Building genomes from scratch
Published November 2016
Small viral and bacterial genomes synthesised from scratch have demonstrated the feasibility of creating synthetic genomes and it may soon be possible to synthesise an entire human genome de novo. This differs from the recoded genomes that have been made possible by genome editing tools such as CRISPR/Cas9 and could allow more widespread manipulation of genetic material.
Are there recent scientific, legal or social developments?
In 2002 scientists described the de novo synthesis of infectious poliovirus using a synthetic genome built from scratch. This was followed in 2010 by the successful construction of the first self-replicating, synthetic bacterial cell. The cell was produced using a bacterial genome constructed from smaller DNA subunits which was then transplanted into the empty cytoplasm of a related bacterium.
In May 2016 an invitation-only meeting of over 100 scientists, entrepreneurs, lawyers and ethicists took place at Harvard University to discuss the Human Genome project – Write (HGP-write) project which was formally unveiled on 2 June 2016. The project describes its primary goal as being to reduce the costs of engineering, or writing, human and other large genomes in cell lines more than 1,000-fold within ten years.
Are there complex ethical issues?
The development of this technology offers the potential for wide-reaching benefits to human health. Potential applications include engineering ‘ultrasafe’ human cell lines which could be used to secrete proteins used in medical treatments but which would be resistant to viruses. Other possibilities include engineering therapeutic cell lines which have been manipulated to ensure cancer resistance, or eventually growing transplantable human organs. The theoretical end-point of such technology, however, would be the possibility of engineering cells to create so-called ‘designer’ humans with no genetic parents, and this inevitably raises considerable ethical dilemmas. Concerns have been raised about the unknown environmental and health impacts of genetically altered organisms. A further concern is related to unwanted commercialisation of the products that emerge from the research as well as the direct financial interests of some of the founding members of the HGP-write project. The technology could lead to the creation or release of organisms that could be used as biological weapons with fears that the research may ultimately pose threats to public health and safety that might outweigh the benefits.
From a philosophical standpoint there may be deeper implications of the reductionist approach to the origin and meaning of life which is implicit in the science of building human genomes from scratch. Some have warned of the danger that the identification and synthesis of minimal genomes will be presented by scientists, depicted in the press, or perceived by the public as proving that life is reducible to, or nothing more, than DNA. If we extend the reductionism implicit in minimal genome research to a definition of human life, this has repercussions for the ethical debates about stem cells/early embryos and abortion. Creating new living organisms from scratch could ultimately change how we frame our ideas of what life is.
Is there a potential policy impact?
The broad scope and potential applications of this technology will call for the development of appropriate regulatory policies. The HGP-write project itself has called for scientific communities to set standards within the context of national and international laws and to develop regulations in the model of existing stem cell research guidelines. As the technology of building genomes advances there will be a need for a new regulatory framework to govern the intellectual property associated with these genes and the resultant new organisms in order to ensure that public and commercial interests are protected.
Is it a subject of public concern?
Whilst the public may not currently be widely aware about recent progress in synthesising genomes, the birth of Dolly the sheep in 1997 and the ensuing tsunami of media attention and public concern highlights society’s deeply rooted fears about the consequences of humanity’s ability to manipulate biology. Press attention for the HGP-write project has highlighted concerns that it might be possible, such as through cloning, to use a synthetic genome to create human beings without biological parents. In particular, the secretive nature of the initial scientific meetings has sparked some public criticism.
Is the consideration timely?
In June the HGP-write project expressed their goal to launch in 2016. Some critics have warned that the HGP-write team has not properly justified its aims, and that the project should be abandoned until there is an adequate public debate with participation from a broad range of people.
Can the Council offer a distinctive contribution?
This topic follows on from many of the issues raised by the genome editing project. The Council may be able to act as an independent body that is able to bring together the views of scientists, policymakers and the public in order to make a critical appraisal of the HGP-write project and to put down a marker about the need for a responsible and ethical approach to building human genomes from scratch.
Possible future work topics
This is one of the topics that have been suggested as possible project areas for further investigation by the Council. These topic summaries do not aim for comprehensiveness; rather, they are intended to sign-post some of the key considerations and to provide a starting point for discussion. Each summary includes links to relevant publications on the topic.