This process map outlines the key governance requirements for conducting research within NSW Health organisations, guiding researchers through ethical review, site-specific authorisation, and compliance with legislative and policy standards to ensure safe, high-quality, and accountable research practices.
Research design and planning
Does the project fit within the NSW Health Research and Governance Framework?
Initiation
- Contracts and agreements
- Stakeholder involvement
- Project registration (REGIS)
- Feasibility and investigator selection
- Legal requirementProtocol design and development:
- Trial management and monitoring
- Trial supplies
- Trial documentation
- Pharmacovigilance
HREA and SSA submission
Trial begins
- GCP and serious breaches
- Safety reporting
- TGA inspections, audit
- Substantial amendments
- Addition of a new site/investigators
Legend
Good practice
Legal requirement
Support with ethics in research
The Research Ethics and Governance Unit offers guidance and support on matters relating to human research ethics and governance.