Responsible Innovation in Plant Breeding: The Case of Hybrid Potato Breeding.

As an emerging innovation, hybrid potato breeding raises high expectations about faster variety development and clean true potato seed as a new source of planting material. Hybrid breeding could, therefore, substantially contribute to global food security and other major sustainable development goals. However, its success will not only depend on the performance of hybrid potato in the field, but also on a range of complex and dynamic system conditions. This article is based on a multidisciplinary project in which we have studied the innovation dynamics of hybrid potato breeding and explored how these dynamics may shape the future of hybrid potato. Inspired by the approach of responsible innovation, we closely involved key players in the Dutch and international potato sector and other relevant actors in thinking about these potato futures. An important and recurrent theme in our work is the tension between the predominant commercial innovation dynamics in plant breeding and promises to respond to the global challenges of food security, agrobiodiversity and climate change. In this article, we, therefore, discuss responsible innovation strategies in (hybrid) potato breeding, which may help to bridge this tension and finally reflect on the implications for the field of plant breeding in general.

Constructing future scenarios as a tool to foster responsible research and innovation among future synthetic biologists.

The emerging field of synthetic biology, the (re-)designing and construction of biological parts, devices and systems for useful purposes, may simultaneously resolve some issues and raise others. In order to develop applications robustly and in the public interest, it is important to organize reflexive strategies of assessment and engagement in early stages of development. Against this backdrop, initiatives related to the concept of Responsible Research and Innovation (RRI) have also appeared. This paper describes such an initiative: the construction of future scenarios to explore the plausibility and desirability of potential synthetic biology innovations. We guided teams of synthetic biology students who participated in the large international Genetically Engineered Machines (iGEM) competition, in constructing scenarios aimed at exploring the plausibility and desirability of potential synthetic biology innovations. In this paper we aim to examine to what extent, and how, constructing such future scenarios contributes to RRI. In order to do so, we conducted observations and interviews to understand what kind of learning and reflection was promoted by constructing the scenarios in terms of four dimensions, which are discussed prominently in the literature on RRI: anticipation, inclusion, reflexivity and responsiveness. While we focus on how constructing future scenarios can contribute to strengthening RRI at a project (and individual) level, we also consider how far our experiment may foster RRI in the iGEM competition in general, and perhaps even inspire constructive collaboration between 'social scientists' and 'natural scientists' in the context of larger scientific research programmes.

Challenges for the European governance of synthetic biology for human health.

Synthetic biology is a series of scientific and technological practices involved in the application of engineering principles to the design and production of predictable and robust biological systems. While policy discussions abound in this area, emerging technologies like synthetic biology present considerable challenges in the articulation of concrete policy options given that their introduction into society may still be in the distant future. This paper reports on a series of governance workshops that focused on synthetic biology's ethical, legal, and social implications (ELSI) as they pertain to human health, and discusses particular limitations of the ELSI approach that we encountered in our work. In an attempt to avoid policymaking for potential implications of uncertain future applications we instead conclude by proposing tangible forms of anticipatory governance that may be more adequate in addressing the more immediate concerns raised by synthetic biology.

Governance strategies for living technologies: bridging the gap between stimulating and regulating technoscience.

The life sciences present a politically and ethically sensitive area of technology development. NBIC convergence-the convergence of nanotechnology, biotechnology, and information and cognitive technology-presents an increased interaction between the biological and physical sciences. As a result the bio-debate is no longer dominated by biotechnology, but driven by NBIC convergence. NBIC convergence enables two bioengineering megatrends: "biology becoming technology" and "technology becoming biology." The notion of living technologies captures the latter megatrend. Accordingly, living technology presents a politically and ethically sensitive area. This implies that governments sooner or later are faced with the challenge of both promoting and regulating the development of living technology. This article describes four current political models to deal with innovation promotion and risk regulation. Based on two specific developments in the field of living technologies-(psycho)physiological computing and synthetic biology-we reflect on appropriate governance strategies for living technologies. We conclude that recent pleas for anticipatory and deliberative governance tend to neglect the need for anticipatory regulation as a key factor in guiding the development of the life sciences from a societal perspective. In particular, when it is expected that a certain living technology will radically challenge current regulatory systems, one should opt for just such a more active biopolitical approach.

The innovation journey of genomics and asthma research.

This article concerns the transformative potential of medical genomics for common disease research. We analysed 13 review articles in asthma research in the period 1999 to 2008. Our aim was to understand how genomics has emerged in this research field, and the attendant changes. Motivated by Lippman's geneticisation thesis, we use the concept of an 'innovation journey' to trace how expectations of improved understanding, prevention, diagnosis and treatment structure a dynamic co-evolutionary process through which a genome-based discourse emerges. We show how the asthma researchers involved continuously struggle to define their contribution to asthma research, as well as to clinical practice. Along the way, the researchers propose changes to both the definition and the aetiological model of asthma, thus highlighting gene-gene and gene-environment interactions. It is, however, difficult to characterise this discourse as one of geneticisation. With increasing attention being given to epigenetics, metabolomics, proteomics and systems biology, the emerging picture suggests an important, but much less deterministic, role for genes.

Governing synthetic biology for global health through responsible research and innovation.

Synthetic biology (SynBio) is a global endeavour with research and development programs in many countries, and due (in part) to its multi-use characteristics it has potential to improve global health in the area of vaccine development, diagnostics, drug synthesis, and the detection and remediation of environmental toxins. However, SynBio will also concurrently require global governance. Here we present what we have learnt from the articles in this Special Issue, and the workshop we hosted in The Hague in February of 2012 on SynBio, global health, and global governance that generated many of the papers appearing here. Importantly we take the notion of 'responsible research and innovation' as a guiding perspective. In doing so our understanding of governance is one that shifts its focus from preventing risks and other potential negative implications, and instead is concerned with institutions and practices involved in the inclusive steering of science and technology towards socially desirable outcomes. We first provide a brief overview of the notion of global health, and SynBio's relation to global health issues. The core of the paper explores some of the dynamics involved in fostering SynBio's global health pursuits; paying particular attention to of intellectual property, incentives, and commercialization regimes. We then examines how DIYbio, Interactive Learning and Action, and road-mapping activities can be seen as positive and productive forms of governance that can lead to more inclusive SynBio global health research programs.

Implementation of preconceptional carrier screening for cystic fibrosis and haemoglobinopathies: a sociotechnical analysis.

OBJECTIVE: To obtain more insight into the process of potential implementation of a screening program, which aims to identify carriers of cystic fibrosis and haemoglobinopathies before pregnancy, in order to enable couples at high risk of having a child with these disorders, to make informed reproductive decisions. METHODS: Use of sociotechnical analysis, based on a model of co-evolution between technology and society, and, for comparison, the study of the implementation processes of two already existing health care programs with similar aspects to the screening program at issue. RESULTS: Factors important for success appeared to be the existence of sociotechnical niches, in which technological options can be developed and studied in an experimental setting; a structural approach of providing information to future parents; a party that can articulate demand; governmental involvement in the attunement between various stakeholders; and a screening infrastructure in which large-scale DNA diagnostic services are available. CONCLUSIONS: Successful implementation of preconceptional carrier screening for cystic fibrosis and haemoglobinopathies will depend on changes at both regime and landscape level, including the establishment of a new preconceptional health care setting and a clearly visible public health authority which can coordinate, monitor and evaluate such an initiative in public health care.

Cancer genetics and its "different faces of autonomy".

In this article we discuss the development of a practice of screening, preventive treatment, and presymptomatic testing for individuals at risk of Familial Adenomatous Polyposis (FAP), a specific hereditary predisposition for colon cancer. We describe this development as a process of co-evolution, showing how this practice has been gradually taking shape in a new network of actors, routines, rules, institutions and technologies. We further argue that, looking at the emergence and transformation of this practice, we can distinguish two different regimes: a regime of prevention and a regime of self-determination. In each of these regimes the autonomy of patients and individuals at risk is shaped in a different way, that is, through a different complex of ideals, procedures, institutions, technologies, and routines. In our view, the interference between these two regimes is an important characteristic of the emergent new genetics and is reflected in the growing debate about non-directivity in genetic counselling. However, as our argument implies, when facing the challenges of the new genetics we should not restrict the debate to the quality and ethics of counselling, but extend our view to the whole complex of elements and activities which shapes individual autonomy in the context of different regimes.