A Lifesaving Checklist
By ATUL GAWANDE
Published: December 30, 2007
http://www.nytimes.com/2007/12/30/opinion/30gawande.html?_r=1&th&emc=th&oref=sloginIN Bethesda, Md., in a squat building off a suburban parkway, sits a small federal agency called the Office for Human Research Protections. Its aim is to protect people. But lately you have to wonder. Consider this recent case.
A year ago, researchers at Johns Hopkins University published the results of a program that instituted in nearly every intensive care unit in Michigan a simple five-step checklist designed to prevent certain hospital infections. It reminds doctors to make sure, for example, that before putting large intravenous lines into patients, they actually wash their hands and don a sterile gown and gloves.
The results 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.
The government’s decision was bizarre and dangerous. But there was a certain blinkered logic to it, which went like this: A checklist is an alteration in medical care no less than an experimental drug is. Studying an experimental drug in people without federal monitoring and explicit written permission from each patient is unethical and illegal. Therefore it is no less unethical and illegal to do the same with a checklist. Indeed, a checklist may require even more stringent oversight, the administration ruled, because the data gathered in testing it could put not only the patients but also the doctors at risk — by exposing how poorly some of them follow basic infection-prevention procedures.
The need for safeguards in medical experimentation has been evident since before the Nazi physician trials at Nuremberg. Testing a checklist for infection prevention, however, is not the same as testing an experimental drug — and neither are like-minded efforts now under way to reduce pneumonia in hospitals, improve the consistency of stroke and heart attack treatment and increase flu vaccination rates. Such organizational research work, new to medicine, aims to cement minimum standards and ensure they are followed, not to discover new therapies. This work is different from drug testing not merely because it poses lower risks, but because a failure to carry it out poses a vastly greater risk to people’s lives.>>>>
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