Federal regulatory officials have cleared the way for a Johns Hopkins physician to continue with his research after a controversial investigation into whether his study of intensive care units violated federal ethics requirements.
The Office of Human Research Protections said in a letter released this week that Dr. Peter Pronovost can continue studying ICU patients in 70 Michigan hospitals to see if use of a checklist reduces catheter-related infections.
The four-year project has reached a stage where the checklists are a firmly established part of ICU care in the hospitals, so anyone collecting data on overall infection rates is "no longer engaged in human subjects research," the office said.
"We do not want to stand in the way of quality improvement activities that pose minimal risks to subjects," said Ivor Pritchard, acting director of OHRP.
Pronovost helped the hospitals set up a program in 2003 that required ICU medical staff to follow a checklist of basic hygiene practices, such as hand-washing and wearing sterile gowns, to see if they cut back on catheter-related infections.
Within 18 months, catheter-related infections dropped by two-thirds. When Pronovost published results in the New England Journal of Medicine in 2006, they were widely seen as a significant step toward reducing the estimated 90,000 deaths each year from hospital infections. Researchers estimated the ICU checklist saved 1,500 lives in Michigan.
But last fall, the OHRP ordered Pronovost to stop collecting information because neither he nor the hospitals obtained patient consent or prior approvals from independent panels, known as an institutional review boards (IRBs), at hospitals where the checklists were implemented. Pronovost had submitted his proposed study to an IRB panel at Hopkins and was granted an exemption.
But Pronovost's checklist wasn't considered an experimental treatment: It included five steps doctors and nurses are supposed to follow in ICUs, but sometimes forget, experts say.
Hospital administrators continue to struggle to understand federal regulations that govern when improvements become research that require extensive reviews, said Dr. Daniel E. Ford, the vice dean for clinical investigations at Hopkins, who oversees institutional review boards at the medical school.
Still unresolved is whether Hopkins and other research institutions are required to undergo the same intensive reviews to studies on improvements in care, like checklists, as they now give to clinical trials where patients are given experimental drugs or treatments, he said.
"We are reviewing quality improvement activities as thoroughly as possible, but would welcome more clarification from the Office of Human Research Protection," Ford said in an e-mail yesterday.
Rules regarding the types of studies involving human subjects are currently being revised, according Kevin Schweers, a spokesman for OHRP.
The OHRP investigation, prompted by an anonymous complaint, sparked criticism among quality care experts concerned that requiring lengthy reviews of studies evaluating improvements in care would chill such research. Some experts expressed relief over the OHRP decision yesterday.
"All of us reacted strongly to what the OHRP initially did, but I think they've backed off to where they should be," said Dr. William Minogue, executive director of the Maryland Patient Safety Center.
Maryland hospitals with ICUs made checklists standard practice in 2005 with help from a group that included Pronovost, Minogue said.
OHRP's decision to conclude the federal review clears the way for Pronovost and other researchers to continue evaluating the checklist as well as other patient safety measures.
"We feel really happy that we'll be able to continue with this work," said Sam R. Watson, executive director of the Michigan-based Keystone Center for Patient Safety and Quality that is working with Pronovost.
In a letter released this week, the OHRP said Pronovost's research probably would have qualified for a waiver of patient consent requirements because of a minimal risk of harm. The work also would likely have been eligible for an "expedited IRB review," which experts say can be completed in a few weeks, depending on the hospital or medical school, experts say.
Pronovost said he has no problem with completing expedited IRB reviews.
"I think, if you look at their latest decision, they're being more reasonable," said Pronovost, a Hopkins professor and medical director of the Center for Innovation in Quality Patient Care.
dennis.obrien@baltsun.com