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20 May 1999 Volume 399 Issue no 6733
A suitable case for treatment
The decision to reprimand a leading US medical school for failing adequately to monitor the protection of human research subjects is a salutary action. It also underlines the need to ensure that monitoring is properly funded.
Last weeks four-day shut-down of research involving the use of human subjects at the prestigious Duke University Medical Center in Durham, North Carolina, has elicited predictable
complaints in the research community (see page 190). Some argue that the move smacked of federal heavy-handedness, pointing out correctly that the lapses at Duke identified by the National Institutes of Healths Office for Protection from Research Risks (OPRR) were procedural. They argue that even if Dukes Institutional Review Board (IRB) the panel responsible for ensuring that government-funded investigators adhere to strict ethics rules kept inadequate records, sometimes lacked quorums, and allowed university grants and contracts officials to vote on whether proposed studies passed ethical muster, these are hardly crimes that justify bringing a multi-million-dollar research enterprise to a grinding halt.
That may well be true. But it is hardly cause for defending a review board that, if OPRR documents are accurate, had let itself slide into an extraordinary degree of sloppiness. The Duke IRB approved informed-consent forms that inaccurately rendered the risks and benefits of the experiments. It requested substantial changes in protocols, and then failed to follow them up. It kept minutes that were so sloppy that it couldnt be ascertained later who had been in attendance for what votes, why changes were required in certain studies, and...