Human Ethics Resources
To comply with the National Statement and to ensure that your ethics approval remains valid, you will need to address a number of project management responsibilities.
- Adverse and unexpected events-notification and reporting
- Amendment of an existing project
- Progress reports
- Closure reports
- Extending a project beyond five years
- Re-opening a project
Adverse and unexpected events – notification and reporting
Definition of an adverse event
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:
- higher than expected incidence of risk factors associated with the research project
- more serious reactions or impacts on participants than were expected by researchers
- any event that might change the ethical acceptability of the project
Required action by you
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;
- the research project may be temporarily suspended by the University until the situation has been resolved
- the University may require modifications to the project to prevent similar adverse events occurring
- it may be necessary to terminate the project as an appropriate response to the risks involved for participants
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).
University information
CRICOS Code: 00126G
