Adverse events are any unforeseen or unexpected outcomes that have a negative impact on participants, researchers or the reputation of the University of Western Australia. These include:
If the adverse event is of a serious nature, the researchers should immediately consider the temporary suspension of research activities until the situation has been resolved. The Human Research Ethics Office (HREO) must be notified immediately the event has occurred, or as soon as possible thereafter. Where the situation is urgent, this notification should occur via telephone and/or email communication.
At the first available opportunity, the researcher must also complete and submit an Adverse Event Report in ROAP.
In reviewing the adverse event, the Human Research Ethics Office (HREO) may seek advice from the Human Research Ethics Committee (HREC) or Low Risk Review Panel (LRRP), and/or any other relevant source of information and advice.
Depending on the seriousness of the adverse event;
In addition to lodging an Adverse Event Report with the Human Research Ethics Office through ROAP, researchers must comply with any other relevant legal and institutional requirements that may apply in a particular instance (e.g. relevant occupational health and safety requirements).