IRB Adverse Event Reporting Procedures

Procedure

The Office of Human Research Protections (OHRP) recognizes that any adverse event in a trial is a potentially important occurrence because it may reflect additional risks to subjects. In accordance with their requirements, these regulatory bodies have charged Institutional Review Boards with the responsibility of conducting continuing review of research. Included in this review is the monitoring of adverse reactions and unexpected events (21 CFR 56.108 and 45 CFR 46.103).