Statement on the Ethical Use of Animals in Bionics Institute Research
At the Bionics Institute, we develop therapies to treat challenging medical conditions which have huge impact on human life. To ensure the safety and efficacy of those therapies, some of our research involves the use of animals.
We recognise and respect the diversity of opinion about the use of animals in research that exists in our organisation, among our supporters, and throughout the community.
This statement outlines why animals are used in our research, and how we meet our commitments to animal research regulations.
Our animal-based research is underpinned by a commitment to respect the animals we work with while achieving the best outcomes for our patients.
We are proud that the results of our research have been used by doctors to ensure deaf people are given the chance to hear, speak and live a full life. Since the cochlear implant was developed by the Bionics Institute over 1 million people worldwide have been given the gift of hearing.
Our research is now focused on improving the lives of people with challenging conditions, from epilepsy, Parkinson’s and Alzheimer’s disease to Crohn’s disease, rheumatoid arthritis and limb loss, while continuing to find solutions to hearing loss.
Australian Code for the Care and Use of Animals for Scientific Purposes
The use of animals for research is bound by strict regulations, including State laws and the Australian Code for the Care and Use of Animals for Scientific Purposes.
Researchers at the Bionics Institute adhere to this Code, which details the specific responsibilities of investigators, animal carers, institutions and ethics committees to ensure that the care and use of animals for scientific purposes is ethically justified; considering whether the potential effects on the well-being of animals are balanced by the anticipated benefits to humans.
Under the Code we are obliged to apply the principles of Replacement, Reduction and Refinement (the 3Rs) at all stages of animal care and use:
- The Replacement of animals with other methods where possible.
- The Reduction in the number of animals used in all studies.
- The Refinement of techniques used to minimise adverse impacts on animals.
At the Bionics Institute we believe that adherence the 3Rs is the best and most reliable way to ensure that alternatives to animals are used wherever possible, and that our research is carried out with care and respect to the animals.
All procedures at the Bionics Institute are carried out to the highest veterinary standards, and our animals are monitored daily by a vet and technicians with veterinary nursing qualifications.
Why it is necessary to test Bionics Institute medical devices in animals
Ensuring the safety and efficacy of medical devices is essential to the Bionics Institute’s mission of creating positive impacts on the lives of people living with challenging medical conditions.
Medical devices developed at the Bionics Institute use electricity and, in some cases, light to stimulate or monitor nerve activity in the treatment or diagnosis of conditions such as Alzheimer’s, Parkinson’s and epilepsy, rheumatoid arthritis, tinnitus and hearing loss.
Some devices developed at the Bionics Institute are implanted internally, which means they cannot be fully assessed in systems such as computer modelling or tissue culture; we can only fully understand how they interact with the body though impacts on a complete living system.
These devices must be tested in animals before further testing can be carried out in the first human volunteers.
Examples of implantable devices are the cochlear implant to treat hearing impairment, vagus nerve stimulation devices to treat inflammatory conditions, and devices implanted in the brain, including deep brain stimulation to treat Parkinson’s.
In contrast, medical devices that are developed to be used externally, such as Transcranial Magnetic Stimulation to treat Alzheimer’s can often be safely tested in humans without the need for animal data.
Implantable medical devices undergo five stages of development. Prototype medical devices and the surgery methods for their implantation are both tested in animals (shown in Figure 1).
Prototype medical devices are modified based on the results of testing until the results show that the prototype is ready for testing in humans.
Regulatory approval to test implantable devices in humans will not be granted until safety and efficacy has been fully established, usually through animal testing.
When known clinical problems are identified for users of particular devices our researchers may carry out research to understand more about potential causes and solutions to the problem, and for implanted devices, this research is likely to involve the use of animals.
Animals Ethics Committee assessment of animal research protocols
Research protocols involving the use of animals at the Bionics Institute are closely assessed by the St Vincent’s Hospital (Melbourne) Animal Ethics Committee (AEC), which is regulated by State law and regularly audited.
To have an AEC is a legal requirement, and Bionics Institute researchers undertake a rigorous process to satisfy the AEC if they are to gain permission to test the safety and efficacy of medical devices on animals.
The AEC must comprise at least four people from the following categories:
- A veterinary surgeon.
- A person with substantial experience in the use of animals for scientific purposes.
- A person with commitment and experience in the welfare of animals not otherwise associated with the Hospital or the use of animals in scientific research.
- A member of the public who is not otherwise associated with the Hospital or the use of animals in scientific research either by employment or education.
The AEC applies the principles of Replacement, Reduction and Refinement to research protocol submissions and assesses the balance of animal welfare with outcomes for medical research and society before deciding to grant or deny approval for the research to proceed as proposed.
More information
The Bionics Institute is committed to ensuring that the use of animals in research is ethical and has signed the ANZCCART Openness Agreement on Animal Research and Teaching in Australia.
If you require further information about the use of animals in Bionics Institute research, please contact our Chief Technology Officer and Head of Research Operations, Professor James Fallon: [email protected]
FAQs
Click on the + to view the frequently asked questions
Animals used in research at the Bionics Institute are housed in purpose-built facilities on the St Vincent’s Hospital (Melbourne) campus.
The Bionics Institute has a dedicated Animal Research Team lead by Dr Peta Grigsby who has over 20 years of experience developing animal models for research.
Bionics Institute staff involved in animal research are trained in the ethical, humane and responsible care of animals.
The team has a variety of educational backgrounds, including PhDs, Masters and bachelor’s degrees in Physiology, Pharmacology and Neuroscience as well as Animal and Veterinary Biosciences.
In addition, key staff hold a Certificate in Veterinary Nursing qualification, accredited though the Australian College of Veterinary Nursing.
The St Vincent’s Hospital Head Vet examines all animals on a regular basis and is available 24/7 in case of an emergency.
Animals used in research at the Bionics Institute are cared for by trained animal technicians who check them multiple times per day and run enrichment programs of play and foraging exercises.
The most appropriate species for each project is determined based on the needs of the research.
Mice and rats are used in Bionics Institute research because there are many disease models (e.g., rheumatoid arthritis, inflammatory bowel disease, Parkinson’s) that have been developed in these species.
The inner ear (cochlea) of guinea pigs has a similar anatomy to that of the human cochlea and they are therefore used by our researchers to test early-stage device prototypes for use in the inner ear.
Sheep are used for research into devices to treat conditions in the brain and peripheral nervous system. Due to their size, they can be used to assess the safety and efficacy of human size devices before human trials.
Cats are used in hearing and vision research because the physiology and size of their eyes and ears is similar to humans.
This means that the devices affect their nervous systems in human-like ways, and that human-size devices, such as the bionic eye and improved cochlear implants can be tested for efficacy.
In addition, like humans, they can support implants for extended periods of time, so that the long-term safety of devices can be tested.
Cats can also be trained to respond to specific stimuli, allowing us to test their perception of complex visual or auditory information, and gain understanding of what people can expect to experience, before those devices are tested in humans.
Benchtop computer-aided design and engineering of implantable medical device prototypes is undertaken until it is necessary to test safety and efficacy in animals.
Animals are only used when it is not possible to test devices any other way.
Submissions to the Animal Ethics Committee contain a mathematical calculation of the minimum number of animals required, a justification for the necessity of using animals, and the potential benefits to society alongside full details of the research protocol.
All research is conducted using humane techniques, which includes anaesthesia, pain medication and health monitoring conducted by a qualified animal technician.
Researchers provide a report on progress of research protocols to the Animal Ethics Committee each year, which outlines procedures conducted, data collected and proposed refinements to ensure replacement and reduction of animal use where possible.
Animal Welfare Victoria conduct an annual report on the number and type of animals used for science each year in Victoria. This can include audits of Bionics Institute projects and the Animal Ethics Committee.
The purpose of this process is to obtain annual statistics to direct policy and compliance programs, and to inform the community about the nature and purpose of animal use.