What’s in the Academy of Medical Sciences’ report on animals containing human material?

Posted on July 25, 2011 by

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By Laura Boothman and Catherine Luckin, policy officers at the Academy of Medical Sciences

As the UK government considers how it will transpose the EU Animals Directive, the Academy of Medical Sciences has published a report considering the use of animals containing human material (ACHM) in biomedical research, which recommends that a national expert body should oversee certain research of this type in the future.

What are ‘animals containing human material’, and why the interest?

Animals containing human cells or genetic information are used to refine pre-clinical research methods, creating animal models that more accurately represent the human body in health and disease. They can also be used to develop and produce new therapeutics. Such models have been used in research for years without major ethical or regulatory difficulties. But as scientists develop these techniques, there is potential for new models to approach the boundaries of what is acceptable.

What happened last week?

The Academy has just completed a working group study that considered the scientific, social, ethical, safety and regulatory aspects of research involving animals containing human material. The study was carried out by a group of 16 experts drawn from fields of social science, biomedical science, philosophy, theology and law. It was chaired by one the Academy’s Fellows, Professor Martin Bobrow CBE FRS FMedSci.

The study began in late 2009. A wide range of evidence was then gathered to inform the work. This included an open call for evidence; oral evidence sessions with scientists, representatives of animal welfare bodies and regulators; material drawn from the scientific literature; and a commissioned programme of public dialogue.

On Friday, the Academy of Medical Sciences published the working group’s report, a report synopsis prepared by Dr Geoff Watts FMedSci, and the report of the public dialogue programme.

What does the report say?

The report concludes that the majority of research involving animals containing human material does not pose ethical or regulatory difficulties. But it identifies three areas that will need careful oversight in future:

  • Modifying an animal’s brain, in a way which might lead it to develop some aspect of ‘human-like cognition’.
  • Changing an animal so it has human appearance or characteristics (e.g. skin, facial or limb features, speech).
  • Developing human-derived sperm or eggs in an animal (especially if fertilisation may occur).

The recommendations include that:

  • The Home Office ensures that a national expert body with a duty to advise on the use of animals containing human material in research is put in place.
  • The Home Office and the Department of Health work closely together, with other bodies where appropriate, to ensure that there are no regulatory gaps, overlaps or inconsistencies in regulation of research of this kind.
  • The UK should lead in raising international awareness of animals containing human material, promoting international consistency in research practice involving their use, and exploring the development of international standards or guidance.

These recommendations should ensure that valuable and justifiable research involving animals containing human material can proceed within a robust, proportionate regulatory system. And that this system can respond to developing scientific knowledge and social attitudes, while avoiding undue bureaucracy and duplication of regulation.

How has the report been received?

The government has welcomed the Academy’s report and has committed to considering the recommendations carefully.

David Willetts, universities and science minister, said,

‘This government is committed to ensuring the UK remains a great place to do science. Getting the regulation around research right, in a way that commands public confidence, is part of that mission.

‘This report makes a valuable contribution to that agenda by combining expert advice with the insight gained from public dialogue on the issue. It is vital that we continue to listen to the public’s hopes and concerns whenever we consider developments in cutting-edge science.’

There was widespread coverage of the report in broadcast and print media and also on-line, including:

Regulations proposed for animal–human chimaeras, Nature (22.07.11)

The legacy of Doctor Moreau, Nature editorial (22.07.11)

Ethical rules needed to curb ‘Frankenstein-like experiments’ on animals, the Telegraph (22.07.11)

Medical research warning over human cells in animals, the Guardian (22.07.11)

What’s human? What’s animal? And what of the biology in between? Comment is free, the Guardian (25.07.11)

The study was supported by the Department for Business, Innovation and Skills’ Sciencewise Expert Resource Centre, the Department of Health, Medical Research Council, and Wellcome Trust.

Posted in: Policy