3 Rs

The guiding principles of the 3 Rs: Replacement, Reduction and Refinement, in all aspects of the care and use of animals, are:

  • Replacement - methods that replace or partially replace the use of animals.
  • Reduction - methods for obtaining comparable levels of information from the use of fewer animals in scientific procedures and/or for obtaining more information from the same number of animals.
  • Refinement - methods that alleviate or minimise potential pain and distress, and enhance animal wellbeing.
 

Activities of special ethical concern

Investigators must plan to give special consideration and attention to the conduct of activities of special ethical concern because of the potential risks to animal wellbeing. These include:

  • unrelieved pain and/or distress and planned endpoints that allow severe adverse effects to occur;
  • death as the endpoint; and
  • re-use and repeated use of animals.

Death as an endpoint

Death as an endpoint is defined in the Animal Code as follows: When the death of an animal is the deliberate measure used for evaluating biological or chemical processes, responses or effects, that is, where the investigator will not intervene to kill the animal humanely before death occurs in the course of a scientific activity.

  • If the death of an animal is the result of planned humane killing at the conclusion of the project, it is not ‘death as an endpoint’.
  • If an animal dies unexpectedly during the course of the research, it is not ‘death as an endpoint’.
  • If an animal unexpectedly deteriorates to the point where it is required to be humanely killed, it is not ‘death as an endpoint’.
The most common situation in the past for ‘death as an endpoint’ was in toxicity studies. Protocols must be designed to avoid death as an endpoint unless it is critical to the aim/s of the project. Rigorous justification must be provided if the proposed study incorporates death as an endpoint e.g. why humane endpoints cannot be inserted prior to death. It is rare for procedures to be approved with death as an endpoint.
 

Adverse event or Unexpected death and humane killing

The Technical Resources Manager is authorised to prevent or halt the handling of animals by any person deemed to lack competency or to compromise the wellbeing of an animal. The AEC Chair and Research Ethics and Integrity must be advised promptly of such incidents. The Chair will advise the AEC by the latest at the next ordinary meeting.

Adverse events

The AEC must be notified promptly of any adverse events. Such events may include (but are not limited to) animal illness, unanticipated reactions of animals, unexpected results that impact on animals, or delays to the protocol.

Unexpected deaths or humane killing

The Chief Investigator is authorised by the AEC to carry out the emergency treatment or humane killing of any animal. If consultation is necessary, or if an external over-riding authority is required, the AEC delegates the Chair, the Animal Ethics Advisor, or Animal Welfare Officer as persons with appropriate authority.

Suitable humane killing techniques must be applied at all times. Use of drugs, such as pentobarbitone by students in the field, must be under the supervision of personnel skilled and experienced in the technique.

It is a requirement that a necropsy or post mortem of the animal is arranged, unless there is special exemption from the AEC. The Chief Investigator and co-investigators are not to perform necropsy examinations of animals that are part of their own project or activity, although they are permitted to be present. The necropsy examination must be conducted by someone competent, suitably qualified and independent of the project.

Investigators undertaking fieldwork are not exempt from this requirement. For wildlife studies where the target species or trapped animal dies, and the cause of death is not immediately obvious (e.g. predation), necropsy needs to be conducted.

Investigators, including those undertaking fieldwork, must notify the AEC within 2 working days of the event if any animal becomes terminally ill, dies unexpectedly or needs to be humanely killed, using the Amendments, Adverse Events and Unexpected Deaths form on IRMA. It is not sufficient to notify the AEC through the Annual Report.

Where an independent evaluation is not provided, the Chief Investigator should advise the reason for not seeking this option.

Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals provides information on accepted techniques such as anaesthetics or humane killing.

Amendments

Investigators must apply to the AEC, using the Amendments form on IRMA, for amendments to any change to the approved animal ethics application and/or AEC conditions e.g. in protocol, housing or animal numbers.

The conditions for amendments to projects and activities are as follows:

1.   A limit of three amendments applies for the duration of the permit, excluding changes to co-investigators. A fourth amendment may be granted by the AEC under extenuating circumstances.

2.   If a change in Protocol is instigated by the AEC, the Chair or delegate, a formal amendment is not required. The change must be noted and agreed to by the Chief Investigator, and a record made on the Protocol in the notes section.

In exceptional cases, where an urgent change is required, the Executive Committee may assess the amendments. If it is a minor amendment, the Executive Committee can approve it. If the amendment is major, then it will be recommended to the AEC for deliberations.
 

Animal Competency and Experience registration

Investigators must complete the University of Western Australia's 'Introduction to working with animals in research and teaching' online module before enrolling in the Animal Ethics Training Workshop.

This registration must be noted on the application form and the certificate sent to the Animal Ethics Assistant.

Other permits or licences

Other required permits and licences from relevant organisations must be obtained and attached to the application.

For applications involving the use of animals interstate or overseas, the investigator must contact Research Ethics and Integrity immediately as there may be a requirement for additional licensing to be undertaken (see also Collaborative projects or activities).
 

Animal requirements

The investigator must provide realistic estimates of required animals, including a rationale for the numbers, to the AEC. If pregnant animals are requested, an estimate of live young must also be provided separately.

Investigators must order live animals for housing in the Animal House or laboratories using the Animal Ethics Animal Order form. A minimum of 3 days must be allowed for this process.

Consider the application of the 3 Rs in determining your animal requirements.
 

Annual Report

The Annual Report is due early each year via IRMA. Please refer to the Key Dates for each year's submission. Investigators will receive a reminder before this deadline. If the investigator is late with the submission, there MAY be a warning.

Failure to meet this requirement jeopardises Murdoch University's licence to conduct animal work. Further, failure to submit the Annual Report contravenes the Animal Code. For these reasons, the AEC takes this requirement very seriously and investigators who fail to meet it may have their ethics approval:

  • suspended; or
  • withdrawn.
If the ethics approval is suspended, the following may apply:

  • access to new animals is suspended;
  • all work using existing animals must cease;
  • the Chief Investigator must apply in writing to the next ordinary meeting of the AEC to re-instate the ethics approval;
  • work using existing animals must not re-commence unless the ethics approval is re-instated.
If the ethics approval is withdrawn, the following apply:

  • access to new animals is withdrawn;
  • all work using existing animals must cease;
  • the Chief Investigator must submit a new application to the AEC at the next ordinary meeting;
  • work using existing animals must not re-commence unless the new ethics application is approved.

As failure to submit the Annual Report jeopardises the University's licence and reputation, the School Dean and Deputy Vice Chancellor (Research) will be informed of the breach.

Cadavers and animal tissue

The use of cadavers or animal tissues helps Murdoch University's developing record of efforts to reduce the use of live animals. The AEC's central concern in the use of cadavers or tissue samples is their provenance.

Where animals are obtained as cadavers or where only animal tissue samples are obtained from third parties (e.g. samples from abattoirs, tissues from another use, fish frames from fishers), investigators must notify the AEC as part of their animal ethics application via the Research or Teaching Application form and the Cadaver and Tissue questionnaire on IRMA BEFORE the use of the cadaver or tissue samples commences. Details required are:

  • source of animal (include AEC permit number, if known);
  • proposed use;
  • samples or procedures to be done;
  • learning outcome and student ratio (if used for teaching); and
  • storage and disposal.

This notification includes the use of cadavers or tissue samples on campus or by personnel off campus, and includes those engaging in teaching activities. Please contact the Animal Ethics Advisor to ensure that the exemption applies to the work being considered. If any of the investigators had a part in humanely killing the animal, or deciding which animal was to be killed to obtain the cadaver or tissue sample, then a full ethics application is usually required.

Collaborative projects or activities

Australian collaborations

Investigators intending to conduct collaborative projects or activities with other Australian institutions must check that an Inter-Institutional Agreement (IIA) is in place to formalise the collaboration between the participating institutions.

Investigators are responsible for seeking ethics approval from their respective AEC.

An investigator who has obtained animal ethics approval from another AEC may apply to the Murdoch University AEC using the Research or Teaching form, and selecting the Reciprocal Approval (Non Standard Approval) questionnaire, on IRMA. The questionnaire will guide you as follows:

  • if not all of the animal work is to be conducted at the other institution; or
  • if all of the animal work is to be conducted at the other institution/s. If so, a copy of the full application submitted to the other institution/s and a copy of the approval letter must be submitted for noting to the Murdoch AEC. The application still needs to be approved by the Murdoch University AEC BEFORE work may commence. The investigator must check with the Animal Ethics Advisor that the other AEC is constituted in accordance with the Animal Code.
Each project or activity must have its own Memorandum of Agreement (MOU) to establish an agreement between the Ethics Officers of the relevant institutions to outline each AEC’s responsibilities (e.g. care and transportation of animals, site visits, who undertakes to monitor the project, report the animal use or receive adverse events reports).

If the collaborating institution is from another state, special licence/s may be required. AEC approval is conditional on a valid Animal Use Licence (or equivalent) being held by any collaborating institution for the state in which animal use will occur. Please check with the Animal Ethics Advisor regarding this and any other requirements.

For fish studies where Murdoch University's AEC is the sole AEC but the fish are housed at other institutions, the Murdoch University AEC reserves the right to inspect the premises and husbandry arrangements prior to approving the ethics application.
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International collaborations

International applications are assessed on a case-by-case and per jurisdiction basis.

The Animal Code requires confirmation of compliance with codes, laws and practices equivalent to those in Australia, and detailed assurance that the wellbeing of the animals will be suitably monitored and maintained.

Investigators should ensure the application addresses how the principles of the Animal Code are met, taking compliance with local requirements into consideration.

  • Where applicable, a copy of the local 'AEC' approval from the collaborating institution or organisation is required.
  • Photographs of facilities may be attached to the application.
  • Applications must also submit a plan for monitoring the health and wellbeing of the animals, including site inspection/s by the Australian AEC or its delegate.
  • The AEC may request for additional reporting requirements beyond the standard Annual Report.

Inspections and approvals

Murdoch University's AEC will ensure that appropriate inspections and approvals of premises and husbandry arrangements are conducted. This task may be conducted directly, delegated or in negotiation with another institution as deemed relevant for particular facilities and locations.

Investigators

An investigator is any person who uses animals for scientific purposes such as researchers, teachers, undergraduate and graduate students and any person involved with product and/or environmental testing, production of biological products and wildlife surveys.

The Chief Investigator named on the ethics application must be a Murdoch University staff member able to take ultimate responsibility for the project or activity. This Chief Investigator must:

  • ensure that all people involved in the project or activity understand and accept their roles and responsibilities;
  • ensure that procedures and resources are in place so that all people involved in the care and use of animals in the project or activity can meet their responsibilities, including their education, training and supervision, as appropriate; and
  • be competent with respect to the wellbeing of animals used in the project or activity.
While the Chief Investigator has ultimate responsibility for the project or activity, this does not relieve the individual responsibility of each investigator involved.

The Principal Supervisor must submit the ethics application on behalf of graduate research students who are not members of Murdoch University staff (although the students may be expected to do the preparation). In particular circumstances, as approved by the AEC, a graduate research student may be granted the position of joint Chief Investigator with their Supervisor.

All persons with a significant role in animal handling or development of a Protocol must be listed as co-investigators. If your project has administration officers who need access to the project's Protocol (approved ethics application), add them as 'Other' investigator types on your application.

Investigators wishing to remove or include additional co-investigators on an existing project or activity must complete the Amendments form on IRMA. Change of Chief Investigators is also made via this form.

ACE Registration

Research Ethics and Integrity is required under the Animal Welfare Act, 2002 to maintain an up-to-date Register of all people involved in animal use at Murdoch University. This must be regularly updated by investigators to ensure details are current.

To be included on the Register, investigators must complete the University of Western Australia's 'Introduction to working with animals in research and teaching' online module as a prerequisite to attending the Animal Ethics Training Workshop.

Investigators who are registered at other institutions may also be required to register with Murdoch University.

Monitoring and inspections

Monitoring is the concept used by the Animal Code for everything done by investigators, animal carers and the AEC to ensure the assessment of animal wellbeing once a project or activity has commenced. Monitoring occurs at different levels and at all stages.

To monitor the animals, investigators and animal carers should complete the Report on Animal Usage form via IRMA.

  • Investigators and animal carers must take appropriate action based on the ongoing assessment of the animals' wellbeing.
  • Investigators and animal carers must also maintain such records of the animals for audit by Murdoch University, the AEC and authorised external reviewers.
While the investigator and animal carers hold the primary responsibility for day-to-day monitoring, the AEC also has obligations.

The AEC and/or delegate may monitor a Murdoch University project or activity by visiting the site, and AEC members will do this at least annually. Investigators are expected to have all animal records available for the AEC to verify that adequate records are maintained in compliance with the Animal Code. Visits are usually pre-arranged, but can also be unannounced.

The AEC delegate (usually the Animal Welfare Officer) makes regular visits to the Murdoch University farms, Animal House and other facilities where animals are kept.

Visits from the Animal Welfare Officer, who is usually a veterinarian, present a helpful way of obtaining positive affirmation or veterinary advice in-situ. This can assist with refinements to the project and may speed up the process for any amendment applications. The visits also offer investigators valuable opportunity to provide feedback to the AEC. The core purpose of this process is animal wellbeing.

Where site visits are not possible, photographic, video and other records may also be reviewed by the AEC as part of their monitoring responsibility.

The AEC also visits animal housing and laboratory areas, at least annually. Identified problems or issues will be followed up.

The AEC may appoint a delegate to monitor and inspect the care and use of animals in projects conducted in another jurisdiction, country or remote location.

Apart from physical visits, animal use and numbers are also reviewed through the Annual Report. A summary of all annual reports is provided to the Department of Agriculture and Food (DAFWA) and to the National Health and Medical Research Council (NHMRC) as part of the University’s annual reporting obligations.

The AEC may also audit publications to check for compliance to ethical conditions.

The AEC is audited by an external panel at least every 4 years. Investigators are invited to contribute to this review process to assist with ongoing improvements.


Observational studies

Observational studies of live vertebrate animals and cephalopods require ethics approval. If your project or activity uses observation only, apply via IRMA using the Research or Teaching Application form and select the Observation Only questionnaire.
 

Privately owned animals

When privately owned animals are to be used for scientific purposes in a project or activity, the owner must be fully informed about the procedures involved and their consent must be obtained BEFORE the work commences. A copy of the consent form must be attached to the application.

Further guidance on the use of privately owned animals is available in the Animal Ethics Use of Privately Owned Animals for Scientific Purposes Guideline.

Provisions for animals at the conclusion of their use

Re-homing animals

Re-homing should be considered wherever possible especially if the project or activity has had minimal impact on the animal's wellbeing, and where the animal's condition indicate that its re-homing would have minimal or transient impact on its wellbeing.

Re-homing at the conclusion of a project or activity must NOT take place unless:

  • AEC approval has been granted;
  • safeguards are in place and AEC approval has been obtained to ensure the ongoing wellbeing of the animal; and
  • transport of animals between sites is in accordance with the Animal Code.
  • If an animal may be suitable for re-homing, contact the Animal Ethics Advisor to find out the best way to go about this. Each case is reviewed separately.
Return to normal husbandry conditions or natural habitat
The return of animals to normal husbandry conditions and the release of wildlife to their natural habitat must be in accordance with current best practice. Contact the Animal Ethics Advisor for details.

 

Humane killing

The humane killing of animals include methods and procedures that:

  • avoid pain or distress, and produce rapid loss of consciousness until death occurs;
  • are compatible with the purpose and aims of the project or activity;
  • are appropriate to the species, age, developmental stage and health of the animal;
  • require minimum restraint of the animal;
  • are reliable, reproducible and irreversible;
  • ensure that animals are killed in a quiet, clean environment away from other animals; and/or
  • ensure that death is established before disposal of the carcass, fetuses, embryos and fertilised eggs.
If the animal has dependent offspring, they must be cared for or humanely killed.

A necropsy must be performed by a competent person if humane killing was due to unforeseen circumstances.

Contact Research Ethics and Integrity IMMEDIATELY. The Amendments, Adverse Events or Unexpected Deaths form via IRMA must be completed within 2 days of the adverse event.

Reuse

The reuse of animals requires AEC approval which considers:

  • the pain and distress, and any potential long-term or cumulative effects, caused by previous activities and conditions;
  • the time allowed for the recovery of the animals between activities;
  • whether an animal has fully recovered from the previous activities;
  • the pain and distress likely to be caused by the next and subsequent activities; and/or
  • the total time over which an animal will be used.

Tissue sharing

If practicable, tissue samples from animals that have died or been humanely killed should be provided or made available to other investigators for their work, or deposited in a tissue bank for subsequent distribution.

Standard Operating Procedures

Investigators must develop Standard Operating Procedures (SOPs) where necessary. Investigators proposing to use a new SOP must submit the proposed procedure/s using the Standard Operating Procedure template on IRMA. While an investigator may be able to link their application to SOPs on IRMA, existing SOPs must also be attached to the ethics application if they are to be used in the project or activity.

Routine veterinary practices must be explained unless they are incidental to the application.
 

Statistics

Independent statistical evaluation should be provided for all projects and activities, unless one of the investigators is widely recognised for their statistical expertise. The independent statistician does not need to be listed as an investigator.

Wildlife projects

See also Unexpected Death - Humane Killing.

Trapping and netting wildlife

Investigators must account for and effectively manage the wellbeing of target and non-target animals in the trapping and netting of animals in wildlife projects and activities. If trapping is to be used for capture, the animal ethics application must include details on:

  • trap design (e.g. size and construction);
  • trap management to minimise negative impact on the animals (e.g. consideration of time spent in traps, protection of trapped animals from predators, parasites and environmental actors such as lack of water, high and low temperatures, and drowning, and lack of food and water);
  • minimisation of the number of days of continuous trapping and deactivating traps that are no longer used or required;
  • minimisation of potential negative impact caused by disruption of social structure and on dependent young (e.g. avoidance of trapping during the breeding season); and
  • minimisation of non-target species trapped and implementation of management plan for captured non-target species that is compliant with the Animal Code.
All trapping activities must be monitored in accordance with the Animal Code.

Estimating numbers when trapping wildlife

Estimating numbers for wildlife projects can be difficult and the AEC takes this into consideration. The ethics application should explain how the estimate was made and why it is not possible to be more accurate e.g. trapping has not been carried out in this area before. The investigator must keep the Animal Ethics Advisor regularly informed if the numbers exceed the estimate or animals not specified in the application are trapped.

Trapping and by-catch estimates are expected to be more accurate in the application for an annual ethics renewal.
 
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