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.

Medical nanotechnology in Star Trek: A force for both good and evil.

Nanotechnology is defined as the study, creation and utilisation of structures ranging in size between 1 and 100 nm. Nanotechnology in Star Trek has been used by both the benevolent Federation (to which humanity belongs) and the Borg, a malevolent cybernetic horde intent on assimilating all individuals into a collective hive mind with complete loss of individuality. Manichaeism is a dualistic philosophy which maintains that principles and actions are either intrinsically good or evil. This paper will demonstrate that the utilisation of nanotechnology by these two Star Trek groupings reveals the Manichean nature of the struggle between the Federation and the Borg. While the Federation utilises nanotechnology for medical purposes, the Borg use this technology solely to forcibly assimilate individuals to serve as "drones," mindless slaves. These narratives also serve as cautionary tales with regard to the potential unintended consequences of unconsidered actions and completely unfettered research.

Reflexões bioéticas acerca da inovação em Nanomedicamentos / Reflexiones bioéticsa acerca de la innovación en Nanomedicamentos / Bioethical Reflections on Innovation in Nanomedicines / Reflexions bioètiques sobre la innovació en nanomedicaments

A nanotecnologia vem se desenvolvendo de forma exponencial na área farmacêutica, prometendo grandes benefícios, entretanto, pode estar sujeita a riscos intrínsecos relacionados a esta ciência. Neste artigo é realizada uma reflexão acerca dos desafios enfrentados pelos órgãos regulatórios em função da ausência, ou ainda, incipiente legislação, especialmente no Brasil, visto que os documentos disponíveis em relação a regulamentação, não incluem especificações para nanomedicamentos, os quais apresentam alterações na dimensão e constituição, e consequentemente comportamento diferente de medicamentos convencionais. A contingência envolvendo o desenvolvimento de nanomedicamentos e a gestão dos riscos para a vida humana e o meio ambiente fazem com que a bioética seja invocada de forma a analisar quais os impactos decorrem deste proceso

Nanotechnology has been developing exponentially in the pharmaceutical area, promising great benefits, however, it may be subject to intrinsic risks related to this science. In this article, a reflection is made on the challenges faced by regulatory agencies due to the absence or incipient legislation, especially in Brazil, since the available documents in relation to regulation do not include specifications for nanomedicine, which present changes in the dimension and constitution, and consequently different behavior of conventional drugs. The contingency involving the development of nanomedicine and the management of the risks for human life and the environment, cause bioethics to be invoked in order to analyze the impacts of this process

La nanotecnología se está desarrollando de forma exponencial en el área farmacéutica, prometiendo grandes beneficios, sin embargo, puede estar sujeta a riesgos intrínsecos relacionados a esta ciencia. En este artículo se reflexiona sobre los desafíos enfrentados por los órganos regulatorios en función de la ausencia, o aún incipiente legislación, especialmente en Brasil, ya que los documentos disponibles en relación a la reglamentación, no incluyen especificaciones para nanomedicamentos, los cuales presentan alteraciones en la dimensión y la constitución, y consecuentemente un comportamiento diferente de los medicamentos convencionales. La contingencia que involucra el desarrollo de nanomedicamentos y la gestión de los riesgos para la vida humana y el medio ambiente hacen que la bioética sea invocada para analizar qué impactos se derivan de este proceso

La nanotecnologia s'està desenvolupant de forma exponencial en l'àrea farmacèutica, prometent grans beneficis; no obstant això, pot estar subjecta a riscos intrínsecs relacionats amb aquesta ciència. En aquest article es reflexiona sobre els desafiaments que enfronten els òrgans reguladors en funció de l'absència, o d’una legislació incipient, especialment al Brasil, ja que els documents disponibles en relació a la reglamentació no inclouen especificacions per a nanomedicaments, els quals presenten alteracions en la seva dimensió i constitució, i conseqüentment presenten un comportament diferent al dels medicaments convencionals. La contingència que involucra el desenvolupament de nanomedicaments i la gestió dels riscos per a la vida humana i el medi ambient fan que la bioètica hagi de jugar un paper a fi d’analitzar quins impactes es deriven d'aquest procés

Smart tattoo: technology for monitoring blood glucose in the future.

New ways of measuring blood glucose bring hope of easing the burden of diabetes management for patients living with the conditions. The smart tattoo is an innovation that represents a nascent nanotechnology, which is designed to be implanted within the skin to provide continuous and reliable glucose detection for individuals diagnosed with diabetes. The potential benefits of the smart tattoo are compelling not only due to the potential of these nanodevices to prevent diabetic complications and decrease the related social costs, but also due to ease of use and relative user comfort. However, despite the advantages of the smart tattoo, it is important that health professionals, in embracing nanotechnology, understand the ethical implications of using these innovative devices.

Criterios éticos y legales para la toma de decisiones en intervenciones relacionadas con nanotecnología / Ethical and legal criteria for decision making related to Nanotechnology

Las tecnociencias fundamentan su avance en la promesa de una mejor calidad de vida para el ser humano. Sin embargo, es necesario evitar el extremo del optimismo ignorante de los condicionantes económicos de las intervenciones tecno científicas, como también la ignorancia de las vulnerabilidades en juego. Una intervención capaz de obtener la legitimidad social implica que todos los involucrados puedan aceptar las consecuencias que se desprenden de ella. En el caso de las nanotecnologías, las intervenciones han de juzgarse según los criterios procedimentales y según la Declaración Universal de Bioética y Derechos Humanos, que al mismo tiempo podrán regir las nuevas reglamentaciones, normas y leyes que las intervenciones requieran, particularmente en previsión de sus resultados futuros personales, sociales y ambientales. (AU)

Technosciences base their innovations on the promise of a better quality of life for human beeings. However, it is essential to avoid the innocent optimism of economic conditionants of technological and scientific interventions as well as to ignore the hazards of these attempts. A socially legitimate intervention implies that every participant involved would be able to accept the consequences that derive from it. As regards to Nanotechnology, such interventions should be analyzed under the light of their procedures criteria and the Universal Declaration of Bioethics and Human Rights, that will also rule a new legislation later required for each development, forthseeing personal, social and environmental outcomes. (AU)

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.

Returning to the Patent Landscapes for Nanotechnology: Assessing the Garden that It Has Grown Into.

The patent landscape, like a garden, can tell you much about its designers and users; their motivations, biases, and general interests. While both patent landscapes and gardens may appear to the casual observer as refined and ordered, an in-depth exploration of the terrain is likely to reveal unforeseen challenges including, for example, alien species, thickets, and trolls. As this Chapter illustrates, patent landscapes are dynamic and have been forced to continually evolve in response to technological innovation. While emerging technologies, such as biotechnology and information communication technology have challenged the traditional patent landscape, resulting in the pruning of certain elements here and there, the overarching framework and design has largely remained intact. But will this always be the case? As the field of nanotechnology continues to evolve and mature, the aim of this Chapter is to map how the technology has evolved and grown within the confines of existing structures and underlying foundation of the patent landscape and the implications thereof for the technology, industry, and the public more generally. The Chapter concludes by asking the question whether the current patent landscape will be able to withstand the ubiquitous nature of the technology, or whether nanotechnology, in combination with other emerging technologies, will be a catalyst for governments and policy makers to completely redesign the patent landscape.

Just a Cog in the Machine? The Individual Responsibility of Researchers in Nanotechnology is a Duty to Collectivize.

Responsible Research and Innovation (RRI) provides a framework for judging the ethical qualities of innovation processes, however guidance for researchers on how to implement such practices is limited. Exploring RRI in the context of nanotechnology, this paper examines how the dispersed and interdisciplinary nature of the nanotechnology field somewhat hampers the abilities of individual researchers to control the innovation process. The ad-hoc nature of the field of nanotechnology, with its fluid boundaries and elusive membership, has thus far failed to establish a strong collective agent, such as a professional organization, through which researchers could collectively steer technological development in light of social and environmental needs. In this case, individual researchers cannot innovate responsibly purely by themselves, but there is also no structural framework to ensure that responsible development of nanotechnologies takes place. We argue that, in such a case, individual researchers have a duty to collectivize. In short, researchers in situations where it is challenging for individual agents to achieve the goals of RRI are compelled to develop organizations to facilitate RRI. In this paper we establish and discuss the criteria under which individual researchers have this duty to collectivize.

Creating Inquiry Between Technology Developers and Civil Society Actors: Learning from Experiences Around Nanotechnology.

Engaging civil society actors as knowledgeable dialogue partners in the development and governance of emerging technologies is a new challenge. The starting point of this paper is the observation that the design and orchestration of current organized interaction events shows limitations, particularly in the articulation of issues and in learning how to address the indeterminacies that go with emerging technologies. This paper uses Dewey's notion of 'publics' and 'reflective inquiry' to outline ways of doing better and to develop requirements for a more productive involvement of civil society actors. By studying four novel spaces for interaction in the domain of nanotechnology, this paper examines whether and how elements of Dewey's thought are visible and under what conditions. One of the main findings is that, in our society, special efforts are needed in order for technology developers and civil society actors to engage in a joint inquiry on emerging nanotechnology. Third persons, like social scientists and philosophers, play a role in this respect in addition to external input such as empirically informed scenarios and somewhat protected spaces.

Scientists' Ethical Obligations and Social Responsibility for Nanotechnology Research.

Scientists' sense of social responsibility is particularly relevant for emerging technologies. Since a regulatory vacuum can sometimes occur in the early stages of these technologies, individual scientists' social responsibility might be one of the most significant checks on the risks and negative consequences of this scientific research. In this article, we analyze data from a 2011 mail survey of leading U.S. nanoscientists to explore their perceptions the regarding social and ethical responsibilities for their nanotechnology research. Our analyses show that leading U.S. nanoscientists express a moderate level of social responsibility about their research. Yet, they have a strong sense of ethical obligation to protect laboratory workers (in both universities and industry) from unhealthy exposure to nanomaterials. We also find that there are significant differences in scientists' sense of social and ethical responsibility depending on their demographic characteristics, job affiliation, attention to media content, risk perceptions and benefit perceptions. We conclude with some implications for future research.

Caring for nanotechnology? Being an integrated social scientist.

One of the most significant shifts in science policy of the past three decades is a concern with extending scientific practice to include a role for 'society'. Recently, this has led to legislative calls for the integration of the social sciences and humanities in publicly funded research and development initiatives. In nanotechnology--integration's primary field site--this policy has institutionalized the practice of hiring social scientists in technical facilities. Increasingly mainstream, the workings and results of this integration mechanism remain understudied. In this article, I build upon my three-year experience as the in-house social scientist at the Cornell NanoScale Facility and the United States' National Nanotechnology Infrastructure Network to engage empirically and conceptually with this mode of governance in nanotechnology. From the vantage point of the integrated social scientist, I argue that in its current enactment, integration emerges as a particular kind of care work, with social scientists being fashioned as the main caretakers. Examining integration as a type of care practice and as a 'matter of care' allows me to highlight the often invisible, existential, epistemic, and affective costs of care as governance. Illuminating a framework where social scientists are called upon to observe but not disturb, to reify boundaries rather than blur them, this article serves as a word of caution against integration as a novel mode of governance that seemingly privileges situatedness, care, and entanglement, moving us toward an analytically skeptical (but not dismissive) perspective on integration.

Princípio de precaução e nanotecnociências / The principle of precaution and the nano-techno-sciences / Principio de precaución y nanotecnociencias

O rápido desenvolvimento das nanotecnociências e a crença de que representam ameaças à sobrevivência no planeta têm levado grupos da sociedade civil organizada a pedir moratória para as pesquisas nanotecnocientíficas, baseando-se no princípio de precaução. Constata-se que esse princípio suscita debates em torno do conceito, da sua forma de aplicação e de suas implicações bioéticas. Alguns termos como “risco”, “perigo”, “dano”, “incerteza”, “ignorância”, “prevenção” e “precaução” são tomados como sinônimos, o que pode levar a decisões políticas por vezes “exageradas”. Aplicado quase sempre como medida de tutela do meio ambiente, o princípio de precaução tem se tornado importante instrumento regulatório das tecnociências, por se acreditar que, junto com os potenciais benefícios, trazem ameaças à vida e ao planeta. As tecnociências não são entes autônomos, mas, sim, pensados, criados e manejados pelo ser humano. Portanto, não há que atribuir um risco inerente a todo e qualquer produto tecnocientífico.

The rapid development of the nano-techno-sciences and the belief that they represent threats to the survival of the planet have led groups of organized civil society to request moratoria on nano-techno-scientific research, based on the principle of precaution. This article takes off from the finding that this principle provokes debates around its concept, its form of application and its bioethical implications. Here terms such as risk/danger, uncertainty/ignorance, and prevention/precaution are confounded as synonyms - which can lead to policy decisions that are at times "exaggerated." Applied almost always as a measure of stewardship of the environment, the principle has become an important regulatory principle of the techno-sciences, because it is believed that together with the potential benefits, they bring threats to life on the planet. The techno-sciences are not autonomous, but rather entities conceived, created and managed by human beings. Thus there is no way to attribute an inherent risk to any and all techno-scientific products.

El rápido desarrollo de las nanotecnociencias y la creencia de que representan amenazas a la supervivencia en el planeta, ha llevado a grupos de la sociedad civil organizada a pedir una moratoria para las investigaciones nanotecnocientíficas, en base al principio de precaución. El artículo parte de la constatación de que este principio suscita debates en torno a su conocimiento, su forma de aplicación y sus implicaciones bioéticas. Algunos términos como riesgo/peligro/daño, incertidumbre/ignorancia, prevención/precaución son confundidos como sinónimos, lo que puede conducir a decisiones políticas, a veces, “exageradas”. Aplicado casi siempre como medida de tutela del medio ambiente, el principio se ha tornado un importante instrumento regulatorio de las tecnociencias por creerse que, junto con los potenciales beneficios, traen amenazas a la vida y al planeta. Las tecnociencias no son entes autónomos, sino que son pensadas, creadas y manejadas por el ser humano. Por lo tanto, no hay que atribuir un riesgo inherente a todo y cualquier producto tecnocientífico.

La gran revolución de lo pequeño: nanotecnologías y prevención de riesgos laborales / The great revolution of the small: nanotechnology and occupational risk prevention

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Nanotechnology, neuromodulation & the immune response: discourse, materiality & ethics.

Drawing upon the American Pragmatic tradition in philosophy and the more recent work of philosopher Karen Barad, this paper examines how scientific problems are both obscured, and resolved by our use of language describing the natural world. Using the example of the immune response engendered by neural implants inserted in the brain, the author explains how this discourse has been altered by the advent of nanotechnology methods and devices which offer putative remedies that might temper the immune response in the central nervous system. This emergent nanotechnology has altered this problem space and catalyzed one scientific community to acknowledge a material reality that was always present, if not fully acknowledged.

A matter of accuracy. Nanobiochips in diagnostics and in research: ethical issues as value trade-offs.

The paper deals with the introduction of nanotechnology in biochips. Based on interviews and theoretical reflections, it explores blind spots left by technology assessment and ethical investigations. These have focused on possible consequences of increased diffusability of a diagnostic device, neglecting both the context of research as well as increased accuracy, despite it being a more essential feature of nanobiochip projects. Also, rather than one of many parallel aspects (technical, legal and social) in innovation processes, ethics is considered here as a ubiquitous system of choices between sometimes antagonistic values. Thus, the paper investigates what is at stake when accuracy is balanced with other practical values in different contexts. Dramatic nanotechnological increase of accuracy in biochips can raise ethical issues, since it is at odds with other values such as diffusability and reliability. But those issues will not be as revolutionary as is often claimed: neither in diagnostics, because accuracy of measurements is not accuracy of diagnostics; nor in research, because a boost in measurement accuracy is not sufficient to overcome significance-chasing malpractices. The conclusion extends to methodological recommendations.