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Informed Consent and Studies of a Quality Improvement Program—Reply
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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.
There were several reasons for not requiring participants to provide informed consent. First, from the patients' point of view, the study was observational because no intervention on the patients was involved; the educational intervention involved only physicians and nurses. Second, patients' participation was completely anonymous. Third, we did not include a control group in whom the educational intervention was withheld. Although this would have strengthened our conclusions, it would have introduced some ethical ambiguities. Fourth, all consecutive patients in the different periods of . . . [Full Text of this Article]
Ricard Ferrer, MD
rferrer@tauli.cat
Antonio Artigas, MD, PhD
Hospital de Sabadell CIBER Enfermedades Respiratorias Barcelona, Spain
Mitchell Levy, MD, FCCM
Rhode Island Hospital Providence
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