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.