Approvals & Registration

All research conducted on or by Melbourne Children’s campus must have Ethics Approval from an NMA accredited HREC that is certified to review paediatric clinical trials.  All NMA-accredited HRECs are certified under the NHMRC’s National Certification Scheme.  See NHMRC’s National Certification Scheme: Institutions with certified ethics review processes.  Each HREC is listed against what they are certified to review.

Consider the ethics submission fees when selecting your reviewing HREC.  Some charge more than others.  Note the RCH HREC does not charge a fee for the review of MCRI-sponsored projects.  See RCH HREC Submission Fees.

If the research is conducted at Melbourne Children’s, the project must have governance authorisation by the RCH Research Ethics & Governance Office (REG).  If the research is conducted outside the Melbourne Children’s, each participating site must have Governance Authorisation from their local Research Governance Office before recruitment can commence at that site.

Continuation of ethics approval and governance authorisation is subject to satisfactory progress reporting and other requirements from the Reviewing HREC and Local Governance Office. The MCRI Sponsor-Investigator is responsible for providing updates on the trial to the reviewing HREC at least annually, in addition to the following expedited reports:

• Safety events – see Safety Assessment, Monitoring & Reporting for further information
• Serious breaches – see Non-Compliance, Serious Breaches & Clinical Incidents

The MCRI Sponsor-Investigator is also responsible for sending confirmation of serious safety events (SUSARs, SSIs, USMs) and serious breaches to the Site PIs who then notify their local RGO. See Safety Assessment, Monitoring & Reporting and Non-Compliance, Serious Breaches & Clinical Incidents for further information.

When commencing the ethics and governance submission process for a new trial that will either be conducted at Melbourne Children’s or require ethics review by the RCH HREC, researchers will need to register the project with the Melbourne Children’s Campus Departmental and Ethics Research Platform (DERP).  Once registered, a platform page will be generated for the project and will allow the researcher to:

·         Determine level of ethical review (based on risk)

·         Determine governance review requirements

·         Determine MCRI sponsorship review requirements

·         Request/respond to peer review

·         Seek sign off from your Head of Department/Group Leader

·         Seek supporting department sign-off from RCH departments

The link to register projects on DERP is located on the RCH Research Ethics & Governance page for New Applications. 

Find more information on Ethics and Governance Processes on the RCH Research Governance and Ethics page. For more in-depth training on this topic, enroll in the Ethics Review Process online course. 

All clinical trials require a trial Sponsor. Eligible trials are considered for MCRI Sponsorship via a formal application process as described in MCTC037b SOP MCRI Sponsorship Application Process for Investigator-Initiated Trials (IITs). The MCRI Sponsorship Committee meets monthly from February to November. 

All IITs led by MCRI/RCH must receive formal MCRI Sponsorship approval before the RCH HREC will grant ethics approval.  It is recommended you submit your application for MCRI Sponsorship either before or at the same time as you submit your ethics application.  This will facilitate a faster ethics approval timeframe.   

Further information about MCRI Sponsorship, including submission dates, can be found at MCRI Trial Sponsorship.

Therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG) before they can be lawfully imported into, exported from, or supplied in Australia unless otherwise subject of an exemption, approval, or authority under the Therapeutic Goods Act 1989.

The Clinical Trial Notification (CTN) and Clinical Trial Approvals (CTAs) schemes provide the avenue for importation into and/or supply of ‘unapproved’ therapeutic goods for use in clinical trials.

Unapproved therapeutic goods include:

•            Any medicine, device or biological not included in the Australian Register of Therapeutic Goods (ARTG)

•            Any therapeutic good included in the ARTG but used in a manner not covered by the existing entry

For a therapeutic good included in the ARTG, a change to any of these variables will render it an unapproved therapeutic good. See Table below.

The CTN scheme will be the appropriate scheme for most investigator-initiated trials using an unapproved therapeutic good.  The CTA may be appropriate if the reviewing HREC does not have access to the appropriate scientific and technical expertise to review the safety of the therapeutic good. The TGA are currently reviewing the CTA Scheme.  Further information is available on the TGA website.  

MCTC is delegated responsibility to manage the submission of CTNs (initial, variations and completion advice) to the TGA for MCRI-sponsored trials. See MCTC CTN & Trial Registration for process of submitting CTN/CTA.  

Trials require evidence of CTN submission prior to receiving The Royal Children's Hospital (RCH) governance approval. We recommend you begin your CTN draft when you submit your study for ethics approval.  

Need a summary here on requirements, responsibilities and our local procedure.

In Australia, all dealings with live and viable genetically modified organisms (GMOs), including import, are illegal unless authorised under the Gene Technology Act 2000 (Cth).  This legislation sets out the national regulatory system for gene technology in Australia, outlines the licensing system under which a person can apply to the Regulator for a licence authorising dealings with GMOs and defines the requirements for issuing GMO licences.

The Office of the Gene Technology Regulator (OGTR) has specific responsibility to administer the gene technology regulations and to identify risks posed by (or as a result of) specific gene technologies and their dealings.  OGTR manages those risks through regulating the dealings (activities) associated with the importation, handling and disposal of gene therapies.  The OGTR issues licenses that authorise defined dealings with each GMO and oversees the licence holder’s adherence to the stated conditions of the licence by performing regular compliance reviews (audits).

The MCRI Institutional Biosafety Committee (IBC) assesses and manages all work relating to working with GMOs at Melbourne Children’s.

If you are planning a project involving the use or administration of a GMO please contact the MCRI IBC for guidance.  Contact details are available on the MCRI IBC intranet page.

Go to the OGTR website to access Guidance for conducting human clinical trials involving GMOs and the Application for a license to conduct a human clinical trial of a GMO.

Registration of trials in a publicly accessible trial registry is universally regarded as good research practice.  The World Health Organization (WHO) considers registration to be “a scientific, ethical and moral responsibility”.

Prospective registration improves research transparency and reduces bias.  It is a requirement of the:

·              International Committee of Medical Journal Editors (ICMJE)

·              Declaration of Helsinki

·              National Statement on Ethical Conduct in Human Research

·              Publication and dissemination of research: A guide supporting the Australian Code for the Responsible Conduct of Research”

Prospective registration is also a condition of both the Medical Research Future Fund (MRFF) grant and NHMRC Clinical Trials and Cohort Studies Grant funding schemes.

All MCRI-sponsored trials must be registered with ClinicalTrials.gov (CT.gov). The Sponsor-Investigator is responsible for ensuring the trial is registered before the first participant is consented.

MCTC is responsible for supporting Sponsor-Investigators to register their trial with CT.gov and maintain their record in accordance with CT.gov requirements. Visit MCTC CTN & Trial Registration for the process of initiating trial registration.