Controversy and quality improvement: lingering questions about ethics, oversight, and patient safety research.
A landmark study that demonstrated the effectiveness of a safety program and a checklist to reduce catheter-related bloodstream infections later generated national attention when the study was temporarily shut down. The Office for Human Research Protections (OHRP), in response to an anonymously filed complaint, acted due to concerns around the need for consent from patients and clinicians involved in the statewide quality improvement initiative. Ultimately, the decision was overturned by OHRP (with considerable pressure from those in the safety community), but it raised several discussions about differentiating quality improvement from research, and whether the former could survive as a field if similar requirements were placed for interventions that mostly target systems rather than individuals. This commentary summarizes the project in question, discusses several ethical and regulatory issues involved in the debate that ensued, and provides a thoughtful dialogue on the outcomes from the scrutiny in moving forward.