This policy establishes the requirements for the prompt identification, reporting and review of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information. It defines the responsibilities of investigators to report events to the DUHS IRB. These requirements are in accordance with federal regulations, institutional policies, and accreditation standards. The overarching goal of this policy is to ensure appropriate oversight of human subject research and to protect the rights, safety and welfare of research participants.