Animal Research and Regulation
What sort of animal research is conducted in Australia?
In Australia, the formal definition of the term ‘animal research’ covers a broader range of activities than in some other countries. Much of this research is not laboratory-based medical research but instead comprises observational studies in locations such as national parks or agricultural farmland. The term also covers the use of animals for teaching purposes which can range from school students studying agriculture through to the training of veterinary students.
The range of animal species used in research or teaching is therefore very broad. In addition to mice and rats which are by far the most commonly used species in medical research, it can include fish, birds, wildlife and farm animals, the majority of which are studied in their normal habitats.
For these reasons, the number of animals used for research or teaching in Australia can seem large compared to other countries. On closer scrutiny, however, this is heavily influenced by differences in the way we count the animals used and the type of research that is included.
Animal research forms part of Australia’s overall research effort into many serious diseases. These include cancers, diseases of the nervous system, infectious diseases, heart disease, and conditions involving chronic pain or inflammation. Animals may also be used directly or indirectly in the production of medical products such as diagnostic reagents, anti-serums and vaccines, and in what is often known as ‘basic research’ – that is research to advance our understanding of fundamental processes to provide a foundation for applied research in the future.
While it is important to appreciate that the path from any sort of research to new medical therapies can be extremely convoluted, animal research has played a role in important Australian medical advances such as the cervical cancer vaccine, the cochlea implant and anti-flu medication. In addition, most of the Nobel prizes awarded to Australian scientists for medical research were for studies in which animal research played a fundamental role.
The species used most frequently in medical research in Australia are mice and rats. These are bred in specialist facilities where strenuous efforts are made to keep them free of disease so that their welfare is safeguarded and scientific results are reliable.
Smaller numbers of other species are also used in medical research. Occasionally these include species that raise particular ethical concerns such as dogs, cats and monkeys. As a result, research involving these species is subject to additional scrutiny both before and after approval.
In most cases, the type of procedures to which animals are subjected have only a minor or transient impact on their welfare. When more severe procedures are conducted, anaesthesia and pain management must be used in the same way as in medical or veterinary practice. Exceptions to this requirement are only permitted rarely and only with strict conditions of ethical justification and monitoring.
Testing of cosmetics and other products
The use of animals for testing cosmetics has not taken place in Australia for some decades and is now banned altogether. Similar bans are in place in many other countries yet the belief that cosmetics are still routinely tested on animals persists as a major misconception.
Although Australian safety regulations do still require animal testing of some other products (including vaccines for example), this is conducted on a smaller scale than many other countries.
Wildlife, agriculture and veterinary research
A great deal of research is conducted in Australia that aims to benefit animals either directly or indirectly. This includes non-invasive studies in wildlife conservation, improved welfare for farm or zoo animals, and clinical trials to assess new veterinary therapies conducted with the informed consent of the animals’ owners.
Most of this research is conducted in the field rather than in an animal facility, and it usually has little or no impact on the animals concerned. Nevertheless, it is still subject to the same process of independent ethical scrutiny as projects using animals for medical research or testing.
A small amount of the research into wildlife, agriculture and veterinary medicine does involve procedures that can impact the welfare of the animals involved. Examples include some studies into increasing the efficiency of livestock production, and manufacture of animal health products such as vaccines. As with all other animal research, however, this work can only proceed after independent ethical review and monitoring.
Use of animals in teaching
The number of animals used in teaching in Australia has declined substantially in recent decades. This applies both to schools and universities (including veterinary schools) where a range of alternatives has taken the place of animals in many courses.
Number of animals used in research and teaching
Institutions that use animals for research or teaching are required to submit an annual report to their government regulatory body providing information about the number of animals used. These reports include the total number of animals of each species, and a breakdown of the totals into broad categories relating to the purpose for which the animals were used and the potential animal welfare impact of the procedures performed.
Since the data are compiled separately and in slightly different ways by each of state and territory government, there is currently no system for publishing national totals in Australia.
Further information about the number of animals used in research and teaching can be obtained from Australian state and territory regulatory bodies (see Regulation of animal research in Australia below).
Alternatives to the use of animals in research or teaching
In Australia, animals may only be used for research or teaching when no alternative method is available.
Examples of alternative methods (also known as ‘new approach methodologies’) include the use of computer models, in vitro systems such as cells grown in a flask or 'organ-on-a-chip' devices, non-sentient organisms such as yeast, data collected through medical surveys (epidemiology), or studies involving human volunteers participating with informed consent (which requires approval under a separate human research ethics review process).
Alternative methods can often deliver results more quickly, with greater reproducibility and at lower cost than animal studies although just like animal-based methods, each alternative method has its limitations. In practice, therefore, alternative methods must often be used alongside animal-based methods in a complementary manner.
A common criticism of animal research is that results can be unreliable because of species differences between animals and humans. These differences can be important and must be considered carefully when designing and interpreting animal research. Overall, however, the similarities between animals and humans are strong. A good illustration of this is the fact that many therapies vets use for treating animals are the same as those used in humans.
Unfortunately, the complexity of human and animal biology means there are still many important questions that cannot be answered without using animals. The ethical acceptability of using animals to answer such questions therefore involves a harm/benefit analysis – a process that is central to the regulation of animal research in Australia.
Regulation of animal research in Australia
The use of animals for research or teaching in Australia is regulated under state and territory laws. One requirement of these laws is that institutions using animals must be licensed or accredited by their relevant state or territory government.
While there is some variation between states and territories, the regulation of animal research or teaching generally applies to any live non-human vertebrate or cephalopod (e.g. squid and octopus), and there is a move towards extending this definition to include decapod crustaceans (e.g. lobsters and prawns).
Incorporated into these laws is a national code, The Australian Code for the Care and Use of Animals for Scientific Purposes (‘The Code’) which is endorsed by the NHMRC, the Australian Research Council, CSIRO and Universities Australia. The Code sets out the responsibilities of researchers, teachers, animal carers and institutions to ensure that the use of animals is ethical, humane and responsible, and is underpinned by an obligation to respect animals. In addition to covering the use of animals in research or teaching, the Code also covers their acquisition, transport, breeding, housing and husbandry.
The Code sets out Governing Principles which include:
- Respect for animals
- Applying ‘the 3Rs’:
- Replacement (animals may only be used if there is no alternative)
- Reduction (the number of animals used must be kept to the minimum required to achieve valid scientific data)
- Refinement (any harm to animals must be avoided or minimised and animal wellbeing must be supported)
- Ethical justification that weighs potential harms against potential benefits
- High scientific standards
Central to this regulatory framework are bodies known as Animal Ethics Committees (AECs). The primary role of an AEC is to ensure, on behalf of the institution for which it acts, that all activities are conducted in compliance with the Code.
AECs must have members representing each of four categories: a veterinarian, a scientist, a person with a demonstrable commitment to and experience in animal welfare, and a member of the general public. Members in the last two categories must be completely independent of the institution; members in the veterinarian category may be independent of the institution and in practice, this is often the case. While other countries also have bodies similar to Animal Ethics Committees, participation by dedicated animal welfare representatives is only mandatory in Australia and New Zealand.
No animals may be used in research or teaching unless the AEC is satisfied that the proposed work is ethically acceptable after balancing whether the potential effect on animal wellbeing is justified by the potential benefit to humans, animals or the environment. The AEC must also be satisfied that the 3Rs have been applied (see above). This form of independent ethical review is not seen in any other area where animals are used for human benefit.
In addition to their role in ethical review, AECs oversee the monitoring of animal welfare once a project has commenced. This involves periodic inspections of animal facilities (which may be unannounced) and reviewing reports on project outcomes and unexpected adverse events.
The Code requires that an independent external review is conducted at least every four years to assess an institution’s compliance with the Code, and to ensure that its AEC is operating effectively. Institutions must consider publishing a summary of the external review report and making it available to the relevant regulatory authority and funding bodies.
Further details of the regulation of animal research and teaching can be found on the government website for each state and territory.