A suitable case for treatment

摘要

Last week's 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 Health's Office for Protection from Research Risks (OPRR) were procedural. They argue that even if Duke's 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 multimillion-dollar research enterprise to a grinding halt.