Research at the WCHN

Human Research

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 research 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 Clinical Trials Group (DTCCTG). 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 research audit, approval must be obtained from the WCHN HREC. In addition, research governance approval is required for all research projects before they may commence. It is highly recommended that the Site Specific Assessment (SSA) application for research governance is submitted concurrently with the HREC application to avoid any delays in project commencement.

The WCHN Human Research Ethics and Research Governance Standard Operating Procedures (SOPs) have been developed for research ethics and research governance matters. They apply to WCHN researchers, external researchers (including students) who are undertaking research at a WCHN site, WCHN research ethics committee members and other staff involved in the conduct and oversight of health and medical research at WCHN. The SOPS take into account the regulations, legislation, ethical and governance principles and guidelines for the responsible conduct of research.

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 2020 Timelines and Meeting Dates
2. HREC Submission of Documentation
3. Human Research Ethics Application (HREA) submissions - both full application and Low Negligible Risk (LNR) submissions.
4. Multi-centre research: HREA and single ethical review
5. Protocol Amendments
6. Audit submissions
7. Case Studies
8. Complaints/concerns
9. Alternate Contact Form / Information sheet
10. Contact WCHN HREC
11. HREC and related forms/documents/policies

The Human Research Ethics Application (HREA)

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

The Human Research Ethics Application was launched on Online Forms on 31 August 2017.

All existing NEAFs remain saved in Online Forms.

The HREA is to be used for Full applications and Low and Negligible Risk (LNR) applications to the WCHN HREC.

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

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. Please note that, whilst the fact sheet advises the SA Low and Negligible Risk (LNR) application form may be used, in keeping with SA Health guidance, the HREA should be used.  The HREA is designed for the use of both LNR and full applications; questions and fields open or close in accordance with researchers' responses to questions.

Any queries can be discussed with the Executive Officer and/or Chair of the WCHN HREC - Refer to contact details on the Research Secretariat page.

last modified: 03 Sep 2020

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