FDA’s recent IRB guidance more style than substance


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.