Clinical Trial Commences
Managing your approved research ethics application
Conducting research ethically means making ethical considerations throughout the project, not just during the project development and ethics approval process.
It may be necessary to seek further approval from the Ethics Committee in some circumstances.
This section includes information on:
- requesting an extension of ethics approval;
- informing the Ethics Committee about changes to the project and requesting approval for them; and
- managing adverse or unforeseen events.
All applications are approved with standard conditions of approval. Some projects may also have further specific conditions of approval.
Monitoring
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 for establishing that a research project is being, or has been, conducted in the manner approved by the HREC.
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. The Research Ethics Team will notify the Chief Investigator by email when the annual progress report is due.
Please note that the HREC also reserves the right to adopt any additional appropriate mechanism for monitoring approved research projects.
Project Extension
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.
Changes to your project
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 HREC before commencement of the change.
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.
Adverse or unforeseen events
Researchers are required by the conditions of their ethics approval to immediately report to the HREC anything that might warrant review of ethical approval of the research project, including:
- serious or unexpected adverse events; and
- unforeseen events that might affect continued ethical acceptability of the project.
Delays in reporting an adverse incident may result in further impacts, such as:
- Breach of National Statement obligations;
- Breach of ECU’s Duty of Care to research participants and stakeholders; and
- Breach of ECU’s Duty of Disclosure obligations to its Insurers, requiring notification of any incidents that may give rise to a claim as soon as is reasonably practicable.
Where there are long delays in reporting 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.
For further information regarding submitting an amendment, extension or adverse event notification can be found on the Research Ethics Website.