When does a submission need to be received in order to placed on the agenda?
To be ensured that a study will be reviewed at a convened meeting, it must be received by the IRB by the Tuesday prior to the scheduled meeting. It is often not possible add items to the agenda that are received after this deadline.
Do all studies that require full board review have to go back to the full board for subsequent reviews?
No. Some studies are determined by the full board to be minimal risk. These are reviewed using expedited procedures for all future reviews. Many amendments to full board studies involve minor changes that do not affect risk to subjects and these may also be reviewed using expedited procedures. Finally, studies whose only remaining procedures involve follow-up or data analysis usually do not require full board review.
What about new studies or amendments that are urgent and can't wait for the next full board meeting?
The CHOP IRB also includes a rapid action IRB, officially titled the CHOP Executive IRB, that can be convened with one or two days notice to review items that are emergencies or urgent matters. In the event that there is insufficient time for this IRB to meet and if the emergency involves an FDA-regulated investigational test article, the investigator may exercise the emergency exemption from prior IRB review. They should call the IRB to confirm whether or not the IRB is able to review the submission prior to the proposed use.