Clinical Trials

A clinical trial is a form of human research designed to find out the effects of an intervention, including a treatment or diagnostic procedure. A clinical trial can involve testing a drug, a surgical procedure, other therapeutic procedures and devices, a preventive procedure, or a diagnostic device or procedure National Statement on Ethical Conduct in Human Research, 2007Chapter 3.3., Introduction.

Clinical Trials must be registered in the publicly accessible database Australian New Zealand Clinical Trials Registry

    The Principal Investigator of the application must be a James Cook University staff member. Applications must be submitted to the Human Research Ethics Committee with a completed Human Research Ethics Application Form.

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    Clinical trials involving multi-centre research with participants recruited from Health Service Districts (in a hospital or in the community) should apply in the first instance to the relevant Health Service District for a multi-site research ethics approval.

    The Human Research Ethics Application Form (HREA) should be used for all multi-centre clinical trials. Please also see the specific submission guidelines for Health Service Districts in New South Wales and Queensland on the HREA website.

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    A condition of ethics approval of any Clinical Trial is approval by James Cook University (JCU) regarding insurance cover. Please email Insurance for information regarding this insurance.

    Ethics approval for the project will not be released until confirmation of insurance is provided.

    Researchers are encouraged to read JCU’s Indemnity, Insurance, and Legal Claims Policy.

    Visit the JCU Connect Ethics team on level 3 in The Science Place (Townsville) or in the Sir Robert Norman Building E2, Room 102C (Cairns).

    Tina Langford 
    Manager, Research Grants, Ethics and Integrity
    (07) 4781 4342 
    tina.langford@jcu.edu.au

    Helen Griffiths

    Helen Griffiths 
    Human Ethics Officer
    (07) 4781 6575 
    helen.griffiths@jcu.edu.au

    Craig Godfrey
    Manager, Animal Welfare and Human Ethics 
    (07) 4781 6506 
    craig.godfrey@jcu.edu.au

    Nicole Little 
    Animal Ethics Officer
    (07) 4781 4484 
    nicole.little@jcu.edu.au