Embedding Ethical Impact Assessment in Nanosafety Decision Support.

Nanotechnology is a key enabling technology, which is developing fast and influences many aspects of life. Nanomaterials are already included in a broad range of products and industrial sectors. Nanosafety issues are still a matter of concern for policy makers and stakeholders, but currently, there is no platform where all stakeholders can meet and discuss these issues. A comprehensive overview of all the issues in one single dashboard presenting the output of a decision support system is also lacking. This article outlines a strategy for developing one innovative part of a modular decision support system, designed to support the work of a new Risk Governance Council (RGC) for nanomaterials which will be established through the combined efforts of the GOV4NANO, NANORIGO, and RiskGONE H2020 projects. This new module will consist of guidelines for Ethical Impact Assessment (EIA) for nanomaterials and nanoenabled products. This article offers recommendations for adapting the European Committee for Standardization (CEN) prestandard on Ethical Impact Assessment CWA (CEN Workshop Agreement) 17145-2:2017 (E), to fit into the more-encompassing decision support system for risk governance of nanomaterials within the RiskGONE project.

Risk Governance of Emerging Technologies Demonstrated in Terms of its Applicability to Nanomaterials.

Nanotechnologies have reached maturity and market penetration that require nano-specific changes in legislation and harmonization among legislation domains, such as the amendments to REACH for nanomaterials (NMs) which came into force in 2020. Thus, an assessment of the components and regulatory boundaries of NMs risk governance is timely, alongside related methods and tools, as part of the global efforts to optimise nanosafety and integrate it into product design processes, via Safe(r)-by-Design (SbD) concepts. This paper provides an overview of the state-of-the-art regarding risk governance of NMs and lays out the theoretical basis for the development and implementation of an effective, trustworthy and transparent risk governance framework for NMs. The proposed framework enables continuous integration of the evolving state of the science, leverages best practice from contiguous disciplines and facilitates responsive re-thinking of nanosafety governance to meet future needs. To achieve and operationalise such framework, a science-based Risk Governance Council (RGC) for NMs is being developed. The framework will provide a toolkit for independent NMs' risk governance and integrates needs and views of stakeholders. An extension of this framework to relevant advanced materials and emerging technologies is also envisaged, in view of future foundations of risk research in Europe and globally.

Comparative, collaborative, and integrative risk governance for emerging technologies.

Various emerging technologies challenge existing governance processes to identify, assess, and manage risk. Though the existing risk-based paradigm has been essential for assessment of many chemical, biological, radiological, and nuclear technologies, a complementary approach may be warranted for the early-stage assessment and management challenges of high uncertainty technologies ranging from nanotechnology to synthetic biology to artificial intelligence, among many others. This paper argues for a risk governance approach that integrates quantitative experimental information alongside qualitative expert insight to characterize and balance the risks, benefits, costs, and societal implications of emerging technologies. Various articles in scholarly literature have highlighted differing points of how to address technological uncertainty, and this article builds upon such knowledge to explain how an emerging technology risk governance process should be driven by a multi-stakeholder effort, incorporate various disparate sources of information, review various endpoints and outcomes, and comparatively assess emerging technology performance against existing conventional products in a given application area. At least in the early stages of development when quantitative data for risk assessment remain incomplete or limited, such an approach can be valuable for policymakers and decision makers to evaluate the impact that such technologies may have upon human and environmental health.

Empowering citizens in international governance of nanotechnologies.

The international dialogue on responsible governance of nanotechnologies engages a wide range of actors with conflicting as well as common interests. It is also characterised by a lack of evidence-based data on uncertain risks of in particular engineered nanomaterials. The present paper aims at deepening understanding of the collective decision making context at international level using the grounded theory approach as proposed by Glaser and Strauss in "The Discovery of Grounded Theory" (1967). This starts by discussing relevant concepts from different fields including sociological and political studies of international relations as well as political philosophy and ethics. This analysis of current trends in international law making is taken as starting point for exploring the role that a software decision support tool could play in multi-stakeholder global governance of nanotechnologies. These theoretical ideas are then compared with the current design of the SUN Decision Support System (SUNDS) under development in the European project on Sustainable Nanotechnologies (SUN, www.sun-fp7.eu). Through constant comparison, the ideas are also compared with requirements of different stakeholders as expressed during a user workshop. This allows for highlighting discussion points for further consideration.

The Just War Theory and the ethical governance of research.

This article analyses current trends in and future expectations of nanotechnology and other key enabling technologies for security as well as dual use nanotechnology from the perspective of the ethical Just War Theory (JWT), interpreted as an instrument to increase the threshold for using armed force for solving conflicts. The aim is to investigate the relevance of the JWT to the ethical governance of research. The analysis gives rise to the following results. From the perspective of the JWT, military research should be evaluated with different criteria than research for civil or civil security applications. From a technological perspective, the boundaries between technologies for civil and military applications are fuzzy. Therefore the JWT offers theoretical grounds for making clear distinctions between research for military, civil security and other applications that are not obvious from a purely technological perspective. Different actors bear responsibility for development of the technology than for resorting to armed force for solving conflicts or for use of weapons and military technologies in combat. Different criteria should be used for moral judgment of decisions made by each type of actor in each context. In addition to evaluation of potential consequences of future use of the weapons or military technologies under development, the JWT also prescribes ethical evaluation of the inherent intent and other foreseeable consequences of the development itself of new military technologies.