So last we heard, the incredibly promising quality intervention known as the simple “checklist” had been blocked by a National Insitutes of Health requirement for human subjects review everytime any institution wanted to use it. (Click here and click here for our prior posts on this subject.) Not so, says NIH. Institutions are free to use the checklist anytime they want so long as they do NOT study the results. If they do want to study the results, they have to get permission from every physician and every patient on whom the checklist is used.
We’re not making this up.
Today’s New York Times has a neat editorial on the subject: “Pointy Headed Regulation.” Well titled. NIH turns us all into anti-government screamers.
Some good folks are working hard on this behind the scenes. Let’s keep our fingers crossed and we’ll keep up updated.
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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.