Speak to us
If you are submitting to us for the first time please call us on (03) 9345 5044 so we can guide you in the right direction. We also have drop-in sessions for you to discuss
your study on Tuesday & Wednesdays 10.00am –
11.00am. Our office is located on Level 4, South Building.
PLEASE NOTE: Drop-in sessions have been cancelled on Tuesday 20th May, Wednesday 21st May, Tuesday 27th May and Wednesday 28th May 2025 as the Research Ethics & Governance office will be temporarily closed from Monday, 19th May to Friday, 30 May 2025.
Submission process
The submission process for a new application depends on the 1) risk profile of the project and 2) whether it is a single or multisite ethics application. Alternatively, if ethics review and approval has been provided from an external institution the application will be for governance only authorisation.
.PNG "Application pathways")
The Ethics and Governance application process
Initial steps
You will need to:
- Obtain the ERM project Id number, if you are
doing a low or high-risk research project
- Register your project on MCC DERP
- Complete the Research Ethics Risk Assessment to
determine your risk
MCC DERP is a system to support your submission in ERM (Ethics Review Manager), it does not replace ERM. For all low and high risk projects, researchers will still be required to use ERM to submit their HREA and study documents related to ethical review (protocol, PICF and other patient facing materials).
In addition to helping reduce the duplication when filling out forms, MCC DERP will also guide researchers into what forms/governance processes are required for their project. It will be used to lodge all research or quality projects on campus.
Project risk
MCC DERP will help you determine your project's level of risk. In
line with the revised National Statement projects
are assessed as low-risk, high-risk or minimal risk.
- High-risk projects require full review by the
HREC.
- Low-risk projects are reviewed by the LREC (a subcommittee
of the HREC)
- Minimal risk projects no longer need ethical
review by the REG Office. They must be registered on MCC DERP with all
accompanying documentation
Submission deadlines
If your project is high risk, you need to submit it to our office by the relevant deadline. See the HREC and DTS
meeting dates.
If your project is low risk, you can submit it to our office any time.
If your project application is for governance only, you can submit it to our office at any time.
ERM Project Id number
To obtain your ERM project Id number and to submit an application you will need to log in to
Ethics Review Manager (ERM). The Victorian Department of Health provide an Applicant
User Guide to ERM. Further ERM guidance is also available on
their website here.
Only low and
high-risk projects need to be submitted on ERM. If you’re not sure of the risk
of your project, you can use MCC DERP to
find out or contact us at rch.ethics@rch.org.au
EMR Study Registration Survey (previously called the pre-submission survey)
You also need to register your study with the Parkville EMR
team at the time of submission. You can do this by completing the EMR Study Registration Survey.
Clinical Trials involving Drug & Devices
If your research project involves the use of a drug or
device, it is crucial to disclose whether the drug or device is approved by the
Therapeutic Goods Administration (TGA) during the application process.
Additionally, you must specify if the drug or device is being used within its
approved indication.
Important Considerations:
- TGA
Approval Status: Clearly state if the drug or device is TGA
approved.
- Approved
Indication: Indicate whether the use of the drug or device aligns
with its approved indication.
Any application involving the use of a drug or device that:
- Is
not registered with the TGA,
- Is
used in an unapproved indication, in an unapproved age group or at an unapproved dose,
- Involves the use of a drug or device in a clinical trial
to gain further information about an approved use (e.g., pharmacokinetic or
pharmacodynamic research
Is considered a high-risk project. Such projects require review by the Drug Trial Subcommittee (DTS).
More information
See below for more information on the submission processes for different types of applications:
2025 HREC & DTS meeting dates
See the HREC and DTS meeting dates.
MCRI sponsorship committee
The MCRI sponsorship committee needs to approve new investigator initiated clinical trials that are not commercially or collaboratively group sponsored. The committee meets on the first Monday of every month to review new trial applications for sponsorship. The committee's role is to identify any requirements for extra indemnity, insurance and contracts for a trial, on a case by case basis. They will advise the Sponsor-Investigator, and REG where necessary, of these requirements. Applications for MCRI Sponsorship must be submitted 10 working days prior to meeting date. All email queries regarding the MCRI Sponsorship Committee can be sent to - mctc@mcri.edu.au
Please review the following for more information:
2025 Meeting Dates:
- May 5th
- June 2nd
- July 7th
- August 4th
- September 1st
- October 6th
- November 10th
- December 1st
HREC payment fee
To determine whether fees are applicable to the review of your submission, please review the schedule of RCH HREC Submission fees.
The RCH HREC Fee Payment Form only need only be submitted if a fee applies. Proof of payment can be made by submitting the remittance advice if payment has been made by electronic transfer.
The fee payment needs to be made in full at the time of initial submission. We cannot undertake the ethics review process until payment is received.
The RCH does not accept any American Express (AMEX) credit card payments. All other credit card payments will incur a 1.5 per cent surcharge fee.
You will be required to
upload evidence of this payment with your Ethics application via MCC DERP.
Please note: Effective January 1, 2025, the HREC submission fee will be increased. Additionally, starting January 1, 2026, an annual fee increase of 3% will be implemented each year.
Electronic signatures
The RCH Research Ethics and Governance (RCH REG) Office support and promote the use of electronic signatures when executing clinical trial governance-related documents including:
- HREC and Governance Applications
- Clinical trial research agreements
- Clinical trial indemnities
PLEASE NOTE: copies of all clinical trial research agreements and indemnities require review from the Research Ethics & Governance office prior to the request to the relevant signatory. Please email the document to rch.ethics@rch.org.au with the HREC application number and state for review prior to requesting signatures. A reply will include whom the electronic signature request should be sent to.