Purpose of the Australian code for the care and use of animals for scientific purposes (the Code) Show
The purpose of the Code is to promote the ethical, humane and responsible care and use of animals for scientific purposes. The Code provides an ethical framework and governing principles to guide decisions and actions of all those involved in the care and use of animals for scientific purposes. The Code details the responsibilities of investigators, animal carers, institutions and animal ethics committees (AECs), and all people involved in the care and use of animals, and describes processes for accountability. An obligation to respect animals underpins the Code. This obligation brings with it a responsibility to ensure that the care and use of animals for scientific purposes is ethically acceptable, balancing whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits to humans, animals or the environment. The use of animals for scientific purposes must have scientific or educational merit; must aim to benefit humans, animals or the environment; and must be conducted with integrity. When animals are used, the number of animals involved must be minimised, the wellbeing of the animals must be supported, and harm, including pain and distress, in those animals must be avoided or minimised. Scope of the Code The Code encompasses all aspects of the care and use of animals when the aim is to acquire, develop or demonstrate knowledge or techniques in any area of science—for example, medicine, biology, agriculture, veterinary and other animal sciences, industry and teaching. It includes the use of animals in research, teaching associated with an educational outcome in science, field trials, product testing, diagnosis, the production of biological products and environmental studies. The Code applies throughout the animal’s involvement in activities and projects, including acquisition, transport, breeding, housing, husbandry, the use of the animal in a project, and the provisions for the animal at the completion of their use. The Code applies to the care and use of all live non-human vertebrates and cephalopods. Institutions are responsible for determining when the use of an animal species not covered by the Code requires approval from an AEC, taking into account emerging evidence of sentience and ability to experience pain and distress. Animals at early stages in their development—that is, in their embryonic, fetal and larval forms—can experience pain and distress, but this occurs at different stages of development in different species. Thus decisions as to their welfare should, where possible, be based on evidence of their neurobiological development. As a guide, when embryos, fetuses and larval forms have progressed beyond half the gestation or incubation period of the relevant species, or they become capable of independent feeding, the potential for them to experience pain and distress should be taken into account. All those involved in the care and use of animals for scientific purposes must be aware of the relevant Commonwealth, state and territory legislation. For research, institutions and investigators are reminded of their obligations under the Australian code for the responsible conduct of research. Structure of the Code Section 1 describes the governing principles and ethical framework to guide decisions and actions of all those involved in the care and use of animals for scientific purposes. The application of these governing principles is further developed in subsequent sections of the Code. Section 2 describes the responsibilities of institutions, AECs, investigators and animal carers. It also outlines responsibilities in situations involving more than one institution and/or AEC, and application to an AEC. Section 3 outlines the principles for supporting and safeguarding the wellbeing of animals used for scientific purposes in terms of the animal’s lifetime experience. Section 4 covers the care and use of animals in teaching activities, where the ’scientific purpose’ is to impart or demonstrate knowledge or techniques to achieve an educational outcome in science. Section 5 describes responsibilities for addressing complaints and non-compliance related to the care and use of animals for scientific purposes. Section 6 describes responsibilities related to the independent external review of the operation of institutions. Section 7 describes responsibilities related to the use of animals for cosmetic testing. Definitions 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 animal ethics committee. See also ‘Project’. Adverse event: any event that has a negative impact on the wellbeing of an animal. See also ‘Unexpected adverse event’. Alternative: encompasses replacement alternatives, reduction alternatives, and refinement alternatives as a whole. See ‘Replacement alternatives’, ‘Reduction alternatives’, ‘Refinement alternatives’. Animal: any live non-human vertebrate (that is, fish, amphibians, reptiles, birds and mammals, encompassing domestic animals, purpose-bred animals, livestock, wildlife) and cephalopods. Animal carer: any person involved in the care of animals that are used for scientific purposes, including during their acquisition, transport, breeding, housing and husbandry. Animal ethics committee (AEC): a committee constituted in accordance with the terms of reference and membership laid down in the Code. 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. Animal wellbeing: see ‘Wellbeing’. Application: a request for approval from an animal ethics committee 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. Biological product: any product derived from animals, including blood products, vaccines, antisera, semen, antibodies and cell lines. Clone: a genetic copy of another living or dead animal. A clone is not a twin derived by the fertilisation of an egg by a sperm. Cloning to generate embryonic stem cells: the process of creating an embryo using cloning technology (usually somatic cell nuclear transfer) for the purpose of generating embryonic stem cells matched to the animal that donated the somatic cell. Code: Australian code for the care and use of animals for scientific purposes. Competent: 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. Compliance: acting in accordance with the Code. 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. Consensus: the outcome of a decision-making process whereby the legitimate concerns of members of the animal ethics committee are addressed and, as a result, all members accept the final decision, even though it may not be an individual’s preferred option. Current best practice: a practice, procedure, method or process that has proven to be most effective in supporting and safeguarding animal wellbeing, and that:
Death as an endpoint: when the death of an animal is the deliberate measure used for evaluating biological or chemical processes, responses or effects—that is, the investigator will not intervene to kill the animal humanely before death occurs in the course of a scientific activity. 'Death as an endpoint' does not include the death of an animal by natural causes or accidents, or the humane killing of an animal as planned in a project or because of the condition of the animal. Distress: an animal is in a negative mental state and has been unable to adapt to stressors so as to sustain a state of wellbeing. Distress may manifest as abnormal physiological or behavioural responses, a deterioration in physical and psychological health, or a failure to achieve successful biological function. Distress can be acute or chronic and may result in pathological conditions or death. 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. Facility: any place where animals are kept, held or housed, including yards, paddocks, tanks, ponds, buildings, cages, pens and containers. Facility manager: person responsible for the overall management of a facility used for the breeding and holding of animals. Genetic modification (of animals): the use of any technique for the modification of genes or other genetic material, but does not include sexual reproduction, homologous recombination or other techniques (as defined in the Gene Technology Act and Regulations, as amended from time to time). Governing body: the body or person responsible for the administration and governance of the institution (e.g. university council or senate, board of an organisation, school board) or, where appropriate, its delegated officer. Harm: a negative impact on the wellbeing of an animal. Humane killing: the act of inducing death using a method appropriate to the species that results in a rapid loss of consciousness without recovery and minimum pain and/or distress to the animal. Institution: any organisation or agency involved in the care and use of animals for scientific purposes, including universities, hospitals, research institutes, government departments, teaching organisations (including schools and colleges), vocational training organisations, agricultural organisations, commercial companies, and organisations involved in animal breeding and supply. 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. Livestock: animals used in agriculture and aquaculture. 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 investigators, animal carers and animal ethics committees). Must: used to indicate an obligatory component of the Code. Pain: an unpleasant sensory and emotional experience associated with actual or potential tissue damage. It may elicit protective actions, result in learned avoidance and distress, and modify species-specific traits of behaviour, including social behaviour. Person with ultimate responsibility: person who is responsible for the overall management and conduct of an individual project, and for ensuring that clear lines of responsibility, communication and accountability regarding the care and use of animals in the project are identified. Procedure: a technique employed when caring for or using animals for scientific purposes. One or more procedures may be used in an activity. Program of veterinary care: system for the provision of veterinary care and advice. Elements of the program should include, where appropriate, animal clinical care; emergency care; preventive medicine; anaesthesia, analgesia and surgery; and animal quarantine. The extent of this program will depend on several factors, such as:
Examples of relevant guidelines include the Guidelines for adequate veterinary care (American College of Laboratory Animal Medicine), Guidance for named veterinary surgeons (Royal College of Veterinary Surgeons) and Guidelines for the veterinary care of laboratory animals (Federation of European Laboratory Animal Science Associations, European Society of Laboratory Animal Veterinarians, and European College of Laboratory Animal Medicine). Project: an activity or group of activities that form a discrete piece of work that aims to achieve a scientific purpose. Reduction alternatives: 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. Refinement alternatives: methods that alleviate or minimise potential pain and distress, and enhance animal wellbeing. Replacement alternatives: methods that permit a given purpose of an activity or project to be achieved without the use of animals. Research: as defined in the Australian code for the responsible conduct of research Reuse: the use of an individual animal more than once for a procedure, activity or project. Routine husbandry: practices or procedures performed in relation to the care and management of animals with the primary purpose of maintaining their health and wellbeing. 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. Should: used to indicate a strongly recommended component of the Code. In some instances, a recommended component of the Code is an example of how it is anticipated that a person will meet the obligatory requirement of the Code. Somatic cell nuclear transfer: moving the nucleus and its genetic material from a somatic cell to another cell (usually an egg cell from which the genetic material has been removed). Teacher: any person in charge of a teaching activity. 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. Unexpected adverse event: an event that may have a negative impact on the wellbeing of animals and was not foreshadowed in the approved project or activity. An unexpected adverse event may result from different causes, including but not limited to:
Vertebrate pest animals: vertebrate animals, including native and introduced species, that are generally regarded, or have been declared under state or territory legislation, as a 'pest species'. Voucher specimen: any specimen, usually but not always a dead animal, that serves as a basis of study and is retained as a reference. ‘Type’ specimen is a particular voucher specimen that serves as a basis for taxonomic description of that subspecies. 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. Wildlife: free-living animals of native or introduced species, including those that are captive bred and those captured from free-living populations. Xenosis: the potential spread of pathogens from a source animal of one species to a recipient animal of another species and, potentially, to the general population of the recipient species. Xenotransplantation: any procedure that involves the transplantation, implantation or infusion of live cells, tissues or organs from another species, or body fluids, cells, tissues or organs that have ex vivo contact with live cells, tissues or organs from another species. Section 1: Governing principlesDefinitions that are particularly relevant to this section:
This section describes the governing principles and ethical framework to guide decisions and actions of all people involved in the care and use of animals for scientific purposes. The application of these governing principles is further developed in subsequent sections of the Code. Each person involved in the care and use of animals for scientific purposes must consider the governing principles when applying the Code to their specific circumstance. Governing principles 1.1 Respect for animals must underpin all decisions and actions involving the care and use of animals for scientific purposes. This respect is demonstrated by:
1.2 The care and use of animals for scientific purposes must be subject to ethical review. 1.3 A judgement as to whether a proposed use of animals is ethically acceptable must be based on information that demonstrates the principles in Clause 1.1, and must balance whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits. 1.4 The obligation to respect animals, and the responsibilities associated with this obligation, apply throughout the animal’s lifetime, including acquisition, transport, breeding, housing, husbandry, use of the animal in a project, and provisions for the animal at the conclusion of their use. Use animals only when justified 1.5 Evidence to support a case to use animals must demonstrate that:
1.6 Projects must only be undertaken:
1.7 An animal ethics committee (AEC) must be satisfied that there is sufficient evidence to support a case that the proposed use of animals is justified. Support the wellbeing of animals 1.8 The wellbeing of animals used for scientific purposes must be considered in terms of the cumulative effects of an animal’s lifetime experience. At all stages of the care and use of an animal, measures should be taken to ensure that the animal’s environment and management are appropriate for the species and the individual animal, and support the animal’s wellbeing. 1.9 Practices and procedures used for the care and management of animals must be based on current best practice that:
Special ethical consideration and AEC approval are required where these conditions are precluded by the requirements of a project or activity. Avoid or minimise harm, including pain and distress, to animals 1.10 Animals have a capacity to experience pain and distress, even though they may perceive and respond to circumstances differently from humans. Pain and distress may be difficult to evaluate in animals. Unless there is evidence to the contrary, it must be assumed that procedures and conditions that would cause pain and distress in humans cause pain and distress in animals. Decisions regarding the possible impact of procedures or conditions on an animal’s wellbeing must be made in consideration of an animal’s capacity to experience pain and distress. 1.11 Steps must be taken at all times to safeguard the wellbeing of animals by avoiding or minimising harm, including pain and distress to the animals. 1.12 Where the aim(s) of the project involves the animals experiencing pain and distress that will not be alleviated, the planned endpoint of the project must be as early as feasible to avoid or minimise pain and distress in the animals. 1.13 ‘Death as an endpoint' must be avoided unless it is essential for the aim(s) of the project. In these circumstances, the means to prevent or minimise harm, including pain and distress, must be considered, implemented and reviewed at all stages of the project. 1.14 Prompt action must be taken to alleviate pain and distress that were not anticipated in an approved project or activity, or occur as the result of an emergency. Such action must take precedence over an individual animal reaching the planned endpoint of the project or activity, or the continuation or completion of the project or activity. Apply high standards of scientific integrity 1.15 Regardless of the potential benefits of a project, the methods used must be scientifically valid, feasible, well designed and carefully conducted so that there is a reasonable expectation that the aims of the project will be achieved. Projects that are not scientifically valid must not be performed, no matter how mild the impact on the wellbeing of the animals. 1.16 Investigators must use methods that accord with current best practice that:
1.17 Animals used must be suited to the purpose of the project or activity, taking into account their biological characteristics, including morphology, physiology, behaviour, genetic makeup, temperament and behavioural conditioning, microbiological and nutritional status, and general state of health. Apply Replacement, Reduction and Refinement (the 3Rs) at all stages Replacement 1.18 Methods that replace or partially replace the use of animals must be investigated, considered and, where applicable, implemented. 1.19 Before the use of animals is considered, all existing information relevant to the proposed aim(s), including existing databases, must be examined. Replacement techniques that must be considered include the use of epidemiological data; physical and chemical analysis; computer, mathematical and inanimate synthetic models; simulations; in vitro systems; non-sentient organisms; cadavers; and clinical cases. 1.20 Opportunities to replace the use of animals must be kept under review during the lifetime of a project. Where relevant and applicable, the outcome of this review must be implemented in current projects and taken into account in planning future projects. Reduction 1.21 The number of animals used in a project must be the minimum necessary to achieve the proposed aim(s) and to satisfy good statistical design. The use of too few animals may invalidate the experimental result and result in wastage of animals. 1.22 The number of animals used may be reduced by the appropriate reuse of individual animals. The benefits of reusing animals must be balanced against any adverse effects on their wellbeing, taking into account the lifetime experience of the individual animal. Reuse of animals requires particular justification and specific AEC approval. 1.23 Activities involving the use of animals must not be repeated within a project or between projects unless such repetition is essential for the purpose or design of the project (e.g. sound experimental design, statistical analysis, corroboration by the same or another investigator). 1.24 Reducing the number of animals used should not result in greater harm, including pain and distress, to the animals used. 1.25 All possible steps must be taken to reduce factors that are not part of the experimental design of the project and are known to contribute to variability of experimental results, including the use of animals of known genetic, biological and behavioural background. Reduction of experimental variables may result in reduced animal use. 1.26 Where practicable, tissue and other biological material from animals being killed must be shared among investigators or deposited in a tissue bank for subsequent distribution. 1.27 Breeding of animals must be managed to avoid or minimise the production of excess animals. A new line of animal should not be generated if a similar suitable animal line is available to the investigator. When a new animal line is generated, the colony should be made available as a source for other investigators, as appropriate. Refinement 1.28 Steps must be taken at all times to support and safeguard animal wellbeing. The effectiveness of strategies for supporting and safeguarding animal wellbeing must be kept under review during the lifetime of activities, including projects. Where relevant and applicable, the outcome of this review must be implemented in current activities and taken into account in planning future activities, including projects. 1.29 People who care for and use animals must ensure that procedures are performed competently, and
1.30 The duration of activities must be no longer than required to meet the aim(s) of the project, and must be compatible with supporting and safeguarding animal wellbeing. Animals must not be held for prolonged periods as part of an approved project before their use, without AEC approval. Accept responsibilities 1.31 Institutions, AECs, and people involved in any aspect of the care and use of animals for scientific purposes must be aware of and accept their responsibilities (see Section 2), and act in accordance with the Code. 1.32 All activities, including projects, that involve the care and use of animals for scientific purposes must:
Section 2: ResponsibilitiesDefinitions that are particularly relevant to this section:
This section describes the responsibilities of:
For research, institutions and investigators are reminded of their obligations under the Australian code for the responsible conduct of research. 2.1: Responsibilities of institutionsAdditional definitions specifically relevant to this chapter:
This chapter describes the responsibilities of institutions regarding the care and use of animals for scientific purposes. The responsibilities of institutions regarding the governance of an animal ethics committee (AEC) are described in Chapter 2.2. The responsibilities of AECs regarding ethical review, approval and monitoring of animal care and use are described in Chapter 2.3. Governing principle Each person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Responsibilities 2.1.1 The governing body of an institution is responsible for ensuring that the care and use of animals for scientific purposes conducted on behalf of the institution complies with the Code. 2.1.2 Institutions must:
Ensure compliance through an animal ethics committee 2.1.3 Institutions must ensure, through the operation of an AEC that is constituted and functioning in accordance with Chapters 2.2 and 2.3, and directly responsible to the governing body of the institution, that all activities involving the care and use of animals comply with the Code. 2.1.4 The institution may use an external AEC or share an AEC with another institution (see Clause 2.6.2). Promote compliance 2.1.5 Institutions must promote compliance with the Code by:
Ensure and support the effective operation of the animal ethics committee 2.1.6 Institutions must ensure and support the effective operation of the AEC by:
Identify clear lines of responsibility, communication and accountability 2.1.7 Institutions must identify clear lines of responsibility, communication and accountability by:
Ensure understanding of responsibilities 2.1.8 Institutions must ensure that all people involved in the care and use of animals understand their responsibilities and the requirements of the Code, are competent for the procedures they perform or are under the direct supervision of a person who is competent to perform the procedures, and have access to appropriate education programs and resources, by: With respect to investigators
With respect to animal care and management, animal carers and veterinary services
With respect to work health and safety
With respect to projects involving more than one institution and/or animal ethics committee, and projects conducted in other countries
Monitor and review compliance 2.1.9 Institutions must regularly monitor and review institutional compliance with the Code by:
2.1.10 Institutions should consider making publicly available:
2.2: Responsibilities of institutions regarding the governance of an animal ethics committeeDefinitions that are particularly relevant to this chapter:
This chapter describes the responsibilities of institutions that establish an animal ethics committee (AEC) regarding the governance of the AEC. Chapter 2.3 describes the responsibilities of AECs regarding ethical review, approval and monitoring of animal care and use. Chapter 2.1 describes the responsibilities of institutions regarding the care and use of animals for scientific purposes. Governing principles Each person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Responsibilities 2.2.1 Institutions that establish an AEC must:
Ensure appropriate animal ethics committee membership Composition of the animal ethics committee Chairperson 2.2.2 Institutions must appoint a chairperson of the AEC. Institutions should consider appointing a chairperson who holds a senior position in the institution. If the chairperson is an external appointee, institutions must provide the chairperson with the necessary support and authority to carry out the role. The chairperson may be appointed in addition to Category A to D members (see Clause 2.2.4). 2.2.3 Institutions should consider appointing a chairperson who is independent of the care and use of animals for scientific purposes. Members 2.2.4 Institutions must ensure that membership of the AEC comprises at least one person from each of four categories of membership:
Additional members to assist the AEC to function effectively 2.2.5 Institutions should appoint to the AEC a person responsible for the routine care of animals within the institution. 2.2.6 Institutions may appoint additional members with skills and background of value to the AEC. Access to expertise 2.2.7 The AEC may invite people with specific expertise to provide advice, as required. Balance of membership 2.2.8 Categories C and D must together represent at least one-third of the AEC membership. Appointment, reappointment and retirement of members 2.2.9 Institutions must develop procedures for the appointment, reappointment and retirement of AEC members. 2.2.10 Procedures must include the declaration of interests by prospective members and the management of conflicts of interest in making appointments. 2.2.11 Before appointment, all members of the AEC must acknowledge in writing their acceptance of the terms of reference of the AEC and any requirements for confidentiality required by the institution (see Clauses 2.1.2 and 2.2.22). 2.2.12 Institutions should ensure that AEC members undergo appropriate induction, and have access to appropriate education programs and resources. Responsibilities of the chairperson 2.2.13 The chairperson is responsible for impartially guiding the operation of the AEC, resolving conflicts of interest related to the business of the AEC, and representing the AEC in any negotiations with the institution’s management. Responsibilities of members 2.2.14 Each member is responsible for deciding whether, in their own judgement, an application or other matter under consideration by the AEC is ethically acceptable (see Clause 1.3) and meets the requirements of the Code. 2.2.15 To fulfil this responsibility, members should:
2.2.16 During their appointment to the AEC, and before any deliberations of the AEC, members must declare any interest that could influence the objectivity of their decision making. 2.2.17 Members must maintain confidentiality regarding the content of applications and the deliberations of the AEC, in accordance with institutional requirements. Ensure the animal ethics committee has terms of reference 2.2.18 The institution must ensure that the AEC has terms of reference that are publicly available and include the following provisions:
Provide the animal ethics committee with adequate resources 2.2.19 The institution must provide the AEC with the resources required to carry out its responsibilities (see Chapter 2.3) and to maintain the AEC, and respond effectively to recommendations from the AEC regarding resources and workloads. Resources should include:
Establish procedures for animal ethics committee governance and operation 2.2.20 Institutions must establish procedures for the effective governance and operation of the AEC that enable the AEC to comply with the Code and relevant institutional policies, and promote competent and timely ethical review of animal care and use. These procedures should include declaration of interests and management of conflicts of interest, confidentiality, appointment of and delegation of functions to an AEC Executive, administrative processes, meeting procedures, communication, complaints and non-compliance, records and documentation. Declaration of interests and management of conflicts of interest 2.2.21 Procedures for declaration of interests and management of perceived or actual conflicts of interest involving AEC members, and experts whose advice is sought by the AEC, must require people with a conflict of interest to remove themselves from the AEC’s decision making on matters that relate to the conflict of interest. Confidentiality 2.2.22 Institutions should develop policies for maintaining confidentiality regarding the content of applications and the deliberations of the AEC, including how members may seek advice without breaching confidentiality. Animal Ethics Committee Executive 2.2.23 If established, an AEC Executive:
Administrative processes 2.2.24 Institutions should develop policies and procedures for the submission, receipt and processing of applications and reports to the AEC, and make these policies and procedures readily available. 2.2.25 At least one member from each of the membership categories A, B, C and D must be present at meetings to establish a quorum for the conduct of a meeting, and must be present throughout the meeting. Categories C and D together must represent at least one-third of those members present. 2.2.26 Documented meeting procedures should include:
Communication 2.2.27 The AEC must clearly communicate its decisions, the reasons for its decisions and any conditions attached to an approval to investigators in writing as promptly as possible. 2.2.28 The AEC should consider face-to-face meetings with applicants to resolve issues. Complaints and non-compliance 2.2.29 Institutions must have procedures for dealing with complaints and non-compliance with the Code, complaints related to the AEC process, and irreconcilable differences between the AEC and an investigator (see Section 5). Records 2.2.30 Institutions must ensure that records related to the AEC business are maintained, including:
2.2.31 Where appropriate, the institution, in consultation with the AEC, should ensure that animal carers have access to records of approved projects and activities. Documentation 2.2.32 Institutions, in consultation with the AEC, must develop documentation for:
Standard operating procedures 2.2.33 Institutions, in consultation with the AEC, may allow the AEC to consider and approve standard operating procedures (SOPs) relating to the care and use of animals. Reference to SOPs can help people prepare applications to the AEC, but may make it more difficult for the AEC to apply rigour when evaluating procedures described in applications. An SOP must only be referenced in an application under the following conditions:
2.2.34 New SOPs must not be used until approved by the AEC, and may be included with an application for consideration by the AEC. 2.2.35 If an approved SOP is not reviewed by the AEC within three years of its approval, approval for the SOP lapses, and the SOP cannot be used. 2.2.36 Approved SOPs must be made available to all relevant people, including AEC members. Conduct an annual review of the operation of the animal ethics committee 2.2.37 The institution must conduct an annual review of the operation of the AEC to ensure that it is effective and consistent with the Code and institutional policies. This must include an assessment of the AEC’s annual report (see Clauses 2.1.9 and 2.3.28–29) and a meeting with the AEC chairperson. 2.3: Responsibilities of animal ethics committeesDefinitions that are particularly relevant to this chapter:
This chapter describes the responsibilities of animal ethics committees (AECs) regarding ethical review, approval and monitoring of animal care and use in accordance with the Code. Chapter 2.2 describes the responsibilities of institutions regarding the governance of an AEC. Chapter 2.1 describes the responsibilities of institutions regarding the care and use of animals for scientific purposes. Governing principles Each person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Responsibilities 2.3.1 The primary responsibility of an AEC is to ensure, on behalf of the institution for which it acts, that all activities relating to the care and use of animals are conducted in compliance with the Code. 2.3.2 The AEC must:
Review and approve new and ongoing activities 2.3.3 The AEC must provide competent, fair, consistent and timely review of applications and reports related to the care and use of animals. 2.3.4 The AEC must make a judgement on whether the proposed use, or continued use, of animals is ethically acceptable. This judgement must:
2.3.5 The AEC may approve only those projects and activities that are ethically acceptable and conform to the requirements of the Code. 2.3.6 The AEC must consider and approve applications for new projects and activities, and the ongoing approval for existing projects and activities, only at quorate meetings of the AEC (see Clauses 2.2.25 and 2.3.12). 2.3.7 Procedures should describe how applications and reports will be assessed in a manner that is fair to applicants and acceptable to all members, including the need to provide AEC members with information in a timely manner. 2.3.8 The AEC must base its decisions on the information it receives from the applicant in the documentation and in any direct discussions with the applicant, and may use information in addition to that obtained from the applicant. 2.3.9 The AEC may decide that:
2.3.10 Decisions should be based on a thorough, fair and inclusive process of discussion and deliberation by AEC members, and should be made only by those present throughout the discussion. 2.3.11 Decisions should be made on the basis of consensus. Where consensus cannot be reached after reasonable effort to resolve differences, the AEC should explore with the applicant(s) ways of modifying the project or activity that may lead to consensus. If consensus is still not achieved, the AEC should only proceed to a majority decision after members have been allowed a period of time to review their positions, followed by further discussion. 2.3.12 For decision making, members with a conflict of interest must withdraw from the meeting. Once such members have withdrawn, the remaining members must constitute a quorum as defined in Clause 2.2.25—that is, one member from each of the membership categories A, B, C and D, with Categories C and D together representing at least one-third of members present. 2.3.13 Decisions of the AEC must be made as promptly as possible. 2.3.14 Pilot studies, where proposed, should be regarded as integral to the overall project, especially to enable assessment of the feasibility of the project and the potential for refinement and reduction. They must be assessed by the AEC according to the criteria applied to project approval. 2.3.15 When considering approval for the reuse of animals, the AEC must take into account:
2.3.16 In determining the duration of approval for individual projects, AECs should take into account the number of years for which the project is funded, any milestones or stages outlined in the project, and any formal agreements between the institution and funding bodies. Monitor the care and use of animals 2.3.17 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. 2.3.18 The AEC must monitor 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. The AEC must ensure that identified problems and issues receive appropriate follow-up and, if necessary, refer suspected breaches of the Code to the institution. 2.3.19 The AEC should monitor activities that are likely to cause pain or distress at an early phase during the conduct of the activity. This requirement should be a condition of approval for the project or activity. These activities could include the study of pain, responses to stressors, models of human and animal diseases, or attempts to change behaviour by physical or chemical means. 2.3.20 A Category C or D member of the AEC should participate in animal facility inspections. 2.3.21 The AEC should determine the frequency and timing of inspections. Influencing factors include the number and accessibility of sites, the number and types of projects and activities, and whether inspections can be combined with scheduled AEC meetings. In addition, the AEC may decide that certain projects or activities require more frequent inspection than others. Inspections may be announced or unannounced. 2.3.22 The AEC must maintain records of inspections that include the names of attendees, observations, any identified problems, recommended actions, ongoing or outstanding issues, and outcomes (see Clause 2.2.30). 2.3.23 AEC procedures should cover the delegation of authority to suitably qualified people to monitor animal care and use, including projects and activities conducted at remote sites (e.g. fieldwork). Procedures should include how reports of such monitoring are to be provided to the AEC (e.g. using still or video images). Take action regarding unexpected adverse events 2.3.24 The AEC must take appropriate action in response to unexpected adverse events to ensure that animal wellbeing is not compromised, the issue is addressed promptly, and activities that have the potential to adversely affect animal wellbeing cease immediately (see Clause 2.1.5). Actions may include consulting with relevant people and, where necessary, suspending or withdrawing approval for the project or activity. Take action regarding non-compliance 2.3.25 When projects or activities that are in breach of the Code are detected, the AEC must ensure that:
Approve guidelines for the care and use of animals 2.3.26 The AEC must consider approval of guidelines for the care and use of animals that are referred to it by the institution (see Clause 2.1.5). Provide advice and recommendations to the institution 2.3.27 The AEC must provide advice and recommendations to the institution regarding the care and use of animals for scientific purposes conducted on behalf of the institution, and strategies required to ensure that the requirements of the Code are maintained and that matters affecting animal wellbeing are addressed. Report to the institution 2.3.28 The AEC must submit a written report on its operations at least annually to the governing body of the institution(s) for which it acts. 2.3.29 The report should advise on:
2.4: Responsibilities of investigatorsDefinitions that are particularly relevant to this chapter:
This chapter relates to the responsibilities of investigators—that is, 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. Governing principles Each person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Responsibilities 2.4.1 Investigators have personal responsibility for all matters that relate to the wellbeing of animals that they use, including their housing, husbandry and care. This responsibility extends throughout the period of use approved by the AEC until provisions are made for the animal at the conclusion of their use. 2.4.2 Investigators must only consider using animals when they are satisfied that a case can be made that the proposed use is ethically acceptable, based on whether such use demonstrates the principles in Clause 1.1, and balancing whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits (see Clause 1.3). 2.4.3 Investigators should seek advice and information from relevant experts, including other experienced scientists, veterinarians, animal care staff, or specialists in laboratory animals, livestock or wildlife, when necessary. 2.4.4 Investigators must:
2.4.5 A person must be identified who has ultimate responsibility for the care and use of animals in a project. This person must:
This person does not relieve the individual responsibility of each investigator working with animals in the project. Planning projects 2.4.6 When planning projects, investigators must only consider using animals when:
2.4.7 When planning projects, the person with ultimate responsibility for the conduct of the project must be identified (see Clause 2.4.5). 2.4.8 During planning, investigators must consider the following factors and be satisfied that: Use animals only when justified (see Clauses 1.1 and 1.5–1.7)
Apply high standards of scientific integrity (see Clauses 1.1 and 1.15–1.17)
Apply Replacement, Reduction and Refinement (the 3Rs) (see Clauses 1.1 and 1.18–1.30)
Support the wellbeing of animals (see Clauses 1.1 and 1.8–1.9)
Avoid or minimise harm, including pain and distress (see Clauses 1.1 and 1.10–1.14)
Accept responsibilities (see Clauses 1.1 and 1.31–1.32)
2.4.9 Investigators must notify the AEC in writing if they are involved in collaborative studies using animals at another institution, or if they are named in an application to the AEC of another institution (see Clause 2.6.8). Obtaining approval from an animal ethics committee 2.4.10 Before commencing a project, or an amendment to an approved project, investigators must:
2.4.11 Investigators must follow institutional and AEC policies and procedures when submitting an application to the AEC (see Clause 2.2.24 and Chapter 2.7), and provide information in the application as outlined in Clauses 2.7.4 and 2.7.6. 2.4.12 Investigators must use plain English in the application to the AEC to ensure that all AEC members are provided with sufficient information to participate effectively in the assessment of the application. Conducting and reviewing projects Clauses 2.4.13 - 2.4.29 are to be read in conjunction with Section 3 ‘Animal wellbeing’. 2.4.13 Investigators must conduct all aspects of a project in accordance with the conditions and requirements of the AEC approval and any subsequent amendments approved by the AEC. 2.4.14 Investigators must cease the conduct of a project or any part of a project if approval from the AEC is suspended or withdrawn. Apply high standards of scientific integrity 2.4.15 Investigators must:
Support animal wellbeing 2.4.16 Investigators must consider the wellbeing of animals used in the project in terms of the cumulative effects of the animal’s lifetime experience. At all stages during the project, the investigator must ensure that the animal’s environment and management are appropriate for the species and support the animal’s wellbeing. 2.4.17 Investigators must ensure that animal care is provided by an adequate number of competent people (see Clause 2.5.1). Avoid or minimise harm, including pain and distress 2.4.18 Investigators must take steps at all times to safeguard the wellbeing of animals by avoiding or minimising known or potential causes of harm, including pain and distress, to the animals. Steps include:
Apply Replacement, Reduction and Refinement (the 3Rs) 2.4.19 Investigators must continually consider how to apply the 3Rs during the conduct of the project (see Clauses 1.18–1.30). Any subsequent amendments to the approved project must only proceed following approval from the AEC. Accept responsibilities 2.4.20 Investigators must:
Provisions for animals at the conclusion of their use and disposal of carcasses and waste material 2.4.21 Investigators must take prompt action regarding provisions for animals at the conclusion of their use, in accordance with procedures and protocols approved by the AEC (see Chapter 3.4). 2.4.22 Investigators must use humane procedures for killing an animal that are appropriate to the species and circumstances (see Clauses 3.3.45–3.3.46). 2.4.23 Unless otherwise required (e.g. as part of a project or for the investigation of a disease outbreak), investigators must ensure that all carcasses and tissues from animals that have died or been humanely killed are disposed of in a sanitary and appropriate manner. 2.4.24 Investigators should ensure that, if practicable, tissue samples from animals that have died or been humanely killed are provided or made available to other investigators for their work, or deposited in a tissue bank for subsequent distribution. Projects involving hazards 2.4.25 For projects that involve hazards to other animals and humans, investigators must ensure that:
Creation and breeding of new animal lines where the impact on animal wellbeing is unknown or uncertain 2.4.26 The creation and breeding of a new animal line, including genetically modified and cloned animals, where the impact of the genotype on animal wellbeing is unknown or uncertain is regarded as a scientific purpose. Persons responsible for animals involved in such projects are regarded as investigators. Their responsibilities extend until the impact on animal wellbeing is known and the AEC has approved the final report on the generation of a new animal line. After this AEC approval, the new line can be treated as breeding stock, and responsibility for the animals and for obtaining AEC approval for procedures applicable to their breeding rests with the facility manager or animal carer (see Chapter 2.5). 2.4.27 Investigators must:
Using privately owned animals 2.4.28 For projects involving the use of privately owned animals (e.g. livestock or companion animals), investigators must:
Xenotransplantation In the context of xenotransplantation:
2.4.29 For projects involving xenotransplantation, investigators must ensure that measures are in place to minimise the potential for xenosis, including the appropriate screening of source animals, management of biohazardous waste and emergency plans for the management of adverse outcomes. Investigators should consider collecting and retaining tissue samples from source and recipient animals. Maintaining records 2.4.30 Investigators must maintain records of the care and use of animals, and make such records available to the institution, the AEC and authorised external reviewers. 2.4.31 Investigators must ensure that records of monitoring and assessment of animals are in accordance with Clauses 3.1.21-3.1.22. 2.4.32 Investigators must ensure that records include:
2.4.33 When activities involve genetically modified animals, records must include:
Reporting 2.4.34 Investigators must provide the following to the AEC in accordance with AEC and institutional policies and procedures (see Clauses 2.2.24 and 2.2.32):
2.5: Responsibilities of animal carersDefinitions that are particularly relevant to this chapter:
The number, training and competence of animal carers are important factors that contribute to high-quality animal care. This chapter relates to the responsibilities of people involved in the care of animals that are used for scientific purposes, including during their acquisition, transport, breeding, housing and husbandry. Governing principles Each person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Responsibilities 2.5.1 The scope of responsibilities of people who provide care to animals is determined by their role and the stage of the animal use:
2.5.2 Animal carers must, within the scope of their responsibilities:
2.5.3 If more than one person is responsible for the care of animals (e.g. animal technicians caring for animals in one or more animal breeding and holding facility, team of animal technicians and researchers caring for animals in a project, team of researchers and wildlife carers involved in the care of wildlife in a research project, several teachers and students caring for animals in a school), a person must be identified who has ultimate responsibility for the care of those animals. Depending on the situation, this person may be the facility manager, or the investigator with ultimate responsibility for a project. Identification of a person with ultimate responsibility for the care of animals does not relieve the individual responsibility of each person who provides care for animals. Support animal wellbeing 2.5.4 Animal carers must:
Avoid or minimise harm, including pain and distress, to animals 2.5.5 Animal carers must:
2.5.6 If an emergency welfare intervention is considered necessary for an animal allocated to a project (e.g. treatment or humane killing of an animal), animal carers must take reasonable steps to first contact the responsible investigator. However, the welfare of the animal must be the priority at all times and may necessitate immediate intervention. Animal carers must promptly advise the responsible investigator of actions taken and the reasons for emergency interventions. Reporting of the event to the AEC, and responsibility for such reporting, must be in accordance with institutional and AEC policies and procedures (see Clause 2.1.5). Ensure provisions for animals at the conclusion of their use, and disposal of carcasses and waste material 2.5.7 Animal carers must take prompt action regarding provisions for animals at the conclusion of their use, in accordance with procedures and protocols approved by the AEC (see Chapter 3.4). 2.5.8 Animal carers must use humane procedures for killing an animal that are appropriate to the species and circumstances (see Clauses 3.3.45–3.3.46). 2.5.9 Unless otherwise required (e.g. as part of a project or for the investigation of a disease outbreak), animal carers must ensure that all carcasses and tissues from animals that have died or been humanely killed are disposed of in a sanitary and appropriate manner. 2.5.10 Animal carers should ensure that, if practicable, tissue samples from animals that have died or been humanely killed are provided or made available to investigators for their work, or deposited in a tissue bank for subsequent distribution. Maintain records 2.5.11 Animal carers must maintain records of the care and monitoring of animals and, for breeding facilities, the health status and breeding performance of animals (see Clauses 3.1.22, 3.2.2 and 2.4.27). Animal carers must make these records available to the institution, the AEC, authorised external reviewers and, if relevant, investigators. 2.5.12 Records of animal monitoring must be sufficient to enable the AEC to verify that the wellbeing of animals has been monitored, and allow review and critical investigation of the cause(s) of and responses to unexpected adverse events as a basis for future prevention strategies. 2.5.13 Animal carers should ensure that records relating to health status and breeding performance include:
People managing and supervising breeding and holding facilities 2.5.14 The person responsible for the overall management of a facility used for breeding and holding animals (the facility manager) must be competent, with appropriate animal care or veterinary qualifications or experience. The person providing oversight of the program of veterinary care, including the care, husbandry and health of animals and biosecurity in a facility, must be competent and hold appropriate veterinary qualifications. 2.5.15 The facility manager, with support as required from the institution and other staff members, and advice from veterinarians, must:
2.5.16 The facility manager should contribute to the development and maintenance of the institution’s animal care policies and procedures, including those covering quality management. 2.5.17 When animals for which they are responsible are ill or injured, or show unexpected abnormalities, the facility manager must:
2.6: Other responsibilities of institutions, investigators and animal ethics committeesDefinitions that are particularly relevant to this chapter:
This chapter outlines the responsibilities of institutions, animal ethics committees (AECs) and investigators in situations involving:
Governing principles Each person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Institutions and investigators that use an external animal ethics committee 2.6.1 An institution that has established an AEC (‘the host institution’) may be approached by another institution (‘the second institution’) seeking to access an external AEC or share an AEC. The host institution may also be approached by investigators who require AEC approval for the care and use of animals for scientific purposes but who lack direct access to an AEC. In such cases, the host institution should consult with their AEC before they accept oversight of the care and use of animals for scientific purposes conducted on behalf of the second institution or investigator. Institutions that use an animal ethics committee that has been established by another institution 2.6.2 When an institution uses an AEC that has been established by another institution, such use must be based on a formal agreement that has been developed in consultation with the AEC. The agreement must include:
Investigators who do not have direct access to an institutional animal ethics committee and use an animal ethics committee established by an institution 2.6.3 When an investigator who does not have direct access to an institutional AEC uses an AEC established by an institution, such use must be based on a formal agreement that has been developed in consultation with the AEC. The agreement must include:
Projects involving more than one institution and/or animal ethics committee Responsibilities of institutions and animal ethics committees 2.6.4 Institutions must ensure that projects involving investigators from more than one institution, or the care and use of animals at more than one institution, are approved and monitored by the responsible AECs. Procedures must be developed and implemented to ensure that:
2.6.5 Institutions may agree to one AEC (the delegate AEC) approving the entire project, provided that all institutions involved agree to delegate the responsibility for decision making to, and support the necessary actions of, that AEC. 2.6.6 Arrangements between institutions should be as a formal agreement. Institutions should avoid unnecessary duplication of processes. 2.6.7 Arrangements should include mechanisms for reporting non-compliant activities between institutions and AECs. Responsibilities of investigators 2.6.8 Investigators must notify the AEC in writing if they are involved in collaborative studies using animals at another institution, or if they are named in an application to the AEC of another institution (see Clause 2.4.9). Projects conducted by Australian investigators and institutions in other countries Responsibilities of institutions 2.6.9 Institutions should have procedures in place to ensure that, as a minimum, projects conducted on behalf of the institution in other countries:
2.6.10 Institutions that operate facilities that use animals for scientific purposes in other countries should ensure that projects conducted at those facilities comply with the principles of the Code as a minimum, provided that such compliance does not breach relevant local legislation. Responsibilities of animal ethics committees 2.6.11 When considering approval for a project to be conducted in another country, the AEC may accept approval granted by a local AEC or its equivalent in that country if it is satisfied that outcomes would be equivalent to those expected through application of the Code. 2.6.12 The AEC must ensure that animal care and use in the other country is adequately monitored. The AEC may appoint an agent or delegate to conduct the monitoring and inspection on its behalf. Responsibilities of investigators 2.6.13 Investigators responsible for a project conducted in another country should, as a minimum, ensure that:
2.6.14 Investigators who plan to use animals in another country must obtain approval from their institutional AEC for such use. Investigators must provide the AEC with advice on how the proposed project can meet the principles of the Code, taking into account compliance with local requirements. 2.7: Responsibilities of institutions when developing an animal ethics committee application formDefinitions that are particularly relevant to this chapter:
This chapter outlines the responsibilities of institutions when developing documentation for application to an animal ethics committee (AEC) for approval for the care and use of animals for scientific purposes. Governing principles Each person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Responsibilities 2.7.1 Institutions that establish an AEC must, in consultation with the AEC, develop documentation (an application form) for applications for AEC approval to commence a project or activity and to amend an approved project or activity (see Clause 2.2.32). The institution will determine the style of the application form (e.g. electronic, web based, paper based). 2.7.2 Institutions must ensure that the design of the application form allows for the provision of information required by the AEC to assess the ethical acceptability of the proposed use of animals (see Clauses 1.3 and 2.3.4). 2.7.3 Institutions must ensure that procedures for applying to an AEC include a requirement for the use of plain English in the application, so that all AEC members are provided with sufficient information to participate effectively in the assessment of the application. Information to be provided to an animal ethics committee for a project 2.7.4 The application form to commence a project must allow the applicant to provide the following information, as appropriate for the circumstances: Using animals only when it is justified (see Clauses 1.1 and 1.5–1.7)
Applying high standards of scientific integrity (see Clauses 1.1 and 1.15–1.17)
Applying Replacement, Reduction and Refinement (the 3Rs) (see Clauses 1.1 and 1.18–1.30)
Supporting the wellbeing of animals (see Clauses 1.1 and 1.8–1.9)
Avoiding or minimising harm, including pain and distress, to animals (see Clauses 1.1 and 1.10–1.14)
Knowing and accepting responsibilities (see Clauses 1.1 and 1.31–1.32)
Information to be provided to an animal ethics committee for activities associated with the care and management of animals in facilities 2.7.5 The application to commence activities associated with the care and management of animals in facilities should include the information outlined in Clause 2.7.4, as appropriate for the circumstance. Information to be provided to an animal ethics committee for an amendment to an approved project or activity 2.7.6 The application for an amendment to an approved project or activity should include the information outlined in Clause 2.7.4, where relevant. Section 3: Animal wellbeingDefinitions that are particularly relevant to this section:
This section applies to all species of animals used for scientific purposes, and to all activities and situations involving their care and use. It outlines the principles for supporting and safeguarding the wellbeing of animals used in terms of the animal’s lifetime experience. These principles underpin the National Health and Medical Research Council (NHMRC) Guidelines to promote the wellbeing of animals used for scientific purposes: the assessment and alleviation of pain and distress in research animals. Information in this section is presented in four chapters:
Information provided in this section is based on the assumption that approval has been obtained from an animal ethics committee (AEC) before any activity, including projects, commences (see Clause 1.32). The necessity and requirements for AEC approval are addressed in other sections of this document. Sources of additional information include:
Governing principlesEach person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
3.1: Strategies to support and safeguard animal wellbeing3.1.1 The planning and conduct of activities involving the care and use of animals must support and safeguard animal wellbeing. Steps include:
Identify known and potential causes of adverse impacts on animal wellbeing 3.1.2 Circumstances with the potential to have an adverse impact on the wellbeing of an animal must be identified. Experimental and non-experimental causes must be considered, including acquisition and breeding, capture, transport, housing and care, social and physical environment, handling, restraint, sample collection, non-surgical procedures, anaesthesia, surgical procedures, genetic modification, humane killing and provisions for the animal at the conclusion of their use. 3.1.3 In each instance, factors that might contribute to the level and duration of harm, including pain and distress, and the risk of such occurrences, must be considered and assessed, taking into account the predicted likelihood and consequences. 3.1.4 If the potential impact on the animal, or the validity and efficacy of criteria for intervention to minimise harm, including pain and distress, cannot be predicted on the basis of available evidence, the incorporation of a pilot study into the design of the project must be considered. Take steps to avoid or minimise adverse impacts on animal wellbeing Support the animals’ wellbeing 3.1.5 Animals must be cared for and managed so that species-specific or strain-specific physiological and behavioural needs are met. 3.1.6 Practices and procedures used for the care and management of animals must be appropriate for the situation, the species and strain of animal, and the activities to be undertaken, and must be based on current best practice. Where the requirements of a project or activity preclude or modify these conditions, special ethical consideration and specific AEC approval is required. 3.1.7 The living conditions in indoor facilities in which animals are bred, held and used must be checked daily (see Clause 3.2.17). 3.1.8 Procedures must be in place at all stages of animal supply, housing and care to ensure that a health status of the animals is maintained that safeguards animal wellbeing and meets the requirements of their proposed use (see Clause 3.2.1). 3.1.9 Animals that are sourced, bred or held for scientific purposes must be suitable for their proposed use, taking into account their biological characteristics, temperament, behavioural conditioning, microbiological and nutritional status, and general state of health (see Clause 1.17). Where appropriate, the suitability of animals should be assessed before they are selected. 3.1.10 Assessment of animals (e.g. wellbeing, suitability for purpose, health) must be undertaken by a competent person, or under the direct supervision of a competent person. 3.1.11 Animals should be acclimatised to the housing/holding conditions, experimental conditions and personnel, and any changes to such conditions, before they are used (see Clauses 3.2.10–3.2.11). Animals that do not adapt satisfactorily should not be used. Prompt provisions should be made for such animals, as appropriate. 3.1.12 For animals that normally live in social groups, social isolation or separation from a group must be avoided unless specific justification is provided to, and approval is obtained from, an AEC (see Clause 3.2.23). 3.1.13 Animals must be identified either individually or in groups. Avoid or minimise harm, including pain and distress 3.1.14 Animals used must be suited to the purpose of the project or activity (see Clause 1.17), and their suitability must be assessed before they are used. 3.1.15 Scientific and educational methods used must accord with current best practice. 3.1.16 Procedures, husbandry and care must be performed competently, by people who are competent or by people under the direct supervision of a competent person. 3.1.17 Potential causes of pain and distress that are not part of the design of a project or activity should be eliminated or controlled to minimise the adverse impact on animal wellbeing and the risks to quality of data. 3.1.18 If pain and distress are predicted or unavoidable consequences of a project, methods for minimising such pain and distress must be incorporated into the design of the project, including:
3.1.19 Where it is established that the aim(s) of the project involves animals experiencing pain and distress that will not be alleviated:
Monitor animals and take appropriate action 3.1.20 Animals must be monitored and assessed:
3.1.21 Methods for monitoring and assessment of animal wellbeing should include:
3.1.22 Records of the monitoring and assessment of animal wellbeing must be:
3.1.23 Prompt action must be taken based on the monitoring and assessment of animals, in accordance with:
3.1.24 Prompt action must be taken in response to unexpected adverse events and emergencies, including alleviation of pain and distress, in accordance with institutional and AEC policies and procedures (see Clause 2.1.5). Alleviation of pain and distress of a severity that was not anticipated in an approved project or activity must take precedence over an individual animal reaching the planned endpoint of the project or activity, or the continuation or completion of the project or activity. If necessary, animals must be killed humanely without delay. 3.1.25 When an animal dies unexpectedly, or is humanely killed due to unforeseen complications, a necropsy should be performed by a competent person (see Clause 2.1.5). Set intervention points and experimental humane endpoints 3.1.26 If pain and distress are predicted or unavoidable consequences of a project, validated criteria that are appropriate for the species and the nature and time course of the predicted effects must be established to identify:
3.1.27 Intervention points and endpoints must be applied as early as feasible and ensure that:
3.1.28 ‘Death as an endpoint' must be replaced with early experimental and humane endpoints whenever possible. Where death as an endpoint is essential for the aim(s) of the project and cannot be avoided:
Review the effectiveness of strategies to support and safeguard animal wellbeing 3.1.29 The effectiveness of strategies to support and safeguard animal wellbeing must be kept under review during the lifetime of a project or activity. Formal review must be conducted at least annually, but preferably more regularly, during the course of a project or activity, and in response to adverse outcomes. Implement changes to the strategy to ensure its ongoing effectiveness 3.1.30 Where relevant and applicable, the outcomes from review of the effectiveness of strategies to avoid or minimise adverse impacts on animal wellbeing must be implemented in current projects or activities and taken into account in planning future activities. Any subsequent amendments to an approved project or activity must not proceed without prior approval from the AEC. Accept responsibilities 3.1.31 The person responsible for the wellbeing of animals at any given time must be clearly identified (see Clauses 2.1.7, 2.4.20 and 2.5.1). 3.1.32 When developing strategies for supporting and safeguarding animal wellbeing, investigators and animal carers should:
3.2: Animal care and managementThis chapter outlines how to support and safeguard the wellbeing of animals during their care and management. Animal health 3.2.1 Procedures for ensuring that a health status of the animals is maintained that safeguards animal wellbeing and meets the requirements of their proposed use (see Clause 3.1.8) must include:
Acquisition and breeding 3.2.2 When animals are specifically bred for scientific purposes, the breeding program must be managed in accordance with current best practice to ensure the wellbeing of the colony, herd or flock, and all animals involved, including:
Further information about breeding animals, including genetically modified animals, is provided in Clauses 2.4.26–2.4.27, 2.5.15 and 3.3.24. 3.2.3 When animals are obtained from a breeding and holding facility outside the institution, the health status of the colony from which the animals are acquired must be assessed before animals are transported, to ensure that the animals will be suitable for the intended scientific purpose and compatible with the biosecurity status and requirements of the receiving facility. 3.2.4 Wildlife must not be taken from their natural habitats or otherwise disturbed unless it is essential for the work proposed and no alternative source of animals or data is available. Practices to minimise transmission of pathogens between animals and between sites must be implemented. Transport of animals 3.2.5 Methods and arrangements for the transport of animals must support and safeguard the wellbeing of the animals before, during and after their transport, and take into account the health, temperament, age, sex and previous experiences of the animals; the number of animals travelling together and their social relationships; the period without food or water; the duration and mode of transport; environmental conditions (particularly extremes of temperature); and the care given during the journey. 3.2.6 Transport methods and arrangements must:
3.2.7 Both suppliers and recipients of animals must ensure that satisfactory delivery procedures are in place, including receipt of the animals by a responsible person, accountability for animal numbers, and adherence to other regulatory codes, such as quarantine. 3.2.8 People responsible for monitoring animals during transport must be able to recognise and respond to animal needs during transport. Admission of new animals to breeding and holding facilities 3.2.9 When new animals are admitted to breeding and holding facilities, their wellbeing must be supported and safeguarded by:
Acclimatisation and conditioning 3.2.10 If there is any change in the housing/holding conditions at the time an animal is supplied or selected for use in a project, sufficient time should be allowed for the animal to acclimatise before the project commences. 3.2.11 Before a project commences, the animals should be conditioned to the handling, experimental conditions and people who will conduct the procedures. 3.2.12 Animals that do not adapt satisfactorily after acclimatisation and/or conditioning should not be used, and prompt provisions should be made for such animals, as appropriate. Housing and care 3.2.13 Animals must be provided with accommodation, physical and social environmental conditions, food, water and care to meet species-specific or strain-specific physical and behavioural needs. If the requirements of a project or activity preclude or modify these conditions, special ethical consideration and specific AEC approval are required (see Clauses 1.9 and 3.1.5). 3.2.14 Facilities must be appropriately staffed, designed, constructed, equipped, maintained and managed to achieve a high standard of animal care. Facilities must be suitable for the type of animals kept and the aims of the activities undertaken. 3.2.15 Animals held outdoors must be protected from adverse environmental conditions and predation, and provided with access to adequate shelter, food and water. 3.2.16 The housing and care of animals that are administered infectious organisms must take into account risks to other animals and to humans, and appropriate procedures to minimise such risks must be implemented. Indoor facilities 3.2.17 Indoor facilities should be designed and operated to:
3.2.18 Indoor facilities must be clean, tidy and in good repair. Walls and floors should be constructed of safe, durable materials that can be cleaned and disinfected readily. There must be adequate storage areas for food and equipment, a reticulated water supply and proper facilities for drainage, if appropriate. 3.2.19 Noxious odours, particularly ammonia, must not exceed a level compatible with the health and comfort of the animals and personnel. 3.2.20 Chemicals used in a facility, including detergents, disinfectants, deodorisers and pesticides must be appropriate for the purpose, and contamination of the animals’ environment must be avoided during their use. Chemicals should be used in consultation with the relevant investigators who use the facility. Pens, cages and containers 3.2.21 Pens, cages and containers must be:
3.2.22 The number of animals in, and placement of, cages, pens or containers should enable the social and environmental conditions for the species to be maintained. 3.2.23 If an animal of a species that normally lives in social groups must be housed in isolation or separated from a group, the duration of such housing conditions must be minimised (see Clause 3.1.12). The animal should be able to see, hear and smell animals of the same species unless such contact is precluded by the requirements of the activity. Food and water 3.2.24 Animals must receive, and be able to access, appropriate, uncontaminated, nutritionally adequate food of a quantity and composition that maintain normal growth of immature animals and normal weight of adult animals, and meet the requirements of pregnancy, lactation or other conditions. 3.2.25 Clean, fresh drinking water must be available at all times, as suitable for the species. 3.3: Specific proceduresThis chapter outlines how the wellbeing of animals may be supported and safeguarded during the conduct of specific procedures. This includes procedures used during the care and management of animals and procedures used during the conduct of approved projects. General requirements that apply to all procedures 3.3.1 Procedures must:
Handling and restraining animals 3.3.2 If handling or restraint is likely to cause harm, including pain and distress, to the animal, the use of chemical restraint (e.g. sedatives) should be considered. 3.3.3 When handling or restraint is required, the animal should be conditioned to the method used, whenever possible. 3.3.4 If prolonged restraint or confinement of an animal is required as part of a project:
Routine husbandry procedures 3.3.5 Routine husbandry procedures must be performed competently, and by a person who is competent for the procedures, or by a person under the direct supervision of a person who is competent to perform the procedures. Routine husbandry procedures are not part of a project and include, for example, clipping coats and nails, and vaccinations. Identification of animals 3.3.6 Methods used to identify animals must:
Injections, blood sampling and non-surgical procedures 3.3.7 When performing injections, blood sampling and non-surgical procedures, procedures used must:
Anaesthesia, analgesia and sedation, and management of pain and distress 3.3.8 The use of local and general anaesthetics, analgesics and sedatives must be considered as part of a plan to manage pain and distress, and such use should at least parallel their use in current veterinary or medical practice. 3.3.9 When anaesthetics, analgesics and sedatives are used, the choice of agent and its administration must:
3.3.10 Unless there is evidence to the contrary, it must be assumed that fetuses have comparable requirements for anaesthesia and analgesia as adult animals of the species. Approaches to avoid or minimise pain and distress in the fetus must be designed accordingly. 3.3.11 Regardless of their mechanism of action, the effectiveness of all anaesthetics must be monitored throughout anaesthesia. 3.3.12 When general anaesthesia is used, procedures must conform with current veterinary or medical practice and ensure that:
3.3.13 Animals that develop signs of pain and distress must be treated promptly, in accordance with the intervention points and humane endpoints approved by the animal ethics committee (AEC), and institutional and AEC policies and procedures (see Clauses 2.1.5 and 3.1.23–3.1.24). 3.3.14 Neuromuscular blocking agents must only be used in conjunction with adequate general anaesthesia or an appropriate surgical procedure that eliminates sensory awareness. The animal must be monitored to ensure that an adequate plane of anaesthesia is maintained or sensory awareness has been eliminated. Because the paralysis abolishes many criteria for assessing anaesthetic depth and pain perception (e.g. character of respiration, and corneal and flexor withdrawal reflexes), continuous or frequent monitoring of physiological variables (e.g. heart rate, blood pressure, pupil size, electroencephalogram), together with the effects on these of mild sensory stimuli, must be used. 3.3.15 Electroimmobilisation must not be used as an alternative to analgesia or anaesthesia. Surgical procedures 3.3.16 The wellbeing of animals that have undergone surgical procedures must be supported and safeguarded by:
Postprocedure care 3.3.17 After any procedure:
3.3.18 If an animal must be housed in isolation or separated from a group after a procedure, the duration of such housing conditions should be minimised. The animal should be able to see, hear and smell animals of the same species unless such contact will interfere with data collection and interpretation (see Clause 3.1.12). 3.3.19 If an animal is to be isolated or restrained for a prolonged period after a procedure, the animal should be conditioned to the housing or restraint conditions before the procedure is undertaken (see Clauses 3.1.11 and 3.3.3). 3.3.20 Animals that have undergone surgery for transplantation of organs or tissues must be managed to avoid or minimise adverse impacts from potential rejection of the transplant and the effects of immunosuppression. Projects involving the fetus or embryo 3.3.21 Where a project involves the fetus or embryo, the requirements for anaesthesia and analgesia of the fetus or embryo must be taken into account (see Clauses 3.3.8–3.3.15). 3.3.22 If a procedure conducted on a fetus or embryo would compromise the ability of the animal to survive after birth or causes untreatable pain and distress, the animal (neonate/fetus/embryo) must be killed humanely before or immediately after birth. Induction of tumours 3.3.23 For animals in studies that involve the induction of tumours, methods used and endpoints chosen must ensure that valid results are obtained with minimal harm, including pain and distress, to the animal. Animal wellbeing must be supported and safeguarded by:
Creation and breeding of new animal lines where the impact on animal wellbeing is unknown or uncertain This clause should be read in conjunction with Clauses 2.4.26–2.4.27 and the NHMRC Guidelines for the generation, breeding, care and use of genetically modified and cloned animals for scientific purposes. 3.3.24 When creating and breeding new animal lines where the impact on animal wellbeing is unknown or uncertain, the wellbeing of the animals must be supported and safeguarded by:
Modification of behaviour and neurological function 3.3.25 Positive reinforcement should be used to motivate an animal to modify their behaviour or perform specific tasks. 3.3.26 Prolonged deprivation of water, food, social interaction or sensory stimuli must not be used to induce an animal to modify their behaviour. 3.3.27 If some form of biological stress is essential for the aims and purpose of the project, the duration and severity of the impact on the wellbeing of the animal must be as mild as possible. 3.3.28 Painful or noxious stimuli should be avoided. If their use is justified, the level and duration of the stimulus must be minimised, and provision must be made for the animal to be able to escape the stimulus. 3.3.29 Projects involving the withholding or restriction of food or water must be designed so that the animal experiences no continuing detrimental effect. Changes in fluid balance or body weight must be monitored, recorded and maintained within the limits approved by the AEC. 3.3.30 When a study involves neurological impairment that produces loss of function in the animal (e.g. impaired movement of the limbs or trunk; loss of sensibility to touch, sound, temperature or pain, or awareness of surroundings; or impairment of appetite or thirst), the special needs of the animal because of that loss of function must be met. Such animals should be provided with special care, caging and other facilities, as required. Immunomodulation and production of antibodies 3.3.31 When agents or treatments are used to suppress the immune system (e.g. irradiation):
3.3.32 When adjuvants are used to produce antibodies, the adverse impacts on animal wellbeing should be minimised by:
Wildlife and field techniques See also clauses on acquisition (Clause 3.2.4), housing and care (Clauses 3.2.13–3.2.25), transport (Clauses 3.2.5–3.2.8) and identification (Clause 3.3.6). General considerations 3.3.33 The wellbeing of wildlife must be supported and safeguarded by:
Capture and handling 3.3.34 To minimise the risk of injury or stress-induced disease, procedures for the capture and handling of wildlife must include:
Use of traps 3.3.35 If trapping is used to capture wildlife, the wellbeing of both target and non-target animals must be considered by:
3.3.36 Wet pitfall traps must not be used to capture vertebrate animals. If wet pitfall traps are used to capture invertebrates, they must be managed and monitored to minimise the inadvertent capture of vertebrates, including by locating the trap where vertebrate entry is unlikely and using the smallest possible trap diameter. Transport, holding and release 3.3.37 Transport of wildlife must be in accordance with Clauses 3.2.5–3.2.8. 3.3.38 If animals are to be held in captivity, the duration must be minimised and consistent with the purpose and aims of the project or activity. If animals are to be released, all possible steps must be taken to avoid their becoming habituated to human activity. 3.3.39 Procedures for any release of wildlife must ensure that:
Tracking the movement of wildlife 3.3.40 When devices are used to track the movement of wildlife, the weight, design and positioning of attached devices must minimise interference with the normal survival requirements of the animal. 3.3.41 Interference activities such as call playback, spotlighting, tiling, rock turning, investigating a nest box and disturbing nest sites must be conducted in a manner that minimises any risk to the wellbeing of the wildlife. 3.3.42 Alternatives to collecting animals as voucher specimens (e.g. tissue samples, digital photography) must be considered, where appropriate. When animals are collected as voucher specimens:
Studies involving vertebrate pest animals 3.3.43 The principles of the Code must be applied equally to animals that are considered to be pests. 3.3.44 Captive feral and pest species must be killed humanely unless the aims of a project require their release, or the study involves death as an endpoint. Humane killing 3.3.45 The method and procedures used for killing an animal must be humane and:
3.3.46 Dependent offspring of animals to be killed must be cared for or humanely killed. 3.4: Provisions for animals at the conclusion of their use3.4.1 Provisions for animals at the conclusion of their use must be made promptly and in accordance with the animal ethics committee (AEC) approval. Provisions may include:
Rehousing (rehoming) 3.4.2 Opportunities to rehome animals should be considered wherever possible, especially when the impact of the project or activity on the wellbeing of the animal has been minimal and their physiological condition and behavioural attributes indicate that they can be introduced to a new environment with minimal, transient impact on their wellbeing. 3.4.3 An animal must not be released to a person at the conclusion of their use unless:
Return to normal husbandry conditions or natural habitat 3.4.4 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. 3.4.5 If release of wildlife animals is permitted, such release must comply with Clause 3.3.39. Section 4: The care and use of animals for the achievement of educational outcomes in scienceDefinitions that are particularly relevant to this section:
This section covers the care and use of animals in teaching activities where the ’scientific purpose’ is to impart or demonstrate knowledge or techniques to achieve an educational outcome in science, as specified in the relevant curriculum or competency requirement. All parts of the Code apply to teaching activities. This section provides additional guidance on the responsibilities outlined in other sections when animals are used for teaching activities. It must be applied in addition to other parts of the Code, particularly Section 2 ‘Responsibilities’ and Section 3 ‘Animal wellbeing’. It is expected that animals used in teaching activities will receive a high standard of care, that their wellbeing will be supported and safeguarded in accordance with the governing principles outlined in Section 1, and that their use will occur only in accordance with approval from an animal ethics committee (AEC). If you are involved in the care and use of animals in teaching activities in a school, you need to:
Governing principlesEach person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
ResponsibilitiesInstitutions 4.1 The responsibilities of institutions involved in the care and use of animals for teaching activities are as outlined in Chapter 2.1. 4.2 The responsibilities of institutions regarding the governance of an AEC overseeing the care and use of animals in teaching activities are as outlined in Chapter 2.2. 4.3 Institutions must ensure that animals are used for teaching only when their use is essential to achieve an educational outcome in science, as specified in the relevant curriculum or competency requirements, and suitable alternatives to replace the use of animals to achieve the educational outcome are not available (see Clause 1.5). 4.4 Institutions must identify the person with ultimate responsibility for the care and use of animals in teaching activities. This person must:
This person does not relieve the individual responsibility of the teacher who is involved in the care and use of animals in teaching activities. Primary and secondary sectors (including secondary agricultural colleges) 4.5 Institutions involved in the care and use of animals in teaching activities in the primary and secondary sectors must ensure that they have access to an AEC. This may be a regional or central state AEC. 4.6 Institutions must ensure that the following activities using animals are not demonstrated to, or carried out by, primary or secondary level students:
4.7 Institutions must ensure that humane killing of animals is not demonstrated to, or carried out by, primary or secondary level students unless it is required:
Animal ethics committees 4.8 The responsibilities of an AEC overseeing the care and use of animals in teaching activities are as outlined in Chapter 2.3. Teachers as investigators and animal carers 4.9 When teachers use animals for teaching activities, the teacher has the responsibilities of an investigator under Chapter 2.4. 4.10 When teachers are responsible for the care of animals that are used for teaching activities, including during their acquisition, transport, breeding, housing and husbandry, the teacher has the responsibilities of an animal carer under Chapter 2.5. 4.11 Teachers have personal responsibility for all matters that relate to the wellbeing of animals that they use, including their housing, husbandry and care. This responsibility extends throughout the period of use approved by the AEC until provisions are made for the animal at the conclusion of their use (consistent with Clause 2.4.1). 4.12 Teachers must ensure that students have the opportunity to discuss the ethical and social issues, and legal responsibilities, involved in the care and use of animals for scientific purposes, at a level appropriate to their learning ability and comprehension, and before the use of animals commences. 4.13 Teachers must ensure that the students are supervised by a person who is competent for the procedure being performed, and that the level of supervision of students takes into account the competency and responsibilities of each student. 4.14 Teachers must ensure that animals are not released to students, or any other person, for temporary care, or at the completion of the use of the animal (see Clauses 3.4.2–3.4.3), unless:
Obtaining approval from an animal ethics committee 4.15 Teachers, and the person with ultimate responsibility for a teaching activity, must follow institutional and AEC procedures when submitting an application to an AEC (see Chapter 2.7) and provide information in the application form as outlined in Clause 2.7.4. The AEC may be a regional or central state AEC (see Clause 4.5). 4.16 AEC approval may be sought to repeat a particular teaching activity that may involve different students, times, locations or animals. 4.17 AEC approval is not required for the training and application of agricultural extension work practices, or the training of students in veterinary science, veterinary nursing or animal technology to achieve competency-based outcomes in routine procedures if all of the following apply:
Section 5: Complaints and non-complianceDefinitions that are particularly relevant to this section:
Institutions may receive complaints about the care and use of animals for scientific purposes. Complaints may be raised by any person or group, including investigators, animal carers, animal ethics committees (AECs), AEC members, students, employees of the institution and members of the public. Complaints may relate to the activities of any party or person involved in the care and use of animals, including investigators, animal carers, the AEC and governance officials. Institutions may also become aware of activities relating to the care and use of animals for scientific purposes that are not being conducted in accordance with the Code. This section outlines the responsibilities of institutions and AECs for addressing complaints and non-compliance relating to the care and use of animals for scientific purposes. Governing principlesEach person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
Responsibilities5.1 Institutions must have procedures for addressing complaints and non-compliance relating to the care and use of animals for scientific purposes, including:
5.2 Institutional procedures must:
5.3 For projects involving more than one institution and/or AEC (see Clauses 2.6.4–2.6.7), procedures should include mechanisms for reporting between the relevant institutions and AECs on complaints and non-compliance. Receiving, investigating and addressing complaints Complaints concerning the care and use of animals 5.4 Institutions must ensure that:
5.5 Following the AEC’s investigation of complaints referred to it by the institution, the AEC:
Complaints concerning the animal ethics committee process 5.6 Where complaints concerning the AEC process of review of an application or report cannot be resolved by communication between the complainant and the AEC that is the subject of the complaint, the institution should ensure that the complainant has access to a person or agency external to the AEC for review of the process followed by the AEC. This person or agency may be within the institution. Following this review, the AEC may need to review its process in reaching its decision regarding the application or report, and re-evaluate its decision in light of the reviewed process. The ultimate decision regarding the ethical acceptability of an activity lies with the AEC and must not be overridden. Complaints concerning the process for independent external review 5.7 Institutions must ensure that the process for conducting an independent external review, developed in consultation with the review panel, includes an appeals process that relates to the process for the review (see Clause 6.5). Referral to a person or agency external to the institution 5.8 Institutions should identify a person or agency external to the institution to whom a person can take a complaint that has not been resolved by the processes referred to in Clauses 5.1–5.7. Addressing non-compliance 5.9 Institutions must have procedures for addressing non-compliance with the Code, so that behaviours that create and support compliance are encouraged, and behaviours that compromise compliance are not tolerated. 5.10 The institution must maintain records of breaches of the Code. Advising regulatory authorities 5.11 Any person can report alleged breaches of legislation to relevant state or territory government authorities. 5.12 The institution should advise relevant state or territory government authorities of alleged breaches of legislation that had a significant impact on animal wellbeing. Section 6: Independent external review of the operation of institutionsDefinitions that are particularly relevant to this section:
Independent external review assists institutions to assess whether the procedures they have established meet the goals set out in the Code, and provides assurance that the institution, through its animal ethics committee (AEC), is delivering effective oversight of the care and use of the animals in its charge. The process should be educational and provide an opportunity for self-assessment so that members of the AEC and those at the institution who have responsibilities for animal care and use are involved in achieving the desired outcomes. Governing principlesEach person involved in the care and use of animals for scientific purposes must consider the governing principles in Section 1 when applying the Code to their specific circumstance; in particular:
ResponsibilitiesInstitutions 6.1 Institutions must ensure that an independent external review is conducted at least every four years to assess the institution’s compliance with the Code, and to ensure the continued suitability, adequacy and effectiveness of its procedures to meet its responsibilities under the Code (see Clause 1.9). 6.2 Institutions must:
6.3 Reviews carried out under the administration of state or territory legislation may satisfy the requirement for an independent external review. Review panel 6.4 Members of the review panel must:
6.5 The review panel must:
Scope and outcomes of the independent external review 6.6 Areas covered by the independent external review should include:
6.7 The review panel should provide recommendations that:
Section 7: Cosmetic TestingDefinitions that are particularly relevant to this section:
The use of animals for cosmetic testing is banned in Australia. This section provides additional guidance about the responsibilities of institutions, animal ethics committees (AECs) and investigators with respect to this ban. This section must be read in conjunction with other sections of the Code. All those considering the use of animals for cosmetic testing must be aware of the requirements under the Industrial Chemicals Act 2019 and the Industrial Chemicals (General) Rules 2019 (as amended from time to time) as they apply to their specific circumstances. Additional definitions relevant to this sectionIn addition to those outlined in the ‘Definitions’ section of the Code, the following definitions apply to this section. Act: the Industrial Chemicals Act 2019, as amended from time to time. Animal test data: data or information obtained from tests involving the use of animals. (For full definition, see the Act and General Rules.) Chemical ingredient: an industrial chemical used as an ingredient or component of a cosmetic (see also ‘industrial chemical’). Cosmetic: substance or preparation:
(For full definition, see the Act and General Rules.) Finished cosmetic product: cosmetic in its final formulation. (For further information and examples, see the Australian Industrial Chemical Introduction Scheme and the Therapeutic Goods Administration websites.) General Rules: the Industrial Chemicals (General) Rules 2019, as amended from time to time. Industrial chemical: a chemical that is used for purposes other than for agricultural, veterinary or therapeutic purposes, or in food or animal feed. An ingredient or component of a cosmetic can be an industrial chemical. (For full definition, see the Act and General Rules.) BackgroundThe use of animals for cosmetic testing is banned in Australia. The ban recognises the existence of viable alternatives to the use of animals for cosmetic testing. It also recognises the need to maintain protection of human health and the environment. Implementation of the ban includes:
Industrial Chemicals Act 2019 The import or manufacture in Australia of industrial chemicals is regulated by the Industrial Chemicals Act 2019 (the Act). Chemicals that are used for agricultural, veterinary or therapeutic purposes, or in food or animal feed are not industrial chemicals and are regulated by other legislation (e.g. Therapeutic Goods Act 1989). The Act establishes the Australian Industrial Chemicals Introduction Scheme (AICIS) and bans the use of animal test data obtained from tests involving the use of animals conducted on or after 1 July 2020 (new animal test data) to support the import or manufacture in Australia of industrial chemicals for use solely in cosmetic products. |