When is a HREA and full HREC review not necessary?
- Some research may be eligible for an exemption from ethical review
- Quality initiatives generally do not require HREC review
- Applications to become an authorised prescriber for unapproved therapeutic goods
Find out more about other types of reviews and approvals
Submit application
Applications submitted to a Metro North HREC are reviewed according to the HREC meeting schedule and 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.
Applications deemed to be low risk or harm are reviewed out of session and may be submitted at any time.
A copy of the HREA and all additional documentation must be uploaded and submitted via ERM.
WARNING: Metro North does not use the correspondence tab in ERM. Do not use this function to communicate with Metro North HREC or research governance.
Mandatory Requirements
Human Research Ethics Application
The Human Research Ethics Application (HREA) must be completed in Ethical Review Manager (ERM) by creating a new project and selecting HREA. Under the newly created project tree, complete the application form and upload all relevant documents.
HREC Cover letter
The cover letter is a mandatory requirement as it provides the reviewing HREC with essential project information. 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. Example protocol templates and a data management template are provided to support research development.
Participant consent
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 apathways for participant consent or justification for a waiver of consent.
Resume/CV
A Resume/CV is required for the Coordinating Principal Investigator (CPI) and/or Principal Investigator (PI) for each site. Associate investigators are not required to provide a resume/CV for ethics and governance submissions unless they are providing specialised expertise for the study.
Fee Template
The relevant fee template must be completed and submitted with the application.
Additional documentation
Submitting Additional Documentation
Additional documents may be required depending on the specific research activities outlined in the HREA and the protocol. Where required, additional documents must be:
- listed on the HREC Cover letter
- uploaded with the HREA in ERM for HREC review
All documentation must include versions and dates that are consistent with the cover letter.
Clinical trials documentation
All clinical trials require additional ethics and governance documentation. All applications to the Metro North HREC to review a clinical trial must refer to the following information.
Data collection tools/instruments
All data collection or study tools such as questionnaires, advertisements, participant cards, letters of invitation, diaries, interview questions, telephone scripts must be submitted for review by the HREC.
QH REDCap is a secure online platform for the collection of research data, and is available for Metro North staff to use through the Office of Research and Innovation (ORI) and eHealth Queensland.
Ionising radiation
Research involving the use of ionising radiation procedures requires additional oversight during the ethical review and research governance approvals process to manage the risks for patient safety and health.
Genetically Modified Organisms (GMO)
Research that involves dealings with a Genetically Modified Organism (GMO) must be approved by the Office of the Gene Technology Regulator (OGTR). Institutional Biosafety Committee’s (IBC) will be required during the approval process. IBC’s review laboratory and clinical studies involving the use of GMOs to ensure research meets the requirements of the Gene Technology Act 2000. The IBC assists supervisors, sponsors and OTGR license holders with obtaining proper study authorisation.
NHMRC Embryo Research License
Research activities that involve the use of human embryos created by assisted reproductive technology (ART) or by other means is regulated by the NHMRC Embryo Research Licensing Committee and requires embryo research licensing. The NHMRC Licensing Committee was established by the Research Involving Human Embryos Act 2002 and oversees the Research Involving Human Embryos Act 2002 (RIHE Act) and the Prohibition of Human Cloning for Reproduction Act 2002 (PHCR Act).
State-specific modules
Collaborative research involving a Victorian or Western Australian site must include the relevant state-specific module(s).
HREC Form of Indemnity
For a Metro North HREC to review commercially sponsored research, including non-clinical trials research, the HREC must be indemnified by the sponsor. Metro North HREC’s use the Medicines Australia Form of Indemnity templates as the standard basis for agreement between a sponsor and the Metro North HREC.
The Metro North HREC will only review private sites where Metro North is the lead site.
A private site may submit a non-standard template to the Metro North HREC Administrator for legal review, however this legal review may incur a discretionary fee. The non-standard indemnity template must be uploaded with the HREA via ERM and the requirement for non-standard legal review listed on the HREC Cover Letter.
The Name and address of the legal entity (indemnified party) is provided below for inclusion in the template:
Metro North Hospital and Health Service (ABN 18 496 277 942), Block 7 Level 14, Butterfield Street, Herston, Qld 4029, Australia
Conflict of interest declaration
A conflict of interest exists where an independent observer might reasonably conclude the professional actions of a person are or may be unduly influenced by other interests. The identification and management of a conflict of interest in research is necessary to maintain the integrity and reliability of research conduct and outcomes, mitigate risks associated with complex relationships between researchers and public and private organisations, and ensure public trust in individuals and organisations involved in research.
As outlined in the National Statement on Ethical Conduct in Human Research, any conflict of interest must be declared to the HREC. 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.
For more information on conflict of interest, please refer to the Metro North Research Policy.
Agreements
A research agreement is required for all research conducted at a Metro North site that also involves any organisation external to Metro North. This includes sponsored, collaborative and student research (e.g. where a Metro North staff member is undertaking the research as part of a Research Higher Degree).
While the research agreement is not submitted for HREC review, Metro North encourages parallel review and submission of ethics and governance applications. Early planning for a research agreement with all participating sites will assist with ethical and governance review and support an efficient study start-up.
Related Information
Pre-approval Planning
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.