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UCD Office of Research Ethics

An Oifig Eitic Thaighde UCD

Unforeseen Adverse Events

What is an Unforeseen Adverse Event?

Any unexpected adverse event or outcome experienced by any participant or researcher, which exceeds the risk that participants were informed of prior to consent or during debriefing. 

You must report all unforeseen adverse events whether minor or major.  Please submit a covering letter to the Chair of the relevant committee (quoting your research ethics reference number) with the following Report to

HR5-Unexpected Events Report Form (Human Research only)

Failure to submit a report at the time of the adverse event could cause a delay to the completion of your study and may result in a halt to the research or future publications.  It is the duty of the researcher to ensure that their research is managed efficiently at all times.

For the AREC version of this form, please visit AREC Intranet .