Ethics and governance

The Ethics Committee Secretariat is committed to providing support to all stakeholders in the research process and to facilitating the conduct of well-designed, scientifically sound and ethically appropriate human research in the public interest.

The Peter Mac Ethics Committee is constituted and operates in accordance with the National statement ethical conduct in human research and relevant state and national legislation, regulations and guidelines. It is certified by the National Health and Medical Research Council to review human research in the area of oncology.

Human research projects may be reviewed and approved by the Peter Mac Ethics Committee and/or supporting committees, panels and administrative processes.

    Multisite Ethical Review

    Peter Mac fully supports initiatives to reduce unnecessary duplication in the review of research, such as the National Mutual Acceptance scheme. Human research projects may be reviewed and approved for multiple sites by the Peter Mac Ethics Committee, or by another certified reviewing human research ethics committee (HREC) followed by governance review at Peter Mac to obtain authorisation to commence here. See the HRECs RGOs and organisations participating in the National Mutual Acceptance scheme.

    The Peter Mac Ethics Committee can provide multisite ethical review under National Mutual Acceptance for:

    • Interventional research for multiple public hospital sites in: Victoria (from November 2009); New South Wales and Queensland (from November 2012); South Australia (from November 2013); Australian Capital Territory (from August 2016) and Western Australia (from September 2017).
    • All types of human health and medical research, including low and negligible risk research, for multiple public hospital sites in: Victoria (from February 2015); New South Wales, Queensland and South Australia (from January 2016); Australian Capital Territory (from August 2016) and Western Australia (from September 2017).

    The Peter Mac Ethics Committee can also provide multisite ethical review for all Research Excellence (REx) partner institutions. The REx partner organisations are: Austin Health; Melbourne Health; Peter Mac; Royal Children's Hospital; St Vincent's Hospital Melbourne; Florey Institute of Neuroscience and Mental Health; Murdoch Children's Research Institute; Northern Health; Royal Women's Hospital; University of Melbourne; Walter and Eliza Hall Institute; and Western Health.

    MATTERS TO CONSIDER BEFORE SUBMITTING AN ETHICS APPLICATION

    Peter Mac as sponsor

    Peter Mac has implemented a review process for clinical research in which Peter Mac is acting as the study sponsor. The sponsor of a clinical research project is an individual or organisation that assumes the overall responsibility for the initiation, management (including ongoing oversight) and financing (or arranging the financing) of a study, as well as the overall scientific integrity of the data derived and results reported.

    If Peter Mac will be the sponsor of a clinical research project, you must consult the Office of Cancer Research (OCR) for assistance when developing your study concept. For further information, contact the OCR: [email protected].

    Note that for clinical research where Peter Mac is acting as the sponsor, approval from the Sponsorship Committee must be submitted to the Peter Mac Ethics Committee along with the application for ethical review.

    First Time in Human Review

    Clinical trials that will be administering an investigational medicinal product to humans for the first time may require a First Time in Human by an expert reviewer. An expert review may be required for all or some of the following areas: Pharmacology & Toxicology; Immunology; and Formulation/Manufacturing. This expert review must be completed before submission of the clinical trial application to the Ethics Committee. Please consult the Ethics Committee Secretariat for advice.

    Institutional Biosafety Committee

    Clinical research involving the use of genetically modified organisms (GMOs) at Peter Mac may require review by the Institutional Biosafety Committee (IBC). To assess whether or not your project requires IBC review, complete the IBC Clinical Trials Questions . If your project requires IBC review for the Peter Mac site, this should be completed prior to submission to the Ethics Committee. For any questions regarding the IBC and for submission requirements, please contact the IBC secretary, Stan Stasinopoulos: [email protected].

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    Our Team

    Dianne Snowden
    Manager
    Monday to Friday
    Phone: (03) 8559 7543
    Email: [email protected]

    Namita Mazzitelli
    Ethics Coordinator
    Monday to Thursday
    Phone: (03) 8559 7542
    Email: [email protected]

    Dianne Biermann
    Research Governance Officer
    Monday to Thursday
    Phone: (03) 8559 7545
    Email: [email protected]

    Robyn Summerhayes
    Ethics Officer
    Monday, Tuesday, Thursday, Friday
    Phone: (03) 8559 7540
    Email: [email protected]

    Catherine Yeowart
    Administrative Assistant
    Monday, Tuesday, Thursday, Friday
    Phone: (03) 8559 7544
    Email: [email protected]

    Contact

    Email: [email protected]
    Phone: (03) 8559 7540