Applying for ethics approval and site-specific authorisation in REGIS involves a structured process designed to ensure research is ethically sound and appropriately governed.
This roadmap outlines each step—from project registration through to final authorisation—helping researchers navigate requirements efficiently across NSW public health organisations.
On this page:
- Step 1. Project registration
- Step 2. Ethics application and site-specific application
- Step 3. Post-approval monitoring
Step 1. Project registration
This step generates application forms but does not submit an application.
- Completed once per study
- Guides the applicant to select the correct options
- Minimise duplication of data entry and ensures consistency across all applications in REGIS
- Facilitates user access and permissions to the applications
- Identifies how many site-specific applications should be created in REGIS
- Creates a list of sites for the Human Research Ethics Committee (HREC)
The ethics and site-specific applications below can be submitted in parallel.
Step 2a. Ethics application
If ethics is managed by a HREC outside of NSW/ACT, this step is not completed in REGIS. Proceed to step 2b.
REGIS uses the national Human Research Ethics Application (HREA).
- Visit the reviewing HRECS website for submission dates and requirement
- Schedule a pre-submission meeting
- Information provided at project registration is populated into the HREA including the protocol
- Supporting documents are uploaded into the HREA
- The application will be reviewed by the HREC or appropriate non-HREC
- Review feedback and application changes are managed in REGIS
Step 2b. Site-specific application
Head of Department support for the applications is required. Speak to them before submission.
- Visit the site's website for submission requirements
- Considers the research activities that are happening at the site
- Can be used for a primary or satellite site in a tele-trial
- Schedule a pre-submission meeting for a single site application
- Site specific applications for NSW Health and TAS Health only in REGIS
- Review feedback and application changes are managed in REGIS
Research activity cannot begin until both ethics approval and site authorisation have been received.
Step 3. Post-approval monitoring
- Amendments
- Progress reports
- Safety reports
Support with ethics in research
The Research Ethics and Governance Unit offers guidance and support on matters relating to human research ethics and governance.