Reporting adverse incidents
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Reporting requirements for researchers
An adverse incident may be a harmful, unpleasant, or undesirable response, reaction, or outcome experienced by a research participant or researcher. Such incidents may include unanticipated harm to participants – including physical harm, anxiety, pain, psychological disturbance, devaluation of personal worth and social advantage – or harm to the reputation of the researchers and/or the University.
Please note the following process relates to all studies other than clinical trials. The following resources provide information and advice regarding established codes of practice within clinical trials:
- Therapeutic Goods Administration clinical trials
- National Statement on Ethical Conduct in Human Research (2007)
Should you require further advice please contact the Ethics Office.
Researchers must report serious incidents within 72 hours to the Human Research Ethics Committee (HREC). If something occurs and you are unsure of what to do please seek advice from the Ethics Office immediately.
Other adverse incidents that might have an impact on the continued ethical acceptability of the project must be reported to the HREC as soon as possible. This includes instances of privacy breaches, loss of data, damage to property and other similar occurrences.
A research participant wishing to report an incident can contact the researcher directly or contact the Ethics Office.
A research participant wishing to lodge a complaint about a research project or researcher can contact the Manager, Ethics Administration.
Reporting requirements for researchers
As outlined in the National Statement on Ethical Conduct in Human Research 2007 (1.7(c)), researchers are responsible for the welfare of participants in the research context. Researchers also have a significant responsibility in the monitoring of research, as they are in the best position to observe any adverse incidents or unexpected outcomes (5.5.3). This includes taking swift and appropriate action should anything untoward occur during the conduct of your research. For some serious incidents this may include the immediate decision to temporarily suspend research activities until the situation has been resolved. The HREC has a responsibility to review the ethical acceptability of the immediate actions taken, as well as your strategy to avert future incidents occurring.
Where the situation is urgent, please contact the Ethics Office via telephone and/or email.
To report to the HREC please complete the adverse incident reporting form (doc) and upload the form in the document tab of an Adverse Event form in IRMA. You can also upload any other supporting documents to the IRMA form. When completed please press the submit button on the form in IRMA. The IRMA form will need to be approved by the Chief Investigator via the “My approvals” tab in the Researcher Profile webpage of IRMA.
Adverse incidents could be related to:
- Research participant(s) – for example, the experience of stress, anxiety or depression following the completion of a sensitive questionnaire, or interview; feeling humiliated, manipulated or in other ways treated disrespectfully or unjustly; the experience of dizziness, nausea, headaches or other physiological responses to physical activities required in a study; painful or unpleasant responses to the use of particular equipment, medication or other substances administered during a study.
- Researchers – for example, a researcher might inadvertently be exposed to a serious health hazard such as contaminated blood; they may inadvertently witness a crime while at a research location; a researcher may become stranded overseas as a consequence of local political upheaval, natural disasters; an incident may occur where a researcher might face harm to their reputation and/or the University.
- Research records or property - for example, loss of research data, participant consent forms; inappropriate storage or destruction of research records; loss or damage to computer, lab or office, breaches in privacy (for instance failure to use the “bcc” function in a group email using personal contact details).
- Other – for example, other individuals who are not research participants, but who are inadvertently involved in the incident