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. 2007 May 1;146(9):666-73.
doi: 10.7326/0003-4819-146-9-200705010-00155. Epub 2007 Apr 16.

The Ethics of Using Quality Improvement Methods in Health Care

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The Ethics of Using Quality Improvement Methods in Health Care

Joanne Lynn et al. Ann Intern Med. .

Abstract

Quality improvement (QI) activities can improve health care but must be conducted ethically. The Hastings Center convened leaders and scholars to address ethical requirements for QI and their relationship to regulations protecting human subjects of research. The group defined QI as systematic, data-guided activities designed to bring about immediate improvements in health care delivery in particular settings and concluded that QI is an intrinsic part of normal health care operations. Both clinicians and patients have an ethical responsibility to participate in QI, provided that it complies with specified ethical requirements. Most QI activities are not human subjects research and should not undergo review by an institutional review board; rather, appropriately calibrated supervision of QI activities should be part of professional supervision of clinical practice. The group formulated a framework that would use key characteristics of a project and its context to categorize it as QI, human subjects research, or both, with the potential of a customized institutional review board process for the overlap category. The group recommended a period of innovation and evaluation to refine the framework for ethical conduct of QI and to integrate that framework into clinical practice.

Comment in

  • Quality improvement and ethical oversight.
    Grady C. Grady C. Ann Intern Med. 2007 May 1;146(9):680-1. doi: 10.7326/0003-4819-146-9-200705010-00156. Epub 2007 Apr 16. Ann Intern Med. 2007. PMID: 17438309 No abstract available.

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