Once you have received ethics approval, there are still requirements to maintain your ethics approval. This includes requesting changes to your ethics approval, and letting us know how you are progressing. All submissions are to be made via InfoEd.
Annual reports
Ethics applications are initially approved for a 12-month period, which can be extended each year upon submission of an Annual Report. You will receive automated reminder emails at 8 weeks before the expiry date, and again at 4 weeks before the expiry date.
If your research is still ongoing, submitting an Annual Report will extend the approval for another year, however if the research has finished, has been discontinued, you can submit a Completion Report.
If you are finished with recruitment and data collection, but are finalising a thesis or manuscript, you can close the record via a Completion Report. But, if there is any chance you will need to collect more data, then please submit an annual report to keep the record open, just in case.
Completions
A completion report must be submitted when all research activities have concluded. This enables the ethics office to formally close the ethics approval and maintain accurate records of approved research.
A project is generally considered complete once:
- participant involvement has ended
- data collection has finished
- there is no further interaction with participants requiring ethics approval.
Researchers should ensure all outstanding reportable events and amendments have been resolved before submitting a completion report.
Change of investigator
When there are any changes to your research team, submit a change of investigator through InfoEd. Use the same form for changing the CI, removing investigators, adding investigators.
When adding new investigators, please also attach a copy of their Research Integrity Training (RIT) certificate
Amendments
If you need to make changes to an approved research project, you must obtain approval before implementing the changes, unless they are necessary to eliminate an immediate risk to participants.
Amendments may include changes to:
- the research protocol or methodology
- participant recruitment or eligibility criteria
- participant information sheets or consent forms
- questionnaires, interview guides or other study documents
- research personnel or study sites
- study timelines or funding arrangements.
Submit an amendment request with sufficient detail to enable the HREC to assess the proposed changes and their potential impact on participants and the ethical acceptability of the research.
Reportable events
Researchers must promptly notify the HREC of any reportable events that may affect the safety, welfare or rights of participants, or the ethical acceptability of the research.
Reportable events may include:
- serious adverse events
- protocol deviations or violations
- unanticipated problems or new information that may affect participant safety or willingness to continue participation
- complaints relating to the conduct of the research
- significant breaches of privacy or confidentiality
- suspension or termination of the project by another institution or regulatory body.
Prompt reporting enables the HREC to assess whether any action is required to protect participants or maintain the ethical integrity of the research.