Ethics

Before starting a research project, researchers must have Ethics approval and Site Authorisation to commence the study.  For research that takes place at RBWH, most ethics approval is provided by the Human Research Ethics Committee (HREC) (EC00172), an HREC certified by the National Health and Medical Research Council (NHMRC) as one that can undertake reviews of multi-centre research. Some studies that take place at RBWH have previously ben approved by other NHMRC certified HRECs and as such do not have to be re-reviewed.

Because the ethics review processes of the HREC have been certified by NHMRC, the HREC can provide a review for multi-centre clinical trials which will be accepted by other HRECs throughout Australia that participate in the National Mutual Accreditation Scheme.

Applications to the RBWH HREC

The following applications and documents can be submitted to the HREC:

• Applications for greater than low risk research studies- these must submitted on the Human Research Ethics Application (HREA)
• Applications for low and negligible risk research studies (submitted on the HREA);
• Requests for Exemption from HREC review for Quality Assurance/Audit/ Service Evaluation projects (these are submitted on the Exemption Form)
• Post approval documents, e.g. Amendments, Progress Reports (Annual/Final/Notifications), Safety Reports, SUSARs, SAEs, DSURs, Protocol Deviations, Investigator’s Brochures, etc.
• Responses to HREC reviews

All of the above must be uploaded into Ethics Review Manager (ERM) and then sent by email to: MetroNorthResearch-Ethics@health.qld.gov.au

Further information and step-by-step guides for ERM can be found in the ERM Quick Guides.  The ERM Researcher User Guide is also a useful tool (available from a Queensland Health computer only).

All submissions are to be submitted via ERM