Adverse Events (AEs), Other Reportable Information and Occurrences (ORIOs), & Other Required Reporting

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.

Instead of using the UM Standard Timetable, investigators can propose a plan designed for their study. A study-specific plan is encouraged for minimal to moderate risk studies that are not under FDA oversight. Many sponsored studies include an AE reporting plan. Know your options! For more information, view the Study-Specific Adverse Event (AE) Reporting Plans guidance.

• the test article or test procedure
• other aspects of the interaction or intervention
• the subject's underlying condition
• the subject's concurrent standard treatment
• research information that is disclosed inappropriately.

AEs may be definitely related, probably related, possibly related, unlikely to be related, or definitely not related to the research. To be considered "related" to the research does not simply mean caused by a test agent like a survey, an investigational drug or device, but encompasses all procedures that are done solely for research purposes (i.e. they would not have taken place had the subject not been in the study).

AEs may be observed in the specified project or in other research settings similar to that of the specified project, or in projects involving a similar intervention.