All research studies must be submitted for ethical review before a study can be given approval to start.
Before you start your submission
Before starting your submission, do either of the following circumstances apply to your research project?
If you answer yes to either question, contact the Office for Research for guidance before starting your ethics submission.
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 research@mh.org.au 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 HRECSubmissions@mh.org.au uploaded on the ERM website and a courtesy email advising of the submission to research@mh.org.au.
RMH Sponsorship review is required for studies where the RMH will be asked to formally act as sponsor of the research, including:
- RMH-led investigator-initiated drug and/or device clinical trials (CTN/CTA clinical trials within the scope of the Therapeutic Goods Act), or
- Large and/or resource-intensive multi-site RMH-led research studies
To request formal RMH sponsorship, call the Office for Research on (03) 9342 8530 at least six weeks before the intended submission deadline date to confirm whether an RMH Sponsorship Review Meeting is required for your project.
If a sponsorship meeting is required, our office will organise a meeting time and forward sponsorship request forms to you to complete and submit before the meeting.
This process must be completed before a trial or study application can be accepted for ethics and/or governance review.
Complete and submit all sections that apply to your study
To assist you with your submission, review the table below to identify which sections apply your project.
|
Section |
Mandatory |
As applicable |
|---|---|---|
|
Section 1: All components in this section are mandatory and must be completed |
Yes ü |
- |
|
Section 2: For projects involving participant-facing documents |
- |
Yes ü |
|
- |
Yes ü |
|
|
- |
Yes ü |
|
|
Yes ü |
- |
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
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