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October 11, 2000

Should Patients in Quality-Improvement Activities Have the Same Protections as Participants in Research Studies?—Reply

Author Affiliations

Stephen J.LurieMD, PhD, Senior EditorIndividualAuthorPhil B.FontanarosaMD, Executive Deputy EditorIndividualAuthor

JAMA. 2000;284(14):1786-1788. doi:10.1001/jama.284.14.1783

In Reply: Several of these authors raise the legitimate concern that our guidelines would curtail or delay important QI initiatives. While we agree that QI should be central to the missions of health care institutions, the importance of any activity to the delivery of quality care, whether research or QI, cannot justify waiving patient protections.

Nor are we convinced by arguments about the burdens of obtaining informed consent. Although the requirement for written documentation of informed consent for chart review if extended to QI, would have a chilling effect on QI, written informed consent is not always required for research.1 As Dr Cretin and colleagues point out, however, some states have this requirement. Nevertheless, this is a symptom of problems with the way that nonclinical research is variably regulated in this country, not with the distinction between research and QI.

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