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National Mutual Acceptance (NMA) enables the mutual acceptance of a single scientific and ethical review for multi site human research. The research needs to be conducted in publicly funded health services across Victoria, South Australia, Queensland, New South Wales, Western Australia and the Australian Capital Territory.Ìý

Mutual acceptance under the NMA scheme requires the HREC conducting the ethical review to be certified under the NHMRC National Certification Scheme. The HREC also needs to be a Certified Reviewing HREC under the NMA scheme.Ìý

Please find more information outlining the process for when the application is across multiple states and possibly multiple computer systems.

Further information on NMA, including a list of certified reviewing HRECs, can be foundÌý.

Submission process

You also need an

If you are submitting a multi-site research application to the RCH HREC, please refer to this checklist:

If your study is being conducted at or by the Melbourne Children's Campus (incorporating RCH, MCRI and/or the University of Melbourne, Department of Paediatrics),Ìý

you will also need to submit for local governance authorisation. You can submit these together and have this occur concurrently with ethical review, or you can submit for ethics review while you prepare your governance submission.

Governance authorisation will require:

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

Deadlines

You need to submit high risk research to the REG office by a deadline. See the HREC and DTSÌýÌýfor information about these deadlines. You can submit low risk research to us any time.Ìý

FAQs

What is a CPI and what responsibilities do they have?

The Coordinating Principal Investigator (CPI) is a local PI who has agreed to take responsibility for submitting the ethics application, obtaining approval and fulfilling all ongoing reporting requirements associated that such approval.Ìý

For additional information, please review the document.Ìý

Is there a process to help me prepare and submit my application?

The following process maps may be useful when preparing the submitting an application:

• Eth
• Ethics and Governance Process map - Lead and AcceptingÌýSites

What is the difference between ethical approval and governance authorisation?

Ethical approval can only be granted by a fully constituted and certified Human Research Ethics Committee (HREC). Ethical approval is required for all research involving humans, irrespective of capacity.Ìý

Governance authorisation is granted by the CEO, or delegate, at each individual site, and is the final requirement before any research can begin. The scope of governance authorisation is different at each site. However, generally it requires the submission of all HREC approved documents along with a Site Specific Assessment Form and Site Specific Informed Consent Documents.Ìý

This process also generally involves the review and authorisation of any legal/regulatory documents, such as indemnities and clinical trial research agreements.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 complete a Medical Physicist Report.ÌýThis is completed via theÌý. 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.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?

If your project includes one of the following, a to the Therapeutic Goods Administration (TGA) is required:

1. A product not entered on the (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; the eCTN form requires site contact details to be included. For RCH/MCRI, the relevant details can be found here. Ìý

The new 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 atÌý mctc@mcri.edu.au.

Departments that conduct a large amount of CTN research can talk to MCTC about gaining a secondary account/log-in to create their departments eCTN forms which can then be lodged by MCTC (on behalf of the sponsor) once approved.

In the event that RCH HREC is providing HREC review only (i.e. the study is being conducted outside the Melbourne Children's):ÌýThe sponsor e.g. commercial or another institution acting as the sponsor, will need to lodge the form directly to the TGA.

The Therapeutic Goods Act requires the sponsors maintain evidence of approval from all necessary parties, allowing the study to start. In place of the hard copy signatures previously captured by the blue CTN form, the following now applies:

• Evidence of Principal Investigator authorisation is the signed declaration within the HREA or SSA;
• Evidence of HREC approval is the HREC approval letter;
• Evidence of Institutional authorisation is the governance authorisation letter; and
• Evidence of Sponsor approval is the submission of the eCTN.Ìý

Is there a fee for the review of multi-site research?

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

What are the review and approval timelines?

The time to approval following submission to the Ethics Office is approximately six weeks. However, if the application is incomplete and/or of insufficient quality, additional information will be sought which will result in a longer time to approval.Ìý

Where can I find more information?

You can find more information on the .Ìý