Our Professor of Healthcare Law, Emma Cave, has chaired a working group looking into how research involving human stem cell-based embryo models (SCBEMs) should be regulated.
SCBEM is an umbrella term for a range of structures created from stem cells which resemble or replicate aspects of an embryo.
The review, led by the Nuffield Council on Bioethics (NCOB), sets out proposals for the governance of research using SCBEMs.
These include legislation to distinguish them from embryos and to provide reassurance that ethical ‘red lines’ are not crossed.
As a research tool, SCBEMs have the potential to bring public benefit through new insights around early human development.
They may also have important applications in the future 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 ethical and governance review co-authored by Professor Cave concludes that a phased approach is needed – ‘soft’ governance implementing the UK SCBEM Code of Practice, as a stepping stone to ‘hard’ law regulation in the medium term.
This would strike the right balance of encouraging innovation whilst ensuring that research respects ethical boundaries and delivers public benefits.
The review identifies the points of greatest ethical concern in relation to the potential use of SCBEMs.
It also 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.
Neither use would be scientifically feasible now, but could become possible in future as the science develops.
The NCOB recommends an amendment to Human Fertilisation and Embryology Act 1990 to expressly exclude SCBEMs from the definition of an embryo.
It also calls for legal provision within the Act for a flexible approach to regulation of SCBEMs called a ‘regulatory sandbox’, which would ensure oversight that can accommodate scientific developments.
The NCOB is also calling for a statutory ban on the transfer of SCBEMs into the reproductive tract of human or non-human animals.
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.
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