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Research Governance Process for Hunter New England Health
Hunter New England Human Research Ethics Rural Research Methods Support Group Clinical Trials Subcommittee Application Forms Newsletters Research Governance Contacts
Under the NSW Health model for single ethical and scientific review, public health organisations (that is, hospitals and area health services) will retain responsibility for authorising the commencement of research to be undertaken within their institutions. As such, public health organisations will be required to undertake a site-specific assessment (SSA) of each research project, thereby allowing the organisation to consider whether it has the capacity to conduct the research at that site. This SSA will involve consideration of such matters as resources, staff, patient availability etc but does not constitute another ethics review. The SSA and HREC ethical review may occur in parallel. However, the decision to authorise or not authorise the commencement of a research project will only be made by the public health organisation when the lead HREC has granted approval and the SSA has been satisfactorily completed
What is involved in the Site Specific Assessment
The SSA involves the Research Governance Officer for the PHO reviewing a Site Specific Assessment (SSA) form and making a recommendation to the Chief Executive or delegate concerning the commencement of that project.
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; whether 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 application submitted to the HREC, as only the Public Health Organisation has responsibility for considering matters of research governance (not the HREC). For multi-centre research, the SSA Form should be completed by the principal investigator at each site. It should be remembered that the information requested on the Site Specific Assessment form was previously requested on the previous version of Hunter New England Human Research Ethics Committee form and so no additional information is being requested.
The SSA form should be completed online via http://www.ethicsform.org/au for multi-centre research as this version of the form interfaces with the Research Ethics Database (AU RED) which is a web-based research tracking and management mechanism that will underpin the new system. For single-site research where the ethics application has not been submitted on the NEAF, the SSA form may be downloaded from the forms page below.
Who is the Research Governance Officer for Hunter New England Health
Dr Nicole Gerrand is now the Research Governance Officer, as well as the Professional Officer (Research Ethics), for Hunter New England Health.
NSW POLICY DIRECTIVES
Authorisation of proposals to conduct research on humans within the NSW public health system (pdf)
Includes the Site Specific Assessment (SSA) Form & Guidance document for completing SSA Form
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