University Projects

​​​​​​​​​​​​​​​​​​​​​​​​​​​​University research projects as part of undergraduate/postgraduate study NOT involving patients (and their data) are not required to submit a full Site Specific Assessment (SSA) Governance Application to the Office for Research. However, a simpler Research Governance application is required, as clarified further below.

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 WH Site Specific Form and 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 Research Governance Application

Requirements in further detail: 

1. Submit a cover letter with your Research Governance Application. 

• Complete a WH Site Specific Form and a ​​Statement of Approval Form for each Western Health department whose services will be required to undertake your research. Researchers are advised to provide original signed copies.
  
• Submit all research project documents as submitted to the university reviewing Human Research Ethics Committee (HREC):
• Final approval letter from reviewing HREC​
• Ethics Application Form – non original signed copy
• Master approved Participant Information and Consent Forms (PICF)
• Site specific Participant Information and Consent Forms based on Master approved PICFs
• Site Specific PICFs must include: WH Logo, local governance/site specific version number and date, PI/researchers contact details & WH local governance contacts details for complaints
• Questionnaires/surveys
• Data Collection Forms
• Advertisements
• Etc
• Investigator's Curriculum Vitae using the Western Health CV Template & valid GCP Certificate (within 3 years)​
  
• Other documents, if applicable:
• ​​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.
  
• Victorian Specific Module
  
• Research Governance Review Fee - see link to fee schedule he​re.
• Submit your research governance/ site-specific assessment application (one original hard copy, PLUS one complete e-copy) to:

Submit the hard copy to:
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.

Submit the e-copy of your research governance/site-specific assessment application 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.