Michigan patient safety study gets HHS approval to resume

The decision raises hopes the agency will re-examine how regulations on human research subjects apply to quality improvement studies.

By Kevin B. O'Reilly, AMNews staff. March 10, 2008.

A patient safety project that helped more than 100 Michigan hospital intensive care units cut their average catheter-related bloodstream infection rate by 66% can start collecting outcomes data again. That was the ruling last month from the Dept. of Health and Human Services' Office for Human Research Protections.

The move was viewed widely as a reversal of OHRP's controversial decision last fall to order the hospitals to suspend data collection. OHRP acted then because researchers had misclassified the project as being exempt from federal human research subject regulations and did not obtain informed consent from ICU patients.

More broadly, the decision seemed to signal a new willingness by the agency to re-evaluate whether rules designed to protect patients involved in high-risk biomedical experiments should also be applied to minimal-risk, evidence-based quality improvement research activities.

Results of the Michigan project were published in the New England Journal of Medicine in December 2006. They demonstrated how systemic changes improved clinicians' adherence to U.S. Centers for Disease Control and Prevention guidelines shown to reduce catheter-related bloodstream infections.

Previously, the intervention had been shown to work at Johns Hopkins Hospital, home to lead study author and principal investigator Peter J. Pronovost, MD, MPH, director of the adult critical care division.

OHRP said in a statement the project had "evolved" since it was first studied from 2003 to 2005, because the intervention is now proven and thus no longer qualifies as experimental research subject to federal rules. Similar projects probably could proceed with expedited institutional review board approval and qualify for a waiver of the informed-consent requirement, the agency said. Expedited reviews average about six weeks and can take up to a year, studies show.