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October 15, 2008

Informed Consent and Studies of a Quality Improvement Program

JAMA. 2008;300(15):1762-1763. doi:10.1001/jama.300.15.1762-a

To the Editor: Dr Ferrer and colleagues1 reported the results of a study of a national educational program based on the Surviving Sepsis Campaign guidelines. The authors found that the educational intervention was associated with improved hospital mortality rates. However, I am interested in their statement that “[t]he need for informed consent was waived in view of the observational . . . nature of the study,” which does not seem accurate.