The Children’s Health Queensland research directorate is responsible for managing and facilitating the ethical and governance review processes for all research conducted on, or by the Children’s Health Queensland Hospital and Health Service. This involves coordinating scientific and ethical reviews of research. The directorate also oversees research governance, including monitoring and the management of legislative and regulatory requirements, policy development, and the provision of researcher support, advice, and risk management.
All Children’s Health Queensland research must receive both ethical approval by a certified Human Research Ethics Committee (HREC), and governance authorisation by the Research Directorate before the project can commence. The parallel submission of Ethics and Governance applications is strongly recommended where possible (as per Queensland Health’s Research Management Policy).
Ethics and governance applications
All ethics and governance applications in Queensland, Victoria and Mater Health are to be created and submitted via the ERM (Ethical Review Manager) website. This system captures Human Research Ethics Committee (HREC) and site-specific assessment (SSA) applications and enables post-approval submissions.
The former ethics and governance application site, Online Forms, is no longer available to new submissions.
Good Clinical Practice training
Good Clinical Practice (GCP) is an internationally accepted standard for the design, conduct, record-keeping and reporting of clinical trials. The Children’s Health Queensland research directorate offers GCP training at no cost to Children’s Health Queensland Hospital and Health Service employees.
National Clinical Trials Governance Framework
Individuals engaged in clinical trials require GCP certification. This is to ensure they are working to international best practice, and in compliance with the upcoming National Clinical Trials Governance Framework (anticipated to take effect by January 2022).
The training is delivered face-to-face and allows for communication, interaction and questions.
Two courses are available:
- Introduction to GCP (Four hours): For staff new to clinical trials or who have not completed comprehensive training
- Refresher GCP (Two hours): For those who have previously obtained GCP certification (required every three years).
This training meets the minimum criteria for ICH E6 GCP Training identified by TransCelerate BioPharma as necessary to enable mutual recognition of GCP training among trial sponsors.
For registration enquiries, please contact CHQ_ResearchEducation@health.qld.gov.au or phone 07 3069 7230.