The Basel Declaration is a call for greater transparency and communication on the use of animals in research. It is supported by an international scientific non profit society, the Basel Declaration Society, a forum of scientists established to foster the greatest dissemination and acceptance of the Declaration, and the dialogue with the public and stakeholders.
The Declaration was issued on 30 November 2010 by over 60 scientists from Switzerland, Germany, the United Kingdom, France and Sweden. The signatories commit to accepting greater responsibility in animal experiments and to intensive cooperation with the public in the form of a dialogue with prejudice. At the same time, they demand that essential animal experiments for obtaining research results remain permitted both now and in the future. With their Basel Declaration, researchers are seeking to achieve a more impartial approach to scientific issues by the public and a more trusting and reliable cooperation with national and international decision makers.
The signatories to the Basel Declaration are actively seeking to show that science and animal welfare are not diametrically opposed and to make a constructive contribution to the dialogue taking place in society – for example in the incorporation of the new EU Directive of 22 September 2010 on the protection of animals used for scientific purposes into the national laws.[1] (The revised EU Directive provides for the use of fewer laboratory animals for scientific purposes in the future and better reconciles the needs of research with the protection of animals without making research more difficult. The EU Member States must incorporate the Directive into national law within two years and apply these national regulations as from January 2013.)
“Animal experiments will remain necessary in biomedical research for the foreseeable future, but we are constantly working to refine the methods with animal welfare in mind.”[2] The signatories to the Declaration commit, amongst other things, to the use of animal experiments only when the research concerns fundamentally important knowledge and no alternative methods are available. As part of this commitment, their two-day conference in November 2010 ended with an affirmation of their allegiance to the 3R principle “Reduction, Refinement, Replacement”:
The 3R principle (replace, reduce, refine) has its origins with William M. S. Russell & Rex L. Burch, who published their “Principles of Humane Experimental Technique” in 1959. These principles are regarded internationally as the guideline for avoiding or reducing animal experiments and the suffering of laboratory animals:
- Replacement: replacement of animal experiments by methods that do not involve animals
- Reduction: reduction in the number of animals in unavoidable animal experiments
- Refinement: improvement in experimental procedures, so that unavoidable animal experiments
The participants in the symposium that adopted the Basel Declaration were unanimously agreed that science must not only take a clear stand with regard to the responsible handling of laboratory animals, but also has to show greater transparency toward the public.[3] To make their motivation and methods more comprehensible to the public and the decision makers, the researchers aim to cooperate more closely with politicians, the media and schools in the future and to give greater importance to the communication of science.
The authors of the Basel Declaration acknowledge the need for greater discussion of animal experiment issues in public and also of the risks of research approaches and possible misuse of new technological developments. In addition, they declare their intention to communicate not only results und scientific controversies, but also processes and approval procedures in the science process, in order to foster a deeper understanding of research.[4] With regard to the improvement of information for the public on research involving experiments the signatories to the Basel Declaration commit to the following:
Modern medicine is based on discoveries of basic biological research and their implementation in applied research. The initial signatories to the Basel Declaration see the tendency to restrict animal experiments, especially in the field of basic research, as a major risk. And they maintain that no stage of research (neither basic nor applied research) must be categorically excluded from those purposes of animal experiments that are deemed permissible. Apart from the difficulty of differentiating the two stages in the field of medical research, applied research is generally inconceivable without basic research. Basic research is not an end in itself, but serves as the basis for further consideration. Basic and applied research is all part of the same continuum in biomedical research and the assignment of a research project to one part or the other is often rather arbitrary. On the other hand, the categorization of an experiment as basic research does not yet justify the use of animals per se. The demonstration that an animal experiment is indispensable is just as necessary as a weighing the interests of animal welfare against the benefits according to the research objective.
Genetically modified animals represent an important instrument of modern biomedical research. In many cases, species higher on the evolutionary scale in animal experiments can be replaced by the use of simpler organisms bred by means of gene technology, such as fruit flies, laboratory worms or fish. This plays a major part in helping to promote the 3R principles of replacement, reduction and refinement of animal experiments. Disease models in genetically modified animals are mainly in rodents, such as mice and rats. However, they cannot adequately depict human physiology in all cases. Research in animal models using mammals, such as even-toed ungulates (especially for animal health) and in very rare cases also monkeys, remains necessary according to participants at the symposium on the Basel Declaration. They see the following advantages in the use of genetically modified organisms in animal experiments:
The participants at the symposium on the Basel Declaration at the end of November 2010 summarized the outcome of their discussions on the subject of experiments in non-human primates as follows:
1. Research in non-human primates is an essential part of biomedical progress in the 21st century. Research in non-human primates has led to the development of crucial medical treatments, such as vaccines against poliomyelitis and hepatitis (jaundice), as well as to improved drug safety thanks to indispensable contributions to the basic principles of physiology, immunology, infectious diseases, genetics, pharmacology, reproduction biology and neuroscience. We predict an increased need for research using non-human primates in the future, e.g. for personalized medicine and neurodegenerative diseases in an aging society. This continuing need is also reflected in the EU Directive of 2010 (2010 /63/EU) on animals used for scientific purposes, in which it is recognized that research in non-human primates will remain irreplaceable in the foreseeable future.
2. Biomedical research cannot be divided into “basic research” and “applied research”: it is a continuum that includes both basic studies on normal functions and their failure in diseases and also the development of treatments. This fundamental research is indispensable for biomedical progress. Any categorical restriction of research in non-human primates in basic research is shortsighted and not justified by any scientific evidence.
3. Researchers working with non-human primates are committed to the 3R principle on the replacement, reduction and refinement of animal experiments. Research in animals must satisfy the highest ethical standards. Non-human primates are only used when there are no alternatives. We are working constantly and intensively on refining experimental methods and keeping the number of non-human primates used to a minimum. A strong commitment to the 3Rs guarantees the best science and the best welfare of the animals.
4. We are committed to informing the public and providing objective information on research in non-human primates.
A model organism is a non-human species that is extensively studied to understand particular biological phenomena, with the expectation that discoveries made in the model organism will provide insight into the workings of other organisms. Model organisms are widely used to research human disease when human experimentation would be unfeasible or unethical. This strategy is made possible by the common descent of all living organisms, and the conservation of metabolic and developmental pathways and genetic material over the course of evolution.
Great ape personhood is a movement to extend personhood and some legal protections to the non-human members of the great ape family, Hominidae: chimpanzees, bonobos, gorillas, and orangutans.
Animal testing, also known as animal experimentation, animal research and in vivo testing, is the use of non-human animals in experiments that seek to control the variables that affect the behavior or biological system under study. This approach can be contrasted with field studies in which animals are observed in their natural environments or habitats. Experimental research with animals is usually conducted in universities, medical schools, pharmaceutical companies, defense establishments and commercial facilities that provide animal-testing services to industry. The focus of animal testing varies on a continuum from pure research, focusing on developing fundamental knowledge of an organism, to applied research, which may focus on answering some question of great practical importance, such as finding a cure for a disease. Examples of applied research include testing disease treatments, breeding, defense research and toxicology, including cosmetics testing. In education, animal testing is sometimes a component of biology or psychology courses. The practice is regulated to varying degrees in different countries.
The Great Ape Project (GAP), founded in 1993, is an international organization of primatologists, anthropologists, ethicists, and others who advocate a United Nations Declaration of the Rights of Great Apes that would confer basic legal rights on non-human great apes: chimpanzees, bonobos, gorillas, and orangutans.
Covance Inc. is a contract research organization (CRO) headquartered in Princeton, New Jersey, providing nonclinical, preclinical, clinical and commercialization services to pharmaceutical and biotechnology industries. The company is owned by LabCorp and employs more than 50,000 people in over 60 countries. According to its website, it is one of the largest companies of its kind in the world, with annual revenues of over $2 billion. It claims to provide the world's largest central laboratory network. It became a publicly traded company in 1997 after being spun off by Corning Incorporated in 1996. In 2018, the Covance parent company, Laboratory Corporation of America Holdings (LabCorp), was rated one of the best places to work for LGBTQ equality by the Human Rights Campaign. Covance has been subject to criticism from animal rights groups including People for the Ethical Treatment of Animals and the British Union for the Abolition of Vivisection for its animal testing procedures.
An animal model is a living, non-human, often genetic-engineered animal used during the research and investigation of human disease, for the purpose of better understanding the disease process without the added risk of harming an actual human. Although biological activity in an animal model does not ensure an effect in humans, many drugs, treatments and cures for human diseases are developed in part with the guidance of animal models. Animal models representing specific taxonomic groups in the research and study of developmental processes are also referred to as model organisms. There are three main types of animal models: Homologous, Isomorphic and Predictive. Homologous animals have the same causes, symptoms and treatment options as would humans who have the same disease. Isomorphic animals share the same symptoms and treatments, only. Predictive models are similar to a particular human disease in only a couple of aspects. However, these are useful in isolating and making predictions about mechanisms of a set of disease features.
A biomedical scientist is a scientist trained in biology, particularly in the context of medicine. These scientists work to gain knowledge on the main principles of how the human body works and to find new ways to cure or treat disease by developing advanced diagnostic tools or new therapeutic strategies. The research of biomedical scientists is referred to as biomedical research.
Animal models of stroke are procedures undertaken in animals intending to provoke pathophysiological states that are similar to those of human stroke to study basic processes or potential therapeutic interventions in this disease. Aim is the extension of the knowledge on and/or the improvement of medical treatment of human stroke.
Gillian Rose Langley is a British scientist and writer who specialises in alternatives to animal testing and animal rights. She was, from 1981 until 2009, the science director of the Dr Hadwen Trust for Humane Research, a medical research charity developing non-animal research techniques. She was an anti-vivisection member of the British government's Animal Procedures Committee for eight years, and has worked as a consultant on non-animal techniques for the European Commission, and for animal protection organizations in Europe and the United States. Between 2010 and 2016 she was a consultant for Humane Society International.
The Foundation for Biomedical Research (FBR) is an American non profit organization, 501(c)(3), located in Washington, DC. Established in 1981, the organization is dedicated to informing the news media, teachers, and other groups about the need for lab animals in medical and scientific research. The organization, together with its partner, the National Association for Biomedical Research (NABR), argues that promoting animal research leads to improved health for both humans and animals.
Experiments involving non-human primates (NHPs) include toxicity testing for medical and non-medical substances; studies of infectious disease, such as HIV and hepatitis; neurological studies; behavior and cognition; reproduction; genetics; and xenotransplantation. Around 65,000 NHPs are used every year in the United States, and around 7,000 across the European Union. Most are purpose-bred, while some are caught in the wild.
Alternatives to animal testing are the development and implementation of test methods that avoid the use of live animals.
Animal testing regulations are laws or guidelines that permit and control the use of non-human animals for scientific experimentation. They vary greatly around the world, but most governments aim to control the number of times individual animals may be used; the overall numbers used; and the degree of pain that may be inflicted without anesthetic.
Tatsuji Nomura M.D., Ph.D. was a pioneer in the development of laboratory animals with the aim of assuring reproducibility of experimental results in medical research. He was Director of the Central Institute for Experimental Animals (CIEA), Japan
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The National Association for Biomedical Research (NABR) is an American non profit organization, 501(c)(6), located in Washington, DC. NABR was formed in 1985 when the Association of Biomedical Research merged with the National Society for Medical Research The NABR advocates for the continued use of animals in biomedical research albeit in as humane a manner as possible.
The European Partnership for Alternative Approaches to Animal Testing (EPAA) promotes the application of Russell and Burch’s 3Rs principles in meeting regulatory requirements for products such as pharmaceuticals, chemicals, soaps, detergents and cosmetics. The EPAA covers research and development, as well as the use of 3Rs approaches in regulatory compliance and communication and dissemination.
The Three Rs (3Rs) in relation to science are guiding principles for more ethical use of animals in testing. They were first described by W. M. S. Russell and R. L. Burch in 1959. The 3Rs are:
EU Directive 2010/63/EU is the European Union (EU) legislation "on the protection of animals used for scientific purposes" and is one of the most stringent ethical and welfare standards worldwide.
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