Reporting Adverse Incidents

Adverse incidents broadly encompass both physical and psychological harms to a subject observed by an investigator or reported by the subject.  They include any abnormal signs, symptoms or reactions temporally associated with the subject’s participation in the research, whether or not they are considered related to that participation.  The principal investigator must submit an Adverse Incident Report to the IRB chair within 24 hours of when he/she becomes aware of the adverse incident.  Concurrently, data collection must be suspended until the Executive Committee has reviewed the incident and determined an appropriate response.

Upon receipt of the report, the IRB chair will inform the Executive Committee of the adverse incident.  After collecting any additional information it deems necessary to render an informed decision, the Committee will notify the investigator as quickly as possible what protocol revisions, if any, are necessary in order to resume data collection.

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