Creating a Code of Practice for stem-cell-based embryo model research

PET and Cambridge Reproduction have jointly published a new Code of Practice for the Generation and Use of Human Stem Cell-Based Embryo Models (the SCBEM Code of Practice), in order to support the development of best practice in research involving stem-cell-based embryo models (SCBEMs).

The Working Group that has drafted the SCBEM Code of Practice is composed of researchers and practitioners at institutions across the UK, including experts in science, law, ethics and regulation. Below, members of this Working Group – beginning with the chair and the principal investigator – offer their reflections on the Code and its significance.

Professor Roger Sturmey (Chair, SCBEM Code of Practice Working Group)
Hull York Medical School/University of Manchester

SCBEMs offer great opportunities for advancing our understanding of early development and studying possible causes of infertility. However, at present SCBEMs are not addressed directly in UK law or regulation.

We are therefore delighted to have published the SCBEM Code of Practice, which will provide much-needed guidance to researchers, while providing wider reassurance that research in this area is being pursued in a responsible manner.

The creation of the Code demonstrates how governance challenges can be addressed quickly and inclusively, in ways that might not be achieved by changing legislation. The Code is robust and yet agile, able to respond quickly to new developments.

Speaking as chair of the SCBEM Code of Practice Working Group, I am confident that the Code will enable the UK to continue to lead the world in research into early human development, while ensuring that this research is ethically robust.

Speaking as a researcher myself, the availability of the Code will give me and my team of collaborators some much-needed clarity as we initiate our own SCBEM research projects. We look forward to adopting these recommendations as we proceed through our work.

Professor Kathy Niakan (Principal Investigator, SCBEM Code of Practice Working Group)
University of Cambridge

The SCBEM Code of Practice provides processes for decision-making in research involving SCBEMs, so that scientists can proceed confidently while maintaining public trust in this vital area of research. SCBEMs have huge potential, and we want to realise this while also limiting the risks. The Code of Practice will allow SCBEMs to be cultured in the laboratory long enough to gain meaningful biological understanding, while asking researchers to justify what they are doing in scientific and ethical terms.

I am incredibly grateful to our UK-wide colleagues who have helped to draft the Code, as well our international colleagues for their valuable feedback. I feel really proud that we have been able to bring together people from so many different disciplines and countries, to collectively deliberate and produce guidance on the use of SCBEMs where previously there was none. It has been a fantastic team effort.

Professor Bobbie Farsides
Brighton and Sussex Medical School

It has been hard work, but also a great privilege, working on the SCBEM Code of Practice. Not only is the science complex, there is also a lot of uncertainty about where it might go.

It was fascinating to work with some of the world's leading scientists to try to ensure that going forward, work on SCBEMs is ethically informed and effectively self-regulated.

Julian Hitchcock
Biolawgy

The SCBEM Code of Practice aims to be more responsive to the pace of scientific development than a set of statutory rules, but is situated within a framework that meets the highest standards of governance. For me, the most significant aspect of the Code is what it doesn't say. In this it differs markedly from, say, the '14-day rule' that applies to human embryo research, applying instead a more responsive and ethically engaged approach.

Whereas embryo research concerns a single type of entity (the human embryo), research involving SCBEMs involves a very wide variety of possible models, many of which the rule-maker cannot predict. Importantly, one such model may invoke quite different ethical considerations to another, judged in each case beside the purpose of the research project. Rules that treat all SCBEM projects on a 'one size fits all' basis would replace ethical appraisal of novel subject matter with an inflexible clerical approach to very different models, the effect of which would be to impede research, with no reasonable basis or benefit.

By contrast, the Oversight Committee proposed in the Code can develop its own rules of assessment, paying due and direct regard to aspects of ethical concern. We anticipate that the Nuffield Council on Bioethics' Rapid Review of ethical issues relating to SCBEMs will prove useful in informing this assessment, and that the Oversight Committee will develop principles to expedite applications, for example by recourse to precedent.

It has been an honour to work with colleagues on the SCBEM Code of Practice Working Group, with Cambridge Reproduction and with PET on the development of the Code. Almost 50 years after the Asilomar Conference on Recombinant DNA agreed rules for the containment of genetically modified organisms, it has been truly inspiring to see how far the scientific community has come in setting out its own rules. Asilomar was a landmark, but it also showed us how to do the job better. I respectfully believe that we have done so.

Professor Kathleen Liddell
University of Cambridge

From a legal standpoint, the SCBEM Code of Practice has a crucial role to play. The current regulatory landscape for SCBEMs is fragmented and incomplete, leaving important issues unaddressed or poorly defined.

In response, the Code establishes guidelines that respect existing regulations governing human stem cells and embryos while recognising the distinct nature of these models, which occupy liminal space in between. This will help to ensure responsible scientific advancement, and will also provide researchers with a much-needed operational framework.

Dr Naomi Moris
Francis Crick Institute

SCBEMs are an incredibly exciting experimental approach, that allow us to study human development at stages that have never before been possible. But as a new and rapidly advancing technology, SCBEMs raise several ethical and regulatory challenges. Our Working Group has come up with the SCBEM Code of Practice, to provide clarity about how embryo models should be used and regulated.

The document has been reviewed by many international researchers, and incorporates public feedback through a public dialogue that was held alongside the project. I am hopeful that the Code will be well-received, and that researchers will make use of the improved clarity around what is expected of them when it comes to such experimental projects.

Professor Jennifer Nichols
University of Edinburgh

The SCBEM Code of Practice is an extremely valuable resource. It will provide a reassuring framework for monitoring and promoting meaningful (and potentially, medically beneficial) research into human embryonic developmental processes.

The Code aims to provide public reassurance that all human stem-cell-based research is conducted following due consideration and diligence, balancing beneficial acquisition of knowledge with sensitivity towards public perception. This is particularly important, in recognition of the past and future donors of the essential material from which stem cell lines are derived.

The Code will also assist in contextualising and monitoring applications for receipt of human stem cell lines, based upon the clearly defined purposes for which stem cell lines are requested.

Dr Peter Rugg-Gunn
Babraham Institute

Research using SCBEMs falls outside existing oversight. This creates uncertainty for scientists, research organisations and the public, and holds back further work in this area. There was an urgent need for clear guidance and review processes, to address this gap.

The SCBEM Code of Practice is a very welcome step forward. It is a relief to have clear guidance in place, allowing us to move forward with our research with renewed stability and confidence. I'm delighted that the Code will bring greater transparency and openness, helping to foster essential communication and understanding between scientists and society.

Establishing this guidance takes SCBEMs out of a grey zone, and onto more stable footing. This will give scientists more confidence to pursue this area of research – which could bring health benefits to society, for example by improving IVF success rates – and will provide reassurance to the public that this research is being conducted carefully, with appropriate scrutiny.

Professor Rosamund Scott
Centre of Medical Law and Ethics, King's College London

The UK is a world leader in the regulation of reproductive technologies and embryo research, so it is fitting that a group within the UK has taken the lead in developing a voluntary Code of Practice for the ethical governance of SCBEMs. As the Code notes, SCBEMs are both different from and similar to embryos in important ways. However, even the more complex forms of existing SCBEMs are much less sophisticated than embryos and, in particular, are not currently thought to have developmental potential equivalent to that of an embryo.

Importantly then, SCBEMs are not considered to be embryos. Nonetheless, if ever a more complex SCBEM were judged (by means of a scientific consensus) to have developmental potential equivalent to that of an embryo, it would then be governed as an embryo, as a matter of ethics and law. Since it is not yet known whether that judgment will ever be formed about a SCBEM, it is important that this research proceeds with caution.

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. They will also be required to be mindful of public sensitivities regarding possible 'parallels' between embryos and SCBEMs, notwithstanding that even the most complex SCBEMs are currently understood to be distinct from embryos. The Oversight Committee will require limits for in vitro culture for each model, and will review with enhanced scrutiny applications relating to more complex models. Since the Committee will also keep a register of all applications, this area of research will be transparent.

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. The SCBEM Code of Practice Working Group has benefited greatly from the public dialogue and public engagement processes that have helped to inform various aspects of the Code, and the Code itself will be reviewed and updated as needed.

Professor Austin Smith
University of Exeter

The ability to mimic the earliest stages of human embryo development using stem cells opens important new ways to study causes of human infertility and miscarriage. The UK is a world leader in this research.

Ethical oversight is essential for public confidence. The SCBEM Code of Practice provides a transparent framework, that will be welcomed by scientists in the field.

PET and Cambridge Reproduction would like to express their gratitude to all the members of the SCBEM Code of Practice Working Group – those who have commented above plus Heather Briggs (Medical Research Council), Professor Andrew Copp (University College London) and Professor Deborah Henderson (Newcastle University).

PET and Cambridge Reproduction are also grateful to Christina Rozeik (SCBEM Code of Practice Project Manager) and Sandy Starr (SCBEM Code of Practice Consultant).