Clare Shelley-Egan

The Ambivalence of Promising Technology

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.

The Challenge of Distributing Regulatory Responsibilities for Unknown Risks: ‘Nano’-Cosmetics and the EU Cosmetics Regulation as a Case Study

The adoption of the European Union’s (EU) Cosmetics Regulation–which came into effect as of July 2013–is significant because it was the first piece of legislation at the national or supranational level to include provisions relating specifically to the use of nanomaterials in any products. While the regulation does not change the fundamental aspects of the regulatory regime, which includes putting full responsibility for ensuring the safety of the cosmetic product on the manufacturer/importer, the provision of consumer labelling of nanomaterials suggests a shifting of responsibilities that is new for cosmetics within the EU market. Although this additional shifting of responsibilities is subtle, we argue that it is nonetheless problematic, given current uncertainties about what a ‘nano label’ actually means, in addition to doubts around the capacity to furnish the consumer with sufficient information to enable them to make a fully informed consumer choice. The aim of this article is to understand the challenge of distributing regulatory responsibilities for unknown or unquantified risks through the lens of the Cosmetics Regulation. We present and discuss data gathered in interviews with a small number of cosmetics stakeholdersincluding industry, representatives of government/regulatory agencies, NGOs/civil society and experts (in industry and dialogue)-as a means of illustrating various elements viewed by stakeholders as necessary to be able to take up responsibilities and identifying the constraining factors to doing so, i.e. regulatory challenges. The overarching aim of the article is to understand the implications of the distribution of responsibilities, as set out by the regulation, for enabling consumers to meaningfully differentiate between conventional cosmetic products and those containing nanomaterials.

A game with rules in the making - how the high probability of waiting games in nanomedicine is being mitigated through distributed regulation and responsible innovation

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.

Responsible Research and Innovation in the context of human cognitive enhancement: some essential features

ABSTRACTHuman 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 HCENA...

Implementing Responsible Research and Innovation in Research Funding and Research Conducting Organisations—What Have We Learned so Far?

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.

On irresponsibility in times of crisis: learning from the response to the Zika virus outbreak

ABSTRACTThis 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.

Devices of Responsibility: Over a Decade of Responsible Research and Innovation Initiatives for Nanotechnologies

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.

The Adequacy of the Frameworks for Ethical Assessment of HCE Applications

In the previous section, we have seen that there are several ethical frameworks that can be used to assess HCE applications and in Chap. 3 we reviewed the general ethical issues raised by HCE applications. We are now in a position to discuss which of the six above mentioned frameworks seem to fit best for assessing HCE applications.

Ethical Concerns in HCE: The Examples of Cognitive Enhancing Drugs and Noninvasive Brain Stimulation

In the mapping of ethical issues regarding human cognitive enhancement, we used a two-tiered approach in which we first carried out a systematic search, followed by the addition of references found in the literature identified in this search. We will here first present the two applications (or rather, areas of applications) that we focused on in our literature search. Then we will go through the main ethical issues that we identified in the search.

Ethical Governance and Ethical Tools

Ethically sensitive decision making is needed both with regard to general policies on human enhancement and with regard to specific enhancement applications. Science, technology and innovation policies may, on the one hand, be developed to support or steer HE technology trajectories in certain directions. This requires societal deliberation regarding the kind of innovation we, as a society, want to encourage. As we argue in Chap. 1, there is, on the other hand, also a need for ethical assessment of specific applications. This kind of ethical assessment will often have a regulatory or decision-making focus. This is the decision making level targeted in this book, where no framework yet has been proposed in the field of HE.