First UK Code of Practice for stem cell-based embryo models in research

Experts from across the UK, representing world-leading expertise in sciences, law, ethics and regulation, have developed the country's first ever guidelines for the creation and use of stem cell-based embryo models in research. One of the experts in ethics, law and regulation was Professor Rosamund Scott, Director of the Centre of Medical Law and Ethics at King's College London. The work was led by the University of Cambridge, in partnership with the Progress Educational Trust.

Stem cell-based embryo models (SCBEMs) are three-dimensional biological structures that mimic aspects of early human embryo development. They can be created in the lab from stem cells, and can provide new insights into critical stages of early human development that are normally inaccessible to researchers.

Embryo model work is expected to lead to new interventions for a range of conditions, including revolutionising treatments for recurrent miscarriage, understanding developmental disorders and improving the success rate of IVF.

Although embryo models are not the same as human embryos, they mimic aspects of early human development, and this has raised ethical concerns.

The previous lack of a regulatory framework for the use of SCBEMs in research has left scientists and research organisations uncertain about the acceptable boundaries of their work, both legally and ethically, and unsupported in their decision-making. Signing up to the SCBEM Code of Practice will remove these obstacles.

The guidelines, released today, provide the first code of practice for the use of stem cell-based embryo models in the UK.

"The new Code of Practice provides processes for decision-making in research using stem cell-based embryo models so that scientists can proceed confidently, while maintaining public trust in this vital area of research," said Kathy Niakan, Chair of Cambridge Reproduction and Professor of Reproductive Physiology at the University of Cambridge, and member of the SCBEM Code of Practice Working Group.

"The Code aims to ensure not only that research can proceed in ways that are likely to advance important scientific and medical knowledge, but also that the public has confidence that this research is being carefully monitored by a process of oversight that scientists themselves welcome," said Rosamund Scott, Professor of Medical Law and Ethics, Director of the Centre of Medical Law and Ethics, King's College London, and member of the SCBEM Code of Practice Working Group.

"By means of an Oversight Committee, researchers will be required to justify their research, to attend to various ethical considerations and to abide by important prohibitions."

Stem cell-based embryo models open new research avenues that can complement, but not replace, the limited studies possible with actual human embryos. The SCBEM Code of Practice states that neither of these areas of research can or should replace the other for the foreseeable future.

The Code is not legislative, but the teamproposes that it should be adopted by UK researchers, funders, research organisations, professional societies and publishers.

Widespread use is expected to set a new precedent for reporting research using stem cell-based embryo models and deter the funding and publication of research that fails to meet the standards set out in the Code. As a result, adherence to the Code will become an essential part of credible science, providing increased transparency and accountability for embryo model research.

Given the rapid pace of research using embryo models, the Code will be reviewed regularly.

The new SCBEM Code of Practice, entitled Code of Practice for the Generation and Use of Human Stem Cell-Based Embryo Models, can be viewed online.

The SCBEM Code of Practice Working Group consists of:

• Professor Roger Sturmey (Hull York Medical School and University of Manchester, UK) (Chair)
• Professor Kathy Niakan (University of Cambridge, UK) (Principal Investigator)
• Heather Briggs (Regulatory Support Centre, Medical Research Council - UKRI, UK)
• Professor Andrew Copp (University College London, UK)
• Professor Bobbie Farsides (Brighton and Sussex Medical School, UK)
• Professor Deborah Henderson (Newcastle University, UK)
• Julian Hitchcock (Biolawgy, UK)
• Professor Kathleen Liddell (University of Cambridge, UK)
• Dr Naomi Moris (Francis Crick Institute, UK)
• Professor Jennifer Nichols (University of Edinburgh, UK)
• Dr Peter Rugg-Gunn (Babraham Institute, UK)
• Professor Rosamund Scott (Centre of Medical Law and Ethics, King's College London, UK)
• Professor Austin Smith (University of Exeter, UK)

The Centre of Medical Law and Ethics, the first centre of its kind in the UK and one of the first internationally, conducts world-leading research and teaching in bioethics and medical law. One of its key strengths is Professor Rosamund Scott's expertise in ethics, law and regulation concerning assisted reproduction, embryo research and new reproductive technologies.

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