Research using neural organoids

We are undertaking a project to assess and advise on the ethical and regulatory issues raised by research neural organoids. This work forms part of our mind and brain focus area which we identified as a priority in our new strategy 'Making ethics matter'.

Call for Evidence - launched 12 July 2024

We have opened a call for evidence seeking expert opinion on the three key areas where we believe further ethical guidance is needed:

• How regulation and governance of neural organoids can be proportionate and future proofed.
• What an informed consent process, able to account for fast-paced developments and an unpredictable direction of research, could look like.
• What current and possible future characteristics of neural organoids could have implications for their moral and legal significance, and so may warrant special ethical consideration.

This call for evidence will help us to assess these challenges which were identified in our policy briefing note. We are keen to hear from a range of people involved in neural organoid research including researchers across academia and industry, research funders, and those who govern or regulate research.

We intend to publish our recommendations by Spring 2025, seeking to guide policymakers and all who carry out, fund and govern neural organoid research. The call for evidence will be open until 18 September 2024.

Policy briefing note - Neural organoids in research: ethical considerations - published March 2024

Organoids are small, lab-grown three-dimensional structures that are made from stem cells to model different aspects of an organ or tissue, such as the liver, gut, kidney and brain.

This policy briefing note focuses on neural organoids, and particularly human neural organoids, which are used to model different aspects of the developing brain.

This briefing note aims to provide an evidence-based and balanced summary of the main ethical considerations in neural organoid research and the ethical issues that might arise in the future as research progresses. We describe the main advances in this area of research, give an overview of relevant regulation and guidance, and present and discuss the main ethical considerations in neural organoid research.

Read the policy briefing note - Neural organoids in research: ethical considerations

Conclusions

• Neural organoids are promising research tools that could have important applications in the future, improving our understanding of a range of brain conditions and treatment options.
• Neural organoid research is, however, still in its infancy and its potential is yet to be fully explored. There is still uncertainty around future possibilities, research directions, likelihood of success, and the extent to which neural organoids currently resemble, and will be able to resemble, the human brain.
• Research is moving at pace, and it is difficult to predict when significant developments will take place. It is important, therefore, for policy makers to work with scientists, ethicists, and publics to ensure that the ethical and regulatory questions are fully explored, in order to ensure that appropriate guidance and regulations will be in place to facilitate innovation and address ethical considerations.

• whether or not more tailored ethical guidance and oversight is needed;
• what might be appropriate consent procedures and processes for tissue donors;
• the potential for neural organoid research to benefit human and non-human animals;
• the importance of balanced and accurate communication of neural organoids’ current and potential future capabilities; and
• the possibility of neural organoids developing capacities increasingly similar to the developing human brain, such as sentience and consciousness, if indeed they ever do.]

• appropriate consent processes that can account for the fast-paced developments and unpredictable direction of research;
• what appropriate, future-looking, and proportionate regulation of these models might look like - if needed - considering developments in assembloids, neural organoid transplantation and other, more advanced technologies; and
• what anatomical or functional ‘hallmarks’ might be used as criteria to attribute consciousness to neural organoids and what the implications for their moral significance might be as a result

Project Lead