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To the Editor: Dr Casarett and colleagues¹ raise appropriate concerns for protecting patients in local efforts to improve quality of care and propose criteria that extend current research protections to such quality improvement (QI) studies. However, we believe that such procedures could actually pose additional risks to patients and would interfere with efforts to address recent concerns about health care safety and quality.²

Human subjects protections arose as a legacy of Nuremberg, in response to abuses in early clinical trials. The Nuremburg Code assumes that participation in research is voluntary and that protecting patients from exploitation is more important than potential medical progress.³ These underlying assumptions may not apply when protections are extended from risks of physical harm associated with experimental treatments to privacy-related risks in QI activities. Experience in states that require written patient consent for retrospective chart reviews reveals consistent difficulties. When consent is required, even intensive procedures . . . [Full Text of this Article]

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