An Unanticipated Problem (UAP) is an incident, experience, or outcome that is unexpected, related or possibly related to participation, and suggests greater risk than previously known.
UAPs may include serious protocol deviations, breaches of confidentiality, unexpected harms, or new information that changes risk understanding. Institutions typically require prompt reporting of UAPs so oversight bodies can evaluate participant protections and determine whether changes are necessary. UAP review often leads to corrective actions, consent updates, or protocol modifications. Clear UAP processes strengthen ethical oversight and support transparent risk communication.