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  • Welcome to our new HREC Chair, Professor Robyn Langham

    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.


    Ionising Radiation  

    The Radiation Health Committee have made changes to how the Radiation Risk Category will now be included on the Ethics Approval Letter. The 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: 

    Radiation Information:

     Imaging Standard of Care

    Yes         NO 

     Effective dose above standard care (mSv)

     XmSv

     Risk Category

     Category I     Category IIa     Category IIb     Category III

     Level of Risk

    Minimal     Very Low     Low     Moderate

     Level of Social Benefit Expected

    Minor     Intermediate     Moderate     Substantial

     Dose Constraint Exceeded

    Yes       No

     DHHS Notification 

     Required     Not Required


    MCRI Sponsorship Committee

    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.

    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

    Quality Projects at RCH - new procedure

    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

    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 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 https://www.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/
    • Society for Clinical Research Sites (SCRS) – basic GCP training is provided on-line at no cost to its members (MCRI is an institutional member) http://myscrs.org/members-only/gcp-training/  - 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