July 4, 2024

expert reaction to Code of Practice for the use of Stem Cell-Based Embryo Models (SCBEMs) in research

Scientists comment on the new Code of Practice for the use of Stem Cell-Based Embryo Models. 

Prof Robin Lovell-Badge FRS FMedSci, Group Leader, Francis Crick Institute, said:

“Guidelines and Codes of Practice are very useful governance mechanisms, especially for fast moving fields of science.  They can be developed, enacted and updated much faster than hard laws, and with buy-in from trusted members of the relevant scientific community they can reassure both researchers, who generally want to work within clear boundaries, and the public that ethical barriers will be respected.  Peer pressure, standards set by critical stakeholders, including funders and science publishers, and the risk that a potentially valuable field of research can be damaged or even closed down by laws, all help to reduce the likelihood of something being done by a researcher that crosses boundaries and loses public trust.  Of course, there can be maverick or rogue scientists who go too far, but these tend to be individuals who would not even respect hard laws.

“The Code of Practice for the generation and use of stem cell-based embryo models (SCBEMs) that has been developed by the group established by the University of Cambridge and Progress Educational Trust will fill a critical gap in the UK’s regulatory landscape.  It is designed to be flexible and to accommodate advances in the field, but through its recommendation to have robust review of projects, it should give reassurance to all interested parties that ethical boundaries will be respected while permitting much valuable research.  It adds to the Guidelines published by the International Society for Stem Cell Research in 2021, which include work with SCBEMs (although these are already a little out of date), but in a way that will mesh better with the UK’s way of governing research on human embryology.

“We don’t yet know where the research on SCBEMs will take us, most likely, however, it will be in multiple directions that will give us much better understanding than we currently have of normal human embryo development, of situations where it goes wrong, whether IVF failure, miscarriage, congenital disorders, or adverse effects of drugs and other substances used in pregnant women, and, hopefully of ways to avoid such problems.  They will never completely replace the need for using some normal human embryos in research, in part because the models need to be validated by comparing them with the latter, but because they can be generated in large numbers, the SCBEMs will permit types of research that could not be conducted on embryos, such as screens for biologically important drugs or genes.”

Peter Thompson, Chief Executive of the HFEA, said:

“Research using stem cell-based embryo models could offer significant benefits for improving our understanding of early development of the embryo and the practice of IVF.  But because embryo models mimic aspects of early human development, despite not being the same as human embryos, ethical concerns have been raised about their use.  The Cambridge Reproduction’s Code of Practice looks to fill this gap and aims to provide confidence and structure to researchers across the country.

“The HFEA is responsible for the regulation of human embryo research; embryo models are not human embryos in the current law.  The law in the UK does not allow embryo models to be used in patient treatment.  Last year, we put forward proposals for law reform, which include ‘future proofing’ it, so that it is better able to accommodate future scientific developments and new technologies, such as these.  In the meantime, this new voluntary code will help researchers who have been uncertain about where they stand legally and ethically.

“The HFEA’s Scientific and Clinical Advances Advisory Committee continues to monitor developments of stem cell-based embryo models to understand these models’ capabilities, and we are also working in partnership with the Nuffield Council on Bioethics to ensure new regulations can appropriately capture advancements in their uses.”

Prof Emma Cave, Chair of the Nuffield Council on Bioethics embryo model working group, and Professor of Healthcare Law at the University of Durham, said:

“We are pleased to see this work published, which shows that there is clear motivation in the field to ensure that research is informed by ethical considerations.  We will consider this guidance and the proposals for oversight mechanisms in our review and hope to contribute independent and ethically robust recommendations to inform the wider governance of this research.” 

Code of Practice for the generation and use of human stem cell-based embryo models’ was published at 00:01 UK time on Thursday 4 July 2024.

Declared interests

Prof Robin Lovell-Badge: “Robin Lovell-Badge is a Principal Group Leader at the Francis Crick Institute.  He has no financial conflicts of interest to declare, but he was involved at several stages in the development of the Code of Practice, including reviewing it at a draft stage, and being associated with public engagement around the topic, and he also chaired the Taskforce responsible for updating the ISSCR’s Guidelines in 2021. Robin is Chair of Trustees of PET (Progress Educational Trust).”

For all other comments, no reply to our request for DOIs was received.