Quality-Improvement Research and Informed Consent

Tens of thousands of patients die each year because of hospitals' failure to adhere consistently to standard procedures of safe and effective medical care. Accordingly, improving the quality of routine hospital care is a public health imperative. An effective way to promote quality improvement is to conduct evaluative research on programs designed to implement standard practices for the safety and care of hospitalized patients.Such research, however, poses an apparent ethical conundrum: it is often impossible to obtain informed consent from patients enrolled in quality-improvement research programs because interventions must be routinely adopted for entire hospitals or hospital units. When, . . .