All research studies must be submitted for ethical review before a study can be given approval to start.

Before starting your submission, do either of the following circumstances apply to your research project?

Is your study a 'first time in human' clinical trial?
Does your investigator-initiated clinical study require the RMH to formally act in the capacity of sponsor as per GCP?

Complete all sections as they apply to your ethics application

Both sections 1 and 5 are mandatory for all submissions.

Complete sections 2, 3 and/or 4 as applicable.

Section 1: Mandatory components for all ethics submissions

All components in section 1 are mandatory and must be completed for all ethics submissions.

Section 2: For projects where participants will be enrolled to the study

Complete section 2 if your project involves participant-facing documents such as information and consent forms, plain language statements, transcripts and survey questions.

Section 3: For projects that involve radiation or genetically modified organisms

Complete section 3 if your project involves radiation and/or genetically modified organisms (GMOs).

Section 4: If your project is a clinical trial investigating a drug or device

Complete section 4 only if your project is a clinical trial investigating a drug and/or device.

Section 5: Submission procedure

Section 5 is mandatory and must be completed for all ethics submissions.

Tips for completing components of your application

  • Before starting your application, review all of the components as you may be able to undertake items in parallel and save a lot of time
  • The order of items is arbitrary
  • Try to submit the Site Specific application (SSA) at the same time as the ethics application
  • Request budget and departmental/service approvals as soon as possible after the protocol has been finalised to save you time preparing your SSA
  • Identify if you require an agreement early in the application preparation process and start drafting
What is a "site" for the purpose of my clinical research project?
Person handling test tubes for research


All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.

This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.

Contact us
Office for Research: Ethics Office
The RMH Parkville
300 Grattan St, Parkville, Victoria
Last updated 24 January 2023