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In March 2023, Cambridge Reproduction launched an ambitious project to develop the first governance for research using stem cell-based embryo models (SCBEMs) in the UK. The Governance of Stem Cell-Based Embryo Models (G-SCBEM) project brings together scientists, legal scholars and bioethics experts, as well as representatives from major funders and regulators. The resulting Code of Practice will promote responsible, transparent and accountable research using SCBEMs which can be widely adopted by scientists, funders and regulators.
Christina Rozeik (Programme Manager at Cambridge Reproduction) discusses how CSaP’s Policy Workshops brought together relevant stakeholders to help G-SCBEM project leads collect feedback on the draft government framework and provided an opportunity to discuss how the framework will work in practice.
"A year after the first CSaP Policy Workshop in September 2022 our project had advanced considerably, and we had a much clearer idea of outstanding questions and absent voices from the project. As such, we worked with CSaP to convene a follow-up event in October 2023 that not only included members of our working group but, crucially, key individuals from all the major regulators with an interest in this research area."
Models created from stem cells mimic some aspects of the early human embryo and are really useful for researchers studying some of the processes that happen in early embryo development. These models also have potential for drug development and toxicology studies – research that cannot happen with pregnant subjects. The development of these models is therefore really exciting and complements research on human embryos. These are models of particular developmental stages or structures found in human embryos, not exact replicas, and there is no evidence that current models have full developmental potential.
This project is especially important as, while research using human embryos in the UK is tightly regulated, there is currently no dedicated regulatory framework for embryo models. They sit in a grey area: they are more than simple tissues or cells, but they are not actually embryos. There is a lot of uncertainty around the regulation of these models. Who should be responsible for regulation and where do these embryo models fall in the current regulatory framework? This issue came to a head in 2023, where we saw significant research advances, many of them in Cambridge. As a result, reports in the media expressed alarm about where this research could go.
Embryo models and the UK regulatory landscape
In July 2022 Cambridge Reproduction held a two-day academic conference about stem cell-based models of reproductive organs and embryos. This event included a session on legislation, regulation, and ethics bringing the aforementioned areas of uncertainty to the fore—particularly on issues around regulation. Following from this, Cambridge Reproduction worked with CSaP to facilitate a Policy Workshop focussing on regulatory questions. The idea of producing a code of practice for researchers came out of this discussion as a fruitful way forward. Rather than trying to change the law—which is a difficult and protracted process—we aimed to produce a more flexible alternative to cope with fast paced developments in this field.
We were particularly interested in clarifying where embryo models sat within the UK regulatory landscape. It was important to bring regulators into the discussion and to draw on the CSaP network to involve a diverse group of participants, including key voices from regulatory bodies. The workshop helped us build links with key individuals, catalysing an exploratory endeavour into a firm outcome.
A voluntary code of practice
This idea of a voluntary code of practice was the key outcome of the first Policy Workshop and we decided to take on this (ambitious) task for ourselves. There are good reasons why Cambridge Reproduction was well placed to lead on the work. Not only is much of the research happening at Cambridge itself, but we are an interdisciplinary institute bringing together biological scientists, and clinicians as well as colleagues in the arts, humanities and social sciences providing a multidisciplinary perspective. The Policy Workshop which precipitated these developments facilitated important contacts with funders who went on to be involved in the project.
We assembled a working group made up of those who would actually be drafting the code of practice. These were experts from Cambridge and beyond as well as representation from key funding bodies. We sought feedback on the first draft of the code of practice from a wide range of stakeholders, including scientists, legal experts, bioethicists, funders, regulators and policy makers. We hope that this consultation will mean that the final code of practice has taken into account a wide range of opinions, and is useful to the people at whom it is aimed.
Bringing in the regulatory and funder perspectives
A year after the first Policy Workshop in September 2022 our project had advanced considerably, and we had a much clearer idea of outstanding questions and absent voices from the project. As such, we worked with CSaP to convene a follow-up event in October 2023 that not only included members of our working group but, crucially, key individuals from all the major regulators with an interest in this research area.
"The CSaP team were able to reach into their network to connect us with relevant, and sometimes previously unknown stakeholders who went on to have a big impact on our thinking."
While we were primarily focussed on the UK regulatory context, participants at the workshop added an important international dimension to the discussion. Our work is ground-breaking in this area and could help inform different international contexts or even be adopted by different countries. While voices representative of funders and regulators were present in the first workshop, which was more exploratory in nature, this second workshop really helped home in on these constituencies. Alongside this, we were able to bring in experts on science ethics with an aim of unpacking issues around maintaining public trust and confidence, as well as legal scholars and practitioners who could help to untangle some of the complex legal and regulatory issues involved.
Encouraging adoption of the governance framework
Publishing the Code of Practice is just the first step, and we are aware that the next stage will be working to see it used as widely as possible. We hope that funders and regulators will support and endorse the code of practice where they feel comfortable in doing so. The document will set out why we are doing this, who the anticipated users are, why we believe it is useful, and how it may be used.
We are also clear about the scope of the code of practice, for instance, it focusses explicitly on human embryo models and not animal embryos models or human embryos, and it lays out how these models are distinct from human embryos. The document outlines basic principles alongside recommendations relating to particular areas (for instance, standards for experiments such as the use of materials). It is designed to tie in with other guidance published in this area – for example, we use terminology that is compatible with that proposed by the International Society for Stem Cell Research’s influential set of guidelines for stem cell and embryo research published in 2021. It is where we believe it would be helpful to have guidance specifically about embryo models that we are trying to fill the gaps.
Some of the challenges faced along the way
It is easy to underestimate how much work it takes to get a project like this off the ground. Initially we had six months funding, however, new opportunities quickly emerged and we had some mission creep. Soon after we started, the Human Fertilisation and Embryology Authority (HFEA) announced a consultation about modernising the Human Fertility and Embryology Act.
We made a submission on behalf of the project about how we would like to see the law updated to take into account new developments in embryo model research. This was obviously not planned, but it was a fantastic opportunity to have real impact on policy and the HFEA later cited our project as an example of work already well developed in this field.
Our team is very multidisciplinary and it has taken some time for us to learn to speak each other’s language and to understand the different viewpoints at play, particularly in some cases where there are very technical interpretations of the law or complex scientific points interacting.
This is a particularly sensitive area of research and it is vitally important to maintain public trust. We were acutely aware of how important it was not to break public trust and to be transparent about the research and to avoid the sense that any voluntary code of practice is designed to help scientists avoid proper regulation. This is all compounded by the fact this this is a very new area of research and there has been very little work done that looks at public attitudes to this research. To mitigate these issues, we successfully applied for some follow-up funding from the BBSRC Impact Acceleration Account, supplemented by matched funding from UKRI Sciencewise, which has facilitated the development of a public dialogue on embryo models, the first piece of public opinion research in this area in the UK (and, we think, internationally!). The findings from this dialogue will inform the final code of practice, resulting in more robust policy.
Engaging with CSaP and their network
I would recommend that researchers be very clear about what it is they hope to achieve. In our case, the first workshop we held was (deliberately) an exploratory exercise, but in the second it was a lot more focussed with a clear set of questions.
It is also important to think about how you are going to capture the outcomes of the discussion and make the best use of CSaP’s ability to identify and engage people that you want to talk to. In some cases, we already had contacts at particular regulatory bodies and knew who we wanted in the room. In other cases, CSaP were able to reach into their network to connect us with relevant, and sometimes previously unknown, stakeholders who went on to have a big impact on our thinking.
On a wider scale, my experience of managing this project has encouraged me to think about other ways to promote policy impacts from research. We are now looking at how we can use the experience gained from this project to develop other policy impact projects based around the interests of researchers in the Cambridge Reproduction network.
Cambridge Reproduction published the 'SCBEM Code of Practice' in July 2024. The Code supports the development of best practice for the generation and use of hyman stem cell-based embryo models.
Policy Workshops bring the expertise of interdisciplinary groups of researchers to bear on relevant policy issues. Workshops are a tried and tested formula for bringing policy makers from across relevant government organisations together with researchers and others from industry, learned societies and civil society, allowing highly effective knowledge exchange and network building. If you are interested in comissioning a Policy Workshop or if you would like further information please get in touch at policyworkshops@csap.cam.ac.uk.
Image from Wikimedia Commons
