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.
