• IRB: ETHICS & HUMAN RESEARCH

Ethical Oversight of Quality Improvement and the Research-QI Boundary: A New Common Rule Changes Little

Quality improvement (QI) is now an important part of the health care delivery system, and health care systems have an obligation to evaluate QI initiatives. However, federal human research regulations (the “Common Rule”) create ambiguous requirements for quality improvement, discouraging the use of careful methods of evaluation. We examine the tension between regulatory oversight and the learning health care system, using our experience with randomized evaluation of a computerized sepsis alert as an example. Recent changes to the Common Rule fail to resolve this tension. While the federal government was right to discard a proposed new definition of QI activities as those designed to change utilization of accepted practices, the new Common Rule retains the problems of the old. What is needed instead is a dedicated framework for QI that encourages rigorous evaluation of QI interventions and imposes clear oversight requirements.