• campus:  a to z index
• map
• directory
• calendar

• Home
• IRB Forms
• Submissions
• Calendar & Deadlines
• Guidelines
• Event Reporting
• • Unanticipated Problems
  • Adverse Event Reporting
  • Protocol Deviation Reporting
• Board Members
• Training
• Participant Resources
• Contact Us

Adverse Event Reporting

• PDF Version of Guidance (version July 2008)
• Adverse Event Decision Chart
• Report Form FAQs
• What should I Submit - Amendment or Report?

Unexpected, related adverse events

Only a subset of adverse events need to be reported to the IRB. The IRB requires the reporting of adverse events that may represent unanticipated problems involving risks to participants or others (UPs).

How do you determine which adverse events are unanticipated problems?

The adverse event must be unexpected and related and suggest that the research places subjects or others at a greater risk of harm than was previously known or recognized. Use this flow chart to determine an adverse event needs to be reported to the IRB.

The Investigator will be asked to determine if the adverse event is an unanticipated problem in the report form. Please be advised that adverse events which do not meet the IRB's definition of an Unanticipated Problem (that is, an unexpected, related adverse event that places subjects at greater risk) should not be reported to the IRB. Report forms will be automatically withdrawn and will not be reviewed by the IRB if the investigator indicates that the adverse event does not meet these criteria.

What is an unexpected adverse event?

An unexpected adverse event is 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, and applicable investigator brochure, and the current IRB-approved informed consent document, and 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?

It is the responsibility if the 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. An adverse event is "related to the research" if in the opinion of the principal investigator, it was more likely than not related to the investigational agent(s) or intervention.

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 seems to affect the rights and welfare of current participants.