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 Wednesdays 9.30 –
10.30am and Fridays 10.30 – 11.30am. 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.
CHANGES COMING TO THE ETHICS AND GOVERNACE SUBMISSION PROCESS
As of the 17th
February 2024 we will begin retiring all the Melbourne Children’s
Campus specific paper/Word forms related to the submission of ethics and
governance submissions. These include:
- REG Application Coversheet
- Peer Review Proforma
- Head of Department Declaration
- Supporting Department Declaration (SDDs)
These forms will all be
incorporated into MCC DERP (Melbourne Children’s Campus Department and Ethics
Research Platform), which has been available since December 2022. 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.
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).
The new version of MCC DERP
will be available for use from the 17th February 2024.
There will be a transition period where both the REDCap and Word document
versions of REG Office forms will be accepted. Please note, we will accept the
Word document version of SDDs where a REDCap version is not available.
We will not accept the paper/Word
forms after the 23rd March 2024
Initial steps
You will need to:
- Determine the project risk
- Obtain the ERM project Id number
- Complete a REG Application Coversheet
- Complete the EMR pre-submission survey
From the 17th February 2024, 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
Project risk
To determine your project's level of risk, please fill out the risk assessment checklist in the
REG Application Cover sheet. This checklist will indicate whether your project is a Low and Negligible Risk (LNR) project, or requires full review by the HREC. A governance only study application will already have had the risk determined by its reviewing HREC.
From 17th February 2024, the REG
Application Coversheet should be filled out via MCC DERP. 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.
As of 17th February 2024 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
REG Application Coversheet
The REG Application Coversheet is required for all submissions and
submission types and must be uploaded to ERM. The Coversheet also requests
confirmation of the pre-submission survey. See below.
From 17th February 2024, the REG
Application Coversheet must be filled out for all projects via MCC DERP
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.
More information
See below for more information on the submission processes for different types of applications:
2024 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.
Please review the following for more information:
2024 Meeting Dates:
- February 5th
- March 4th
- April 1st
- May 6th
- June 3rd
- July 1st
- August 5th
- September 2nd
- October 7th
- November 11th
- December 2nd
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.
From 17th February 2024 you will be required to
upload evidence of this payment with your Ethics application via MCC DERP.
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.