What are the steps for making unanticipated problem or adverse event reports to the IRB?
Unanticipated problems involving risks to subjects or others (UPIRSOs) whose nature, severity, and frequency were not described in the information provided to and approved by the IRB or provided to participants in the consent document must be reported to the IRB within 72 hours. Examples include unexpected complications in a participant, missteps in the consent documentation, or breaches of confidentiality. Sometimes a study must be suspended to ensure participants’ safety. The report of the event should include: § the facts of the case, including the date and a description of the participant(s) § whether the event is related to the study’s procedures or to the participant’s condition § the steps that have been taken to address the problem § whether the event is likely to recur § whether the event provides new information about the study’s risks that should be conveyed to participants, in a revised consent form These reports usually receive expedited review, but in some cases the full
