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

ID: 
31
Personal Details
Organisation Name: 
Royal Perth Hospital Animal Ethics Committee
C. Additional Information
Please identify the best term to describe the Organisation: 
Hospital
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?: 
  • Overall, the information in the document is clearly presented; albeit somewhat repetitive. 
  • The document should clearly state that the Code’s governing principles are designed to enable AECs to make sound, ethical decisions, and to facilitate the application of ethical principles by all parties involved in the care and use of animals for scientific purposes.
  • Refinement section requires clarification on how pest control studies and translocation protocols fit into these principles
2. Are the terms “should’ and “must” used appropriately in the document?: 
  • This point is not relevant in WA as the Code is embedded into State legislation, which interprets both terms as “must”.   
  • It is important that obligatory components of the Code remain focused on staff, investigators and activities that directly effect animal welfare and outcomes.  Requirements for administrative activities and documentation which provide little to no benefit to animal care or welfare, need to be kept to a minimum.  Time and resources spent on these types of activities are counter-productive to the development and implementation of tangible animal welfare initiatives.   

 

3. Does the document clearly and concisely set out, and correctly attribute, responsibilities of all parties involved?: 
  • 2.1.7 (iii):  development and annual review of an institutional triennial plan for the implementation and resourcing of institutional responsibilities, including goals and strategies for achieving the 3Rs

We would prefer this point be removed from the Code as it has the potential to impose another layer of unnecessary bureaucracy on AEC activities.    AECs already undertake strategies to promote implementation of the 3Rs in all animal-based activities including the requirement for these principles to be justified in project applications and annual reports.   The effectiveness of these strategies is reviewed annually and up-dated as required.    If necessary, responsibility for developing and assessing strategies for achieving the 3Rs could be formally incorporated into the AEC Chair JDF.

If this statement remains in the Code, it needs to reflect reality; and acknowledge that it will be the AECs who will be required to develop and implement animal welfare strategies (eg. 3Rs) for the Institution.   Therefore, if it remains, the statement should read:

“providing the AEC with resources to develop and implement an institutional triennial plan, including goals and strategies for achieving the 3Rs.   The outcomes achieved are to be presented to the Institution for comment and endorsement as part of the AEC annual report to the Institution.   The plan is to be reviewed, and revised as required, as part of the annual meeting between the Institution and the AEC Chairperson. 

  • 2.1.7 (v):  this point needs to be cross-referenced to 2.2.38 & 39 and 5.6.   Clarification of Institution vs AEC separation of powers is also required eg:
    • It is the Institution, not the AEC, that has the authority and responsibility to enforce disciplinary action, and inform the State and National regulators, if required
    • AECs can only advise the Institution of non-compliance issues and recommend disciplinary action be taken in serious cases. 
    • Determination of the level of seriousness of a non-compliance is the responsibility of the AEC and must not be overruled by the Institution (5.6 (iii)).
    • Determination of research or teaching misconduct is the responsibility of the AEC and is to be made in accordance with the Australian Code for the Responsible Conduct of Research.*
    • Given the Code for responsible Conduct forms part of Institutional policy, the Institution has the authority and responsibility to act on all misconduct activities reported by the AEC.

* We have been informed that the Australian Code for the Responsible Conduct of Research does not cover teaching.  Therefore, a Code covering teaching misconduct would need to be identified and referenced. 

  • 2.2.4  and 2.2.15  – all AEC’s should be comprised of a minimum of FOUR persons, one from each category A,B,C and D. Those institutions operating or maintaining animal facilities may also elect to have one or more members from Category E, where appropriate (see Question 10).
  • 2.3.12 – AECs must have flexibility in addressing this requirement, particularly those Committees covering facilities outside the metropolitan area where time, logistics and expense become issues.   In these cases, the Chair and/or designated AEC members should be allowed to conduct inspections at regular intervals and report back to the full Committee for approval.
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?: 
  • Increased use of references to practical guidelines for specific points, and inclusion of direct links to other relevant documents is recommended.  

For example, 1.29Breeding of animals must be managed to minimise the production of excess animals.   Possible reference - “Guidelines for the generation, breeding, care and use of genetically modified and clones animals for scientific purposes (2006)”.  

  • Mechanisms need to be established to ensure the referenced guidelines and linked documents remain current.
5. Should the document include specific guidance regarding the responsibilities of Veterinarians and Animal Welfare Officers?: 
  • No.  Given the vastly different activities governed by AECs, the document should state that the provision of specific guidance regarding the responsibilities of veterinarians and animal welfare officers and their involvement on individual projects is to be determined by the Institutional AEC.  This will ensure the duties of these positions are relevant to the activities governed by the Committee, and can be implemented in a practical & effective manner.
    • Direct veterinary involvement would put huge limitations on projects that are field-based.
    • Evidence provided by a veterinarian that suitable trained personnel are capable of performing designated procedures should be sufficient.

 

  • If guidance information for these positions is to be provided in the Code, it should only be of a general nature:  For example: The Veterinary Service Provider(s) should:

(i)            Be competent and hold appropriate veterinary qualifications.  The experience and training of these individuals should be relevant to the activities of the institution.    

(ii)          Report directly to the Animal Care Manager to ensure integration and coordination of veterinary service provision with animal-based activities. 

(iii)         Be available to provide veterinary advice, training, technical support etc.. to the Institution for all animal-based activities upon request.

(iv)        Be responsible for training and/or confirming the competency of technical staff and investigators conducting animal-based activities involving invasive surgical procedures requiring anaesthesia as required. 

(v)          Be available to attend an unexpected adverse event at short notice as required. 

Similarly, the Animal Welfare Officer (AWO) should:

(i)            Be competent and hold appropriate qualifications (eg. veterinary, animal technician, veterinary nurse), training and/or experience.  

(ii)          Report directly to the AEC to ensure the Committee is fully informed of any animal welfare issue in a timely manner.

(iii)         Be independent of animal facility management and researcher/teaching groups conducting animal-based activities to minimise potential conflict of interest.

(iv)        Respond to any animal welfare issue (real or potential) as directed by the AEC or requested by the Animal Care Manager, animal care staff and/or investigators.

(v)          Inform the Animal Care Manager of any animal welfare issue as soon as practical to ensure the issue is handled in accordance with AEC directives, Code guidelines and facility procedures.

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.: 
  • The intent to focus on governing principles within the Code and provide best practise information by reference to relevant guidelines is both appropriate and practical.  
  • Timely provision of new and/or up-dated guidance documents to AECs will be essential.  Direct links to other relevant documents is also recommended. 
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)?: 
  • 3.7 Conduct of projects – Specific Procedures; Anaesthesia and the management of pain and distress.  
    • Additional information and/or clarification on specific procedures (eg. anaesthesia, analgesics, pain management, euthanasia etc..) would be beneficial. 
  • Recommended changes to wording are underlined. 
    • 3.7.2 The choice and administration of anaesthetics, analgesics and sedatives must be suitable for the species, the duration of the procedure and the aims of the project, and must take into consideration the age and physiological status of the animal, the type of procedure and the scientific or educational aims. The use of such agents should at least be comparable with their use in current medical or veterinary practice.
    • 3.7.5 General anaesthetic induction should be performed with minimum distress to the animal, permit smooth continuation of anaesthesia and avoid major physiological disturbances including cardiovascular and respiratory depression and hypothermia.  An anaesthetic record must be kept detailing the use of all drugs, patient monitoring and the management of undesirable events.
    • 3.7.10 Neuromuscular blocking agents may only be used with adequate general anaesthesia and analgesia, or an appropriate surgical procedure that eliminates sensory awareness, and positive pressure ventilation, that is, mechanical ventilation.  Immobilisation of an animal solely with a neuromuscular blocking agent is not acceptable. When neuromuscular blocking agents are used, specialist advice should be obtained. Special care must be taken to ensure the maintenance of an adequate plane of anaesthesia. Since the usual criteria for monitoring anaesthesia, such as character of respiration and corneal and flexor withdrawal reflexes, cannot be used, continuous or frequent monitoring of physiological variables such as heart rate, blood pressure, pupil size and, if available, the electroencephalogram, together with the effects on these of mild sensory stimuli should be employed.
    • 3.7.12 Procedures should be performed using recognised techniques and standards of good practice relevant to the species and based on guidelines that are informed by evidence of the potential negative impact on the wellbeing of the animals and include strategies to minimise such effects.
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?: 
  • Although the definition of scientific purposes does include all the areas of science covered by the Code, the inclusion of “research & teaching” in the title would clarify the scope of the Code to all interested parties.  

Recommended titles: 

  • “Australian Code for the Care and Use of Animals in Research and Teaching”.
  • Australian Code of Ethical Practice for Animals in Research and Education” (ACEPARE)
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)? : 
  • Agree with the current definition of “animal”.  Inclusion of animals in early stages of their development (eg. embryonic, foetal, & larval forms) would require an accepted definition of “live”, which is a contentious issue at best. 
  • Although animals in early stages of their development are not formally included in the definition, the Code does include pain management strategies (3.7.3) anaesthesia considerations (3.7.25) and human killing requirements (3.7.36) for procedures involving foetal or embryonic animals.   
  • The Code needs to allow AECs the scope to interpret the definition on a case-by-case basis.
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?: 
  • Strongly disagree that AECs of institutions that operate or maintain animal facilities MUST include a Category E member.   

Given the vastly different activities governed by AECs, it would be difficult to impossible for some Committees to identify a person who would fulfil the current definition of this category (2.2.15 (v) - a person employed by the Institution with responsibility for the routine care of animals).   For this reason, the inclusion of this category member should remain at the discretion of the individual Committee and should NOT be mandatory.  

  • In cases where independent advice on routine animal care or specific animal usage is required, the Committee already has the authority to invite a person(s) with appropriate knowledge to the meeting.   This person can contribute to Committee discussions but does not have voting rights.  This avoids any actual, perceived and/or potential conflict of interest due to their involvement and/or responsibility for projects being conducted.

This would also avoid the issue of maintaining the required Category balance for quorum meetings (i.e. one-third Cat. C and D members).

  • Point 2.2.4 & 2.2.15 Recommended wording:   For institutions that operate or maintain animal facilities, the AEC must comprise at least four full members, one for each of four categories (A, B, C & D).   An informed advisor with relevant knowledge of the routine care and/or specific usage of animals may be invited to attend the meetings and participate in meeting discussions (Category E).  However, to avoid any conflict of interest, this person should not be a full Committee member and should not have voting rights.
  • 2.2.4 (v): Recommended wording:   Category E (optional) – an informed person invited to attend meetings to provide independent information and advice relevant to routine animal care and/or specific animal usage.   This person should not be a full member of the Committee and should not have voting rights to avoid any conflict of interest. 
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? : 
  • No.   The document should state that the Institutional AEC has the authority to set the duration of a project on a case-by-case basis, with project type (eg. routine teaching, field studies etc..) and funding amount/duration taken into consideration.  
  • In general, a new project application should be required every 3 years to allow a review of the 3Rs, and ensure technical advancements (eg. technical improvements, new non-animal models) and new information can be incorporated into the project within a reasonable timeframe.   
  • Long-term project that are likely to have little change in procedures or methodology may be considered for longer term approvals if justified e.g. animals held in display for educational purposes.    Reporting requirements will need to be defined to ensure any adverse events are identified in a timely manner. 
Comment on specific Sections, clauses or sentences of the draft revised Code of Practice
Specific Comments: 
Definitions

The definition for “Wellbeing” has to be flexible enough to allow wildlife studies (eg. capture, handling, use of traps, transport, holding, release, identification & tracking), including studies involving vertebrate pest animals, to be conducted as required. 

Section 2-Clauses 2.2.1 to 2.2.11

2.2.7.   

  • The extent to which AEC information is made publicly available needs to be carefully considered and internally controlled.     No information should be made publically available that would allow identification of individual members.
  • General access to the AEC terms of reference is appropriate.  However, access to information about some Committee activities needs to remain restricted for confidentiality and/or safety reasons.    
  • To meet transparency requirements, restricted information should be available on the Institutional system; but with access limited only to individuals who are approved by an authorised person or department section.
Section 4-Clauses 4.4.12 to 4.4.17

Part C. Application to the AEC:  2.4.17 (vii)

  • Needs to include the requirement for reporting the number of animals used for the creation and maintenance of genetically modified animals (eg. breeding & culled animals required to obtain experimental animals of interest) as per 3.7.55.  This is particularly important for projects where the specific genotype required is of low frequency and/or low viability.   In this way, both the investigator and the AEC are aware of the actual animal usage associated with the project and are better able to determine whether the predicted benefits are justified.  
  • Suggested rewording: 

2.4.17 (vii) (b):  number of animals required, including (if relevant) breeding and culled animals required to obtain the experimental animals for the project, and the justification for this number.

Section 2-Clauses 2.4.38

2.4.38 (v) is a repeat of (iv).

Section 2-Clauses 2.4.39 to 2.4.47

2.4.47 (ii) (a) Death as an end-point – The goals of a project where death as an end-point is required needs to be clarified to ensure the Code does not prevent studies investigating humane methods of managing animals and animal numbers (eg. feral animal populations) from being conducted.      

      Recommended wording:   (a):   Investigators must not use death as an end-point in a project unless no other end-point is feasible to achieve the aims of the project, and the goals of the project are the prevention, alleviation, or cure of a life-threatening disease or situation in humans or animals (see 1.35 (vi)), or the humane management of animals and animal numbers to address environmental and/or health issues. 

Section 6-Clauses 6.3.1 to 6.3.8

6.3 Conduct of the external review:  6.3.2:  “members of the review team must be external to the institution and the AEC under review”

  • External review is important and the review panel needs to be independent of the organisation being reviewed.     However, qualified individuals who have a past association with the organisation should not be automatically excluded provided a suitable amount of time has passed.  These individuals would actually have more insight into the activities of the organisation and therefore be able to provide more constructive recommendations.    Similarly, a qualified individual associated with the institution or AEC via an inter-institutional agreement should not automatically be excluded.   Potential conflicts of interest should be recorded in both instances to ensure transparency and accountability. 
  • The external review panel should be given the authority to determine the frequency of external reviews based on compliance and review findings.    For example, the panel may determine that highly compliant Institutions only need to be reviewed every 5 years, whereas Institutions with numerous adverse findings need to be reviewed every 1-2 years depending upon number and severity of the findings. 
Definitions
  • Definition of ‘animal carer’ needs to incorporate education i.e. ‘any person involved with the care of animals that are bred, supplied or held for scientific and/or educational purposes’.  This needs to be consistently used through the document.  
  • Need to clearly distinguish between the specific responsibilities of investigators and animal facility staff as “animal carers”, either in the definition or the relevant section of the Code.
General Comments
General Comments: 

Standard Application Form: 

  • The development of a generic application form would be supported by our AEC provided it actually makes the application process easier for both the investigator and the AEC. 
  • A generic template would allow the essential aspects required for any project to be provided in a standardised format.  
  • The program would need to be extensive enough to cover all project types; but flexible enough to allow selection and use of only those sections relevant to the project (eg. use of dropdown boxes that automatically skips to the next relevant section).     
  • The program would need to be accessible, user-friendly and secure.  
  • Use of the generic application should be optional and at the discretion of the AEC.

Page reviewed: 1 March, 2013