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Section 1 - Introduction
(1) The University of Newcastle (University) recognises the value of research involving animals and supports the use of animals in research where:
- the welfare of research animals is assured;
- the principles of Replacement, Reduction, and Refinement (the 3Rs), and responsibilities as described in the Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition (2013) (the Code), and A Guide to the Care and Use of Australian Native Mammals in Research and Teaching are applied; and
- the research complies with the relevant legislation and is ethically sound with potential benefits to humans, animals, or the environment.
(2) In accordance with the Animal Research Act 1985 No 123 (the Act) and Animal Research Regulation 2021 (NSW) (the Regulation), the University will maintain accreditation as an animal research establishment.
(3) This Manual must be read in conjunction with the University's associated policies, applicable legislation, and any associated information regarding the use of animals in research, including but not limited to:
- Animal Research Act 1985 No 123;
- Animal Research Regulation 2021 (NSW);
- Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition (2013);
- Prevention of Cruelty to Animals Act 1979;
- Poisons and Therapeutic Goods Act 1966 No 31;
- Poisons and Therapeutic Goods Regulation 2008;
- Drug Misuse and Trafficking Act 1985;
University Policies and Guidelines
- Responsible Conduct of Research Policy;
- Collaborative Research Procedure;
- Research Peer Review Guideline for Ethics Applications;
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- Best Practice Methodology in the Use of Animals for Scientific Purposes (2018);
- Use of Animals in NHMRC Funded Research;
- A Guide to the Care and Use of Australian Native Mammals in Research and Teaching;
- Genetically Modified and Cloned Animals;
- PREPARE Guidelines for Planning Animal Research;
- Animal Research: Reporting of In Vivo Experiments (ARRIVE) Guidelines;
- Department of Primary Industries - The Use of Restricted Drugs and the Conduct of Restricted Acts of Veterinary Science in Animal Research.
Section 2 - Scope
(4) This Manual applies to the breeding, holding, and use of all animals at the University for the purposes of research, as defined by the Animal Research Act 1985 No 123. In this context ‘research’ includes teaching.
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Section 3 - Intent
(5) This Manual and its associated documents are designed to ensure that animal research at the University is conducted in an ethical manner and in accordance with legislation.
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Section 4 - Audience
(6) This Manual must be read and complied with by all personnel involved in research, animal care and use, including but not limited to Chief Investigators, Investigators (teachers and Researchers, including students), veterinary staff, Research Ethics and Integrity Unit staff, BioResearch Facilities staff, and the Animal Care and Ethics Committee.
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Section 5 - Document Specific Definitions
(7) In the context of this Manual, the following definitions apply:
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- “Acclimatisation period” means the length of time given to animals that are newly received by the University for physiological, behavioural and nutritional acclimatisation prior to their use in a research project. This period is a minimum of 5 days and is routinely between 5 and 7 days, unless otherwise approved by the ACEC.
- “Animal” means any live non-human vertebrate (that is, fish, amphibians, reptiles, birds, and mammals, encompassing domestic animals, purpose-bred animals, livestock, wildlife) and cephalopods.
- “Animal husbandry check” means the daily process conducted by BioResearch Facilities staff to ensure animals have food, water, and an appropriate environment. Animal husbandry checks do not include monitoring for predicted adverse effects or completing a Monitoring Checklist.
- “Animal Research Authority” means an authority issued to any individual to carry out animal research for the purpose of a particular research project (as outlined in the Act, Clause 25). The authority is issued by an accredited research establishment, in this case, the University.
- “Competent” as defined in the Code, means the consistent application of knowledge and skill to the standard of performance required regarding the care and use of animals. It embodies the ability to transfer and apply knowledge and skill to new situations and environments.
- “Investigator” means any person who uses animals for scientific purposes. It 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.
Section 6 - Animal Research Policy
Part A - The Animal Care and Ethics Committee
(8) The University:
- has established the Animal Care and Ethics Committee (ACEC), which is directly responsible to the Vice-Chancellor;
- ensures, through the ACEC, that all animal research conducted at the University complies with relevant legislation, national guidelines, and codes;
- provides the ACEC with the resources and authority to fulfill its terms of reference and operate as set out in the legislation; and
- accepts the responsibility to respond effectively to recommendations made by the ACEC to ensure that all animal research within the University remains in accordance with the legislation, national guidelines, and codes.
(9) The ACEC Terms of Reference are outlined in the ACEC Constitution.
(10) All animal research at the University must be approved by the ACEC prior to the research commencing. In accordance with the governing principles of the Code, the ACEC will only approve those research projects for which animals are essential, justified, and which conform to the requirements of the Code.
(11) In accordance with the Code and the Animal Care and Ethics Committee Procedure, the content of ACEC applications and deliberations remain confidential unless required to be shared under a collaborative agreement.
(12) The ACEC may identify other issues that, while outside their area of responsibility, are required to be considered by the University administration (e.g. reputational or indemnity issues). In such instances the ACEC must refer these matters to the Deputy Vice-Chancellor (Research and Innovation). Any such referral may impede the issuing of an Animal Research Authority.
Part B - Investigators
(13) Investigators must:
- be aware of their responsibilities in the Code Chapter 2.4;
- fully disclose and discuss ethical issues in research project applications;
- address the 3Rs in applications to the ACEC, and report any methods used to implement the 3Rs to the ACEC;
- be knowledgeable about the species to be used in their research project;
- justify the choice of species to the ACEC in terms of current knowledge about the species and its applicability to the proposed research methods and required outcomes;
- use quality design, statistical, and procedural methods of research practice as prescribed in Best Practice Methodology in the Use of Animals for Scientific Purposes 2018; and
- prior to applying for an Animal Research Authority, have completed animal research training required by the University or the ACEC, including modules of the in-house the Code and Animal Research Ethics (CARE) training suite as described in clause 19.
(14) Chief Investigators are ultimately responsible for the conduct of their animal research projects and Researchers under their supervision, and must be aware of their particular responsibilities in the Code clause 2.4.5 in addition to the requirements listed in Clause 19.
Part C - The Care and Use of Animals
Accountability and Responsibility
(15) The Deputy Vice-Chancellor (Research and Innovation) is responsible for overall institutional governance for the care and use of animals.
(16) To ensure the highest level of care for animals, the University will:
- ensure that practices and procedures for the care and management of animals are developed and reviewed on a regular basis so as to encompass current best practice;
- ensure that adequate numbers of competent people are employed to provide care for animals;
- maintain the role of the Animal Welfare Officer as the role responsible for the direction of competent animal care; and
- support availability and access to appropriate veterinary and diagnostic services.
Competency of People Involved in Animal Care and Use
(17) The University and the ACEC recognise that animal research involves a broad range of duties and procedures, some simple and some very complex, and that Investigators competent in a particular procedure are the best personnel to supervise, train, and assess competency in others for that procedure.
(18) Persons carrying out animal research who are considered ‘yet to be competent’ must be under the direct supervision of a person who is competent, and a monitoring strategy must be in place until competency is attained.
(19) The minimum level of competency for Investigators at the University is completion of the CARE 1+2 module prior to joining an animal ethics protocol, and re-completion again once every three years thereafter. Further competency requirements for Investigators, BioResearch Facilities staff, and the ACEC are described in the University's Animal Research Competency Procedures as outlined in this Manual (Section 7, Part E).
(20) Chief Investigators must ensure that all persons responsible for making observations of animals from which an intervention point or an endpoint will be determined, are trained in and competent in evaluating the normal physiology, behaviour, and body condition of the animals under observation, and the anticipated specific changes from what is considered to be normal.
Animal Care, Animal Husbandry and Breeding and Holding Facilities
(21) The Senior Manager, BioResearch Services is responsible for ensuring Standard Operating Procedures are current, effective, and approved by the ACEC for:
- animal care during supply;
- animal husbandry; and
- breeding and holding facilities.
Monitoring and Adverse Events
(22) The University will ensure adequate monitoring of animals and prompt and appropriate response to all adverse events where animal wellbeing may be compromised. All staff involved in the care and wellbeing of animals are required to comply with the Animal Research Monitoring and Adverse Events Procedures as outlined in this Manual (Section 7, Part G).
(23) BioResearch Facilities staff required to undertake any special responsibilities for monitoring animals, in addition to routine husbandry, must become part of the research team.
(24) The University recognises the Code (Clause 3.1.12) requirement for animals in social isolation or separation from a group. The ACEC allows a maximum duration of such housing conditions of up to 4 weeks for mice or rats only. Timeframes beyond 4 weeks require ACEC approval.