The Nuffield Council on Bioethics (NCOB) says there is a clear need for guidance on how to conduct ethical research using neural organoids, warning that governance gaps reflect wider weaknesses in the UK's outdated regulatory ecosystem which could hinder scientific progress.
The NCOB says rapid advances in biotechnology are creating governance gaps that threaten public trust in science and could undermine the UK Government's effort to support responsible innovation. As such, it is calling on the Government to scope new approaches to including biotechnologies in statutory regulation, that can anticipate regulatory needs and proportionately govern emerging technologies.
Neural organoid research is a fast-developing area of science that uses human stem cells to make small, three-dimensional models able to mimic aspects of brain function and development.
Research using these organoids could advance our understanding of the brain and neurological disease, and potentially reduce reliance on animals in research. However, as the models become more sophisticated, their potential to replicate aspects of brain function may increase. This raises ethical questions, including the possibility of developing sentience and potential new risks to animals arising from unknown impacts of transplanting human neural organoids into them.
Alongside developing a new approach to regulating emerging biotechnologies, the NCOB says there is an urgent need for sector-wide best practice guidance. This should provide clear, shared ethical parameters for researchers using neural organoids, which will improve consistency of decision making.
A shared definition of what is meant by sentience in the context of neural organoids and similar models should be a key focus of the guidance, say the NCOB. They propose that an interdisciplinary alliance of key stakeholders including research institutions, funders and regulators should be brought together to work on this.
The NCOB also says the guidance should articulate best practice on animal welfare in neural organoid research, particularly in relation to the transplantation of human organoids into non-human animals.
And they urge for the review of consent processes to ensure tissue donors understand how their samples may be used - including to create neural organoids.
To support these efforts and help shape proportionate governance, the NCOB calls for research funders to invest in robust public engagement to shape the future of this research.
Danielle Hamm, Director of the Nuffield Council on Bioethics, said:
"The governance gaps we have identified in neural organoid research are reflective of a much wider challenge: the UK's regulatory system is not keeping up with the pace of scientific discovery.
"If the UK is to remain a leader in responsible, ethical innovation, governance must be anticipatory, not reactive. We need urgent action to close these gaps before they become barriers to both public confidence and scientific progress."
Professor Emily Jackson, Chair of the NCOB Working Group and Professor of Law, London School of Economics and Political Science, said:
"Neural organoids hold huge promise for understanding more about brain development, but there is an urgent need for clear guidance to close a growing regulatory gap and ensure this science continues to develop responsibly.
"Continued uncertainty about the ethical acceptability of this research could undermine both public confidence and scientific progress. The guidance we propose would give researchers clearer parameters while helping reassure the public this research is advancing in the public interest."
