FAQs
Frequently asked questions… answered
Dr Hadwen Trust Faqs
1. Does the Dr Hadwen Trust fund research into all Three Rs?
2. What does the Dr Hadwen Trust aim to achieve with its research programmes?
3. What is the Dr Hadwen Trust’s research budget per annum?
4. What research approaches does the Dr Hadwen Trust support?
5. What peer review process does the Dr Hadwen Trust use for grant applications?
Replacing animal experiments Faqs
6. What counts as “animal” and “non-animal” in replacing animal experiments?
7. How can whole-organism level research be done without using animals?
8. How does the Dr Hadwen Trust’s research differ from the research of mainstream medical charities?
9. What is ECVAM’s role?
Legislation and regulation Faqs
10. What legislation covers animal experiments in the UK and Europe?
11. Does Britain have the strictest laws on animal experiments in the world?
12. Are animal experiments required by law?
13. As there are legislative requirements for animal tests in drug development, how can the Dr Hadwen Trust replace animal experiments in medical research?
14. Does legislation require the replacement of animal experiments?
15. Do governments fund research into the Three Rs?
Animal experiment statistics Faqs
16. How many animals are used in experiments?
17. Are statistics on animal experiments accurate?
Dr Hadwen Trust Faqs
1. Does the Dr Hadwen Trust fund research into all Three Rs?
The Dr Hadwen Trust was established to support and promote medical research with potential to replace experiments on animals. It is the UK’s leading medical research charity funding exclusively non-animal research techniques to replace animal experiments, benefiting people and animals. Replacement is the only one of the Three Rs (replacement, reduction and refinement of animal experiments) that brings about technological innovation, advances medical progress, and provides an alternative to laboratory animals.
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2. What does the Dr Hadwen Trust aim to achieve with its research programmes?
The Dr Hadwen Trust is a registered charity established in 1970 to fund the development and promote the use of techniques and procedures to replace the use of animals, mainly in medical research and testing. Most researchers, research funders and regulators now accept the importance of replacing animal procedures, and agree that the ultimate goal is to conduct medical research and safety testing without using living animals. We believe that excellence in medical research can and should be pursued without animal experiments.
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3. What is the Dr Hadwen Trust’s research budget per annum?
The available budget for research grants varies from year to year, depending on a number of factors including existing commitments. As a guideline, in the period 2004-2007, the total grants awarded each year (mainly for three-year research projects) were as follows:
2004: £456,000 2005: £316,000 2006: £718,000 2007: £513,000
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4. What research approaches does the Dr Hadwen Trust support?
The aim of the Dr Hadwen Trust is not simply to fund non-animal medical research and testing, but to promote the replacement of animal procedures with non-animal methods. So, if a non-animal approach has no potential to replace animal procedures, for example because animal experiments are not conducted in that field of work, it is not eligible for funding by the Dr Hadwen Trust.
We will consider funding research involving human cell lines, ex vivo or primary human tissues and cells, human sub-cellular components in vitro, ethical human volunteer studies, epidemiology, micro-organisms, plant tissues, physico-chemical techniques and computer technology. The Dr Hadwen Trust does not fund research using living animals, ex vivo or primary animal tissues or cells, or animal cell lines.
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5. What peer review process does the Dr Hadwen Trust use for grant applications?
We operate a rigorous review process to ensure that our research is of the highest quality and has strong potential both to replace animal experiments and advance medical understanding. Grant applications fulfilling the Dr Hadwen Trust’s policies are submitted on our standard forms. They undergo independent peer review by external, often international experts. Applications are treated as confidential and we seek the opinions of three expert referees of our own choosing for each application. Feedback from referees may be made available to unsuccessful applicants on an entirely non-attributable basis.
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Replacing animal experiments Faqs
6. What counts as “animal” and “non-animal” in replacing animal experiments?
A fundamental aim of replacing animal experiments is to prevent pain, distress and suffering. Therefore procedures on living sentient animals should be replaced with models that are non-sentient (the exception being ethically approved research with fully informed and consenting human volunteers).
No-one knows for certain where the dividing line falls between sentiency and non-sentiency within the animal kingdom. In practice, some organisations simply follow the definition of “protected animal” in the European Directive 86/609/EEC, although this is under review.
The British Animals (Scientific Procedures) Act 1986, currently covers living vertebrates (excluding humans) plus one invertebrate species, Octopus vulgaris. The Act, therefore, considers that any other invertebrate species may be a replacement model for a vertebrate animal, although there have been discussions at government level about bringing further invertebrate species under the Act.
In the Dr Hadwen Trust’s view it is likely that a number of invertebrate species other than the common octopus may have the capacity to feel pain or distress. Therefore in our work we take a precautionary approach and avoid research using living animals with any potential for sentiency, excepting ethically approved research involving human volunteers.
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7. How can whole-organism level research be done without using animals?
There are many examples where non-animal research methods have been used to study systems-level processes. This can be achieved in a number of ways.
Firstly, in medical research and testing the ‘whole organism’ of interest is the human animal. Increasingly, safe and ethical studies of healthy and patient volunteers can be conducted using techniques such as neuroimaging, iontophoresis, ultrasound, stable isotope methods, microdosing, microdialysis, and genetic and other analyses of tissue samples.
Secondly, the system may be ‘de-constructed’ into its component parts, studied at the molecular, cellular or tissue levels, and then ‘re-constructed’. An example is the prediction of absorption, distribution, metabolism and excretion (ADME) characteristics of a novel drug. Using drug-specific physicochemical and in vitro data, combined with human species-specific standard physiological information, physiologically-based pharmacokinetic computer simulations can replace some animal studies.
Thirdly, a paradigm shift or novel technology may allow a new perspective in answering a question. Parenteral medicines used to be tested for bacterial contamination by measuring a systemic fever response in rabbits. Today, in vitro assays based on the key step – the activation of monocytes – are replacing rabbit tests.
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8. How does the Dr Hadwen Trust’s research differ from the research of mainstream medical charities?
Very few, if any, mainstream medical research charities have a serious, pro-active agenda to prioritise the replacement of animal procedures. No doubt they fund much research which happens not to use animals, but they seldom support research which is specifically aimed at innovating or developing techniques to replace animal experiments. A non-animal research technique does not become a replacement method until it is recognised and used instead of living animals.
In contrast, the Dr Hadwen Trust’s work is highly focused on achieving the replacement of animal experiments and advancing medical progress. Our funding policies, our grant application process, our peer review and all our other strategies reflect that focus. Therefore our grantholders are, from the start, looking for replacement methods and not just happening to use non-animal techniques. In addition to funding research, we also horizon-scan for new methodologies with replacement potential, and we work actively to advance the profile of the issue among a range of stakeholders.
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9. What is ECVAM’s role?
Following the implementation of Directive 86/609/EEC in the European Union, the Commission (and Member States) acted on their legislative duty to encourage the development of research and testing methods that use fewer animals or none at all. As a result, the European Centre for the Validation of Alternative Methods (ECVAM) was created in 1991 as a unit of the Commission. ECVAM is based at the Commission’s Joint Research Centre in Italy, and by 2007 had successfully validated more than 18 full or partial replacement methods, about half of which have already gained regulatory acceptance.
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Legislation and regulation Faqs
10. What legislation covers animal experiments in the UK and Europe?
The Animals (Scientific Procedures) Act 1986 covers experimentation in Britain and Directive 86/609/EEC is the equivalent in the European Union. The latter is currently in the process of being revised and updated.
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11. Does Britain have the strictest laws on animal experiments in the world?
The government and some researchers often claim that Britain has the toughest legislation and tightest restrictions in the world when it comes to protecting laboratory animals. The Dr Hadwen Trust questions this claim for a number of reasons.
The relevant legislation is the Animals (Scientific Procedures) Act 1986. It contains a number of restrictions on animal use, and requires that non-animal methods replace animal procedures where practicable.
However, Germany, the Netherlands and Switzerland all have legislation at least as tough as Britain’s, though they vary in detail. Proposed research on primates has recently been refused permission in Germany on ethical grounds; similar work is licensed in Britain. In 1998, the Dutch government stopped experiments to clone cattle for recombinant protein production in their milk until the company, Pharming, could show that the product would be better than that obtained from a non-animal system; similar experiments were approved in Britain.
It is undoubtedly true that some countries in the world have very little legislation governing animal experiments and consequently very few restrictions. Britain and other EU member states do have comprehensive legislation, although in many cases this is 20 years old and has not kept up with changing views and concerns.
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12. Are animal experiments required by law?
There is no legislation requiring animal experiments for basic medical research, e.g. that conducted in efforts to discover the causes, diagnosis or progression of human illnesses. Animal experiments in fundamental research are not required by law either. However, in the development and safety testing of products such as medicines and chemicals, in Europe, the USA, Japan and elsewhere it is currently required that companies should conduct a range of animal tests.
As new, non-animal methods are developed, testing requirements should be updated and animal tests replaced. This has certainly happened in recent years, although the acceptance by regulatory authorities of scientifically validated non-animal methods has been remarkably slow. Some of the Dr Hadwen Trust’s research was fundamental in developing an ex vivo method, the BCOP assay, to replace the Draize rabbit eye test for severe eye irritants.
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13. As there are legislative requirements for animal tests in drug development, how can the Dr Hadwen Trust replace animal experiments in medical research?
Drug development is only one aspect of medical research and is most often conducted or commissioned by pharmaceutical companies. Most of the research funded by the Dr Hadwen Trust is not in drug development and testing, but is basic medical research focused on understanding human illnesses: their causes, progression, and the underlying features that might allow them to be prevented, diagnosed earlier or treated more effectively.
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14. Does legislation require the replacement of animal experiments?
Every country has different legislation and not all impose a requirement to use valid non-animal methods instead of animal procedures. In the US, although researchers must consider replacement techniques, there is no legal requirement that they must use them. In countries like Japan and China, legislation is very weak or non-existent.
European Directive 86/609/EEC makes it clear that the Commission and the Member States have a duty to encourage the development of alternative techniques, using fewer or no animals. In Britain and other European Union member states, legislation states that scientifically satisfactory methods using fewer animals or none must be used in place of animal experiments. However, the rigour with which this is implemented and monitored varies from country to country and leaves much to be desired.
In Britain, for example, the requirement to demonstrate in project licence applications that consideration has been given to replacement (and reduction and refinement) is surprisingly weak. The institutional Ethical Review Processes (ERPs), involved in the development of project licence applications, often have no members with replacement expertise. Decisions to award project licences are made by Home Office staff, most of whom have no specialist knowledge of the Three Rs, especially replacement.
At present, new licensees under the British Animals (Scientific Procedures) Act undergo a training course as an introduction to important animal experimentation issues. The consideration and implementation of replacement methods is covered only very superficially. Many established researchers doing animal experiments have never attended a training course.
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15. Do governments fund research into the Three Rs?
Some governments fund research into the Three Rs, but others don’t. In Germany, for example, the Centre for Documentation and Evaluation of Alternatives to Animals Experiments (ZEBET) was established by the Federal government in 1989. ZEBET has played, and continues to play, a very active role in researching, validating and implementing non-animal replacement methods. Over a 17-year period from 1980-1997, it’s estimated that the German government invested £41 million in the Three Rs, while over a similar period (1986-2003) the British government spent an estimated £3.8 million.
In 2004, the British government established the National Centre for the Replacement, Refinement and Reduction of Animals in Research (NC3Rs). This is funded by the government and some Research Councils, as well as by industry. In 2005-6, the NC3Rs spent approximately £236,442 on replacement research of which an estimated £193,442 was provided by the Home Office. The Home Office also separately invested about £84,235 in replacement research in 2005-6, but from 2007 onwards no longer independently funds such research. Also in 2005-6, and separately from the NC3Rs, DEFRA spent £825,725 on non-animal research aimed at replacing animal procedures and the MoD an estimated £70,000. These are small sums, given that in the same year the Dr Hadwen Trust alone spent £269,837 on research to replace animal experiments.
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Animal experiment statistics Faqs
16. How many animals are used in experiments?
In Great Britain in 2007, 3,201,581 procedures were conducted on 3,125,826 animals. This is an increase of 6% on the number of procedures conducted in 2006.
All countries in the European Union are required to return information on the number of animals used in experiments, for central collation. In 2005 (the latest year for which statistics are available), 12.1 million animals were used in laboratories in the EU.
Many countries outside the EU do not collect statistics of animals used in experiments, or they collect only partial figures, so it is difficult to estimate the total number of animals used worldwide. For example, in the US, the largest user of animals in scientific procedures in the world, the government only requires laboratories to submit data on certain animals, and the numbers of rats, mice, birds, fish, reptiles and amphibians are not recorded.
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17. Are statistics on animal experiments accurate?
As with any statistics, those for animal experiments are not as clear as they seem. Some though not all countries’ statistics, for example, only include experiments and animals in the year the procedures start. Experiments lasting more than 12 months do not appear in subsequent years’ statistics, even though they continue.
Of particular concern is the failure to record the animals that are bred for research but not needed and are killed, or are bred and killed for their tissues. Their exclusion leads to a considerable under-representation of the number of animals killed for scientific purposes. Several other countries such as the Netherlands, Australia, Germany, France and Sweden do count animals killed for their tissues in their national statistics.
Statistics on unborn animals are also questionable. Currently in Britain, developmental forms are included under the law from halfway through development or when capable of independent feeding. However, they are not recorded in the statistics. This under-estimates, at least by hundreds of thousands, the number of animals used in procedures.