FAQ: Site Specific Assessment (SSA)
When is an SSA required? | Is an SSA required for private facilities? | Is the SSA application reviewed by the HREC? | Which application form should I complete? | Why is there some duplication between the ethics and SSA application forms? | Who should submit the application for SSA? | Who should obtain the signatures for the ‘declarations of support’ in the SSA application form? | Can I submit the SSA application form at the same time as I submit my ethics application? | I’ve received an approval letter from the HREC, what do I do now? | How do I know who the Research Governance Officer is for this site?When is an SSA required?
An SSA must be completed for all human research projects to be conducted at sites under the control of NSW Public Health Organisations, even ones involving low or negligible risk to participants. For example, SSA is required if the project involves one or more of the following activities at a site under the control of a NSW Public Health Organisation:
- Enrolling participants into research (e.g. obtaining informed consent, screening);
- Carrying out protocol-specific research procedures with or on participants; and
- Managing and analysing data, tissue and responses from surveys and questionnaires collected for or from research.
Is an SSA required for private facilities?
The requirement for site authorisation following SSA or access request review 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.
Why is it necessary to complete the SSA application form in addition to the ethics application?
The purpose of the ethics application form is to enable the HREC 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 SSA application form is to allow the NSW Public Health Organisation 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: the 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; and compliance with legislative requirements. It is necessary for the investigator to complete a separate SSA application form, in addition to the ethics application form, as they seek different information and only the Public Health Organisation has responsibility for considering matters of research governance (not the HREC).
Is the SSA application reviewed by the HREC?
No. The HREC does not see the SSA application form. The Research Governance Officer undertakes SSAs.
Which application form should I complete?
Applications for SSA must be submitted using one of the following forms:
- SSA Form; or
- SSA Form for Low and Negligible Risk Research (LNR SSA Form).
The SSA Form should be used for research projects that have been submitted for full HREC review by a NSW Health HREC. The LNR SSA Form should be used for research projects that have been submitted for expedited review by a NSW Health HREC.
A separate application must be made for each site at which the research project is to be conducted. For example, even if the project is to be conducted at two sites under the control of a single NSW Public Health Organisation, a separate application must be made for each site.
The forms must be completed online via the Online Forms Website at https://ethicsform.org/au/. The Online Forms Website provides guidance on how to complete the application forms and supporting documents required for making an application.
Why is there some duplication between the ethics and SSA 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.
Who should submit the application for SSA?
Application for SSA must be made by the Principal Investigator to the Research Governance Officer.
Who should obtain the signatures for the 'declarations of support' in the SSA application form?
The Principal Investigator is responsible for obtaining signatures from the relevant:
- heads of department (or divisional directors or other authorities) responsible for the site where the research is to be conducted;
- heads of supporting department(s); and
- nominated authorities for data provision.
Can I submit the SSA application form at the same time as I submit my ethics application?
Yes. You should contact the relevant Research Governance Officer and individuals that need to provide a declaration of support, and start to prepare an application for SSA at the earliest possible opportunity. It is not necessary to wait for the outcome of HREC approval before preparing and submitting an application for SSA. If the project is a clinical trial, you can submit documentation on insurance and indemnity arrangements and a copy of the clinical trial agreement to the Research Governance Officer ahead of making a full SSA application.
However, both HREC approval and a satisfactory SSA 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 HREC, what do I do now?
Provide a copy to the relevant Research Governance Officer. The Research Governance Officer will attach this to your SSA 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.
How do I know who the Research Governance Officer is for this site?
Contact details for Research Governance Officers and information on the facilities, locations and services covered by them are maintained on the NSW Ministry of Health website at: