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.

This policy provides the procedures around the IRB's placing a study on hold, suspending a study, or terminating a study.

This policy defines an active research study and outlines the notification procedures for IRB expiration.  The policy also discusses lapses in IRB approval.

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.