Managing Approved Projects
Scheduled Reporting
The Code requires consistent reporting to ensure continued accreditation.
The AEC can approve research projects for up to three years.
The authority to use animals is only valid for one year.
You must submit either a request for continuation or an end of project report. You must do this before the anniversary of the project approval.
It is your responsibility to submit the reports on time. You should check the dates of approval against AEC meeting and submission dates.
If you gain approval for your project but it does not proceed, you will need to submit an end of project report.
Changes to an Approved Project
You must notify the AEC immediately if you need to make changes to the project. This includes changes in personnel. You must submit a Project Modification form to the next AEC meeting. You must identify what you need to change for each individual project.
Unexpected adverse events/ impacts
The Code defines an unexpected adverse event as “an event that may have a negative impact on the wellbeing of animals and was not foreshadowed* in the approved project or activity.
An unexpected adverse event may result from different causes, including but not limited to:
- death of an animal, or group of animals, that was not expected (e.g., during surgery or anaesthesia, or after a procedure or treatment).
- adverse effects following a procedure or treatment that were not expected.
- adverse effects in a larger number of animals than predicted during the planning of the project or activity, based on the number of animals actually used, not the number approved for the study.
- a greater level of pain or distress than was predicted during the planning of the project or activity.
- power failures, inclement weather, emergency situations or other factors external to the project or activity that have a negative impact on the welfare of the animals.”
It is the responsibility of the chief investigator to take “prompt action, including alleviating pain and distress and promptly notifying the AEC, in response to unexpected adverse events and emergencies, in accordance with institutional and AEC policies and procedures. Alleviating unanticipated pain and distress must take precedence over an individual animal reaching the planned endpoint of the project, or the continuation or completion of the project. If necessary, animals must be humanely killed without delay.”
If you do not have foreshadowed adverse events in your AEC application or if they were not approved, then all adverse events will be treated as unexpected and must be reported promptly. They should be reported to the Animal Ethics Partner using the Unexpected Adverse Event Report.
It is important to note that all adverse events, whether foreshadowed or unexpected, must be reported in the annual and end-of-project reports. In addition, all animal outcomes must be reported in the statistics for each state that which the projects were carried out. Ongoing animal monitoring and record keeping is essential as well as scrutiny as to whether an event is classified as unexpected to ensure the wellbeing of animals is supported.
For more information on Adverse events, reporting, necropsy requirements or incorporating expected adverse events into your application refer to the Charles Sturt Guidelines on Adverse Events or contact the Animal Welfare Officer.