The Nuffield Council on Bioethics (NCOB) has announced it has started a rapid review project to assess and advise on the ethical and regulatory issues raised by research using human stem cell-based embryo models.

The questions we are exploring include:

  • Do these models raise specific ethical considerations and could they merit the requirement for special protections?
  • Are current UK governance mechanisms suitable and sufficient?
  • How will these governance mechanisms need to evolve as science advances and embryo models become more sophisticated?

Earlier this year, in our new strategy, we confirmed Reproduction, Parenthood and Families to be a priority area for us to focus on. With the completion of this review, we hope to be able to provide robust, actionable recommendations for decision makers working in this area before the end of 2024.

Danielle Hamm, Director of the Nuffield Council on Bioethics said:

Advances in developmental and reproductive research raise some of the most urgent ethical, social and policy issues. Our independence and interdisciplinary approach mean we are well placed to offer a distinctive contribution to the conversations that need to be had. And our experience means we are in a strong position to identify and advise on the practical solutions policy makers could utilise when grappling with the decisions laid before them."

An interdisciplinary working group, which will include a representative from the Human Fertilisation and Embryology Authority (HFEA) will lead our work. Our insights will build upon, and contribute to, the considerations that have been, and continue to be, discussed by experienced researchers, policy makers, and other UK and international experts.

Emma Cave, Professor of Healthcare Law at the University of Durham and nominated Chair of the NCOB working group said:

I am delighted to take up this role and look forward to leading the Nuffield Council on Bioethics' work on this very important topic, which should help inform a proportionate approach to regulation in this highly complex and fast-moving area of science."

Current research using stem cells can generate structures that mimic parts of human embryos, at different stages of development. In future, it is thought that it could be possible to generate stem cell-based models that bear increasing resemblance to human embryos.

Research using donated human embryos is permitted in the UK, but their availability is limited. In contrast, lab created embryo models can be generated in large numbers using donated stem cells which are more readily obtainable. This enables research to be performed at a different scale. And as techniques develop, we may reach a point where it is possible to produce models that can mimic later stages of development, which are currently illegal to observe in donated embryos. This means these models could offer new opportunities for us to better understand human embryonic development, and, for example, the causes of disease and infertility.

Embryo models are not explicitly covered in UK laws or regulations, though work is underway to develop guidance on best practice for researchers.

Dina Halai, Head of Regulatory Policy at the HFEA said:

Research on stem cell-based embryo models have the potential to offer significant benefits and continues at pace. We welcome this work which should offer a timely contribution as we consider how regulation can be future proofed so that it is better able to accommodate future scientific developments and innovative technologies. We look forward to being on the working group and discussing the challenges posed by such novel developments and the boundaries of what could be legally permitted in the UK."

Find out more about this project, including membership of the working group, here.