This SYNENERGENE workshop on “Responsible Research and Innovation in Synthetic Biology” took place at the Schader-Forum, Darmstadt (Germany), on 23 - 25 June 2014. It was jointly organized by the Institute of Technology Assessment and Systems Analysis (ITAS) / Karlsruhe Institute of Technology, the Institute for Philosophy at the Technical University of Darmstadt, and the Schader Foundation (Darmstadt).

The workshop aimed to bring together various actors, including people from academic research, industry, civil society and politics to discuss in an experimental format questions concerning pre-requisites for ‘Responsible Research and Innovation’ in synthetic biology.

The workshop started with a lecture and discussion event “Engineering Life? Responsible Research and the Limits of Design” on the evening of 23 June.  Supported by the Schering-Foundation (Berlin), the evening event was open to the public.

Two talks initially presented two different perspectives on 'responsible research and innovation' (RRI) in synthetic biology: that of governance and ethical deliberation in and around science, and that of economical and policy aspects.  The first of these perspectives was represented by René von Schomberg (European Commission), one of the most important advocates of RRI in Europe who spoke in personal capacity. He stressed the need for developing a “Science 2.0” that have to become more open for societal challenges and thus more mission-oriented in order to better serve societal needs, as well as explaining key ideas linked to RRI. In the second talk, James Philp (Science and Technology Policy Analyst at the OECD, and lead author of the latest OECD report on synthetic biology) represented a second more “economic” perspective on RRI. He focused on bioeconomy aspects as ways to combat by synthetic biology threats from some of the grand societal challenges (such as energy security, climate change, rural regeneration), as well as to secure the chemicals sector for the future in Europe– and how synthetic biology fits into the bio-based production picture. Furthermore, he outlined some emerging policy issues (including the biosecurity issue) of synthetic biology.

These presentations were commented by two workshop participants. From the point of view of innovative product development, Stephen van Dien (Director, Technology Development, Genomatica Inc., San Diego) pointed out the opportunities of synbio for the sustainable production of existing bulk chemicals (rather than generating replacement compounds with unknown properties) in a cost-competitive way. From a more ethics and policy oriented perspective, Wolf-Michael Catenhusen (former Secretary of State at the German Ministry of Research and currently vice-chairman of the German Ethics Council) suggested that the relatively early stage of synthetic biology is the right time to initiate a common learning process among stakeholders, integrating different learning processes from EU member states related to earlier technological developments, such as synthetic chemistry, genetic engineering and nanotechnology.

The presentations and comments were followed by a discussion with the audience which comprised about 30 workshop participants and 20 people from outside. It covered topics such as biosecurity and the FBI’s outreach approach to the scientific and the biohacker communities in the USA; the role of codes of conducts for RRI; criteria for concerns and risk assessment; regulatory issues related to biosafety and the basic question who decides / should decide what is responsible.

For programme and pictures of this public evening event , see http://www.schader-stiftung.de/uploads/tx_schaderstiftung/Flyer_Engineering_Life_Responsible_Research_and_Design_23_06_2014_01.pdf and http://www.schader-stiftung.de/veranstaltungen/artikel/public-panel-engineering-life-responsible-research-and-the-limits-of-design/, respectively.

The closed part of the stakeholder workshop on “Responsible Research and Innovation in Synthetic Biology” on 24-25 June involved 35 participants from Europe and the USA. It included people from academic synthetic biology research, science and technology studies (STS), students of the iGEM competition, industry, civil society organizations, the biohacker community, research funding and policy advice bodies. The workshop aimed to identify and discuss preconditions for ‘responsible research and innovation’ (RRI) in synthetic biology (synbio). It staged roundtable discussions on four separate ‘dimensions’ of 'responsible research and innovation' in four sessions:

1.            Value sensitive design

2.            Conditions for Co-Responsibility – Rights and Privileges, Commitments and Obligations

3.            Responsible Representation – Knowledge and Ignorance, Limits of Control

4.            Monitoring, Observation and Regulation – Collective Experimentation and Social Learning

Each of the four topics started with a brief presentation of an example or potential ‘prototypic’ model case related to RRI (by workshop participants or the organizers) as well as a set of questions and theses.

1. Value sensitive design

Implicit and explicit values and “societal needs”, such as sustainability, or privacy and safety by design, have increasingly gained relevance in research policies (e.g. related to nanotechnology) and in certain technology sectors (e.g. in communications technology). Questions in this session addressed the possibilities and potential limits for value-sensitive design in synbio research and development (R&D) processes.

As a  possible ‘prototypic’ model, Stephen van Dien (Genomatica Inc., San Diego)  presented the production of 1,4-butanediol (an important commodity chemical produced from oil and natural gas, and not synthesized by any known organism)  from renewable materials by a ‘synthetic’ pathway in bacteria.

The prototypic model case initiated the discussion and delineation of various factors that affect, or should affect, values to be included / considered in R&D processes. Such factors can be ‘commercial drivers’ (e.g. market opportunities for ‘green chemicals’ or new synbio-based pharmaceuticals) or ‘societal benefits’ (public good). The relation between these two factors, and their role in RRI was controversially discussed between participants (e.g. from industry and innovation research on the one hand, and STS scholars and civil society on the other), without reaching consensus: Should RRI be mainly, or even exclusively, guided by values not immediately addressed by market mechanisms? And can these be at all separated from commercial drivers and markets? In addition the role and need for ethical limits (to manipulate organisms), of individual people (in institutions) and factors affecting the justification of research on certain applications were suggested to need consideration.

2. Conditions for co-responsibility – rights and privileges, commitments and obligations

Research and development in (potential) key technologies can be shaped by various societal actors. These range from investors, public or private research, the legislature, to certification bodies for sustainable production of goods – not to neglect the roles of NGOs/CSOs, consumers, or journalism. However, consequences of technological innovation are often the effects of collective action or societal effects which cannot be linked to intentional individual actions: How can individuals be embedded in a process of co-responsibility? – What are appropriate institutional models for constructive stakeholder participation and input in the innovation process in synbio?

As a possible ‘prototypic’ model, the organizers presented two not-for-profit international certification initiatives, Forest Stewardship Council (FSC) and Roundtable on Sustainable Biomaterials (RSB), the latter of which has already relations to synbio. Both are models for democratically governed initiatives between various societal actors, including social and environmental NGOs and profit-making companies: Could they provide models for constructive stakeholder participation to affect innovation and product development in synbio? (e.g. related to new generations of biofuels or bio-based chemicals). And, could they further incorporate a ‘societal dynamics’ into the design of the synbio R&D process - and also shape research and research agendas in basic (and translational) science?

The example of product certification schemes brought up arguments regarding their benefits for creating co-responsibility and, as an institutional model, for constructive stakeholder participation. There appeared to be consensus that such schemes could strengthen co-responsibility between stakeholder groups, largely independent on governments (which some stakeholders may not trust). Such third –party, independent certification might also provide a model for non-governmental risk assessment (especially so in cases where capacities for governmental risk assessment might become insufficient, as was suggested a possibility for synbio in future). On the other hand, many participants raised concerns that such product-oriented schemes are not ‘upstream’ enough. And could thus not be able to affect research process or allow participation in setting research agendas. Instead, STS and CSO participants suggested the need for changes regarding science policy and ‘constitutionality’, also imposing responsibility on politics to ‘answer’.  These changes should allow an empowerment of society – and would depend on the creation of structures and incentives that let societal actors to acquire knowledge and to gain authority / legitimacy.

3. Responsible Representation – Knowledge and Ignorance, Limits of Control

Synbio’s primary focus appears to be not on the discovery and testing of grand explanatory theories, but on problems that need to be solved to enable next steps within a larger research project, emphasizing the need for innovation and economic growth. It thus contributes to a design process, broadly conceived, e.g., to develop cures for disease, to improve the collection and storage of energy. Responsible Research and Innovation begins with an adequate self-understanding of practitioners in the field of synthetic biology but also needs to be seen for what it is by outsiders: How to resolve the tension between ambitions for construction and design on the one hand, and on the other hand the appreciation of limits of knowledge and control, emergent properties and evolutionary change of living systems. How is synthetic biology presented and represented?

As a possible ‘prototypic’ model, Daniel Sachs (iGEM team Darmstadt) presented the iGEM competition and possible relations of activities in iGEM and iGEM teams related to RRI.

Discussion started around the questions to what extent iGEM may be the ‘public face’ of synbio, and whether it could be a good model for RRI. Though iGEM appeared to be widely known among the workshop participants, it was suggested that other ‘synbio faces’ may actuallybe  more 'public', such as the prominent US researcher Craig Venter or the company Monsanto. Though, as suggested by one participant from industry, some important corporate player may not want become a public ‘synbio face’ and don’t use the term synthetic biology in public communication.

The thesis that iGEM could serve as a good model for RRI, especially regarding responsible representation, was questioned by various participants, including people that have participated in iGEM. Mainly for two reasons: First, it were not clear whether iGEM really represents research or science. And second because of its strong use of engineering and technical metaphors in language and communication, pretending life can be engineered and becomes controllable like machines. This was seen to contrast with the role of emergence and evolution, neglecting or ousting potential limits of control. It was also suggested that such language is actually used to drive research project and attract funding. Various participants felt that this is an issue that can be found throughout the synbio field. Such strategic use of words was seen as contrasting with intellectual honesty, finally suggested to be an important foundation for responsible representation in RRI.

4. Monitoring, Observation and Regulation – Collective Experimentation and Social Learning

This session aimed at discussing and exploring possibilities for translating knowledge and uncertainty into responsible decision making and governance processes. Points of departure were existing governance structures and societal analysis by the social sciences that may represent collective or ‘real-world’ experimentation on emerging technologies.

As a possible ‘prototypic’ model, Eleonore Pauwels (Woodrow Wilson International Center for Scholars, Washington D.C.) presented “Trading zones“ as a set of methods for collaborations between different “epistemic cultures”,  meaning collaborations across disciplines and sectors, with the goal to address the uncertain and complex challenges posed by synthetic biology. The primary aim in this model is not to reach a consensus among participants, but to develop a common language between scientists from different disciplines (such as synbio and ecology research) as well as various more upstream and downstream actors. This should allow to unveil potential zones of uncertainty and allow mutual learning in a kind of co-evolution process.

Discussion around the trading zone model focused on the way this concept could involve and foster communication with societal actors other than scientists, and how it could contribute to “real” governance solutions in practice. A major topic of discussion here was how to transfer knowledge to civil society and empower it (or its organizations) to build up their own expertise, in order to participate in scientific and political debates. This included suggestions for structures, incentives or collaborations with governments.  These issues led the discussion to other possible schemes or models that may contribute to a ‘responsible’ governance process. Ideas ranged from web-based decentralization strategies of knowledge, data and communication that could allow to open up discussions; to participation of civil society in research funding and councils of regulatory agencies; to systematic observation mechanisms based on ‘institutions for permanent real-time vigilance’ for more robust  research processes and innovation systems. Especially these latter ‘observation mechanisms / institutions’ let to questions of legitimacy (who can / should observe or analyze?; how independent could they be?) and to suggestions that such observation would not suffice, but would have to be coupled to political decision making processes.

Based on the previous sessions, a final discussion round dealt with the question of how to go on in a mutual learning process to ‘responsible research and innovation’ in synbio. This discussion brought up very basic issues that should be considered in future discussions on RRI and synbio. These included questions as to what such mutual learning should be for: Could / should it go beyond a merely enabling process for society / stakeholder to engage in debates? What can its role in political decisions be? Who will actually decide on what is good or bad in research and development (R&D) processes? Furthermore, what is the role of ethical issues and limits (related to notions of ‘life’, or genetic identity of organisms) in this process rather than procedural questions, and who will discuss them?

From the basic nature of these questions and (open) issues, as well as discussions in the four workshop sessions related to practicability and possible governance schemes, it appears that RRI is a concept that is still rather vague, and difficult to relate to the practice of R&D as well as policy. This seemed to be true for both academic researchers –though maybe less so for researchers from STS / accompanying research— and all other societal actors (such as corporate actors or civil society) among participants. Thus this workshop on pre-conditions for RRI in synbio may suggest that questions of RRI need to be discussed related to more concrete issues in synbio or R&D processes, and in the context of more specific political conditions (e.g. certain science policy / research funding contexts, or regulatory / policy bodies).

(For programme and pictures of the  stakeholder workshop, see http://www.schader-stiftung.de/uploads/tx_schaderstiftung/Flyer_Workshop_ResponsibleResearch_2425062014.pdf and http://www.schader-stiftung.de/veranstaltungen/artikel/workshop-responsible-research-and-innovation-in-synthetic-biology/, respectively.)