Read Getting Started before you begin.
All research projects involving humans undertaken in, or under the support and oversight of Peninsula Health, require formal approval prior to commencement.
Single site lower risk projects are reviewed to ensure the project is ethically sound and approved by the Peninsula Health Research Ethics Committee (HREC).
In parallel the Peninsula Health Research Governance Officer reviews Governance/Site-Specific Assessment (SSA) to determine whether a project is feasible and appropriate to conduct at Peninsula Health and can be authorised to commence at the site.
Lower Risk Research is defined as: Research in which there is no risk of harm, but in which there is a risk of discomfort and in which there may also be a foreseeable burden (low risk research) OR research in which there is no risk of harm or discomfort, but which includes a potential for minor burden or inconvenience (minimal risk research). National Statement 2025
Research That Does Not Qualify for review through the Lower Risk Pathway
Projects involving any of the following are not eligible for low risk review:
- Inexperienced qualitative researchers
- Overseas research
- Studies involving or uncovering illegal activity
- Research involving Aboriginal or Torres Strait Islander peoples, especially if they are a distinct subgroup
- Sensitive or high-risk procedures, including:
- Tissue collection (e.g., blood, urine, biopsies)
- Covert observation, deception, or concealed research purposes
- Human genetics or stem cell research
- Clinical or non-clinical interventions or therapies
- Involvement of patient family members
- Additional radiation beyond standard care
- Randomisation or control groups
- Sensitive topics (e.g., death, illness, mental health, sexuality, religion)
- Vulnerable populations (e.g., children, elderly, pregnant women, people with mental illness or cognitive impairment)
More information is available at https:/www.clinicaltrialsandresearch.vic.gov.au
Lower Risk Research Approval and Authorisation Requirements
Research Ethics and Research Governance Applications MUST be submitted at the same time.
How do I apply for approval and authorisation?
Applications are submitted via ERM. If you do not have an account register here Login – ERM Applications.
All Investigators, Head of Department, Head of Supporting Department(s) must also have an ERM account for electronic signature through ERM.
The Applicant user guide to ERM provides comprehensive guidance on how to use ERM.
A Low Risk VIC Application and Low Risk VIC Site Specific Assessment (SSA) application are both required.
Approval
- Createa Low Risk VIC Application on ERM.
- Complete the Low Risk VIC Application Form, upload other required documents and submit via ERM Applications.
Authorisation
- CreateaLow Risk VIC SSA Form on ERM.
- Complete the Low Risk VIC SSA Form, upload other required documents and submit via ERM Applications.
What documents do I need to submit?
Below is a list of the documents required for submission. Incomplete applications will not be accepted for review.
All documents must have a version number and date (no draft documents or those with comments or tracked changes will be accepted as part of the initial submission).
Use the Lower Risk Research Checklist to assist with compilation of your application.
Mandatory:
- Low Risk VIC Application
- Protocol
- Investigator(s) CV
- Low Risk VIC Site Specific Assessment (SSA) Form
- Lower Risk Research Checklist
Project Dependent:
- Participant Information and Consent Forms
- Data Collection Tools / Instruments
- Recruitment/Advertising Materials
- Other documents used in the project
- Research Agreement
- Contracts Checklist
- Ethics/Governance Payment Form – Recipient Created Tax Invoice (RCTI)
Low Risk VIC (HREC) Submission
- Complete the Low Risk VIC Application ensuring all investigators listed in the protocol are also listed on the application form. See Applicant user guide to ERM
- Upload other required documents
- Sign the application form using ERM’s electronic signature process for all required signatories (ie. Investigators, Head of Department, Head of Supporting Department(s)). You will not be notified when signed, check in ERM for completeness.
- Complete the Lower Risk Research Checklist and upload.
- Submit the Low Risk VIC application only when all steps above are complete
Low Risk VIC SSA Submission
- If you have an Agreement (Collaboration Agreement or CTRA) send the unsigned document to ResearchContracts@phcn.vic.gov.au for review as soon as possible. The budget amounts do not need to be entered, only the text will be reviewed. This can occur while you collect your costs and other documents.
- Complete the Low Risk VIC SSA Form.
- Upload other required documents.
- Sign the Low Risk VIC SSA application form using ERM’s electronic signature process for all required signatories (ie. Investigators, Head of Department, Head of Supporting Department(s)). You will not be notified when signed, check in ERM for completeness.
- Submit the Low Risk VIC SSA application only when all steps above are complete.
How is my project reviewed?
HREC Review
The HREC meets monthly to review new projects
Note: Only the first 5 complete applications received per HREC meeting will be reviewed. An application is considered complete only when it meets all submission requirements and includes all necessary signatures.
You will receive feedback via ERM within 7 days of the Committee Meeting.
Low Risk VIC SSA Review
- The Research Governance Officer assesses the Low Risk VIC SSA application and liaises with the Principal Investigator or Study Coordinator..
- Feedback, requests for additional information (and the fully signed Agreement if required for this project) will be sent via ERM.
- If the Research Governance Officer authorises the application you will be provided with a formal letter detailing both HREC approval and SSA authorisation from Peninsula Health and the project can commence.
Research at Peninsula Health must not commence until a formal signed HREC approval letter indicating Site Authorisation is received from Peninsula Health.
Amendments and Reporting
Researchers must comply with all monitoring and reporting obligations outlined in the approval letter.