Adverse Events

Although all adverse events should be summarized at continuing review, only a subset of adverse events (AEs) need to be promptly reported to the IRB using the ERICA Report Form application. The IRB requires the prompt reporting of adverse events that may represent unanticipated problems involving risks to participants or others (UPs).  Promptly means within 10 business days after learning about the event, or 5 business days for VA research.  

How to Report an Adverse Event

1. Use the UP criteria and instructions for reporting. You may use the Adverse Events Decision Flowchart [PDF] to document the investigator’s decision for reporting according to the UP criteria.
2. Please be advised that adverse events which do not meet the IRB's definition of an Unanticipated Problem (UP) should not be promptly reported to the IRB using the Report Form application. Report Forms will be automatically withdrawn and will not be reviewed by the IRB if the investigator indicates that the adverse event does not satisfy the definition of a UP.

What is an unexpected adverse event?

Any adverse event occurring in one or more subjects participating in a research protocol whose nature, severity, or frequency is not consistent with either:

• The unknown or foreseeable risk of adverse events associated with the procedures involved in the research that are described in the protocol related-documents, such as: the IRB-approved research protocol, applicable investigator brochure, the current IRB-approved informed consent document, and/or other relevant sources of information, such as product labeling and package inserts; or
• The expected natural progression of any underlying disease or condition of the subject(s) experiencing the adverse event.

What is a related adverse event?

An adverse event that, in the opinion of the principal investigator, was more likely than not related to the investigational agent(s) or intervention. It is the responsibility of the University of Utah Principal Investigator to make the initial determination of a relationship between an adverse event (either internal or external) and any investigational agent(s), intervention, or research study procedure.

Is follow-up information concerning an adverse event required?

A follow-up report is NOT required unless you receive information that suggests that the severity of an event has increased, OR that suggests the event is more likely to be related to the study than currently thought, OR that the event seems to affect the rights and welfare of current participants.