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Low risk research projects

Find out how to submit a low risk research project application, including all required documents and procedures.
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Submitting your research application 

Before you submit your application, please ensure you are familiar with Western Health’s Standard Operating Procedures – Good Clinical Practice documents for research. 

These outline the standards expected for conducting research at Western Health. The Office for Research may conduct an audit at any time to ensure compliance. 

Please note: 
  • There is no deadline for submitting applications.
  • You must submit your application via ERM (Ethics Review Manager) only once it is fully prepared and meets all our requirements.
  • You do not need to email us immediately after submitting your application. If you have not received any communication from the Office for Research after 5 business days, you may send a follow-up email to [email protected]. 


Staff involvement in research projects 

All research projects conducted at Western Health must involve a Western Health employee.  

Even for externally initiated projects, a permanent Western Health employee must be nominated as the Principal Investigator (PI).  

The nominated Western Health employee 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. 

 

Incomplete submissions 

  • Please ensure your application is complete before submitting it.
  • Incomplete applications will not be accepted. They will be returned to the Principal Investigator and study contact without being reviewed.
  • Submitting a complete application in one package allows us to review it once, rather than across multiple stages. This helps the Office for Research work more efficiently, provide faster feedback and deliver a better service to all researchers and partners. 

 

Document submission requirements  

For an overview of the submissions process for low risk projects, please refer to the LREP Submissions Process Map. 

1. The Victorian Low Risk Form (LR VIC) 
  •  Create the LR VIC Form on the Ethics Review Manager (ERM) website.
  • To ensure you can submit to Western Health, please answer these questions in the LR VIC Form (Level of Risk section) with the following:
    • Question: HREC or ethics review body to which this application will be submitted – Please select "Western Health"
    • Question: Have you consulted the organisation's research office regarding the risk level for this research project? – Please select "Yes"
    • Question: Did the organisation's research office advise completion of the LR VIC? – Please select "Yes"
  • The system will generate an ethics reference number for you. Please ensure that the form is formally submitted on ERM to be reviewed. You will know this form is submitted successfully if you have a review reference number located on the bottom left of the page when the PDF is generated.
  • Do not complete the HREA form.
  • All investigators are required to sign and date the researcher declarations either electronically through their own ERM logins or by signing the Investigator Declaration Page.
  • For ERM technical assistance, email Infonetica Helpdesk at [email protected].
  • For useful guides and tools for using ERM, visit the Ethical Review Manager overview webpage.   
2. The Victorian Low Risk SSA Form (LR VIC SSA) 
  • Create the LR VIC SSA Form under the LR VIC Form as a "Sub-Form".
  • You can complete the form in the ERM system. Please ensure that the form is formally submitted on ERM to be reviewed.
  • You will know this form is submitted successfully if you have a review reference number located on the bottom left of the page when the PDF is generated. 
3. Research Protocol 
  • Refer to the Research Protocol Word doc template.
  • Submit a detailed protocol and any other documentation such as:
    • documents to be given to participants e.g. letters of invitation, transcripts for telephone contact, questionnaires, patient diaries
    • verbal scripts
    • assessment tools
    • advertising materials
    • data collection sheets and case report forms.
  • Please insert a version number and date either in the footer or header of all documents. 
Privacy and data management 
  • We are all responsible for the protection and handling of private personal information at Western Health. The Office for Research highly recommends that a Privacy Impact Assessment (PIA) is performed and completed during the development and planning of your project and protocol to identify potential privacy risks and to implement mitigation strategies to comply with the Privacy & Data Protection Act 2014 (PDP Act 2014) before a project commences.
  • Please see the Office of the Victorian Information Commission (OVIC) website for the PIA and guidelines.
  • Please note that this form does not need to be submitted to the Office for Research. For guidance and review of data management plans, contact Western Health’s Corporate Records Manager, Mymoena Abrahams at [email protected].
  • Please also note that if your project is audited, this document may be requested for review as a supporting document. 
4. Western Health LREP Site Specific Form 
  • This form is to be completed to clarify site-specific requirements for resources and facilities required at Western Health to conduct your project.
  • Download the LREP Site-Specific Form.
  • This is not the Site-Specific Assessment (SSA) form on ERM – please complete the correct form. If unsure, contact the Office for Research at [email protected]. 
5. Statement of Approval Form 
  • Download the Western Health’s Statement of Approval Form.
  • Head of Department and Heads of Supporting Department signatures are required – please ensure their names and department names are clearly stated and that they have ticked the relevant boxes.
  • Where an investigator on the team is also the Head of Department, sign-off should be obtained from the next line of reporting, e.g. Divisional Director or Clinical Director. 
6. Curriculum Vitae 
7. International Conference on Harmonisation - Good Clinical Practice (ICH-GCP) Training Certificate 
  • It is mandatory for all investigators (Principal/Associate Investigators, Study Coordinators, Students etc.) to have completed GCP Training – please provide a copy of their completion certificates.
  • GCP Training must be valid and completed within the last 3 years. 
8. Participant Information and Consent Form (PICF) 
  • Complete a PICF if the study involves participants from whom you are obtaining consent.
  • Please use Western Health’s Low Risk PICF template.
  • Electronic PICFs must be submitted in an editable Microsoft Word format (not as a PDF) so that reviewers are able to make comments if required. 
9. Research Agreement 
  • Only required if applicable.
  • In accordance with the Australian Code for the Responsible Conduct of Research, organisations involved in a joint research project should ensure that agreement is reached with the partners on the management of the research. This agreement should be in writing.
  • Please see the Research Agreement page for submission requirements.
  • A minimum of 2 original handwritten signatures of the agreement once endorsed must be provided. 
​10. ​Budget 
  • This is only required if the project is funded.
  • An itemised budget is to be signed by the Principal Investigator and approved/endorsed by the departmental Business Analyst​ (signature on budget or email confirmation is acceptable). 
11.  Honorary Researcher Application Form 
  • This form is intended for use where an external researcher wishes to conduct research which requires access to Western Health patients and/or their associated data by way of an honorary researcher appointment.
  • A police check and immunisation clearance may be required – please contact your Western Health Supervisor or the Head of Department for cost centre details.
  • See the Honorary Researcher Appointments web page or the Honorary Researcher Eligibility flowchart to determine whether this is required. 
12. Databank Registration Form 
13. Application Fee 
  • All projects incur a review fee. For details, please see our fee schedule page. All fees must be accompanied with a completed compliant tax invoice. 

  

Electronic file naming convention 

To ensure the electronic files submitted are easily identifiable, please use the format outlined below, including version numbers and dates in the file name. 

Projects submitted with documents that do not follow the below naming convention 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 

For more details, refer to the electronic naming convention document. 

 

Related resources 

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