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