How does the IRB review adverse events, other unanticipated problems, and protocol violations?
First, the Chair or designated reviewer will determine if the event meets the requirements for reporting. If the event does not meet the requirement for reporting, this finding will be noted on the report and it will be sent back to the PI. If the Chair determines the events meets the requirement for reporting to the IRB, the Chair or his/her designee will review the event report and decide what further IRB related action/review is indicated. The Chair or his/her designee will summarize his/her review directly on the form and return a copy of the form to the PI. For all events submitted, the IRB Chair reserves the right to request additional information to assist in making a determination or decision regarding the event and any revisions to the approved consent form(s). In addition, the Chair may ask the Committee to review the adverse event at a convened IRB meeting.
