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Userguides

Below user guides contain detailed step-by-step information on how to use the system. Please look at the relevant guide for more information.

Human Ethics- ERM Applicant User guide

Biosafety- ERM Applicant User guide

Contact Information

To contact the research office email resethics@swin.edu.au

For more information on ERM including userguides see here. 

Click here for HRECs within Swinburne University of Technology 


National Statement on Ethical Conduct in Human Research

Click here to access the latest version of the National Statement.

The National Statement on Ethical Conduct in Human Research (National Statement) consists of a series of guidelines made in accordance with the National Health and Medical Research Council Act 1992. It is intended for use by:

  • any researcher conducting research with human participants;
  • any member of an ethical review body reviewing that research;
  • those involved in research governance; and
  • potential research participants.

    • The National Statement is developed jointly by the National Health and Medical Research Council, the Australian Research Council and Universities Australia. It replaced the 1999 National Statement on Ethical Conduct in Research Involving Humans.

    Compliance with the National Statement is a prerequisite for receipt of NHMRC funding.

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    Human Research Ethics Committees

    Human Research Ethics Committee (HRECs) play a central role in the Australian system of ethical oversight of research involving humans. HRECs review research proposals involving human participants to ensure that they are ethically acceptable and in accordance with relevant standards and guidelines. 

    There are more than 200 HRECs in institutions and organisations across Australia. Many other countries have similar systems.

    In undertaking this role, HRECs are guided by relevant standards. Standards include those in the National Statement on Ethical Conduct in Human Research (the National Statement) issued by NHMRC.

    The National Statement sets out the requirements for the composition of an HREC and the relevant ethical principles and values by which research should be designed and conducted and to which HRECs should refer when reviewing research proposals. It also identifies requirements and responsibilities for:

    • Institutions/organisations in establishing HRECs
    • researchers in submitting research proposals to HRECs
    • HRECs in considering and reaching decisions regarding these proposals and in monitoring the conduct of approved research.

    In some circumstances HRECs charge fees for considering research application.

    Further information on HRECs is available on the NHMRC website here.

    HREA Clinical Trial Protocol description:

    For advice on how to prepare a clinical trial protocol please see:

    TGAs Clinical Trial Handbook

    SPIRIT 2013 Statement

    Privacy Act Definition of Personal, Sensitive and Health Information

    • Personal information is defined in the Privacy Act 1988 as information or an opinion about an identified individual, or an individual who is reasonably identifiable:
      • Whether the information or opinion is true or not; and
      • Whether the information or opinion is recorded in a material form or not.
    • Sensitive information is defined in the Privacy Act 1988 as:
      • information or an opinion about an individual’s:
        • racial or ethnic origin; or
        • political opinions; or
        • membership of a political association; or
        • religious beliefs or affiliations; or
        • philosophical beliefs; or
        • membership of a professional or trade association; or
        • membership of a trade union; or
        • sexual orientation or practices; or
        • criminal record; that is also personal information; or
        • health information about an individual; or
      • genetic information about an individual that is not otherwise health information; or
      • biometric information that is to be used for the purpose of automated biometric verification or biometric identification; or
      • biometric templates
    • Health information is defined in the Privacy Act 1988 as:
      • information or an opinion about:
        • the health, including an illness, disability or injury, (at any time) of an individual; or
        • an individual’s expressed wishes about the future provision of health services to the individual; or
        • a health service provided, or to be provided, to an individual; that is also personal information;
      • other personal information collected to provide, or in providing, a health service to an individual;
      • other personal information collected in connection with the donation, or intended donation, by an individual of his or her body parts, organs or body substances;
      • genetic information about an individual in a form that is, or could be, predictive of the health of the individual or a genetic relative of the individual.
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