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New agency needed for animal studies involving human tissue

Technological advances pushing ethical boundaries, say researchers

Caroline White

Friday, 22 July 2011

A new expert body is needed to oversee animal research involving human tissue, so that it can go ahead with full public backing, says an influential group of academics.

Technological advances have opened up opportunities to transplant human cells into animals to explore the impact of treatments and disease processes that more closely mimic those in people, where these cannot be accurately deduced from cell cultures or through computer simulation and where experiments using humans are unfeasible or considered unethical, says the Academy of Medical Sciences in a report published today.

But some of these possibilities involve functions that are perceived as uniquely human, such as the workings of the brain or the reproductive system, so additional oversight is needed “to enable innovative science to flourish within clearly defined ethical boundaries,” it says.

While most of this research does not raise new ethical or regulatory concerns, the fast moving pace of this science means that it might very well do so in the future, says the report. The UK has one of the strictest systems of animal research regulation, but scientists and the public agree that this must stay ahead of emerging research practices.

Professor Martin Bobrow, who chaired the Academy working group that produced the report said: “This is a complex research area and there should be ongoing dialogue between scientists, regulators and the wider public to address emerging issues.

Our report recommends that the Home Office puts in place a national expert body, within the existing stringent system of animal research regulation, to provide specific advice on sensitive types of [this type of] research.”

The working group considered evidence from experts in academia, government, industry, animal welfare groups and professional bodies. An Ipsos MORI public opinion survey, specially commissioned for the report, revealed that most respondents backed this type of research if used to improve human health or fight disease.

Current examples of the practice include mice implanted with human tumour cells to study the development and spread of cancer and to test new treatments; and the introduction of human stem cells into rats to study the human brain’s potential for repairing the damage caused by stroke.

But both the public and scientists expressed concerns about research involving modification of the animal brain that could potentially develop human “cerebral” capacity; the fertilisation of human eggs or sperm in an animal; and the creation of characteristics perceived as uniquely human, such as facial shape, skin texture, or speech.
The report recommends classifying this type of research into three categories to determine the level of regulatory scrutiny required.

The general use of animals in research should proceed under current regulation, it says; a limited number of experiments should be permissible, subject to scrutiny by the expert body; and a very limited range should not be undertaken, at least until the potential consequences are more fully understood. This system should be regularly reviewed, says the report.

“We are not aware of research of the third type taking place in the UK today,” said Professor Bobrow. “We have started the conversation now so that future decisions can be made with the support of both scientists and the public,” he added.

Professor Sir John Bell, President of the Academy of Medical Sciences, commented: ‘This is an area of research with real potential to deliver scientific advances and bring new treatments to the clinic.”

Current changes in EU regulations on the use of animals in research provided an important opportunity for the Home Office to act on the Academy’s recommendations, and put in place a national expert body to advise on the issue, he suggested.

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