When does quality improvement count as research? Human subject protection and theories of knowledge

The publication of insights from a quality improvement project recently precipitated a ruling by the lead federal regulatory agency that regulations providing protection for human subjects of research should apply. The required research review process did not match the rapid changes, small samples, limited documentation, clinician management, and type of information commonly used in quality improvement. Yet quality improvement can risk harm to patients, so some review might be in order. The boundaries and processes are not clear. Efforts have been made to determine what constitutes "research", but this has proved difficult and often yields irrational guidance with regard to protection of patients. Society needs a workable way to separate activities that will improve care, on the one hand, and those that constitute research, on the other. Practitioners who lead both quality improvement and research projects claim that those which rapidly give feedback to the care system that generated the data, aiming to change practices within that system, are "quality improvement" no matter whether the findings are published, whether the project is grant funded, and whether contemporaneous controls do not have the intervention. This criterion has not previously been proposed as a possible demarcation. The quandaries of which projects to put through research review and how to ensure ethical implementation of quality improvement need to be resolved.