Ethics Approval2024-06-19T02:59:53+00:00

Ethics Approval

Human Research Ethics Committee (HREC) review is the first step in the research approval process, required for all human research conducted within Metro North. 

On this page

    About the Committee

    Find out more about the Human Research Ethics Committee (HREC) and its meeting dates

    Fees

     The relevant fee template must be submitted with your application.   

    Protocol

    A project 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.   

    Clinical Trials Documentation

    All clinical trials require additional documentation for ethical approval.

    Human Research Ethics Application (HREA)

    Researchers are required to complete a Human Research Ethics Application (HREA) as part of their submission.  

    To create a new application, you will first need to create a new project in Ethical Review Manager (ERM) and select HREA.  Under the newly created project tree, complete the application form and upload all relevant documents.  

    When you apply for ethics approval, you’ll need to be able to show that: 

    • your research has scientific merit 
    • any benefits outweigh any associated risks 
    • the people who work on your research have the proper qualifications 
    • you treat the participants with respect, especially vulnerable groups 
    • you considered the ethical issues associated with the methodology you’ll use. 

    Applications deemed to be low risk or harm are reviewed out of session and may be submitted at any time.  

    Cover letter

    • The cover letter must clearly include:  
      • Sponsor/lead institution of the study (this is the institution who has overall responsibility for the project).  For collaborative investigator-initiated projects this will be the institution that the CPI is representing.     
      • Chief or Coordinating Principal Investigator (CPI)  
      • List of all sites and Principal Investigators requiring approval    
      • List of all documents submitted, including versions and dates   
      • If requesting low risk review –justification for the lower risk review pathway as per the National Statement and your assessment of the risk of harm to participants. Please note that while researchers may consider their project low risk, it is ultimately the decision of the Chair of the HREC.    

    Cover letter template

    Curriculum Vitae/Resume

    • A CV/Resume is required for the CPI and/or PI for each site. 
    • The associate investigators are not required to provide a resume/CV for ethics and governance submissions.  

    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. The HREC will review each declaration on a case-by-case basis.   

    Where an employee participates in research activities conducted within Metro North Health, a conflict of interest must be declared as a function of the internal administrative processes at the time of submission of HREC and site-specific assessment (SSA) applications for research projects. 

    Metro North Health – Conflict of Interest (Metro North Health employees only)

    Data management

    The protocol should provide sufficient detail regarding data management. Alternatively, a separate data management plan can be provided.  

    Find out more about data management

    Consent mechanism

    The protocol should clearly outline the consent mechanism via a participant information sheet and consent form or provide justification for a waiver of 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 your 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 PHA approval or data custodian approval will be required for research governance.

    Participant Information and Consent form

    The requirement for participants to consent to take part in research is the cornerstone of ethical research practice.  As part of the consent process, potential participants are generally given written descriptions of the research and a consent form to sign.   

    Supporting documentation

    Depending on the study, other documents may be required.  

    Multi-site research

    Victorian specific module or Western Australian module is required for research that includes a Victorian or Western Australia site. 

    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 accept 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 which can be reviewed by Metro North legal.  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 

    Submit application

    Applications must be submitted by 12.00pm on the HREC meeting closing date; there are no exceptions; and incomplete applications will not be accepted.  Research applications are capped for each meeting; therefore, it is recommended that 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. 

    Ethics Review Manager 

    Research Governance

    Research cannot commence without institutional research governance/SSA approval. Find out more about the SSA process 

    After you have been approved

    Find out more about the Post Approval process

    Other types of reviews and approvals

    Find out how to request an exemption or seek authorised prescriber approval

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