WHY support the 10Rs+ Strategy?
PATIENTS and the PUBLIC:
Patients and research volunteers are those most directly affected by preclinical animal research data whenever they take medications and/or participate in clinical trials. They, together with patient organisations should be concerned that the research they expect to help provide cures and treatments is being conducted in a manner that wastes funding and fails to use the best known scientific methods and practices. The 10Rs+ will help to ensure transparency and accountability of animal research and thereby improve the evidence-base of data that results from it. This in turn will improve the safety and efficacy of medical research. Patients and research volunteers need to see that the 10Rs+ together with our proposed strategy is implemented if medical research is to improve. (See the paper 'Can animal data translate to innovations necessary for a new era of patient-centred and individualised healthcare? Bias in preclinical animal research.') The 10Rs+ will assist policy makers to direct funding to where patients most need it instead of addressing questions that are only of interest to animal researchers or industry. Because of bias and vested interests in research medical science can no longer be trusted to self-correct and action by the public must be taken.
It is unethical and potentially harmful to carry out research on patients and research volunteers using animal data that is known to be based on inadequate methods and prone to publication bias. It is unethical to withhold relevant information and to carry on doing research while not using the best scientific evidence and methods.
This measure can identify where unnecessary spending may be cut and would lend support to the claims made by the UK government that animal research in the UK comes under the tightest controls compared with other countries that carry out animal research.
FUNDERS OF ANIMAL RESEARCH:
The major funders of animal research and others were called upon in 2005 by the Nuffield Council on Bioethics in their report 'The ethics of research involving animals' to fund and carry out systematic reviews of animal research. The report said "We recommend that the Home Office in collaboration with major funders of research such as the Wellcome Trust, the MRC, the Biotechnology and Biological Sciences Research Council (BBSRC), animal protection groups and industry associations such as the Association of the British Pharmaceutical Industry (ABPI) should consider ways of funding and carrying out these reviews. Since then little has been done by these players in this direction and yet much commentary accumulates in the scientific literature about how unreliable animal data are for predicting the human response. The 10Rs+ has since been developed to protect patients and research volunteers from unreliable animal data and therefore funders of animal research should require the 10Rs+ before funding any new animal research.
MEDICAL RESEARCH CHARITIES:
This measure would help the funding arms of the medical research charities by providing them with an evidence-base that is more reliable. It is unethical [in medical research] to conduct more studies while existing studies have not been evaluated using systematic reviews. Failure to refer to systematic reviews of existing evidence from animal studies when allocating funding for clinical research based on animal research can result in harm to human health. This is unethical and medical research charities may be failing in their duty to protect patients and research volunteers while this continues.
RESEARCH ETHICS COMMITTEES:
There is a set of principles in animal research called the 3Rs which are for animal welfare purposes (Reduce, Refine and Replace experiments). However, we have introduced the 10Rs+ to protect patients and research volunteers from unsound animal research. In any event unless the 10Rs+ are implemented researchers will never be able to adequately fulfil the animal 3Rs requirements. This should be considered unethical by Animal Ethics Committees. The 3Rs remain in place for animals and the 10Rs+ are for patients. Since the 1950's laboratory animal research has had the animal 3Rs paradigm in place with the aim of protecting animal welfare. However, patients and trial volunteers have had no such protection from poorly conducted research and unsound preclinical research data. This is unethical for those who participate in research that evaluates medicines (and other interventions) and for those who take the medicines once approved for market consumption. Research Ethics Committees should be aware of this weakness in protecting patients and research volunteers and support the 10Rs+.
Ethics committees (animal and human) will have better quality information with which to make decisions about approval of animal research with the 10Rs+ in operation. In 2005 the Nuffield Council on Bioethics reported: "The question about the scientific validity of animal experimentation for medical purposes is often confused with questions about complex ethical issues. Separation of scientific and ethical questions is essential if greater clarity is to be achieved in the debate about animal research. At present, there is a relatively limited number of useful systematic reviews and meta-reviews that address the question of the scientific validity of animal experiments and tests. In principle, it would therefore be desirable to undertake further systematic reviews and meta-analyses to evaluate more fully the predictability and transferability of animal models." (paragraph 10.39) Animal protection groups and others (see Funders of Animal Research) were called upon by the Nuffield Council on Bioethics in their report to support and fund systematic reviews of animal studies to determine the validity of animal experiments.
It would assist in the cost/benefit strategies required by the medical and biological research councils when they decide which areas of research to fund. Funding is wasted where animal research is poorly conducted and not evaluated through systematic reviews. The scientific evaluation of animal research is fundamental to the cost-benefit assessment of any research.
Good quality systematic reviews of animal studies should be a requirement for researchers to cite when applying for funding. Failure to prepare and refer to systematic reviews of existing evidence from animal studies can and has resulted in harm to human health. It will improve the accountability of animal research and will help to identify biased reporting. It will assist authors in the requirement to adhere to the 3Rs (refine, reduce, replace) principles in the research protocol.
ANIMAL PROTECTION GROUPS:
There are insufficient means in place for evaluating how animal studies translate to human health. Without this safeguard research using animals may be funded without reliable evidence to support it. This is unethical for patients and laboratory animals. The 3Rs animal welfare principles of reduction, refinement and replacement cannot be applied without sound and rigorous scientific evidence. Indeed we would suggest that it has not been possible to fully uphold the 3Rs principles because of poor research methodology and as a result unnecessary animal research has been carried out. In addition without the 10Rs+ measure in place animal researchers may not be able to show that they have adequately searched for non-animal technologies in their research protocol. The 10Rs+ would fully support the 3Rs in practice. Animal protection groups and others (see Funders of Animal Research) were called upon by the Nuffield Council on Bioethics in their report to support and fund systematic reviews of animal studies to determine the validity of animal experiments
For industry the cost of research is always an issue. Shareholders are unhappy with unprofitable investments and venture capitalists tend to avoid early-stage life science research because of its unpredictability. Expensive laboratory animal research that is unproductive could be avoided if industry had access to good quality systematic reviews of animal studies and the 10Rs+ fully implemented.
Investment in the life sciences would carry less risk potential and become more profitable if the 10Rs+ was fully enforced and in operation.