THE 10Rs+ Strategy

 

To support our mission of better science for better healthcare we offer ten recommendations and a strategy.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Background

 

Animals are used in medical research to observe disease mechanisms in what is termed 'basic research' and in preclinical trials mainly to test pharmaceutical drug treatments. They are used as ‘models’ with the purpose of learning about the progression of disease and to predict the safety and efficacy of drugs and surgical interventions intended to benefit human health.

 

This type of research forms a large part of biomedical research and, while it is mainly used for drug development and testing, many other fields of medicine and biology also use it. It attracts proportionately more funding than clinical research (research focusing on humans).

 

Whether or not the public agree that it is ethical that animals are used in this way, clinical researchers (investigators) continue to use animal data (information from animal experiments) to design drug trials involving patients and research volunteers. In this case the investigators evaluation of the animal studies for their relevance to human medicine is critical. It is our concern that not only do investigators fail to use all the scientific research assessment tools available but that their work is insufficently regulated to achieve high enough standards of conduct.

 

Added to this there is a disturbing lack of scientific rigor in the way animal research is funded and carried out. This impacts clinical research which in turn can result in harm to patients and research volunteers and waste resources. There is also the finding that much animal research does not translate to human health.

 

The debate

 

There is a long history of debate about animal research and with it comes a persistent lack of objectivity in discussion about the scientific issues. This has led to polarised and entrenched positions. While one side is controlled by animal research advocacy groups and the pharmaceutical industry making generalised, promotional and unsupported claims about its value, the opposing side has been occupied by anti-vivisectionists with a poor or incomplete understanding of science. One member of UK Parliament recently summed up the situation "People often think that the debate is just scientists against people who care about cuddly animals and have an emotional response, rather than people who are interested in the most effective scientific methods."

 

The pivotal position of the charity evolved out of this scenario with the aim of adding quality and insight to the debate and to call for improvements and revisions in policy.

 

The 10Rs+

RESPOND - REPLICATE - REGISTER - REPORT - RECORD - REVIEW - REGULATE - REAPPRAISE - RATIONALISE - REINVENT - REPRESENT Download file (below) for more detail:

 

Strategy

1. Systematic review: a moratorium on animal trials (in line with calls for a moratorium on efficacy clinical trials) while a large-scale global programme of systematic reviews of existing animal studies is carried out, including systematic reviews of the value of animal research for the seven leading causes of death (Western world).

 

2. Scientific evaluation: a) evaluation of the validation methods of animal models and in relation to the higher standards set for the validation methods of non-animal models and technologies. b) a large-scale research programme to evaluate the predictive value of existing animal studies (as set out by van Meer and colleagues).

 

3. Inquiry: a full scale inquiry into why unreliable animal data are accepted by regulatory authorities while at the same time non-animal models and technologies with predictive value are less likely to be adopted.

 

4. Audit: a full and independent public health audit of spending on animal research

 

5. Apply the 10Rs+ Recommendations to animal research.

 

 

 

 

 

 

 

 

BMC logo 10Rs+ TABLE aba0006h BMC Medical Ethics - 'Bias in preclinical animal research' - Debate paper Systematic Reviews logo