Human research ethics
Reporting adverse events
The Human Research Ethics Committee that approves an ethics application is responsible for monitoring the project. This includes the progress of the project and any impacts the research activities have on participants.
Serious or unforeseen events impacting participants, or others involved in the project, need to be reported to the approving HREC through an adverse event report. This allows the HREC to confirm that the approved risk management strategy for the project is appropriate and that the research is being conducted in accordance with the HREC approval.
Examples of adverse events include:
- the reaction of a potential participant during recruitment
- a participant being impacted during data collection (e.g., unforeseen impact during the administration of a survey or an interview)
- related or unrelated reaction to being exposed to a substance or intervention
- a participant being impacted due to a departure from an approved ethical protocol.
Adverse event reports for projects approved by the University’s HREC are reviewed by the full committee during its monthly meetings.
Serious or unforeseen adverse events must be reported in RIMS within 72 hours of the occurrence of the event or the chief investigator receiving advice of the event.
Details of adverse events which are not serious or unforeseen can be included in the project’s next annual progress report.
The University of Newcastle acknowledges the traditional custodians of the lands within our footprint areas: Awabakal, Darkinjung, Biripai, Worimi, Wonnarua, and Eora Nations. We also pay respect to the wisdom of our Elders past and present.