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Ethics and Governance Application Process

The process that occurs before the trial can commence.

Submitting the ethics application

The process for submitting an ethics application is determined by the following factors:

  • Trial design: single-site or multi-site
  • Type of health service: publicly or privately funded
  • Location of site: i.e. the state/territory

For single-site trials and any privately funded health services that are part of a multi-site trial, the Sponsor-Investigator must use the reviewing Human Research Ethics Committee's (HREC) ethics application process.  

If the trial is multi-site, National Mutual Acceptance (NMA) supports the acceptance of a single scientific and ethical review for all sites that are publicly-funded health services across all states and territories in Australia.  

Under the nationally harmonised approach, multi-site research projects are subject to a single ethical review by a HREC at a certified institution. If the project is approved, ethics approval may be adopted by participating institutions. 

Further information about submitting an ethics application for multi-site research under the NMA scheme is available from the Victorian Health website.

Submitting the research governance or site-specific assessment application

A research project that has been ethically approved is also subject to Site-Specific Assessment (SSA) by institutions wishing to participate in the research, each of which must authorise the project before it can proceed at its site/s. 

For information about submitting a research governance/SSA application for sites participating in the NMA scheme, refer to the Victorian Health website.

Factors impacting ethics process

Download factors impacting the ethics process.

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