 2 death of Ellen Roche, a 24-year-old healthy subject of a university asthma treatment study. The government also threatened to suspend funding for the institution.
Since then, Johns Hopkins has worked hard to bring its research regulations in line with federal rules, university officials say.
Federal regulations require researchers to explain their studies to research subjects and to obtain their voluntary consent to participate. They also subject human study proposals to the approval of an institutional review board that must assess the risks, benefits and scientific value of any proposed project.
Child researchers face additional restrictions. They must have the consent of one or both parents, depending on the risks and benefits a study poses to a child’s health.
The state may expand the scope of these federal rules, Schwartz said.
“There undoubtedly will be bills that will come before the committee,” said Environmental Matters Committee Chairman John Hurson, D-Montgomery, “bills with language covering research areas that are not federally funded and add to the federal regulatory process.”
Advocates for the subjects of the lead paint study said universities and institutions haven’t concentrated enough on subject safety. The state needs to monitor human research, they said, adding that they were disappointed they did not have a voice in the briefing.
“It was one-sided,” said Henri Thompson, a representative of a Baltimore neighborhood, Park-Reist Corridor, affected by the lead paint study. “No, we’re not satisfied with it.”
The study subjects were not invited to speak for fear that speaking in front of the committee could damage their legal cases, Hurson said later.
“It was not a hearing about the cases,” Hurson said. “It was a briefing about essentially the impact of the court rulings on research.”