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?
For first time in human phase 1 clinical trials, to be reviewed under the CTN scheme, the HREC follows the Scientific Expert Review Toolkit – Early Phase Clinical Trials developed by the Department of Health.
All first time in human clinical trial applications for submission for HREC will require the following:
- Notification by the Chief Principal Investigator via email to firstname.lastname@example.org no less than six weeks before the advertised HREC Submission date with the following information:
- Name of Chief Principal Investigator
- Title of study
- Summary of proposed trial
- Study sponsor
- Submission of the application no less than four weeks before the advertised HREC Submission date. The application must be emailed to email@example.com uploaded on the ERM website and a courtesy email advising of the submission to firstname.lastname@example.org.
The RMH is able to act in the capacity of Sponsor for investigator-initiated clinical studies to meet the regulatory requirements of the Therapeutic Goods Administration (TGA) and GCP.
If you would like RMH to be Sponsor, contact the RMH Office for Research at email@example.com to schedule a pre-submission sponsorship meeting.
Our office will organise a meeting time to discuss. Ideally a study synopsis or study protocol should be provided at the time of the meeting request.
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.
All components in section 1 are mandatory and must be completed for all ethics submissions.
Complete section 2 if your project involves participant-facing documents such as information and consent forms, plain language statements, transcripts and survey questions.
Complete section 3 if your project involves radiation and/or genetically modified organisms (GMOs).
Complete section 4 only if your project is a clinical trial investigating a drug and/or device.
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
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.