Once ethics approval is obtained, the data collection phase of the research may commence (please refer to the HREC Standard Conditions Of Approval, or visit the Committee page).
Once approval is obtained, a researcher is only approved to undertake the research as outlined in the application and its approval conditions. Any changes or amendments must be approved before they are implemented.
The National Statement requires that approved research is monitored, and that researchers must comply with the following minimum requirements:
Amendments
Changes to the research project following approval must be made through an amendment application which asks:
- what are the proposed changes; and
- justify why these changes are needed.
It is assumed that you know which issues to address to achieve ethics approval, based on the experience from the original ethics application.
Most amendments are expedited and approved within a few working days. Complex or contentious amendments are reviewed by the full HREC.
An amendment application can be submitted through IRMA.
Annual project reports - NEED 2024 VERSION.
At each anniversary of the ethics approval, researchers must submit a brief Annual Project Report to advise on the progress of the research. A reminder will be sent approximately two weeks before this report is due. Please note, the Annual Project form is a PDF / Adobe format. To ensure this form works correctly, please right-click and "Save link as" to download the form to your PC / Mac before completing
The Annual Report is the minimum reporting required by the National Statement to maintain approval. If this report is not provided, the HREC may re-consider the approval status of the research project including suspension or cancellation of ethics approval.
If the research is likely to continue for more than 4 years, it may be extended for up one additional year. If the research is ongoing for more than 5 years, towards the end of the fifth year, the HREC conducts a more formal review of the ethics associated with the project which is achieved by submitting a new, updated application.
Closure reports
At the end of the project - once all communication with participants, including the provision of feedback, has been completed - the project must be closed. This is done via the Annual Project Report. This is an important compliance requirement.
Please note, the closure report can be provided even if the thesis or publications are still being written up, so long as no participant will be contacted again as part of this research project.
Adverse incidents
Occasionally things go wrong, unexpected or unforeseen things happen with a negative impact on participants. Sometimes participants can make a complaint. In rare instances a participant may be hurt or harmed in some way. In such events:
- Notify Research Ethics and Integrity immediately that the event has occurred.
- Ensure that complete records of the event, including all conversations and communications are retained.
- In most cases an Adverse Event Notification will need to be completed.
- In some cases the research may need to halt at least until the HREC has reviewed the adverse incident report and determined its seriousness, potential for impact on the remainder of the project and any additional conditions which may need to be met by the researcher/s. Possible considerations include modification of the project to avoid similar events occurring.
- In extreme cases, the project may have to cease if continuation might prove harmful to participants.