Treating safety research like other clinical studies slow...( Progress in patient safety research ...),Health

Progress in patient safety research could slow to a crawl unless regulators work out a host of ethical issues, Johns Hopkins researchers assert in an upcoming opinion piece.

We cant apply a clinical paradigm to patient safety research. It just isnt the right fit, says Nancy Kass, Sc.D., deputy director for public health at the Johns Hopkins Berman Institute of Bioethics and an author of the article.

The piece, published in the June issue of The Joint Commission Journal on Quality and Patient Safety, was sparked by a 2006 study led by Peter Pronovost, M.D., Ph.D., professor of anesthesiology, critical care medicine, and surgery at the Johns Hopkins University School of Medicine. In the study, Pronovost, an expert on patient safety, implemented a checklist in intensive care units (ICUs) at 67 Michigan hospitals aimed at preventing bloodstream infections whenever doctors insert catheters.

The results were markedly positive: Bloodstream infections from catheters fell by two-thirds, and on average, infection rates in the ICUs went from 4 percent to zero. Over the course of the study, the program saved more than 1,500 lives and nearly $200 million.

Shortly after the studys results were published, however, an anonymous complaint led to a federal reexamination of the ethical oversight of the study. As in most human research, Pronovosts study had been reviewed by an institutional review board (IRB)an internal group required at most research institutions to use federal regulations to make sure research studies protect the welfare of human subjects.

Because Pronovosts study enforced safety measures already known to be effective, and because no data were ever collected from patients by name, the Johns Hopkins IRB classified Pronovosts study as exempt from further IRB review. This designation meant that informed consent was not necessary from the ICU patients and that IRB review from each of the 67 Michigan hospitals that part
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