Research at the WCHN

Human Research Ethics

The Women's and Children's Health Network (WCHN) Human Research Ethics Committee's (HREC) responsibilities are outlined in its Terms of Reference. The HREC has responsibility to review, and where appropriate, approve research or audit projects involving patients, patients’ families, patient tissue, patient information, and/or WCHN staff.

Protocols involving a drug or therapeutic substance are also reviewed by the Drug and Therapeutics (DTC) Clinical Trials Group (CTG). The DTCCTG is an advisory and recommending body to the WCHN HREC. Its responsibilities are outlined in its Terms of Reference.

Before commencing a research project or audit, approval must be obtained from the WCHN HREC. In addition, research governance approval is required for all research projects before they may commence.

The WCHN HREC is a NHMRC certified Committee that operates in accordance with the principles set out in the National Statement on Ethical Conduct in Human Research. The National Statement is produced by the National Health and Medical Research Council (NHMRC); for more information on the NHMRC visit their website at http://www.nhmrc.gov.au.

For more information regarding submissions to the WCHN HREC see the relevant link below:

1. HREC and DTC CTG 2018 Timelines and Meeting Dates
2. HREC Submission of Documentation
3. National Ethics Application form (NEAF) submissions
4. Low and Negligible Risk (LNR) submissions
5. Multi-centre research: NEAF and LNR submissions – single ethical review
6. Protocol Amendments
7. Audit submissions
8. Complaints/concerns
9. Alternate Contact Form / Information sheet
10. Contact WCHN HREC
11. HREC and related forms/documents/policies

NEAF and the transition to the HREA

As part of the initiative to streamline ethics approval, NHMRC has developed the Human Research Ethics Application (HREA) as a replacement for the National Ethics Application Form (NEAF).

The date of transition is now confirmed - the Human Research Ethics Application (HREA) will launch on Online Forms on 31 August 2017.

SA Health have indicated the HREA will be live as of 1 September 2017. After that date, you can create a HREA and can no longer create a new NEAF.

Existing NEAFs are not affected. Any NEAF that is already in the Online Forms system can be completed, submitted and processed. All existing NEAFs remain saved in Online Forms.

Site Specific Assessment (SSA) forms for research governance are not affected.

SA Health has prepared a fact sheet that provides further information on the implementation of the HREA across SA Health. Please read this important document before using the HREA for the first time.

Any queries can be discussed with the Executive Officer and/or Chair of the WCHN HREC.

The WCHN Research Secretariat will try to assist you with any queries, but note that the HREA is new to us too, so we may not have all the answers immediately.

last modified: 23 Nov 2017

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