The submission process for a new application is dependent on the level of risk associated with the project and whether it is single or multi-site.
To determine the level of risk associated with the project, please complete the risk assessment checklist REG Application Cover sheet. This will indicate whether the project is eligible for review as Low or Negligible Risk project, or requires full review by the HREC.
To submit an application you
will need to log in to Ethics Review Manager (ERM). The Royal Children's Hospital have a User Guide available and the Department of Health have now released a Application User Guide.
Please select from the following list for more information:
Changes to the
From 01 January 2020, all
research studies must have a single unique identification number for use across
the Parkville Precinct and the Melbourne Children’s Campus. This unique ID will
now be the ERM Project ID. This is a 5 digit number generated in ERM when a
project is created. You will find the ERM Project ID at the top right hand
corner of your screen on ERM. Ex. 55555
With the introduction to the
Parkville Precinct fully integrated Electronic Medical Record (EMR) Project we
are having to move across to one precinct reference number.
All studies are still required to pre-register prior to submission. You can do this by completing the pre-registration form. Any new submissions submitted during this time will need to fill in the pre-registration form after the 6th January 2020, however are still able to submit the REG department.
You need this number to
communicate with REG and for all internal communications, as well as all
supporting service departments on campus. Please quote this number in all email
and other correspondence.
MCRI Sponsorship Committee
As of the 1st January 2020 all NEW Investigator Initiated Clinical Trials conducted by MCRI that aren’t commercially or collaborative group sponsored will require approval from the MCRI sponsorship committee.
The MCRI Sponsorship Committee meets on the first Monday of every month from March 2020 to review new trial applications for sponsorship.
See below for the closing dates for new submissions and meeting dates for the first six months of 2020:
|Closing dates for new submissions: ||Meeting dates:|
|24 February||2 March|
|30 March||6 April|
|27 April||4 May|
|25 May||1 June|
|29 June||6 July|
The Sponsorship Committee will identify any requirements for extra indemnity, insurance and contracts for a trial, on a case by case basis and will advise Sponsor-Investigator (and REG where necessary) of these requirements for each trial reviewed.
The MCRI Sponsorship Committee will review and approve sponsorship for Investigator Initiated Trials (IIT) conducted at sites within Australia. For sponsorship of international sites additional consideration is required by the sponsorship committee. Investigators requesting sponsorship for an IIT must be employees of, or have honorary appointments with, The Royal Children’s Hospital and/or MCRI.
MCRI will not support individual members of staff to personally act as the sponsor of a clinical trial. This requires Investigators to submit their IIT protocol and supporting documentation to the MCRI Sponsorship Committee for review and approval before obtaining HREC approval and prior to commencement of the project.
If Investigators are unsure if the sponsorship process applies to them, please refer to the Standard Operating Procedure, Application Form or contact the Director of the MCTC for clarification, guidance and new submissions.
Clinical Trials involving GMOs
A process for using Genetically Modified Organisms (GMOs) has been developed by the Murdoch Children's Research Institute that must be followed for researchers intending to conduct clinical trials involving GMO at Melbourne Children's Campus. Please refer to the below link on the process:
IBC - Performing Human Clinical Trials involving Genetic Modified Organisms (GMOs) in Melb Children’s Campus – A Process
Only high risk research needs to be submitted to the REG office by a deadline. Low risk research can be submitted any time. See the HREC and DTS meeting dates.
RCH HREC fee payment
Please note as of the 1st July 2018 the changes to the HREC Payment Fees. These are payable in full at the time of the initial submission of a project or amendment.
All payments that are submitted to
the Research Ethics and Governance Office at RCH must be completed using this form or the payment remittance advice provided (proof of payment).
RCH HREC Fee Payment Form
There are three options for payment
Credit Card, Electric Funds Transfer and Internal Cost Centre Transfer.
If payment does not accompany the initial submission or amendment the Ethics review process
will not be able to start until it has been received.
To determine whether fees are applicable to the review of your submission, please review the schedule of Submission Fees. You do not need to submit this form if no fee applies.