The Academy of Medical Sciences has launched a study to examine the use of animals containing human material in scientific research.
The Academy study brings together experts from a range of research fields including developmental genetics, clinical neuroscience, veterinary medicine, bioethics and law to examine the scientific, social, ethical, safety and regulatory aspects of the creation and use of non-human animals and embryos incorporating human material.
The Chair of the working group undertaking the study, Prof Martin Bobrow CBE FRS FMedSci, said: 'The call for this study originates from within the scientific community itself and is supported by parliamentarians.
'It is important to ensure that this exciting research can progress within limits that scientists, the government and the public support.
'We will not only be focusing on the ethical dimensions of this research but also on how it is perceived by the public.' He added: 'Do these constructs challenge our idea of what it is to be human? It is important that we consider these questions now so that appropriate boundaries are recognised and research is able to fulfil its potential.' The creation and use of animals incorporating human material has a longstanding, successful research history and has made significant contributions in basic and translational science.
There are already thousands of animals containing human cells or DNA, mostly mice with a single gene sequence of human origin, in widespread use throughout laboratories worldwide.
Research involving these animals has enabled groundbreaking advances in our understanding of the causes and treatment of disease.
However, the increasing power and sophistication of methods for introducing human material into animals, including new stem-cell technologies, is likely to present opportunities and significant regulatory and ethical challenges in the future.
Current examples of research involving animals containing human material include; rhesus macaques that carry a human form of the Huntington's gene and allow scientists to investigate the development of the disease, and mice with human-like livers in which the effects of new drugs can be studied.
The hope for the future is that animals containing human material, particularly human stem cells, will provide unprecedented opportunities to develop treatments for conditions such as retinal blindness, diabetes and stroke.
Prof Bobrow continued; 'Several pieces of national and international legislation impact on research on animals containing human material and further consideration of the interface between these regulations is required.
'Our study will be an important step in developing guidance on how different entities along the human/animal spectrum are treated for the purpose of law and regulation in the future.' The Academy's commitment to undertake work on these issues was welcomed in parliamentary debate around the Human Fertilisation and Embryology Act (2008).
The supporting organisations include two of the UK's major medical research funders, the Wellcome Trust and Medical Research Council, and the Department of Health and the Home Office, which oversees scientific research on animals within the UK.
Support from the Department of Business, Innovation and Skills' Sciencewise-ERC programme will enable a significant programme of public dialogue to be included in the study, ensuring that its recommendations are informed by the views of scientists and members of the public.
The study is expected to take 12-18 months to complete.
It will stand as comprehensive text on a burgeoning area of research and will reinforce the UK's lead in developing policy and legislation in challenging areas of medical science that is recognised worldwide.
