Research governance

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

Site specific assessment (SSA)

The submission of a Site Specific Assessment (SSA) form is a requirement for all ethically approved research being undertaken across the South Australian public health system. The SSA provides information to the relevant site/s to allow them to assess the governance requirements of each research project.

Research GEMS

For all greater than low risk studies, the SSA must be completed using the online system Research GEMS.

To enable the Research Governance Officer to assess whether the research project can be granted site authorisation, the following documents are required:

Site Specific Assessment form
HREC approved study protocol and human research ethics application form
Confirmation of ethics approval from a SA Health HREC or certified National Mutual Acceptance HREC
Participant Information Sheet and Consent Form (both master and site-specific versions) (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
for clinical trials, certificates of Good Clinical Practice for research team members
CV’s for the site Principal Investigator and any relevant research members (see each LHN website for specific details)

SSAs for low risk projects

The application procedure for low risk SSAs differs for each research office and may be external to Research GEMS. Review the Flowchart for SA Health ethics applications risk pathways (PDF 31KB) and contact the relevant research office before commencing the application.

Insurance

All research projects and clinical trials must be adequately insured and indemnified prior to their commencement at a SA public health organisation. Further information regarding indemnity and insurance requirements applicable to research studies involving SA Health can be found in the Guidance for Indemnity Insurance for Research Trials (PDF 109KB).

Pre-screening and screening research participants

There are several steps involved in participant recruitment into health and medical research, including clinical trials. These can be summarised into developing a recruitment plan or strategies that cover the entire recruitment period. This process includes pre-screening and screening the participant to ensure that they meet the inclusion and exclusion criteria mapped out in the approved research protocol.

When conducting health and medical research, including clinical trials within SA Health in accordance with section s93(3)(f) of the Health Care Act 2008, investigators and research teams cannot commence pre-screening and screening until the protocol has both ethical approval and governance authorisation, including head of department endorsement.

These records are referred to as a participant screening log and participant enrolment log respectively.

Good Clinical Practice (GCP) for clinical trials requires these records are kept for every participant that undergoes pre-trial screening and enrolment.

Research Agreements — Third Party Advice

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.

SA Health Research Governance Policy

The SA Health Research Ethics and Governance Policy 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.