Quality-Improvement Research and Informed Consent

Franklin G. Miller, Ezekiel J. Emanuel | The New England Journal of Medicine | 21 Feb 2008

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, for instance, research on a quality-improvement initiative that affects routine care is conducted in an intensive care unit (ICU), surgical suite, or emergency room, individual patients have no opportunity to decide whether or not to participate. Can it be ethical to conduct such research without informed consent?

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