In this section
For the purposes of an HREC review, the Melbourne Children’s Campus is considered one site. Therefore, research conducted at or by RCH, MCRI and/or The University of Melbourne Department of Paediatrics is eligible for single-site review. This includes home-based, school-based and community-based studies.
Single-site research may also be classified as Low or Negligible Risk (LNR). To determine if your research can be classified as LNR, please complete the checklist in the
REG application cover sheet. Most Victorian hospitals, including the RCH, do not accept the Vic LNR NEAF. Please complete the HREA for all studies.
You need an ERM project number to communicate with REG and all supporting service departments on campus. Please quote this number in all email and other correspondence.
You need to pay your RCH
HREC fees in full at the time of the initial submission of your project or amendment. We cannot start the ethics review process until we receive your payment. Use the RCH HREC Fee Payment Form
or the payment remittance advice provided as you need proof of payment.
There are three options for payment: credit card, electric funds transfer and internal cost centre transfer. We no longer accepts American Express (AMEX) credit card payments. All other credit card payments will now incur a 1.5 per cent surcharge fee.
To find out whether fees apply to your submission, please review the schedule of
Submission Fees. You do not need to submit this form if no fee applies to your project.
Please see the following checklist for all single-site submissions to the RCH HREC, including single-site clinical trials:
RCH REG Application Coversheet
Medical Physicists Report if applicable
The HREC cannot review your application until you provide this.
Supporting Department Declarations if applicable
For clinical trials only, please also submit the following:
You must upload all of these documents to
ERM. Give each of your documents a clear file name that includes the version number and date. The version number and date in the file name should be the same as the version number and date in the body of your document.
Your project is single-site if you are asking the HREC to provide approval for one site. You may have more than one site in your project - for example, overseas sites. However, if you are only asking the HREC to approve one site in Australia, your project is still single-site.
A 'site' is more than simply a physical location. To be a site, an area should have its own study team, for example, its own Principle Investigator. The site should also recruit research participants.
Your study may have multiple sites, such as private hospitals, that are not part of the National Mutual Acceptance (NMA) scheme. In this case, you may wish ask these sites whether they are willing to accept the reviewing HREC's approval, or
whether they wish to receive and review the study as a single site application. If they agree to accept the HREC's approval, you can submit your application as a multi-site project. Private sites will need to provide indemnity to the RCH HREC for their review.
Ethical approval can only be granted by a fully constituted and certified HREC. A HREC needs to approve all research involving humans.
Governance authorisation is granted by the CEO or delegate at each individual site. It is the final requirement before any research can begin. The scope of governance authorisation is different at each site. However, it generally requires the submission of all HREC approved
documents along with Site Specific Informed Consent Documents. This process also generally involves the review and authorisation of any legal and regulatory documents, such as indemnities and clinical trial research agreements. If your project begins as a single site but then turns into a multi site project, you also need to submit a Site Specific Assessment form.
All research projects that involve ionising radiation, regardless of whether the procedures are part of routine clinical care or additional to it, should complete the Medical Physicist Report Request form. The RCH RSO can be contacted for assistance to complete this form. As applicable, the Medical Physicist report must be included as part of the ethics application. If the Medical Physicists Report advises that the Department of Health (DH) must be notified, the project can only be notified to the DH once the project has ethics approval and authorisation by RCH. It is the responsibility of the researcher to notify DH.
Please note: the application will not be reviewed by the HREC until the Medical Physicist Report is provided.
You need to submit a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration if your project includes:
Sponsors are required to complete an eCTN form online. The eCTN form requires site contact details to be included. For RCH/MCRI, the relevant details can be found
The process is as
For studies where MCRI is
the sponsor: the Principal Investigator (or delegate) must make an appointment with the Melbourne Children's Trial Centre (MCTC) to complete the eCTN. As the sponsor must be the one to lodge the eCTN, MCTC has taken this role for MCRI (and have the primary account). MCTC can be contacted by email at
firstname.lastname@example.org. Departments that frequently conduct CTN research can contact MCTC about gaining a secondary account/log-in to create their
departments eCTN forms. These can then be lodged by MCTC, on behalf of the
sponsor, once they are approved.
For studies where the RCH HREC
is providing HREC review only - that is, the study is being conducted outside Melbourne Children's: The sponsor needs to lodge the form directly to the Therapeutic Goods Act (TGA).
The TGA requires the sponsors maintain evidence of approval from all necessary parties. Sponsors need to provide evidence of:
To determine whether fees are applicable to the review of your submission, please review the schedule of
Our office's review and approval timelines will depend on the nature of your application.
Low and Negligible Risk projects take about two to four weeks to approve.
Greater than Low Risk projects take about six to eight weeks to approve.
However, some projects have issues that delay these turnaround times. For example, if you submit an incomplete or poorly written application, the turnaround time will take longer. To avoid this, please review the resources on our website, including the PICF templates and resources.