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Animal Ethics Conduct of Projects Procedure

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Section 1 - Purpose

(1) The purpose of this procedure is to document how Animal Ethics Projects should be conducted.

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Section 2 - Scope

(2) This procedure applies to all;

  1. Melbourne Polytechnic staff, Students and any persons involved in the care and use of Animals for Teaching Activities and research purposes, and
  2. all Project Participants, including Project Investigators (formally referenced as Project Co-ordinators).
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Section 3 - Procedure

Animal Ethics Project Application and Approval Procedure

(3) All Animal care and use for the purposes of Teaching Activities and research requires Animal Ethics approval. In accordance with Melbourne Polytechnic’s Delegations and Authorisation Instrument delegations’ relating to Animal Ethics approvals can only be exercised by the Animal Ethics Committee (AEC). Approval is based upon the principle that the intended Animal use activities (Animal Ethics Projects), must comply with the Code and Act. Animal Ethics approval by the AEC also requires consideration of the following:

  1. using Animals only where it is justified;
  2. ensuring the principles of Replacement, Reduction and Refinement (the 3Rs) are followed at all stages of Animal care and use. This includes implementation of strategies to ensure:  
    1. Reduction in the number of Animals used;
    2. Replacement of Animals with alternatives;
    3. Refinement of techniques used to minimise the impacts on Animal Wellbeing;
  3. avoiding or minimising harm, including pain and distress, to Animals;
  4. current best practice in supporting and safeguarding Animal Wellbeing; and
  5. whether the Animal Facility / Farm Manager has been made aware of the requirements of approved Applications.

(4) The Project Investigator is responsible for the Animal Ethics application, which is undertaken by developing an ‘Animal Ethics Project’. The Animal Ethics Project is described within the Animal Ethics Project Proposal form and any supporting documentation. AEC approval decisions are based upon the information provided in the Animal Ethics Project Proposal Application.

(5) In completing the Animal Ethics Project Proposal form the Project Investigator must undertake the following tasks:

  1. review the Code. In particular, the Project Investigator should pay close attention to the following Sections of the Code and Animal Ethics Policy and ensure review of the following:
    1. Section 2: Responsibilities;
    2. Planning Projects.
    3. Section 4: The care and use of Animals for the achievement of educational outcomes in science; and
    4. Section 3: Animal Wellbeing;
  2. provide a summary of the Project (summary section) along with a detailed description of the intended Animal use activates in the Animal Ethics Project Proposal form;
  3. ensure that all intended Project Activities are consistent with the Code and the Act;
  4. detail Project participants, ensuring they are qualified, experienced and are aware of obligations within the Code and the Act;
  5. clearly describe details of the Animals including species, sex, age, Animal number, Animal use location, Animal housing, repeated use frequencies and justifications;
  6. provide an assessment of the potential impact on the animals;
  7. prove an overview the potential teaching or scientific benefit of the project;
  8. complete all required sections of the form including the Declaration;
  9. ensure all language used in the form is clear, unambiguous and in plain English;
  10. submit the completed form to the AEC Executive Officer using the email address AnimalEthics@melbournepolytechnic.edu.au;
  11. take note that the Animal Ethics Application submitted 10 working days before a scheduled AEC meeting can be tabled for approval at the upcoming meeting.

(6) The Project Investigator is responsible for ensuring that no Animal Ethics Project will begin before written AEC approval is obtained.

(7) Project proposal number will be allocated by the AEC (contact the AEC Executive Officer via email AnimalEthics@melbournepolytechnic.edu.au for this information).
Refer: Planning Projects the Code.

(8) The AEC Executive Officer will be responsible for:

  1. registering all Applications;
  2. checking that all Applications are complete prior to submitting to the AEC;
  3. notifying the Project Investigator where Applications are not complete; and
  4. collating of Animal Ethics Project Proposal for AEC consideration.

(9) The AEC is responsible for approving Animal Ethics applications, by reviewing the intended Animal use (Animal Ethics Project Proposal form) and ensuring the Teaching Activity or research Activity complies with any relevant Policies the Code and the Act.

(10) The AEC in making Approval judgements must:

  1. determine if the proposed use of Animals is ethically acceptable and meets the requirements of the Code;
  2. make a judgment as to whether the potential effects on the Wellbeing of the Animals involved is justified by the potential benefits;
  3. ensure that decisions are made on the basis of consensus;
  4. ensure that declarations of Conflict of Interest, that may influence decision are appropriately dealt with in accordance with the AEC Terms of Reference and Code; and
  5. maintain confidentiality of contents of the Project proposal and discussion.

(11) The AEC members should review the following sections of the Code to assist with approvals:

  1. Section 1 for Governing Principles;
  2. Section 2 for Responsibilities;
  3. Section 3 for Animal Wellbeing considerations; and
  4. Section 4 for the care and use of Animals for the achievement of educational outcomes in science.

(12) The AEC Executive Officer will be responsible for:

  1. retaining and storage of all Project proposals submitted Applications;
  2. recording the AEC decision of the Animal Ethics Project (e.g. approved, approved with requirements or rejected);
  3. providing feedback to the Project Investigator if changes required prior to final approval and request Project Investigator to amend and resubmit proposal; and
  4. communicating in writing, the AEC decision and requirements to the Project Investigator.
  1. The Project Investigator will receive written notification of AEC decision from the Executive Officer, in which case:
  1. where AEC Project approval (including requirements) has been obtained, the Project Investigator can proceed to step 13; or
  2. where AEC has rejected the Project proposals, the Project Investigator is required to;
    1. ensure that that none of the Teaching Activity or research activities detailed in the Animal Ethics Project are undertaken;
    2. update the application (it is recommended that AEC feedback is incorporated); and
    3. proceed to step 1 of the Procedure and resubmission of the application will be required.

(13) The Project Investigator and all Project participants, can commence the Project once written approval is received from the AEC and conduct all aspects of a Project in accordance with the conditions and requirements of the AEC approval and any subsequent amendments made by the AEC.
Refer: Animal Ethics Use of Animals for Scientific and Teaching Purposes Guidelines for the use of Animals for scientific and teaching purposes in Projects.

(14) Where an Animal Ethics Project purpose is to support Melbourne Polytechnic Teaching Activities or research, Melbourne Polytechnic will be responsible for:

  1. ensuring that monitoring and assessment requirements adhere to the Code Clause 3.2: Animal care and management of Animals during their care and management. Melbourne Polytechnic will appoint staff to care for Animals, like the Animal Facility Manager or Farm Manager.
  2. housing and care of Animals adheres to the Code.
  3. evidencing of continuity of care of animals demonstrated by the Animal Facility Manager or Facilities Manager.

(15) Where teachers use Animals for Teaching Activities, the teacher has the responsibilities of an Project investigator (see the Code, Clause 4.9 – 4.14).

(16) The Project Investigator is responsible for:

  1. ensuring that project monitoring progress is undertaken and that records are maintained;
  2. maintaining and storage of the project records in a dedicated Animal Ethics Projects Teams site and managed in accordance with MP Records Management Policy, Procedure and Guidelines;
  3. ensuring that monitoring and assessment requirements cited in step 14 adhere to the Code Section 3.2: Animal care and management monitoring and assessment of Animals.
  4. that Animals used in Projects have been appropriately housed and care for, as described in the Code, Housing and Care Subsection of 3.2;
  5. addressing and recording any issues that may arise, for example Unexpected Adverse Events.  Refer to the Animal Ethics Complaints, Non-Compliance and Adverse Events Procedure;
  6. providing an annual progress report to the AEC, that includes Progress with objectives. Animals used and Animal Welfare concerns. Email reports using AnimalEthics@melbournepolytechnic.edu.au;
  7. providing provisions for Animals at the conclusion to their use as described in clause 3.4 of the Code;
  8. providing provisions for Animals at the conclusion of their use;
  9. promptly recording provisions for animals at the conclusion to their use to the AEC as described in the Code Clause 3.4. Complete the Animal Ethics Project Summary Form to record provisions; and
  10. submitting the completed Animal Ethics Project Summary Form to the AEC by emailing the Executive Officer at AnimalEthics@melbournepolytechnic.edu.au. for tabling and discussion at next AEC meeting.

(17) The AEC will review Project annual reports and determine if Activity continues, is suspended, modified or discontinued.

(18) The AEC Executive Officer will inform the Project Investigator of AEC Project review outcomes within 10 working days.

(19) The Project Investigator must cease the conduct of a Project or any part of a Project if approval from the AEC is suspended or withdrawn.

Amendments to Approved Project Procedure

(20) The Project Investigator is required to identify amendments to the approved Project. Amendments may include:

  1. changes to the number or type of Animals used;
  2. changes to Project Investigators;
  3. changes to Facilities;
  4. requesting to extend approval timeframe; and
  5. changes that are not likely to cause harm to the Animals, including pain and distress.

(21) The Project Investigator is required to complete and submit a revised proposal form to AEC Executive Officer. Refer to the Animal Ethics Project Proposal.

(22) The AEC Executive is required to:

  1. consider the amended proposal to determine if the amendment is ethically acceptable and meets the requirements of the Code and the Act;
  2. approve/not approve the amended proposal; and
  3. ratify approval at the next AEC meeting.

(23) The AEC Executive Officer is required to advise the Project Investigator of the outcome within 5 working days of AEC decision.

(24) The Project supervisor can continue the Project once approval has been received from the AEC Executive.

Monitoring the Care and Use of Animals Procedure

(25) The AEC monitors the care and use of Animals by inspecting Animals, Animal housing and the conduct of Procedures, and/or reviewing records and reports.

(26) The AEC is responsible for establishing a schedule for monitoring all activities relating to the care and use of Animals (including the acquisition, transport, breeding, housing and husbandry of Animals) on a regular and ongoing basis to assess compliance with the Code and decisions of the AEC.

(27) The AEC is responsible for monitoring project activities. If any problems or issues are identified, the AEC discuss with Project investigator.

(28) The AEC is responsible for conducting inspection visits including recording the names of attendees, observations, any identified problems, recommended actions, ongoing or outstanding issues, and outcomes. The AEC is responsible for identifying any Non-Compliance and assessing severity of breaches. For additional information, please refer to Animal Ethics Complaints, Non-Compliance and Adverse Events Procedure.

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Section 4 - Responsibility and Accountability

(29) All Melbourne Polytechnic staff, Project Investigators, Project participants, students and AEC members must comply with the Code and the Act.

(30) The Project Investigator is responsible for:

  1. Animal Ethics Projects complying with the Code and the Act;
  2. seeking AEC approval for Projects where Animals are used for the purpose of Teaching Activities or research involved in the care and use of Animals for Teaching Activities and research;
  3. Animal Ethics Project Applications (including completion of the Animal Ethics Project Proposal forms and timely submission to the AEC);
  4. following all AEC Project requirements and making sure records are available to Melbourne Polytechnic, AEC and any external reviewers;
  5. obtaining a written approval from the AEC before commencing a Project/s,
  6. ensuring that only Projects with AEC approval commence and run. Projects should only be conducted in accordance with the conditions and requirements of the AEC approval and any subsequent amendments made by the AEC;
  7. providing all Project participants with a copy of the approved Project Proposal before any Animal Teaching Activity or research activities commence. The information provided must include AEC conditions and requirements for the project.
  8. ensuring all Project records and reporting requirements are adhered to, including the Annual Project report, Animal Use Returns and reporting of issues like Unexpected Adverse Events;
  9. identifying Project amendments and requesting the AEC approval to identified amendments; and
  10. Upon project competition, complete and submit the Animal Ethics Project Summary Form to the AEC.

(31) The AEC members are responsible for:

  1. reviewing, considering and approving of Project Applications;
  2. Project approval judgements;
  3. providing feedback for the Project Investigator;
  4. establish monitoring schedules;
  5. monitoring of Project activities, including issues described as Unexpected Adverse Events;
  6. reviewing of annual Project reports;
  7. considering making judgements on Project amendments, approve and ratify at the next AEC meeting.
  8. conducting and recording inspection visits; and
  9. Identify any Non-Compliance and assessing severity of breaches.

(32) The AEC Executive is responsible for:

  1. registering all Project Applications;
  2. checking Project Applications are complete prior to submitting to AEC;
  3. providing in writing AEC feedback and judgments to Project Investigators, that include:
    1. Animal Ethics Project Approval Outcomes including AEC Project conditions and requirements; and
    2. AEC Project Amendment Decisions
  4. recording AEC inspection visit requirements; and
  5. collating and storing all Project Application and AEC records.

(33) The AEC Executive Officer is responsible for:

  1. providing support and advice to Project Investigator proposal;
  2. registering of all Applications;
  3. checking Applications are all complete prior to submitting to AEC, and where they are not complete, following up with the Project Investigator;
  4. Provide feedback to Project Investigator where changes are required prior to final approval. Requesting that the Project Investigator implement these changes into the Project Application and resubmit proposal;
  5. advising in writing the AEC Project assessment outcome to the Project Investigator, within 10 working days;
  6. advising the Project Investigator in writing the outcome of Project amendments within 5 working days of AEC decision;
  7. contacting the Project Investigator to alert them of the Project end period;
  8. supporting the AEC with monitoring Project Activity requirements, where problems or issues arise, that may need to be addressed;
  9. supporting the AEC in the development of monitoring schedules;
  10. forwarding all report templates as required including the Animal Ethics Project Summary Form to Project investigators, including deadline return dates;
  11. upon request, provide Melbourne Polytechnic Education Department(s) with information to staff and AEC members;
  12. supporting the AEC with Complaints, Non-Compliance and Unexpected Adverse Events of Projects;
  13. assisting with the AEC agenda setting and supporting AEC meetings with administrative duties; and
  14. Maintaining and storing AEC records, including but not limited to, AEC meeting organisation, AEC meeting record keeping, maintaining the meeting action lists, annual Melbourne Polytechnic and Department required reporting. Records must be stored in a dedicated Animal Ethics Projects Teams site and managed in accordance with MP Records Management Policy, Procedure and Guidelines.

(34) All named Project personal, including Melbourne Polytechnic teaching and Animal care staff, are responsible for:

  1. only participating in Projects that have been granted Animal Ethics approval by the AEC;
  2. obtaining (from the Project Investigator) and reviewing the Animal Ethics Project application, adhering to all AEC conditions before Project Activity commences;
  3. obtaining (from the Project Investigator) and reviewing AEC approved amendment notifications.
  4. ensuring that only Projects with AEC approval commence and run. Projects should only be conducted in accordance with the conditions and requirements of the AEC approval and any subsequent amendments made by the AEC;
  5. providing the Project Investigator with Project details for records and reporting requirements. Reporting requirements may include the Annual Project report, Animal Use Returns and the reporting of issues like Unexpected Adverse Events. Requested information should be provided in a timely manner;
  6. ensuring that AEC approved project amendments are undertaken; and
  7. providing upon Project competition, the Project Investigator with requested information that is required for the Animal Ethics Project Summary Form.
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Section 5 - Supporting Documents and Template

(35) Related Melbourne Polytechnic policies and procedures:

  1. Animal Ethics Conscientious Objection Procedure
  2. Animal Ethics Complaints, Non-Compliance and Adverse Events Procedure
  3. Animal Ethics PolicyRecords Management Policy
  4. Records Management Procedure 
  5. Student Complaints Policy and procedure

(36) Related Forms:

  1. Planning Projects
  2. Animal Ethics Project Proposal
  3. Animal Ethics Project Summary Form
  4. Animal Ethics Return Reporting Template.

(37) Related Terms of Reference:

  1. Animal Ethics Committee

(38) Related Legislation and Regulation:

  1. Australian code for the care and use of animals for scientific purposes 8th edition 2013Prevention of Cruelty to Animals Act 1986 (POCTA)
  2. Prevention of Cruelty to Animals Regulations 2008

(39) Related Guidelines:

  1. Animal Ethics Use of Animals for Scientific and Teaching Purposes Guidelines
  2. Records Management Guidelines.
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Section 6 - Definitions

(40) For the purpose of this procedure the following definitions apply:

(41) Act: Prevention of Cruelty to Animals Act 1986 (Vic).

(42) Activity: Any action or group of actions undertaken that involves the care and use of Animals, including acquisition, transport, breeding, housing and husbandry of those Animals. An activity may involve one or more procedures. Activities are described in an Application to the AEC. See also ‘Project’.

(43) Animal: Any live non-human vertebrate (that is, fish, amphibians, reptiles, birds and mammals encompassing domestic animals, purpose-bred animals, livestock, wildlife) and cephalopods.

(44) Animal Ethics Committee (AEC): A committee constituted in accordance with the terms of reference and membership laid down in the Code.

(45) Animal Ethics Project Proposal: The AEC approval Application that documents the Project or Activity.

(46) Animal Welfare: An Animal’s quality of life, which encompasses the diverse ways an animal may perceive and respond to their circumstances, ranging from a positive state of wellbeing to a negative state of distress.

(47) Application/s: A request for approval from AEC to carry out a Project or Activity. An Application may be for commencement of a Project or Activity, or an amendment to an approved Project or Activity.

(48) Code: Australian Code for the care and use of animals for scientific purposes 8th edition 2013 (updated 2021), described as ‘The Code’.

(49) Compliance: Acting in accordance with the Code and the Act.

(50) Conflict of Interest: A situation in which a person’s individual interests or responsibilities have the potential to influence the carrying out of his or her institutional role or professional obligations, or where an institution’s interests or responsibilities have the potential to influence the carrying out of its obligations.

(51) Ethics: A framework in which actions can be considered as good or bad, right or wrong. Ethics is applied in the evaluation of what should or should not be done when Animals are proposed for use, or are used, for scientific purposes.

(52) Facility: Any place where animals are kept, held or housed, including yards, paddocks, tanks, ponds, buildings, cages, pens and containers.

(53) Non-Compliance or Non-Compliant: Failure to act in accordance with:

  1. the Code;
  2. the Act;
  3. any relevant regulations;
  4. approved by Melbourne Polytechnic's AEC; and
  5. Projects and standard operating Procedures.

(54) Monitoring: Measures undertaken to assess, or to ensure the assessment of, the Wellbeing of Animals in accordance with the Code. Monitoring occurs at different levels (including those of Project Investigators, Animal carers and AECs).

(55) Project: An Activity or group of activities using Animals for Teaching Activities or research purposes that have been given approval by AEC.

(56) Project Investigator: Any person who uses Animals for Scientific Purposes. Includes researchers, teachers, undergraduate and postgraduate students involved in research projects, and people involved in product testing, environmental testing, production of biological products and wildlife surveys.

(57) Reduction: methods for obtaining comparable levels of information from the use of fewer Animals in Scientific Procedures or for obtaining more information from the same number of Animals.

(58) Refinement: methods that alleviate or minimise potential pain and distress, and enhance Animal Wellbeing.

(59) Replacement: methods that permit a given purpose of an Activity or Project to be achieved without the use of Animal

(60) Scientific Procedures: Include the use of animals for:

  1. acquiring, demonstrating or developing scientific knowledge
  2. acquiring, demonstrating, developing or exercising scientific techniques
  3. developing or testing the use, hazards, safety, or efficiency of vaccines, substances, drugs, materials or appliances intended for use in connection with human beings or Animals.

(61) Scientific Procedures Premises Licence: A scientific procedures premises licence (SPPL) authorises the licence holder to use animals for research, teaching or testing in Victoria, at the sites nominated on their licence, under the approval of a nominated Animal Ethics Committee.

(62) Scientific Purposes: All activities conducted with the aim of acquiring, developing or demonstrating knowledge or techniques in all areas of science, including teaching, field trials, environmental studies, research (including the creation and breeding of a new animal line where the impact on animal wellbeing is unknown or uncertain), diagnosis, product testing and the production of biological products.

(63) Teaching activity: Any action or group of actions undertaken with the aim of achieving a scientific purpose, where the scientific purpose is imparting or demonstrating knowledge or techniques to achieve an educational outcome in science, as specified in the relevant curriculum or competency requirements.

(64) Wellbeing: An animal is in a positive mental state and is able to achieve successful biological function, to have positive experiences, to express innate behaviours, and to respond to and cope with potentially adverse conditions. Animal wellbeing may be assessed by physiological and behavioural measures of an animal’s physical and psychological health and of the animal’s capacity to cope with stressors, and species-specific behaviours in response to social and environmental conditions.