What if an adverse event occurs?
Under federal regulations, the IRB is responsible for receiving and reviewing information about adverse events experienced by research subjects. Adverse events are those that are not expected to occur, are more serious than anticipated when they do occur, or occur more frequently than reasonably anticipated. Unexpected adverse events must be reported to the IRB by the researcher in a timely manner. Unexpected adverse events that occur in research subjects enrolled under Mount Carmel IRB approval must be reported on the Adverse Event Reporting Form.
