In this section
We would like to
welcome Professor Robyn Langham to the team as the new Chair of the Human
Research Ethics Committee (HREC). Professor Langham is an adult nephrologist
and clinician researcher, and has spent much of her career in public hospital
and university roles, as Director of the Renal Unit at St Vincent’s in
Melbourne, and then as the Head of School of Rural Health at Monash University.
As a researcher, she has worked in translational research part of the team
successful in the development of novel anti-inflammatory and anti-fibrotic
agents. A member of the Therapeutic Goods Administration Advisory
Committee on Medicines, and a past Chair of the St Vincent’s HREC, she is
looking forward to the new world of paediatric clinical research. We look
forward to introducing you all to Robyn soon.
The Radiation Health Committee have made changes to how the
Radiation Risk Category will now be included on the Ethics Approval Letter.
Ethics Approval Certificate should list the radiation risk category considered by the lead HREC when giving its approval. We will
now include the following information on the Ethics Approval Letter:
Category I Category IIa Category IIb Category III
Minimal Very Low Low Moderate
Minor Intermediate Moderate Substantial
Required Not Required
The MCRI sponsorship committee needs to approve new investigator initiated clinical trials that are not commercially or collaboratively group sponsored. The committee meets on the first Monday of every month to review new trial applications for sponsorship.
The committee's role is to identify any requirements for extra indemnity, insurance and contracts for a trial, on a case by case basis. They will advise the Sponsor-Investigator, and REG where necessary, of these requirements.
They review and approve sponsorship for Investigator Initiated Trials (IIT) conducted at sites within Australia. For sponsorship of international sites, additional consideration is required by the sponsorship committee. Investigators requesting sponsorship for an IIT must be employees of, or have honorary appointments with, The Royal Children’s Hospital and/or MCRI.
MCRI cannot support individual members of staff to personally act as the sponsor of a clinical trial. This requires Investigators to submit their IIT protocol and supporting documentation to the MCRI Sponsorship Committee for review and approval before obtaining HREC approval and prior to commencement of the project.
If Investigators are unsure if the sponsorship process applies to them, please refer to the
Standard Operating Procedure,
Application Form or contact the
Director of the MCTC for clarification, guidance and new submissions.
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
Projects that meet the definition of a
'quality project' may be exempt from ethical review, and may now be submitted through the formalised
organisational project management process. This process replaces the previous process of registering quality projects on RiskmanQ.
If you are not sure whether your project is quality or research, please refer to the quick survey found in Step 2 on the
Getting Started - Project Management page.
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
If you are conducting a clinical trial at the Melbourne Children’s Campus, you must provide evidence that the PI has successfully completed TransCelerate accredited GCP training in order to obtain governance authorisation.
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
Other free courses include: