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The January 2010 issue of Nature features several pieces about synthetic biology. To access click here

The December 2009 issue of Nature Biotechnology has a Focus on Synthetic Biology. The papers investigate a range of issues including intellectual property, the definition of synthetic biology, safety, regulation and the relationship with policy. To be taken to the journal click here or paste the hyperlink below into your URL:

http://www.nature.com/nbt/journal/v27/n12/index.html

For further links to journals and papers concerned with synthetic biology click here

For more information click here and/or here

“[T]he engineering of biology: the synthesis of complex, biologically based (or inspired) systems which display functions that do not exist in nature. This engineering perspective may be applied at all levels of the hierarchy of biological structures…. In essence, synthetic biology will enable the design of ‘biological systems’ in a rational and systematic way.”

SynBio involves interplay between engineering and biology. It encompasses the intentional and rational design of artificial biological systems, using either naturally occurring or entirely synthetic components/parts. The emphasis is on creating these systems from scratch, as opposed to seeking to understand naturally occurring systems.

SynBio will use a ‘toolbox’ of parts to create novel products. These could be naturally occurring, redesigned or completely synthetic. Bhutkar has proposed the following classification:

• Synthetic Elements: fundamental building blocks that provide primitive functionality; ‘off the shelf’ components for SynBio;

• Synthetic Networks: individual components made from synthetic elements;
• Synthetic Organisms: arising from assembly of a minimal genome; and
• Synthetic Systems: multiple synthetic organisms working synchronously to achieve a complex objective.

SynBio methodology is broad-ranging and multi-disciplinary. It encompasses tools and approaches from many scientific disciplines – notably engineering, genetics, biotechnology and biochemistry; but also nanotechnology, physics and computational modelling.

(Image Alexandra Daisy Ginsberg Aesthetic Experiments
What might synthetic biology look and feel like?)

Hope and Hype

Although developments in SynBio have progressed hand-in-hand with an awareness of ethical issues, it is time to consider some of the specificities of innovation in SynBio and the ethical issues these will generate. An area of particular interest is the planned applications of SynBio for human health and well-being. Specific issues on this topic to be addressed within SYBHEL are: the philosophical and ethical conceptions of life, including a consideration of concepts such as instrumental versus intrinsic value and the ethics of creating life per se; critiquing and assessing various approaches to applied ethical reasoning in SynBio for health, to arrive at a conclusion as to what methodological approach might be best; and a detailed analysis of the possibilities for SynBio in human health and the kinds of issues that will arise. Numerous vignettes will be used in this process and will be continually updated throughout the study as scientific advances continue.

Underpin research with a consistent awareness of the SYBHEL cross-cutting themes, namely: the definition of SynBio; scientific research; safety and justice;

SYBHEL will be informed by previous and concurrent work on the scientific state-of-the-art in SynBio definitions, research, safety aspects and preliminary ethical analysis. The findings of SynBio research are, however, changing rapidly, so various strategies will be adopted to ensure that the work packages can flexibly respond to new findings in SynBio as they will affect human health – for example each work package will have involvement from scientists working in SynBio.

A final cross-cutting theme is justice and the distribution of the benefits of SynBio. As with any new technology, there will be a challenge with SynBio to ensure that the benefits of this technology are distributed in a just and equitable way. A particularly relevant aspect of SynBio is that it may offer alternatives for drug development to those which currently rely on rare naturally occurring pre-cursors. But these applications of SynBio will have to be distributed in a fair and just way. The cross-cutting theme of justice will help these issues to be considered across the whole SYBHEL project.

Create a hub for researchers and policy-makers interested in ethical, legal and social issues arising in SynBio as it applies to human health to meet and exchange ideas.

A project website will be created and disseminated early in the SYBHEL project to ensure all who are interested in Europe and beyond have the opportunity to contact partners and to register their details to receive updates. Partners will also be encouraged to exploit these early contacts to include them in members of expert working groups, as participants in workshops or to invite responses to reports and other scholarly activities. Links will also be established with other ongoing projects, policy activities and public engagement initiatives across Europe. At the end of the SYBHEL project the consortium will have access to a network of academics and policy-makers with whom to explore the next stage of research in Europe.

Debate and agree key recommendations for regulation and commercialisation of SynBio as it applies to human health and well-being.

No current laws or guidelines in the EU specifically address synthetic biology. The SYBHEL project will consider whether specific regulation is required to facilitate the robust and appropriate use of SynBio for human health and if so, what form such regulations or policies might take. SynBio is a lucrative area for intellectual property yet this raises prospects that the benefits of this research may not be available to all. Moreover, a harmonised EU response to SynBio has yet to be questioned in detail, particularly with respect to this technology being applied for human health.

Determine a strategy for policy deliberation for SynBio in human health.

The novel nature of SynBio means that public debate on SynBio is not yet widespread. However it is not unlikely that new developments will give momentum to this debate and that SynBio will gain increasing attention in the public domain. Work package 6 will therefore draw on the outcomes of work packages 2-5 to yield insights on how the various issues raised could be considered in EC policy. This work, which will be carried out with key policy organizations and stakeholders, will culminate in an international workshop, recognizing the global importance of SynBio.

(Image Alexandra Daisy Ginsberg Carbon Monoxide Detector
From The Synthetic Kingdom)

Ethical implications of creating life

Existing literature on the concept of ‘life’ from other disciplines will be re-examined in light of SynBio for human health and integrated with the ethical context. This inter-disciplinary and cross-cultural work will include the definitions of life and living organisms as applied to SynBio, to explore the ethical and philosophical distinction between ‘natural’ and ‘artificial’ life forms. The concepts of nature and naturalness and instrumental and intrinsic value are also relevant and they will be compared to and contrasted with the biological and reductionist definitions of life and the concepts of machines, in particular that of ‘living machines’ as implied by SynBio Normative recommendations will be developed which will reflect existing debates and concepts.

Defining a ‘SynBioEthics’ for Human Health

To determine how to deliberate about the ethics of SynBio for human health and to reach normative conclusions, several ethical frameworks will be synthesised and evaluated from bioethics, medical ethics, engineering ethics, ‘nanoethics’and environmental ethics. This will lead to a conception of how ethical analysis should take place within SynBio. There will also be a discussion of inter-disciplinary methodology, for example the use of empirical research.

Ethics and SynBio for health

SynBio for human health gives rise to several new ethical and philosophical issues, as well as the requirement to re-consider existing issues. The scientific promise of SynBio will first be analysed, followed by an ethical investigation. Concepts to be investigated will include: suffering as a part of the human condition; risk-benefit analysis and the cross-cutting theme of Justice. Existing literature will be synthesised and applied to SynBio.This will then feed in to an analysis of how SynBio may alter our conceptual understandings of the nature of health, well-being, disease and therapy.

Commercialisation and Regulation

Consideration of the regulation of SynBio has focussed on the discipline in its entirely rather than specialised applications in areas like human health. The SYBHEL analysis will commence from a baseline of general issues in regulation, before considering issues such as the need for new laws in Europe to govern the application of SynBio to human health and the acceptability of patenting and other commercial activities in this area.

Public Policy and SynBio for health

SYBHEL will provide the first public policy consideration of SynBio for human health. This will involve taking into account the outcomes of work packages 2-5 as well as identifying which European policy fields will be affected and challenged by existing and future developments in SynBio for human health. This will lead to the identification of various policy options. European policy, political and public debate will also be linked with debates in other countries.

Image: Alexandra Daisy Ginsberg Pollution Sensing Lung Tumour
From Synthetic Pathologies

Some of the benefits that SynBio may offer for human health:

SynBio could lead to new devices for tissue repair or regeneration inside the body. These could be built with biological components to specifically target diseased tissues, for example to deliver chemotherapy directly to tumour sites, repair damaged or blocked blood vessels or rebuild collagen networks. A person’s existing cells could also be modified to gain new functions before being re-introduced. This could also improvements in our body’s immune system, or advances in removing bodily toxins.

SynBio could be exploited to design drugs to be taken in the usual way, but which remain inactive until reaching a target site. The compound would then perform a diagnostic activity to determine whether to activate and release the drug. Likewise, SynBio could help design truly personalised drugs specific to individual needs.

SynBio could be used to develop devices to live in our bodies and monitor the internal environment, such as hormone levels. If an imbalance is detected the device would secrete the relevant compound in response. This could help patients with chronic conditions and will negate continual clinical monitoring and drug delivery.

Advances in DNA synthesis mean that lengthier and more complex DNA structures can now be generated artificially. This could lead to the design or modification of tailored non-pathogenic ‘viruses’ to contain synthetic genes for use in gene therapy. These could be targeted to specific cells or areas in the genome for site-specific recombination; overcoming major barriers to gene therapy. Likewise, the new ‘toolbox’ of DNA synthesis and components could lead to a virtually limitless palette of scientific inspiration from nature, tailored to new products to boost human health. This could end supply problems with natural drug pre-cursors for malaria, cancer and HIV.

Adaptations of DNA, RNA, nucleic acids and proteins are currently limited to working with naturally occurring components. SynBio could overcome the limits of natural chemistry to create new or modified molecular components for the design of new proteins. This could  optimise uptake of new drugs across cellular membranes.

(Image Daisy Ginsberg)

Throughout the recent history of scientific research and biomedicine, there has been criticism that ethical analyses have lagged behind the pace of research. The opportunity to address a new technology like SynBio from an ethical perspective early in its development is transient and should not be missed. Indeed, the European Commission has recognised that:

“It is… important to address ethical and safety concerns, and to address potential or perceived risks of synthetic biology from the very beginning, so that future development work can be done in conditions of public trust.”

Synthetic Biology (SynBio) researchers have been interested in the ethical aspects of their discipline since the outset. Discussions on ethical, safety and regulatory aspects of SynBio have been included in the programmes of the first four SynBio global conferences. The field is also attracting attention from policy-makers. Yet there is now a need for further sustained ethical and regulatory analysis, particularly beyond the general principles and application of SynBio. Little work has yet been undertaken to address any of the specific anticipated outcomes of SynBio.

The challenge of global health and well-being is a significant issue for Europe and beyond as we progress through the twenty-first century. Increasing migration and cross-cultural considerations will introduce new challenges for the optimisation of population health. There are myriad existing issues, not least ensuring the fair allocation of health resources.

The domain of health care is one area where SynBio shows great promise. The technologies of SynBio could be used in areas such as drug development, drug targeting, virus synthesis, synthetic stem cells, vaccine development and creating live therapeutic agents. To date, no work has considered the ethical, legal or social issues that will arise in the application of SynBio for human health. The SYBHEL project will address this gap, whilst taking into account the current scientific state-of-the art of SynBio and the more generalised ethical debates already in progress.

SYBHEL will commence from a starting point of good integration with the current scientific state-of-the-art for SynBio (particularly through direct engagement with researchers working in the field) and will then progress to offer the first sustained analysis of the issues in SynBio as they apply to human health and well-being. The project consortium will constantly liaise with scientists to ensure that all work undertaken is in keeping with the latest advances in this rapidly developing field. Existing debates in SynBio and bioethics more generally will also be accounted for by including these as cross-cutting themes in the project.

The SYBHEL consortium is comprised of five partners from across Europe and involves ethicists, philosophers, lawyers, scientists and policy experts. The consortium will also be advised by an Expert Advisory Group with a global membership, including key players in the science and ethics of SynBio. The three-year SYBHEL project will proceed by way of eight work packages that together will lead towards a set of policy recommendations for the use of SynBio in human health and well-being. Throughout the project, the SYBHEL project team will work closely with scientists, policy-makers, non-governmental organisations (NGOs) and the lay public to ensure that project work and dissemination activities are targeted to all stakeholders.

(Image Alexandra Daisy Ginsberg Swarming bacteria)