Research

Managing your project

A focus on research of an international quality and the fostering of an outstanding research culture have positioned UWA as one of the best universities in Australia and in the top 150 in the world.

Human Ethics Resources


What Do You Want To Do

Managing Your Research Data

Policies And Advisory Notes

Managing Your Project
Obtaining ethics approval to commence a human research project is the first stage in meeting your obligations for the design and conduct of ethical research.

To comply with the National Statement and to ensure that your ethics approval remains valid, you will need to address a number of project management responsibilities.

Adverse and unexpected events – notification and reporting

Definition of an adverse event

Adverse events are any unforeseen or unexpected outcomes that have a negative impact on participants, researchers or the reputation of the University of Western Australia. These include: 

  • higher than expected incidence of risk factors associated with the research project
  • more serious reactions or impacts on participants than were expected by researchers
  • any event that might change the ethical acceptability of the project

    Required action by you

    If the adverse event is of a serious nature, the researchers should immediately consider the temporary suspension of research activities until the situation has been resolved. The Human Research Ethics Office (HREO) must be notified immediately the event has occurred, or as soon as possible thereafter. Where the situation is urgent, this notification should occur via telephone and/or email communication.

    At the first available opportunity, the researcher must also complete and submit an Adverse Event Report Form.

    In reviewing the adverse event, the Human Research Ethics Office (HREO) may seek advice from the Human Research Ethics Committee (HREC), a Regional Ethics Review Committee (RERC), and/or any other relevant source of information and advice.

    Depending on the seriousness of the adverse event;

    • the research project may be temporarily suspended by the University until the situation has been resolved
    • the University may require modifications to the project to prevent similar adverse events occurring
    • it may be necessary to terminate the project as an appropriate response to the risks involved for participants

      In addition to lodging an Adverse Event Report with the Human Research Ethics Office, researchers must comply with any other relevant legal and institutional requirements that may apply in a particular instance (e.g. relevant occupational health and safety requirements).