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Higher risk research projects

Learn how to submit higher risk ethics review applications and site-specific assessments for higher risk research projects at Western Health.
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Overview

For all higher risk research projects and any projects reviewed under the multi-centre research process, you must submit a Research Governance application, also known as a Site-Specific Assessment (SSA), to the Office for Research.

Western Health is a participating site under the National Mutual Acceptance (NMA) Program for Streamlined Ethical Review, coordinated by the Department of Health. 

Projects at Western Health 

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

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

 How to submit 

You will need to submit an ethics application to Melbourne Health Human Research Ethics Committee (MH HREC). Find out more about their submission requirements.  

For paediatric studies, you will need to submit an ethics application to the Royal Children's Hospital Human Research Ethics Committee (RCH HREC). Visit their website for more information.  

Please note: After you’ve submitted your ethics application to one of the approved HRECs, you must also submit a Research Governance Application (Site-Specific Assessment or SSA) to Western Health. Even if your ethics approval has been granted, you cannot begin your project at Western Health until the governance review is complete, and you’ve received formal site authorisation from the Office for Research.  

Learn more about submitting a Research Governance Application/SSA

 

Multiple-site projects 

​​If your project will be conducted at more than one site, it may require review under the Streamlined Ethical Review Process (SERP) or National Mutual Acceptance (NMA).  

These processes are managed by Safer Care Victoria through the Consultative Council for Clinical Trial Research. 

How to submit 

You will need to contact the DHHS and submit an application to an assigned HREC for ethical review. You must also submit a Research Governance Application (or SSA) to Western Health for governance review and site authorisation before you commence your​ project.​ 

Please refer to the Victorian Government’s Clinical Trials and Research website for more information. 

For a summary of this process, please visit the National Mutual Acceptance (NMA) information page on the Department of Health’s website.  

Learn more about submitting a Research Governance Application/SSA

 

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