University research projects
Find out what you need to know if you're completing a university research project at Western Health as part of your undergraduate or postgraduate studies.
For projects not involving patients or patient data
- You must submit a Site-Specific Assessment (SSA) Governance Application through the Ethics Review Manager (ERM) system to the Western Health Office for Research.
For projects involving patients or patient data
- If your project involves Western Health patients or their personal data, please refer to the specific guidelines for the type of ethics submission required for:
Involving a Western Health investigator
To be approved to conduct research at Western Health:
- A permanent WH employee with research experience must be involved in every project.
- That person must be listed as the Principal Investigator (PI) at the WH site.
The nominated PI must:
- have expertise in a discipline relevant to the project
- have more than 2 research publications, or demonstrate equivalent research experience if no publications exist (to be detailed in their curriculum vitae)
- act as a liaison between the external researchers and Western Health
- provide local knowledge to support the conduct of the research
- be kept regularly updated on the project’s progress and by the external researchers.
Student researchers
- Students with limited research experience or fewer than 2 publications should not be listed as the Principal Investigator (PI) on a project.
- Instead, their supervisor or a senior researcher with appropriate experience should take on the role of PI and be responsible for managing the project.
- This helps ensure that all research projects have the necessary leadership and oversight.
Submitting a Research Governance Application
Follow the steps below to submit your Research Governance (Site-Specific Assessment) Application for research projects conducted at or by Western Health:
Submit a cover letter
- Refer to the WH Cover Letter template.
- This must be signed by the Principal Investigator.
Create a Minimal Dataset Form (MDF) and SSA form through the ERM system
- The MDF captures basic project details already included in your Ethics Application submitted to the reviewing HREC.
- The MDF is not linked to or reviewed by the university’s HREC.
- It is only used to generate your Site-Specific Assessment (SSA) form and will be reviewed by our Office for Research team.
- Please note: After creating the SSA form on ERM, you will see this statement: “Do not upload ethics supporting documents”. Please ignore this statement (as this is applicable to projects other than a University HREC Approved Project submission). You must upload all your ethics supporting documents (see Step 4).
Obtain signatures and declarations
- Each investigator must either:
- Sign the WH Site-Specific Declaration Signature Form.
- Digitally sign the SSA form in ERM.
- If your research involves services from any Western Health department, you must obtain a Statement of Approval from each Head of Department:
- Use the WH Statement of Approval Form (signed by hand and scanned), or
- Provide digital approval via ERM.
Submit research project documents (as provided to the university’s HREC), including:
- final HREC approval letter
- completed Ethics Application Form
- master Participant Information and Consent Forms (PICF) as approved by HREC
- site-specific PICFs, based on the master version, including:
- Western Health logo
- local governance/site-specific version number and date
- Principal Investigator/researcher contact details
- Western Health local governance contact details for complaints.
- any questionnaires, surveys, data collection forms, advertisements, etc.
Provide investigator qualifications
- Submit the following for the Principal Investigator and all researchers:
- Curriculum vitae (CV) using the Western Health CV template
- Good Clinical Practice (GCP) certificate (must be dated within the past 3 years).
Submit additional documents (if applicable)
- For collaborative research across institutions (excluding clinical trials), submit a Research Collaboration Agreement.
- If your project involves transfer of materials, complete a Material Transfer Agreement.
- Contact the Office for Research regarding either of these two agreements: Bill Karanatsios, (03) 8395 8073.
- Submit a completed Victorian Specific Module (if required).
- Pay the Research Governance Application Fee (see our Fee Schedule).
Notify us of your submission
- After submitting your SSA application on ERM, please email the Office for Research at [email protected].
Mandatory electronic file naming format
To ensure your documents are easily identifiable and meet submission requirements, each file must follow the below naming format:
[ERM Project ID] [Document Name] [version number] [Date DDMMMYY]
Example:
41234 Protocol v1 01Jan19
For CVs, GCP & Codes (where applicable):
- [First Name][Last Name] WH CV DDMMMYY
- [First Name][Last Name] GCP DDMMMYY
- [First Name][Last Name] WH Code DDMMMYY
Please note:
- Documents that do not follow this naming format will not be accepted.
- They will be returned via email, and your submission will be considered incomplete.
- Project review will not commence until all documents are correctly named and resubmitted.
- For more information, see our Electronic Submission Naming Format guidelines.