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 higher 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.
Higher Risk Research is defined as Research in which there is a risk of harm and in which there may also be a foreseeable burden. The risk of harm in higher risk research may or may not be a risk of significant harm and may be harm to the individual, group, community, societal or global level. National Statement 2025
More information is available at https:/www.clinicaltrialsandresearch.vic.gov.au
Higher 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 Ethical Review Manager 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 Human Research Ethics Application (HREA) and Site Specific Assessment (SSA) application are both required.
Approval
- Create an HREA Form on ERM.
- Complete the HREA Form, upload other required documents and submit via ERM Applications.
Authorisation
- Create an SSA Form on ERM.
- Complete the 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 Higher Risk Research Checklist to assist with compilation of your application.
Mandatory:
- Human Research Ethics Application (HREA)
- Victorian Specific Module (VSM)
- Protocol
- Investigator(s) CV
- Investigator(s) Good Clinical Practice Certificate (only for Clinical Trials)
- Site-Specific Assessment (SSA) Form
- Higher Risk Research Checklist
Project Dependent:
- Participant Information Consent Form
- Data Collection Tools / Instruments
- Advertising / Recruitment Materials
- Research Agreement
- Ethics/Governance Payment Form Recipient Created Tax Invoice (external researchers only)
How do I submit?
HREA and Victorian Specific Module (VSM) Submission
- Complete the HREA ensuring all investigators listed in the protocol are also listed on the application form.
- 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 Higher Risk Research Checklist and upload.
- Create the VSM as a sub-form of the HREA.
- Complete the VSM Form and upload.
- Submit the HREA and VSM applications only when all steps above are complete.
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 SSA Form.
- Upload other required documents.
- Sign the 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 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.
SSA Review
- The Research Governance Officer assesses the 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.
Additional Requirement for Clinical Trials of a Drug
For single-site clinical trials involving drugs or devices, HREC approval will only be granted after the Peninsula Health Drugs and Therapeutics Committee has reviewed the trial.
Amendments and Reporting
Researchers must comply with all monitoring and reporting obligations outlined in the approval letter.