CHECKLIST FOLLOWUP….Last night I blogged about Atul Gawande’s New Yorker article from December about the lifesaving benefits of using a simple checklist to reduce line infections in hospitals. I didn’t see this at the time, but a reader alerts me to an op-ed Gawande wrote a few weeks after the original article appeared:
The results [of using the checklist] were stunning. Within three months, the rate of bloodstream infections from these I.V. lines fell by two-thirds. The average I.C.U. cut its infection rate from 4 percent to zero. Over 18 months, the program saved more than 1,500 lives and nearly $200 million.
Yet this past month, the Office for Human Research Protections shut the program down. The agency issued notice to the researchers and the Michigan Health and Hospital Association that, by introducing a checklist and tracking the results without written, informed consent from each patient and health-care provider, they had violated scientific ethics regulations. Johns Hopkins had to halt not only the program in Michigan but also its plans to extend it to hospitals in New Jersey and Rhode Island.
….Scientific research regulations had previously exempted efforts to improve medical quality and public health — because they hadn’t been scientific. Now that the work is becoming more systematic (and effective), the authorities have stepped in. And they’re in danger of putting ethics bureaucracy in the way of actual ethical medical care. The agency should allow this research to continue unencumbered. If it won’t, then Congress will have to.
Wouldn’t it be great if Congress held hearings on this instead of preening for the cameras over Roger Clemens’s alleged steroid use? Or is that too much to ask for?
