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Research & Ethics: Research Governance and Site Specific Assessments

Who is a Research Governance Officer (RGO)?

The RGO Research Governance Office(r) within an institution / district is responsible for assessing the site-specific aspects of research applications, make a recommendation to the District CEO / delegate as to whether a research study should be granted authorisation at that site, and overseeing that authorised research at the site meets appropriate standards (research governance).


What is a site specific assessment (SSA)?

Site Specific Assessment is used by health service facilities within Queensland Health, to document the level of support and suitability of a research study to be conducted at a site, whether that study is multi-centre or single-site.

 An SSA is required to be submitted to every site that your research will be conducted,  it is the second step in your application and should only be submitted once you have received HREC approval.

An SSA it can take up to 25 days to process. It is best to consider this time frame when planning your study and allow enough time for the SSA process from your intended start dates, as you cannot start a project at a site without authorisation. During this time the RGO will inform the applicant if their SSA requires corrections and then if the project has been authorised or not.


SSA requirements

What is required in the SSA will vary between research projects but at a minimum the following should always been completed and included:

  • Include all attachments listed in the SSA checklist that are relevant to your project including but not limited to:
    • A copy of the HREC approval letter
    • The HREC approved research protocol
    • HREC application form (NEAF or LNR)
    • Master and Site specific patient information sheet and consent form (PICF)
  • Ensure that you have answered all questions as instructed on the SSA.
  • All investigators have signed the SSA where required.
  • A Signature has been sought from a supporting head of department that works at the site where required.
  • The budget section has been completed including in kind costs that will be provided by the site and is signed by the site's financial delegate.

For more information

A useful area of the Queensland Health website to access is the  Health and Medical Research Unit  (HMRU) which contains information about the Ethics and SSA process and other  information for Researchers and Research Sponsors. From here you can access key documents including  a link to download Researcher User Guide (RUG) which has detailed instructions on how to complete the ethics and SSA process.

You are also encouraged to contact the RGO if you need further information about the SSA. View the Research Governance Officers List for contact details.


 

This information was authored by Sarah Keating (NWHHS Librarian and  RGO), last updated 08/07/2016.