EMAN Animal Ethics Application Guideline

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Section 1: Governing principles

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. using animals only when it is justified
  2. supporting the wellbeing of the animals involved
  3. avoiding or minimising harm, including pain and distress, to those animals
  4. applying high standards of scientific integrity
  5. applying Replacement, Reduction and Refinement (the 3Rs) at all stages of animal care and use:
    1. the Replacement of animals with other methods
    2. the Reduction in the number of animals used
    3. the Refinement of techniques used to minimise the adverse impact on animals
  6. knowing and accepting one’s responsibilities.

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. the project has scientific or educational merit, and has potential benefit for humans, animals or the environment
  2. the use of animals is essential to achieve the stated aims, and suitable alternatives to replace the use of animals to achieve the stated aims are not available
  3. the project involves the minimum number of animals required to obtain valid data
  4. the project involves the minimum adverse impact on the wellbeing of the animals involved.

1.6 Projects must only be undertaken:

  1. to obtain and establish significant information relevant to the understanding of humans and/or animals, or
  2. to maintain and improve human and/or animal health and welfare, or
  3. to improve animal management or production, or
  4. to obtain and establish significant information relevant to the understanding, maintenance or improvement of the natural environment, or
  5. to achieve educational outcomes in science, as specified in the relevant curriculum or competency requirements.

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:

  1. takes into consideration the relevant aspects of species-specific biology, physiology and behaviour
  2. is based on the best available scientific evidence (or, in the absence of scientific evidence, accepted practice), which includes the potential adverse impact of conditions and procedures on the wellbeing of the animals
  3. includes strategies to minimise adverse impacts.

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. take into consideration relevant aspects of species-specific biology, physiology and behaviour
  2. are based on the best available scientific evidence, which includes the potential adverse impact of conditions and procedures on the wellbeing of the animals
  3. include strategies to minimise adverse impacts.

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


(i) 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.

 

(ii) 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.

 

(iii) 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. be competent for the procedure they perform, or
  2. be under the direct supervision of a person who is competent to perform the procedure.

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:

  1. be subject to ethical review, approval and monitoring by an AEC
  2. commence only after approval has been granted by an AEC
  3. be conducted in accordance with the AEC approval
  4. cease if approval from the AEC is suspended or withdrawn.

 

Section 2: Responsibilities

This Section describes the responsibilities of Animal Ethics Committee (AEC) regarding ethical review, approval and monitoring of animal care and use in accordance with the Code.

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:

 

  1. Institution, AEC, and people involved in any aspect of the care and use of animals for scientific purposes must be aware of and accept their responsibilities, and act in accordance with the Code (see Clause 1.31).
  2. All activities, including projects, that involve the care and use of animals for scientific purposes must:
    1. be subject to ethical review, approval and monitoring by an AEC
    2. commence only after approval has been granted by an AEC
    3. be conducted in accordance with AEC approval
    4. cease if approval from the AEC is suspended or withdrawn (see Clause 1.32).
  3. An AEC must be satisfied that there is sufficient evidence to support a case that the proposed use of animals is justified (see Clause 1.7).

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:

  1. review applications for projects and approve only those projects that are ethically acceptable (see Clause 1.3) and conform to the requirements of the Code
  2. review applications for activities associated with the care and management of animals in facilities, including procedures applicable to breeding programs integral to the maintenance of an animal line, and approve only those activities that are ethically acceptable and conform to the requirements of the Code
  3. monitor the care and use of animals, including housing conditions, practices and procedures involved in the care of animals in facilities
  4. provide advice and recommendations to the applicants

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:

  1. be based on information provided by the applicant that demonstrates the application of the principles outlined in Section 1.
  2. balance whether the potential effects on the wellbeing of the animals involved is justified by the potential benefits.

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.
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:

  1. an application to commence a project or activity, or amend an approved project or activity, is approved with or without conditions, deferred subject to modification, or not approved following review of the annual report for an approved project or activity and possible consultation with the applicant, the approval for the project or activity is continued, suspended, modified or discontinued
  2. an approval is suspended or withdrawn.

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, 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:

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

2.3.16 In determining the duration of approval for individual projects, AEC 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
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 [v]).
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:

  1. numbers and types of projects and activities assessed, and approved or rejected
  2. the physical facilities for the care and use of animals by the institution
  3. actions that have supported the educational and training needs of AEC members and people involved in the care and use of animals
  4. administrative or other difficulties experienced
  5. any matters that may affect the institution’s ability to maintain compliance with the Code and, if appropriate, suitable recommendations.