Ethics & Governance Framework

All human research that takes place in NSW public health organisations (PHOs) and Specialty HealthNetworks (SHNs) must be ethically and scientifically reviewed and approved by a Human Research Ethics Committee (HREC) in accordance with the National Health Medical Research Council National Statement on Ethical Conduct in Human Research (2007), and the Policy Directive Research – Ethical & Scientific Review of Human Research in NSW Public Health Organisations.
This includes but is not limited to clinical research, clinical trials, epidemiological research, health services research, population health research, and qualitative research.

NSW supports single ethical review for studies taking place in more than one NSW PHO/SHN. NSW is also part of the National Mutual Acceptance scheme, where research taking place in public health organisations in more than one participating Australian jurisdiction needs only one* ethical and scientific review. Some exemptions apply and are available on the National Mutual Acceptance page.

For more information, visit the Ethical & Scientific page.

In addition to ethical and scientific review, all human research that takes place in NSW public health organisations, or that requires support from a NSW public health organisation in the form of access to participants, tissue or data, must be reviewed and authorised by the organisation’s Chief Executive, or their delegate before commencement. The projects must not commence until the applicant has received written notification of documented authorisation.

Site authorisation enables NSW public health organisations 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 the organisation, and/or whether the provision of access to participants, their tissue and/or data should be supported
be aware of all research taking place at sites under their control.

There are two pathways to site authorisation in NSW, depending on the research activities:
Site Specific Assessment
Access Request review
Site authorisation must be sought and conducted in accordance with Policy Directive Research – Authorisation to Commence Human Research in NSW Public Health Organisations.
Enquiries or advice about applications for site authorisation (i.e. site specific assessments and access requests) should be directed to the relevant Research Governance Officer. The NSW Research Governance Officers directory lists contact details and facility information including locations and services covered.

For more information, visit the Site Authorisation & Access Request page.

Australian state and territory health departments have signed a Memorandum of Understanding for the mutual acceptance of ethical and scientific review of multi-centre human research projects undertaken in public health organisations.

The scope of National Mutual Acceptance (NMA) includes any form of human research as defined in the latest version of the National Statement on Ethical Conduct in Human Research (National Health and Medical Research Council) for which an application must be made to a Human Research Ethics Committee for the purpose of being conducted at a public health organisation.

For more information, visit the National Mutual Acceptance page.

The Research Ethics and Governance Information System (REGIS) supports ethics and governance management of human research projects across multiple jurisdictions.

REGIS is a joint initiative between eHealth and the Office for Health and Medical Research. REGIS is used for

• Single site & multi-centered research projects & approvals
• Projects that fall under National Mutual Acceptance (NMA) guidelines.
• Managing Ethics Approvals & HREC Meetings
• Post Approval Activities

For more information, visit the REGIS page.