Serious breach reports - Peter Mac ethics

Serious breach reporting replaces Protocol Deviation/Violation reporting

A 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
  • The reliability and robustness of the data generated in the research project 

It is the responsibility of the Sponsor to determine whether any suspected breach meets the definition of a serious breach. 

Third parties may report a serious breach directly to the HREC in the following situations: 

  • The investigator/institution has good evidence that a serious breach has occurred, but the sponsor disagrees with their assessment and is unwilling to notify the HREC 
  • The investigator/institution has become aware that the sponsor may have committed a serious breach 

The items below required to be submitted to the Peter Mac HREC by the Sponsor (or delegate) will be acknowledged by the Peter Mac HREC. 

The procedure to be followed is provided in the below table: 

Reporting party 

Report required and timeline 

Supporting information required 

SPONSOR or delegate 

Serious breaches should be notified to the HREC within 7 calendar days of the sponsor confirming that a serious breach has occurred 

Details of the serious breach 

Impact of the serious breach on any of: 

  • Patient safety 
  • Participant rights 
  • Reliability and robustness of data 

Details of any action taken to date: 

  • Investigations being conducted 
  • Outcome of investigations 
  • How the serious breach will be reported in publications 
  • Corrective and preventative actions to be implemented 

SPONSOR or delegate 


Notify the reviewing HREC if a serious breach leads to the closure of a site 

Reason for closure of site 

Ongoing plan for site participants 

Implication for other sites, if any 

Third party 

Serious breaches can be reported directly to the reviewing HREC 

Details of the serious breach 

Impact of the serious breach of any of: 

  • Participant safety 
  • Participant rights 
  • Reliability and robustness of data