Multi-site Research

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.

Peninsula Health is a participating organisation in National Mutual Acceptance (NMA) for eligible multi-site research projects.

Peninsula Health’s Human Research Ethics Committee (HREC) does not conduct ethical and scientific review of multi-site research projects.

Peninsula Health accepts a single ethical review conducted by a certified reviewing HREC listed in the NMA’s HRECs, RGOs and Organisations document. Peninsula Health must be listed as an participating site.

The Peninsula Health Research Governance Officer reviews Research 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.

More information is available at https:/www.clinicaltrialsandresearch.vic.gov.au 

Multi-site Research Approval and Authorisation Requires

The following Research Ethics and Research Governance processes must be approved before the project can commence.

Research Ethics – HREC approval is granted by Peninsula Health. The project is ethically sound. Peninsula Health is listed as a participating site.

Research Governance – Site Specific authorisation is issued by Peninsula Health. The project is feasible and appropriate to conduct at Peninsula Health.

How do I apply for Site Authorisation?

• Applications are submitted via Ethical Review Manager (ERM). If you do not have an ERM account register hereLogin – 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.
• The lead site will create a Site Specific Assessment (SSA) Form as a sub-form of the Human Research Ethics Application (HREA) on ERM and transfer access to you.
• You can prepare the SSA and required documents while you wait for HREC approval.
• 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.

Use the Multi-site Site Specific Assessment Checklist to assist with compilation of your application.

How do I submit?

• SSA submissions are not subject to fixed deadlines.
• If you have an Agreement, Indemnity +/- Insurance send to ResearchContracts@phcn.vic.gov.au for review as soon as possible. The budget amounts do not need to be final, only the text will be reviewed. This can be reviewed while you collect your other documents.
• Complete the SSA 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 Multi-site Site Specific Assessment Checklist and upload.
• Submit the application only when all steps above are complete.

How is my project reviewed?

• 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 and Indemnity will be sent via ERM.
• If the Research Governance Officer authorises the application you will be provided with a Site Authorisation Letter from Peninsula Healthand the project can commence.

Research at Peninsula Health must not commence until a formal signed HREC approval from the reviewing HREC and Site Authorisation Letter from Peninsula Health are received.

Amendments and Reporting

Researchers must comply with monitoring and reporting requirements from:

• Peninsula Health
• The Reviewing HREC, and