IRBs are charged by Federal regulations, the Dean of the Medical School, and the University's Vice President for Research with the oversight of human subjects research conducted by faculty, students, or staff of the University, the Medical School, and the University of Michigan Health System. This is a cooperative mission carried out through a relationship between the IRBs and investigators.
Human subjects research may include interactions and/or interventions directly with subjects or involve the collection or analysis of information created or received by the Health System in caring for its patients or from other private or public sources.
An essential element of human subjects protection is identifying, analyzing the causes of, and responding appropriately to expected and unexpected adverse events, as well as unanticipated problems involving risks to subjects or others. Investigators are required to identify and help analyze the events and to formulate responses.
The IRB is required to make independent judgments concerning the significance of events and information in the context of the research project and the need for changes to the study protocol and/or informed consent process to protect research subjects.