Research GEMS – Now Live
The WCHN Research Secretariat is now accepting new applications for ethics and site assessments through Research GEMS. Please note the following:
A handful of guides are available through the SA Health website. As some GEMS user guides are still under development, the guides available for the NSW REGIS system are compatible and are good source for instructions as well. These guides can be accessed via the REGIS webpage.
All new HREC and/or SSA applications must now be submitted via the Research GEMS.
Documents related to previously approved/authorised studies including amendments, annual reports, deviations, SAEs etc. should be submitted via Research GEMS.
Audits are still required to be submitted via email following the instructions provided on our webpage.
If you have any questions, please do not hesitate to contact our team and we will try to help where we can, but please note, we are also learning how to use the system.
The WCHN Research Secretariat Team
Research at the WCHN
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:
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: 19 Jan 2021