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Australian code of practice for the care and use of animals for scientific purposes submission

ID: 
40
Personal Details
Organisation Name: 
Australian National University
C. Additional Information
Please identify the best term to describe the Organisation: 
University
E. Submission
Types: 
Online Written Submission
Written Submission: 
Specific issues requiring particular consideration
After consultation with stakeholders during the initial phases of this review, specific issues have been identified as requiring particular consideration. Your comment is invited on these issues.
Comment on specific Sections, clauses or sentences of draft revised Code of Practice
Select if you wish to provide comment on specific Section, clauses or sentences within the draft revised Code of Practice.
General Comments
Select if you wish to make general comments about the draft revised Code of Practice.
Specific issues requiring particular consideration
1. Does the document clearly and concisely set out governing principles?: 
  • Generally speaking the draft Code clearly sets out guiding principles.  The intent to include provision for the Code to refer to evidence- based guidelines and other elements of best practice is a good one. 
  • Governing principles or key principles are included at the beginning of each section.  Section 3 Animal Wellbeing has general principles but they are along different lines compared to the other sections.  It is felt that Key Principles (respect for animals, using animals only when justified, applying high standards of integrity etc.) should also be outlined in section 3 as well.
2. Are the terms “should’ and “must” used appropriately in the document?: 

We feel that they are used appropriately

3. Does the document clearly and concisely set out, and correctly attribute, responsibilities of all parties involved?: 
  • It clearly sets out, and clearly attributes responsibilities of all parties involved, although we feel the role of veterinarians is understated and we make specific recommendation concerning that later in this submission.
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?: 

We feel it does.

5. Should the document include specific guidance regarding the responsibilities of Veterinarians and Animal Welfare Officers?: 
  • The role of veterinarians may be said to be understated in the draft Code. The public guide to the technical discussion in the invitation to make a submission concerning responsibilities of veterinarians asks whether some procedures such as anaesthesia and surgery procedures should only be performed by a veterinarian.  This institution doesn’t believe so because it has animal carers who, with regard to rodents and rabbits, are very competent with specific surgical procedures, general anaesthetic administration, autopsies, and the ability to conduct preventative medicine programs, and we would therefore strongly resist the notion that the above procedures should only be performed by a veterinarian. However we do feel that broad veterinary oversight is absolutely essential in an institution that has animal breeding &/or holding facilities.  2.1.9 (vi)  of this draft Code talks in terms of institutions ensuring availability and access to veterinary services with relevant experience to assist in the proactive management and oversight of a program of veterinary care, quality management and project design to safeguard animal wellbeing. There is a “must” at the beginning of that sub-section and therefore the need for veterinary oversight is ensured. However we feel that the important role of veterinarians is understated throughout the draft Code.  We therefore advocate the inclusion of a small section 2.6 relating to the role of the veterinarian and alerting institutions to the broad range of services by which veterinarians may enhance the broad standards of a scientific animal operation:

 The Role of the Veterinarian

 2.1.9(vi) states that institutions must ensure availability and access to veterinary services with relevant experience to assist in the proactive management and oversight of a program of veterinary care.    The comprehensive nature of veterinary training equips veterinarians to manage a diverse range of professional responsibilities relevant to the oversight of the use of animals for scientific purposes and animal welfare. These responsibilities include:

 

  • Preventative medicine programs
  • Disease treatment and diagnosis
  • Provision of research support
  • Veterinary aspects of animal wellbeing and animal care
  • Animal anaesthesia and analgesia
  • Surgery and post-surgical care
  • Training of research and technical personnel
  • Provision of relevant advice to researchers and the institution
  • Quarantine
  • Euthanasia

 

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.: 

Within the institution there is difference of opinion concerning the balance between principles and detailed guidance.  It is felt by those that use the Code most that the balance is sufficient.

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 there is.

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?: 
  • We feel the title of the document should be amended to the Australian Code for the care and use of animals for scientific purposes.  The words “of practice” should be deleted.
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)? : 

We did not have an agreed opinion on this.

10.Comment is sought regarding the proposal for a Category E membership category for an Animal Ethics Committee to be mandatory for institutions that have or maintain animal breeding or holding facilities. How would the proposed changes work for your AEC?: 
  • We endorse the proposal for full Category E membership to be mandatory for institutions that have or maintain breeding or holding facilities.  We have had Category E membership on our AEC for a considerable time and our experience is that this has added considerable value to the Committee in terms of commenting with authority on all factors relating to optimal animal care, the provision of relevant training to research personnel, the contribution to the development of new improved techniques, and the identification of actual or potential adverse events.
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? : 

We believe the maximal time for an AEC approval should be three years and that this should be stated in the document.

Comment on specific Sections, clauses or sentences of the draft revised Code of Practice
Specific Comments: 
Definitions

Good practice is mentioned in the Code.  It is felt that it should be defined in this section.

Section 1-Clauses 1.24 to 1.29

1.24: The addition of a sentence is suggested:  Investigators should consider using the advice of a statistician in animal based experimental design.

Section 1-Clauses 1.30 to 1.35

1.35(iii) This discusses the removal of animals from wild habitats. To this should be added: Investigators should consider all factors that may impact on the wellbeing of an animal before releasing it back into the wild.

Section 2-Clauses 2.4.1 to 2.4.9

2.4.8: To this sub-section we would suggest adding: Investigators must ensure all staff working on an approved project are competent and trained in the required techniques.

Section 2-Clauses 2.4.10 to 2.4.14

New 2.4.13 new (xiii): The testing of biological materials for pathogens that may impact negatively on animal studies.

Section 2-Clauses 2.4.18 to 2.4.37

2.4.30: to issues that involve potential risk to animal wellbeing should be added:  Food and water deprivation and also the use of pathologic agents that have the potential to cause animal disease.

2.4.37 (and 2.5.18): It is not practicable to have a necropsy performed on all animals that die unexpectedly and the AEC notified promptly –especially in large rodent facilities. This may be more practical in instances where large animals are utilised, or the number of unexpected deaths in a particular line or facility has risen above a background level.

Section 2-Clauses 2.5.1 to 2.5.3

2.5.3, to this should be added: (iii) It is the responsibility of animal carers to confidentially report animal welfare concerns to the AEC.

Section 2-Clauses 2.5.4 to 2.5.22

2.5.8: We wholeheartedly agree with the requirement for an animal carer re emergency animal welfare interventions to notify the investigator and that animal welfare takes priority over other concerns. Emergency animal welfare interventions we see as including any rodent whose welfare is in anyway compromised.  Relative to large rodent colonies we question that a copy of each treatment or euthanasia by an animal carer be copied to the AEC. The AEC could be inundated with data. How is the AEC going to handle that data and to what purpose? They already have big workloads and these are voluntary appointments.

2.5.14: There appears to be a typo here.  As it stands it says persons supervising the care, husbandry and health of animals and biosecurity in facilities must be competent and hold appropriate veterinary qualifications, training and or experience. There are a minority of animal facility managers who hold veterinary qualifications, but they are few in number.

2.5.15, an additional point: All animal breeding must be within the terms of an approved proposal.  It is the responsibility of the facility manager to ensure animals are bred in accordance with approved proposals, and breeding plans should aim at minimising animal waste.

Section 3-Clauses 3.7.18 to 3.7.26

3.7.20, an additional point: The AEC must consider the need for veterinary involvement in complex anaesthetic and surgical procedures in species such as non-human primates, horses, cattle, sheep, goats, pigs, dogs, cats, zoological animals, and endangered or threatened species.

 

Section 3-Clauses 3.7.44 to 3.7.55

3.7.52: This asks that the AEC be advised when the clinical status of genetically modified animals changes to a degree that was not unexpected.  Chemical mutagenesis programs cause random mutagenesis and therefore the clinical status is not able to be predicted. The definition at the beginning of the draft Code defines genetic modification as the use of any technique for the modification of genes or other genetic material, but not including the use of natural processes such as sexual reproduction.  Therefore genetically modified animals within this draft Code includes those resulting from chemical mutagenesis.

 

3.7.53: In large rodent breeding facilities, particularly those where a chemical mutagenesis program is in operation, the sheer number of new lines makes AEC formal approval of the final report of new lines of genetically modified animals impracticable. Again it must be stated that there are limits to what the AEC can handle.  Certainly GM lines that raise animal welfare concerns must be reported to and discussed by the AEC.

 

3.7.54: Some networks (e.g. Australian and international phenomic networks) are designed to share animals around the country, and world, prior to detailed phenotyping. This makes it impractical to require “newly created genetically modified animals and their offspring cannot be sold or transferred to another facility unless the recipient of the animals recepts full responsibility for completion of the phenotype assessment”. Many animals, embryos or sperm are transferred to groups that specialise in a specific area of research and would only be one area of the phenotype being assessed. Phenotype can be an extremely broad area and would need further definition of the types of tissues, behaviours, clinical biochemistry etc. to be incorporated into any panel.

 

 

General Comments
General Comments: 

Some of these comments are specific tolarge rodent colonies.

Given the research advantages offered by genetically targeted rodents and a general move away from larger animals within larger biomedical institutions, we feel it pertinent to indicate that there are sections of the draft Code that contain impracticalities as regards their application to large rodent facility operations, particularly those where these are predominantly genetically modified. These impracticalities relate largely, but are not confined to, the logistics of resulting AEC work load.

 

Page reviewed: 1 March, 2013