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

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E. Submission
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Select if you wish to make general comments about the draft revised Code of Practice.
General Comments
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Submission to NHMRC in response to the “Draft revision of the Australian code of practice for the care and use of animals for scientific purposes (7th Edition 2004)”


It is notable that the code of practice embraces two linked but distinct areas, namely the welfare of the animals that are being used for research purposes and a less well-defined and poor;y codified area, namely ethics.  The research community, government and the community in general have maintained a clear cognizance of the need for practices which ensure the minimization of animal suffering. A “minimal distress” model of practice, which is commensurate with the value to society of solving a particular biomedical problem, is widely deemed to be appropriate.  The welfare dimension is readilly codified; the balance of value and cost ie the "ethical" dimension  and the practicalites of weighing and balancing ethical value judgments appears to cause the greatest practical and emotive difficulty for an ethics committee and evokes significant disparity in outcomes between ethics committees.


The proposed concept of  “governing principles” is welcomed if such principles” reflect core and sustained societal ethical values that have been proven with the test of time to be central to national and international models of best practice and integrity.  A key requirement of any governing principles is that they can form a sustainable framework that is universally understood by ethics committees, researchers, government and society.  Such codified core ethical and welfare principles cannot and should not be rapidly reactive to transient changes in attitudes within sub groups of society as to do so would debase their real and perceived worth. 


Paradoxically the draft proposes a scenario where a concept of “governing  principles” could conflict with the articulated concept that a change in composition of an ethics committee might be a sufficient trigger for a change in determination as to the ethical values of a project.


The document notes:

“Should the document include a guide regarding the longest duration of approval granted by an AEC for a project before submission of a new application is required? The submission of a new application for a continuing project would be to take into account factors such as changes in societal attitudes and scientific knowledge and standards, and changes in AEC membership?”


The notion that changes in AEC membership may influence outcome implies that there is no consistency in the ethical principles that might be applied within Australia.  As the ethical principles themselves are not clearly articulated in current documentation, disparity in the performance of individual committees is currently inevitable.  A mechanism for improved education of AEC members (by NHMRC) on an annual basis as to the governing principles, overlaid with evolving concepts and societal positions regarding animal ethics (as opposed to animal welfare) would enhance the value of the decision making process.


The maximum duration of the approval for a procedure is currently limited to a three-year limit in Queensland (with annual renewals), which reconciles well with the 3 year term of a project grant but creates uncertainty for 5 year project and program grant holders.  In each case the agreed plan of research, and thus taxpayer-funded outcomes, may be compromised if the ethical framework is too volatile.  It is noted that the shorter the interval for approval duration, the higher the compliance burden for all parties. Any move to reduce the cycle time for re-evaluation would increase the burden on AEC members.  Given the high current work load of current animal welfare/ethics committees any additional workload is likely to reduce the quality of the evaluation process for all applications, potentially leading in some instances to reduced welfare standards.  The current system of three (and possibly five year ie program-grant duration) would appear to be appropriate, subject to the retention of annual reporting on progress and outcomes.


A key area of concern is the suggestion that a veterinary officer must be present or oversea surgery or anesthesia.  The current position which has served the community well, relies on the animal welfare committee, in concert with the AWO and Veterinary Officer on the committee approving only those projects where the named investigator has provided evidence of competencies in these areas.  The approval process, based upon initial demonstration of such skills, or the development of the skills by organized training paradigms, would appear to be the only practical scenario.


Conversely, the concept of a veterinary officer being in attendance at every experiment involving anesthesia and/or surgery would severely compromise research programs.  In my own organizational unit multiple groups perform surgery on a weekly basis. It would be impossible for the University veterinary officer to attend all instances of such.  It is unlikely that a research-intensive organization could recruit and retain sufficient numbers of research-trained veterinary officers to fulfill this role, even with a significant expansion in resources.


Category E membership of committees:

It has been the experience of many ethics committees that a category E person may provide significant practical inputs into the welfare dimension of the decision-making process.  Much of this starts in many institutions with an initial consultation with a category E person in a pre-submission phase ie how many animals, how to house etc.  The limited staff resources in all institutions effectively limit participation of category E personnel in the committee process.  The removal of a category E person from their primary role of ensuring animal well-being in an animal holding facility or similar may have an overall negative impact on animal welfare within that facility.  A process whereby the submission of an ethical application requires demonstration that advice has been already been sought from a category E person, and acted upon, may be a more effective and streamlined strategy. 



In conclusion, as a person who has sat for many years on institutional and an international ethics body (the ARVO committee for animal use in vision and ophthalmology) I welcome the draft and embrace the concept of governing principles.  I suggest that a nationally funded process for development of ethics committee members is essential, to aid them in understanding the governing principles, the framework that they would create and their effective application to the daily tasks of routine evauation and critique of animal ethics applications.

Page reviewed: 1 March, 2013