Our organisation, the ethics committee and investigators must ensure that the research continues to conform to approved ethical standards, and in accordance with the RMH Research Policy throughout its lifecycle.

In this section


From time to time, amendments to research projects are required often due to protocol changes, updated investigator brochures, personnel changes on the study, site additions, and more. Researchers and sponsors must notify the HREC of such changes. 

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Auditing research projects

Internal audit of research is an important means by which the Royal Melbourne Hospital ensures research auspices is conducted in accordance with good clinical practice (GCP) and approved ethical guidelines

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Progress & final reports

Annual progress reporting is a condition of ongoing ethics approval.

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Post-approval monitoring

The Royal Melbourne Hospital is required to monitor all approved research until the completion of the project.

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Safety & adverse event reports

Maintaining and reporting of adverse events and safety information in research will ensure that RMH complies with the NHMRC's National Statement.

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Serious breaches

Serious Breach is a breach of Good Clinical Practice or the protocol that is likely to affect to a significant degree the safety or rights of a research participant or the reliability and robustness of the data generated in the research project.

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Contact the Ethics team at RMH where:

  • Unforeseen events have occurred, or
  • Any other matters not covered elsewhere that may impact on the conduct of the project at the RMH

In these instances, provide details (including the local project number) and submit them to hrecCorrespondence@mh.org.au