SCBEM is an umbrella term for a range of structures created from stem cells which resemble or replicate aspects of an embryo. As a research tool, SCBEMs have the potential to bring public benefit through new insights around early human development and may in future have important applications that help improve IVF and pregnancy care. However, there is debate about their status – for example in relation to human embryos – and how they should be used.
The working group – of which, NDWRH Honorary Research Lecturer, Dr Andy Greenfield is a member - recommends that a phased approach – ‘soft’ governance in the short term, and ‘hard’ law in the medium term – is needed to strike the right balance of encouraging innovation whilst ensuring that research respects ethical boundaries and delivers public benefits.
The NCOB’s review identifies the points of greatest ethical concern in relation to the potential use of SCBEMs and sets out what policy makers and those who have an influence on this field of research could do now to help address them.
These ‘red lines’ include:
- any attempt to develop SCBEMs for reproductive use or to transfer SCBEMs to the reproductive tract of a living person or non-human animal
- and any potential for SCBEMs to be developed that have the capacity to feel pain or awareness.
The NCOB welcomes the UK SCBEM Code of Practice as a proportionate step to guide researchers at the present time. But it says that in order to reinforce the ethical red lines the NCOB have described, it needs to be strengthened through inclusion of an interim upper threshold for how far SCBEMs are allowed to develop in culture.
Whilst learnings from scientific development and wider public dialogue are needed in order to determine what a long-term upper threshold would look like, the interim threshold should be tested and reviewed on an ongoing basis, the NCOB says. It adds that the threshold should be used by the proposed SCBEM oversight committee when setting a case-by-case limit for research proposals, to ensure that models are cultured to the minimum stage required to achieve the specific research objectives.
However, relying solely on soft governance will not address all the risks posed by advancements in research, says the NCOB. The possibility of SCBEMs becoming increasingly able to replicate human embryo development could trigger a reactive response such as a decision to regulate them in the same way as embryos, which would be a poor fit, overly burdensome and ought to be avoided, the NCOB concludes.
The NCOB recommends revising the Human Fertilisation and Embryology Act 1990 to explicitly exclude SCBEMs from being categorized as embryos. They also propose including legal provisions in the Act to support a flexible and adaptive regulatory framework for SCBEMs, described as a 'regulatory sandbox', which would allow for oversight that evolves alongside scientific progress.
Moreover, the NCOB calls for a statutory ban on the implantation of SCBEMs into the reproductive systems of humans or other animals, arguing that enforcing legal penalties on the development of SCBEMs for reproductive aims would help uphold this ethical red-line, especially if research advances to a point where implantation becomes possible.
“We welcome the UK Code of Practice as a proportionate response to governing stem cell-based embryo model (SCBEM) research at the present time and we call on funders, researchers and regulators to support its implementation and oversight. However, our working group is clear that as SCBEM research advances and the models become increasingly sophisticated in mimicking aspects of embryonic development, additional measures are required.
We are calling for legislative action to help give the public confidence that ethical red lines will not be crossed, and to provide reassurance to the research community on the legal status of SCBEMs, so that ethical research that has potential to benefit the public is supported.”
Danielle Hamm, Director of the Nuffield Council on Bioethics, says:
“There is considerable public stake in research using SCBEMs. We know that applications which are perceived to push ethical boundaries could impact negatively on the overall acceptability of this field of research. Alongside our proposals to strengthen the regulation of SCBEMs incrementally, we strongly encourage wider debate around the benefits, risks and costs and public interest in this research as the science advances. Whilst we have focused primarily on the UK context in our review, we acknowledge the global nature of SCBEM research and hope our conclusions will be of value to the international scientific community and policy makers in other countries.”