Ethics Update – Serious Adverse Events

Serious Adverse Events rarely happen in Social Sciences and Humanities research but you should be aware of the below change in procedures at the Office of Human Research Ethics just in case.

The Office of Human Research Ethics (OHRE) has developed a Serious Adverse Events (SAE) application form in ROMEO. Beginning October 3, 2016, please submit your SAE reports (local and non-local) in ROMEO and NOT through the online Adverse Events Reporting website. Please see the Unanticipated Problem Reporting-Adverse Events guideline document to determine which SAEs require reporting to the REB. If the submission does not meet the reporting requirements for events that constitute Unanticipated Problem, the submission will be withdrawn.

 photo credit: Iceland ~ Dramatic Falls ! Iceland ~ Landmannalaugar Route ~ Ultramarathon is held on the route each July ~ A Fails Wonder via photopin (license)

About the Author

Kueneman, Karen

Staff, 2015 Fall

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