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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 . Most Victorian hospitals, including the RCH, do not accept the Vic LNR NEAF. Please complete the HREA for all studies.Ìý

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.Ìý

Only low-risk and high-risk projects will need to be submitted via ERM, minimal risk research projects only need to be submitted via . Projects that do not need to be submitted in ERM will be assigned a project ID when registered on the platform, which can be used to communicate with REG and supporting service departments. Ìý

HREC fee paymentÌý

You need to pay yourÌýRCH HRECÌýfeesÌýin fullÌýat the time of the initial submission ofÌýyour project or amendment.ÌýWe cannot start the ethics review process until we receive your payment.ÌýUse the RCH HREC Fee Payment FormÌý 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.ÌýWe no longer accepts American Express (AMEX) credit card payments. All other credit card payments will now incur a 1.5 per cent surcharge fee.Ìý

Evidence of payment must be uploaded to as part of your ethics submission

ToÌýfind outÌýwhether feesÌýapply to your submission, please review the schedule of Submission Fees.ÌýYouÌýdo 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:

For clinical trials only, please also submit the following:

Only your protocol and patient-facing materials are required to be uploaded to ERM. These are uploaded within the HREA. If you are unsure where to upload each document will guide you through what is required for your project.

FAQs

How do I know if my study is single-site?

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,Ìýits ownÌýPrincipal Investigator.ÌýThe site should also recruitÌýresearch participants.ÌýÌý

Your study may have multiple sites, such as private hospitals,Ìýthat are not part of the National Mutual Acceptance (NMA)Ìýscheme. 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.

What is the difference between ethical approval and governance authorisation?

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.Ìý

Clinical Trials involving Drug & DevicesÌý

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:ÌýClearly state if the drug or device is TGA approved.
• Approved Indication:ÌýIndicate 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 aÌýhigh-risk project. Such projects require review by the Drug Trial Subcommittee (DTS).

Do I need a Medical Physicist Report?

All research projects that involve ionising radiation, regardless of whether the procedures are part of routine clinical care or additional to it, should completeÌýa Medical Physicist Report.ÌýThis is completed via theÌý.Ìý The RCHÌýÌýRSOÌýcan be contacted for assistance to complete this form. As applicable, the Medical Physicist report must be included as part of the ethics application.ÌýIf the Medical Physicists Report advises that the , 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.

ÌýPlease note:Ìýthe application will not be reviewed by the HREC until the Medical Physicist Report is provided.Ìý

Do I need to submit an eCTN?

You need toÌýsubmit aÌýClinical Trial Notification (CTN) to the Therapeutic Goods Administration if your project includes:

1. aÌýproduct not entered on the Australian Register of Therapeutic Goods (ARTG), including any new formulation of an existing product or any new route of administration, or
2. use of a registered or listed product outside the conditions of its marketing approval.

How do I lodge an eCTN?

Sponsors are required to complete an eCTN form online.ÌýThe eCTN form requires site contact details to be included. For RCH/MCRI, the relevant details can be found here.

The process is as follows:

• Sponsors should log into the system, complete the form and submit a hard copy draft of the eCTN at the time of ethics submission. This replaces the hard copy blue CTN form which we no longer require.Ìý
• Once ethics and governance approval has been issued, the sponsor should log back into the system and submit the eCTN.Ìý

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 mctc@mcri.edu.au. DepartmentsÌýthat frequentlyÌýconduct CTN researchÌýcan contactÌýMCTC 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 theÌýRCH HREC is providing HREC review only - that is, the study is being conducted outside Melbourne Children's:ÌýThe sponsor needs to lodge the form directly to theÌýTherapeutic Goods Act (TGA).

The TGA requires the sponsors maintain evidence of approval from all necessary parties.ÌýSponsors need to provide evidence of:

• Principal Investigator authorisationÌývia aÌýsigned declaration within the HREA or SSA
• HREC approvalÌývia theÌýHREC approval letter
• institutional authorisationÌývia the governance authorisation letter
• sponsor approvalÌývia the submission of the eCTN.Ìý

Is there a fee for the review of multisite research?

To determine whether fees are applicable to the review of your submission, please review the schedule ofÌý Submission Fees.

What are the review and approval timelines?

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 sixÌýto eight weeks to approve.

However,Ìýsome projectsÌýhave issues that delay these turnaround times.ÌýFor example,Ìýif you submit an incomplete or poorly written application, the turnaround time will take longer.ÌýTo avoid this, please review the resources on our website, including the Ìý