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High Risk Projects

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High Risk Projects

All high risk projects and all projects reviewed under the multi-centre research umbrella are required to submit a Research Governance application/Site Specific Assessment (SSA) to the Office for Research.

Western Health(WH) is an accepting site under the Streamlined Ethical Review Process (SERP) coordinated by the Department of Health.

​High Risk Projects - WH site only​
 

This pathway is relevant if your project falls under any of the following:

  • The project is high risk and Western Health is the only participating site.
  • It is not eligible for the Streamlined Ethical Review Process​
     
  • It is a part of the Research Excellence  (REx) Streamlined Ethical Review Process

You will need to submit an ethics application to Melbourne Health Human Research Ethics Committee (MH HREC) according to their submission requirements. Please see their website here.


 

For Paediatric studies, You will need to submit an ethics application to the Royal children's Hospital Human Research Ethics Committee (RCH HREC) according to their submission requirements. Please see their website ​here.


 

Once an ethics submission has been made to the above HRECs, researchers MUST also submit a Research Governance/SSA Application to WH for Governance review and site authorisation before commencing the project even if ethics approval has been given.


 

To submit a Research Governance Application/SSA, please see our webpage here​.

​
 

High Risk - Multiple sites

​​Your project may require review under the Streamlined Ethical Review Process (SERP)/National Mutual Acceptance (NMA) managed by The Department of Health & Human Services (DHHS), Consultative Council for Clinical Trial Research.

You will need to contact the DHHS and submit an application to an assigned HREC for ethical review and submit a Research Governance/SSA Application to WH for Research Governance review and site authorisation before you are able to commence your​ project.​

Please refer to the Home - Clinical Trials and Research for more information.


 

For a brief summary of this process, please see the Department of Health Brochure for Streamlining Clinical Trials in Victoria (link downloadable on right hand side)


 

Once an ethics submission has been made to the reviewing HREC, researchers MUST also submit a Research Governance/SSA Application to WH for Governance review and site authorisation before commencing the project even if ethics approval has been given.


 

To submit a Research Governance Application/SSA, please see our webpage here​.


 

 

Fig 1. Streamline Ethical Review Process - Ethics and Governance Review to be processed in parallel.​

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