Amendments and Safety Reports

All reports about the ongoing conduct of approved research projects must be submitted online in the Research Governance Service.

Monitoring reports include:

• Amendments: Modifying the study protocol or documents (e.g., participant information sheet and consent form), extending the HREC approval period, adding a new study site or changing personnel.
• Reports of significant safety events or protocol breaches occurring at a site covered by the HREC approval.
• Reports of the suspension or early termination of a project.
• Submitting an annual or final report.

If you have any questions about monitoring/reporting requirements for research, please contact the Research Hub Administrative Officer via EMHS.REG@health.wa.gov.au, quoting the project’s Research Governance Service number.

Following submission in Research Governance Service, researchers will receive acknowledgement or approval notification via the Research Governance Service. The nature and time of the approval or acknowledgement depends on the type of report.

Research Audit Program

EMHS strives to achieve excellence in research and part of maintaining this high standard is the regular auditing of selected approved projects. Auditing of approved projects is a necessary component of the overall monitoring of health research.

The research audit program aims to:

The audit program is designed to be collaborative and supportive, with broad, generalisable learnings guiding research education planning and policy and process reviews.

Resources

• EMHS Research Audit Program Guide
• Self-Audit Tool
• Audit Program Tool