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Letters |

Informed Consent and Studies of a Quality Improvement Program—Reply

Ricard Ferrer, MD; Antonio Artigas, MD, PhD; Mitchell Levy, MD, FCCM
JAMA. 2008;300(15):1762-1763. doi:10.1001/jama.300.15.1762-b.
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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 the study were included, without any random assignment to different groups. Fifth, the educational program focused only on teaching the therapeutic recommendations that are included in the guidelines (with several levels of evidence based on previous research) but not always implemented, without adding any risk to the patients. Moreover, previous studies in this field done by several investigators in Europe and the United States did not include informed consent.13

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October 15, 2008
François Lemaire, MD
JAMA. 2008;300(15):1762-1763. doi:10.1001/jama.300.15.1762-a.
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