In addition to ethical and scientific review, any human research conducted within, or requiring support from, NSW Health Organisations, such as access to participants, tissue or data, must be reviewed and authorised by the organisation’s Chief Executive (or their delegate) before it begins. Projects cannot commence until written notification of this authorisation has been received.
Site authorisation enables NSW 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 (SSA)
- Access request review via the NSW Health Access Request Form
For more detailed information regarding each pathway please refer to the NSW Health Research Handbook. Site authorisation must be sought and conducted in accordance with the Research – Authorisation to Commence Human Research in NSW Public Health Organisations policy directive.
Site authorisation assessment and Human Research Ethics Committee (HREC) ethical and scientific review may proceed in parallel; however, a NSW Health Organisation can only decide to authorise a research project once HREC approval has been granted and the SSA or access request has been satisfactorily completed.
Enquiries or advice about applications for site authorisation 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 Instructions on how to complete the Research Ethics and Governance Information System (REGIS) SSA, please see the Quick Reference Guide: Completing a Site Specific Assessment.
Use the Project registration roadmap as a guide to applying for ethics approval and/or site-specific authorisation in REGIS.
Research agreements, insurance and indemnity requirements
For further information regarding clinical trial research agreements, the National Clinical Trial Agreement (NaCTA) Panel, insurance and indemnity requirements please refer to the NSW Health Research Handbook.
Frequently asked questions
Site specific assessment (SSA) authorisation is only required for NSW PHOs. It is up to each private institution to determine how it authorises research conducted at its facilities.
There are two site authorisation pathways in NSW, depending on the research activities:
SSA application
Required for sites under the control of a NSW Health Organisation, if the project involves:
- enrolling participants (e.g. obtaining informed consent, screening)
- carrying out protocol-specific research procedures with or on participants
- managing and analysing data, tissue, and survey and questionnaire responses collected for or from research.
Access Request
Required if your project requires support from a NSW Health Organisation in the form of access to participants, tissue, or data but does not involve conducting research at that NSW Health Organisation is not required to undergo the SSA application process. An Access Request must be submitted to the NSW Health Organisation for review before authorisation can be granted by the Chief Executive or their delegate.
Research projects suitable for review via an Access Request include projects that involves:
- participant recruitment through posters, leaflets and letter of invitation but not recruitment through direct contact with potential participants or enrolment
- distribution of surveys and questionnaires through NSW Health Organisation staff but not collation and analysis of responses at the NSW Health Organisation, and
- access to data or tissue held at the NSW Health Organisation (but not processing or analysis at that NSW Health Organisation).
To determine the most appropriate pathway, refer to the NSW Health Access Request decision tree.
No. The HREC does not review SSA applications or Access Requests. The Research Governance Officer undertakes these reviews.
The ethics application form enables HRECs to consider whether the research project is ethically and scientifically acceptable, and meets requirements of the NHMRC National Statement on Ethical Conduct in Human Research.
The SSA application form allows NSW Health Organisations to gather information about the research project, to determine if the research meets its governance requirements.
These requirements are additional to the ethical and scientific acceptability and include consideration of matters including resources (financial, in-kind and equipment/infrastructure), staff involvement, head of department support, and contract, insurance and indemnity requirements.
Some aspects of research need ethical, scientific and governance considerations (for example, investigator’s skills, training and experience, and resources (financial, infrastructure, equipment, conflict of interest). For this reason, there is some duplication between the two forms.
Yes. Contact the individuals that must provide declarations of support (e.g. Heads of Department), and start preparing an SSA application in REGIS as early as possible. It is not necessary to wait for the outcome of HREC approval before preparing and submitting an SSA application. For clinical trials, you can submit insurance, indemnity arrangements and a copy of the Clinical Trial Research Agreement to the Research Governance Officer before making a full SSA application.
HREC and SSA review may occur in parallel, however research can only start at the site once HREC approval and the SSA authorisation are both granted.
For REGIS SSA guidance, see the Quick Reference Guide: Completing a Site Specific Assessment.
If the HREC is external to NSW, you must upload the approval and Human Research Ethics Application with the approved documents to REGIS. This is in addition to uploading all other site-specific documents required for the SSA application.
If the HREC is within REGIS (NSW), the approval and related approved documents will be made visible to the Research Governance Officer in REGIS so there is no requirement for you to upload (unless specifically requested).
Legal Services Panel
The NSW Government has established a Legal Services Panel which offers a range of legal services and expertise to meet the external legal needs of NSW Government agencies.
NSW PHOs may engage the Panel for advice on all legal matters, which may include Clinical Trial Research Agreements and research governance matters. The Panel rules require staff to approach their in-house legal team to obtain legal services as only legal staff are permitted to obtain external legal services on behalf of their Agency (subject to any specific rules established by individual local health district).
Contact information is available via info.buy.nsw.gov.au. Go to ‘Information for buyers’ then ‘How to buy from this scheme’ and follow the instructions to complete the Legal Services Order Form.