Clinical trial ethical approval2024-06-19T05:42:52+00:00

Clinical trial ethical approval

Clinical trials require additional documentation for Human Research Ethics Committee (HREC).  

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    Do I need approval?

    If you are a Metro North researcher intending to conduct a clinical trial of an unapproved device or medicine (including not approved for the specific cohort, or dose) sponsored by Metro North, you must seek approval to do so prior to submitting your ethics application.

    Request approval

    Good Clinical Practice Certificate

    A GCP certificate is required for the CPI and site PIs if conducting a clinical trial 

    Clinical trials involving ionising radiation

    Clinical trials that will expose participants to ionising radiation should provide information that enables consent to be properly considered by research participants.  

    Investigator’s Brochure/s

    Product information or an Investigator Brochure (IB) is required for all drug and/or device trials. An IB is a compilation of the clinical and nonclinical data for the investigational product(s) being trialled in the study and provides the rationale for key features of the protocol, such as the dose, dose frequency/interval, methods of administration: and safety monitoring procedures. If more than one version of the IB has been approved by the HREC, provide the most recent approved version. 

    Clinical Trial Notification (CTN)

    Any research using an approved drug or device or an approved drug in a manner (dose or cohort) that is approved as per the Australian Register of Therapeutic Goods (ARTG) must provide copy of the eCTN registration with the application. 

    CTN registration details

    Metro North Health HREC A

    HREC Name  Metro North Health HREC A 
    HREC Code  EC00172 
    Contact Officer  Dr Sarah Winch 
    Phone number  07 3646 5280 
    Email  MetroNorthResearch-Ethics@health.qld.gov.au 

    Metro North Health HREC B

    HREC Name  Metro North Health HREC B 
    HREC Code  EC00168  
    Contact Officer  Dr Lynn Woodward 
    Phone number  07 3646 5280 
    Email  MetroNorthResearch-Ethics@health.qld.gov.au 

    Metro North Health approving authority (for studies to be conducted at Metro North) 

    Approving authority  Metro North Hospital and Health Service 
    Name   Adjunct Professor Jackie Hanson 
    Position   Chief Executive, Metro North Health 
    Phone number   07 3647 9550   
    Email   MetroNorthResearch-RGO@health.qld.gov.au 

    Teletrials

    Projects intending to run as a teletrial require the following: 

    • CV of Associate Investigator at Satellite Site (operating under the PI) 
    • Principal Investigator statement that they are satisfied that the Associate Investigator is suitably qualified to undertake the role of Associate Investigator at a Satellite Site – this can be by way of the cover letter  
    • Certificate of Good Clinical Practice for Associate Investigator  
    • Evidence of Sponsor Agreement for the inclusion of this site 
    • Master versions of all PICFs must include the optional Teletrials Specific Wording for review by the HREC.  This wording may be omitted for those sites not participating in the teletrials model.   
    • The Sponsor agreed process by which consent will be obtained at Satellite Sites must also be provided to the HREC 

    Insurance

    Where clinical trials involve collaborators or parties external to Queensland Health, the contract must include reference to insurance and indemnity arrangements.  

    For commercially sponsored research, the relevant Medicines Australia Clinical Trial Research Agreement (CTRA) and Medical Technology Association of Australia Clinical Investigation Research Agreement contain clauses relating to the Insurance to be provided for the project.  

    Certificates of Currency (insurance certificates) should be submitted with the research governance application, and their expiry dates noted to ensure there is no lapse in cover. There are no requirements for specific insurance companies to be used, but the insurance company should have offices or representatives in Australia to facilitate processing of any claims that may be made. 

    The certificate of currency (or insurance certificate) should contain the following information: 

    • Full Study Title
    • The type of insurance – Public and Product Liability – or equivalent such as General Liability or Clinical Trials Insurance
    • The full legal name of the Australian entity acting as the sponsor
    • The full legal name of the insurer (which must be approved by the Australian Prudential Regulation Authority or a foreign equivalent). All insurers are required to hold Standard & Poor’s financial rating of not less than ‘A-’.
    • The period of insurance
    • That the insurance coverage allows for a minimum of AUD$10 million for any one occurrence and in the annual aggregate

     For collaborative or other non-commercial clinical trials, each institution will generally provide their insurance for the project. The Medicines Australia CTRA – Collaborative Research Group (CTRA -CRG) contains specific clauses covering this. 

    Generally speaking, Queensland Health will not provide insurance or indemnity for external parties. 

    Clinical trials registry

    Under Section 19 of the Declaration of Helsinki (2008) “Every clinical trial must be registered in a publicly accessible database before recruitment of the first subject. In addition, the International Committee of Medical Journal Editors (ICMJE) has made an essential criterion for publication of a trial in one of their journals that the details of a trial should be publicly available in a clinical trials registry.  

    The clinical trial registration number must be recorded on the SSA application. The two primary clinical trials registries are: 

    Australian New Zealand Clinical Trials Registry

    (please be aware that the trial registration process can take up to 8 weeks). 

    ClinicalTrials.gov

    If the clinical trial involves a US site 

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