Speak to us
If you are submitting to us for the first time please refer to the information below. If you have further queries please come to one of our drop-in sessions to discuss
your study on Tuesday & Wednesdays 10.00am –
11.00am. Our office is located on Level 4, South Building.
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:
2026 HREC and DTS meeting dates
See the HREC and DTS meeting dates.
MCRI Sponsor Investigator Initiated Trials
MCRI Sponsorship is a requirement for all investigator initiated clinical trials here at MCRI. The MCRI Sponsorship Committee is responsible for the review and approval of application of trials applying for MCRI sponsorship.
If you require MCRI to sponsor your trial you
will need to submit an application to the MCRI
Sponsorship Committee. More information can be found on the MCTC website.
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 1st January 2026, the payment fees for RCH HREC services will be adjusted as outlined below.
1. Fee Payment Schedule
- For projects that are sponsored by MCRI, RCH, and UoM - Dept of Paeds, the three organisations subsidise the ethical review of projects they sponsor. Therefore, REG don’t charge for projects led by these three organisations.
- For projects led by other organisations (including commercially sponsored projects), the cost of ethical review is charged directly to the study team.
- For non-commercially sponsored projects where ethical approval has already been obtained via NMA and governance authorisation at Melbourne Children’s is required, MCRI, RCH, and UoM - Dept of Paeds cover the governance review costs to enable their participation as a collaborating site.
2. Annual Adjustments from 1st January 2026
Beginning 2026, fees will be reviewed and adjusted annually on 1st January. These adjustments are anticipated to align with inflation, targeting an approximate increase of 3% each year.
Should you have any questions or require further details, please don’t hesitate to reach out to us. Thank you for your understanding and continued collaboration.
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 RCH 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.