FAQs fish

FAQs

In summary: A treatment that improves or extends life is a genuine benefit. However, the historical involvement of animal research does not justify keeping animal models as the default. Research should begin with the human question and the most human-relevant methods available. 

It is too absolute to say that every medicine was developed either ‘because of’ or ‘in spite of’ animal research. Drug development usually combines laboratory studies, chemistry, computational work, animal studies, clinical observation and human trials. The evidence of whether a medicine is safe and effective for humans ultimately comes from human data. 

Animal results sometimes align with human outcomes and sometimes do not. They may help generate hypotheses while failing to predict outcomes in patients. AFSA does not deny that animal studies have formed part of successful development histories;  but it challenges the assumption that historical use proves continuing necessity or makes animal models the routine ‘gold standard’. 

AFSA’s position is that an animal model should not be the starting point simply because it is familiar, established or expected. Researchers, funders and institutions should first ask whether the question can be answered using human data, computational models, and in vitro methods like patient-derived cells or tissues, organoids, organs-on-chips, or a combination of the above Non-Animal Methods. 

The burden of justification should rest with those proposing animal use. They should be able to show that relevant NAMs used alone or together have been properly considered, explain why they cannot answer the question, and demonstrate that the expected benefit is realistic and proportionate to the harm involved. Familiarity, existing infrastructure, status quo, or regulatory are not, by themselves, sufficient scientific reasons to default to animals. 

It is ethically important to acknowledge the animals who were used and harmed in research that contributed to medical knowledge. But acknowledging that history does not require us to preserve the same methods indefinitely. The appropriate response to successful treatments is to build on medical progress with methods that are more directly relevant to patients—not to preserve animal use by default. 

In summary: Medical progress has never depended on just a single research method. Human observation, epidemiology, clinical research, imaging, autopsy and donated tissue, cell culture, engineering, chemistry and computational science have all contributed to scientific and treatment advances. 

Some examples include – identifying the relationship between smoking and lung cancer through population research; understanding disease through clinical observation and post-mortem examination; developing technologies like X-rays, CT, MRI and PET through physics and engineering; and improving treatments through human clinical trials. 

Other human-based sources answer different questions: genetics can identify how inherited variation contributes to disease; donated cells and tissues can reveal patient-specific mechanisms; biobanks, health records and large population datasets can uncover patterns across many people; and clinical trials determine whether an intervention is acceptably safe and effective in humans. The advent and increased uptake of Non-Animal Models including in vitro technology through patient-derived organoids, induced pluripotent stem cells, organs-on-chips, artificial intelligence and other computational models. 

Animals have also been used during the history of many discoveries. However, their presence along the research pipeline does not by itself show that the animal study was essential, that it predicted the human outcome, or that the discovery could not have been achieved any other way. A fair historical account asks what each method contributed and whether the evidence that ultimately mattered produced translatability and human relevant outcomes. 

AFSA’s position is forward-thinking, today’s model should be chosen because it is the most scientifically appropriate and ethically responsible way to answer the question, not just because it is traditional. Non-Animal Methods now allow researchers to study mechanisms and variation that many historical approaches could not capture (CSIRO, 2023; FDA, 2025). 

Reference:

Commonwealth Scientific and Industrial Research Organisation (CSIRO) (2023) Non-animal models: a strategy for maturing Australia’s medical product development capabilities. Available at: https://www.csiro.au/en/work-with-us/services/consultancy-strategic-advice-services/CSIRO-futures/Health-and-Biosecurity/Non-animal-models (accessed 19 August 2026).

In Summary: For some research questions, there is not yet one accepted Non-Animal Method that can replace every part of an animal test. However, a combination of NAMs and human data may provide the information needed. Claims that there is “no alternative” should be carefully questioned, as the barrier may be limited funding, access, expertise or regulatory acceptance. Animal use should not continue simply because it is familiar; it must be regularly reviewed and justified. 

Replacement is not always a one-for-one exchange. An animal study may be replaced by a combination of NAMs ,for example, human cell-based methods, computer models, existing human data, read-across, microdosing and evidence from clinical research or real-world settings. In some cases, the research question can also be redesigned so that the information is obtained more directly from humans. 

Claims that there is “no alternative” should be carefully questioned. This may mean that a method has not yet been accepted by a regulator, that no single NAM can reproduce every part of the existing animal test, or that the research team lacks the funding, access or expertise to use or develop a suitable method. These are different barriers and do not necessarily mean that animal use is the only scientifically valid option. 

AFSA supports a planned transition away from animal use. This means prioritising areas where replacement is most achievable, assessing methods against human evidence, investing in their development and standardisation, and providing clear regulatory guidance. The FDA is implementing a roadmap to reduce animal testing in drug development, while the NIH is prioritising NAMs. The European Commission has also adopted a roadmap towards phasing out animal testing for chemical safety assessments.  Australia should build on this global progress by reviewing existing animal-testing requirements and removing those that are no longer scientifically necessary. Animal tests should not remain the default simply because they are familiar or have always been used. 

References:

United States Food and Drug Administration (FDA) (2025) Roadmap to reducing animal testing in preclinical safety studies. Available at: https://www.fda.gov/media/186092/download

National Institutes of Health (NIH) (2025) ‘NIH to prioritise human-based research technologies’. Available at: https://www.nih.gov/news-events/news-releases/nih-prioritize-human-based-research-technologies

In summary: Institutional support reflects the current research system, legal responsibilities and status quo. It is not proof that animal models are always necessary or optimal. 

Governments and medical bodies are responsible for protecting patients while supporting research. They may view established animal studies as part of precautionary evidence, particularly where no accepted alternative yet exists. For decades, research funding, facilities, professional training and regulation have also been organised around animal models. 

Institutions can be slow to change because they must manage uncertainty and because abandoning a familiar method carries perceived legal and reputational risk. There is also genuine disagreement: scientists differ about the value of particular animal models and about how quickly NAMs can replace them. 

What’s important to note is that policy is changing. The FDA has a roadmap to reduce animal testing; the NIH now prioritises human-based research technologies and no longer designs new funding opportunities exclusively around animal models; and the UK published a 2025 strategy aimed at replacing animals in all but exceptional circumstances. These changes show that support for the status quo is neither universal nor permanent (NIH, 2025; UK Government, 2025). 

References: 

In summary: Research methods do not cure diseases on their own. New treatments are developed through many stages of research, so it can be misleading to claim that either animal research or Non-Animal Methods (NAMs) alone produced a cure. 

 Human-based research has played an essential role in medical progress. Studies involving people have helped identify the causes and risk factors of disease. Human cells have been used to study viruses and cancer, while computer models can help researchers design and screen possible medicines. Patient-derived organoids can be used to better understand a person’s disease and, in some cases, help predict how they may respond to treatment. Organs-on-chips are also beginning to help researchers decide which possible treatments should move forward. 

Cystic fibrosis is one example. Researchers can grow small intestinal organoids using cells from a patient. These organoids can be used to study how the disease affects that person and whether they may respond to certain medicines. Human iPSC and organoid models are also supporting research surrounding neurological, genetic and infectious diseases. 

AFSA does not claim that NAMs have independently cured diseases. Rather, NAMs can provide important evidence throughout the research process, from understanding disease and assessing safety to selecting treatments and preparing them for clinical trials. Because these methods are based on human biology, they can also reduce the uncertainty involved in applying or translating results from one species to another. 

The methods used to develop treatments matter as well as the final outcome. Research should aim to produce reliable and relevant evidence while avoiding harm wherever possible. As NAMs continue to develop and gain greater regulatory acceptance, they offer an important opportunity to improve human health while replacing the harmful use of animals in research and it is a realistic expectation to see drugs approved without animal safety or efficacy data in the near future.  

AFSA resource: AFSA case studies

In summary: Reliability depends on the question being asked. The right comparison is how well each method answers that question, including whether its results can be repeated and whether they are relevant to people. 

 Some non-animal methods already have a defined role. Researchers can use reconstructed human skin to assess skin irritation under an OECD guideline. Another guideline sets out how laboratory tests and computer predictions can be combined to assess whether a chemical may cause a skin allergy.These methods have clear procedures and purposes. 

Newer methods need to be assessed for their particular uses. Nephroscreen, a device containing human kidney cells, has produced reproducible results in studies of certain forms of drug-related kidney injury and drug interactions. That is encouraging evidence for those questions; it does not mean the device can predict every effect of every drug. 

The same scrutiny should apply to animal tests. Housing and stress can affect animal study results, and a response in another species may not reflect a human response. A long history of use does not, by itself, establish that a test is the best choice. 

AFSA supports careful assessment of non-animal methods. We also want researchers to examine the evidence behind established animal methods rather than assume they are the benchmark. The question is which approach gives us the most dependable, human-relevant answer while avoiding harm wherever possible. 

In sumarry: AI can help replace animal testing by using existing data to predict chemical safety and interpret results from human tissue models.

Artificial intelligence learns patterns from the biological and chemical data we already have, so a computer can predict how a substance will behave in the human body instead of an animal being used to find out. Thomas Hartung’s team at Johns Hopkins built a database of around 10,000 chemicals and 800,000 studies from European safety records, then used machine learning to predict the results of the nine most common safety tests. (Luechtefeld, T., Marsh, D., Rowlands, C. & Hartung, T, 2018). The software got about 87% of predictions right across 190,000 chemicals with known classifications. Later work assessed more than 4,700 food chemicals in about an hour, equivalent to some 38,000 animal studies and over US$250 million (Hartung, 2024). In March 2026, Hartung endorsed the launch of ToxIndex, an AI platform that gathers toxicology data from across the literature and produces a full, traceable chemical safety assessment in a few hours (EurekAlert! (2026) 

AI works best combined with other animal-free methods, and Australia has a strong example. Brisbane biotech Gelomics grows tiny three-dimensional human tissue models, including tumours taken from patient biopsies, and has partnered with Google Australia to use AI to keep those tissues consistent and to predict how a tumour will respond to an experimental drug — analysis that would otherwise take researchers months (Google Australia, 2026) 

References 

  • Luechtefeld, T., Marsh, D., Rowlands, C. & Hartung, T. (2018). “Machine Learning of Toxicological Big Data Enables Read-Across Structure Activity Relationships (RASAR) Outperforming Animal Test Reproducibility.” Toxicological Sciences, 165(1), 198–212. https://doi.org/10.1093/toxsci/kfy152 

In summary: Historical animal can provide a useful measure of comparison, but they should not be treated as the final measure of accuracy. A NAM should be assessed against the biological effect or outcome it is intended to predict. If the purpose of research is to understand human health, the strongest benchmark is evidence that is human relevant, not simply whether the method reproduces an animal result. 

Legacy animal methods were not subject to the stringent validation standards required today and many were ‘grandfathered’ into global guidelines, becoming a test reference for new methods.. This comparison showed whether the new method could reach the same regulatory decision. It did not prove that the animal test accurately reflected what would happen in humans. 

Today, validation is moving towards more human-relevant evidence, including clinical outcomes, population data, responses in human tissues, known biological pathways and real-world evidence. It is also important to distinguish between reliability—whether a method produces consistent results—and human relevance—whether it measures the biology that matters for the decision being made. An animal test may be consistent without being an accurate predictor of human outcomes. 

This distinction is also ethically important. If animal evidence is automatically treated as the “correct” result, a non-animal method may be rejected simply because it identifies a human-specific response that the animal test cannot detect. This reinforces animal testing as the default, even where it may be less relevant to humans. Furthermore, methods should be judged against the most scientifically appropriate evidence, not protected because they are familiar or historically accepted – embedded in the research infrastructure. Continuing to use animals also requires clear ethical justification, particularly where more human-relevant methods are available. 

OECD Test Guideline 497 provides a useful example. Its defined approaches for assessing skin sensitisation were evaluated using both mouse data and carefully reviewed human data. When compared with human outcomes, these approaches performed as well as or better than the mouse test. This shows why validation should not simply ask whether a non-animal method can reproduce an animal result. The more important question is whether it can provide reliable and relevant evidence for protecting and advancing human health (ICCVAM, 2024; OECD, 2025b).

References:
  • Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) (2024) Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies. Available at: https://doi.org/10.22427/NICEATM-2
  • Organisation for Economic Co-operation and Development (OECD) (2025b) Supporting document to Test Guideline 497 on Defined Approaches for Skin Sensitisation. OECD Series on Testing and Assessment. Available at: https://one.oecd.org/document/ENV/CBC/MONO%282025%292/en/pdf 

In summary: Yes. Basic research is essential but it’s crucial to understand that this does not mean that animals are automatically the appropriate model for every basic question. 

Basic research looks at how cells, biological processes and diseases work. It may not directly lead to a new treatment, and sometimes its value only becomes clear later on. However, that does not mean animals are automatically the right or most appropriate model. Fundamental questions can also be explored using human cells and tissues, organoids, organ-on-chips, computer models, microorganisms and ethically conducted research involving people. 

There is also a risk that findings from animals are presented as though they tell us more about humans than they actually do. If the purpose of research is to help us understand human biology or disease, then human relevance should be prioritised and considered from the beginning. Researchers should be honest and transparent about what the animal model can actually tell us, as well as its shortcomings. 

AFSA supports scientific discovery. However, curiosity itself is not enough to justify harming a sentient being. Where the possible benefit is uncertain or adds little value, justifying that harm needs to be examined under greater scrutiny. Funders, institutions and Animal Ethics Committees need to be asking: Has this research been done before? Is animal use really necessary? Were NAMs genuinely considered? Animal research should not face less scrutiny simply because it is labelled “basic research.”

There is no legal requirement for animal experimentation in basic research, nor for it to be part of education and training. However, Government regulators require that new consumer products, medicines, and industrial and agricultural chemicals are tested to identify potential dangers to human and animal health, as well as to the environment. For some product types (drugs and vaccines, biologicals), this includes testing for efficacy as well as safety (toxicity). Before a drug can be marketed in Australia, it must be evaluated by the Therapeutic Goods Administration (TGA). Whilst the TGA Act does not mandate animal testing, the underlying guidelines often imply that animal test data is expected. For example, one of the stages in the evaluation process is to evaluate animal pharmacology and toxicology data. A drug sponsor may request a waiver where validated alternatives exist or there is no animal model to mimic the disease under investigation. For more information, see here. 

In summary: Scientists can now study how human cells respond to a drug, build small models of human organs and screen chemicals using computers and laboratory tests. Some of these methods are already used in internationally recognised safety testing. Others are still being developed and assessed for wider use. 

Human organ-on-chips offer a fascinating example. These small devices contain living cells and create particular conditions the cells would experience inside the body. Nephroscreen, a kidney tubule-on-chip, uses human kidney cells to investigate drug-related injury. Researchers have shown that it can produce repeatable results for the effects they studied. A human Liver-Chip has also been tested against 27 drugs whose effects were already known. It identified most of the drugs known to cause liver injury in that study. This does not mean a chip can predict every side effect. It shows how researchers can test a specific concern using human tissue. 

Researchers are also building models to explore the brain. BrainSpheres are small, three-dimensional groups of human cells that develop some features of brain tissue. Scientists can measure their electrical activity—how the cells communicate—and investigate whether exposure to a chemical changes it. Another model recreates aspects of the blood–brain barrier, the protective boundary that controls what moves from the bloodstream into the brain. Such a chip can help researchers study how that barrier works and what happens when it is disrupted. These are research tools, rather than miniature complete brains. 

For chemical safety, the US Environmental Protection Agency’s ToxCast program uses automated tests involving cells and proteins to screen large numbers of chemicals. The results help researchers identify effects worth investigating further. Computer models can contribute predictions alongside those test results. They are useful for deciding where to focus attention, but their predictions still need to be checked. 

Some non-animal approaches have already made it into international guidelines. Researchers can use reconstructed human skin to assess whether a chemical causes irritation. To assess whether it may cause a skin allergy, they can combine results from different laboratory tests and computer predictions using an agreed set of rules.

What connects these examples is the way the method follows the question. A kidney chip helps investigate kidney injury; a brain model helps examine effects on human nerve cells. No single method answers everything. For AFSA, their promise lies in building better evidence from human biology—and making animal use something researchers must justify, rather than assume. 

In summary: There is no single Australian approval pathway for every NAM. The evidence required depends on the method’s intended use whether that be, drug development, chemical safety,  veterinary medicines or medical devices , etc. 

Australia does not currently have one clear national process for validating and accepting NAMs. The pathway depends on what the method will be used for, and researchers often rely on validation undertaken internationally. 

In simple terms, validation asks whether a method works reliably for a clearly defined purpose. Researchers may need to show that it produces consistent results, reflects the relevant biology, includes appropriate controls and has clearly understood limitations.  

Importantly, a NAM should not always be required to reproduce the result of an older animal test. If the method is intended to predict a human response, its relevance to human biology should be central to how it is assessed. However, this is not always the case with current validation processes which often compare the NAM with animal data or endpoints traditionally generated by animal models.  

For chemical safety testing, Australia can use non-animal methods included in internationally recognised OECD Test Guidelines, for which the Department of Climate Change, Energy, the Environment and Water is involved. Through the OECD’s Mutual Acceptance of Data system, participating countries can accept results produced according to these guidelines and Good Laboratory Practice. This means Australia does not need to create or repeat a separate national validation process for every internationally accepted method.  

Pharmaceutical testing guidelines developed by the International Council for Harmonisation (ICH) and the International Cooperation on Harmonisation of Technical Requirements for Registration of Veterinary Medicinal Products (VICH) cover animals used for human drug development and veterinary medicines..   The responsible agencies in Australia are the Therapeutic Goods Administration (TGA) and the Australian Pesticides and Veterinary Medicines Authority (APVMA), working alongside Animal Medicines Australia (AMA)

These agencies are responsible for adopting international guidelines and may consider alternative methods and supporting NAMs validation evidence within an individual application, but Australia does not have a dedicated, coordinated pathway that tells developers how NAMs will be assessed and accepted across different uses. 

This lack of a clear national pathway can create uncertainty for researchers and companies. They may have developed a scientifically credible NAM but still be unsure what evidence an Australian regulator will require or whether the method will be accepted. 

Depending on its intended use, the process may involve: 

  • Developing the method: clearly defining what it measures and what it is intended to do. 
  • Assessing its performance: examining its reliability, human relevance and known limitations. 
  • Independent testing: determining whether other laboratories can produce comparable results. 
  • Scientific review: having independent experts assess the supporting evidence. 
  • Regulatory acceptance: deciding whether the method provides sufficient evidence for a specific regulatory purpose. 

Acceptance for one purpose does not automatically mean that a method will be accepted for every use. Australia therefore needs clearer guidance, stronger coordination and earlier engagement between NAM developers and regulators. 

AFSA resource: Regulation of Human Medicines

In summary: Supporters can help ensure non-animal methods receive the funding, attention and practical support needed to move into wider use. 

You can ask where research funding goes. Write to an elected representative, university or research charity and ask whether it supports human-cell research, organoids, organ-on-chips and computer methods. Ask about training and studies to establish where those methods work well. Developing a technology is only one step; researchers also need the means to use it. You can take part in public consultations on research funding and animal research policy. A short submission can explain why replacement matters and ask that researchers properly investigate non-animal approaches before proposing animal use. Australia’s animal research code already requires replacement methods to be considered.91 Public input can help make that expectation more meaningful. 

Some people may choose to join an ethically approved study or patient registry or donate tissue for research. Participation should be informed and appropriately protected.

Animal use is deeply embedded in research systems. Changing that takes investment, clear pathways for new methods and people willing to ask whether there is a better way to answer the question. 

AFSA Resource: 

In summary: Yes. No country has fully replaced animal research, but some have introduced stronger laws, clearer and more accessible public reporting and national plans for moving towards NAMs. Australia does not necessarily need to copy one system. It can draw on the strongest parts of several.

The United Kingdom has a national licensing system and publishes summaries of approved animal research that easily readable and accessible for the public. Its 2025 strategy also set a long-term mission to eliminate animal use in all but exceptional circumstances, and includes goals for funding, regulatory support and timelines for replacing certain tests (UK Government, 2025).

The European Union requires a recognised non-animal method to be used where one is available. It also supports dedicated organisations that assess NAMs and helps move them into regulation. In 2026, the European Commission adopted a roadmap towards phasing out animal testing for chemical safety assessments (European Commission, 2026).

In the United States, the FDA is reducing animal testing in drug development and providing clearer guidance on when evidence from NAMs can be accepted instead of animal data. Its approach is being introduced gradually, beginning with certain antibody-based medicines. The NIH is also giving greater priority to human-based research in its funding approach (FDA, 2025; NIH, 2025).

These systems still allow extensive animal use, so none provides a complete model. However, they show what Australia could adopt: stronger national oversight, transparent reporting, dedicated funding for NAMs, clearer regulatory pathways and meaningful timelines for replacing animal tests.

AFSA resource: From promises to implementation: global moves advancing animal-free research

In summary: A non-animal method can be valuable in research before regulators have a clear process for using its results. Developers need to know what evidence to provide, and regulators need the expertise and resources to assess it. 

 Before a new medicine or chemical can be sold in Australia, its maker has to prove it’s safe. There are now human-based ways to do much of that work: lab-grown human tissue, organ-on-chip devices that mimic how a human organ responds to a drug, and computer models that predict toxicity.

Whilst other international jurisdictions are leading the way, there is no clear commitment by the Australian Government to a phase out of animal testing for regulatory purposes, and the Therapeutic Goods Administration lacks direction and resourcing on providing clear pathways to regulatory acceptance of new drugs and therapeutics without animal testing. 

Australia has no national body that assesses and approves new non-animal safety tests, so we wait for the United States, Europe or Japan to approve one first, then adopt it. Responsibility is also split: the Therapeutic Goods Administration handles medicines, a separate scheme handles cosmetics and household chemicals, and another handles farm and veterinary products, so no single agency is driving the change. 

AFSA is addressing these challenges by engaging with regulators such as the Therapeutic Goods Administration (TGA), via our advocacy for funding for NAMs, preparing submissions and lobbying for increased resourcing of the TGA to enable regulatory adoption of NAMs, and coordinating and presenting at relevant regulatory sector events. 

AFSA is a member organisation of the International Council on Animal Protection in OECD Programmes (ICAPO) and the International Council on Animal Protection in Pharmaceutical Programmes (ICAPPP), promoting the integration of non-animal methods in global guidelines.

In summary: Investing in non-animal methods can help researchers use funding more effectively. Some methods can test possible treatments earlier and more efficiently, while better information about human responses could reduce spending on drugs that fail later. There is also an opportunity for Australia to develop the skills and technologies behind this research. 

 Animal experiments carry ongoing costs, including breeding, housing, care and specialist facilities. Some human-cell and computer-based methods can screen many substances before researchers commit to more costly stages of development. But a non-animal method is not automatically cheaper: organ-on-chips and other advanced models can require expensive equipment, training and studies to establish how well they work. 

That initial investment may pay off over time. If a method helps researchers identify a safety problem or an ineffective treatment earlier, it could prevent further spending on a drug unlikely to succeed in people. In one study, a human Liver-Chip identified drug-related liver injury in a set of previously studied medicines. The researchers modelled substantial potential gains in drug-development productivity if the method were adopted widely. Those figures are projections, rather than savings already achieved across the industry. 

CSIRO has identified both the economic potential of organoids and organ-on-chips in Australia and the work needed to realise it. Its report calls for a coordinated approach to developing these models and bringing them into wider use. CSIRO also notes that their costs need to come down and their performance needs to be demonstrated across more applications.

For AFSA, the question is what research funding ultimately delivers. Investing in methods that provide useful, human-relevant evidence could reduce animal use and avoid some of the cost of pursuing treatments that do not work in people. We should assess those benefits method by method, rather than promise that every non-animal test will be cheaper. 

In summary: A person does not lose their right to bodily autonomy because they have committed a crime. Prisoners can take part in research, but only when their choice is genuinely voluntary and they are protected from pressure or exploitation. However, protecting prisoners does not make it acceptable to transfer the harm to animals. The ethical response is not to find another vulnerable group to experiment on, but to develop research methods that do not depend on harming either. 

 Modern research protections were developed partly in response to serious abuses involving people who were captive, marginalised or unable to freely consent. The Nuremberg Code and the Declaration of Helsinki make it clear that medical research must respect the rights, safety and dignity of participants. A prison sentence removes a person’s liberty; it does not remove their humanity or give researchers permission to use their body (Nuremberg Code, 1947; WMA, 2024). 

This question also creates a false choice between experimenting on prisoners and experimenting on animals. We should not protect one group by transferring harm to another. Animals cannot consent, withdraw from a study or explain what they are experiencing. Their vulnerability should give us a greater responsibility to protect them—not make them more available for experimentation. Australia’s animal-research Code itself states that respect for animals must underpin decisions about their use and that harm, including pain and distress, must be avoided or minimised (NHMRC, 2013). 

From AFSA’s perspective, the better question is not who else can we experiment on? It is how can we conduct meaningful research without deliberately harming those who have the least power to refuse? Human-relevant Non-Animal Methods offer a more scientifically progressive and ethically responsible way forward. 

References:

In summary: Mice, rats and fish are among the animals most commonly used in research, but their numbers and default use do not make their suffering less important. “Vermin” is a label people give to certain animals; it does not change their ability to experience pain, fear or distress. Ethical consideration should be based on an animal’s capacity to suffer—not on how humans view, value or imbue a particular species. 

Calling an animal ‘vermin’ describes a human judgement about the animal; it is not a biological category that removes capacity for pain, fear or distress. The same rat can be treated as a companion, a research subject or a pest depending on context, while the animal’s capacity to experience harm remains constant. 

Scientific evidence shows pain perception in fish, although their nervous systems and expressions of pain differ from mammals. Australian animal-research frameworks include fish within protected species, reflecting the need for ethical oversight. 

Numbers also matter. Mice, rats and fish are often used in large numbers, but their use receives less public attention than research involving animals such as dogs, cats or primates. This can make their suffering easier to overlook. AFSA’s position is consistent across species: ethical scrutiny should be based on sentience, the harms imposed, the claimed benefit and whether a scientifically appropriate non-animal approach is available—not on how familiar or likeable the species is. 

In summary: When the intended patient is an animal, NAMs can be developed using cells, tissues and data from that species. Veterinary knowledge can also be advanced through clinical research involving animal patients who already have the condition, rather than deliberately creating illness or injury in healthy animals. AFSA supports research that genuinely benefits animal health and wellbeing and does not treat animals primarily as a means of advancing human or commercial interests. 

Veterinary NAMs can use cells, tissues, organoids and organs-on-chips developed from the species the research is intended to benefit. Other approaches include computer modelling, advanced imaging, ethically donated animal bodies, realistic simulators, stored biological samples and clinical research involving animal patients who already have the condition being studied. 

Research involving an animal patient is ethically different from deliberately causing disease or injury in a healthy animal. Like clinical research involving humans, it should be designed to offer the animal patient a reasonable chance of benefit, involve informed consent from their guardian, undergo independent ethical review and provide appropriate veterinary care. Guardians must also clearly understand the difference between treatment intended to benefit their animal and research that may not provide a direct benefit. Any conflicts of interest should be openly identified and carefully managed. 

AFSA supports veterinary research that genuinely aims to improve the health and wellbeing of animals, this includes the development of species-specific NAMs. Animals should not be harmed primarily to increase productivity or advance human interests when they receive no meaningful benefit. The value of the research must be considered alongside its purpose, and the harm involved and whose interests it ultimately and is intentionally trying to serve.

Summary: Outsourcing is a possibility whenever regulations are strengthened, but that risk alone does not justify keeping weaker protections in Australia. Australian institutions should remain responsible for research they fund, commission or conduct overseas. The aim should be to prevent animal harm from being relocated, while investing in NAMs that replace the research altogether.

There is always a risk that people or organisations will try to avoid stronger laws by moving an activity elsewhere. We see this across many areas of regulation. However, we do not usually respond by deciding that regulation is pointless. The possibility that a law may be avoided does not mean the law should not exist—particularly where harm is involved. 

The same principle applies to animal research. Australia should not overlook weaknesses in its current system because an institution might move its research overseas. That would mean allowing the threat of outsourcing to set our ethical standards. It would also place the interests of research institutions ahead of the animals who experience the harm. 

Instead, Australian institutions should remain accountable for animal research they fund, commission or conduct overseas. The Australian Code already states that overseas projects involving Australian researchers or institutions should follow its governing principles and must not be moved overseas to avoid Australian requirements. These projects also require AEC approval and appropriate monitoring (NHMRC, 2013). 

These responsibilities should be strengthened and properly enforced. Institutions should have to explain where overseas research is taking place, why it is being conducted there and how the animals are being protected. Australian funding and research contracts should also require equivalent standards, regardless of the country in which the work occurs. 

Most importantly, stronger regulation should not simply push the same animal experiment across a border. Australia should be investing in NAMs that offer more human-relevant and reliable ways of conducting research without animal harm. The purpose of reform is not to export the ethical problem. It is to change the research landscape so that reliance on animals is no longer treated as inevitable. 

AFSA Resource: A Problematic Phenomenon: Animal Research’s Flight from Regulation – Animal-Free Science Advocacy

References:

National Health and Medical Research Council (NHMRC) 2013, Australian code for the care and use of animals for scientific purposes, 8th edn, updated 2021, NHMRC, Canberra, clauses 2.6.9–2.6.14, Australian Code.

In Summary: Language shapes what people notice, whose interests count and which practices appear normal or not. Accurate, respectful wording helps shape public understanding that animals used in research are sentient individuals, not equipment, commodities, or raw materials.

Terms such as ‘laboratory animal’ can define an animal entirely by the human purpose and interest imposed on them. ‘Animals used in research’ or ‘animals in laboratories’ makes the action and setting visible. Where practical, naming the species—such as ‘mice used in an experiment’—is clearer still. Referring to an animal as ‘they’ rather than ‘it’ avoids treating a living being as an object. 

This distinction matters because language carries associations. Describing an animal as ‘it’ or solely as a research tool can make a living individual seem like an object or an interchangeable unit. Describing them as ‘they’, or as a mouse, dog or primate who was used in research, reminds us that the subject is a someone rather than a something: a sentient being capable of experiences and with interests of their own. 

Language can also hide harm. ‘Sacrificed’ may mask that an animal was killed; ‘procedure’ may obscure experiences ranging from a minor intervention to severe suffering; and ‘humane endpoint’ does not mean the animal experienced no harm.  

Terminology matters scientifically too. AFSA uses ‘Non-Animal Methods or Non-Animal Models’ and ‘NAMs’ for methods that do not use live animals. In regulatory settings, ‘New Approach Methodologies’ can be broader and may include approaches that reduce or refine animal use. Clarifying the intended meaning prevents confusion and protects AFSA’s message. 

Thoughtful language is not about policing every word. It is about communicating honestly, avoiding euphemism and keeping both the animals and the scientific question visible. 

Acknowledging animal personhood and granting them a right to dignity is not an act of charity, but a duty of rightful respect toward our fellow living beings, to achieve this we need to consider the language we use to discuss them. 

In summary: Ethics asks us to examine what we value, how we justify our decisions and whose interests may be affected by them. It encourages us to move beyond black-and-white thinking and consider different perspectives, competing interests, potential harms and benefits, and our responsibilities to both humans and animals.

Ethics is connected to morality and the law, but it is not the same as either. Something can be legal without necessarily being ethical. Ethics asks us to look beyond what is permitted and consider what is right, what is fair, what may cause harm and whether that harm can genuinely be justified. 

Our ethical views are shaped by our experiences, environment, culture and the value we give to different lives and interests. Every issue has multiple angles and shadows. Ethics encourages us to question our assumptions and consider perspectives beyond our own, particularly those of individuals who are vulnerable, unable to consent or whose interests may otherwise be overlooked. 

This is essential when discussing animal research. We cannot consider only the hoped-for benefit to humans. We must also consider the animals who experience the harm, whether they receive any benefit, whether the research is necessary and scientifically sound, and whether Non-Animal Methods could be used instead. 

Moving away from animal experimentation is not only about preventing animal suffering. It is also about producing better science for humans. Greater use of human-relevant methods can improve how well research applies to human biology, help identify ineffective or unsafe treatments earlier, reduce research waste and make better use of public funding. More efficient and accurate research can lead to better outcomes for patients and the wider community. 

For AFSA, these scientific and ethical considerations are closely connected. If a method avoids animal harm while also producing evidence that is more relevant to humans, prioritising that method benefits both animals and humankind. Ethical scrutiny must therefore ask more than how harm to animals can be reduced. It must ask whether their use is necessary at all, whether the expected human benefit is realistic and whether a more responsible and human-relevant approach is available. 

AFSA opposes the harmful use of animals in research and teaching on both ethical and scientific grounds. We believe it is unethical to cause harm to sentient beings for research that offers them no direct benefit, particularly when they cannot consent to their use or refuse participation.

Our ethical position is founded on five key principles:

  • Animals are sentient, meaning they are capable of experiencing pain, fear, distress, and other subjective experiences
  • Animals are used in research that provides them with no direct benefit
  • Animals cannot give informed consent to participate in research
  • The potential benefits of animal experimentation do not justify the ethical costs of harming animals, particularly given the scientific limitations arising from species differences
  • Animal experimentation can also harm humans by producing misleading or non-predictive data that can delay or compromise medical progress

AFSA believes ethical review should extend beyond asking how animals are used to asking whether they should be used at all. While the Australian Code for the Care and Use of Animals for Scientific Purposes seeks to minimise harm, it begins from the assumption that animal use is acceptable and gives insufficient weight to animals’ autonomy, sentience and intrinsic interests. 

We therefore advocate for stronger ethical scrutiny of animal research, greater recognition of animal sentience, and accelerated investment in modern, human-relevant, animal-free methods that deliver better outcomes for both animals and people. 

AFSA supports the application of principles guiding the research ethics of human subjects extending to non-human animals in light of their vulnerable status and inability to dissent (or for such dissent to be recognised and acted upon). These principles include respect for autonomy, obligations to beneficence and justice, and special protections for vulnerable individuals and population..

Ultimately, AFSA advocates for the replacement of animal experimentation with modern, human-relevant research methods and for a stronger ethical framework that scrutinises whether animal use is justified, rather than simply how it is conducted.

For more information on the ethical case for opposing animal experimentation, see this bioethicist’s webinar, or watch peter Singer’s video on ethics in animal research

Further resources on ethics:

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