Stem-cell-based embryo models (SCBEMs) are, as the term suggests, similar to embryos in some respects but different from embryos in other respects. This is what makes SCBEMs so fascinating and useful in research, but this is also what makes them challenging to think about. Adding to the challenge is the existence of a large (and growing) variety of SCBEMs, which can differ considerably in their nature and extent of similarity to human embryos.
Perhaps unsurprisingly, the question of how best to categorise different SCBEMs and assess their most significant attributes is not fully settled. Arriving at a satisfactory answer to this question involves an interplay between scientific, ethical, regulatory and other considerations that is as subtle, in its way, as the interplay between biological phenomena that enables scientists to create SCBEMs in the first place.
All of this has led to some uncertainty regarding what rules should apply to research involving SCBEMs, and whether established rules are sufficient or whether new rules are called for. It became increasingly apparent to both of us, and to the organisations where we work respectively, the Progress Educational Trust (PET, the charity that publishes BioNews) and Cambridge Reproduction (an interdisciplinary initiative that brings together researchers across Cambridge) that there is a need for clearer guidance on the way SCBEMs can, and should, be used in UK research.
This need became particularly apparent at two workshops organised by Cambridge Reproduction in 2022, at which key figures from a wide variety of disciplines suggested that there should be some form of dedicated governance for SCBEM-related research in the UK. A major concern expressed at those workshops was that failure to establish dedicated governance would jeopardise research on (at least) two fronts it threatened to undermine public trust in research, and it was already undermining the confidence of researchers themselves, who wanted to know the boundaries within which they could pursue their work.
In order to address this pressing need for governance, PET and Cambridge Reproduction collaborated in 2023 to launch a project called Governance of Stem Cell-Based Embryo Models (G-SCBEM). For the past year, this project has been developing a Code of Practice for UK research involving SCBEMs (see BioNews 1194).
Work on the Code of Practice is drawing upon the insights of experts and practitioners from various areas of science, law and ethics, both within the UK and overseas. This sort of input is necessary, if the G-SCBEM Code of Practice is to be robust and credible, but it is not sufficient. A vital element that has to be included is the contribution of the general public.
The G-SCBEM Code of Practice will set out things that researchers ought to do and ought not to do so as to meet ethical standards, demonstrate responsibility and transparency, and take account of public hopes, concerns and sensitivities. If these stipulations are to be meaningful, then the Code of Practice must be informed by an accurate sense of how people understand the relevant ethical considerations, what people think is adequate in relation to demonstrating transparency, and what people's hopes, concerns and sensitivities actually are.
For all of these reasons and more, we were delighted to collaborate with social research agency Hopkins Van Mil and other colleagues (with support from Sciencewise and from the Biotechnology and Biological Sciences Research Council) on a recent public dialogue about SCBEMs. The content and findings of this public dialogue are presented in a new report.
Although the dialogue concerned SCBEMs, all of its public participants had previously participated in a 2023 public dialogue about human embryo research, which was conducted as part of the Human Developmental Biology Initiative (see BioNews 1213). This meant that participants had already had occasion to reflect in depth on the science and ethics of research involving human embryos. This left them well-placed to consider whether, and in what respects, research involving SCBEMs should be regarded differently.
Of course, public views are liable to evolve and the science is developing rapidly, so the G-SCBEM Code of Practice will be revised periodically to take account of the latest developments. But we are keen that the views of the wider public, as well as the views of the other stakeholders in our orbit, should inform the Code of Practice at the very outset. It is thanks to the public dialogue that we will be able to ensure that this is the case.
A growing number of projects, besides ours, are exploring ethical and policy dimensions of SCBEMs. In the UK, there has been a recent briefing on the subject by the Parliamentary Office of Science and Technology, and there is also a project underway from the Nuffield Council on Bioethics. Elsewhere, public perceptions of SCBEMs have recently been explored in the Netherlands, while the International Society for Stem Cell Research is building on its important earlier guidance in this area. We hope that the publication of this public dialogue report, and the imminent publication of the G-SCBEM Code of Practice, will help to establish a clearer context for all of these discussions.
Finally, we wish to conclude by expressing our heartfelt gratitude to the participants in the SCBEM public dialogue. As you will read in the public dialogue report, these participants were asked to consider some of the most cutting-edge achievements and conundrums in present-day research and policy, thinking through and weighing up both the related opportunities and the related risks. This was no easy task, but the insights that they offered in response were and are invaluable.
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Stem cell-based embryo models: addressing the governance gap PET - BioNews