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Volume 358:765-767 February 21, 2008 Number 8 Next

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Editor's Note: On February 15, 2008, after this article had gone to press, the Office for Human Research Protections (OHRP) issued a statement (www.hhs.gov/ohrp/news/recentnews.html#20080215) expressing its new conclusion that Michigan hospitals may continue to implement the checklist developed by Pronovost et al. "without falling under regulations governing human subjects research," since it "is now being used . . . solely for clinical purposes, not medical research or experimentation." OHRP further stated that in the research phase, the project "would likely have been eligible for both expedited IRB review and a waiver of the informed consent requirement."

Tens of thousands of . . . [Full Text of this Article]

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Dr. Miller is a faculty member and Dr. Emanuel is the chair of the Department of Bioethics, National Institutes of Health, Bethesda, MD.

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