Healthcare News

Academy Launches Study On The Use Of Animals Containing Human Material

April 16, 2017

The Academy of Medical Sciences has launched a new study to examine the use of animals containing human material in scientific research. Consideration of this rapidly advancing area of science is needed to ensure that research into our understanding of diseases and their treatment can take place in the UK within a robust ethical and regulatory framework.

The Academy study brings together leading experts from a wide 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, Professor 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. 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 long-standing and 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 world-wide. 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 new 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 which 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.

Professor 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 both 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 world-wide.

Academy of Medical Sciences

The independent Academy of Medical Sciences promotes advances in medical science and campaigns to ensure these are translated into benefits for patients. The Academy's Fellows are the United Kingdom's leading medical scientists and scholars from hospitals, academia, industry and the public service.

Academy of Medical Sciences, 10 Carlton House Terrace, London SW1Y 5AH.

Animals containing human material project details

The Academy's project will include an expert working study, chaired by Professor Martin Bobrow FRS FMedSci. To ensure that the study's findings are also informed by the views of the wider public, a programme of public dialogue will be included.

The scope of the study is to: examine the scientific, social, ethical, safety and regulatory aspects of research involving non-human embryos and animals containing human material.

More specifically, the project will seek to:

- Agree definitions for animals, and animal embryos, containing human genetic or cellular material.

- Describe the current use of animals containing human material in medical research, and to anticipate future research directions and challenges for this work.

- Assess future applications of research involving animals containing human material - including potential requirements for preclinical (animal) studies of candidate human stem cell therapies.

- Address safety concerns surrounding the generation and use of animals containing human material in research, and to consider welfare issues which apply specifically to animals containing human material.

- Explore societal and ethical aspects of medical research involving the creation of animals that include significant amounts of human material, and to develop a constructive public dialogue in this area.

- Explore the current and future regulation of the use of animals and embryos containing human material for research purposes, including primary legislation, regulations and guidelines.

- Draw conclusions and make recommendations for action.

To focus the study, and to avoid replication of previous work and debates, the following areas will not be considered in depth:

- Scientific or ethical issues relating to the general use of animals in research.

- The use of human admixed embryos in research (and other issues addressed in the debates of the Human Fertilisation and Embryology Act (2008)).

- Broader issues relating to the genetic modification of animals or plants (e.g. the genetic modification of plants or animals for agricultural purposes).

Financial support for this study has been given by the Department of Health, Sciencewise- ERC, the Medical Research Council and Wellcome Trust.

Academy of Medical Sciences