Little if any of the scholarly literature on nanotechnology (NT) and ethics is directed at NT researchers. Many of these practitioners believe that having clear ethical guidelines for the conduct of NT research is necessary. This work attempts to provide such guidelines. While no qualitatively new ethical issues unique to NT have yet been identified, the ethical responsibilities identified below merit serious attention by NT researchers. Thirteen specific ethical responsibilities arising at (...) three levels are identified. They are derived by applying four fundamental ethical responsibilities of scientists and engineers to the specific conditions of NT research and researchers in contemporary Western societies. Since society is placing increasing importance on producing scientists and engineers who combine high technical competence with a sensitive ethical compass, study of the ethical dimension of NT, including the identified ethical responsibilities, should become a required element of the formal education of all NT researchers. (shrink)

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 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. (shrink)

A study was conducted of nanotechnology (NT) researchers’ views about ethics in relation to their work. By means of a purpose-built questionnaire, made available on the Internet, the study probed NT researchers’ general attitudes toward and beliefs about ethics in relation to NT, as well as their views about specific NT-related ethical issues. The questionnaire attracted 1,037 respondents from 13 U.S. university-based NT research facilities. Responses to key questionnaire items are summarized and noteworthy findings presented. For (...) most respondents, the ethical responsibilities of NT researchers are not limited to those related to safety and integrity in the laboratory. Most believe that NT researchers also have specific ethical responsibilities to the society in which their research is done and likely to be applied. NT appears to be one of the first areas of contemporary technoscientific activity in which a long-standing belief is being seriously challenged: the belief that society is solely responsible for what happens when a researcher’s work, viewed as neutral and merely enabling, is applied in a particular social context. Survey data reveal that most respondents strongly disagree with that paradigmatic belief. Finally, an index gauging NT researcher sensitivity to ethics and ethical issues related to NT was constructed. A substantial majority of respondents exhibited medium or high levels of sensitivity to ethics in relation to NT. Although most respondents view themselves as not particularly well informed about ethics in relation to NT, a substantial majority are aware of and receptive to ethical issues related to their work, and believe that these issues merit consideration by society and study by current and future NT practitioners. (shrink)

To what extent do nanotechnology researchers discern specific work-related ethical responsibilities that are incumbent upon them? A questionnaire was designed and administered to answer this question. Analysis of responses to 11 ethical responsibility statements (ERSs) by 213 researchers at the Stanford Nanofabrication Facility revealed widespread agreement about a number of work-related ethical responsibilities and substantial divergence in the views about several others. Explanations of this divergence are proposed. A new variable is defined (...) that gauges the respondent’s overall level of discernment of the ethical responsibilities referenced in the ERSs. The mean discernment level score for respondents who had taken a course that included discussion of ethical issues closely related to science, technology, or engineering was significantly higher than for those who had not. Further, among respondents who had taken such a course, the mean discernment level score for those who had taken an ethics course devoted to exploration of ethical issues closely related to science, technology, or engineering was significantly higher than for those who had taken a technical science or engineering course that typically pays only fleeting attention to such issues. Implications of these findings are discussed. (shrink)

Little previous research has examined attitudes about societal and ethical issues (SEI) among interns participating in research experience for undergraduate programs (REUs) in nanotechnology, thus neglecting an important population for understanding the burgeoning views of the next generation of nanotechnology researchers. This study surveyed a sample of interns (N = 85) participating in the National Nanotechnology Infrastructure Network’s (NNIN) REU program during the summer of 2012. Our questions focused on interns’ experiences with education on (...) class='Hi'>ethical issues, as well as their attribution of responsibility for considering ethical issues, motivations to talk about ethical issues, and comfort level of discussing ethical issues with faculty, mentors, lab staff, and other REU students. Among key findings was that lab culture related to the extent to which REU interns felt comfortable discussing ethical issues. In addition, those who reported more discussions about ethical issues with their mentors were more likely to consider themselves as responsible for considering ethical issues. We conclude with recommendations and future research directions. (shrink)

This book disentangles the complex meanings of responsibility in nanotechnology development by focusing on its theoretical and empirical dimensions. The notion of responsibility is extremely diversified in the public discourse of nanoscale technologies. Addressed are major disciplinary perspectives working on nanotechnology, e.g. philosophy, sociology, and political science, as well as the major multidisciplinary areas relevant to the innovation process, e.g. technology assessment and ethics. Furthermore, the interplay between such expertises, disciplines, and research programmes in providing a multidisciplinary understanding (...) of responsibility is emphasized. (shrink)

Responsible Research and Innovation 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. (shrink)

Responsible research and innovation 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. (shrink)

Examining those risk and benefit perceptions utilised in the formation of attitudes and opinions about emerging technologies such as nanotechnology can be useful for both industry and policy makers involved in their development, implementation and regulation. A broad range of different socio-psychological and affective factors may influence consumer responses to different applications of nanotechnology, including ethical concerns. A useful approach to identifying relevant consumer concerns and innovation priorities is to develop predictive constructs which can be used to (...) differentiate applications of nanotechnology in a way which is meaningful to consumers. This requires elicitation of attitudinal constructs from consumers, rather than measuring attitudes assumed to be important by the researcher. Psychological factors influencing societal responses to 15 applications of nanotechnology drawn from different application areas were identified using repertory grid method in conjunction with generalised Procrustes analysis. The results suggested that people differentiate nanotechnology applications based on the extent to which they perceive them to be beneficial, useful, necessary and important. The benefits may be offset by perceived risks focusing on fear and ethical concerns. Compared to an earlier expert study on societal acceptance of nanotechnology, consumers emphasised ethical issues compared to experts but had less concern regarding potential physical contact with the product and time to market introduction. Consumers envisaged fewer issues with several applications compared to experts, in particular food applications. (shrink)

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. (shrink)

Researchers do not owe their subjects the same level of care that physicians owe patients, but they owe more than merely what the research protocol stipulates. In keeping with the dynamics of the relationship between researcher and subject, they have limited but substantive fiduciary obligations.

Asia is the most diverse continent in the world in terms of culture, religion, population size, finance, education, health care, academic research, general population skills, and governmental drug regulations. Each Asian country has its own unique qualities when it comes to attracting industry sponsored clinical trials. Factors that influence selecting location of a study site for a sponsored trial are mainly population size, infrastructure, education levels, and quality of health care, cost and drug regulatory platform. Conducting research in traditional countries (...) like Pakistan adds another dimension to the problems in assuring that research conducted in an ethical manner. The indigenous layer of the cultural values makes it even more difficult task, but this is the task that we are morally and ethically bound to shoulder. (shrink)

There have been several conscious efforts made by different stakeholders in the area of nanoscience and nanotechnology to increase the awareness of social and ethical issues (SEI) among its practitioners. But so far, little has been done at the laboratory level to integrate a SEI component into the laboratory orientation schedule of practitioners. Since the laboratory serves as the locus of activities of the scientific community, it is important to introduce SEI there to stimulate thinking and discussion of (...) SEI among practitioners, which would eventually contribute toward the responsible development of this technology. In this article, through an example (at the Cornell NanoScale Science and Technology Facility (CNF), practitioners of which represent a section of the nano researchers’ community in the USA), it is shown how a SEI component can be incorporated into the laboratory orientation schedule of the practitioners from diverse disciplinary and institutional backgrounds. Results show that, at CNF, the practitioners enjoyed the discussion since most of them learned about SEI for the first time in their professional career. At the same time, some of them were also knowledgeable about SEI and contributed to the debates. Moreover, the SEI orientation had significant positive impact on the scientific community enabling them to self-reflect upon their own research and its implications for the wider society. This article also describes the efforts that were undertaken to disseminate this form of SEI orientation to other 13 USA universities within the National Nanotechnology Infrastructure Network (NNIN, one of the biggest networks funded from National Science Foundation for Nanotechnology research, of which CNF is a part). As a result of this effort, most of the NNIN sites have already started or were in the process of integrating a SEI component into their nanofabrication laboratories to make their users aware of SEI, ensuring eventual robust socio-technical integration in the NNIN laboratories. In the future, this form of SEI orientation can also be disseminated to other nanofabrication laboratories in the USA. (shrink)

In recent years, exposome research has been put forward as the next frontier for the study of human health and disease. Exposome research entails the analysis of the totality of environmental exposures and their corresponding biological responses within the human body. Increasingly, this is operationalized by big-data approaches to map the effects of internal as well as external exposures using smart sensors and multiomics technologies. However, the ethical implications of exposome research are still only rarely discussed in the literature. (...) Therefore, we conducted a systematic review of the academic literature regarding both the exposome and underlying research fields and approaches, to map the ethical aspects that are relevant to exposome research. We identify five ethical themes that are prominent in ethics discussions: the goals of exposome research, its standards, its tools, how it relates to study participants, and the consequences of its products. Furthermore, we provide a number of general principles for how future ethics research can best make use of our comprehensive overview of the ethical aspects of exposome research. Lastly, we highlight three aspects of exposome research that are most in need of ethical reflection: the actionability of its findings, the epidemiological or clinical norms applicable to exposome research, and the meaning and action–implications of bias. (shrink)

Societal and ethical implications of nanotechnology have become a hot topic of public debates in many countries because both revolutionary changes and strong public concerns are expected from its development. Because nanotechnology is, at this point, mostly articulated in visionary and futuristic terms, it is difficult to apply standard methods of technology assessment and even more difficult to consider it in engineering ethics courses. In this article, the authors suggest using selected science fiction stories in the engineering (...) ethics classroom to provide students with ethical skills and cultural knowledge required for engaging in public debates and for responsible decision making. Against the background of general debates on teaching engineering ethics, they do so by discussing the advantages and possible drawbacks of this approach and by presenting two examples of nano-science fiction classics. (shrink)

Anticipation is one of the main goals of new governance models, such as Responsible Research and Innovation. However, there is not a single mode of anticipation in this model. Two approaches can be addressed within the RRI framework: a socio-empirical one, which tends to underline the role of the democratic processes, aimed at identifying values on which governance needs to be anchored ; and a normative one, which stresses the role of EU goals as ‘normative anchor points’ in governance. These (...) two approaches also address two different models of anticipation: one based on the construction of shared pathways for reflexivity on the purposes of innovation, the other based on the progressive implementation of constitutional goals in risk assessment and management tools. However, both can be deemed partially unsatisfactory from the standpoint of human rights since one puts individual rights in the middle of the ‘values lottery’ where any participatory process ultimately leads; the other can be inadequate since fundamental rights are balanced alongside other goals and thus can be sacrificed, exposing the system to possible adverse court decisions. The normative framework of human rights can help to counterbalance both models aimed at maximising inclusion and those aimed at pursuing constitutional normative principles at the basis of technologically advanced societies, strengthening their dimension of anticipation according to a rights-based perspective. (shrink)

This article aims to explore the debate on human enhancement from the perspective of the evolutions of responsibility paradigms, and in particular from the perspective of the so-called Responsible Research and Innovation approach. The aim is not to explore the arguments pro or contra the ethical legitimacy and/or technical feasibility of human enhancement, but rather exploring if, and how, the RRI perspective can shape the debate on human enhancement.In particular, the human enhancement debate will be read through the lenses (...) of four main responsibility paradigms that we sketch by examining both, the historical and conceptual evolution of the responsibility idea and the dynamics of its ascription. In order to provide a useful scheme for interpreting human enhancement, RRI will be characterised as a distinctive responsibility model that can subsequently be used to frame the debate on HE with a particular emphasis on its normative implications, as well as on its social and political significance. (shrink)

The European Union is strategically committed to the development of nanotechnology and its industrial exploitation. However, nanotechnology also has the potential to disrupt human health and the environment. The EU claims to be committed to the safe and responsible development of nanotechnology. In this sense, the EU has become the first governing body in the world to develop nanospecific regulations, largely due to legislative action taken by the European Parliament, which has compensated for the European Commission’s reluctance (...) to develop special regulations for nanomaterials. Nevertheless, divergences aside, political bodies in the EU assume that nanotechnology development is controllable and take for granted that both the massive industrial use of nanomaterials and a high level of environmental and health protection are compatible. However, experiences such as the European controversy over agri-food biotechnology, which somewhat delegitimized the regulatory authority of the EU over technological safety and acceptability, arguably show that controllability assumptions are contestable on the grounds of alternative socio-economic and cultural preferences and values. Recently developed inclusive governance models on safety and innovation, such as “Responsible Research and Innovation”, widely claim that a diversity of considerations and issues are integrated into R&D processes. Even so, the possibility of more radically alternative constitutions of socio-technical safety seems to be seriously limited by the current ideology of innovation and economic imperatives of the global, knowledge-based, capitalist economy. (shrink)

Background The COVID-19 pandemic has forced rapid and widespread change to standards of patient care and nursing practice, inevitably leading to unprecedented shifts in the moral conditions of nursing work. Less is known about how these challenges have affected nurses’ capacity to meet their ethical responsibilities and what has helped to sustain their efforts to continue to care. Research objectives 1) To explore nurses’ experiences of striving to fulfill their ethical responsibilities of care during the COVID-19 (...) pandemic and 2) to explore what has fostered nurses’ capacity to fulfill these responsibilities. Research Design A generic qualitative approach was used incorporating concepts coming from fundamental features of care. Participants Twenty-four Canadian Registered Nurses from a variety of practice settings were interviewed. Ethical Considerations After receiving ethics approval, signed informed consent was obtained before participants were interviewed. Findings Four themes were identified. 1) Challenges providing good care in response to sudden changes in practice. 2) Tensions in juggling the responsibility to prevent COVID-19 infections with other competing moral responsibilities. 3) Supports to foster nurses’ capacity to meet their caring responsibilities. 4) The preservation of nurses’ moral identity through expressions of gratitude and health improvement. Discussion Infection control measures and priorities set in response to the pandemic made at distant population and organizational levels impacted nurses who continued to try to meet the ideals of care in close proximity to patients and their families. Despite the challenges that nurses encountered, the care they received themselves enabled them to continue to care for others. Nurses benefited most from the moral communities they had with their colleagues and occasionally nurse leaders, especially when they were supported in a face-to-face manner. Conclusion: Moral community can only be sustained if nurses are afforded the working conditions that make it possible for them to support each other. (shrink)

While the entire “wish-list” of expected benefits from nanotechnology has received little scrutiny in the U.S. with regard to issues of social justice, ethics specialists and social scientists are beginning to focus on the responsible conduct of actual nano research and development (R&D) in government, commercial, and academic institutions. In view of the current rush to commercialization, the rush by universities to “get aboard,” and the importance of public trust, it is essential to investigate strategies to promote responsible conduct (...) in the nano area. As this paper discusses, public engagement is one strategy; another is the formulation and implementation of standards of care that are the outcome of inclusive, deliberative processes. (shrink)

We describe the national health research ethics review system of Uzbekistan and identify policy and program gaps that impede the protection of human research subjects. We find that the National Ethic Committee (NEC), functioning at the national level, is solely responsible for conducting research ethics review. There is little evidence that regional ethics committees work as intended, and there is no research ethics review at medical institutes and research centers even though they conduct CDTs (clinical drug trials). There is no (...) national policy for the ethical review of non-clinical trials. We recommend the establishment of institutional review boards (IRBs) at medical institutes and research centers while at the same time building capacity at the national level to oversee and support the research ethics review system of the entire country. (shrink)

Research question and aimClinical Ethics Committees (CECs) aim to support healthcare professionals (HPs) and healthcare organizations to deal with the ethical issues of clinical practice. In 2020,...

The prospect of using genome technologies to modify the human germline has raised profound moral disagreement but also emphasizes the need for wide-ranging discussion and a well-informed policy response. The Hinxton Group brought together scientists, ethicists, policymakers, and journal editors for an international, interdisciplinary meeting on this subject. This consensus statement formulated by the group calls for support of genome editing research and the development of a scientific roadmap for safety and efficacy; recognizes the ethical challenges involved in clinical (...) reproductive applications of genome editing but, importantly, rejects the idea that human reproductive germline modification is necessarily morally unacceptable; and highlights the importance of meaningful engagement in discussions of genome editing and the development of regulation and oversight mechanisms to govern future uses of such technologies. (shrink)

New and Emerging Science and Technology (NEST) based innovations, e.g. in the field of Life Sciences or Nanotechnology, frequently raise societal and political concerns. To address these concerns NEST researchers are expected to deploy socially responsible R&D practices. This requires researchers to integrate social and ethical aspects (SEAs) in their daily work. Many methods can facilitate such integration. Still, why and how researchers should and could use SEAs remains largely unclear. In this paper we aim (...) to relate motivations for NEST researchers to include SEAs in their work, and the requirements to establish such integration from their perspectives, to existing approaches that can be used to establish integration of SEAs in the daily work of these NEST researchers. Based on our analyses, we argue that for the successful integration of SEAs in R&D practice, collaborative approaches between researchers and scholars from the social sciences and humanities seem the most successful. The only way to explore whether that is in fact the case, is by embarking on collaborative research endeavours. (shrink)

The exponential developments of internet services and resources have brought enormous benefits, but also enormous moral and ethical challenges. This paper introduces the contributions from a research workshop, tasked with defining new ethical responsibilities for Internet Service Providers (ISPs).

New and Emerging Science and Technology (NEST) based innovations, e.g. in the field of Life Sciences or Nanotechnology, frequently raise societal and political concerns. To address these concerns NEST researchers are expected to deploy socially responsible R&D practices. This requires researchers to integrate social and ethical aspects (SEAs) in their daily work. Many methods can facilitate such integration. Still, why and how researchers should and could use SEAs remains largely unclear. In this paper we aim (...) to relate motivations for NEST researchers to include SEAs in their work, and the requirements to establish such integration from their perspectives, to existing approaches that can be used to establish integration of SEAs in the daily work of these NEST researchers. Based on our analyses, we argue that for the successful integration of SEAs in R&D practice, collaborative approaches between researchers and scholars from the social sciences and humanities seem the most successful. The only way to explore whether that is in fact the case, is by embarking on collaborative research endeavours. (shrink)

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. (shrink)

Background Studying global health problems requires international multidisciplinary teams. Such multidisciplinarity and multiculturalism create challenges in adhering to a set of ethical principles across different country contexts. Our group on health system responses to violence against women (VAW) included two universities in a European high-income country (HIC) and four universities in low-and middle-income countries (LMICs). This study aimed to investigate professional and policy perspectives on the types, causes of, and solutions to ethical challenges specific to the ethics approval (...) stage of the global research projects on health system responses to VAW. Methods We used the Network of Ethical Relationships model, framework method, and READ approach to analyse qualitative semi-structured interviews (n = 18) and policy documents (n = 27). In March-July 2021, we recruited a purposive sample of researchers and members of Research Ethics Committees (RECs) from the five partner countries. Interviewees signposted policies and guidelines on research ethics, including VAW. Results We developed three themes with eight subthemes summarising ethical challenges across three contextual factors. The global nature of the group contributed towards power and resource imbalance between HIC and LMICs and differing RECs’ rules. Location of the primary studies within health services highlighted differing rules between university RECs and health authorities. There were diverse conceptualisations of VAW and vulnerability of research participants between countries and limited methodological and topic expertise in some LMIC RECs. These factors threatened the timely delivery of studies and had a negative impact on researchers and their relationships with RECs and HIC funders. Most researchers felt frustrated and demotivated by the bureaucratised, uncoordinated, and lengthy approval process. Participants suggested redistributing power and resources between HICs and LMICs, involving LMIC representatives in developing funding agendas, better coordination between RECs and health authorities and capacity strengthening on ethics in VAW research. Conclusions The process of ethics approval for global research on health system responses to VAW should be more coordinated across partners, with equal power distribution between HICs and LMICs, researchers and RECs. While some of these objectives can be achieved through education for RECs and researchers, the power imbalance and differing rules should be addressed at the institutional, national, and international levels. Three of the authors were also research participants, which had potential to introduce bias into the findings. However, rigorous reflexivity practices mitigated against this. This insider perspective was also a strength, as it allowed us to access and contribute to more nuanced understandings to enhance the credibility of the findings. It also helped to mitigate against unequal power dynamics. (shrink)

In lieu of an abstract, here is a brief excerpt of the content:Convention for Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Biomedicine: Convention on Human Rights and BiomedicineCouncil of EuropePreambleThe Member States of the Council of Europe, the other States and the European Community signatories hereto,Bearing in mind the Universal Declaration of Human Rights proclaimed by the General Assembly of the United Nations on 10 December 1948;Bearing in mind the (...) Convention for the Protection of Human Rights and Fundamental Freedoms of 4 November 1950;Bearing in mind the European Social Charter of 18 October 1961;Bearing in mind the International Covenant on Civil and Political Rights and the International Covenant on Economic, Social and Cultural Rights of 16 December 1966;Bearing in mind the Convention for the Protection of Individuals with Regard to Automatic Processing of Personal Data of 28 January 1981;Bearing also in mind the Convention on the Rights of the Child of 20 November 1989;Considering that the aim of the Council of Europe is the achievement of a greater unity between its members and that one of the methods by which that aim is to be pursued is the maintenance and further realisation of human rights and fundamental freedoms;Conscious of the accelerating developments in biology and medicine;Convinced of the need to respect the human being both as an individual and as a member of the human species and recognising the importance of ensuring the dignity of the human being; [End Page 277]Conscious that the misuse of biology and medicine may lead to acts endangering human dignity;Affirming that progress in biology and medicine should be used for the benefit of present and future generations;Stressing the need for international co-operation so that all humanity may enjoy the benefits of biology and medicine;Recognising the importance of promoting a public debate on the questions posed by the application of biology and medicine and the responses to be given thereto;Wishing to remind all members of society of their rights and responsibilities;Taking account of the work of the Parliamentary Assembly in this field, including Recommendation 1160 (1991) on the preparation of a Convention on bioethics;Resolving to take such measures as are necessary to safeguard human dignity and the fundamental rights and freedoms of the individual with regard to the application of biology and medicine;Have agreed as follows:Chapter IGeneral provisionsArticle 1. (Purpose and object)Parties to this Convention shall protect the dignity and identity of all human beings and guarantee everyone, without discrimination, respect for their integrity and other rights and fundamental freedoms with regard to the application of biology and medicine.Each Party shall take in its internal law the necessary measures to give effect to the provisions of this Convention.Article 2. (Primacy of the human being)The interests and welfare of the human being shall prevail over the sole interest of society or science.Article 3. (Equitable access to health care)Parties, taking into account health needs and available resources, shall take appropriate measures with a view to providing, within their jurisdiction, equitable access to health care of appropriate quality. [End Page 278]Article 4. (Professional standards)Any intervention in the health field, including research, must be carried out in accordance with relevant professional obligations and standards.Chapter IIConsentArticle 5. (General rule)An intervention in the health field may only be carried out after the person concerned has given free and informed consent to it.This person shall beforehand be given appropriate information as to the purpose and nature of the intervention as well as on its consequences and risks.The person concerned may freely withdraw consent at any time.Article 6. (Protection of persons not able to consent)1. Subject to Articles 17 and 20 below, an intervention may only be carried out on a person who does not have the capacity to consent, for his or her direct benefit.2. Where, according to law, a minor does not have the capacity to consent to an intervention, the intervention may only be carried out with the authorisation of his or her representative or an authority or a person or... (shrink)

The genetically manipulated organism crisis demonstrated that technological development based solely on the law of the marketplace and State protection against serious risks to health and safety is no longer a warrant of ethical acceptability. In the first part of our paper, we critique the implicitly individualist social-acceptance model for State regulation of technology and recommend an interdisciplinary approach for comprehensive analysis of the impacts and ethical acceptability of technologies. In the second part, we present a framework for (...) the analysis of impacts and acceptability, devised—with the goal of supporting the development of specific nanotechnological applications—by a team of researchers from various disciplines. At the conceptual level, this analytic framework is intended to make explicit those various operations required in preparing a judgement about the acceptability of technologies that have been implicit in the classical analysis of toxicological risk. On a practical level, we present a reflective tool that makes it possible to take into account all the dimensions involved and understand the reasons invoked in determining impacts, assessing them, and arriving at a judgement about acceptability. (shrink)

No one really knows where nanotechnology is leading, what its pursuit will mean, and how it may affect human and other forms of life. Nevertheless, its research and development are moving briskly into that unknown. It has been suggested that rapid movement towards 'who knows where' is endemic to all technological development; that its researchers pursue it for curiosity and enjoyment, without knowing the consequences, believing that their efforts will be beneficial. Further, that the enthusiasm for development comes (...) with no malicious intent but rather from simple ignorance. Contrary to that commonly held perception about the collective pursuit of technological development, there are individual research scientists and engineers who are quite willing to reflect on the meaning of their work in nanotechnology. Nanotalk is a book of conversations and explorations with thirty five such nano-research scientists and engineers who share their ideas, experiences, perceptions, and beliefs about their work, humanity, nature, change, and the future of the world with nanotechnology. Precisely because of the unknowable nature of nanotechnology research and development, conscientious foresight and ethical reflection are warranted every step of the way. Not only do nanotechnology research and development represent enormous financial commitments, but they also require a profound leap of faith regarding its possible outcomes. Using these conversations as the basis of reflection and deliberation, the author explores the possible significance of nanotechnology to humanity and how it might be pursued conscientiously and ethically. (shrink)

Bioethicists frequently call for empirical researchers to engage participants and community members in their research, but don't themselves typically engage community members in their normative research. In this article, we describe an effort to include members of the public in normative discussions about the risks, potential benefits, and ethical responsibilities of social and behavioral genomics (SBG) research. We reflect on what might—and might not— be gained from engaging the public in normative scholarship and on lessons learned about (...) public perspectives on the risks and potential benefits of SBG research and the responsible conduct and communication of such research. We also provide procedural lessons for others in bioethics who are interested in engaging members of the public in their research. (shrink)

We are currently witnessing the emergence of a discourse on responsible research and innovation in the field of quantum technology. Working on the assumption that the initial stage of discourse is of particular importance with regard to the ascription of meaning to an emerging field, our point of departure is a small corpus of prominent policy-oriented reports on quantum technology recently published in Europe. With a view to these publications, the article analyses various approaches to RRI and discusses lessons learned (...) in nanotechnology discourse as these may impact on emerging discourse on quantum technology and its stance towards RRI. On the basis of our analyses, we outline a strategy for fostering RRI in this promising field of science and technology. We propose implementing a “strong” RRI approach which entails linking parliamentary or other core policy processes to stakeholder dialogues, decision-supporting public engagement and a wide variety of other public communication activities. At the same time, taking our cue from lessons learned in nanotechnology discourse, we argue that a strong RRI approach to quantum technology should be modest and focused in terms of thematic and societal scope. (shrink)

This book features the contribution of major European research projects on the governance and ethics of Nanotechnology. They focus on the responsible development of nanotechnology and on the understanding of public debate.

Developing countries face numerous barriers to conducting effective and efficient ethics reviews of international collaborative research. In addition to potentially overlooking important scientific and ethical considerations, inadequate or insufficiently trained ethics committees may insist on unwarranted changes to protocols that can impair a study's scientific or ethical validity. Moreover, poorly functioning review systems can impose substantial delays on the commencement of research, which needlessly undermine the development of new interventions for urgent medical needs. In response to these concerns, (...) the Drugs for Neglected Diseases Initiative, an independent nonprofit organization founded by a coalition of public sector and international organizations, developed a mechanism to facilitate more effective and efficient host country ethics review for a study of the use of fexinidazole for the treatment of late stage African Trypanosomiasis. The project involved the implementation of a novel ‘pre-review’ process of ethical oversight, conducted by an ad hoc committee of ethics committee representatives from African and European countries, in collaboration with internationally recognized scientific experts. This article examines the process and outcomes of this collaborative process. (shrink)

A Decent Proposal: Ethical Review of Clinical Research Donald Evans and Martyn Evans Centre for Philosophy and Health Care University of Wales Swansea, UK The investigation and development of modern medicines and medical technology can create numerous ethical dilemmas both for clinical researchers and research ethics committees. A Decent Proposal: Ethical Review of Clinical Research seeks to facilitate and encourage good clinical research by exploring the concerns, responsibilities, general issues and particular pitfalls associated with (...) class='Hi'>ethical aspects of research. It provides practical guidelines for researchers on how to improve the quality of research design, while for those appointed to scrutinise research proposals it offers advice on how to apply consistent, careful and critical reasoning to the process of assessing ethical standards. As such, it will provide invaluable assistance to clinical researchers and ethics committees alike in understanding the moral challenges posed by modern health care. (shrink)

The assessment of nanotechnology applications such as nanocarrier-based targeted drug delivery has historically been based mostly on toxicological and safety aspects. The use of nanocarriers for TDD, a leading-edge nanomedical application, has received little study from the angle of experts’ perceptions and acceptability, which may be reflected in how TDD applications are developed. In recent years, numerous authors have maintained that TDD assessment should also take into account impacts on ethical, environmental, economic, legal, and social issues in order (...) to lead to socially responsible innovation. Semi-structured interviews were conducted with French and Canadian researchers and research trainees with diverse disciplinary backgrounds and involved in research related to emerging technologies. The interviews focussed on scenarios presenting two types of TDD nanocarriers in two contexts of use. Content and inductive analyses of interviews showed how facets of perceived impacts such as health, environment, social cohabitation, economy, life and death, representations of the human being and nature, and technoscience were weighed in acceptability judgments. The analyses also revealed that contextual factors related to device, to use, and to user influenced the weighting assigned to perceived impacts and thus contributed to variability in interviewees’ judgments of acceptability. Giving consideration to researchers’ perspective could accompany first steps of implementation and development of nanomedicine by producing a first, but wide, picture of the acceptability of nanocarrier-based TDD. (shrink)

The informed-consent process should be one of meaningful information exchange between researchers and study participants. One of the responsibilities of research ethics committees is to oversee appropriate informed consent. The committee must consider various matters before deciding whether the process is appropriate, including the adequacy and completeness of the written information provided to study participants, and the process of obtaining informed consent. This study aimed to identify, quantitatively and qualitatively, consent-related issues in different types of malaria proposals submitted (...) to the Faculty of Tropical Medicine, Ethics Committee. This study reviewed proposal documentation submitted to two panels of the Ethics Committee of the Faculty of Tropical Medicine, Mahidol University, from 2011 to 2015. The documentation included proposals, notifications to researchers of review outcomes and ethical issues of concern to committee members. Each element of the informed-consent process was identified and analyzed by study classification, design, and specimen use, including whether the study involved a vulnerable population. Summative content analysis was used to analyze patterns of common issues raised in reviews. Of the 112 proposals reviewed, 63 required an informed consent process. All researchers proposed communicating with their study participants; however, about two-thirds needed to improve their explanations of study procedures to participants. About 40% of the proposals attracted comments on informed-consent process elements--risk and discomfort, vulnerable status, and compensation. Studies that planned to collect or use new/linked specimens raised more issues around informed consent than studies using linked data/records. Studies that involved vulnerable populations raised more issues than those that did not. The committee usually asked researchers to clarify, elaborate, revise, or paraphrase the consent process elements that were considered to involve inadequate information exchange between researcher and study participant. This study aimed to describe lessons for malaria researchers about common informed-consent process issues in different types of malaria proposals. The information and analysis of informed-consent elements should assist the preparation of malaria-research proposals. (shrink)

The circular economy (CE) framework has captured the attention of industry and academia and received strong policy support. It is currently deemed as a powerful solution for sustainability, despite ongoing criticism on its oversimplification and lack of consideration of socio-ethical issues. In parallel, the concept of RRI has emerged strongly with a strong focus on the integration of social desirability in innovation under transparency, democracy and mutual responsiveness principles. In this paper, we critically examine the literature on the CE (...) and RRI in order to find out how the different focus of RRI may provide an innovation governance framework to strengthen the CE framework. There are two main ways in which RRI could further the CE: first, anticipating unexpected consequences, helping to break disciplinary barriers and acknowledging systemic limits that are not currently taken into consideration; and second, the integration of socio-ethical issues in the CE, and addressing the social implications of the CE through stakeholder participation. However, future research should look at remaining blind spots of CE and RRI, such as non-technological innovation, the demand-side of innovation and the development of business models. With that objective, we suggest a research agenda for common development of the frameworks. (shrink)

This article contributes to the debate on governance of emerging technologies, focusing in particular on the international level and taking into account the fact that these technologies are developed through a common effort of different stakeholders including governments, research communities, industry and civil society actors. These issues are explored from the perspective of communitarian ethical criticism of liberal social contract thinking, in order to enhance visibility of the influence collective non-state actors exercise on the development of these technologies. In (...) particular, the effect of different values in the discussion on emerging technologies on the perceived governance options is explored. A paradigm shift from defensive values such as security, risk and human rights to more optimistic values like peace, justice and integrity of creation is proposed and discussed. (shrink)