Among the various experiments in ‘new governance’, the model of Responsible Research and Innovation is emerging in the European landscape as quite promising. Up to now, there have been two versions of RRI: a socio-empirical version which tends to underline the role of democratic processes aimed at identifying values on which governance needs to be anchored and a normative version which stresses the role of EU goals as ‘normative anchor points’ of both governance strategies and policy making. Both versions are (...) unsatisfactory. The first since it suggests movable anchorage which could clash with prefixed values, such as individual rights. The second since it does not safeguard fundamental rights in the process of balancing ‘anchor points’. This result is counterintuitive because it exposes governance to the risk of facing adverse court decisions in the defense of individual rights, thus losing its anticipative attitude. In order to avoid this outcome, the paper argues that it is only through better integration between the system of human rights and that of EU fundamental rights that the anticipative feature of RRI can be preserved. (shrink)

Notwithstanding the EU endorsement, so far Responsible Research and Innovation (RRI) is discussed as regards its definition, its features and its conceptual core: innovation and responsibility. This conceptual indeterminacy is a source of disagreements at the political level, giving rise to a plurality of outcomes and versions upheld within the same model of governance. Following a Charles Taylor’s suggestion, this conceptual opening of the RRI model can be explained by the existence of plural, clashing moral frameworks: discourse ethics, Aristotelian ethics, (...) care ethics, dignitarian ethics, rights-based moralities etc. Given the diffusion in the RRI literature of references to care ethics and its justification of participation and responsibility, I will compare the conceptual premises of this philosophical line with those of ethics of rights, which have been criticised by advocates of care ethics. I will argue that public engagement based on only needs cannot lead to responsible outcomes since it produces however the exclusion of some needs, covered instead by rights. In order for participation to be effective, rights or an alliance between the two perspectives is required. (shrink)

Expectations play a central role in understanding scientific and technological changes. Future-oriented representations are also central with regard to nanotechnologies as they can guide policy activities, provide structures and legitimation, attract different interests, focus policy-makers’ attention and foster investments for research. However, the emphasis on future scenarios tends to underrate the complexity of the challenges of the present market of nanotechnologies by flattening them under the needs and promises of scientific research. This is particularly apparent if we consider the viewpoint (...) of the regulator who faces two different ranges of problems with regard to the market and research and is expected, simultaneously, to manage two different types of regulatory instruments, pursuing at the same time the same goals. Instead, by favoring only the future scenarios, the regulator runs the risk of abruptly shifting from more flexible and elastic tools to forms of hard legislation, wasting, thus, the resources of the soft-regulation, in particular those of self-regulation. By referring primarily to the European context, human rights, also thanks to their normative structure of principles, can help in strengthening both the legislation needed for regulating the present market and the soft instruments needed for steering research and for fostering the stakeholders’ participation without sacrificing the coherence of the regulatory response. (shrink)

Researchers sometimes engage in various forms of dishonesty and unethical behavior, which has led to regulatory efforts to ensure that they work according to acceptable standards. Such regulation is a difficult task, as research is a diverse and dynamic endeavor. Researchers can disagree about what counts as good and acceptable standards, and these standards are constantly developing. This paper presents and discusses recent changes in research integrity and ethics regulation in Norway, Denmark, and Sweden. Recognizing that research norms are developed (...) through practice and are therefore unsuited for comprehensive national regulation, the Scandinavian countries focus on empowering the research community to regulate itself instead, except for the most severe cases of misconduct. This empowerment takes the form of giving research institutions tools and investigatory powers while also holding them responsible for ensuring that both the institution and individual researchers are up to date on relevant norms. In this way, the Scandinavian governments seek to avoid some of the challenges found in more legalistic approaches, which risk lagging behind the continuous development of research norms and can be insensitive to the fact that different disciplines have different norms. While the new approach in Scandinavian has several potential benefits, it also involves potential trade-offs and limitations. The new laws can create confusion about what researchers are allowed to do. Another issue is that it only addresses the fundamental drivers of misconduct to a limited extent. (shrink)

Nanotechnology presents significant challenges in terms of developing a regulatory framework. This is due to a lack of scientific knowledge about the behaviour of the technology in its interactions with biological and ecological processes, the environment and other technologies. Crucially, there is a great deal of uncertainty surrounding the potential environmental and human health and safety impacts of NT. Consequently, the development of NT is a potential test case for framing new models of ‘soft law’ voluntary governance as a substitute (...) for traditional command and control type regulation. Driven by ‘new science governance,’ an approach based on a combination of ideas in anticipatory ethics, future-oriented responsibility, upstream public engagement and deliberation and theories of justice may offer a solution. The uniqueness of the approach can be found in the incorporation of anticipatory approaches via public participation and deliberation as the input into procedural justice approaches with distributional justice as the output. The overarching objective of this work is to contribute to the discussion in relation to the internalisation of responsibility and the building of intellectual and societal capacity to anticipate negative consequences before they arise in the hope that such an approach could be the antithesis of the retrospective imposition of responsibility and liability after the harm is done, which is the outcome of traditional regulatory and ethical approaches. Ultimately, the purpose is to contribute to the long-term sustainability of NT. (shrink)

Soft regulation has increased its importance in science and technology governance. Despite such indisputable significance, the literature on technology policy and regulation so far seems to have dedicated only a limited attention to a systematic understanding of the factors affecting compliance with these soft rules. This article addresses this limitation. By way of a literature scoping exercise, we propose a taxonomy of the mechanisms affecting compliance with soft regulation. We subsequently apply the taxonomy as a guide to examine the opinions (...) of a small group of scientists and company managers in the Italian nanotechnology sector. The case study does not assess compliance in a direct way, i.e., observing how organizations comply with regulation, but it explores the opinions on what the factors affecting compliance are. (shrink)

Current nanotechnology regulation is focussed on risks. On the other hand, technical guidelines and other soft law tools are increasingly replacing hard law. This risk reduction approach does not seem to be fully aligned with open principles like sustainable nanotechnology. Indeed, risk optimization tends to be rather a continuous process than a way to settle ultimate lists of risks. There is therefore a need for a more dynamic view: Life cycle assessment contributes to add momentum and context to the models. (...) However, a complementary perspective is here suggested, based on information technologies: nanotechnology platforms. Platforms for nanotechnology governance are supposed to complement and enhance the nano-regulation, adding risk assessment and management. These platforms are mainly offering information, coordination, and context or situational awareness. More recently, some informal platforms appear to play a, certainly limited but still clear, co-regulatory role. Can these informal platforms play a relevant role in nanotechnology governance? In the context of the EU Better Regulation strategy, why not envision some of these informal platforms as future co-regulation tools? The main goal of this paper is to start a discussion on the requirements these informal co-regulatory platforms should fulfill before their hypothetical inclusion in a future better regulation toolbox. (shrink)

Nanotechnology has revolutionized various industries and has become a notable catalyst for economic growth. The emerging issues of human health and safety associated with nanotechnology development have raised regulatory concerns worldwide. In occupational settings, the same novel characteristics of nanomaterials that are utilized for innovation may also be the source of toxins with adverse health effects for workers. The existing regulatory framework may function effectively to regulate chemical substances in their conventional forms but may not be adequate with regard to (...) the specific issues of nanoform substances. A foundation of knowledge concerning properties of nanomaterials, and risk management approaches for these materials have been established, but conclusive results remain elusive. It is difficult for lawmakers to regulate nanotechnology-related activities effectively if conventional regulatory mechanisms are applied. The present article analyses in a country study the adequacy of existing Malaysian occupational safety and health law with regard to the specific issues presented by nanotechnology. The applicable regulatory approaches are examined to justify the adoption of soft law instruments as regulatory mechanisms for nanotechnology. A number of soft law best practices are briefly discussed as a basis to recommend practical solutions to close the existing regulatory gap. (shrink)