IRBs Lambasted for Excessive Red Tape; 'Pediatric Research Courts' Proposed
WASHINGTON — Frustrated researchers are calling for the gutting of what they see as faltering institutional review boards now charged with the monitoring of medical research on children.
At a meeting of the President's Council on Bioethics, scientists told council members that institutional review boards (IRBs) are overburdened with bureaucratic red tape and are increasingly hamstrung in their efforts to scrutinize pediatric research.
The bureaucracy, they said, comes from federal laws laid down in the 1970s exerting tight IRB control over research protocols. The rules were enacted to prevent lapses in the wake of several well-publicized child research ethics scandals. Instead of protecting children, the rules have weighed down IRBs and made their deliberations arbitrary, experts charged.
Dr. Robert J. Levine, professor of internal medicine at Yale University, New Haven, Conn., and others warned that IRBs now spend much of their time exercising perfunctory annual reviews of ongoing research protocols. The reviews include scrutiny of each adverse event occurring during a trial. “What I see now is a turn toward excessive bureaucracy, excessive attention to pointless detail” with IRBs, Dr. Levine said.
Dr. John Lantos, a professor of pediatrics at the University of Chicago, said that IRBs routinely struggle to enforce federal rules requiring guardians of minor subjects to give informed consent for trials posing more than a “minimal” risk to patients. Whereas the rules were meant to protect child subjects, IRB decisions on what constitutes a minimal risk have become “amateurish” and “idiosyncratic,” he said.
As a fix, Dr. Lantos urged the council to recommend a new system of what he dubbed “pediatric research courts.” The courts would operate with regional or national jurisdiction and would render decisions on whether trials meet federal standards for ethical science.
“It would do this by hearing cases, publishing rulings, establishing precedents, [and] generalizing interpretations in a way that was truly public, meaningfully accountable, and transparent,” said Dr. Lantos, adding that such a court should have “regulatory teeth.”
“It should come up with an answer the way the Supreme Court comes up with an answer,” he said.
The council is scheduled to issue recommendations on the monitoring of child research ethics, although those recommendations won't have the force of law. It will be up to Congress to enact any changes, and it is unclear whether lawmakers will back drastic changes to the IRB system.
Regardless, others who spoke before the council agreed that IRBs have lost the ability to effectively monitor pediatric research.
“We've just got ourselves stuck into a situation that is going to get worse and worse and worse,” said Dr. Paul R. McHugh, a professor of psychiatry at Johns Hopkins University, Baltimore.
