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

ID: 
56
Personal Details
Organisation Name: 
Ludwig Institute for Cancer research
C. Additional Information
Please identify the best term to describe the Organisation: 
Biomedical research institute / organisation
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.
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?: 

Yes

2. Are the terms “should’ and “must” used appropriately in the document?: 

Yes

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?: 

Yes

General principle suggested to be added to new draft Code of Practise for use and care of animals used for scientific purposes:

Each establishment which breeds, supplies, or uses animals for scientific purposes must have a designated veterinarian, or a suitably qualified expert, with knowledge and competence in laboratory animal science to advise on the well-being and treatment of the animals.[i][ii]

Section 1

In Section entitled: “Accepting Responsibilities”

Add to S1.15,

(v) ensure a humane program of animal care and use is in place.

(vi) ensure that a Designated Veterinarian[iii], or a suitably qualified expert, is appointed to oversee an adequate program of veterinary care, and provide advice on matters as specified in later section on the Responsibilities of a designated veterinarian.

And after S1.19, add:

Designated Veterinarian

S1.20 A Designated Veterinarian, or a Designated suitably qualified expert, should have appropriate knowledge, expertise, competence and experience relevant to the health, care and welfare of the animals used

S1.21 A Designated Veterinarian will be charged with advisory duties in relation to the health, wellbeing and treatment and use of the animals, including implementation of the 3Rs of Replacement, Reduction and Refinement; as well as provide training and take action to protect animals where there is concern for their health or welfare.

 

S1.22 A Designated Veterinarian will also provide input to the AEC.

 

Section 2 – add Designated Veterinarian

 

To add:

S2.1.6

(iii) nominating a designated veterinarian or designated other suitably qualified expert (see above and footnotes).

 

To add: (Under Responsibilities):

 

S2.6 Responsibilities of Designated Veterinarians or Designated Other Suitably Qualified Experts

  • provide clinical veterinary care or advice on the health, care and wellbeing of animals when required;
  • overseea appropriate program of preventative veterinary care;
  • provide advice on health surveillance, diagnosis, treatment, control and management of potential pathogens and other diseases, including the management of disease outbreaks;
  • manage experimentally induced adverse event, whether expected or unexpected;
  • provide advice on anaesthesia, analgesia, surgery, asepsis and pre-, intra- and post-operative care;
  • conduct routine inspections of animal facilities and observe animal use on a regular basis, and make recommendations for improvement, where appropriate;
  • in facilities where is not possible or practicable, the veterinarian should seek regular updates from the responsible investigator and/or Animal Facility Manager;
  • be actively involved in management decisions relating to animal facility planning and design, and choice of facility equipment and infrastructure which may have potential impact on animal health and wellbeing;
  • be involved in the training and assessment of competence in procedures that may influence animal welfare;
  • assist the AEC in the recommendation of new measures, policies or changes which enable continuing refinement in line with current best practice standards in the research animal field.

 

Other – to add: (as per EU Directive)

 

Fates: Reuse and Rehoming[iv]

 

-          an animal already used in one or more procedures, when a different animal on which no procedure has previously been carried out could also be used, may only be reused in a new procedure provided that the following conditions are met:

(a) the actual severity of the previous procedures was ‘mild’ or ‘moderate’;

(b) it is demonstrated that the animal’s general state of health and well-being has been fully restored;

(c) the further procedure is classified as ‘mild’, ‘moderate’ or ‘non-recovery’; and

(d) it is in accordance with veterinary advice, taking into account the lifetime experience of the animal.

-          At the end of a procedure, a decision to keep an animal alive shall be taken by a veterinarian or by another competent person. An animal shall be killed when it is likely to remain in moderate or severe pain, suffering, distress or lasting harm.

-          Where an animal is to be kept alive, it shall receive care and accommodation appropriate to its state of health.




[i] As per new EU Directive 2010/63/EU

[ii] Note, the Home Office UK stated in June 201 that a “other suitably qualified person” is acceptable when “no suitable veterinary surgeon is available and the "other suitably qualified person” has considerable, proven expertise relevant to the health and welfare of the particular types of protected animal held and the range of regulated procedures performed at the establishment.

[iii] As per the new EU Directive 2010/63/EU

[iv] As per new EU Directive 2010/63/EU

 

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?: 

No

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)? : 

Yes

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?: 

 

2.2.4 Cat E membership –good idea but can anticipate problems with the quota as may need 2 or 3 Cat E to cover different areas of animal facilities eg [mouse facility and large animal facility]

q.  for quota purposes can this category not be included, as the Chair,  or included in C and D?

2.2.24  for practical purposes if representatives of Project are invited to AEC to explain project and answer questions then this could be interpreted as ‘review’ . The persons with conflict of interest should remove themselves from the deliberations,  suggest remove ‘review from this statement.

3.7.16 is a statement only

3.7.63 and 3.7.64 should be combined to make sense

Category E membership should be a non voting as per the chairperson to avoid potential conflicts 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

General Comments
General Comments: 

 

Responsibilities of animal carer  - this should recognise the hierarchy in animal facility  especially in reference to ‘diagnosis, treatment and control’ [2.5.5 iv], and emergency interventions.[2.5.8].

Animal facility manager or supervisor should make these decisions – animal carer could be work experience student or inexperienced junior technician.

 

In general this has been a well thought out revision and we wish to acknowledge the hard work and dedication to all involved.

 

Page reviewed: 1 March, 2013