RESEARCH INTEGRITY Animal Ethics Committee Web: http://sydney.edu.au/research_support/ethics Project Officer Australian code of practice for the care and use of animals for scientific purposes Health and Research Ethics Section Research Translation Group NHMRC GPO Box 1421 CANBERRA ACT 2601 Dear Project Officer, Thank you for the opportunity to comment on the draft NHMRC guidelines for the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes. This submission is made on behalf of the University of Sydney. Public consultation on Proposed Revision of the Australian Code of Practice for the Care and Use of Animals for Scientific Purposes 2004 1. Does the document clearly and concisely set out governing principles? Yes. 2. Are the terms should and must used appropriately in the document? Refer to specific comments below. 3. Does the document clearly and concisely set out, and correctly attribute, responsibilities of all parties involved? Yes. 4. Does the document provide all relevant parties with sufficient practical guidance on the application of principles of Code of Practice in terms of their responsibilities? Yes. 5. Should the document include specific guidance regarding the responsibilities of Veterinarians and Animal Welfare Officers? Should the document include a requirement for direct veterinary involvement in the oversight of a veterinary care program and research involving animals including, for example, the conduct of procedures such as anaesthesia and surgery? While we recognise there are divergent opinions in the community on this matter, in a research intensive University like Sydney, it would not be practicable or possible to have a veterinarian present at all anaesthetic and surgical procedures. Veterinarians often do not have expertise in specialised procedures involving laboratory animals and so direct veterinary oversight of procedures may not add value. Address for all correspondence: Level 6 Jane Foss Russell Building G02 The University of Sydney NSW 2006 AUSTRALIA Animal Ethics Officer Paul Sou T: +61 2 8627 8175 E: animal.ethics@sydney.edu.au AEC Secretariat: Roslyn Todd T: +61 2 8627 8174 E: roslyn.todd@sydney.edu.au ABN 15 211 513 464 CRICOS 00026A
Veterinarians have a unique perspective on animal welfare and should be involved in the planning of research and teaching programs involving animals. This is currently the case through veterinary membership of the Animal Ethics Committees, and a proposal to expand this role through the provision of guidance to Animal Welfare Officers and veterinarians would be supported providing it is designed to enable rather than restrict research. Please refer to specific comments below. 6. As a principles based document, the impact of the revised Code of Practice may be lost if too much detail is included. Comment is therefore specifically sought on whether there is sufficient balance between principles and detailed guidance. There appears to be sufficient balance. 7. Is there clear connection between the Code of Practice 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) (Wellbeing Guidelines)? Yes. 8. Do you believe the title of this document should be amended to reflect the focus of the Code of Practice on ethical principles and best practice guidance, and to more clearly indicate the scope of the Code of Practice; for example, Australian Code for the care and use of animals in research, science and education? If so, suggestions for a title would be helpful. Yes, Australian Code for the care and use of animals in research and education or Australian Code for the care and use of animals in science and education. 9. Is animal appropriately defined? Should the definition account for animals at the early stage of their development (i.e. embryonic, fetal and larval forms)? If you disagree with the definition, it would be very helpful if you could provide evidence for your view. Yes, animal is appropriately defined. 10. Comment is sought regarding the proposal for the Category E membership category for an Animal Ethics Committee ( a person who is responsible for the routine care of animals from within the institution ) to be mandatory for institutions thatt have or maintain animal breeding or holding facilities (see Section 2.2) How would these proposed changes outlined in Section 2.2 work for your Animal Ethics Committee (Animal Ethics Committee)? Category E membership should be encouraged but should not be mandatory. An acceptable alternative would be for Category E members to attend AEC meetings as observers or non voting members. Refer to specific comments below (2.2.15(v)). 11. Should the document include a guide regarding the longest duration of approval granted by an Animal Ethics Committee (AEC) for a project before submission of a new application is required? 2
Yes, so long as it is reasonable. Currently, we give approval for 3 years with the condition that an annual report must be submitted and must satisfy the AEC. Researcherss are eligiblee to have their projects extended for up to 1 year following the three year period on application. The table appended below provides specific suggestions on the draft revised code that was circulated with comments on the reasons for each suggestion. Yours sincerely Original Signed REBECCA HALLIGAN Director of Research Integrity Research Integrity Research Portfolio T +61 2 8627 8502 M +61 431 657 625 E Rebecca.Halligan@sydney.edu.au W http://sydney.edu.au/research_ support/ 3
RESEARCH INTEGRITY Animal Ethics Committee Web: http://sydney.edu.au/research_support/ethics Australian code of practice for the care and use of animals for scientific purposes: Draft October 2011 Page Item Comments Suggestions General items 7, 24 Ethical discussion by AECs Concerns have sometimes been raised that AEC discussions are too heavily focussed on technical or administrative matters and not enough on the ethical implications of research proposals. Although it is stated at the outset of the document that the Code is a framework to facilitate "the application of ethical principles to guide decisions", the importance of genuine reflection on ethical issues could be emphasised more strongly. 5, 29 Seeking alternatives Further emphasis on the importance of seeking alternatives is recommended. Suggest replace the wording in 1.16 with AECs must ensure that all care and use of animals is conducted in compliance with the Code. This must include approval and monitoring of housing conditions, husbandry and all procedures relating to the care and use of animals for scientific purposes. Suggest replace 1.17 with The operation of AECs must be based on the application of ethical principles to guide decisions as to if and how animals are to be used for scientific purposes. While due attention must be given to technical and administrative matters, the AEC must give particular thought to the broader ethical context and potential outcomes of the issues under consideration. The wording in 1.1(i) could be expanded to give specific emphasis to alternatives and so might read "using animals only when it is justified and alternatives are not available. Address for all correspondence: Level 6 Jane Foss Russell Building G02 The University of Sydney NSW 2006 AUSTRALIA Animal Ethics Officer Paul Sou T: +61 2 8627 8175 E: animal.ethics@sydney.edu.au AEC Secretariat: Roslyn Todd T: +61 2 8627 8174 E: roslyn.todd@sydney.edu.au ABN 15 211 513 464 CRICOS 00026A
50 Environmental enrichment Althoughh more properly dealt with in detail in the 'Guidelines', the need to consider environmental enrichment could be highlighted further. Insert another clause after 3.3.33 worded along the lines "Consideration must be given to meeting essential behavioural needs of animals through providing environmental enrichment compatible with the scientific aims of the project." 1 Definitions Adverse event: any event that has a negative impact on the wellbeing of an animal. (See also 'unexpected adverse event'). This definition includes planned and approved research activities which can have a negative impact but are not "adverse events". Modify definition to exclude planned and approved research activities. 2 Consensus: the outcome of a decision making process whereby the legitimate concerns of members of the AEC are addressed, and as a result, all members accept the final decision, even though it may not be an individual's preferred option. "legitimate" cannot easily be defined. Remove "legitimate". 2 Governing body: the body responsible for the administration and governance of the institution (e.g. University council or Senate, Board of an organisation) and where appropriate its delegated officer. A delegated officer is responsible for the Animal Ethics Committee in the majority of organisations. It is confusing to refer to a governing body throughout the document. Replace all "governingg body" with "governing body or delegated officer". 2 Minor amendment: any change to an approved project that does not involve an impact on the wellbeing of animals. Difficult to find examples of changes that would not, or could not potentially impact on the wellbeing of animals. 1 "Competency" Term "competency" is not defined and has been the subject of much discussion. More detailed guidance as to what is required to achieve competency should be included in an appropriate place in the document. Add definition or criteria for "competency". 5
Section 1: Principles for the care and use of animals for scientific purposes 6 6 1.6(i) 1.9 It is not clear whom or what the term "beneficial" applies to. The wording of the first sentence implies that animals have consistently different neurological mechanisms to humans. This is not correct. More clearly define the term beneficial by including to whom the benefit should accrue and how benefit will be measured. Change wording to: Although animals may perceive and respond to some circumstances differently to humans, it must be acknowledged they have a capacity to experiencee pain and distress. 7 1.11 Since some research inevitably involves novel procedures, it will not always be possible to assess in advance whether a method is scientifically valid. Suggest removing "scientifically valid" from first sentence. 14 Section 2: Responsibilities 2.1.12 Grammatical error: conduct of an external review Grammatical error: Include "of". 15 2.1.13(vii) The decision about who should be responsible for executing agreements should be made by the institution. It should not be a requirement that the AEC chair executes agreements. In some instances, institutions may have multiple animal ethics committees. Remove requirement for AEC chair to sign letters of understanding. 6
19 2.2.15(v) The requirement for a compulsory Category E member may be difficult to implement and may result in a quorum not being met on occasion. Institutions should be encouraged to have a Category E person as a member or an observer of the AEC but this should not be compulsory. Persons with responsibility for animal care might not necessarily be employees of the institution where the animals are kept or where the AEC is convened. Suggest modify text so that Category E membership is not compulsory. Suggest change the wording to "a person with responsibility for the routine care of animals at the institution where the proposed research is to be performed. 26 2.3.10 Monitoring of acquisition and transport likely to be impractical. 26 2.3.12 Define laboratory areas; are they distinct from procedure rooms? 26 2.3.10 to 2.3.16 Independent monitoring of animal research is an extremely important role of the AEC. In practice, however, the frequency of inspections of animal facilities by committee members can be constrained by availability and other practical considerations. Other, suitably qualified parties such as Animal Welfare Officers can therefore be valuable in providing additional independent monitoring. It is recommended that the Code make clearer provision for AECs to delegate some of the responsibility for monitoring of animal welfare and compliance to suitably qualified persons. This should not, however, diminish the AEC's responsibility in this area. Suggest that Clause 2.3.16 be modifiedd along the following lines: AEC procedures should cover the delegation of authority to suitably qualified and independent persons to monitor approved projects between inspections by the Committee and to inspect and monitor projects at remote sites (conflicts of interest should be appropriately managed). 28, 30, 32 2.4.7, 2.4.12 (xi) and 2.4.18 "until the future" is unclear. Wildlife investigators cannot be responsible for animals after their release (e.g. radio tracking and mark recapture studies) See comment. 7
28 2.4.8 (i) A student s supervisor may not be the chief investigator. Students should also be required to accept their responsibilities. Suggest wording along the lines Students undertaking research projects that use animals must accept an appropriate degree of responsibility although ultimate responsibility rests with the chief investigator. 30 2.4.13(x) Compliance with the requirements of the Australian Pesticides Veterinary Medicines Authority (APVMA) is very important. Add APVMA to examples. 32, 41 2.4.20 and 2.5.6 The exact meaning of the term day to day is unclear. If it means literally everyday (7 days a week), then this would be impractical and even undesirable in some situations. For example, to inspect breeding animals too frequently is likely to cause unnecessary stress resulting in cannibalism of young in some species. Also, there is a difference between these two clauses: 2.5.6 suggests animal carers have to monitor every day whereas 2.4.20 suggests monitoring is only as agreed by the AEC. Not possible in wildlife capture and releasee study. The intent of 'day to day' should be clarified. 35 34 35 2.4.37 2.4.38(iv) and (v) 2.4.41(ii) Often not practicable. Does audit report mean monitoring sheets? (iv) and (v) are the same. Not practical where, for example pet dogs are being used in low impact or observational studiess (e.g. owners monitoring appetite or itchiness). Requirement for pet owners to understandd the code will prohibit this research from taking place. Where practical. Clarify wording. Remove duplication. 8
42 2.5.12 Include the concept of respect in relation to the disposal of dead animals. Modify end of sentence to say " a sanitary, appropriate and respectful manner." 45 48 48 48 51 Section 3: Animal Wellbeing 3.1.8 3.3.5(i) 3.3.10 3.3.13 3.4.3 What is difference between 'competency' and 'necessary skills and experience'? Wording should be modified to allow for acquisition of for example horses, and farm animals which have not been purpose bred for research. Wording should also allow for the capture of wildlife. necessary' does this mean as deemed necessary by the Animal Ethics Committee? Add reference to alleviation of pain and distress during transport. If it is mandatory for someone to be responsible for monitoring animals during transport, this should be specified. Replace ' should' with 'must'. Please define. Please clarify. 51 52 52 53 53 3.5.1 3.5.4 3.5.8 3.7 3.7 Add clause: 'procedures must be performed by a person who is competent, or under the direct supervision of a competent person' Replace ' should' with 'must'. Insert 'humanely' before killed using methods appropriate... Anaesthetics/neuromuscular blocks must only be administered and monitored by a competent person. Design of anaesthetic/analgesic program should be regularly reviewed in consultation with the AEC or their delegate (e.g. Animal Welfare Officer) ). Include clause. Include clause. Include clause. 9
53 3.7.3 Typographical error: Insert 'be' before 'assumed'. 54 3.7.15 17 Performed by a competent person. 55 62 63 3.7.33 3.8.29 3.9.3 Animals should be monitored by a competent person. There is disagreement to the validity of model predators. Replace ' should' with 'must'. Remove clause. Section 4: The use of animals in teaching 68 69 65 4.4.5, 4.4.10 4.4.17 Section 4 Include requirement for AEC to investigate negative impacts and take measures to improve situation in future applications, which may include further training for investigators in the primary school setting. Include provided such a demonstration does not further negatively impact on the wellbeing of the animal before it is humanely killed. Clauses 6.1.3 and 6.1.4 from the 7th edition appear to have been omitted resulting in a less clear requirement to promote ethical discussion and consideration of alternatives. Include clause. Include clause. Reinstate Clauses 6.1..3 and 6.1.4 from 7th edition. 10