Ethics approval establishes whether you should do this research. All research involving humans conducted within the NSW public health system must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee  in accordance with the National Health and Medical Research Council National Statement on Ethical Conduct in Human Research (2007).

NSW supports a single ethical review for studies taking place in more than one public health organisation across one or more Australian jurisdictions under National Mutual Acceptance.  NSW Health is excluding all Adult Early Phase Clinical Trials (EPCT) from the National Mutual Acceptance Model. All new adult EPCT applications proposed to be conducted in a NSW Public Health Organisation site, must be submitted to Bellberry HRECs for ethics review. Click here further information about EPCT’s involving adults and children and young  people under the age of 18.

In NSW the Research Ethics and Governance Information System (REGIS) is the system used by researchers to manage research ethics 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 that contain step by step instructions for all users including Applicants, Heads of Supporting Departments and Authorising Chief Executive/Delegate. Different systems are used in other states of Australia.

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.

Research in General Practice and Primary Care

The Royal Australian College of General Practitioners’ (RACGP’s) National Research and Evaluation Ethics Committee (NREEC) is the only general practice-specific HREC in Australia. Research to be conducted in, with or about general practice and primary care should have ethics approval from the NREEC.

Who can help?

The Ethics officer for the HREC where you plan to/did submit your ethics application for ethics-related questions. Your research officer may also be able to assist.

• 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

• HMRI Clinical Trials Unit
• 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).