Adverse Events/Unanticipated Problems

Adverse events and unanticipated problems occurring in research studies must be reported to the IRB. Principal investigators or other research personnel should use the Incident report form when reporting issues that occur. Serious adverse events (that result in death, hospitalization, significant disability, life-threatening situations, or concerns about physical health or future health of subjects) should be reported to the IRB within one week of an investigator becoming aware of the event or effect. All other incidents or experiences should be reported to the IRB within two weeks.

Adverse events include unfavorable physical or psychological harm that occurs in a human subject during the course of a research study, whether or not considered related to the subject's participation in the research. Unanticipated problems involve experiences that are unexpected in nature, severity, or frequency, and suggest that the research places subjects or others at a greater risk of harm than was previously noted in the consent form or protocol. The IRB will review the report and take appropriate action, including notifying the investigator of the action(s) taken.

UM Policy on Reporting Adverse Events and Unanticipated Problems