National Statement Reference Guide
DOCX 67 KB
The National Statement Reference Guide is for use by researchers when preparing or amending an ethics submission.
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 (2007, updated 2018) ‘National Statement’, Australian Code for the Responsible Conduct of Research and SA Health's Code of Fair Information Practice.
All research ethics applications must be submitted through the Research GEMS online system.
Research GEMS allows researchers to:
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.
When submitting an ethics application to the DHW HREC, please use the submission checklist (PDF 374KB) to ensure all relevant documents are attached to the application in Research GEMS.
Every research ethics application must have a separate study protocol (DOCX 418KB).
It is a requirement of the SA Health HREC that each ethics application undergoes 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.
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 submitted by the 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.
Applicants who are seeking to access SA Health data held by SA NT DataLink should consult with the SA Department for Health and Wellbeing HREC to determine the appropriate ethical review pathway. Applications submitted to the DHW HREC must be accompanied by the SA NT DataLink Letter of Feasibility.
All applicants must ensure they address the conditions for a Waiver of Consent listed above. Where applicable, applicants must also address the matters listed for consideration in paragraph D.5 of the Guidelines Approved under Section 95A of the Privacy Act 1988, 2001; or, the matters listed for consideration in paragraph 3.3 of the Guidelines under Section 95 of the Privacy Act 1988, 2000.
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.
For further information relating to the DHW HREC, contact:
HREC Executive Officer
Office for Research
PO Box 287
Rundle Mall SA 5000
Telephone: (08) 8226 8102