NHMRC Public Consultations

Skip Navigation and go to Content
Visit NHMRC website

Draft Principles and guidelines for the care and use of non-human primates for scientific purposes submission

ID: 
34
This submission reflects the views of
Organisation Name: 
Monash University
Please identify the best term to describe the Organisation: 
Educational institution – tertiary
Personal Details
Option 1 - Online comments
SPECIFIC ISSUE FOR PUBLIC CONSULTATION - NOTIFICATION REQUIREMENTS TO THE ANIMAL WELFARE COMMITTEE: 
Suggested amendments to NHMRC Principles and guidelines for the care and use of non-human primates for scientific purposes - Public consultation draft 2015. These comments reflect input from scientific investigators, veterinary care staff and facility managers at Monash University who have direct experience with marmoset and macaque husbandry, breeding and research. One overall comment on the document is that it does not always make appropriate distinction between the different requirements of facilities that are primarily used for scientific investigation, versus those primarily involved in breeding and long-term housing. Consequently, in many cases the current draft wording does not make sufficient distinction between scientific investigators and animal care staff. Overall, we feel that it is necessary and appropriate in many cases to distinguish housing and handling requirements which may be necessary at scientific research facilities, from those found in breeding facilities. Specific examples of this distinction are listed below. Therefore, we would like to see some form of words stating that the exact combination of procedures applicable to a research project should be carefully considered, on a case by case manner, by the local AEC, in order to achieve the appropriate balance between animal welfare and scientific objectives. This can be incorporated, for example, into the fourth paragraph of the Introduction. Below, we suggest and justify other desirable changes to the document:
General comments on section/paragraph of the draft NHP Guidelines: 
Introduction

Introduction (Page 1)

The present introductory statements do not give sufficient consideration to the scientific value and importance of research that requires the use of non-human primates, and some of the statements appear scientifically inaccurate. To achieve a better balance, we offer a few specific suggestions:

-        Second paragraph: amend sentence to “The primary reason why some non-human primates are used as an animal model in biomedical research is their close phylogenetic relationship to humans, which often translates into unique anatomical and physiological characteristics that cannot be adequately studied in other mammals”. Yet, it is precisely because of this similarity… (delete “genetic”- this is not the only relevant measure)

-        Third paragraph: amend last sentence to “Notwithstanding marked variations between species of non-human primates, there is a widely held view…”. It is scientifically inaccurate to treat primates as a homogeneous group and there are wide variations which require recognition and appropriate measures to be taken.

Part A - Using non-human primates only when justified

1. (page 5). For clarity, we suggest changing “Non-human primates must not be used for scientific purposes except when” to “Non-human primates must only be used for scientific purposes when

9. (Page 6). Remove Point 9. The main arguments covered here are already adequately addressed by Point 10, but point 9 is arguably incorrect in its generalisation, since not all primates have complex social needs (for example, some are solitary, or show seasonal patterns of interaction). Point 10 is clearer in referring to “species-specific” needs. We therefore suggest deletion of point 9.

11. (Page 6). Point 11 appears redundant, and could be deleted without loss. It refers only to accommodation, which is encompassed by Point 8 (care and management incorporates accommodation).

17. (Page 6). This paragraph as it stands is focused on restrictions to importation, but does not acknowledge situations in which this may be essential. To address this imbalance, we suggest the following edits:

a. Preface the current paragraph with the following: "Importation of non-human primates should be recognized as an essential part of good colony management practice (e.g. in order to maintain genetic diversity), and may also be essential for achievement of scientific outcomes of a project (e.g. in order to obtain animals with specific genetic traits)".

b. Continue the paragraph with a slight edit to the current version, i.e. "When importation of non-human primates is proposed, the investigator (or his/her institution) must provide..."

Add new paragraph to “Sourcing, supply, importation” (probably last paragraph, after current point 20), to specify that:

"Deliberations about the importation of non-human primates should balance the time-line for compliance with national, state and international regulations, against the need to achieve scientific outcomes in a timely manner. Timeliness can be a significant factor, for example, in the case of urgent research focused on treatment of epidemics".

 

28. (Page 8). For clarity, the three points raised under 28 would be best re-phrased in the spirit of the replacement, reduction and refinement of animal use, as they are not specific to non-human primates.

Part B - B.1. Animal health

1.5-1.7 (Animal deaths, page 9). Strictly speaking, the technical term “necropsy” refers to a specific type of procedure, which is applicable to medical pathology. In most cases, this type of procedure is not relevant in terms of maintaining the health status of an animal colony. A formal necropsy procedure would necessarily impede collection of any samples from the animal prior to the examination, and hence impede acquisition of valuable scientific data. While agreeing with the need to have a thorough post-mortem done in case of unexpected deaths, the current wording may have the unintended consequence of restricting the range of options available.

We therefore suggest the following minor edits:

1.5 Substitute “A necropsy must be performed by a veterinarian” with “a post-mortem examination should be performed by a veterinarian”.
1.6 Replace “the necropsy” with “post-mortem examination”.
1.7 Replace “the necropsy” in the first sentence with “post-mortem examination”.

5.4 (Page 11). Amend sentence: “A well designed facility will have the added benefit of improving the conditions for those responsible for the animals’ care while maximising the quality and utility of scientific research data.” This is one of the examples where, by emphasising only the utilitarian aspect of routine animal care, the current draft runs the risk of losing sight of the scientific need for obtaining data in a reliable manner. 

5.7 (Page 11). Here and elsewhere, the meaning of the word “isolation” is unclear. For clarity, we believe a definition should be added before the last sentence of 5.7.
The term Isolation should refer to a situation in which an animal has no physical, visual or auditory contact with other animals. This could be required, for example, in the case when the animal is the carrier of an infectious disease, which could spread to other members of the colony. We suggest using the term individual-housing to refer to the situation in which an animal is the single occupant of a cage or enclosure during part or most of the day, but continues to have visual and auditory contact, and/ or limited physical contact, with other residents of the same facility. Individual housing may be a valid requirement of the scientific design of experiments.

5.8 (Page 11). For reasons of animal safety, remove the specific reference to “such as grooming through cage dividers”. We recommend that the degree of physical contact needs to be determined on a case-by-case basis, in consultation with the local AEC and veterinary staff, by taking into consideration the species, and even the animal’s individual temperament as part of a specific group.

5.8 (Page 11). It may be useful to clarify situations under which individual caging of animals might be appropriate.

5.14 (Page 12). Remove “in particular”. This point (and sub-clauses) as they currently stand seems to be centred primarily on the requirements of breeding and holding facilities. There are numerous other aims of reward-based training, and in any case such training is only relevant for a small number of projects involving non-humans primates. We suggest the following wording for 5.14:

Where applicable, reward-based training using positive reinforcement techniques should be considered as part of the experimental design. In some cases, reward-based training can be achieved by managing the timing of delivery of food and water as a useful tool for reinforcing certain behaviours”. (delete sub-clauses)

6.4 (Page 13). This point does not consider caging situations when single (individual) housing is appropriate or necessary from the scientific point of view (see point 5.7 above). Therefore, we suggest the following wording: “Caging should be large enough to accommodate group housing, except in specific situations where individual housing is necessary to the achievement of scientific objectives of a project, as assessed by the relevant AEC”.

6.6 (Page 13). This point appears very specific, and out of tune with the level of detail in the rest of the document, and could probably be deleted.

7.5 (Page 13). This topic as it stands seems to be centred on the situation and requirements of breeding and holding facilities. In order to cover foraging behaviours in the controlled conditions of an experimental facility, a new sentence should be added: “Give consideration to experimental designs that incorporate foraging for food and liquid as part of a routine that satisfies both the scientific need to elicit certain behaviours in a reliable manner, and the desirability to increase the time spend in foraging”.

8.5 (Page 14). This sentence seems to be focused on the needs of the breeding and holding facilities, and of a small number of projects that involve long-term holding and interaction between researchers and animals. While it is necessary for all animal care staff to receive training through the breeding colonies, the husbandry procedures employed in the colonies have limited or no relevance for the vast majority of researchers, and when necessary these procedures are most commonly (and preferably) carried out by qualified animal handlers. Requiring breeding-colony based training is also impractical for investigators in all states. The current wording also fails to recognise that new investigators may have received relevant training overseas; thus, it is better to use the term “inexperienced” rather than “new”.

To address this deficiency, we suggest the following edit to the first sentence of point 8.5: “When applicable due to the requirements of a research project, training of inexperienced animal carers and researchers must be arranged in consultation with…”

 

9.7 (Page 15). We request that the advice from a specialist in infectious diseases is sought. Immunisations for Q fever and rabies do not seem relevant here, and are not required in overseas facilities.

9.9i (Page 15). Change “good laboratory practice” to “best practice”. The term Good Laboratory Practice (GLP) has a specific technical meaning (which is relevant for FDA approval of a new drug, device or procedure). This would be unlikely to be relevant for the vast majority of research projects.

9.9x (Page 15). For clarity, change to “handling unfixed primate tissues. In alignment with AQIS regulations, fixed tissue is not considered dangerous. A blanket statement as in the present draft could be interpreted as including fixed specimens, or even microscope slides.

 

Part C

Project checklist

5. (Page 17). For clarity, append to the last sentence “by the potential benefits of the proposed scientific research.”

10.4 (Page 18). Noting that negative reinforcement and painful procedures are not allowed in any circumstance, positive reinforcement is not always required as part of scientific projects involving non-human primates. Replace “Are training methods based on positive reinforcement techniques” with “Have positive reinforcement techniques been considered as part of the experimental design”.

 

AEC checklist

16-18 (Page 21) – Facility approval and inspection (which is the focus of this checklist) should not depend on specific teams of investigators who are going to be using the facility, as these change all the time. The competency of the investigators is assessed through the individual AEC Project checklist, in the previous section (page 19, points 12.1 and 12.2). We suggest changing the heading preceding points 16-18 from “Investigators” to “Animal carers”, and to remove “and investigators” from Point 16.

Page reviewed: 16 September, 2016