Research governance

Learn how you can apply for your project's review and authorisation, including if you're an external researcher or university student.

Overview

All research conducted at Western Health must undergo research governance review.

Research governance is the system of processes, policies and standards that ensures research is conducted safely, responsibly, ethically and legally.

It provides a framework for institutions, researchers and sponsors to manage and oversee research activity in a way that protects participants, maintains public trust and ensures high-quality outcomes.

Key elements of research governance

Complying with all relevant laws, regulations, guidelines and codes of practice
Gaining ethics approval
Securing governance approval through a Site-Specific Assessment (SSA)
Monitoring and auditing research activities to ensure ongoing compliance
Managing legal and insurance matters, including participant consent, indemnity and research agreements
Following policies for responsible research conduct, including how to handle misconduct, complaints and conflicts of interest
Ensuring all researchers are properly trained, credentialed and have completed induction
Protecting intellectual property and supporting collaborative research agreements
Managing research budgets and finances appropriately
Tracking research performance through regular reporting and planning
Identifying and managing risks throughout the life of the project.

Low Risk Governance (Site Specific Assessment) Submissions:

Ethics approval alone does NOT permit a research project to commence at Western Health. All low-risk research projects also require governance authorisation through a Site-Specific Assessment (SSA), granted by the Office for Research.

While ethical review considers whether the research should be conducted, research governance considers whether it can be conducted (i.e., is feasible) at Western Health - confirming that the site has the appropriate resources, personnel, departmental support, agreements, and insurance arrangements in place to support the safe and accountable conduct of the project.

For low-risk projects, the governance review assesses:

Investigator suitability: qualifications, valid GCP training, and a current WH Curriculum Vitae for all investigators
Departmental support: Head of Department and Heads of Supporting Department sign-off via the Statement of Approval Form
Resources and feasibility: confirmation the project can be conducted within the department's capacity
Agreements and appointments: research agreements where external organisations are involved, and honorary researcher appointments for external investigators requiring access to WH patients or data
Funding arrangements: budget endorsement where the project is funded
Safety monitoring arrangements: confirmation that appropriate arrangements are in place for identifying, managing, and reporting safety issues arising from the project

Western Health Principal Investigator Requirements

A Western Health employee must be nominated as the contact person and as the Principal Investigator in ALL projects undertaken at Western Health. The nominated WH employee listed as Principal Investigator must:

Have expertise in a discipline relevant to the project
Provide a link between the researchers and Western Health
Provide local knowledge that can facilitate the conduct of the research
Be updated on the progress and status of the project on a regular basis by the external researchers

How to Submit - Which Pathway Applies to Your Project?

Pathway 1

Your project is being reviewed by the Western Health Low Risk Ethics Panel (LREP)

Your low-risk submission involves two forms in ERM:

LR VIC Form

Ethics application
Reviewing Body: Western Health Low-Risk Ethics Panel (LREP)
Purpose: Describes the research itself (aims, methodology, participants, consent, and data)

LR VIC SSA Form

Governance application
Reviewing Body: Western Health Office for Research (OfR)
Purpose: Describes how the project will be conducted at Western Health (investigators, departments, resources, agreements, and funding)

Both forms must be submitted, and both ethics approval and governance authorisation issued, before your project can commence.

Pathway 2

Your project already has (or is undergoing) ethics review by another HREC (multi-site low-risk projects)

Where ethics review is being conducted by an external reviewing HREC, you must still submit a Research Governance/SSA application to Western Health and obtain governance authorisation before commencing the project at WH - even if ethics approval has already been given.
Ethics approval does not replace governance authorisation, and both must be obtained before the project can commence at Western Health.
Once your ethics submission has been made to the reviewing HREC, submit your SSA to the WH Office for Research via ERM.

Please note: Incomplete applications will not be accepted and will be returned to the Principal Investigator and study contact without being reviewed.

We are enforcing this instruction because receiving a complete application in one package allows that application to be reviewed once, as opposed to multiple times, which promotes efficiency and allows the Office for Research team to provide a more timely and comprehensive service to all of our researchers and research partners.

After Authorisation

Authorised projects remain subject to ongoing governance oversight, including:

Safety reporting: Adverse events, significant safety issues, serious breaches, and protocol deviations must be reported to the Office for Research in accordance with NHMRC safety monitoring and reporting guidance and WH requirements. While safety events are expected to be uncommon in low-risk research, any event where a participant's reaction exceeds discomfort and becomes distress or harm must be reported, as the project may no longer meet the low-risk criteria. Please see the Safety and Adverse Event Reporting page for more details.
Amendments: All changes to the protocol, study documents, or investigator team must be submitted for authorisation prior to implementation. Please see the Low-Risk Post Approval page for more details.
Annual progress reports: Annual progress reports are required for the duration of the project. Please see the Low-Risk Research Annual and Final Progress Reporting page for more details.
Audit: Including completion of the WH Self-Audit Form as part of annual/final progress report submissions; the Office for Research may conduct an audit at any time.
Final reporting: A final report must be submitted at project completion or closure. Please see the Low-Risk Research Annual and Final Progress Reporting page for more details.

For questions about governance requirements for your project, please contact the Office for Research.

Submitting an SSA application

The Site-Specific Assessment (SSA) process is the formal governance review for each research project site. SSA authorisation must be obtained before any research activity begins at Western Health, even if ethics approval has been granted.

To find out the steps involved in submitting an SSA application, visit our SSA Application page.

University research projects

If you’re completing a research project as part of your undergraduate or postgraduate studies, learn what’s involved in seeking governance authorisation for university research.

Making amendments post-authorisation

Once a research project has received governance authorisation, any changes to the approved protocol, documents, investigators or study procedures must be submitted as a governance amendment for review and authorisation before implementation.

Learn more by visiting our Amendments to Approved and Authorised Research Projects page.

Rporting requirements for research projects

All research projects which have received both ethics approval and Site-Specific Assessment (SSA) authorisation to be conducted at Western Health are subject to ongoing monitoring and reporting obligations to ensure compliance with national guidelines.

Find out about your responsibilities and how to submit relevant reports on our Research Reporting page.

Safety monitoring and study breaches

All the safety events and study breaches throughout a project’s lifecycle are required to be monitored and reported to RGO by the Principal Investigators.

Learn about what’s involved in reporting a safety issue or serious or suspected breach of trial protocol.

Information for external researchers

If you’re working with Western Health as an external researcher or through a partnership with another institution, you may need to apply for an Honorary Researcher Appointment.