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 (HREC) in accordance with the National Statement on Ethical Conduct in Human Research (2007).

Human Research Ethics Applications (HREA) for projects in NSW and ACT public health organisations (PHOs) and local health districts (LHDs) must be completed in the Research Ethics and Governance Information System (REGIS). 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.

• NHMRC Human Research Ethics Application (HREA) is the national application form for research involving humans. IMPORTANT: do not create a HREA for a NSW public health HREC at the NHMRC’s HREA website as REGIS cannot import the application.
  • If you are the Coordinating Principal Investigator at a NSW or ACT PHO and your site is the ONLY site for the clinical trial, you will need to complete the HREA in Research Ethics and Governance Information System (REGIS).
  • If you are at a NSW or ACT PHO, your study is a multi-site study and you are NOT acting as the Coordinating Principal Investigator  you will only be required to complete a Site-Specific Assessment Application for NSW Public Health Organisations for governance in REGIS.
• 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.
  • If you are at a NSW or ACT PHO, your study is a multi-site study and you WILL act as the Coordinating Principal Investigator, you will need to complete the HREA in REGIS on behalf of all public health sites from jurisdictions participating in the National Mutual Acceptance scheme.
  • NSW Health excludes all Adult Early Phase Clinical Trials (EPCT) from the National Mutual Acceptance Model. All new adult EPCT applications proposed to be conducted in NSW PHOs, must be submitted to Bellberry HRECs for ethics review. Click here and here for further information about EPCT’s involving adults and children and young people under the age of 18.

Consumers and community members should be involved in developing all participant facing materials like PICFs and ethics applications. Public involvement can increase assurance of the acceptability and feasibility of research processes to HRECs and help inform the review of ethics applications. See Module 3.3 – Consumer and Community Involvement and ethics applications – Monash Partners for ideas on how to do this.

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)
• NSW OHMR Clinical Trial Ethics and Governance Information
  
  

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)