Western Health has entered into a Memorandum of Understanding with 11 partner organisations to work together to streamline and harmonise ethical and governance review of all multi-centre human health research.
The physical proximity and multiple levels of collaboration across healthcare, medical research and academia throughout Western Health and our affiliated University of Melbourne partners, through the Melbourne Academic Centre for Health (MACH), provide us with a great opportunity to build a seamless and streamlined system that facilitates changes in clinical practice in response to evidence generated amongst our group.
To realise this goal, the partners have established a Steering Committee to oversee, develop and implement a comprehensive framework to deliver a highly efficient and effective overarching system for streamlined, harmonised and standardised ethical and governance review within our group. This initiative includes participation in the existing National Mutual Acceptance Program for single ethical review of multicentre clinical trials and any new State or National streamlining initiatives that may arise in the future.
This submission process is only applicable and available for projects reviewed and approved by the Research Excellence (REx) Partners:
Accepting participating sites:
Please note: A Western Health employee should be nominated as a contact person as an associate researcher in ALL projects undertaken at Western Health.
Why are we enforcing this instruction?Receiving a complete application in one package allows that application to be reviewed once, as opposed to multiple times. This promotes efficiency and will allow the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.
Please ensure you are familiar with the WH Standard Operating Procedures - Good Clinical Practice (WH SOP-GCP) for research. The Office for Research may conduct an audit at any time.
The SSA form to be completed is different depending on the project type.
Quality Assurance Projects
Complete the WH Site Specific Form.
Low & Negligible Risk Projects
Complete the SSA form that is generated from the Ethics Review Manager (ERM). This SSA is generated from the HREA reviewed by the ethics committee.
Submit all research project documents as submitted to the reviewing Human Research Ethics Committee (HREC) e.g.:
Curriculum Vitae (CV)
Researchers involved at WH site are required to provide a CV using the Western Health CV template and sign the declaration that they have read and understood the WH Research Code of Conduct (2018). If researchers do not use the WH CV template, please sign and date their preferred full CV and sign and date the declaration located on the last page of the WH Research Code of Conduct (2018).
International Conference on Harmonisation – Good Clinical Practice (GCP)
It is mandatory for the Principal Investigator to have completed GCP training. Please provide a certificate of completion; this must be completed within the last 3 years.
Honorary Researcher Appointment
This is required for any external researchers who may be coming on site and who may have contact with patients, access identifiable data, or using our resources/facilities. Please see Honorary Researcher Appointment process here.
Research Agreement (Commercial, Investigator-Initiated or Collaborative studies) – see requirements and process here for legal review of endorsement of agreements.
Once endorsed, please provide 3 x copies with original wet ink signatures in hardcopy for signing.
Please contact Bill Karanatsios for any queries. [email protected]; 03 8395 8073
Both Electronic and Hardcopy submissions must be made. See instructions for both below.
Applicants must submit both the ethics application via Ethics Review Manager (ERM) and email ([email protected])
Mandatory electronic file name convention:
To ensure the electronic copies submitted are easily identifiable, the format outlined below must be used for all electronic files. As shown in example below, include version numbers and dates in the file name.
Projects submitted with documents that do not follow the below naming convention/format will not be considered and will be returned via email to sender.
Convention: [ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
E.g. 41234 Protocol v1 01Jan19
By post/drop-off: Manager Office for Research Level 3 Western Health Centre for Health Research & Education – Sunshine Hospital, Furlong Road, St Albans VIC 3021
Drop-off/after hours: A drop off box is located in the Ground Level Staircase (right of the elevators) of the Western Health Centre for Health Research & Education Building, Sunshine Hospital, Furlong Road, St Albans VIC 3021. Please note that this box will be checked once a day.