A controversy over human subjects protections in quality improvement studies brings an unforeseen benefit.
Not many researchers would expect anything good to come from the government shutting down their study. Even fewer would expect a wave of sympathetic publicity.
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Yet that’s what happened last year when the Office of Human Research Protections, part of the U.S. Department of Health and Human Services, temporarily halted a life-saving patient safety study in Michigan designed by Hopkins researchers. Although the program had reduced catheter-related bloodstream infections in scores of intensive care units, the government claimed that the research amounted to running an experiment without patients’ consent.
Hopkins had stopped collecting data last July, pending further review. Although the study was finally reinstated in February, the episode has left many researchers worried that expensive and time-consuming regulations may lie ahead for research in patient safety and quality improvement.
“The health care community exploded against the OHRP and the potential implications of putting up barriers to doing quality improvement studies,” says Peter Pronovost, the study’s lead investigator and medical director of Hopkins’ Center for Innovation in Quality Patient Care.
The study that caused the controversy targeted bloodstream infections in ICUs by requiring medical staff to use a checklist of five universally recognized safety procedures, such as hand washing. Sixty-seven hospitals in Michigan signed on to the program and agreed to send their data to the Hopkins researchers.
Results from that program, which researchers estimate saved at least 1,500 lives in its first 18 months, were published in The New England Journal of Medicine in December 2006. Less than two months later, the OHRP sent Hopkins a letter raising concerns about the study.
At issue was whether it required informed consent and institutional review board approval. When Pronovost submitted the study to the IRB at Hopkins, that body declared it exempt from the federal regulations governing human subjects research. The decision waived the need for patient consent.
But the government decided that participating hospitals also should have obtained IRB approval before releasing information for use in a larger study.
The American Hospital Association decried the government’s position. New York Times health columnist Jane Brody urged her readers to complain to their congressional representatives. Pronovost received copies of dozens of e-mails requesting that HHS secretary Mike Leavitt reinstate the study.
When OHRP withdrew its objections, it explained that the long-term project had reached a point where the checklist was part of the standard practice in ICUs and no longer qualified as “human subjects research.” However, it didn’t resolve questions about future oversight criteria for other quality improvement studies.
“At this point, the OHRP case has not dramatically changed the way we review quality improvement projects at Hopkins,” says Daniel Ford, vice dean for clinical investigation. “However, we are reviewing such activities with greater care and changing our threshold to classify more activities as research.” A fundamental question, he says, is whether quality improvement efforts carry significant risks.
Meanwhile, the publicity surrounding this case has increased Pronovost’s ability to preach the benefits of using standard operating procedures for a wide range of patient safety efforts. In a December New Yorker article, Boston surgeon Atul Gawande writes that Pronovost’s work has already saved more lives than that of any laboratory scientist in the past decade.
Over the last few months, the professor of anesthesiology and critical care medicine has heard from people who want to become his disciples, or ghostwrite his life story, or merely gather some advice on how to get their own checklist action.
Hospitals in Tennessee will soon begin studies using the same bloodstream infection-control checklist while other states consider how best to implement the program. Pronovost has also signed up ICUs in Spain and plans to meet with patient safety representatives from the Netherlands and Ireland.
In April, he and Dean/CEO Edward Miller will speak about the importance of such quality improvement studies to the Committee on Oversight and Government Reform, the investigative committee of the U.S. House of Representatives. In May, he will appear at the Institute of Medicine to discuss the oversight of QI initiatives.
“We need to view this kind of work as a real science that needs to be reviewed with appropriate guidelines,” Pronovost says. “We have to protect human subjects, but find a way to do it wisely.”
–Linell Smith
, March 2008
