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Managing your approved animal research ethics application

All applications are approved with standard conditions of approval. In addition to the standard conditions of approval, investigators must comply with the below, as well as ensuring any further specific conditions of approval are met prior to the research or activity commencing:

  • The Animal Welfare Act indicates that any investigator at a field site must have a copy of the ECU Licence to Use Animals for Scientific Purposes with him or her at the field site. Please ensure that you carry a copy of the licence when you are undertaking any field work.
  • The start and end dates of any fieldwork must be disclosed to DPIRD prior to the commencement of any scientific use of animals at field work locations. The DPIRD Notification Form must be completed and returned when notifying DPIRD of these details. If you have an approved project but do not have a copy of the License or the DIIRD Notification Form please contact the research ethics team (RET)

Monitoring

All research and teaching activities involving animals are approved subject to compliance with monitoring procedures as defined by The Australian Code for the Care and Use of Animals in Research. Monitoring is the process of verifying that the conduct of research or activity conforms to the approved ethics application.

Institutions are responsible for ensuring that the research or activity is reliably monitored and establishing that a research project or activity is being, or has been, conducted in the manner approved by the Ethics Committee. The Code affirms that “the AEC must monitor all activities relating to the care and use of animals on a regular and ongoing basis to assess compliance with the Code and the AEC.” (section 2.3.18)

Monitoring for approved animal ethics projects involves completion of an annual progress report (if your project is longer than one year), completion of a final report at the end of your project, welfare monitoring forms, and potentially post-approval monitoring by an independent party. The AEC decides on a case-by-case basis if post-approval monitoring is required.

An Annual Statistical Return is also required to comply with the regulations under the WA Animal Welfare Act. Guidelines are available to assist with completing the Annual Statistical Return.

You will be notified when a report is due and will need to complete the Ethics Report Form. The same form can be used for either an annual progress report or a final report.

The Ethics Committees also reserve the right to adopt any additional appropriate mechanism for monitoring approved research projects.

Extension of ethics approval

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 Ethics Committee – before the original approval expires. Please note, the Committee does not extend projects for more than 1 year per request. The only exception being when tissue or samples have already been collected and stored.

To request an extension of ethics approval, please complete the required section of the Ethics Report Form with clear reasons why the extension is needed and giving the new expected date of completion. If your ongoing project has already collected tissue/specimens and/or wants to hold these for an extended period of time, you may be exempt from applying for an extension provided no new specimens will be collected. Please indicate in your annual report if you are holding tissue or specimens collected under a valid permit and will not be collecting any new specimens or tissue samples.

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 the welfare of the animals and/or that may have ethical implications must be reviewed and approved by the Ethics Committee before commencement.

To request approval for a change, please complete the Amendment to an Approved Animal Ethics Project form and send it to the Research Ethics Team.

The Amendment to an Approved Animal Ethics Project form can be used to request approval for both minor and major amendments.

  • A minor amendment is a change to the project that does not increase the impact on the animals.
  • A major amendment is a change that is likely to increase the impact on the animals and/or affect their welfare in a more negative manner.

Adverse or unforeseen events

Definition of an adverse event

An adverse event is any event that has a negative impact on the wellbeing of an animal.

An unexpected adverse event is an event that may have negative impact on the wellbeing of animals and was not foreshadowed in the approved project or activity. For example, death of an animal, or group of animals, that was not expected (e.g. during surgery or anaesthesia, or after a procedure or treatment).

An unexpected adverse event may result from different causes, including but not limited to:

  • 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.

Required action

Investigators are required to immediately report unexpected adverse events to the Animal Ethics Committee most appropriately within 24 to 48 hrs of the event. The Committee understand that field work being done in remote locations may experience delays in reporting. This immediate action should comprise of an email notification to the Research Ethics Team and later followed by the completion and submission of the Adverse Event Report form.

If the event is of a serious nature, the researcher/investigator should immediately consider the temporary suspension of research or activity until the situation has been investigated by the Animal Ethics Committee.

Investigators must also immediately report unforeseen events that might affect continued ethical acceptability of the project

All unexpected animal research adverse events need to be reported to the Research Ethics Team using the Adverse Event Report Form.

This reporting needs to take place as soon as practicable after the event occurs and should also form part of your project’s annual and final reporting.

If a serious unexpected adverse event has occurred, your project activity may immediately be suspended while the event is investigated by the Animal Ethics Committee. Historically most unexpected adverse events have been less serious in nature and only required minor amendments to rectify.

Should you require further guidance please contact the Research Ethics Team.

Risks posed by a delay in reporting

Delays in reporting an adverse incident or event may result further impacts, such as:

  1. Breach of obligations under the Australian code for the care and use of animals for scientific purposes;
  2. Breach of ECU’s Duty of Care; and
  3. Breach ECU’s Duty of Disclosure obligations to its Insurers, requiring notification of any incidents that   may give rise to a claim as soon as reasonably practicable.
  4. Breach of Animal Welfare Act 2002
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