Treating safety research like other clinical studies slows progress

Regulations for human studies may need overhaul, Hopkins researchers say

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 can’t apply a clinical paradigm to patient safety research. It just isn’t 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 study’s results were published, however, an anonymous complaint led to a federal reexamination of the ethical oversight of the study. As in most human research, Pronovost’s 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 Pronovost’s 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 Pronovost’s 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 participated wasn’t required. However, after the anonymous complaint, the federal Office for Human Research Protections, a branch of the U.S. Department of Health and Human Services that oversees IRBs, determined that patient consent and Michigan hospital IRB review should have taken place.

According to Kass, who served for more than 10 years on a Johns Hopkins IRB and is an expert in the ethics of human research, such a decision ignores the differences between patient safety research of this sort and other types of research that include riskier and more burdensome interventions and procedures, such as human trials for new drugs.