Blog4th November 2024
Since the publication of our briefing note in March 2024, we have launched a further project exploring the governance and regulation of neural organoids. We concluded our latest evidence-gathering last week, with a roundtable event attended by researchers and regulatory experts from across this diverse and interdisciplinary area of research.
The evidence-gathering phase of our project has involved running a call for evidence, a series of targeted stakeholder engagement meetings, a workshop, and last week’s roundtable. All these activities have allowed us to get important insights into the ethical questions arising from imminent and possible future innovations, and better understand the real world-challenges faced by decision-makers in this space. Our goal is to advise on the complex ethical and regulatory issues arising from the use of these models, and to produce useful recommendations that can guide decision-makers and all those who carry out, fund and oversee neural organoid research. In this blog, I reflect on what we have learnt so far, and what we will be taking away as we take the project forward.
Neural organoids are powerful research tools. As research advances at pace, these models could offer important insights into how the human brain works. In time, they could play an important role in improving our understanding of a range of brain conditions, and in helping us identifying new viable treatment options. Progress in the past ten years has seen these tiny blobs on a Petri dish being linked together to form assembloids, transplanted into the brain of other animals, and even connected to sensors that provide an interface with computers.
As science advances and these models are improved and perfected, what might be the ethical limits to this research? What, if anything, might make, neural organoids morally and legally significant? How can their regulation and governance be proportionate and future-proofed? And what could an informed consent process, able to account for fast-paced developments and an unpredictable direction of research, look like?’ These are some of the questions that we have explored throughout our evidence-gathering activities.
Whilst there isn’t – perhaps predictably – a straightforward answer to these questions, three themes have emerged from our work to date, providing valuable insights into how they might be approached. The first of these is the need to address the regulatory gap in which neural organoid research currently falls. In the absence of agreed principles on which to base decisions, decision-making responsibility falls on individual researchers, funders, biobank steering groups and research ethics committees are operating. We heard concerns that those needing to make such decisions do not always feel equipped to do so, and that there may be a lack of consistency when the principles guiding decision-making vary across institutions.
The second theme relates to the importance of maintaining a relationship of trust between the public and the scientific community as research advances. Public trust is integral to ensuring ethical research practices and uses. There was a strong consensus around the need for public views and perspectives to inform the development of any policy and guidance on how neural organoids are used in research, and how they ought to be used in the future.
The third theme is around the need for flexibility in any governance mechanisms developed so that they are both proportionate and future-looking. We heard concerns about the impact of posing undue barriers and restrictions on research, which could limit or prevent valuable applications from being realised. At the same time, we heard nervousness about the characteristics that these models of the human brain may acquire in the short- and medium-term, and that a lack of appropriate safeguards around these could result in a number of potential harms. Balancing proportionality with encouragement of innovation is a clear challenge ahead, but our stakeholders agreed that consensus on where the ethical limits lie is key to tackling it.
The evidence and insights we have gathered to date will inform our advice to the sector and next steps. We have benefitted greatly from hearing a diverse range of voices and perspectives, and will continue to listen to these going forward. We believe that this will bring clarity to the complex ethical and regulatory questions that neural organoids pose and enable the development of robust and relevant recommendations for those who carry out, fund and oversee the use of neural organoids in research.