Forms and Templates
Initial Ethics Application Forms
All New Ethics Applications must be submitted in REGIS
Full HREC review
Expedited Review of Low and Negligible Risk (LNR) Research
Guidance to Completing the HREA
Access request (see Research Governance)
Projects Exempt from HREC Review that may result in external presentation/publication
Ethics Amendments
Amendment form in REGIS
A Notification of an Amendment to a Research Study is to be completed in REGIS against your Ethics Application.
There are 4 amendment types:
1. General Amendment
Affecting the conduct, design or methodology of a trial and includes changes to:
- Information previously given in the HREA
- The Protocol
- The Information sheet(s) and consent form/s for participants
- Any other supporting documentation for the study
2. Request for an extension of HREC Approval
Approval to extend the project beyond the original period granted by the HREC
(NOTE: For requests of over 12 months you should contact the Research Office first, as a full re-submission may be required)
3. Addition of a Site
Update the study details of the additional site(s) and investigator(s)
(NSW sites will have a site application form generated in REGIS)
4. Change to CPI/PI
Notify the HREC of changes to the Coordinating Principal Investigator and/or Site Principal Investigator(s)
- QRG – Ethics Amendment – Completing & Submitting
- Ethics Amendment Submission Checklist (under development)
Protocol Templates
Suggested Protocol Templates for Clinical Trials
Suggested Protocol Templates for Non Clinical Trials (including Biological Studies and Data Studies)
Participant Information Sheets and Consent Forms
Information Statements and Consent Form Templates
- Guidance for Participant Information Statements and Consent Forms
- Master Executive Summary
- Master Participant Information Statement
- Master Participant Consent For
- Master Parent/Guardian Information Sheet
- Master Parent/Guardian Consent Form
- Master Child Information Statement 8-12 years
- HNE Complaint Statements for Participant Information Statements
Annual Progress/Final Reports
In REGIS against your Ethics Application via Milestones
Annual Progress Reports and Final Reports
- Milestone Report (Annual Report) via REGIS
- QRG – Submitting a Progress/Final Report
Safety Reporting
In REGIS against your Ethics Application via Forms