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.

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.

Reporting 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.