A yearlong federal investigation into alleged research abuses of children in New York City came to a close yesterday with the release of findings indicating multiple shortcomings in patient protections at two of three research centers examined.
The federal Office for Protection from Research Risks (OPRR) said the Mount Sinai School of Medicine and the City University of New York breached federal regulations meant to protect human subjects in a study several years ago of elementary school children with attention deficit hyperactivity disorder (ADHD).
The report does not conclude whether any children were harmed. But in its most serious charge, the OPRR determined that Mount Sinai researchers subjected four healthy, normal children in a "control group" to a level of medical risk not allowed under federal regulations--including placement of intravenous lines for a full day of multiple blood drawings; the infusion of a drug called fenfluramine for a purpose not approved by the Food and Drug Administration; and unspecified genetic testing procedures.
In a June 8 letter released yesterday, the OPRR demanded that the hospital contact those children's families and give them a thorough "debriefing" of the medical center's noncompliance with federal rules.
One expert in patient protections, speaking on the condition of anonymity, predicted that the decision could lead to legal troubles for the hospital, since almost any psychiatric or behavioral ailment exhibited by the children in the future might be blamed on the research, no matter how unlikely the medical connection may be.
Separately, the OPRR, part of the National Institutes of Health, exonerated the New York State Psychiatric Institute for similar research it had conducted in 1994 and 1995. That research came under fire last year and became a rallying point for patient activists for its alleged racial discrimination, unjust recruiting inducements and use of fenfluramine in healthy children. OPRR concluded that the small risks were justified because, as required by federal regulations, the research had the potential to answer questions about the childrens' "conditions."
Psychiatric Institute director John Oldham yesterday said he was gratified that the government had found no problems with the research, which involved brain chemistry studies on 6- to 10-year-old minority children whose older siblings had been arrested. The researchers hoped to find biological clues to the causes of violent behavior.
But critics who had attacked the study last year criticized the OPRR's report yesterday for not addressing the question of what "condition" the participants suffered from, other than being related to petty criminals.
Oldham said yesterday that he and his colleagues had explained to the OPRR that younger siblings of delinquents have a condition in that they're "at increased risk" of antisocial and violent behavior as adults, and that some of them had already been "in trouble" at school.
The OPRR cited City University's research review board for failing to review properly the ADHD study, conducted with Mount Sinai, and for its failure to consider extra patient safeguards, as required for vulnerable subjects such as children.
It called the failings "consistent with the systemic deficiencies in CUNY's system for protecting human subjects that were previously documented" during an OPRR site visit in 1997. That visit had resulted in restrictions on CUNY's federal license to conduct human research, which the OPRR said yesterday will continue until "corrective actions" are taken.
The OPRR cited Mount Sinai for additional shortcomings in the ADHD study. Children were taken off their medications and subjected to brain chemistry tests but were not given "an adequate description of the reasonably foreseeable risks and discomforts," OPRR concluded. Mount Sinai's federal license to conduct human research has now been restricted.
In a statement yesterday, the medical school said the study had been reviewed in advance by two committees at the National Institute of Mental Health, and neither had identified any risks to participants.