Women's and Children's Hospital, Adelaide
Research Governance

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.

  • 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 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.   

Kind regards,

The WCHN Research Secretariat Team

 

Research at the WCHN

WCHN Research Governance

Before a human research project may commence at Women's and Children's Health Network (WCHN) it must undergo a Research Governance Review, also known as Site Specific Assessment (SSA). This review is in addition to the Human Research Ethics Committee (HREC) review.

The PDF iconWCHN 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 purpose of the Site Specific Assessment (SSA) form is to evaluate the assessment of the suitability of the resources at the site where the study will be conducted, and whether the site is sufficient to ensure satisfactory conduct and completion of the project. The Research Governance Officer (RGO) considers whether appropriate consultation and approval has been granted by the local decision makers (i.e. WCHN Human Research Ethics Committee and heads of affiliated departments) to permit the project to be undertaken at the site.

Applications for Research Governance Review at the WCHN must be made by completing the SSA Form found at GEMS.

The Research Governance Officer (RGO) will also require other documentation to be submitted together with the SSA for approval.  For this information, the Word iconWCHN SSA Submission Guidelines and Checklists will assist the applicant in ensuring which documents need to be provided to the RGO.

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 study can only commence once the RGO and the Executive Director, Corporate Services have signed off on the SSA, and the RGO has provided the applicant with an authorisation letter or email for the study to commence at WCHN.

SA Health Research Governance and Policy Directive and the  PDF iconWCHN 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.

For further information on the SSA submission at WCHN, or any matters related to Research Governance, please contact:

Dr Carmel Murone
Research Governance Officer
Phone (08) 8161 6688
Email:
carmel.murone@sa.gov.au

 

Research governance requirements

WCH page link iconDocument Links

 

SA Health Policies

Link iconSA Health Research Governance Policy Directive

PDF iconSA Health - SSA advice to applicants

PDF iconSA Health - Clinical Trial Agreements Policy (March 2012)

 

 

last modified: 19 Jan 2021