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Single-site research

  • 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. 

    HREC fee payment 

    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:

     Document  Number of Copies
    Pre-submission form Complete prior to submission

    RCH REG Application Coversheet 

    One electronic copy
    Peer Review Proforma  One electronic copy
    Parent/Guardian Information and Consent Form One electronic copy
    Participant Information and Consent Form One electronic copy
    Child Information Sheet One electronic copy
    Study Protocol - see Guidance and Protocol templates One electronic copy
    Human Research Ethics Application Form (HREA)  One electronic copy, signed by the PI and AIs
    Victorian Specific Module (VSM) if applicable One electronic copy, signed by the PI

    Medical Physicists Report if applicable     

    The HREC cannot review your application until you provide this. 

    One electronic copy      
    Head of Department Declaration One electronic copy

    Supporting Department Declarations if applicable

    One electronic copy per supporting department
     MCRU Supporting Department Declaration - if applicable One electronic copy of the signed approval - PDF
    Other documents such as flyers, letterscontact forms, advertisements questionnaires One electronic copy    

    For clinical trials only, please also submit the following:

    Document   Number of Copies
    Investigators Brochure (or Product Information if IB is unavailable) One electronic copy                             
    Research Agreement (if commercially sponsored or collaborative) One electronic copy
    Form of Indemnity (if commercially sponsored) One electronic copy
    Insurance Certificate (if commercially sponsored) One electronic copy

    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. 

    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, 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.

    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. 

    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 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. 

    Do I need to submit an eCTN?

    You need to submit a Clinical Trial Notification (CTN) to the Therapeutic Goods Administration if your project includes:

    1. a product 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. The 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. 
    • Once ethics and governance approval has been issued, the sponsor should log back into the system and submit the eCTN. 

    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. 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:

    • Principal Investigator authorisation via a signed declaration within the HREA or SSA
    • HREC approval via the HREC approval letter
    • institutional authorisation via the governance authorisation letter
    • sponsor approval via the submission of the eCTN. 

    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 of  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 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.