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.