About ethics and governance
Ethics and governance frameworks make sure that research involving people is safe, fair, respectful and scientifically sound. They also ensure that research is compliant with policies, and organisational responsibilities.
NSW Ministry of Health Policy PD2010_056 Research - Authorisation to Commence Human Research in NSW Public Health Organisations and GL2011_001 Research Governance in NSW Public Health Organisation outline that all human research that takes place in NSW Public Health Organisations (PHOs) must meet appropriate governance standards.
Our Research and Education Network (REN) offers Western Sydney LHD researchers support in preparing and submitting research projects for ethics approval and governance authorisation.
For more information contact the Research Office:
Email: WSLHD-REN-REGO@health.nsw.gov.au
Phone: (02) 8890 9007
About the Research Ethics and Governance Office
The Research Ethics and Governance Office is the central point that supports, guides and oversees health and medical research carried out within Western Sydney LHD.
The office can help with:
- Ethics and governance: we make sure research projects involving people, data, or tissue samples meet strict ethical and legal standards. We help researchers apply to the Human Research Ethics Committee (HREC) and ensure projects comply with NSW Health and national guidelines.
- Approvals and monitoring: we review research proposals, give formal approval for studies to start, and keep track of projects to make sure they stay safe, ethical, and compliant.
- Advice and support: we provide help to researchers with applications, study design requirements, and navigating policies, especially around patient safety, consent, and privacy.
- Training and resources: we run training sessions, guidance documents and resources to build research capacity among clinicians, students and staff.
- Collaboration and partnerships: we connect researchers with hospitals, universities, government bodies and industry partners to encourage high-quality research.
For more information you can contact the Research Ethics and Governance Office on (02) 8890 9007 or email: wslhd-researchoffice@health.nsw.gov.au
Research Office staff contacts
| Administration officers | Human Research Ethics and Governance officer | Human Research Ethics Manager | Research Governance officers |
|---|---|---|---|
Morgan Pogoriutschnig
| Elyssa Frelingos | Tina Newman | Pauline Geale Seema Manoj (Acting) |
|
|
|
|
Kellie Hansen – Manager, Research Ethics and Governance Office.
Phone: 0429 270 660
Ethical conduct is more than simply doing the right thing. It involves acting in the right spirit, out of an abiding respect and concern for one’s fellow creatures.
National Health and Medical Research Council, 2023
Research governance
Find out about what you will need for your submission, post approval and the reporting activities related to your research governance application.
- Governance submission cover letter (DOCX 67.29KB)
- RO-008-Guide to Preparing your Governance Application (PDF 289.56KB)
- RO-006-Guide to Declarations of Support (PDF 255.3KB)
- RO-007-Guide to Access Request (PDF 264.79KB)
- WSLHD AI Ethics Assurance Assessment 2025 (DOCX 33.46KB).
If your study is multicentre, please provide the ethically approved master documents and the site documents based on the approved master with your site application.
All eligible submissions must meet the following criteria:
- Cover letter – RGO submission cover letter
- Staff link numbers for all investigators (all team members should complete their profile in REGIS this information is then populated when they are added to any project)
- Fee transfer or invoice form
- Participant information and consent forms
- Single site
- Correct complaints contact
- Clinical contact must be the Principal Investigator
- Page numbering and footer correctly formatted
- Multicentre
- Correctly tracked from the HREC approved Master – including correct referencing to the Master in the footer.
Contact the Research Ethics and Governance Office for clinical trial contracts and agreements, including:
- Clinical Trial Research Agreement Medicines Australia CTRA: Collaborative or Research Group-CRG Studies – Standard Form
- Clinical Trial Research Agreement Medicines Australia CTRA: Contract Research Organisation acting as the Local Sponsor
- Clinical Trial Research Agreement Medicines Australia – Standard Form
- Clinical Trial Research Agreement Phase 4 Clinical Trial (Medicines)
- Clinical Trial Research Agreement Phase 4 Clinical Trial (Medicines) – Contract Research Organisation acting as Local Sponsor
- Clinical Trial Research Agreement Subcontract for Studies Conducted Under a Tele-Trials Model.
Contact the Research Ethics and Governance Office at:
Phone: (02) 8890 9007
Email: WSLHD-REN-REGO@health.nsw.gov.au
Any changes made to an approved project must receive ethics approval and governance authorisation. Regardless of the size of the change, it cannot be incorporated into the project until it is approved.
RO-GUIDE - Submission of a Governance Amendment - February 2024
Submit your amendment in REGIS, using the “forms” tab on the STE. There are several forms available, select the form that best describes your change request:
- Reporting local safety events to the institution
- Site amendment
- Addition of a new site
- CPI change notification
- PI change notification
- Extension of HREC approval notification
- Change site investigators or site administration contacts
- Change to contracts
- General.
Amendments will not be accepted if annual reports are not up to date.
The conditions for the release of data from the Wester Sydney LHD are described in Disclosure of unit record data by Local Health Districts for research or contractor services (PD2018_001). This policy is currently under review by the Ministry. Until a revised policy is released the PD2018_001 will remain in effect within Western Sydney LHD.
If your project requires the release of data, please contact the Research Ethics and Governance Office at:
Phone: (02) 8890 9007
Email: WSLHD-REN-REGO@health.nsw.gov.au
Research approval processes
Ethical approval
In Australia, all research studies involving human participants, human tissues and clinical data must adhere to the National Statement on Ethical Conduct in Research Involving Humans (2025).
Projects for research study must be approved by an accredited Human Research Ethics Committee (HREC).
NSW Health Policy Directive PD2010_056 Research - Authorisation to Commence Human Research in NSW Public Health Organisations, sets out the mechanism to be used by Public Health Organisations (PHO) to authorise the commencement of human research projects at sites under their control.
Research Governance Site Authorisation
Local Health District compliance with this policy is mandatory. All research projects involving humans must be authorised by the Chief Executive (or designee) before research may commence at any PHO.
Within Western Sydney LHD, human research proposals are first submitted to the Research Ethics and Governance Office for managing and administering the ethical and governance review processes.
More information is available on how to make ethics and governance submissions.
All HREC submission must adhere to the following points. If they do not the submission will not be accepted and will be returned for resubmission.
- PI: all Western Sydney LHD sites must have a PI with an appointment with Western Sydney LHD
- Fee form: proof of payment must be included in the submission
- Protocol: study must have a protocol – The protocol and PICF should only list the CPI and PI
- Sites and PIs: sites and PIs must be listed consistently in the submission checklist, project registration and HREA
- HREC submission checklist: must be uploaded with the correct information:
- Documents uploaded in REGIS must be listed in the submission checklist
- The version number and date recorded in the footer of each document matches those recorded in the submission checklist
- Sponsored study & International study
- Waiver of Consent application form: a Western Sydney LHD Waiver of Consent Application must be submitted.
- The WSLHD research complaints contact document (PDF 207.33KB) is required as part of your Ethics and Governance submission.
All successful submissions must meet the following criteria:
- Cover letter – RGO submission cover letter
- Staff link numbers for all investigators
- Fee form - this includes cost codes
- PICFs correctly tracked from the HREC approved master – including correct referencing to the master in the footer
- PICFs must have the correct complaints contacts
- Clinical contact must be the Principal Investigator
- The WSLHD research complaints contact document (PDF 207.33KB) is required as part of your Ethics and Governance submission.
Ethics and Governance documents
- Catholic standard wording pregnancy and contraception (DOC 32.5KB)
- CTIG informed user guide 2026 (PDF 822.68KB)
- Informed consent master template (DOCX 90.4KB)
- Informed consent site template 2025 (DOCX 276.9KB)
- Lay language alternative terms (PDF 117.69KB)
- Person responsible participant information and consent form (DOCX 17.55KB)
- Waiver of consent application form July 2025 (DOCX 28.91KB)
- WSLHD human research ethics committee pregnant partner release of information form 2021 (DOC 182KB)
- WSLHD online survey landing page implied consent (DOCX 61.79KB)
- WSLHD oral consent 2020 (PDF 415.27KB)
- WSLHD standard wording tissue bank participant information and consent form (DOC 182.5KB)
- WSLHD withdrawal of consent master template (DOCX 19.14KB)
- Documents required for HREC submission (DOCX 575.95KB)
- HREC position document 2024 (DOCX 173.99KB)
- Statement on consumer and community involvement in health and medical research
- WSLHD Human Research Ethics Committee members for 2026 (DOCX 163.2KB)
- WSLHD human research ethics committee terms of reference (DOCX 181.75KB)
REGIS
Research Ethics and Governance Information System (REGIS) is the portal used to manage all ethics and site governance approvals of human research projects in NSW, TAS, ACT Public Health Organisations (PHOs), Allied Health Organisations (AHOs) and local health districts (LHDs)
Researchers can submit and track the progress and status of their ethics and governance applications.
The first step in the process is to register your application in REGIS; you will find helpful information and guides in REGIS.
Human Research Ethics Committee meeting dates 2026
WSLHD HREC TOR December 2023 (PDF 243.14KB)
WSLHD HREC SOP December 2023 (PDF 425.25KB)
Human Research Ethics Sub-Committee meeting dates
The HREC Sub-Committee meeting dates are published to support submission of amendment request to ethically approved studies. Public schedules help researchers, industry groups, and the community plan and participate in consultations.
HREC Sub-Committee Submission and Meeting Dates 2026 (PDF 204.8KB)
Research Policy – Complaints and Breaches
There is a WSLHD policy, The Responsible Conduct of Research - WSLHD and an accompanying procedure Managing and Investigating Potential Breaches to the WSLHD Policy for Responsible Conduct of Research . (PDF 612.96KB)These are applicable to all research carried out in and on WSLHD facilities. See the Advisers of Research Integrity page for names and details. Follow the links here or use the WSLHD Policies and Procedures link above.
Prof Mark McLean
Executive Director of Research | Western Sydney Local Health District
Conjoint Professor of Medicine – Western Sydney University
Honorary Professor – Faculty of Medicine and Health, University of Sydney
Consultant Endocrinologist, Westmead and Blacktown Hospitals
Prof Anthony Harris
Professor of Psychiatry, Westmead Clinical School
Clinical Director, Brain Dynamics Centre, The Westmead Institute for Medical Research
Consultant psychiatrist, Prevention Early Intervention and Recovery Service (PEIRS), Western Sydney Local Health District
Prof Jennifer Gunton
Professor Jenny Gunton heads the Centre for Diabetes, Obesity and Endocrinology Research (CDOER) and Westmead Institute for Medical Research (WIMR).
Chair of Medicine at Westmead Hospital
Clinical endocrinologist / diabetologist, Westmead Hospital.