Human Research Ethics Application (HREA)
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 a Human Research Ethics Application
The minimum ethics application requirements are:
- Cover Letter
- Protocol
- Participant consent mechanism
- Supporting documentation
- Curriculum Vitae/Resume
- Fee Template
Additional documentation may be required for certain projects, in particular, clinical trials.
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)
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.
Participant 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.
Participant Information and Consent Form (PICF)
The requirement for participants to consent to take part in research is the cornerstone of ethical research practice. The Participant Information and Consent Form (PICF) provides a written description of the research and allows participants to provide informed consent to participate in research.
The PICF must be submitted for HREC review for research studies involving participant consent.
Wavier of Consent
If consent is not being obtained, justification for a waiver of consent as per the National Statement is required (National Statement Chapter 2.3). Insufficient consideration to the justification for a wavier of consent will delay the approval process.
In Queensland if you are requesting the HREC to grant a waiver of consent, you also need to consider the legal permissions for the lawful access of data under the (i) Public Health Act 2005 (PHA) or (ii) the Hospital and Health Boards Act 2011 (HHBA). Evidence of the requisite approval will be required for research governance.
Supporting 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:
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.
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.
Fee Template
The relevant fee template must be completed and submitted with the application.
More information on fees
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
Multi-site research
For multi-site research involving a site in Victoria or Western Australia, the state specific modules must be included.
Submit application
Applications must be submitted by 12.00pm on the HREC meeting closing date.
Metro North HREC Meeting Schedule
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.