• Section 1 - Introduction
• Legislation
• University Policies and Guidelines
• Section 2 - Scope
• Section 3 - Intent
• Section 4 - Document Specific Definitions
• Animal
• Investigator
• Section 5 - The Animal Care and Ethics Committee
• Submission, Receipt and Processing of Applications to the ACEC
• Section 6 - Investigators
• Chief Investigators
• Section 7 - The Care and Use of Animals
• Accountability and Responsibility
• Competency of People Involved in Animal Care and Use
• Animal Care, Animal Husbandry and Breeding and Holding Facilities
• Monitoring and Adverse Events
• The Use of S4 and S8 Drugs
• Quarantining and handling animals that pose risk to other animals and humans
• The Immediate Use of Animals
• Section 8 - Collaborative Animal Research
• Section 9 - Complaints and Non Compliance
• Section 10 - External review

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:

1. the welfare of research animals is assured;
2. the principles of Replacement, Reduction, and Refinement (the 3Rs), as described in the Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition (2013) (the Code), are applied; and
3. 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 2010 (NSW) (the Regulation), the University will maintain accreditation as an animal research establishment.

(3) This policy should 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:

Legislation

1. Animal Research Act 1985 No 123
2. Animal Research Regulation 2010 (NSW)
3. Australian Code for the Care and Use of Animals for Scientific Purposes 8th edition (2013)

University Policies and Guidelines

1. Responsible Conduct of Research Policy
2. Collaborative Research Procedure
3. Animal Research Monitoring and Adverse Events Guidelines
4. Animal Research Competency Guidelines
5. Research Peer Review Guideline for Ethics Applications
6. Animal Research S4 and S8 Drug Use Guidelines

Section 2 - Scope

(4) This policy covers the breeding, holding and use of all animals at the University for the purpose of research as defined by the Animal Research Act 1985 No 123. In this context ‘research’ includes teaching.

Section 3 - Intent

(5) This policy and the associated documents are designed to ensure that animal research at the University is conducted in an ethical manner and in accordance with legislation.

(6) The University and its investigators, animal care staff and the Animal Care and Ethics Committee are required to comply with this policy and its associated documents and legislation.

Section 4 - Document Specific Definitions

Animal

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

Investigator

(8) 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.

Section 5 - The Animal Care and Ethics Committee

(9) The University of Newcastle:

1. has established the Animal Care and Ethics Committee (ACEC), directly responsible to the Vice-Chancellor;
2. ensures, through the ACEC, that all animal research conducted at the University complies with relevant legislation and national guidelines and codes;
3. provides the ACEC with the resources and authority to fulfill its terms of reference and operate as set out in the legislation; and
4. accepts the responsibility to respond effectively to recommendations from the ACEC to ensure that all animal research within the University remains in accordance with the legislation, national guidelines, and codes.

(10) The ACEC Terms of Reference are outlined in the ACEC Constitution. 

(11) In accordance with the governing principles of the Code, the ACEC will approve only those projects for which animals are essential, justified, and which conform to the requirements of the Code.

(12) During consideration of an application at an ACEC meeting, the ACEC will consider: 

1. the impact of the proposed project on the wellbeing of the animals; 
2. the benefit of the research (i.e. scientific or educational outcome); and
3. the ethical issues associated with the project, both those identified by the applicant and those identified by ACEC members.

(13) The ACEC may seek additional advice to achieve the above considerations, as outlined in the Animal Care and Ethics Committee Procedure.

(14) 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.

(15) The ACEC may identify other issues that, while outside their area of responsibility, should be considered by the University administration (e.g. reputational or indemnity issues). In such instances the ACEC will refer these matters to the Deputy Vice-Chancellor (Research and Innovation), which may affect the issuing of an Animal Research Authority. 

Submission, Receipt and Processing of Applications to the ACEC

(16) All investigators at the University must obtain approval from the ACEC prior to the use of animals for research or teaching purposes.

(17) Submissions for approval from the ACEC must undergo peer review in accordance with Research Peer Review Guideline for Ethics Applications prior to submission for approval to the ACEC.

(18) The website “Obtaining approval for animal research” provides resources to assist with the submission process. 

Section 6 - Investigators

(19) Investigators must:

1. be aware of their responsibilities in the Code Chapter 2.4;
2. fully disclose and discuss ethical issues in project applications;
3. address the 3Rs in applications to the ACEC, and report any methods used to implement the 3Rs to the ACEC;
4. be knowledgeable about the species to be used in their research project;
5. 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; and
6. complete animal research training required by the University or the ACEC, including modules of the Code and Animal Research Ethics (CARE) as described in clause 23.

Chief Investigators

(20) Chief Investigators are ultimately responsible for the conduct of their animal research projects, and must be aware of their particular responsibilities in the Code clause 2.4.5 in addition to the requirements listed in Clause 19. 

Section 7 - The Care and Use of Animals

Accountability and Responsibility

(21) At the University the Deputy Vice-Chancellor (Research and Innovation) is responsible for overall institutional governance in relation to the care and use of animals.

(22) To ensure the highest level of care for animals, the University will:

1. 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;
2. ensure that adequate numbers of competent people are employed to provide care for animals;
3. maintain the role of the Animal Welfare Officer as the role responsible for the direction of competent animal care; and
4. support availability and access to appropriate veterinary and diagnostic services. 

Competency of People Involved in Animal Care and Use

(23) The minimum level of competency for investigators at the University is completion of CARE modules 1 and 2 upon joining an animal ethics protocol and once every three years thereafter. Further competency requirements for Investigators, animal care staff, and the ACEC are described in the University's Animal Research Competency Guidelines.

(24) 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 normal.

Animal Care, Animal Husbandry and Breeding and Holding Facilities

(25) The Associate Director, Research Infrastructure is responsible for ensuring Standard Operating Procedures are current, effective, and approved by the ACEC for:

1. animal care during supply;
2. animal husbandry; and
3. breeding and holding facilities.

Monitoring and Adverse Events

(26) The University will ensure adequate monitoring of animals and timely 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 Guidelines.

(27) BioResearch Facilities (BRF) staff required to take any special responsibilities for monitoring animals in addition to routine husbandry must become part of the research team. BRF staff details must be included on the Animal Research Authority for the project, via the New Project Application or a via a Variation Application. The addition of BRF staff to the project will need to be approved by the Chief Investigator of the project and the Director, Research Facilities & Infrastructure, and agreed to by the BRF staff member/s involved.

The Use of S4 and S8 Drugs

(28) The University requirements regarding the use of S4 and S8 drugs in animal research are described in the Animal Research S4 and S8 Drug Use Guidelines.

Quarantining and handling animals that pose risk to other animals and humans

(29) Investigators and Animal Care staff are required to comply with the University's Animal Hazards Procedure.

The Immediate Use of Animals

(30) The University recognises the Code requirement for the immediate use of animals in the event of unexplained and severe disease outbreaks, or morbidity/mortality in animals or people.

(31) The Animal Care and Ethics Committee Procedure should be referred to when the immediate use of animals, as outlined in the Code, becomes a requirement.

Section 8 - Collaborative Animal Research

(32) Investigators are required to comply with the Collaborative Research Procedure and associated documents.

Section 9 - Complaints and Non Compliance

(33) Please refer to the Animal Care and Ethics Committee Procedure.

Section 10 - External review

(34) The University will ensure that an independent external review of its compliance with the Code is carried out at least every four years. Generally the triennial accreditation inspection carried out by the Animal Research Review Panel (ARRP) will satisfy this requirement.

(35) The University may make arrangements for a review to be conducted in accordance with the Code where the ARRP is unable to inspect within four years of the previous external inspection, or where the University considers an additional external review is required.