To submit a research project for ethical review by a Human Research Ethics Committee (HREC), a Human Research Ethics Application (HREA) must be completed in Ethical Review Manager (ERM).
Applications submitted to a Metro North HREC are reviewed according to the HREC meeting schedule. Applications deemed to be low risk or harm are reviewed out of session and may be submitted at any time.
To start a new application, create a new project in ERM and select HREA. Under the newly created project tree, complete the application form and upload all relevant documents.
Submit application
Applications must be submitted by 12.00pm on the HREC meeting closing date.
There are no exceptions to HREC meeting closing date or times, and incomplete applications will not be accepted.
Research applications are capped for each meeting. It is therefore recommended researchers submit early to ensure their study will be tabled at the next meeting agenda.
The HREA and all relevant supporting documents must be submitted via ERM. Under the relevant ERM project tree, complete the HREA form and upload all relevant documents. and click the submit action.
Mandatory Requirements
Cover letter
A cover letter is a mandatory requirement for all submissions to a Metro North HREC. The cover letter template provided below sets out the minimum requirements for inclusion in a submission.
Protocol
A protocol is an essential element of all applications and should be developed early in the research process. The protocol should have appropriate version and date control.
Data management
The protocol should provide sufficient detail regarding data management. Alternatively, a separate data management plan can be provided.
Consent mechanism
When designing a research project conducted with or about people, their health information, data or tissue, the protocol should clearly outline the consent mechanism via a participant information and consent form, or provide justification for a waiver of consent.
Curriculum Vitae/Resume
A CV/Resume is required for the Coordinating Principal Investigator (CPI) and/or Principal Investigator (PI) for each site.
The associate investigators are not required to provide a resume/CV for ethics and governance submissions.
Additional documentation
The HREC requires copies of all supporting documentation in order to appropriately review an application. The documentation required will depend on specific research activities outlined in the HREA, protocol and consent mechanism:
Conflict of Interest
Any conflict of interests need to be declared to the ethics committee as outlined in the National Statement. If you are considering whether a situation may constitute a conflict of interest or not, it is best to disclose.
A conflict of interest may be declared on the HREA. The HREC will review each declaration on a case-by-case basis.
Metro North staff can refer to the Metro North Health Policy – Conflict of Interest (Queensland Health employees only)
Data collection tools/instruments
All data collection or study tools such as questionnaires, advertisements, participant cards, letters of invitation, diaries, interview questions, telephone scripts all must have versions and dates
For projects using QH REDCap, a copy of the project codebook and user rights.
Clinical trials documentation
All clinical trials require additional documentation for ethical review
Genetically Modified Organisms
Office of the Gene Technology Regulator (OGTR), licence for dealings with a Genetically Modified Organism (GMO).
HREC Form of Indemnity
Medicines Australia Form of Indemnity for Clinical Trials (Standard form for HREC Review Only) is required for all commercially sponsored projects.
Metro North Health only accepts review of private sites when Metro North is a lead site. HREC indemnity is also required for these private sites. The Medicines Australia template may also be used for private sites and non-clinical trials.
If a private site does not find this template appropriate, private sites are welcome to provide their own template to the Metro North HREC Administrator via ERM, who will arrange Metro North legal review. Legal review of non-standard templates may incur a fee.
Legal entity name
Metro North Hospital and Health Service (ABN 18 496 277 942), Block 7 Level 14, Butterfield Street, Herston, Qld 4029, Australia