FAQ: Site Specific Assessment (SSA)
What is a site?When is an SSA required?
Is an SSA required for private facilities?
Can a research project begin without an SSA?
Why is it necessary to complete the SSA Form in addition to the ethics application?
Why is there some duplication between the SSA Form and the NEAF?
Who is responsible for completing and submitting the SSA Form?
How do I complete the SSA Form?
Can I submit the SSA Form at the same time as I submit my ethics application?
I’ve received an approval letter from the lead HREC, what do I do now?
How do I know who the Research Governance Officer is for this site?
Is the SSA Form reviewed by the local HREC?
Can the Research Governance Officer request changes to the research project?
Can sites make changes to the Participant Information Sheet and Informed Consent documents?
How do I add a site once the application has been reviewed/approved?
How do I make changes to the SSA Form once it’s locked?
Is there an appeal mechanism if the SSA is not approved?
Where can I get more information/advice?
What is a site?
The location/s at which study-related activities are conducted. This may be a single public hospital, a collection of public hospitals within a defined area, or an entire area health service. It is a matter for each public health organisation to determine the sites within its jurisdiction which require separate site specific assessment of research projects. Investigators should check with the public health organisation to ascertain whether the site/s at which they propose to conduct the research necessitate separate site-specific assessments.
When is an SSA required?
An SSA must be completed for all human research projects conducted at sites within the NSW public health system, even ones involving low risk such as medical record requests.
An SSA is required when study related activities involve the use of the staff, resources or patients of an entity/institution under the control of a public health organisation within NSW and must be conducted regardless of whether the research is 'single-site' or 'multi-centre'.
Is an SSA required for private facilities?
The system for single ethical and scientific review of multi-centre research, including the requirement that all research projects undergo a site-specific assessment, applies to the NSW public health system only. It is entirely a matter for the private institution to determine the mechanism it will use for authorising the conduct of research within its facilities.
Can a research project begin without an SSA?
No. A research project cannot commence at a site until written authorisation has been received from the Chief Executive or their delegate. Authorisation to commence the research project will only be granted when a site-specific assessment has been completed and the reviewing HREC has granted ethical approval. Chief Executives and their delegates retain the right to not authorise the commencement of research projects within their sites, even if the HREC has granted ethical approval.
Why is it necessary to complete the SSA Form in addition to the ethics application?
The purpose of the ethics application form/NEAF is to enable the HREC to consider whether the research project is ethically and scientifically acceptable, and whether it meets the requirements of the NHMRC National Statement on Ethical Conduct in Human Research (2007). The purpose of the SSA Form is to allow the 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 separate to the ethical and scientific acceptability of research and include consideration of whether: the facilities and resources required for the research to be conducted at the site have been identified, are appropriate and available; the researchers involved in the project at the site have the requisite skills, experience, training and expertise; and whether, in all the circumstances, the public health organisation wishes the research to be conducted at a site under its control. It is necessary for the researcher to complete a separate SSA Form, in addition to the ethics application, as only the public health organisation has responsibility for considering matters of research governance (not the HREC).
Why is there some duplication between the SSA Form and the NEAF?
Some aspects of research governance may involve ethical considerations (for example, consideration as to whether a particular participant group at a site is being unfairly burdened with participation in research). For this reason, there are some questions in the SSA Form which are similar to questions asked in the NEAF. Wherever possible, the online forms website enables the answers supplied in the NEAF to be automatically populated in the SSA Form.
Who is responsible for completing and submitting the SSA Form?
Applications for site-specific assessment should be made by the principal investigator responsible for the research project at the site. For multi-centre research projects where there is not a local principal investigator, the SSA form may be completed and submitted by the co-ordinating investigator.
How do I complete the SSA Form?
For multi-centre research projects, the application must be completed electronically via the online forms website at: http://www.ethicsform.org/au This allows the SSA Form to be automatically populated with information from the NEAF. Using the online forms website also allows you to monitor the status of the application.
When the NEAF is not used, a hard copy of the form can be completed. This can be found within the NSW Health policy 'Authorisation of proposals to conduct research on humans within NSW public health system', which can be accessed at: www.health.nsw.gov.au/policies/pd/2007/pdf/PD2007_043.pdf
Can I submit the SSA Form at the same time as I submit my ethics application?
Yes. The SSA Form can be submitted at the same time as an ethics application, or it can be submitted at a later time (for example, if a new site is added some time after the project has received HREC approval). However, both the HREC 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 lead HREC, what do I do now?
Submit a copy to the relevant Research Governance Officer. The Research Governance Officer will attach this to the SSA Form and submit the form 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?
The name of the Research Governance Officer to whom you should submit your SSA Form, will be available from the public health organisation (generally, this information will be available from the Research Office). Details of all Research Governance Officers are also available on the NSW Department of Health website at: