In European research and innovation policy, Responsible Research and Innovation (RRI) and Open Science (OS) encompass two co-existing sets of ambitions concerning systemic change in the practice of research and innovation. This paper is an exploratory attempt to uncover synergies and differences between RRI and OS, by interrogating what motivates their respective transformative agendas. We offer two storylines that account for the specific contexts and dynamics from which RRI and OS have emerged, which in turn offer entrance points to further unpacking what 'opening up' to society means with respect to the transformative change agendas that are implicit in the two agendas. We compare differences regarding the 'how' of opening up in light of the 'why' to explore common areas of emphasis in both OS and RRI. We argue that while both agendas align with mission-oriented narratives around grand societal challenges, OS tends to emphasize efficiency and technical optimisation over RRI's emphasis on normative concerns and democracy deficits, and that the two agendas thus contrast in their relative legitimate emphasis on doable outcomes versus desirable outcomes. In our conclusion, we reflect on the future outlook for RRI and OS' co-existence and uptake, and on what their respective ambitions for transformation might mean for science-society scholars and scholarship.@en

The Ebola epidemic in West Africa between 2014 and 2015 was the deadliest since the discovery of the virus four decades ago. With the second-largest outbreak of Ebola virus disease currently raging in the Democratic Republic of the Congo, (DRC) it is clear that lessons from the past can be quickly forgotten-or be incomplete in the first instance. In this article, we seek to understand the health challenges facing marginalised people by elaborating on the multiple dimensions of marginalisation in the case of the West Africa Ebola epidemic. We trace and unpack modes of marginalisation, beginning with the “outbreak narrative” and its main components and go on to examine other framings, including the prioritisation of the present over the past, the positioning of ‘Us versus Them’; and the marginalisation-in responses to the outbreak-of traditional medicine, cultural practices and other practices around farming and hunting. Finally, we reflect on the ‘lessons learned’ framing, highlighting what is included and what is left out. In conclusion, we stress the need to acknowledge-and be responsive to-the ethical, normative framings of such marginalisation.@en

Background: Pandemic mortality rates in 1918 and in 2009 were highest among those with the lowest socioeconomic status (SES). Despite this, low SES groups are not included in the list of groups prioritized for pandemic vaccination, and the ambition to reduce social inequality in health does not feature in international and national pandemic preparedness plans. We describe plans for a systematic review and meta-analysis of the association between SES and pandemic outcomes during the last five pandemics. Method: The planned review will cover studies of pandemic influenza that report associations between morbidity, hospitalization, or mortality with socioeconomic factors such as education and income. The review will include published studies in the English, Danish, Norwegian, and Swedish languages, regardless of geographical location. Relevant records were identified through systematic literature searches in MEDLINE, Embase, Cinahl, SocIndex, Scopus, and Web of Science. Reference lists of relevant known studies will be screened and experts in the field consulted in order to identify other additional sources. Two investigators will independently screen and select studies, and discrepancies will be resolved through discussion until consensus is reached. Covidence will be used. Results will be summarized narratively and using three meta-analytic strategies: coefficients expressing the difference between the highest and lowest socioeconomic groups reported will be pooled using (a) fixed and random effects meta-analysis where studies involve similar outcome and exposure measures and (b) meta-regression where studies involve similar outcome measures. In addition, we will attempt to use all reported estimates for SES differences in (c) a Bayesian meta-analysis to estimate the underlying SES gradient and how it differs by outcome and exposure measure. Discussion: This study will provide the first systematic review of research on the relation between SES and pandemic outcomes. The findings will be relevant for health policy in helping to assess whether people of low socioeconomic status should be prioritized for vaccines in preparedness plans for pandemic influenza. The review will also contribute to the research literature by providing pooled estimates of effect sizes as inputs into power calculations of future studies. Systematic review registration: PROSPERO 87922@en

This special section addresses Responsible Research and Innovation (RRI) as an increasingly global concept that is translated and transformed in heterogenous national contexts. Based on seven national perspective articles from the RRI-Practice project, this introduction outlines a framework of transduction through which RRI becomes contextually negotiated and reconfigured. Read together, the national explorations of the special section make visible aspects of responsibility not readily apparent in abstract, European or global scale discussions of RRI. They not only point up important particularities of national contexts, but unexpected points of overlap in national contexts not often thought to have distinct commonalities.@en

Responsible research and innovation (RRI) has emerged in recent years, especially in Europe, as a science policy framework that (a) seeks to align technological innovation with broader social values and (b) supports institutional decisions concerning the goals and trajectories of research and innovation under conditions of uncertainty, ambiguity and ignorance. Rather than relying simply on consumer choice and market mechanisms on the one hand, or risk-based regulation on the other, RRI seeks to determine what constitute the goals, purposes and trajectories of (and alternatives to) technoscience and innovation, and thus the directions towards which these should be oriented, suggesting that these should be underpinned by shared public values. In addition to this overall philosophy of RRI, the European Commission has focused on five constituent policy keys (sometimes called pillars) of RRI that have their historical roots in the Science-in-Society programme; namely societal engagement, gender in research, open access, science education, and ethics. Action on these keys is seen as integral to an RRI approach and to Europe’s ability to respond to societal challenges. A further issue in the European context concerns how to ‘federate’ the RRI community in the EU and promote institutional changes to foster RRI in research institutions (a topic addressed at the European Commission RRI conference in Rome November 2014). This implies engaging stakeholders, research organisations, universities, funding agencies and public authorities in RRI. Some European research conducting and research funding organisations have begun to make formal policy commitments to RRI; others have developed RRI programmes and others still have embedded explicit RRI elements within broader programmes of emerging technologies and innovation. The European Commission’s ‘open to the world’ agenda implies involving non-European countries in the RRI discourse. However, beyond Europe, in emerging economies in the Global South (Brazil, India and China) and also in some advanced economies (Japan, Australia), there is little awareness of the concept of RRI, although some elements of the EC’s constituent keys have been taken up as thematic priorities by national research organisations. Considerable work needs to be done before RRI is recognised as a concept that offers traction in non-European contexts and research initiatives. There is a dearth of research that has assessed the challenges, efficacy and impact of the ongoing programmes on RRI, partly due to a lack of standardised methodologies that would be required to produce comparative results, and partly because these initiatives are themselves quite new. The project Responsible Research and Innovation in Practice (RRI-Practice), funded by the European Commission Horizon 2020 Science-with-and-for-Society programme (grant no 709 637), is an attempt to respond to this situation. The RRI-Practice project intends to advance European and global awareness of RRI, support its implementation in practice and provide a solid empirical knowledge base on RRI implementation. The main aim of RRI-Practice is to analyse RRI related discourses and pathways to implementation, including barriers and drivers, in a number of research conducting and research funding organisations worldwide, in order to identify, understand, disseminate and promote RRI implementation best practices that can be scaled up at European and global levels. The project started September 2016 and has so far concentrated on mapping the national RRI discourse in the 12 partner countries. As part of this work, national workshops have been held. This paper will present the analytic concept of the project and the results from the workshops, and will reflect on challenges identified in the work so far.@en

The notion of “responsible research and innovation” (RRI) and its cognates emerged in response to significant challenges related to the development of nanotechnologies. In this chapter, we trace the rise of RRI from the preresponsible development days through to the emergence of Responsible Innovation in the 2000s and subsequent evolution to RRI in the late 2000s. We home in on a number of key RRI initiatives that have been initiated in response to nanotechnologies and identify key funding programs that have underpinned such work and have contributed to the overall development and uptake of RRI. We address current framings and applications of RRI in other emerging technology areas. Finally, we explore the future of RRI within and beyond the European Union and emphasise the need to evaluate RRI as a policy tool, given significant public sector involvement in the framework.@en

This chapter presents the main findings of the EU-funded SATORI project on ethics assessment of research and innovation (R&I) in its first 18 months. It offers summarised descriptions of the ways in which ethics assessment and guidance of R&I are currently practiced in different scientific fields, in different countries in Europe, the United States and China, and in different types of organisations. The main findings include the following. Although the most extensive institutions, policies and activities exist in the medical and life sciences, there is evidence of a growing institutionalisation of ethics assessment in non-medical fields. Increasing coordination and cooperation between ethics assessors can be observed at the EU and global levels. Each of 15 types of organisations that were studied performs an important role in ethics assessment, which may not always be well established and sometimes poses significant challenges. Although significant differences exist among the countries that were studied in terms of the degree to which ethics assessment of R&I is institutionalised, all seem to be expanding their ethics assessment and guidance infrastructures. The findings are an important means by which partners in the SATORI project will take their next steps: the identification of best practices, the development of proposals for harmonisation and shared standards, and, to the extent possible, the proposal of common principles, protocols, procedures and methodologies for the ethical assessment of research and innovation in the European Union and beyond. @en

This chapter delineates some institutional initiatives and supportive tools that aim to enhance scientists' ethical reflexivity and offers a discussion of their objectives and challenges. It reframes the endeavour to 'enhance' reflexivity in terms of capacity building, namely working with the capacities for ethical reflexivity that scientists already possess and facilitating further building of capacities, specifically with regard to the articulation and performance of ethical reflexivity and the broadening of perspectives. The chapter describes and discusses tools and approaches with regard to how they contribute to enabling the articulation and performance of reflexivity. The notion of 'reflexivity' has emerged as a key dimension of responsible research and innovation (RRI), a policy discourse particularly visible at European Union (EU) level since around 2010. The interest in RRI seeks to extend scientific responsibility so as to include future societal impacts of technological development.@en

Responsible research and innovation (RRI) has come to represent a change in the relationship between science, technology and society. With origins in the democratisation of science, and the inclusion of ethical and societal aspects in research and development activities, RRI offers a means of integrating society and the research and innovation communities. In this article, we frame RRI activities through the lens of layers of science and technology governance as a means of characterising the context in which the RRI activity is positioned and the goal of those actors promoting the RRI activities in shaping overall governance patterns. RRI began to emerge during a time of considerable deliberation about the societal and governance challenges around nanotechnology, in which stakeholders were looking for new ways of integrating notions of responsibility in nanotechnology research and development. For this reason, this article focuses on nanotechnology as the site for exploring the evolution and growth of RRI.@en

This book offers the policy-maker or decision-maker key insights and practical information regarding the features of ethics frameworks best suited to the ethical assessment of human cognitive enhancement (HCE) applications, such as pharmaceutical cognitive enhancers and noninvasive brain stimulation techniques. This book takes as its departure point the entrenched philosophical debate between opponents and proponents of HCE and the increased feasibility of some applications of HCE. Recent calls for policy-making in the area of human enhancement reflect the need to find a balance between addressing current ethical issues and issues that are more speculative in nature or are underpinned by abstract philosophical concepts. Practical ethical approaches for policy or decision-making should enable the development of an evidence base for the risks and benefits of HCE applications. Moreover, such practical approaches should also incorporate a broader range of value bases that would facilitate convergence regarding certain decisions and judgements. This book identifies and evaluate tools that help us to go beyond polarised philosophical debates in order to assist practical decision makers in concrete ethical deliberation and decision-making. The focus is on systematic methods with which to identify relevant ethical values and assess the impacts of an HCE application on those values in order to facilitate decision-making regarding the ethical acceptability or desirability of the application. @en

This perspective paper offers some first thoughts regarding the current Zika virus outbreak and the immediate response it generated in health and research policy. We suggest that in times of emergent health crises, irresponsibilities may arise in the way responses which involve science and technology are framed and implemented. These pertain both to how such situations emerge under a crisis frame, and to pre-existing irresponsibilities which condition how such crises unfold. Reflecting on these irresponsibilities helps to clarify both how crucial it is to promote responsibility in research and innovation in everyday situations, and how important it is to maintain vigilance in times of crisis. We argue that care for the future needs to incorporate attention to persisting inequalities, which become especially salient in moments of emergency and which condition how crises are dealt with and the role innovation is perceived to play in their solution.@en

Human cognitive enhancement (HCE) is an area in which non-therapeutic enhancements have been widely debated. Some applications are already on the market and available for home use (e.g. non-invasive brain stimulation devices), while other forms of enhancement such as ‘smart drugs’ or pharmacological enhancers are readily available (albeit ‘off-label’ or illegally obtained). Private and public interest in HCE may well intensify as the field engages with broader societal trends such as an increasingly competitive work-life and greater demands for productivity, in addition to increased interest in cognitive enhancement more generally. There is thus a need for some dedicated and timely consideration of the area, particularly with regard to governance issues. Responsible Research and Innovation (RRI) offers one possible approach that aims to anticipate and reflect on potential implications and societal expectations with respect to research and innovation. This article takes up current work on the HCENAT (Naturalness in Human Cognitive Enhancement) project and offers some essential features of RRI for HCE.@en

This paper takes as its point of departure the pressure for industry to take up the notionof ‘responsible development’ of nanotechnology when there is little clarity as to what thismight mean in practice. Due to increased complexity, actions to be taken cannot be simplyspecified. It is necessary to further articulate the issues of responsible development, assuch, and through learning by doing;it is on this point that interview data with industrialactors, collected in an earlier project (Shelley-Egan, 2011) are presented as a means ofunderstanding industry’s response to the pressures for responsible development ofnanotechnology, along with the articulation of further issues. The findings show that thereis differential uptake of pressure for responsible development, and ambiguities andattempts at their resolution. However, in new developments related to the responsible development of nanotechnology, one sees new practices and interactions which maycontribute to making the problem manageable at least.@en

The Collingridge dilemma—the problem of reacting to emerging technology either “too early” or “too late”—is one that is readily recognized by developers and promoters of nanotechnologies. One response can be found in the rise of a discourse of “responsible development” in the science and innovation policy landscape. While a number of commentators have discussed the potential of such initiatives, it remains unclear how responsible development is actually being configured “on the ground,” in private sector nanotechnology. This paper addresses this question by analyzing empirical engagements in Europe and the United States in order to map industry operationalizations of “responsibility” in these contexts. We show that a number of different articulations of “responsibility” are present, including as a response to public lack of trust and perceived public pressure, and as the management of risk. We close by relating these findings to the theoretical literature on responsibility, other contemporary accounts of the ways in which responsible development can be operationalized, and the possibilities that these articulations of responsibility may open up.@en

This paper focuses on the contribution of meta-regulation in responding to the regulatory needs of a field beset by significant uncertainties concerning risks, benefits and development trajectories and characterised by fast development. Meta-regulation allows regulators to address problems when they lack the resources or information needed to develop sound “discretion-limiting rules”; meta-regulators exploit the information advantages of those actors to be regulated by leveraging them into the task of regulating itself. The contribution of meta-regulation to the governance of nanotechnologies is assessed in terms of responsibilisation. Responsibilisation is regarded as a pre -requisite for regulatory actors to internalise social values (such as consumer safety and occupational health) and to ensure that these values are built into regulatory practice. In order to explore the potential of responsibilisation, the Code of Conduct for Responsible Nanosciences and Nanotechnologies Research launched by the European Commission in 2008 is evaluated. The Code is a good case of meta-regulation that aims to steer the self-regulation of nanotechnological business and research organisations. The paper concludes that, while efforts were made on the part of meta-regulators and self-regulators to contribute to responsibilisation, important opportunities for responsibilisation such as dissemination and promotion of the Code, trust-building activities, and failure to provide rewards, incentives and stakeholder guidance were not taken up. In order to foster responsibilisation within the meta-regulatory instrument of the EC Code, a number of crucial activities to be undertaken by meta-regulators are recommended.@en

The potential benefits of nanotechnologies in healthcare are widely expected to be enormous and a considerable amount of investment is already pouring into public research in this area. These high expectations of benefits are coupled with uncertainty surrounding the potential risks of the prospective products containing nanomaterials, in addition to concerns about the adequacy of regulatory oversight. These challenges add another level of uncertainty for those deciding to invest in nanotechnology R&D and threaten to impede product development and commercialisation. Nanotechnology in healthcare (often labelled as nanomedicine) presents a situation where waiting games are a strong possibility; however, waiting games have been avoided (so far) through the unlocking of the dominant regulation regime. This paper describes how an innovation impasse in nanomedicine could have ensued if the traditional wait and watch strategies of legislators and regulators had been followed. We describe how waiting games were avoided through the opening up and distribution of regulatory approaches.@en

Issues of responsibility in the world of nanotechnology are becoming explicit with the emergence of a discourse on ‘responsible development’ of nanoscience and nanotechnologies. Much of this discourse centres on the ambivalences of nanotechnology and of promising technology in general. Actors must find means of dealing with these ambivalences. Actors’ actions and responses to ambivalence are shaped by their position and context, along with strategic games they are involved in, together with other actors. A number of interviews were conducted with industrial actors with the aim of uncovering their ethical stances towards responsible development of nanotechnology. The data shows that standard repertoires of justification of nanotechnological development were used. Thus, the industrial actors fell back on their position and associated responsibilities. Such responses reinforce a division of moral labour in which industrial actors and scientists can focus on the progress of science and technology, while other actors, such as NGOs, are expected to take care of broader considerations, such as ethical and social issues.@en