Changes to the HREC Submission Fee 

Effective 1st January 2026, the payment fees for RCH HREC services will be adjusted as outlined below.  

1. Fee Payment Schedule

• For projects that are sponsored by MCRI, RCH, and UoM - Dept of Paeds, the three organisations subsidise the ethical review of projects they sponsor. Therefore, REG don’t charge for projects led by these three organisations.
  
• For projects led by other organisations (including commercially sponsored projects), the cost of ethical review is charged directly to the study team.
• For non-commercially sponsored projects where ethical approval has already been obtained via NMA and governance authorisation at Melbourne Children’s is required, MCRI, RCH, and UoM - Dept of Paeds cover the governance review costs to enable their participation as a collaborating site.
  
  

2. Annual Adjustments from 1st January 2026
Beginning 2026, fees will be reviewed and adjusted annually on 1st January. These adjustments are anticipated to align with inflation, targeting an approximate increase of 3% each year.

Please find the RCH HREC Submission Fees here and the RCH HREC Submission Fee Payment Form here. 

Should you have any questions or require further details, please don’t hesitate to reach out to us.

Thank you for your understanding and continued collaboration.

Join us for Drop-in sessions!!! 

When:       every Tuesday & Wednesday from 10:00am - 11:00am. 

Where:      our office is located on Level 4, South Building. 

What to expect: the team are here to discuss your study and answer questions. 

Ionising Radiation  

The Radiation Health Committee have agreed to recommendations made to facilitate the National Mutual Acceptance program when multiple sites Radiation Safety Letters were previously required for HREC review, as often differed as Standard of Care differs across sites. The Lead HREC will review one Radiation Safety letter (ideally that with the highest dose) and consider the risks and benefit to the participants based on that report. The approved Risk Category will then be included on the Ethics Approval Letter (Category I, IIa, IIb or III) . The Governance Officer at each site will review their own site’s Radiation Safety letter as part the Site-Specific Application. Site governance authorisation will only be provided if the Risk Category is at or below that which was ethically approved. If not, the Radiation Safety letter (with a higher dose level) must be submitted back to the HREC as an amendment for re-consideration. 

Clinical Trials involving GMOs

MCRI has developed a process for using Genetically Modified Organisms (GMOs). It must be followed by researchers intending to conduct clinical trials involving GMOs at Melbourne Children's Campus. Please refer to the below link on the process: 

IBC - Performing Human Clinical Trials involving Genetic Modified Organisms (GMOs) in Melb Children’s Campus – A Process

Consent forms and EMR

Participant information statements and consent forms for clinical trials (and other clinical research as appropriate) should be scanned into the EMR.

After consultation with Health Information Services, it has been clarified that researchers should send a high quality copy of the consent document for scanning into the EMR. This does not need to be a certified copy. Original consent documents should always be retained within the site file. To ensure transparency and accountability, it is strongly recommended that researchers mark the original as having been sent to EMR to ensure multiple copies are not sent for scanning.

Please note, if you send the original document to EMR for scanning, it will be archived off site and will not be retrievable.

A SOP is currently being prepared to detail this process, however in the interim, it is recommended that researchers amend current processes to incorporate the above.

If you have any queries relating to this matter, please contact REG on 9345 5044 or rch.ethics@rch.org.au

Good Clinical Practice training 

If you are conducting a clinical trial at the Melbourne Children’s Campus, you must provide evidence that the investigative team has successfully completed TransCelerate accredited GCP training in order to obtain governance authorisation. This includes all investigators, study coordinator, research nurse, pharmacist, and anyone undertaking a trial-specific procedure that is additional to standard of care. It is strongly recommended that all investigators for other clinical research also complete GCP training.

MCRI have a number of GCP workshops scheduled throughout the year. These are free for campus staff & students. PIs, and any other members of the research team, are welcome to enrol in one of these at mcri.edu.au/research/facilities-resources-and-training/clinical-research-development-office-crdo/crdo-workshops.

Other free courses include: 

• NIDA Clinical Trials Network (part of the National Institutes of Health in the US) is now Transcelerate-recognised and we are recommending this to those unable to attend our face-to-face CRDO workshops. Go to https://gcp.nidatraining.org/
  
• Australian Clinical Trials Education Centre (A-CTEC) – GCP training designed for Australian audiences is provided on-line at no cost through A-CTEC (you just need to set up a free account) https://actec.myopenlms.net/enrol/index.php?id=156 - this course is Transcelerate-recognised
• Contact CRDO ( crdo.info@mcri.edu.au) if you would like to take this option and they will provide you with log in / registration details