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 and advice
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.
Site Specific Assessment of research proposals
Site Specific Assessment is required for sites under the control of a NSW public health organisation, even if the project has low or negligible risk to participants, if the project involves one or more of the following activities:
- enrolling participants into research (e.g. obtaining informed consent, screening)
- carrying out protocol-specific research procedures with or on participants
- managing and analysing data, tissue, and responses from surveys and questionnaires collected for or from research.
Site Specific Assessment involves consideration of such matters as resources, staff, insurance and indemnity requirements etc.
The Site Specific Assessment and Human Research Ethics Committee ethical and scientific review may occur in parallel, however the decision to authorise or not authorise the commencement of a research project is only made by the public health organisation when the responsible Human Research Ethics Committee has granted approval and the Site Specific Assessment has been satisfactorily completed.
All applications for Site Specific Assessment must be made on the standard Site Specific Assessment Form in either Online Forms or REGIS (Research Ethics and Governance Information System), and submitted to the relevant Research Governance Officer within the public health organisation. Please see the REGIS website for the most up-to-date information on which sites are using REGIS versus Online Forms to accept Site Specific Assessment applications.
Applications for Site Specific Assessment must be submitted using the Site Specific Assessment Form regardless of project risk level (e.g. high, low or negligible risk research). For Instructions on how to complete the REGIS Site Specific Assessment, please see the Quick Reference Guide: Completing a Site Specific Assessment.
Application for Site Specific Assessment must be submitted by the Principal Investigator. The Principal Investigator is also responsible for obtaining signatures from the relevant:
- heads of department (or divisional directors or other authorities) to whom each investigator at the site is responsible
- heads of supporting department(s), whose departments will be involved in the research, including the nominated authorities for data provision the data custodians for a data set required to be accessed as a part of the research
- student supervisors for participating investigators.
Research governance officer checklists and review forms
The Research Governance Officer Working Party through consultations and feedback from NSW research governance officers has developed the Review Forms and Checklists. The Office for Health and Medical Research hosts these documents as a resource for both research governance officers and researchers for use during the submission and review processes.
The Review Forms were intended to facilitate research governance officers in undertaking the review of NEAF SSA and LNR SSA. They have not yet been updated to reflect the Human Research Ethics Application (HREA). The Checklists are envisioned for the use of the researchers to ensure that their submission is complete with the relevant documentation.
An Access request review is required to be completed for all human research projects that require support from a NSW public health organisation in the form of access to participants, tissue or data but do not involve the conduct of research at that public health organisation.
Access request review should be used when the project involves one or more of the following at the public health organisation:
- participant recruitment through posters, leaflets, handouts, and letter of invitation but not recruitment through direct contact with potential participants or enrolment (both of which require a Site Specific Assessment);
- distribution of surveys and questionnaires through staff of the Public Health Organisation but not collation and analysis of responses at that Public Health Organisation (which requires a Site Specific Assessment); and
- Access to data or tissue held at the Public Health Organisation but not processing or analysis at that Public Health Organisation (which requires a Site Specific Assessment).
The Research Governance Officer has the discretion to request that the application is submitted for site specific assessment if they consider that the project involves the conduct of research at a site.
Access Requests are managed external to REGIS. Requests for access request review should be made by the Coordinating Principal Investigator to the Research Governance Officer. The Coordinating Principal Investigator is also responsible for obtaining written agreement from relevant heads of the facilities, locations and services that will provide the access required.
A written request (e.g. letter, public health organisation form or NSW Health form) must be submitted requesting access to participants, tissue and/or data. In the request, the applicant should provide the following information, at a minimum:
- Project title and short title
- Relevant project identifiers
- Coordinating Principal Investigator name and contact information
- Name of study sponsor, if applicable
- Name of Human Research Ethics Committee reviewing the research project
- The resources/services being requested
- The proposed process for accessing those resources/services
- Attached letters or emails confirming the support of each facility, location or service (written evidence of support).
Only one access request per Research Governance Officer is required for each research project, even if the project requires access from a number of facilities, locations or services covered by that Research Governance Officer.
Frequently asked questions
Is a site authorisation required for private facilities?
The requirement for site authorisation applies to the NSW public health system only. It is entirely a matter for a private institution to determine the mechanism it will use for authorising the conduct of research within its facilities.
Is the Site Specific Assessment application or Access Request reviewed by the Human Research Ethics Committee?
No. The Human Research Ethics Committee does not see the Site Specific Assessment application form nor Access Requests. The Research Governance Officer undertakes these reviews.
Why is it necessary to complete the Site Specific Assessment application form in addition to the ethics application?
The purpose of the ethics application form is to enable the Human Research Ethics Committee to consider whether the research project is ethically and scientifically acceptable, and whether it meets the requirements of the National Statement on Ethical Conduct in Human Research (2007). The purpose of the Site Specific Assessment application form is to allow NSW public health organisations to elicit information about the research project, thereby enabling it to consider whether the research meets its research governance requirements.
These requirements are additional to the ethical and scientific acceptability of research and include consideration of:
- investigator’s skills, training and experience
- availability and suitability of facilities and resources for the proposed research
- funding for the project;
- insurance and indemnity arrangements
- contractual arrangements
- compliance with legislative requirements.
Why is there some duplication between the ethics and Site Specific Assessment application forms?
Some aspects of research need ethical, scientific and governance considerations (for example, investigator’s skills, training and experience). For this reason, there is some duplication between the two forms.
Can I submit the Site Specific Assessment application form at the same time as I submit my ethics application?
Yes. You should contact the relevant Research Governance Officer(s) and individuals that need to provide a declaration of support, and start to prepare an application for Site Specific Assessment at the earliest possible opportunity. It is not necessary to wait for the outcome of Human Research Ethics Committee approval before preparing and submitting an application for Site Specific Assessment. If the project is a clinical trial, you can submit documentation on insurance and indemnity arrangements and a copy of the Clinical Trial Research Agreement to the Research Governance Officer ahead of making a full Site Specific Assessment application.
However, both Human Research Ethics Committee approval and a satisfactory Site Specific Assessment are required before the Chief Executive or their delegate may grant authorisation for the research to commence at the site.
I’ve received an approval letter from the Human Research Ethics Committee, what do I do now?
Provide a copy to the relevant Research Governance Officer. The Research Governance Officer will attach this to your Site Specific Assessment application form and submit all the documentation to the Chief Executive or their delegate along with a recommendation that the research be authorised, not authorised, or that Chief Executive consideration is required.
Updated 1 year ago