It is the responsibility of the researcher to ensure that all necessary reporting requirements associated with their ethics approval are met. Failure to meet the reporting requirements of the Animal Welfare Committee (AWC) may result in withdrawal of ethics approval, suspension of projects and other disciplinary action.
As all application forms are periodically updated, we strongly recommend you re-download forms from the relevant website each time you submit a new application to ensure you are using the correct version.
Over the duration of a project circumstances may change and it may become necessary to modify your animal ethics approval.
Use this Modification Coversheet ONLY for new projects or projects that have only been modified ONCE using the forms entitled 'Modification Application Form'.
Further modification requests on the project should continue to use the 'Modification Coversheet'.
In order to modify your project, you will need to take the following action:
- Download and complete the Modification Coversheet, available from the Application Forms, Cover Sheet and Templates page.
- TRACK CHANGE your approved application with the modifications you wish to make to the project.
- Submit the Modification Coversheet, along with a WORD version of your approved application WITH TRACK CHANGES, and a newly signed WORD or PDF signature page. If the request is urgent, submit directly the Animal Welfare Committee (AWC), otherwise submit the application to the relevant Sub-Committee.
Modification Application Form
Continue to use the Modification Application Forms for projects that have previously been modified MORE THAN ONCE using these forms.
In the event that you require an extension of time or there are changes to personnel working on your project, you will need to take the following action:
- Download and complete the Modification Application Form – Extension of Time or Modification Application Form – Personnel Change, available from the Application Forms, Cover Sheet and Templates page.
- Submit a signed electronic version of your application as a single PDF file directly to the Animal Welfare Committee (AWC), together with any required supporting documentation, prior to the submission deadline.
In the event that there is a combination of changes to time, personnel, animals and/or experimental steps required, you will need to complete the following steps:
- Download and complete the Modification Application Form, available from the Application Forms, Cover Sheet and Templates page.
- Submit your completed application to the relevant Sub-Committee, together with any required supporting documentation, prior to the submission deadline.
Researchers with projects aligned to the College of Medicine and Public Health may submit their application to the Animal Ethics Review Sub-Committee, prior to the submission deadline.
Researchers with projects aligned to the College of Science and Engineering may submit a signed electronic version of their application to the Animal Welfare Sub-Committee prior to the submission deadline.
Please note that in cases where the modifications alter the originally approved aims of the project, a new application will need to be submitted
Annual Reports of Progress
Researchers are required to submit an Annual Report of Progress to the Animal Welfare Committee (AWC) by 1 February each year, for all projects which are subject to animal ethics approval. Researchers will receive a reminder via email prior to the due date.
If an Annual Report of Progress is not received by this time, ethics approval will be withdrawn and the researcher and relevant Animal Facility Manager will receive notification that the project has been suspended. The project may only resume following the submission and approval of a new application for animal ethics approval.
The Executive Dean of the relevant College, relevant funding body/bodies, the DVCR and the relevant funding body (if applicable) will be notified in the event that a project is suspended as a result of a researcher’s failure to meet the reporting requirements of the AWC, as this is considered to be a performance issue.
You can download the template for the Annual Report of Progress here.
Researchers are required to submit a Final Report to the Animal Welfare Committee (AWC) for any projects which are subject to animal ethics approval by 1 February, unless a request for extension of ethics approval has been received by 31 December in the year of expiry.
At the expiration of the animal ethics approval, the relevant Animal Facility Manager will be advised that the use of animals in the project must now cease.
Researchers will receive a reminder via email prior to the due date.
The Executive Dean of the relevant College, relevant funding body/bodies and the DVCR will be notified in the event that a researcher fails to submit a Final Report to the AWC by this time, as this is considered to be a performance issue.
You can download the template for the Final Report here.
Unexpected Adverse Events
What is an Unexpected Adverse Event?
An Unexpected Adverse Event is an event that is unexpected and was, therefore, not foreshadowed in the application approved by the Flinders University Animal Welfare Committee (AWC). Unexpected adverse events may be caused by, but are not limited to, the following:
- Death of an animal, or group of animals, that was not expected or was prior to planned death (e.g. during surgical procedure, during anaesthesia, following a procedure or treatment).
- Adverse effects following a procedure or treatment that were not expected. Examples of clinical signs that may develop include, but are not restricted to, diarrhea, vomiting, respiratory difficulty, collapse, abdominal swelling, rapid weight loss.
- If at any point in the project, the percentage of morbidity or mortality exceeds the stated amount in the application, this constitutes an Unexpected Adverse Event.
- A greater level of pain or distress than was predicted during the planning of the project.
- Power failures, inclement weather etc. that impact on the welfare of the animals.
Reporting an Unexpected Adverse Event
Following an unexpected adverse event, the Animal Welfare Officer must be immediately notified (within 24 hours of the incident) via phone (0450 424 143) with a follow-up email (firstname.lastname@example.org). In the event that you are unable to contact the Animal Welfare Officer, you should contact the Manager of the relevant Animal Facility AND the Animal Ethics Officer (email@example.com).
A post-mortem examination MUST be performed following an unexpected adverse event according to the post-mortem examination guidelines document - which can be downloaded from Reporting Templates section here.
An Unexpected Adverse Event Report must be submitted to the Animal Ethics Officer within 3 working days. The report must include the following information:
- Summary of circumstances leading up to the adverse, unexpected event
- Actions taken from the time the problem was noticed
- Results of the post-mortem examination, if available, where animals have died
- Proposed actions to prevent or correct the specific or probable cause of the problem
- Attach all Clinical Record Sheets and Maintenance Monitoring Sheets relating to the affected animals, even if they do not appear to include any useful information
You can download the unexpected adverse event guidelines and reporting template here.
Clause 2.5.5 of the Australian Code for the Care and Use of Animals for Scientific Purposes, 8th edition 2013 requires investigators, teachers and animal facility managers to promptly notify the Flinders University Animal Welfare Committee (AWC) of any unexpected adverse event that may impact on the wellbeing of an animal in their care.
In addition, in the event that an animal dies unexpectedly or is euthanized due to unforeseen complications, a post-mortem examination must be performed by a person with appropriate qualifications and/or experience or the Animal Welfare Officer, and the AWC must be notified promptly (See clause 3.3.24). Requirements of the Code are also embedded in the Animal Welfare Act, 1985 under Part 4 – ‘Teaching and research involving animals’. More generally, all persons involved in the care of animals used for scientific purposes have a duty-of-care towards those animals to take action to minimize pain and suffering. This means that anyone who notices that an animal is showing signs of distress should report it immediately to the Animal Welfare Officer (0450 424 143) AND the Chief Investigator (CI).