As We Now Think

Reflections, commentary and analysis from Consortium for Science, Policy and Outcomes at Arizona State University.

FDA’s recent IRB guidance more style than substance

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By Lee Seabrooke, HSD, PhD student

The guidance provides useful operational issues to consider, such as the identification of “those studies for which IRB oversight is being transferred” and the establishment of “an effective date for transfer of oversight, including records, for the clinical investigation(s).” However, the guidance fails to provide solid recommendations regarding the level (e.g., full board vs. expedited review) for the receiving IRB or institution. Such an omission could result in the lack of an adequate review by a receiving IRB and carries the potential for undue risk to research participants.

Read more in The Hill
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This entry was posted on June 9, 2014 by in Uncategorized and tagged , .
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