Fees Policy for the Review of Research Ethics and Governance Applications
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Fees Policy for the Review of Research Ethics and Governance Applications - uniform fee structure for research ethics and governance review
Research governance broadly addresses the quality, safety, privacy and confidentiality, risk management, financial management and ethical acceptability of research.
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.
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:
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.
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:
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).
SA Health should not enter into any agreements requiring SA Health to ensure that its employees personally enter into agreements with any third parties. Moreover, SA Health should not direct its employees to enter into any agreements personally with any third parties.
Only SA Health should enter into the relevant agreement with a third party in relation to any project (i.e. such as a CTRA / CIRA). Under such an agreement, SA Health can accept liability for the actions of its employees which cause any breach of the terms of the agreement. SA Health should make certain that it has processes in place to ensure that its employees comply with the relevant terms of the agreement, which may include making the employees aware of the terms of the agreement and directing them to comply with those terms.