This policy establishes the requirements and responsibilities for the DUHS IRB’s review and reporting obligations of unanticipated problems involving risks to subjects or others (UPIRTSO), allegations of noncompliance, serious or continuing noncompliance, and other reportable information. 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.