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SA Department for Health and Wellbeing Human Research Ethics Committee

The SA Department for Health and Wellbeing Human Research Ethics Committee (DHA 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) ‘National Statement’, Australian Code for the Responsible Conduct of Research and SA Health's Code of Fair Information Practice.

Submitting an application to the DHA HREC

The DHA HREC reviews social health, public/population health, epidemiology, data linkage and qualitative research applications.

All applications must be submitted on the Human Research Ethics Application (HREA) form through the Online Forms portal.

The application must be on the Human Research Ethics Application (HREA) Form through the Online Forms website, and include a covering letter (DOC 42KB), a separate study protocol (DOCX 261KB) and all other attachments as outlined in the Submission Checklist (PDF 583KB).

Low or Negligible Risk Applications

Applications that meet the criteria as low or negligible risk (as defined by the National Statement, Chapter 2.1) may be reviewed via an expedited process.

The HREC Chairperson will decide whether to send the application to the full committee, or through to a subcommittee for LNR review.

When seeking a LNR review, applicants must also submit LNR Assessment Form.

Amendments

Amendments to approved research proposals must be submitted to the DHA HREC with a cover letter outlining the request and updated application form clearly showing any modifications – either using tracked changes or highlighted.

The Chairperson will determine whether the amendment can be reviewed out-of-session or at the next full meeting of the HREC.

Ongoing Reporting and Monitoring

Adverse Event Reporting

Unexpected Adverse Event: an unforeseen harmful, unpleasant or undesirable response, reaction or outcome experienced by a research participant or researcher. Such incidents may include unanticipated physical, psychological, emotional, cultural, financial or legal harm.  It may also include where an unexpected event has occurred which may potentially harm participants, researchers, or the study organisation.

Serious Adverse Event: any untoward medical or psychological occurrence that results in death, is life threatening, requires inpatient hospitalisation or prolongation of existing hospitalization, or results in persistent of significant disability or incapacity.

It is a condition of approval that the DHW HREC must be notified by the investigators of any serious or unexpected adverse events that take place while a participant is taking part in a study using this form. Adverse events should be reported to the DHW HREC and copied to local Research Governance Officers within 72 hours Adverse Event Reporting Form (DOC 53KB).

Protocol Deviations

A protocol deviation is any change, divergence, or departure from the study design or procedures of a research protocol that has not been approved by the ethics committee.

It is a condition of approval that the DHW HREC must be notified by the investigators of any protocol deviations that take place as soon as possible Protocol Deviation Reporting Form (DOC 64KB).

Fees for Ethical Review

A fee structure applies within the SA public health system for the review of research ethics submissions (new applications and amendments). Not all submissions are invoiced, and applicants should review the SA Health Research Ethics and Research Governance Fees Schedule (PDF 185KB) (effective 11 December 2017).

If you are required to pay a fee for ethical review, please submit the DHA Fee for Ethical Review Form (DOC 60KB) with your submission. Please note: submissions will not be processed until the necessary fee paperwork has been received.

Peer review

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.

Data Linkage applications

Applicants who are seeking to access SA Health data held by SA NT DataLink must submit to the SA Department for Health and Wellbeing HREC. The HREA application must be accompanied by the SA NT DataLink Statistical Application Form.

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.

Contact

For further information relating to the DHA HREC, please contact:

HREC Executive Officer

Office for Research
SA Health

PO Box 287
Rundle Mall SA 5000

Telephone: (08) 8226 7235
Email: HealthHumanResearchEthicsCommittee@sa.gov.au

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