What Is an Adverse Event
An adverse event is any undue or unplanned harm to a research participant. There are several types of adverse events that can be reported:
- An event that in the opinion of the principal investigator (1) was unexpected and (2) was related to
the research procedures; - An event that requires prompt reporting according to the research sponsor (if any);
- An accidental or unintentional change to the IRB approved protocol that involves risks or has the
potential to recur; - A deviation from the protocol without prior IRB approval to eliminate any apparent immediate
hazard to a research participant; - A publication in the literature, safety monitoring report, interim result, or other finding that indicates
an unexpected change to the risk/benefit ratio of the research; - A breach in privacy/confidentiality/data security/loss of study data that may involve risk to
participant(s); - A complaint of a participant that indicates an unanticipated risk or cannot be resolved by
the research staff.
Reporting Adverse Events
To report an adverse event, please complete the Unanticipated Problems/Adverse Event Report and immediately email it to the IRB at IRB@westcoastuniversity.edu
One original copy of the form must be mailed to:
IRB/University Research Compliance
WEST COAST UNIVERSITY
Center for Graduate Studies
590 North Vermont
Los Angeles, CA 90004
