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July

New report on the use of animals containing human material published today

A new report published today by the Academy of Medical Sciences examines the use of animals containing human material (ACHM) in biomedical research and calls for a national expert body to be set up to advise on this complex and sensitive area of research. The report explores in great detail the scientific, social, ethical, safety and regulatory aspects of ACHM research.

Professor Christopher Shaw at the Institute of Psychiatry at King's, and a member of the Academy working group that produced the report, says: 'In the UK, we have some of the strictest regulation in the world when it comes to using animals in research. The complexity and sensitivity of this area of research means that there needs to be an ongoing discussion between scientists, regulators and the public as issues emerge. That's why we have recommended that the Home Office establish a national body of experts who can take all of these issues into consideration and advise on the regulation of ACHM research.'

ACHM are widely used to model human diseases that cannot be studied in cells grown in the laboratory, and where experiments using humans would not be feasible. 'By adding human genes or cells to an animal we can study the disease processes in much greater detail and test the effectiveness of therapies for the human disease.  In my research we use mouse models to study the harmful effects of the genes that cause motor neuron disease, a fatal neurological disease.'

The report considered evidence from experts in academia, government, industry, animal welfare groups and professional bodies. Additionally, the Academy commissioned a public dialogue on the use of ACHM, so that the report's discussion and recommendations would reflect current public concern and opinion. The findings showed a high degree of public acceptance of ACHM research provided it is well regulated and conducted to improve human health or to combat disease. The public consultation also identified three areas of particular sensitivity: ACHM research involving the brain, reproductive tissues and aspects of human appearance.

Whilst the report concludes that the majority of ACHM experiments present no new issues and should continue to be regulated as they are now, it finds that a limited number of types of ACHM research should only be permitted subject to scrutiny by a national expert body. The report also identifies a small number of ACHM experiments that should not be undertaken because of they are unethical concerns and lack of scientific justification.

As scientific understanding and social attitudes evolve, the categories will change over time, requiring a suitable regulatory framework capable of staying ahead of and overseeing ACHM research. However, the current UK regulatory system relating to this area of research is complex and not suitable for the rapid pace of ACHM research. It involves several Government agencies, including the Home Office and the Department for Health, as well as numerous regulatory bodies such as the Human Fertilisation and Embryology Authority (HFEA) and the Human Tissue Bank (HTA).

In order to ensure consistency of practice and the best use of specialist expertise, the report recommends that the Home Office put in place a single, national expert body to advise on sensitive types of ACHM research. The body would be taking into account social, ethical and scientific considerations of ACHM research. 

The study was funded by the Department of Health, the Department for Business, Innovation and Skills' Sciencewise-ERC programme, the Medical Research Council and the Wellcome Trust, with support from the Home Office. 

For full report: http://www.acmedsci.ac.uk/p47prid77.html

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