ERICA will be offline all day on Saturday, August 30th and Sunday, August 31st for maintenance and the following updates to the IRB Report Form:

1. In the opinion of the local Principal Investigator, was the event unexpected?
2. In the opinion of the local Principal Investigator, was the event related to research?
3. In the opinion of the local Principal Investigator, does the event suggest that the research places subjects or others at greater risk of harm?

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. Please review the event reporting policy on the IRB website.

Beginning Monday, September 1st, adverse event reports will be automatically withdrawn if the Investigators’ responses to these questions indicate that the adverse event is expected, not related, or does not involve greater risk of harm. These reports will not be reviewed by the IRB.

Investigators must maintain a record of all unreported adverse events. A summary of all adverse events should be submitted annually at continuing review.

All other types of events and problems will be reviewed by the IRB and do not apply to this automatic withdrawal process.

Please email Ann Johnson, IRB administrator, or call 801.587.9134 if you have questions regarding this change or the reporting policy.