Comments on: Checklist Redux II: NIH Is Nuts http://blog.hcfama.org/2008/01/27/checklist-redux-ii-nih-is-nuts/ The Ultimate Massachusetts Health Care Insider Information Fri, 10 Feb 2012 15:41:33 +0000 hourly 1 http://wordpress.com/ By: A Healthy Blog » Checklist Chronicles: Feds Give the Checklist an A-OK http://blog.hcfama.org/2008/01/27/checklist-redux-ii-nih-is-nuts/#comment-1440 Fri, 22 Feb 2008 12:04:52 +0000 http://blog.hcfama.org/?p=1410#comment-1440 [...] posts on the controversy over the use of “checklists” to improve quality — click here for the latest summary post. Briefly, Brigham & Women’s Surgeon Atul Gawande wrote a [...]

]]> By: Dave http://blog.hcfama.org/2008/01/27/checklist-redux-ii-nih-is-nuts/#comment-1439 Mon, 28 Jan 2008 03:26:32 +0000 http://blog.hcfama.org/?p=1410#comment-1439 Pertinent federal regulations state, in part:

(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent . . . or waive the requirements to obtain informed consent provided the IRB finds and documents that:

(1) The research involves no more than minimal risk to the subjects;

(2) The waiver or alteration will not adversely affect the rights and welfare of the subjects;

(3) The research could not practicably be carried out without the waiver or alteration; and

(4) Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

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