SA Department for Health and Wellbeing Human Research Ethics Committee

The SA Department for Health and Wellbeing Human Research Ethics Committee (DHW HREC) receives and examines research and evaluation proposals initiated or conducted by SA Health staff and/or external researchers seeking access to SA Health data and/or clients. Proposals are assessed in accordance with the National Statement on Ethical Conduct in Human Research 2023, Australian Code for the Responsible Conduct of Research and SA Health's Code of Fair Information Practice.

Submitting an application to the DHW HREC

Before beginning an ethics application, review the DHW HREC application process flowchart (PDF 155KB) for summary steps and tips to better understand the application process. Also consider the level of risk involved for the research project. 

All research ethics applications must be submitted through the Research GEMS online system. 

Refer to the DHW HREC submission checklist (PDF 374KB) to ensure all relevant documents are attached to the application in Research GEMS. Mandatory documents include:

The DHW HREC is committed to reducing duplication between the protocol and the national Human Research Ethics Application (which is completed in Research GEMS). Please include all project details within the protocol, and when completing the HREA online, respond with ‘Refer to section xxx in the protocol’.

Research GEMS

All research ethics applications must be submitted through the Research GEMS online system.

Research GEMS allows researchers to:

  • complete and submit the project registration, Human Research Ethics Application (HREA) and Site Specific Assessment forms, concurrently
  • monitor approval progress of the research project
  • Submit post-approval monitoring information to the relevant research office, including milestone reports, amendments (including project extensions), adverse event reports and protocol deviations.

Once submitted, the system will automatically notify the relevant research office that the submission is available for review. For more information on the DHW Site Specific Assessments, see the Research Governance page.

Peer review

The DHW HREC recommends that research ethics applications undergo a peer review process by a person independent of the project team, in accordance with the expectations outlined in the Australian Code for Responsible Research Conduct. Details of this review should be outlined in the ethics application form and a copy of the peer review report provided as an attachment to the application. Please note that the HREC reserves the right to require a peer review as part of its review process.

Notification of a study-related adverse event

It is a condition of approval that the DHW HREC must be advised of any serious or unexpected adverse events that take place while a participant is taking part in a study. Where possible an adverse event should be reported by investigators via the forms function in the Research GEMS online system.  However, if the person reporting an adverse event does not have access to GEMS,  then completing and submitting a Notification of a study-related adverse event form will notify the DHW HREC Executive Officer. Adverse events should be reported to the DHW HREC and copied to the local Research Governance Officers within 72 hours of the event occurring.

Ethical exemptions

As stated in the National Statement, some research may be eligible for exemption from ethics review. If a study satisfies the criteria within the Exemption checklist and request process, complete the form and email it to the HREC Executive Officer. 

Quality assurance and evaluation activities

Quality assurance and evaluation activities are important in making better outcomes and more efficient and effective work processes for an individual or an organisation. The DHW HREC can review quality assurance projects and assess if ethical exemption is required. The committee is guided by the NHMRC’s Ethical Considerations in Quality Assurance and Evaluation Activities guidelines. Contact the Executive Officer for more information.

Contact

For further information relating to the DHW HREC, contact:

HREC Executive Officer
Office for Research
SA Health
PO Box 287
Rundle Mall SA 5000
Telephone: (08) 7117 6635
Email: HealthHumanResearchEthicsCommittee@sa.gov.au