Conor M.W. Douglas

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.

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.

Governing biological material at the intersection of care and research: the use of dried blood spots for biobanking

A series of governance issues currently surrounds the multiple uses and multiple users of dried blood spots (DBS) for research purposes. Internationally there is a discussion on storing DBS resulting from newborn screening for public health and using them as the basis for large biobank-like collections to facilitate biomedical research. If such a transformation were to be formalized, then DBS would sit at the intersection of care (ie, public health) and research, with the mechanisms through which such a collection could be managed not totally self-evident. What is more, a DBS collection raises questions about the fuzzy boundaries between privacy and anonymity; how to control or define quality control uses of DBS; medical vs nonmedical uses; as well as benefit sharing and stakeholder involvement. Our goal here is to explore some of the key questions relating to DBS governance by way of the bio-objects and bio-objectification concepts. By embracing – rather than resisting to – the blurring of boundaries and problems in categorization that have come to characterize bio-objects and bio-objectification processes recently described in this journal, we attempt to highlight some issues that might not be currently considered, and to point to some possible directions to go (or avoid). Building from our knowledge of the current DBS situation in the Netherlands, we outline questions concerning the uses, management, collection, and storage of DBS.

Socio-Cultural characteristics of usability of bioinformatics databases and tools

Abstract With the increasing importance of the usability of bioinformatics systems and databases, this paper examines the socio-cultural characteristics that may affect the usability of such tools. We understand socio-cultural characteristics to be the norms, values, and beliefs that mediate the interactions between the structures and institutions of science (i.e. disciplines, universities, funding organizations), and its practitioners. These factors are not necessarily distinct from the technical features of a database, but do nevertheless affect the context in which one chooses to use a particular set of tools. We have developed three socio-cultural characteristics of bioinformatics database usability: accessibility, utility, and portability. By ‘accessibility’, we mean the social and cultural attributes that make resources open and available for use, such as intellectual property arrangements or institutional reputation and prestige. ‘Utility’ in this context means the perceived usefulness of a database, which can be determined by non-technical matters such as trust and taste. ‘Portability’ refers to the social aspects of criteria such as maintenance funding, and input and storing standards that allow a database to move through space and time. In this article, we call for a social science research programme on these — and other — socio-cultural characteristics to usability. We invite researchers in human–computer interaction, bioinformatics, usability engineering and other areas to extend their work to examine the social contexts in which these systems are used, and the sociocultural factors that mediate their use. Such a research programme would increase the multidisciplinary nature of these emergent fields, and help address the complexities of work in the post-genomic era.

Governing the research-care divide in clinical biobanking: Dutch perspectives

Biobanking, the large-scale, systematic collection of data and tissue for open-ended research purposes, is on the rise, particularly in clinical research. The infrastructures for the systematic procurement, management and eventual use of human tissue and data are positioned between healthcare and research. However, the positioning of biobanking infrastructures and transfer of tissue and data between research and care is not an innocuous go-between. Instead, it involves changes in both domains and raises issues about how distinctions between research and care are drawn and policed. Based on an analysis of the emergence and development of clinical biobanking in the Netherlands, this article explores how processes of bio-objectification associated with biobanking arise, redefining the ways in which distinctions between research and clinical care are governed.

The politics of representation in the governance of emergent 'secondary use' biobanks: The case of dried blood spot cards in The Netherlands.

Abstract There is an international discussion to transform the collection of dried blood spot (DBS) card collections resulting from neonatal public health screening programs into a kind of biobank through the formalization of their (prolonged) retention and by expanding their use in medical research and development (R&D) practices. Given the scale of neonatal heel prick screening, these blood samples are increasingly being considered as a wealth of biological data for medical R&D. Due to the fact that donors are newborns and that the primary purpose of DBS is health care, the card collection is not a conventional biobank. However, it may be treated as such if there could be societal support and if a management body could be developed to deal with prolonged retention and use policies. One strategy to gain support for biomedical research is to involve citizens, donors, patients and their representatives and advocates at various stages and levels of the R&D process. This article explores the feasibility of existing notions of patient participation in the governance of medical R&D (in particular biobanking) in relation to the possible transformation of the Dutch DBS collection into a more formal biobank. In doing so we describe some of the current challenges of using of DBS cards for medical R&D, and explore what role patients have played in research processes in general and specifically in biobanking as well as the management of DBS collections. We focus on the current management structure of the Dutch DBS collection, and explore what role for patients and publics is needed to address the current proposal for changes to their storage, management, and use. We conclude by exploring a model of ‘adaptive governance’ in which a Participant Association is created to elect a Participant Board to operate alongside and within the biobank’s management structure (O’Doherty et al. 2011), which could work to increase transparency and trust of R&D decisions on DBS collection. This would neither preclude patient involvement, nor positions such involvement as a kind of panoptic answer to challenges in governance.

Special issue editorial: synthetic biology, global health, and its global governance

In 2009 the journal Systems and Synthetic Biology published a special issue outlining the societal aspects of synthetic biology (Schmidt 2009). Its contributions clearly showed the importance of contextualizing the hope and hype of synthetic biology (SynBio) with the ethical, legal, and social dynamics that might sometimes be seen to be outside of the conventional practice of science and technological development. Some papers that were included addressed biosafety and biosecurity issues pertinent to SynBio, as well as technical (i.e. Bedau et al. 2009; Danchin 2009) and governance (Kelle 2009; Weir and Selgelid 2009; Marliere 2009) strategies to mitigate such risks. Others presented media and public perceptions of SynBio (Cserer and Seiringer 2009; Kronberger et al. 2009; Pauwels 2009), while still others dealt with philosophical (Deplazes and Huppenbauer 2009), ethical (Rabinow and Bennett 2009), economic (Gaisser and Reiss 2009; Wellhausen and Mukunda 2009), and theological challenges (Dabrock 2009). This Special Issue seeks to expand on this work in two ways. First it focuses on a particular set of SynBio applications and process as they relate to global health. Second, we seek here to expand the scope of ‘societal aspects’ to explore how they might play-out, and what their governance might look like, when placed in a global setting. Global health can be understood to operate with many of the same objectives as public health in terms of promoting health and preventing disease; however, it stresses ‘consideration of the health needs of the people of the whole planet above the concerns of particular nations’ (Brown et al. 2006: 62) or particular publics.1 SynBio is positioned to address major global health issues through advanced vaccine development, diagnostics, drug synthesis, and the detection and remediation of environmental toxins. Concerted attention to issues relating to SynBio, global health and global governance is well warranted at a time when considerable research funds have been made available by the Bill & Melinda Gates Foundation under their ‘Explorations’ portfolio to ‘Apply Synthetic Biology to Global Health Challenges’ (see Rooke in this issue). What is more, the not-for-profit drug manufacturer OneWorld Health has begun its production and distribution of synthetic artemisinin, which has widely and loudly been heralded as considerable weapon in the global fight against malaria.2 However, in the face of these developments challenges to the global governance of SynBio in a global health context continue. In 2012 debates ragged over whether or not to publish research on versions of avian H5N1 influenza virus 2012,3 and in the context of artemisinin, some have suggested that ‘is not clear that producing a drug of this sort in developed countries is the best way of either eradicating malaria in the long term or supporting sustainable development in the poorest countries’ (Balmer and Martin 2008: 26). With the aim to expand the discussion on societal aspects of SynBio in a global health context, and to explore what governance might entail for the global practice of SynBio, we held a workshop in The Hague in February of 2012 as a part of the SYBHEL project.4 We invited twenty-seven participants from four constituencies of actors from around the world (e.g. China, India, Canada, United States of America, France, Spain, Switzerland, Belgium, Germany, England, Scotland, and the Netherlands). This included those with scientific and technical expertise in the practice of SynBio, and specifically those whose work seeks to address global health issues or whose practices are not bound by national borders or institutions (i.e. DIYbio). The second constituency were representatives from key international organizations that specialize in global health (i.e. WHO), global technological development and deployment (i.e. the OECD, the Health Impact Fund), and the global availability of biological parts for SynBio (i.e. the BioBricks Foundation). The third constituency were academics with expertise in the safe and responsible use of technologies for global health, and our fourth constituency were representatives from key regions that are involved in the development of SynBio for global health and/or the target of such interventions. Much of the contents of this Special Issue are based on contributions of these different groups of participants to this workshop. This workshop intended to focus on questions concerning the global practice of SynBio on the one hand, and on the other hand the role that policy could play in fostering a relationship between SynBio and global health issues. Invited participants were asked to prepare papers, presentations, and comments on the following questions, which structured the workshop. How can synthetic biology be used to address global health issues, relating for example to vaccine development, drug synthesis, diagnostics and environmental monitoring for human health threats (including pandemics and bio-security threats)? What are the conditions necessary to support the use of synthetic biology for addressing global health issues, like social and political conditions for SynBio research and innovation and take-up of its products in different regions of the world, technical and legal conditions relating to the access and availability of SynBio tools and biological parts, policy and regulatory conditions (including transnational collaboration), etc.? How can policy ensure the safe, fair and responsible implementation of synthetic biology on a global level, taking into account environmental and health related bio-safety and bio-security issues, ethical questions (including questions of global justice) and a diversity of public and cultural perceptions of synthetic biology? In addressing these questions, those with the scientific and technical expertise in the practice of SynBio outline how products or processes could be used towards the alleviation of global health burdens. In this Special Issue Jenny Rooke lays out the portfolio of projects on SynBio and global health that have recently been supported by the Bill & Melinda Gates Foundation. Prerna Vohra and Gary Blakely describe their work that is funded under that program to develop a range of multivalent oral vaccines against the most common diarrhoea-causing bacteria (e.g. Escherichia coli, Shigella and Salmonella). Such work by Vohra and Blakely represents a very targeted approach through which a specific SynBio application might address a particular global health challenges. Next to this ‘project approach’ that targets a particular global health challenge with a specific SynBio product is the work James Carothers appearing in this issue, which sees the development of modelling and computer-aided design tools to facilitate a multi-use research platform. For him, such technological platforms make viable marketable products that can be ‘reengineered to produce low cost global health materials’ (Carothers this issue). While there is much promise in both the targeted and multi-use approaches to SynBio for global health, Henk van den Belt and Aidan Hollis explore the dual problem of access and availability of such potential products. Van den Belt explores the relationship between SynBio, global health, intellectual property and access-to-knowledge frameworks; whereas Hollis outlines how the Health Impact Fund could be used to incentivize innovation in SynBio for global health, and to more fairly distribute the products of that innovation. In other work appearing in this Special Issue Joy Zhang explores how specific trans-boundary features of SynBio actively disrupt established boundaries between professionals and amateurs, between scientific disciplines, and between geopolitical areas. For her, these trans-boundary features of SynBio both elicit and require new approaches to its global governance. This call is then addressed in part by the works of Betten, Roelofsen and Broerse, as well as Landrain, Meyer, Perez, Demouchy and Sussan, which both demonstrate how effective global health solutions require an opening of the SynBio innovation process to include end-users as well amateur communities. Landrain et al. examine the capacities of the Do-It-Yourself Biology movement to both practice SynBio around the global and participate in its (self) governance, and Betten et al. lay out a social science Interactive Learning and Action methodology that can be deployed throughout the SynBio innovation process to better address the needs and requirements of global health users. The overall goal of this Special Issue is to increase our collective understanding of the practice of SynBio research and development for human health at the global level, and to better appreciate the role policy plays in enabling and/or constraining the responsible development of SynBio for global health. Our own contribution to the Special Issue works to summarize the dynamics between SynBio, global health, and global governance through the framework of ‘responsible research and innovation’ (Owen et al. 2012; von Schomberg 2013). In doing this we relate to the different contributions of the Special Issue, and synthetize them in a comprehensive review. While all contributions here agree on the potentialities of SynBio to help address some major global health challenges, all would also readily acknowledge the importance of taking into account features that are not directly related to the technological configuration of products. For this a multidisciplinary approach is needed, and we hope that we have provided the foundation for that here.

The Roles of User/Producer Hybrids in the Production of Translational Science

This paper explores the interface between users and producers of translational science (TS) through three case studies. It argues that effective TS requires a breakdown between user and producer roles: users become producers and producers become users. In making this claim, we challenge conventional understandings of TS as well as linear models of innovation. Policy-makers and funders increasingly expect TS and its associated socioeconomic benefits to occur when funding scientific research. We argue that a better understanding of the hybridity between users and producers in TS is essential to encouraging effective TS activities. In arguing for broader understandings of the hybrid roles of user/producers in TS we rely on empirical observations made during our four-year (2006–2009) study of three translational pathways here labeled clinical, commercial, and civic. These pathways were identified in a large-scale network of scientists investigating the pathogenomics of innate immunity (i.e. “the PI.2 network”). Through our examination of “user-firms” in the commercial TS case study, of patients and clinician-scientists as users in the clinical TS case study, and of bioinformaticians as user/producers in the civic TS case study, we suggest that the iterative and dialectical nature of TS blurs the lines between users and producers, rendering such distinctions arbitrary and sometimes misleading. We suggest that such a blurred boundary may be a constitutive, if underappreciated, component of TS. Acknowledging the important role of user/producers may be a crucial step in overcoming translational challenges currently facing the biomedical domain, and in appreciating broader transformations in science.