Adverse or Reportable Events

Any adverse effects on research participants or reportable events must be reported within 72 hours to the Human Research Ethics Office (humanethics@unisa.edu.au) using the Adverse or Reportable Event Form.

An Adverse Event is "any untoward medical occurence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment". (Wikipedia, viewed online 3 Oct 2019)

A Reportable Event is one in which the participant has been caused distress.  This could be, but is not limited to, psychological or emotional distress, breach of confidentiality or privacy or other issues.