Research governance

Research governance broadly addresses the quality, safety, privacy and confidentiality, risk management, financial management and ethical acceptability of research.

SA Health Research Governance Policy

The SA Health Research Governance Policy (PDF 111KB) outlines the research governance requirements that apply to researchers and institutions involved in the conduct and administration of health and medical research across the South Australian public health system.

Research governance compliance

The research governance requirements outlined in the Research Governance Policy are applicable to all Local Health Networks, Statewide Services and the SA Department for Health and Wellbeing, encompassing the following:

  • regional health services
  • hospitals
  • community health services
  • public health clinics
  • SA Health researchers
  • external researchers who are undertaking approved research activity within the South Australian public health system.

Site Specific Assessment

A Site Specific Assessment (SSA) supports the research governance process by enabling the institution to consider key areas relevant to the governance of the research. 

The submission of a Site Specific Assessment form is a requirement for all ethically approved research being undertaken across the South Australian public health system.

The Site Specific Assessment must be completed online using the Research GEMS system. The appropriate Research Governance Officer will be notified automatically once it is submitted.

Insurance

All research projects and clinical trials must be adequately insured and indemnified prior to their commencement at a SA public health organisation.

To enable the SA public health organisation to assess whether the insurance and indemnification arrangements are satisfactory for a proposed research project or clinical trial, the Principal Investigator must contact the SA Health Research Governance Office/r responsible for the site/s where the research is to be conducted and provide them with the following documents as part of the Site Specific Assessment (SSA) submission:

  • Confirmation of Ethics Approval from a SA Health or certified NMA HREC.
  • A completed Site Specific Assessment form, including relevant attachments, and (where requested) the HREC approved ethics application form.
  • Participant Information Sheet and Consent Form (if applicable).
  • For investigator-driven research involving external organisations (e.g. universities or research institutes), proof of indemnity, including current certificates of insurance (if applicable).
  • For sponsored research, including clinical trials, Third Party Sponsor insurance Certificate of Currency (if applicable).
  • For clinical trials, the Medicines Australia Form of Indemnity – Standard, completed and signed by the Sponsor, appropriately identifying the public health organisation/trial site.

Further information regarding indemnity and insurance requirements applicable to research studies involving SA Health can be found in the following Guidance for Indemnity Insurance for Research Trials (PDF 109KB).

Further information

For further information on the governance process, please refer to the SA Health Research Governance Policy (PDF 111KB) or contact the relevant Research Governance Officer contacts (PDF 46KB).