In Reply: In response to Dr Lemaire, Edusepsis is a clinical research study of quality improvement. Quality improvement is an intrinsic part of good clinical care, in which data from clinicians' own settings guide them in improving their practices. However, ethical issues arise because attempts to improve quality may inadvertently cause harm. The Edusepsis study was completely evaluated by the independent research ethics committees of participating hospitals.
Ferrer R, Artigas A, Levy M. Informed Consent and Studies of a Quality Improvement Program—Reply. JAMA. 2008;300(15):1762-1763. doi:10.1001/jama.300.15.1762-b