The Code Governing principles

Transcription

1 The Code Governing principles

2 LEARNING OBJECTIVES This training module will familiarise you with the purpose of animal welfare legislation, animal use and governing principles around the use of animals for scientific purposes. The expected time to complete this module is 15 minutes. The following topics will be covered: The Australian Code for the care and use of animals for scientific purposes (8 th edition, 2013) and the purpose of animal welfare legislation Animal use for scientific purposes Governing principles (Section 1 of the Code) Use animals only when justified Support the wellbeing of animals Avoid or minimise harm Apply high standards of scientific integrity Apply the 3Rs at all stages Accept responsibilities 2

3 AUSTRALIAN CODE FOR THE CARE AND USE OF ANIMALS FOR SCIENTIFIC PURPOSES AND LEGISLATION All researchers or teachers using animals must be familiar with the Code. The Australian Code for the Care and Use of animals for Scientific Purposes (8 th edition 2013) is enacted under legislation in all States and Territories In Queensland, the Code is enacted under the Queensland Animal Care and Protection Act 2001 and Regulations (2012) Additional state or Territory-based legislation governs the prevention of cruelty to animals 3

4 THE AUSTRALIAN CODE FOR THE CARE AND USE OF ANIMALS FOR SCIENTIFIC PURPOSES (2013) The code consists of the following sections. This Module covers Section 1, Governing principles. Animal Wellbeing (Section 3), and Responsibilities of investigators and the UAEC (Section 4) are covered in Modules 2 4. Section 1: Section 2: Section 3: Section 4: Section 5: Section 6: Governing Principles Responsibilities of Institutions, AECs, investigators and animal carers Animal Wellbeing Care and use of animals for the achievement of educational outcomes Complaints and non-compliance Independent external review of the operation of institutions 4

5 ANIMAL WELFARE LEGISLATION The Code and legislation were developed in response to community concerns regarding animal use in research and teaching. The Code: Ensures animal use is humane, considerate, respectful, responsible and justified Provides a mechanism for public accountability Provides a framework for actions to be taken Enables prosecution for unapproved and inappropriate use under the Animal Care and Protection Act 2001 Ensures that research is conducted in accordance with legislation and provides protection for investigators against undue criticism 5

6 ANIMAL USE - DEFINITION Animal use for scientific purposes includes any of the following in connection with which an animal is used: Procedure Test Experiment Inquiry Investigation Field study Teaching activity or study This is defined in the Animal Care and Protection Act 2001, Chapter 4. 6

7 ANIMAL USE DEFINITION OF AN ANIMAL An animal is defined in the Code as any live vertebrate (excluding human beings). From This includes: Amphibians Birds Fish Reptiles Mammals Embryonic, foetal and larval forms And higher order invertebrates including cephalopods - such as octopus and squid 7

8 ANIMAL USE - EMBRYONIC, FOETAL AND LARVAL FORMS The Code states that: Animals in their embryonic, foetal and larval forms can experience pain and distress As a guide, when embryonic, foetal and larval forms have progressed beyond half the gestation or incubation period, or they become capable of independent feeding, the potential for the experience of pain or distress should be taken into account. At this stage they are considered as sentient beings and must be counted as animals in the annual report on animal usage 8

9 ANIMAL USE UAEC APPROVAL All scientific use of animals for research or teaching must be approved by a UAEC before the study commences Animals used in research or teaching must be obtained from a licensed animal supplier Respect for animals must underpin all decisions and actions involving the care and use of animals for scientific purposes The obligation to respect animals, and the responsibilities associated with this obligation, apply throughout the animals lifetime 9

10 THE CODE - GOVERNING PRINCIPLES Respect for animals and obligations towards them must apply at all stages including: The acquisition of the animal Transport Breeding Housing Husbandry Use of the animal in a project The provisions for the animals at the conclusion of their use 10

11 USE ANIMALS ONLY WHEN JUSTIFIED Sufficient evidence must be provided to satisfy the UAEC that the proposed use of animals is justified (Sections ) Janet Stephens/Wikimedia Commons Evidence provided in the application must demonstrate that: The project has sufficient scientific or educational merit It has potential benefit for humans, animals or the environment The use of animals is essential for the project to meet its aims The minimum number of animals required to obtain valid data is used The project has minimal adverse impact on animal wellbeing 11

12 SUPPORT THE WELLBEING OF ANIMALS The wellbeing of animals must be considered in terms of the cumulative effects of the animals lifetime experience (Section 1.8) At all stages measures must be taken to ensure that the animal s environment and management is appropriate for the species and the individual animal s wellbeing 12

13 SUPPORT THE WELLBEING OF ANIMALS Animal wellbeing is defined by the Code as an animal being in a positive mental state. An animal must be able to: Achieve successful biological function Have positive experiences Express innate (natural) behaviours Respond to and cope with potentially adverse conditions 13

14 SUPPORT THE WELLBEING OF ANIMALS Animal wellbeing can be assessed by physiological and behavioural measures of: An animal s physiological and psychological health Capacity to cope with stressors Species-specific behaviours in response to social and environmental conditions 14

15 SUPPORT THE WELLBEING OF ANIMALS Novartis AG Care and management must be based on current best practice and take into account species-specific requirements in terms of: Biology Physiology Behaviour And the best available scientific evidence including: Potential adverse impacts Strategies to minimise adverse impacts 15

16 APPLY HIGH STANDARDS OF SCIENTIFIC INTEGRITY Current best practice must be used when designing projects Photo by Mel Williams via Wikimedia Commons Methods must be: Scientifically valid Feasible Well designed Carefully conducted There should be a reasonable expectation that the aims will be achieved 16

17 APPLY HIGH STANDARDS OF SCIENTIFIC INTEGRITY Animals used must be suited to the purpose Novartis The following characteristics should be taken into account: Physiology Behaviour Morphology Genetic makeup Temperament Behavioural conditioning Microbial status Nutritional status 17

18 AVOID OR MINIMISE HARM TO ANIMALS Animals have the capacity to experience pain and distress Animals may perceive and respond to circumstances differently from humans Pain and distress may be difficult to evaluate in animals It must be assumed that procedures or conditions that would cause pain and distress in humans cause pain and distress in animals (unless there is evidence to the contrary) Steps must be taken at all times to avoid and minimise harm, including pain and distress 18

19 AVOID OR MINIMISE HARM TO ANIMALS Jodi Rowley Australian Geographic Prompt action must be taken to alleviate pain and distress: That were not anticipated in an approved project, or Occur as a result of an emergency Action must take precedence over the continuation or completion of the project or activity 19

20 APPLY THE 3RS AT ALL STAGES Replacement of animals with other methods Reduction in the number of animals used Refinement of techniques and procedures to minimise adverse impact on animals 20

21 REPLACEMENT METHODS Methods that replace or partially replace the use of animals must be investigated, considered and, where applicable, implemented (section 1.18) Alternative methods may include In vitro methods and models Cell and tissue culture Engineered alternatives Inanimate synthetic models Physical and chemical techniques Mathematical and computer models Larval forms, micro-organisms or plants Human studies Analysis of existing databases Epidemiological data Clinical cases 21

22 REDUCTION Section The number of animals used must be the minimum necessary: To meet the aims of the study To satisfy good statistical design The use of too few animals could invalidate the experimental results Animal use should not be repeated within or between projects unless repetition is essential for the design of the project Reducing animal numbers should not result in greater harm, pain or distress to the animals 22

23 REDUCTION TISSUE SHARING Tissue or biological material should be: Shared among investigators, or Deposited in a tissue bank for subsequent distribution Stanford Pathology A tissue use application may be required, however, full ethical approval is required from UAEC if the life or death of the animal is influenced by the project in any way. 23

24 REDUCTION TISSUE USE Examples of tissue use include the use of animal tissue only, including cadavers, tissue samples, bones, fluids or excreta If an animal is killed specifically for scientific use, or for teaching, a full application to the UAEC is required For the use of tissues from wildlife, additional requirements may need to be met For more detail regarding tissue use refer to the OREI website 24

25 REDUCTION BREEDING ANIMALS Section 1.27 Breeding must be managed to avoid or minimise the production of excess animals A new line of animal should not be generated if a similar line is available 25

26 REDUCTION EXPERIMENTAL DESIGN Section 1.25 All possible steps must be taken to reduce factors that are known to contribute to variability of the experimental results This includes the use of animals of known genetic, biological and behavioural background Reduction of the number of experimental variables may lead to reduced animal use 26

27 REFINEMENT Section Investigators must support and safeguard animal wellbeing at all times The effectiveness of these strategies must be kept under review throughout the project Procedures must be performed competently and people who care for and use animals must: Be competent in the procedure, or Be under the direct supervision of someone competent to perform the procedure 27

28 REFINEMENT Section 1.30 The duration of the activity must: Only be as long as required to meet the aims Be compatible with supporting and safeguarding animal wellbeing Animals must not be held for prolonged periods before their use without UAEC approval 28

29 ACCEPT RESPONSIBILITIES Section 1.31 People involved in any aspect of the care and use of animals for scientific purposes must: Be aware of and accept their responsibilities (Section 2.4), and Act in accordance with the Code 29

30 ACCEPT RESPONSIBILITIES Section 1.32 All activities must: Be subject to ethical review, approval and monitoring by the UAEC (including annual reports) Commence only after written approval has been granted Be conducted in accordance with the UAEC approval Cease if approval is suspended or withdrawn Note that a variation must be submitted and approved prior to any changes to the approved protocol 30

31 THE NHMRC GUIDELINES TO PROMOTE THE WELLBEING OF ANIMALS USED FOR SCIENTIFIC PURPOSES Investigators at QUT are also required to comply with NHMRC Guidelines You must, therefore, be familiar with the Guidelines to promote the wellbeing of animals used for scientific purposes: the assessment and alleviation of pain and distress in research animals This resource contains useful information for designing projects and for ethics applications 31

32 QUT CONTACTS Office of Research Ethics and Integrity Faculty / School Research Ethics Advisors Health - A/Prof Katrina Schmid Health - Dr Fatemeh Chehrehasa SEF - Dr Roland Steck SEF - Dr David Hurwood article.wn.com Animal Welfare Officer - Prof Lisa Chopin 32

33 REFERENCES This module is based upon: The Australian Code for the Care and Use of animals for Scientific Purposes (8 th edition 2013) and the NHMRC Guidelines to promote the wellbeing of animals used for scientific purposes: The assessment and alleviation of pain and distress in research animals (2008). 33

34 ACKNOWLEDGEMENT The contribution of the University of Queensland Animal Welfare Unit, in particular Ann Higgins and Dr Michael Uren, in the preparation of this training material is gratefully acknowledged. Voiceover Patrick Thomas 34

35 COMMONWEALTH OF AUSTRALIA Copyright Regulations 1969 WARNING This material has been reproduced and communicated to you by or on behalf of The Queensland University of Technology. pursuant to Part VB of The Copyright Act 1968 (The Act). The material in this communication may be subject to copyright under The Act. Any further copying or communication of this material by you may be the subject of copyright protection under The Act. Do not remove this notice. Animal Ethics Online Training by Office of Research Ethics and Integrity, Queensland University of Technology (QUT) is licensed under a Creative Commons Attribution- NonCommercial-ShareAlike 4.0 International License. Permissions beyond the scope of this license may be available at orei.enquiries@qut.edu.au. 35