Women's and Children's Hospital, Adelaide

Research at the WCHN

Human Research

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 specific GEMS user guide is still under development, however, there are some modules available on the SA Health website. If these are not sufficient, please check the guides provided for the NSW REGIS system on their webpage.

All new HREC and/or SSA applications must now be submitted via the Research GEMS.

Researchers who have an active research project within SA Health will have had their project migrated into GEMS and should have received a welcome email. If you are the coordinator or contact for the project and you cannot see your active projects once you log in, please check whether the projects are visible under the log-in of the PI. If projects are visible under PI log-in, then the PI can share or transfer the projects to other personnel. If no projects are visible, then please let us know as there will have been an issue with the data migration. Please note, as part of data migration, only the meta-data of the project will have been migrated. Documents which were uploaded into OnLine Forms were not migrated, but if you need copies, we may be able to scan them from the Research Secretariat files.
Additional functionality such as low and negligible risk (LNR) applications will be delivered as part of Phase 2, anticipated to be released in June 2021. Continue to apply for LNR studies as per instructions on our webpage.
Documents related to Ethics and Governance approvals 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.

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. 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.