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

ID: 
22
Personal Details
First Name: 
Andrew
Last Name: 
Knight
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
5. Should the document include specific guidance regarding the responsibilities of Veterinarians and Animal Welfare Officers?: 

In particular, should procedures such as anaesthesia and surgery be performed only by a veterinarian or under the direct supervision of a veterinarian?

 

The answer is Yes. Both anaesthesia and surgery on animals are such highly specialized skills that it is only possible to guarantee practitioners are consistently likely to possess the necessary skills and knowledge if they have graduated from an accredited course in veterinary anaesthesia and surgery. Presently, such courses are generally only available to veterinary students or qualified veterinarians undergoing post-graduate training. Therefore, only successful graduates of such courses should be permitted to perform or directly supervise these procedures.

 

Students enrolled in an accredited veterinary course may also perform such procedures under the direct personal supervision of a licensed veterinarian, and often do so, as part of their clinical externships. This means the veterinarian must physically be in the same room, and must be directly and personally supervising the procedure, and able to step in to assist or take over, if necessary. It is not acceptable for veterinarians to be present elsewhere in the same building, or off the premises.

 

Veterinary students are permitted to participate in such procedures to assist in the development of their clinical skills. However, such permission is also granted because veterinary students receive extensive theoretical and practical training within their formal education, providing them with the background knowledge and skills necessary to participate in these procedures under close supervision. They are not generally permitted to participate in surgery until in their senior years, when they are also being taught surgery and anaesthesia.

 

It is certainly possible for non-veterinarians and non-veterinary students to practice animal surgery in theory, but it is not easy to see how the necessary skills and standards would be consistently guaranteed in people who have not undergone such training. These include correct surgical technique, standards of surgical asepsis and analgesia, and appropriate induction and maintenance of anaesthesia. It is hard to envisage how it could be acceptable to licence a system in which people are able to perform surgery and conduct anaesthesia without having undergone extensive training in these skills, thereby ensuring a reasonable expectation these procedures will be undertaken competently, without jeopardising either animal welfare or experimental outcomes. Presently, accredited veterinary courses appear to be the only reliable way to achieve this.

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?: 

Re: the suggestion, “Australian Code for the care and use of animals in research, science and education”. Science and research and partially duplicative so one should be eliminated. Education should remain, as should the other elements. So I would suggest: 'Australian code of practice for the care and use of animals for scientific and educational purposes'.

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?: 

On the one hand, it may be worthwhile to have a person with direct personal knowledge regarding the routine care of the animals in the institution. On the other hand, this should also be part of the responsibilities of the Category B representative(s), who are defined as:

 

‘a suitably qualified person with substantial and recent (i.e. within the last three years) experience in the use of animals for scientific purposes relevant to the institution.’

 

As stated by clause 2.4.18: ‘Once an animal is allocated to a project, investigators have personal responsibility for all matters related to the wellbeing of that animal including their housing, husbandry and care.’

 

So, if investigators and Category B representative(s) are correctly upholding their defined responsibilities, then in theory, a Category E representative should be unnecessary.

 

There are very important additional considerations, as well. The primary responsibility of an AEC is to assess the ethical merits of proposed research protocols, and to decide whether or not they should be permitted to proceed at all in their proposed forms. Oversight of the care of the animals is very important, but is less of a core AEC role. In order for the AEC to correctly fulfil (and for it to be seen to fulfil) its core role, the viewpoints of the AEC about animal research must be balanced. Such balance is likely to be lost through the addition of Category E representative – who presumably would not be employed to assist with such research if they were not generally supportive of it – as much as it would be lost through the addition of extra Category B representatives.

 

Additionally, inclusion of Category E representative(s) opens the possibility of the inclusion of additional, justified categories as well. Others could include, for example, statisticians, lawyers, doctors, qualified animal welfare science specialists, and 3Rs experts. Some additional categories are more strongly justified than others. Those most strongly justified include statisticians, qualified animal welfare science specialists and 3Rs experts.

 

Published studies have repeatedly demonstrated a high prevalence of poor sample size choices and lack of statistical justifications of sample sizes within animal studies. This can decrease the robustness of results, and potentially waste animal lives and scientific resources if experiments subsequently require repetition. Such studies should not even be approved by ethics committees, without the required modifications. Hence, there is an even stronger justification for the inclusion of a statistician within AECs, than there is for the additional of a Category E member, in general. Most animal studies do require sample size calculations and statistical justifications, so there is a good case for making such an expert a permanent committee addition, rather than an ad-hoc consultant. Furthermore, unlike a category E representative, the day to day employment of the statistician would not create a fundamental conflict of interest relevant to judgements about whether or not animal research should be approved by the AEC in general.

 

So, in conclusion, Category E members should not be added without the concurrent addition of statisticians and possibly other categories as well. AEC sizes and quorum sizes are also relevant considerations.

 

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? : 

Yes. The 3 years often referred to seems appropriate.

 

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

Replacement alternatives

‘animal ‘volunteers’ as in body donation programs,’

 

This is entirely incorrect terminology. Animals can in no way be considered ‘volunteers’ in body donation programs, and should not be referred to as such.

 

Ethically-sourced cadavers are defined in the published scientific literature by this author and others as those derived from animals that have died naturally, in accidents, or, most commonly, been euthanized for genuine medical reasons. They are not derived from animals directly killed for organ or tissue sourcing, nor from animals killed for ethically debatable reasons, including meat production in slaughterhouses, greyhounds retired from racing, or research animals killed when surplus to requirements.

 

The use of cadavers that are truly ethically-sourced is ethically commendable, and also brings certain additional advantages. There are several names for body donation programs, but ‘animal/pet body donation program’ does seem the clearest and simplest choice, in the opinion of this author. However, the donations are clearly being made by the animals’ guardians or owners. The animals are clearly not volunteers – which would necessitate informed consent.

Definitions

Vertebrate pest animals

‘vertebrate animals, … that are generally regarded, or have been declared under State or Territory legislation, as a ‘pest species’.

 

In my opinion, ‘commonly regarded’ would be a wiser choice than ‘generally regarded’, as the labelling of some animals as ‘pests’ is controversial. This is because a significant ethical or academic case might be made against such labelling, and that it is not clear that society (particularly, a majority of people) ‘generally’ believes this for all animals that might be labelled as such. 

Definitions

Zoonosis

‘any disease communicable to man from another animal species.’

 

To avoid potential offence to those (such as this male reader) offended by sexist language, care should be taken throughout to comply with modern protocols regarding the use of non-sexist language. Hence, ‘man’ should be corrected to ‘humans’ in this instance. It is no longer acceptable simply to assert that ‘the masculine also refers to the feminine’ or similar, particularly given how easy it actually is to use non-sexist language in practice.

Section 1-Introductory paragraph

Governing principles

I suggest: ‘using animals only when it is well justified’

Section 1-Clauses 1.6 to 1.19

1.10

I suggest emphasising the cumulative nature of many welfare impacts, thus:

‘The wellbeing of animals used for scientific purposes must be considered in terms of the animal’s lifetime experience. The welfare state of an animal will often reflect an accumulation of previous experiences and impacts.’

Section 1-Clauses 1.20 to 1.23

1.20 – 1.35, Replacement, Reduction and Refinement alternatives

It should be noted that the use of multiple alternative methods in combination should be considered, to achieve experimental objectives and decrease animal impacts.

Section 1-Clauses 1.20 to 1.23

1.23

It should also be noted that:

‘Opportunities to replace the use of animals should be kept under review during the lifetime of a project and, where relevant, the outcome of these deliberations should be incorporated within current projects and should also be taken into account in planning future activities.’

Section 1-Clauses 1.24 to 1.29

1.27

Additional strategies may decrease experimental variability, and hence should perhaps be mentioned, including:

 

1. the appropriate use of environmental enrichment, aimed at decreasing physiological variation resulting from barren laboratory housing and stressful procedures (which has been documented in a large number of published studies and at least two sizeable reviews);

2. choosing, where possible, to measure variables with relatively low inherent variability;

3. the use of genetically homogeneous (isogenic or in-bred) or specified pathogen-free animal strains; and,

4. screening raw data for obvious errors or outliers.

 

Measurement errors can also be reduced via repeated measurements, standardised protocols, improved equipment, and staff training – which may reduce, for example, intra- and inter-observer variation in behavioural assessments.

 

Strategies such as these, aimed at maximising the statistical power of small samples, are particularly appropriate when marked ethical, financial, or practical constraints limit the number of animals that may be used (e.g. in experiments involving primates).

Section 1-Clauses 1.30 to 1.35

1.30 – 1.35, Refinement

Published reports indicate that analgesic and anaesthetic modalities remain considerably under-utilised, partly due to concerns – well-founded or otherwise – that their use may alter experimental outcomes. Accordingly, it should be explicitly stated that analgesics and/or anaesthetics or sedatives should be utilised wherever possible, where procedures are likely to cause pain or distress. This is currently addressed in clause 2.4.25, but not at other locations where it should be.

 

While the use of such drugs undoubtedly alters normal physiology, claims that such alterations are sufficiently important to hypotheses under investigation to warrant their exclusion should be carefully scrutinised. It may, for example, be the case that physiological variations in response to painful stimuli are of greater consequence. Modification, rather than elimination, of drug protocols, including the use of alternate drug choices, may be appropriate.

Section 2-Clauses 2.2.1 to 2.2.11

2.2.7 (d)

AEC Terms of reference should include:

‘approval, in advance, for the immediate use of animals if required for the diagnosis of unexplained and severe disease outbreaks, or morbidity/mortality, in animals or people.’

 

‘morbidity’ should be deleted, because it’s definition denotes disease in general, rather than only serious disease. Such advanced approval for immediate animal use should not be given in the case of minor disease, but inclusion of ‘morbidity’ allows this, contrary to the apparent intent of this clause. Such approval is already given in the case of serious disease, by the preceding phrase. 

Section 2-Clauses 2.2.12 to 2.2.25

2.2.19 - 2.2.26

These rules about the composition of the AEC allow the created of committees biased towards (or, more rarely), against, animal research. International (e.g. US) experience has shown that very biased committees can result, where the numbers of representatives in various categories are permitted to be different. This is wholly unacceptable, and unless I am mistaken, contrary to previous versions of the Code. As I understand it, a previous version required 2 members in each of categories A-D.

 

Fixed and equal numbers in each voting category must be fundamental to AEC composition in order to eliminate this obvious potential for major bias. Advisors with specific expertise (e.g. scientific, medical, statistical, animal welfare, legal) should always be sought where appropriate, but their role should remain advisory. They should not have voting or other AEC administrative rights or responsibilities. To preserve the ethical balance and overall impartiality of the committee as much as possible, additional appointees should not be permitted, with the possible exception of category E members and statisticians, as previously discussed. The numbers of any such additional appointees should be similarly fixed to minimize bias of the committee overall.

 

Committee composition should be maintained to minimize bias during the creation of voting quorums, as specified in p. 20, 2.2.26.

Section 2-Clauses 2.3.4 to 2.3.9

2.3.9

AECs must consider: ‘the pain or distress and any potential long-term or cumulative effects caused by previous procedures’

 

Such cumulative assessment of adverse impacts during an animal’s lifetime provide a much truer picture of its welfare status, and its ability to cope with future impacts. However, considerations should be broadened from ‘previous procedures’ to include previous and current husbandry standards (particularly, laboratory housing), and previous and current health and nutritional status (e.g. previous or concurrent ill-health may be highly relevant).

Section 2-Clauses 2.4.10 to 2.4.14

2.4.12

‘When planning projects, investigators must take into account the need to demonstrate to the satisfaction of the AEC that the principles of the 3Rs have been applied (1.20–35),…’

 

As stated previously, and given the importance of this point, it should be explicitly stated here that analgesics and/or anaesthetics or sedatives should be utilised wherever possible, where procedures are likely to cause pain or distress.

 

Investigators should also address this point in clauses (p. 31) 2.4.17 (viii) (b), and (p. 32) 2.4.19.

Section 2-Clauses 2.5.4 to 2.5.22

2.5.5

Carers should implement ‘appropriate preventative protocols including animal biosecurity, quarantine, and disease surveillance, diagnosis, treatment and control.’

 

Disease diagnosis and recommendations concerning treatment options may be defined as acts of veterinary medicine under applicable legislation, and therefore the sole legal domain of licenced veterinarians. Accordingly, this should perhaps be modified along the lines of ‘in consultation with a veterinarian, where necessary’, notwithstanding the earlier reference to veterinary care and advice in general.

Section 3-Clauses 3.2.1 to 3.2.12

3.2.3

‘If there is uncertainty as to the potential risk of animals experiencing pain and/or distress or the time course and effects are not well defined, investigators must consider conduct of a pilot study to identify risks, and inform the development and validation of strategies to minimise such pain and/or distress.’

 

To this should be added words to the effect that: Where doubt remains about the potential for significant pain and/or distress, investigators should provide animals with the benefit of that doubt, and should implement such strategies where appropriate, as a precaution’.

Section 3-Clauses 3.5.1 to 3.5.11

3.5, Humane killing

Consideration should be given to providing a table of killing methods (columns) and species (rows), indicating with a tick/cross in each cell the methods acceptable for use in each species, in accordance with best practice standards. Such tables are available within policies and guidelines elsewhere, such as (but not limited to) the American Veterinary Medical Association Guidelines.

Section 3-Clauses 3.6.1 to 3.6.7

3.6.4 – 3.6.7, Animal housing and care requirements

It should be explicitly stated that housing and husbandry standards should comply with best practice standards specified in policies such as (but not limited to) the ILAR Guide and the European Convention for the Protection of Vertebrate Animals Used for Experimental and Other Scientific Purposes, Appendix A.

 

Environmental enrichment is important both to enhance welfare and to decrease pathological behavioural, cognitive and physiological variations, resulting from standardised, relatively barren laboratory housing. However, environmental enrichment is barely, if at all, mentioned in the Code. It should be explicitly mentioned both here and at other appropriate locations.

Section 3-Clauses 3.7.1 to 3.7.11

3.7.3

‘It must assumed that foetuses have comparable requirements for anaesthesia and analgesia as adult animals of the species. Pain management strategies for the foetus must be designed accordingly.’

 

However, it may also be worth noting that immature development of drug metabolism and excretion organs such as the liver and kidney may necessitate different anaesthetic and analgesic protocols – without necessarily reducing the animal welfare and ethical need for such protocols.

Section 3-Clauses 3.8.1 to 3.8.32

3.8.1 – 3.8.6, Wildlife and field techniques, General considerations

 

Some mention should be made of the need to comply with any applicable regulations re: the protection of wildlife and endangered species.

Section 3-Clauses 3.9.1 to 3.9.10

3.9.6

The following phrase should be expanded, thus:

‘the investigator must take all reasonable steps at the time of release to protect the animals from hunger, thirst, adverse weather conditions, injury and predation.’

Section 4-Clauses 4.4.12 to 4.4.17

4.4.14

‘Institutions must ensure that tertiary-level students are informed if their choice not to participate in the use of animals as part of a course would prevent them from achieving the educational outcomes due to the lack of suitable alternatives to the use of animals.’

 

The current wording of this clause is extremely problematic. One the one hand, it is commonly the opinion of faculty members, faculties and universities that certain uses of animals are necessary to achieve certain educational objectives. However, the following points are also indisputably true: (i) a wide range of non-animal or non-harmful alternatives have now been developed for most educational applications, (ii) approximately 90% of the 30+ published educational studies covering virtually all disciplines in which animals are used have demonstrated that students using alternative methods achieve educational objectives at least as good as those trained via traditional, harmful animal use (indeed, approximately one third of studies overall indicate that such students actually perform better, for several reasons), (iii) such alternatives have been successfully implemented within many courses internationally, including those at leading universities.

 

Hence, whilst it is commonly the opinion of faculty members, faculties and universities that certain uses of animals are necessary to achieve certain educational objectives, this is also commonly and demonstrably untrue. Such incorrect opinions frequently result from a lack of knowledge about points (i) – (iii) above. This was so in the case of the Australian veterinary school this author attended as a veterinary student. Following legal investigation, the case presented by my veterinary school was found to be lacking. Alternatives were ultimately introduced, against the will of some faculty, that proved highly successful. Similar experiences at other veterinary schools, and in other tertiary-level life and health sciences courses internationally, are not uncommon.

 

The current wording of this clause is very clearly open to abuse, by faculty members who wish for whatever reason to misrepresent their opinions about the necessity of certain animal use – particularly, harmful animal use, to which many students would not otherwise consent – as fact. To allow such opinions to be misrepresented to students in this way, strongly supported by this clause, could only reasonably be expected to markedly decrease student requests for non-animal or non-harmful alternative learning methodologies. This would be clearly contrary to upholding animal welfare, to the intention of the Code, and could also result in significant student stress resulting from participation in harmful use, which also has the potential to adversely affect learning.

 

Therefore, this clause should at least be altered, thus:

 

‘Institutions must ensure that tertiary-level students are informed if their choice not to participate in the use of animals as part of a course would prevent them from achieving the educational outcomes due to the lack of suitable alternatives to the use of animals, in the opinion of their institution. However, they must [should is not acceptable here] also inform such students that opinions about the necessity of educational animal use and the suitability of alternatives vary among institutions domestically and internationally, and that a considerable body of scientific literature examining the use of non-animal or non-harmful alternatives in virtually all educational disciplines has been published, much of which [in truth, it is the overwhelming majority of which] supports their use.’

Section 5-Clauses 5.1 to 5.10

5.1 (i)

I suggest changing ‘coursework’ to ‘academic progress’, because this also includes academic penalty, which is a bigger student concern. (This author, for example, has personally experienced it, in exactly this context).

Section 5-Clauses 5.1 to 5.10

5.1 (ii)

‘procedures developed in consultation with the AEC to deal with grievances related to the AEC process, including resolution of disagreements between AEC members, between the AEC and investigators or teachers, or between the AEC and the institution’

 

The list of potentially aggrieved parties should be expanded to include ‘animal carers, other employees, or students’.

 

These additional parties should also be included in (p. 71) clause 5.4.

General Comments
General Comments: 

At all appropriate locations throughout the Code, it should be clearly specified that prohibited procedures include:

 

- use of great apes, other than non-invasive observational or behavioural studies of free-living or sanctuary populations

- procedures resulting in severe or long-lasting pain, suffering or distress

- those resulting in death as an end point

- those deliberately exposing prey animals to predators

- the production of monoclonal antibodies by the ascites or other in vivo methods (given the contemporary available of non-animal bioreactors for this purpose)

 

These procedures can no longer be reasonably considered ethically acceptable. It is not sufficient that such procedures be merely discouraged.

 

Other procedures with high potential for resulting in severe welfare impacts should be particularly closely scrutinised, including those that:

 

- use primates

- involve surgical procedures

- involve major physiological challenges

- involve the deliberate infliction of pain or exposure to noxious stimuli

- deliberately inflict neurological impairment

- involve the production of genetically modified animals

- re-use animals

- involve prolonged restraint or confinement

Page reviewed: 1 March, 2013