University Projects

​​​​​​​​​​​​​​​​​​​​​​​​​​​​University research projects as part of undergraduate/postgraduate study NOT involving patients (and their data) are required to submit an ERM Site Specific Assessment (SSA) Governance Application to the Office for Research.

For research projects involving WH patients a​nd their data, check links on relevant submission types (QA, Low Risk or High Risk) for further details.​

IMPORTANT:

All projects undertaken at Western Health must involve a Western Health employee. Where an externally initiated project is being submitted, a permanent Western Health employee should be nominated as the Principal Investigator in ALL projects undertaken at Western Health.

• The nominated Western Health employee/Principal Investigator must:
• Have expertise in a discipline relevant to the project.
• Have more than 2 research publications or equivalent research experience if no publications made (to be clarified in Curriculum Vitae (CV))
• Provide a link between the researchers and Western Health
• Provide local knowledge that can facilitate the conduct of the research.
• Be updated on the progress and status of the project on a regular basis by the external researchers

Students who have little research experience or less than 2 publications should not be listed as a PI, their Supervisor or Senior should be the PI and they should be responsible for the project management.

Submitting Research Governance Application

Brief overview of requirements for submitting research projects conducted at or by Western Health:

1. Submit a Cover Letter, signed by the Principal Investigator
2. Complete departmental approval forms
3. Submit all research project documents as submitted to the Reviewing HREC/Ethics committee
   
4. Investigator Qualifications - CVs & GCP
5. Other documents, if applicable:
• Research Collaboration Agreement
  
• Materials Transfer Agreement
  
6. Research governance review fee
7. Submit your application on Ethics Review Manager (ERM) website by creating a Minimal Dataset Form (MDF) for your research project. MDF is a minimal dataset form that helps in completing basic data from the Ethics Application form which was submitted to accredited HREC for review. The MDF is NOT sent to or connected to the reviewing University HREC. The purpose of it is ONLY to enable the creation of a Site-Specific Assessment (SSA) form for your project and will be reviewed by our Office for Research team.  Please Note: After creating the SSA form on ERM a statement will be displayed as “Do not upload ethics supporting documents”. Please ignore this statement (as this is applicable to projects other than a University HREC Approved Project submission) and upload all your ethics supporting documents as required for ethical review. E.g. all documents that have been reviewed and approved on your HREC Approval Letter.
   

Requirements in further detail: 

1. Submit a cover letter with your Research Governance Application.
2.  Complete and submit Minimal Dataset Form (MDF) and Site-Specific Assessment (SSA) Form – to be created on Ethics Review Manager (ERM).
   
3. Declaration Signatures to be obtained using the WH Site Specific Declaration Signature Form or digitally signed on ERM SSA form for each investigator.
4. Please obtain Statement of Approval declarations for each Western Health department whose services will be required to undertake your research either by using the WH Statement of approval form (wet ink signed and scanned) or digitally signed on ERM SSA form for each Head of Department.
   
5. Submit all research project documents as submitted to the university reviewing Human Research Ethics Committee (HREC):
   

• ​​For Collaborative Research Across Institutions (research other than clinical trials) - submit a Research Collaboration Agreement.
  
  Please contact the Office for Research regarding review of research agreements: Mr Bill Karanatsio​s, 03 8395 8073.
  
• Complete a material transfer agreement if applicable. Please contact the Office for Research regarding this agreement, Mr Bill Karanatsios, 03 8395 8073.
  
• Victorian Specific Module
  
• Research Governance Review Fee - see link to Fee schedule.
  
• Notify of your research governance/site-specific assessment submission on ERM to us by sending an email to: [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

CVs, GCP & Codes (where applicable) to be named as: 

• [First Name][Last Name] WH CV DDMMMYY
• [First Name][Last Name] GCP DDMMMYY
• [First Name][Last Name] WH Code DDMMMYY

See electronic naming convention document (download on right hand side links) for more details.