Adverse Event Reporting

Adverse event reporting entails documenting and reporting harmful outcomes observed during research to a designated monitoring committee or system, review board, and/or institution. Adverse events are unanticipated problems experienced during research which places human subjects or others at a greater risk of harm than was previously known, including physical, psychological, economic, or social harm. Such events may lead to a pause and/or termination of the research to fully evaluate the direct or indirect cause of the harmful events. These can be thought of primarily as harmful events or outcomes not expected by researchers, and not included in Institutional Review Board (IRB) or other review submissions. In addition, expected adverse events, if more severe than previously known, are also reported and further evaluated. Thus, unexpected harmful ...