Obtaining ethics approval to commence a (human/animal) research project is the first step in meeting your obligations for the design and conduct of ethical research.
To comply with the National Statement and ensure that your ethics approval remains valid, you will need to manage your project at various stages through to completion.
Conducting research ethically means making ethical considerations throughout the project, not just during the ethics approval process. It may be necessary to seek further approval from the Ethics Committee in some circumstances.
This section includes information on:
All applications are approved with standard conditions of approval. Some projects may also have further specific conditions of approval. For more information download the HREC/AEC Conditions of approval.
For managing an approved animal ethics application, please see the Managing your approved animal research ethics application web page.
All research projects are approved subject to compliance with monitoring procedures. Monitoring is the process of verifying that the conduct of research conforms to the approved ethics application.
Institutions are responsible for ensuring that research is reliably monitored and establishing that a research project is being, or has been, conducted in the manner approved by the Human Research Ethics Committee or Animal Ethics Committee.
Monitoring involves completion of an annual progress report (if your project is longer than one year) and completion of a final report at the end of your project.
You will be notified when a report is due and will need to complete a report in one of two ways.
The Human Research Ethics Committees and Animal Ethics Committee also reserve the right to adopt any additional appropriate mechanism for monitoring approved research projects.
All applications are approved with standard conditions of approval. Some projects may also have further specific conditions of approval which must be met and approved before research commences. If there are specific conditions of approval attached to your application, these will be outlined on your approval email. Please read this document carefully.
For more information download the HREC Conditions of approval or the AEC Conditions of Approval.
All research projects are approved for a specified period of time – from the date of approval until the date of completion provided in the ethics application.
Ethics approval covers both the collection and use/analysis of data, information and/or samples. Researchers should ensure that the period of time requested for ethics approval is sufficient.
If an extension of the approval period is required, a request must be submitted to the Human Research Ethics Committee – before the original approval expires. To request an extension of ethics approval, please review the following:
For managing an approved animal ethics application please see the Managing your approved animal research ethics application web page.
The Ethics Committee understands that research designs do change, particularly for long-term projects. Amendments to the research design that may affect participants and/or that may have ethical implications, must be reviewed and approved by the Human Research Ethics Committee or Animal Ethics Committee before commencement.
For human research, any changes to documents and other material used in recruiting potential research participants, including advertisements, letters of invitation, questionnaires, information sheets and consent forms, should also be approved by the HREC.
For managing an approved animal ethics application, please ssee the Managing your approved animal research ethics application web page.
To request approval for a change, please review the following:
Definition of an adverse event (please see Managing your approved animal research ethics application for definitions pertaining to animal research)
Adverse events are any unforeseen or unexpected outcomes that may alter the continued ethical acceptability of a project and/or have a negative impact on participants, researchers, or the reputation of the University.
Examples include:
The following questions can be useful in determining an adverse event:
Researchers/investigators are required by the conditions of their ethics approval to immediately report to the Human Research Ethics Committee or Animal Ethics Committee any event that might warrant review of the ethical approval of the research project.
If the adverse event is of a serious nature, the researcher/investigator should immediately consider the temporary suspension of research activities while the event is reviewed by the Ethics Committee.
At the first available opportunity, the researcher/investigator must complete and submit an Adverse Event Report.
All human or animal research adverse events approved in REMS need to be reported in the REMS Portal. Click on the report icon for the appropriate project and enter the online reporting system. Select ‘Adverse Event’, enter details, including a description of the event and any actions already taken, and submit.
If your project was approved in STREAM unexpected adverse events need to be reported to the Research Ethics Team using the Adverse Event Report Form.
This Report needs to be completed as soon as practicable after the event occurs and should also form part of your project’s annual and final reporting.
If a serious adverse event has occurred, your project activity may immediately be suspended while the event is investigated by the relevant Ethics Committee. Historically most adverse events have been less serious in nature and only required minor amendments to rectify.
Should you require further guidance please contact the Research Ethics Team.
Please note: you may also be required to log the event in Riskware. To Log the event in the Incident/Hazard Module of RiskWare please use the Easy Login link via the Student / Staff Portal or via the OSH website.
Delays in reporting an adverse incident or event may result further impacts, such as:
Where there are long delays in reporting of adverse incidents, ECU (or the research participant) may have reduced or limited capacity to make a claim against an insurance policy, or cover may not be available. If cover is not available due to a delay in reporting, it may result in the research budget being called upon to cover any costs associated with the adverse event.
If you wish to lodge a complaint or concern about research conduct at ECU please do so through the ECU Research Concerns and Complaints Report form. More information is available at the Managing and Reporting Breaches to the Code webpage or from research.integrity@ecu.edu.au