All human research that takes place in NSW Public Health organisations requires site authorisation by the chief executive or their delegate prior to commencement.

Site-specific governance review establishes whether you can do this research, at your site. All human research that takes place in NSW Public Health organisations requires site authorisation by the Chief Executive of that PHO or their delegate prior to commencement. Your organisation must be satisfied by the evidence you provide in your Site-Specific Application that the certain conditions have been satisfied in order for your clinical trial to be authorised to proceed.

Your research will require site authorisation to:

• Ensure that the proposed research project complies with appropriate ethical, scientific, regulatory and professional standards
• Consider whether the project should be conducted at and supported by your organisation, and/or whether the provision of access to participants, their tissue and/or data should be supported
• Allow your organisation to be aware of all research taking place at sites under their control.

In NSW REGIS is the portal used by researchers to manage site governance of human research projects in NSW and ACT public health organisations (PHOs) and local health districts (LHDs). Researchers and department heads use the system to process, review and manage research projects throughout the study. There are Quick Reference Guides available in REGIS that contain step by step instructions for all REGIS users including Applicants, Heads of Supporting Departments and Authorising Chief Executive/Delegate.

COORDINATING/ LEAD SITE: If your study is a multi-site study and you will act as the Coordinating Principal Investigator or if your site is the ONLY site for the clinical trial, you will need to complete the ethics application on behalf of all public health sites from jurisdictions participating in National Mutual Acceptance in the REGIS.

Non-Lead Site: If you are not acting as the Coordinating Principal Investigator you will only be required to complete a site-specific application (SSA) for governance in REGIS.

Who can help?

The Ethics Officer for the HREC where you plan to/did submit your ethics application for ethics-related questions.

Your local Research Office can also assist you with ethics and governance related questions.

• Calvary Mater Newcastle Research Office
• Central Coast Local Health District Research Office

• Hunter New England Local Health District Research Office 
• Mid North Coast Research and Knowledge Translation Unit
• University of Newcastle Research Office
• University of New England Research Office
• The Royal Australian College of General Practitioners’ (RACGP’s) National Research and Evaluation Ethics Committee (NREEC)

The REGIS Help Desk for technical issues such as system issues or faults, account access issues, system advice. Call 1300 073 447 or email support@f1solutions.com.au. The help desk is open Monday to Friday from 7am to 7pm (excluding public holidays).