SA Health research governance

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

Site specific assessments 

In accordance with the SA Health Research Ethics and Governance Policy, the submission of a site specific assessment (SSA) application is a requirement for all ethically approved research being undertaken across the South Australian public health system including any SA Health facility, or involving SA Health resources, data, staff, patients or clients. The SSA provides information to the relevant site to allow them to assess the governance requirements of each research project. One study may involve multiple sites, and each site must receive its own SSA authorisation.

Research sites and SA Health local health networks 

Each SA Health site that is being accessed for research purposes is governed by a local health network (LHN) research office.

For a list of all Adelaide metropolitan hospitals and their corresponding LHN, see the Metropolitan Local Health Networks and Hospitals map (PDF 798KB). Please be aware the Women’s and Children’s Health Network (PDF 847KB) is non-geographical.

For a list of all regional hospitals and their corresponding LHN, see the Regional and Rural South Australia Local Health Network (LHN) Map (PDF 695KB).

SA Health research governance offices

Each LHN research office is responsible for assisting and reviewing the research projects within their jurisdictions. SA Health has research offices in the following locations:

Submitting an SSA

For all greater than low risk studies, an SSA must be completed via Research GEMS online. Low risk studies may be considered via an expedited review process, however this should be discussed with the relevant research office prior to beginning the application process.

To enable the research governance officer to assess whether the research project can be granted site authorisation, the following documents are required, at a minimum:

  • site specific assessment (SSA) form
  • confirmation of ethics approval from a SA Health HREC or certified National Mutual Acceptance HREC
  • HREC approved study protocol and Human Research Ethics Application (HREA) form 
  • participant information sheet and consent form (both master and site-specific versions) (if applicable)
  • for investigator-initiated research involving external organisations (e.g. universities or research institutes) proof of indemnity, including current certificates of insurance (if applicable)
  • CV’s for the site Principal Investigator and any relevant research members (see each LHN website for specific details).

Clinical trials require additional documents, including:

  • Medicines Australia Form of Indemnity – Standard, completed and signed by the Sponsor, appropriately identifying the public health organisation/trial site
  • certificates of Good Clinical Practice for research team members
  • for sponsored clinical trials, Third Party Sponsor insurance Certificate of Currency (if applicable).

SSAs for lower risk projects 

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

Insurance

All research projects must be adequately insured and indemnified prior to their commencement at a SA Health site. 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 Projects/Clinical Trials (PDF 109KB).

Pre-screening and screening research participants 

There are several steps involved in participant recruitment into health and medical research. 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

An investigator employed within SA Health should not personally enter into any agreement with a third party.

Only SA Health (as an entity) can enter into a relevant agreement with a third party in relation to any project (i.e. such as a CTRA/CIRA). The Principal Investigator may acknowledge, receipt, or review documents but must not personally enter into any formal agreement.

Such agreements can only be signed by an individual or delegate with appropriate authority to sign on behalf of SA Health, such as the Executive Director of Medical Services/nominated delegate within an LHN. Under such agreements, SA Health can accept liability for the actions of its employees which cause any breach of the terms of the agreement. SA Health employees must be aware of, and comply with, the relevant terms of the agreement.

Advice sought from the Crown Solicitor’s Office states that SA Health should not enter into any agreement requiring its employees to personally enter into agreements with third parties, nor should it direct its employees to enter into any such personal agreements. Examples of such agreements include FDA1572-like forms, financial disclosure documents and other investigator agreements.

Investigators can consider alternative approaches instead of personally entering into an agreement with a third party:

  1. The wording in the document should be amended in such a way that does not seemingly bind the Principal Investigator. The advice of legal services may need to be sought in such instances to ensure the document and any agreements entered into is in line with SA Health policy.
  2. The document may be signed by an individual or delegate with appropriate authority to sign on behalf of SA Health and acknowledged by the Principal Investigator.

Please also note that any changes to the standard agreement template will need to be reviewed by a SA Health legal representative prior to signing.