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Showing posts with label SUPPORT Study. Show all posts
Showing posts with label SUPPORT Study. Show all posts

Monday, June 10, 2013

SUPPORT Update: OHRP’s Compliance Actions on Hold

By John B. Lantos
The Hastings Center Bioethics Forum
Originally posted June 5, 2013

In a thoughtful, nuanced letter to the University of Alabama (the home of the Principal Investigator of the SUPPORT study), the Office for Human Research Protection announced that it has “put on hold all compliance actions against UAB relating to the SUPPORT case.”  Further, OHRP promises not to initiate compliance actions “in studies involving similar designs” until it clarifies the guidelines for such studies. In doing so, it acknowledges “widespread misunderstanding about the risks that are required to be disclosed in obtaining informed consent for certain types of studies.”  (Previous posts on the SUPPORT controversy are here, here, here, and here.)

OHRP promises that the process of drafting new guidelines will be “as open as possible, with input from all interested parties.”  To achieve this, it will “engage in the usual notice and comment process with regard to draft guidance” and “will also conduct an open public meeting on this topic.” This is a welcome development.

The letter also suggests the positions that OHRP will take in these discussions. It focuses on three main points.

First, the letter acknowledges that these discussions will focus on situations where the standard of care includes known and widespread practice variation with no reliable evidence on which practices are associated with which risks or benefits. “When the SUPPORT study was initiated,” it states, “there was no clear recent evidence indicating that different oxygenation levels with the then-current standard of care (85%- 95%) would produce differences in neurological damage or survival.”

The entire blog post is here.