Multi-site Greater than Low Risk Applications
Multi-site projects include any projects that involve more than one site, institution or Centre. Each site should have its own Principal Investigator and recruit/collect data from that site.
Greater than low risk research is where the risk, even if unlikely, is more than discomfort (National Statement, 2007 – updated 2018).
Multi-site greater than low risk applications for BH HREC review
At Barwon Health, greater than low risk research projects are reviewed by the BH HREC. Please visit the HREC page for meeting dates and submission deadlines.
If you’re not sure whether your research is suitable for a multi-site greater than low risk application, please visit the how to prepare an application page or download and complete the ‘Level of Risk Checklist’. You may also contact [email protected] with any queries.
Collaborating Sites - things to consider
If your collaborating sites are metro or interstate, you will need to submit your multi-site project to one of the 7 Victorian HREC ‘Reviewing’ sites:
- Alfred Health
- Austin Health
- Melbourne Health
- Peter MacCallum Cancer Centre
- The Royal Children’s Hospital
- Monash Health
- St Vincent’s Hospital (Melbourne)
If your collaborating sites are regional sites, please see Regional Health Service Collaborations page for further information.
IMPORTANT NOTE: ERM does not currently facilitate BH HREC multi-site review, however by way of a workaround;
- When preparing your submission in ERM, please select ‘single-site’. This will allow you to select Barwon Health HREC as your reviewing HREC. Ensure you list the participating sites and site PIs elsewhere within your submission. For example, within your protocol.
All application submission, feedback, correspondence, information requests and approvals occur within Ethical Review Manager (ERM).
Tips for completing the Ethics Application Process
- Prior to commencing your application, review all of the items noted in the process below (including information drop-downs) before commencing with your application. Note that the numbering system is arbitrary and that multiple steps can be undertaken in parallel to save you time.
- You can submit the research governance application at the same time as the ethics application
- Start drafting your research agreement early (link to research agreement page)
Multi-site greater than low risk Governance Only applications (External HREC review)
Before beginning with a multi-site governance submission, ensure the Co-Ordinating Principal Investigator or Lead Site has created an SSA subform for Barwon Health OR provided you access to the project HREA in ERM to allow you to create an SSA subform for Barwon Health from the HREA.
Read all the points in the process (including information drop-downs) before commencing with your application. Note that the numbering system is arbitrary and that multiple steps can be undertaken in parallel to save you time.
Contact REGI with any queries or concerns
REGI is here to help. If you are not sure where to start or have a question regarding your research project, email us at [email protected] and a member of the REGI team will get back to you within 24 hours. If you have a current application underway, please ensure you include your Barwon Health reference number in your enquiry.
For more information on submission requirements see the Victorian Clinical Trials and Research website.
Last Modified: Thursday, 19 May 2022