In this section
The submission process for a new application depends on:
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 project, or requires full review by the HREC.
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.
To submit an application you will need to log in to
Ethics Review Manager (ERM). The hospital has a User Guide available. The Department of Health also have an Application User Guide.
See below for more information on the submission processes for different types of applications:
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.
They 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 cannot 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.
Please note: the Sponsorship Committee meets on the first Monday of the month to consider new applications.
The Royal Children's Hospital can no longer accept any American Express (AMEX) credit card payments. All other credit card payments will incur a 1.5 per cent surcharge fee. See RCH HREC Payments for more information.
We cannot undertake the ethics review process until we receive your payment.
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.
The Royal Children’s Hospital Research Ethics & Governance (RCH REG) Office) support and promote the use of electronic signatures when executing clinical trial governance-related documents including:
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 email@example.com with the HREC application number and state for review prior to requesting signatures. A reply will include whom the electronic signature request should be emailed directly to.