When Dr. Peter Pronovost assembled a checklist of proven safety procedures and required critical care doctors to use it, the results were indisputable: It prevented infections and saved lives.
But the veteran Johns Hopkins safety researcher also drew critical scrutiny from government regulators. In a decision last month that upset his colleagues nationwide, the federal Office of Human Research Protections said using a safety checklist - and studying its effects - amounted to conducting an experiment without a patient's consent.
So the agency directed the 70 Michigan hospitals that participated in Pronovost's study to stop sending him data on future infection rates.
Both Pronovost and federal officials play down the dispute. But elsewhere, researchers say the government's heavy-handed treatment of a simple, commonsense project that has saved more than 1,500 lives - at almost no cost - could delay similar safety initiatives nationwide.
"I think it's ludicrous. It probably will kill people if they don't fix this soon," said Dr. Robert Wachter, a national expert on patient safety at the University of California, San Francisco. "This is regulation run amok."
Richard J. Umbdenstock, president of the American Hospital Association, called the decision "wholly inappropriate and detrimental to the patients and communities we serve."
Experts considered Provonost's findings, reported in the New England Journal of Medicine in 2006, a major step in efforts to reduce the estimated 90,000 deaths from hospital infections each year.
Both federal officials and Pronovost, a Hopkins professor and and medical director of the Center for Innovation in Quality Patient Care, emphasized that hospitals in Michigan, Maryland and elsewhere are continuing to use intensive-care unit checklists and that no sanctions would be imposed.
"Punishment was not on the table. We told them to take corrective action, and they have," said Ivor Pritchard, acting director of the OHRP.
But before Pronovost can continue to study infection rates in Michigan's intensive-care units, hospitals there must have the work reviewed by independent oversight groups called institutional review boards.
In some cases, that could take months, researchers said. They suggested that federal officials misapplied regulations originally designed to protect patients in clinical trials of experimental drugs and procedures.
