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.
The whole shebang.