Event Review: The Ethics of Engineering Biology – An NCoB workshop

At this event, the Nuffield Council on Bioethics (NCoB) gathered scientists, policymakers, regulators and ethicists for an afternoon of talks and discussion on the ethical implications of engineering biology.

Previously known as 'synthetic biology', engineering biology uses the tools of engineering and the principles of biology to create tangible products with practical applications, such as lab-grown meat, biopharmaceuticals, stem-cell-based embryo models (SCBEMs), and neural organoids. The field has grown in the UK post-Brexit, attracting much political interest and financial support – but due to the novelty of the products created, there are ethical grey areas and new ethical questions.

The pace of development is outstripping both regulation and public awareness; for example, SCBEMs and neural organoids are both unregulated. However, a Code of Practice has recently been released to govern the use of SCBEMs in research (see BioNews 1246).

NCoB produced this event, a workshop titled 'The ethics of engineering biology', to gather impressions from those in the field of the current ethical guidelines and regulatory frameworks governing this area, and to generate new avenues for NCoB to interrogate. It was conducted under Chatham House rule to ensure a free-flowing discussion.

The unique ethical issues arising from engineering biology have been recognised for some time; a 2008 report by the Biotechnology and Biological Sciences Research Council warned of 'issues of ownership, misuse, unintended consequences, and accidental release'. During the first half of the event, which comprised talks from experts, one speaker delivered a strong warning that since this 2008 report, there has been a 'collective amnesia' about work done on the ethical implications of engineering biology.

While the report had stressed that 'the potential benefits of the technology must not be overhyped, for this risks both creating excessive public anxiety and unrealistic hopes', the speaker felt that engineering biology had consistently been overhyped, citing a 2012 speech by the then Chancellor of the Exchequer, George Osborne, in which he said that synthetic biology 'will heal us, heat and feed us'. A second speaker from government confirmed that such hyperbolic sales pitches are still being made with inadequate evidence to support them.

On a more positive note, participants agreed that progress has been made in public engagement – something whose importance was also highlighted by the 2008 report. Participants noted that funders, especially in the charity sector, now expect lay advisory panels to play a role in study design for engineering biology projects. Although there was initially scepticism about this approach among researchers, especially as regards lab-based rather than clinical work, researchers at the event felt that this development has ultimately been a positive as it has contributed to the diversity of questions taken into consideration by scientists designing studies.

The most uniformly praised example of public engagement was the mitochondrial donation debate, which occurred in the run-up to the procedure's legalisation by UK Parliament in 2015 (see BioNews 826). This involved a public dialogue about the ethical issues raised by what some feared were 'three-parent babies'.

Mitochondrial donation, also known as mitochondrial replacement therapy, involves using the mitochondria of a third-party donor during the creation of embryos via IVF. Nuclear material from one embryo (created from the mother's egg and the father's sperm) is moved to another embryo (created from the mitochondrial donor's egg and a sperm) that has had its own nuclear material removed. Alternatively, nuclear material from the mother's egg is moved to a mitochondrial donor's egg that has had its own nuclear material removed, and the resulting egg is then fertilised with the father's sperm to create an embryo.

The embryo that is ultimately created contains nuclear material from the parents, and mitochondria from the donor, in order to avoid the transmission of faulty mitochondria from mother to child, which can cause debilitating genetic diseases.

Participants felt that public trust in the procedure was built through deliberative engagement with the ethical issues, and that the mitochondrial donation debate could therefore serve as a useful model for future engineering biology projects.

Given how rapidly engineering biology is evolving, another tricky ethical area addressed was informed consent. One scientist working with neural organoids flagged that when a patient consents to the use of their cells for research, scientists need to ensure that what the patient consented to five years ago is still relevant to how their cells are being used now. Technology moves at such a pace that this can be difficult – for example, in the creation of chimeric models from stem cells (see BioNews 1245, 1223 and 1177).

The second half of the event involved a three-horizons exercise, in which participants considered how the field of engineering biology should evolve in future.

Many were disappointed that commercial viability is now the main priority of research in engineering biology, and regretted that UK funders don't value curiosity-driven research more highly, in contrast with the USA. Some felt that academics were more successful in their funding applications if they had an industry partner involved; but flagged that industry partnerships are difficult to navigate ethically, and more guidance is needed about how industry partners' conflicts of interests affect their suitability for public funding. Some suggested that as funding constitutes an ethical decision, ethicists should be more involved in decisions about who gets funding.

There was a strong consensus that current regulatory approaches needed reform, and that the UK's regulation required future-proofing to account for emerging innovations and technologies. Many participants endorsed the idea that specific applications should be regulated, rather than broader methods and techniques. There was also a desire expressed for a more global approach to engineering biology regulation, allowing the field to grow without facing different restrictions in different territories.

Overall, this NCoB event was a fascinating insight into the problems faced by scientists, policymakers, and academics in the field. Given the importance of robust debate to the ethical roll-out of engineering biology, the event was a model of the ethical progress that was its subject-matter.