Nanotechnology, which involves manipulation of matter on a ‘nano’ scale, is considered to be a key enabling technology. Medical applications of nanotechnology are expected to significantly improve disease diagnostic and therapeutic modalities and subsequently reduce health care costs. However, there is no consensus on the definition of nanotechnology or nanomedicine, and this stems from the underlying debate on defining ‘nano’. This paper aims to present the diversity in the definition of nanomedicine and its impact on the translation of (...) basic science research in nanotechnology into clinical applications. We present the insights obtained from exploratory qualitative interviews with 46 stakeholders involved in translational nanomedicine from Europe and North America. The definition of nanomedicine has implications for many aspects of translational research including: fund allocation, patents, drug regulatory review processes and approvals, ethical review processes, clinical trials and public acceptance. Given the interdisciplinary nature of the field and common interest in developing effective clinical applications, it is important to have honest and transparent communication about nanomedicine, its benefits and potential harm. A clear and consistent definition of nanomedicine would significantly facilitate trust among various stakeholders including the general public while minimizing the risk of miscommunication and undue fear of nanotechnology and nanomedicine. (shrink)

There is little doubt that the development and commercialisation of nanotechnologies is challenging traditional state-based regulatory regimes. Yet governments currently appear to be taking a non-interventionist approach to directly regulating this emerging technology. This paper argues that a large regulatory toolbox is available for governing this small technology and that as nanotechnologies evolve, many regulatory advances are likely to occur outside of government. It notes the scientific uncertainties facing us as we contemplate nanotechnology regulatory matters and (...) then examines the notion of regulation itself, suggesting new ways to frame our understanding of both regulation and the regulatory tools relevant to nanotechnologies. By drawing upon three different conceptual lenses of regulation, the paper articulates a wide range of potential regulatory tools at hand. It also focuses particularly on the ways various tools are currently being used or perhaps may be employed in the future. The strengths and weaknesses characterising these tools is examined as well as the different actors involved. The paper concludes that we will increasingly face debate over what is likely to work most effectively in regulating nano technologies, the legitimacy of these different potential approaches, and the speed at which these different regimes may be employed. (shrink)

There are increasing calls internationally for the development of regulation and policies related to the rapidly growing nanotechnologies sector. As part of the process of policy formation, it is widely accepted that deliberative community engagement processes should be included, enabling publics to have a say about nanotechnologies, expressing their hopes and fears, issues and concerns, and that these will be considered as part of the policy process. The Australian Federal and State governments have demonstrated a commitment to these ideals, undertaking (...) a number of public engagement activities in recent years. However, despite promises that these community engagement activities will enable policy makers to identify complex and contested community attitudes, and that these will be included as part of the policy making process, a closer look at Australia’s engagement activities reveals something quite different. Through an analysis of a number of Australia’s nano-engagement activities, this paper demonstrates the limits of public engagement related to the development of nanotechnology related policies and regulation in Australia. Our analysis reveals the extent to which industry interests have captured policy makers and regulators, dissenting voices have been excluded from engagement processes, and engagement processes have not connected with actual policy making activities. Reflecting on these limits, this paper concludes with recommendations for improving public engagement processes related to nanotechnologies in Australia. (shrink)

In contrast to many countries, the political debates in the Netherlands on reproductive technologies and embryo research have paid particular attention to the issue of health risks to women. This article focuses on the question to what extent the discourse of gender has contributed to shaping the space for embryonic research in this country. The author argues that in the policy arena flexible conceptualizations of risks and burdens to women and of the identities of embryos have been crucial in (...) drawing and maintaining a discursive boundary between the domains of medically assisted reproduction and embryo research. The author shows that feminist intervention challenging this discursive strategy has had an impact on the present regulation of research. However, the main weakness of this temporary and partial feminist success is the virtual absence of a public debate on the meaning and desirability of embryo research. (shrink)

Alternative proteins, including plant-based and cell-based meat and dairy analogues, are discursively positioned as a new form of meat and dairy and as a solution to the myriad of issues associated with conventional animal agriculture. Animal agricultural industries across various nations have resisted this positioning in regulatory spaces by advocating for laws that restrict the use of meat and dairy terms on the labels of alternative proteins products. Underlying this contestation are differing understandings of, and vested interests in, desirable (...) futures for animal agriculture. In Australia, this broader contestation led to a national-level inquiry by a Senate parliamentary committee entitled _Definitions of meat and other animal products_ (the Inquiry). This paper reports findings from a study of the problematizations developed through the Inquiry using a framework for policy discourse analysis referred to as Bacchi’s ‘What’s the Problem Represented to be’ methodology. It shows how the dominant discourse throughout the Inquiry moved away from the initial problematization of alternative proteins as a threat to animal agriculture. Instead, both industries were ultimately positioned as not in competition and only labelling laws were problematized with the solution being amendments to ensure ‘consumer clarity’. This outcome ignored a range of alternative problematizations related to the ethical, environmental, health, social and economic issues raised by animal agriculture and by alternative proteins. This lack of scrutiny benefits both industries, by closing off the policy discourse to consideration of a range of alternative interests, voices, and potential solutions, such as stricter health and welfare regulation. (shrink)

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA (...) policy, we argue, does not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA (...) policy, we argue, does not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

We argue that nano-technology in the form of invisible tags, sensors, and Radio Frequency Identity Chips (RFIDs) will give rise to privacy issues that are in two ways different from the traditional privacy issues of the last decades. One, they will not exclusively revolve around the idea of centralization of surveillance and concentration of power, as the metaphor of the Panopticon suggests, but will be about constant observation at decentralized levels. Two, privacy concerns may not exclusively be about constraining (...) information flows but also about designing of materials and nano-artifacts such as chips and tags. We begin by presenting a framework for structuring the current debates on privacy, and then present our arguments. (shrink)

We argue that nano-technology in the form of invisible tags, sensors, and Radio Frequency Identity Chips (RFIDs) will give rise to privacy issues that are in two ways different from the traditional privacy issues of the last decades. One, they will not exclusively revolve around the idea of centralization of surveillance and concentration of power, as the metaphor of the Panopticon suggests, but will be about constant observation at decentralized levels. Two, privacy concerns may not exclusively be about constraining (...) information flows but also about designing of materials and nano-artifacts such as chips and tags. We begin by presenting a framework for structuring the current debates on privacy, and then present our arguments. (shrink)

The hype surrounding the emergence of nanotechnology proved extremely effective to raise public attention and controversies in the early 2000s. A proactive attitude prevailed resulting in the integration of social scientists upstream at the research level, research programs on Ethical, Legal and Societal Impacts, and various public engagement initiatives such as nanojury and citizen conferences. Twenty years later, what happened to the promises of SHS integration and public engagement in nanotechnology? Was it part of the hype, one of the many (...) promises made by the champions of nanotechnology initiatives that never materialized? As a contribution to this broad question, this paper focuses on public engagement initiatives in France and ventures some general reflections on their fate. I will first report, from an insider’s perspective, the public debates conducted by a civil society organization VivAgora, in the national context of fierce controversies. Then I will describe the permanent forum NanoRESP opened in 2013 when nano controversies waned out. On the basis of this case study, I will argue that the STS ideal of co-production of science and society gradually gave way to a more modest co-learning process between stakeholders in the 2010s. (shrink)

Debates about the regulatory requirements surrounding the introduction of nanotechnology products have, at least in Australia, remained largely within disciplinary boundaries and industry and academic circles. This paper argues for a more interdisciplinary and inclusive upstream debate about the introduction of ethical, regulatory and legal frameworks that may avoid the loss of public trust that has characterised the introduction of many new technologies in the past. Insights from risk-perception theory and research are used to introduce the notion (...) of risk as narrative as a framework for action. This paper suggests three main strategies for moving forward; drawing insights from the “trust gap” experiences of other new technologies; the application of the active form of the precautionary principle; and, the creation of nano-futures that meet both community and industry values through effective public engagement. (shrink)

This chapter combines rhetorical with conceptual analysis to argue that the concept of convergence of technologies is a teleological concept that does not describe or predict any recent past, present, or future development. Instead it always expresses or attributes political goals of how future technology should be developed. The concept was already fully developed as a flexible rhetorical tool by US science administrators to create nanotechnology (as nano-convergence), before it was broadened to invent the convergence of nano-, bio-, (...) info-, and cogno-research (NBIC-convergence). Analyzing the use of “convergence” in various US reports, such as in convergence did, does, can, will likely, will necessarily, should, and ought to happen, sheds new light on how science policy avoids public debates about goals and values in deliberating the future, which poses new challenges to STS. (shrink)

In October 2015, the European Union’s Scientific Committee on Consumer Safety issued a Preliminary Opinion on Hydroxyapatite (nano). Past industrial experience with this material and participation in ISO/TC-229, Nanotechnologies, led me to submit comments on the Committee’s interpretations of physico-chemical properties, especially solubility, that in retrospect were also probing of the Committee’s collective understanding of nanomaterials. The Committee’s responses are examined against a background of other Opinions issued in the same time period. The expert’s role and responsibility, whether as (...) an individual or a group member or in representing a scientific discipline, are examined through the concept of epistemic community taken from the public policy literature. A central theme is the Committee’s framing of chemical narratives such that its administrative procedures are projected onto the nanomaterial safety literature that is itself undergoing considerable investigation and revision. Inherent to this analysis is the singular role of toxicologists in the regulatory process. A related exchange by Australian and New Zealand colleagues is examined for its parallels to the SCCS actions, and there is a cursory discussion of later SCCS Opinions regarding Hydroxyapatite (nano). (shrink)

Both experimental and therapeutic uses of the new reproductive technologies have been governed not by the medical ideology of the best interests of patients and their children, but by the market ideology of profit maximization under the guise of "reproductive liberty." Government in our constitutional, democratic society has the authority and obligation to make and enforce reasonable regulations to manage the new reproductive market in order to protect the interests of the public, prospective parents, and their future children. The "cloning" (...) debate provides a useful opportunity to compare and contrast the competing regulatory models of the free market, professional guidelines, and government restrictions. (shrink)

The cis-regulatory hypothesis is one of the most important claims of evolutionary developmental biology. In this paper I examine the theoretical argument for cis-regulatory evolution and its role within evolutionary theorizing. I show that, although the argument has some weaknesses, it acts as a useful example for the importance of current scientific debates for science education.

Policy makers from around the world are trying to emulate successful innovation systems in order to support economic growth. At the same time, innovation governance systems are being put in place to ensure a better integration of stakeholder views into the research and development process. In Europe, one of the most prominent and newly emerging governance frameworks is called Responsible Research and Innovation. This article aims to substantiate the following points: The concept of RRI and the concept of justice can (...) be used to derive similar ethical positions on the nano-divide. Given the ambitious policy aims of RRI, the concept may be better suited to push for ethical outcomes on access to nanotechnology and its products rather than debates based on justice issues alone. It may thus serve as a mediator concept between those who push solely for competitiveness considerations and those who push solely for justice considerations in nano-technology debates. The descriptive, non-normative Systems of Innovation approaches should be linked into RRI debates to provide more evidence on whether the approach advocated to achieve responsible and ethical governance of research and innovation can indeed deliver on competitiveness. (shrink)

BackgroundThis paper highlights the issues that one of the 90 Italian Research Ethics Committees (RECs) might encounter during the approval phase of a clinical trial to identify corrective and preventive actions for promoting a more efficient review process and ensuring review quality. Publications on the subject from Italy and the rest of Europe are limited; encouraging constructive debate can improve RECs’ service to the subject of the clinical trial.MethodsWe retrospectively reviewed a cohort of 822 clinical trial protocols, initially reviewed by (...) REC, from June 2014 to December 2018. Data collected for each protocol were type of trial, sample size, use of placebo, number and kind of revisions requested by the REC before approval, and time taken for approval. Data for each protocol were collected by a trained clinical research assistant using the REC’s files and electronic archives.ResultsAlmost 45% of the reviewed studies (374/822) required clarifications, significant changes to the documentation, or minor changes before final approval.ConclusionsPreventive measures are needed to reduce the number of requested corrections and thus also the time required for approval, while maintaining review quality. All critical points and proposals presented in this paper require harmonization through updates to European regulations, as regulatory harmonization produces better compliance with rules and reduces the number of changes required before the trials’ final approval. Such updates include the development of standardized formats for informed consent, the verification of any evidence in favor of using off-label treatments over placebo as comparators, using multidisciplinary staff in clinical trials with children and adolescents, improving the legal definition of RECs to assign responsibilities and ensure independence, and providing guidance for RECs to engage clinical research assistants in internal audits. (shrink)

The Nanoessence project aims to examine life at a sub-cellular level, re-examining space and scale within the human context. A single HaCat skin cell is analysed with an Atomic Force Microscope (AFM) to explore comparisons between, life and death at a nano level. The humanistic discourse concerning life is now being challenged by nanotechnological research that brings into question the concepts of what constitutes living. The Nanoessence project research is based on data gathered as part of a residency at (...) SymbioticA, Centre of Excellence in Biological Arts, University of Western Australia and the Nanochemistry Research Institute, (NRI) Curtin University of Technology. The space of the body can be seen at an atomic level as having no defining boundaries. More generally, molecular self-assembly seeks to use concepts of supramolecular chemistry, and molecular recognition in particular, to cause single-molecule components to automatically arrange themselves into some useful conformation (reference Wikipedia). Nano assembly, or bottom-up approach, is the construction of a supramolecular chemistry by the assembly of nanoscopic particles, or even atoms and molecules. The proposal for nanotechnology to reshape nature atom by atom develops an interesting debate as to the constitution of life. The Nanoessence project aims to construct a physical experience to examine this scientific and metaphysical world. Nanoessence is an interactive audio-visual installation. In the Nanoessence installation the viewer will interface with the visual and sonic presentation through his or her own breath. In the context of the project breath has a strong conceptual and metaphorical link to a Biblical inception of life. The project attempts to maintain a high quality of authentic data to engage the viewer in a sensorial qualitative experience of quantitative data. (shrink)

This paper addresses recent calls to study the role of the state in private regulation. Integrating current scholarship on the state as a catalyst of private regulatory regimes with prior literature on regulatory failure and self-regulation, it identifies and problematizes unsettled assumptions used as a starting point by this growing body of research. The case study traces the evolution of public debates and the interaction of different regulatory initiatives dealing with corporate social responsibility issues in Canada’s (...) mining industry. Findings reveal the conditions under which the state is more likely to encourage firm-level, fragmented initiatives than facilitate and promote industry-wide regulatory strengthening and consolidation. I discuss the need for greater analytical precision regarding the variation in regulatory policy preferences across time and branches of government and the interaction between public and private regulatory initiatives. The conclusion outlines suggested areas for future research as well as the likely outcome of Canada’s current CSR policy framework. (shrink)

This article addresses salient conceptual issues in social organisational psychology in probing change in organisational systems, e.g., culture, innovation and implementation, reflective practice and change models. Insights from chaos–complexity research in the natural sciences which underpin the dynamics of flux and change to unravel the hidden, the unexplained, the disordered will be built on to explore the phenomena of change from a social psychological perspective. The concept of nano-psychology is introduced to open up a creative debate in the social (...) psychological field on creative change which builds on the nano-insights evolving in the natural science field. (shrink)

Roboethics is a recently developed field of applied ethics which deals with the ethical aspects of technologies such as robots, ambient intelligence, direct neural interfaces and invasive nano-devices and intelligent soft bots. In this article we look specifically at the issue of (moral) responsibility in artificial intelligent systems. We argue for a pragmatic approach, where responsibility is seen as a social regulatory mechanism. We claim that having a system which takes care of certain tasks intelligently, learning from experience (...) and making autonomous decisions gives us reasons to talk about a system (an artifact) as being “responsible” for a task. No doubt, technology is morally significant for humans, so the “responsibility for a task” with moral consequences could be seen as moral responsibility. Intelligent systems can be seen as parts of socio-technological systems with distributed responsibilities, where responsible (moral) agency is a matter of degree. Knowing that all possible abnormal conditions of a system operation can never be predicted, and no system can ever be tested for all possible situations of its use, the responsibility of a producer is to assure proper functioning of a system under reasonably foreseeable circumstances. Additional safety measures must however be in place in order to mitigate the consequences of an accident. The socio-technological system aimed at assuring a beneficial deployment of intelligent systems has several functional responsibility feedback loops which must function properly: the awareness and procedures for handling of risks and responsibilities on the side of designers, producers, implementers and maintenance personnel as well as the understanding of society at large of the values and dangers of intelligent technology. The basic precondition for developing of this socio-technological control system is education of engineers in ethics and keeping alive the democratic debate on the preferences about future society. (shrink)

Livestock production has been confronted with several epidemics over the last decades. The morality of common animal disease strategies—stamping out and vaccination—is being debated and provokes controversies among farmers, authorities and the broader public. Given the complexity and controversy of choosing an appropriate control strategy, this article explores the potential of nano-enabled diagnostics in future livestock production. At first glance, these applications offer promising opportunities for better animal disease surveillance. By significantly shortening the reaction time from diagnosis to appropriate (...) control, they could complement the current disease management strategies. Although nano-enabled diagnostics will not make livestock disease eradication strategies redundant or completely free of the culling of infected animals, these diagnostics could significantly reduce the number of culled animals and animal suffering. This article aims to demonstrate that the ethical assessment of advanced diagnostics can build on the experiences with decision making in biomedical ethics where nonmaleficence, beneficence, autonomy and justice serve as important benchmarks. Nano-enabled diagnostics may be an ethically sound solution if it can resolve the dilemma between stamping out and vaccination in favor of the latter and if it can balance the autonomy–paternalism dilemma between farmers and authorities. The technology should allow to be switched on and off by farmers, whilst simultaneously allowing for a weak paternalism on behalf of authorities in order to benefit the farmer and broader society and to protect them from harm. (shrink)

Many developing countries have allocated significant amounts of funding for nanoscience and nanotechnology research, yet compared to developed countries, there has been little study, discussion, or debate over social and ethical issues. Using in-depth interviews, this study focuses on the perceptions of practitioners, that is, scientists and engineers, in one developing country: India. The disciplinary background, departmental affiliation, types of institutions, age, and sex of the practitioners varied but did not appear to affect their responses. The results show that 95% (...) of the Indian practitioners working in the area of nanoscience and nanotechnology research recognized ethical issues in this research area, and 60% of them could offer specific examples, which included possible ill effects on environment and human, use as a weapon, hype, professional ethics, laboratory testing on animals, cyborgs, widening the gap between rich and poor, self-replication, and longevity of human life. The results may offer opportunities for future cross-cultural research, as well as offer examples that can be used to raise the awareness of other practitioners in India and elsewhere regarding the importance of ethical issues. (shrink)

The very existence of explicit techno-scientific controversies in the “nano” arena is often denied on behalf of a conception of science, risks, public engagement and responsibility which borders on a disembodied idealism and merits at least serious discussion. The recurrence of this view prompted us to clarify our position regarding our common field of research, in order to avoid being trapped in the seemingly clear divide between the universal and neutral pursuit of pure science, on the one hand, and (...) on the other hand the infinite variety of values and opinions that lead to the horrors throes of pure relativism. We therefore launched an internal trans-disciplinary project, in order to overhaul the premises underpinning both this idealistic standpoint and our own work, and to find a better definition of our approach to the exploration of the real policy implications of NST research initiatives. Indeed, the debates surrounding NST clearly have wider implications for the examination of issues of Science, Technology and Society as a whole. A first step in this clarification process was taken in Paris, at the conference which has now been published in this issue of Foundations of Chemistry. We further develop it in this paper, in the hope that it will contribute to the joint construction of a better nano-future. (shrink)

Nanotechnology is an important platform technology which will add new features like improved biocompatibility, smaller size, and more sophisticated electronics to neuro-implants improving their therapeutic potential. Especially in view of possible advantages for patients, research and development of nanotechnologically improved neuro implants is a moral obligation. However, the development of brain implants by itself touches many ethical, social and legal issues, which also apply in a specific way to devices enabled or improved by nanotechnology. For researchers developing nanotechnology such issues (...) are rather distant from their daily work in the lab, but as soon as they use their materials or devices in medical applications such as therapy of brain diseases they have to be aware of and deal with them. This paper is intended to raise sensitivity for the ethical, legal and social aspects (ELSA) involved in applying nanotechnology in brain implants or other devices by highlighting the short term problems of testing and clinical trials within the existing regulatory frameworks (A), the short and medium-term questions of risks in the application of the devices (B) and the long-term perspectives related to problems of enhancement (C). To identify and address such issues properly nanotechnologists should involve ethical, legal and social experts and regulatory bodies in their research as early as possible. This will help to remove pressure from regulatory bodies, to settle public concern and to prevent non-acceptable developments for the benefit of the patients. (shrink)

This special issue gathers together a selection of papers presented by international experts during a workshop entitled ‘Ethics of Cyber-Conflicts’, which was devoted to fostering interdisciplinary debate on the ethical and legal problems and the regulatory gap concerning cyber conflicts. The workshop was held in 2013 at the Centro Alti Studi Difesa in Rome under the auspices of the NATO Cooperative Cyber Defence Centre of Excellence . This NATO-accredited international military organisation that has always placed a high value on (...) an interdisciplinary approach to cyber defence, uniting as it does perspectives from technical, policy, legal, and strategic domains. The Centre’s mission is to enhance capability, cooperation, and information-sharing between NATO, its member states, and partner countries in the area of cyber defence by virtue of research, education, and consultation. The workshop was one of the projects supported by the Centre to achieve this mission.Readers may .. (shrink)

Robert Crandall writes as if the regulatory state is a simple failure. In fact, however, from the economic point of view there have been many successes, in the form of regulations whose benefits exceed their costs. Moreover, economic criteria are inadequate for evaluating regulatory performance, since even well?aggregated private willingness to pay provides a poor basis for assessing government regulation. It is now necessary to move beyond sterile debates about whether regulation is desirable; nonregulation is not an (...) option, since laissez faire is itself a regulatory system. Democratic, economic, and constitutional criteria hold out the promise of much better regulatory tools, in the form of flexible incentives rather than rigid commands. (shrink)

ABSTRACTIt has been estimated that more than 80% of people in Africa use traditional medicine . With the HIV/AIDS epidemic claiming many lives in Africa, the majority of people affected rely on TM mainly because it is relatively affordable and available to the poor populations who cannot afford orthodox medicine. Whereas orthodox medicine is practiced under stringent regulations and ethical guidelines emanating from The Nuremburg Code,1 African TM seems to be exempt from such scrutiny. Although recently there have been calls (...) for TM to be incorporated into the health care system, less emphasis has been placed on ethical and regulatory issues.In this paper, an overview of the use of African TM in general, and for HIV/AIDS in particular, is given, followed by a look at: the relative laxity in the application of ethical standards and regulatory requirements with regards to TM; the importance of research on TM in order to improve and demystify its therapeutic qualities; the need to tailor‐make intellectual property laws to protect traditional knowledge and biodiversity. A framework of partnerships involving traditional healers’ associations, scientists, policy makers, patients, community leaders, members of the communities, and funding organizations is suggested as a possible method to tackle these issues. It is hoped that this paper will stimulate objective and constructive debate that could enhance the protection of patients’ welfare. (shrink)

This paper examines regulatory responses to the presence of previously undetected and unlabelled nanoparticles in the Australian food system. Until 2015, the Australian regulatory body Food Standards Australia New Zealand denied that nanoparticles were present in Australian food. However, and despite repeated claims from Australia’s food regulator, research commissioned by civil society group Friends of the Earth has demonstrated that nanoparticles are deliberately included as ingredients in an array of food available for sale in Australia. This paper critically (...) examines how nanoparticles have come to be integrated into Australia’s food system under the radar of Australia’s food regulator. Our case study of FSANZ—including its responses to the civil society-led science that determined the existence of nanoparticles in Australian food—raises a number of important questions about the governance of risk in relation to emerging technologies such as nanotechnology. In this paper, we argue that FSANZ’ response to the presence of nanotechnology in Australia’s food system is an example of ‘governing with ignorance’. This is demonstrated via the denial and dismissal of science claims as a basis for limited regulatory intervention. FSANZ’ response intersects with the centrality of commercial interests in shaping science research and commercialisation, alongside the ‘hands off’ approach to regulation that is characteristic of neoliberal governance approaches. We conclude by arguing that in the current food governance framework, and alongside a paucity of impact science, civil society plays a vital role in attempts to democratise the Australian food system. (shrink)

The Human Fertilization and Embryology Authority policy on permitting ova provision for research purposes breaches good regulatory practice in being inconsistent, unaccountable and untargeted. This article will illustrate how these breaches have resulted in a policy which is unfair to ova providers who wish to contribute to stem cell research and undermines the intentions behind the policy's very inception. (This article is based on a paper entitled Appropriate Recompense for Oocytes in Stem Cell Research presented at the Stem Cells: (...) Hope or Hype debate, North West Genetics Knowledge Park, Manchester in May 2007.). (shrink)

Whistleblower bounty schemes that pay individuals a cash “bounty” for surfacing information about illegal conduct have rapidly gained public and scholarly attention, fueling calls to install a bounty approach across numerous regulatory areas, from workplace safety, environmental protection, and civil rights to political corruption, immigration, and antitrust. Yet despite the enthusiasm, bounty regimes have remained confined to the fraud context. This Article uses this fact as a jumping off point and, looking across the regulatory state, aims to answer (...) some basic questions about bounty regimes that have thus far eluded sustained scholarly attention: What features of a given regulatory area make it more or less conducive to a bounty approach? Given this, how might existing bounty regimes be revised? And if bounty regimes were to break out of the fraud area, where might they most profitably spread? It offers some initial answers to these questions by constructing a simple framework that shows how two features of the regulatory environment - the directness of the harm to be regulated and the determinacy of the legal mandate to be implemented - structure the choice among competing bounty approaches. These aspects of regulatory context, I argue, map onto the two most vexing challenges facing regulatory architects weighing a bounty mechanism or choosing among competing designs: optimizing the quantity and quality of information revelation and maintaining public control over the elaboration of legal mandates. The framework brings into relief some of the fault-lines in the growing scholarly debate about the optimal use and design of bounty schemes, including the choice between a simple cash-for-information scheme and a more elaborate qui tam scheme in which whistleblowers are vested with independent enforcement authority via a private right of action. It also yields a rough regulatory roadmap showing where existing bounty schemes might be revised and also the areas to which a bounty approach might be usefully exported. (shrink)

As policy makers struggle to develop regulatory oversight models for nanotechnologies, there are important lessons that can be drawn from previous attempts to govern other emerging technologies. Five such lessons are the following: public confidence and trust in a technology and its regulatory oversight is probably the most important factor for the commercial success of a technology; regulation should avoid discriminating against particular technologies unless there is a scientifically based rationale for the disparate treatment; regulatory systems need (...) to be flexible and adaptive to rapidly changing technologies; ethical and social concerns of the public about emerging technologies need to be expressly acknowledged and addressed in regulatory oversight; and international harmonization of regulation may be beneficial in a rapidly globalizing world. (shrink)

Nanotechnology is the latest in a growing list of emerging technologies that includes nuclear technologies, genetics, reproductive biology, biotechnology, information technology, robotics, communication technologies, surveillance technologies, synthetic biology, and neuroscience. As was the case for many of the technologies that came before, a key question facing nanotechnology is what type of regulatory oversight is appropriate for this emerging technology. As two of us wrote several years ago, the question facing nanotechnology is not whether it will be regulated, but when (...) and how.Yet, appropriate regulation of nanotechnology will be challenging. The term “nanotechnology” incorporates a broad, diverse range of materials, technologies, and products, with an even greater spectrum of potential risks and benefits. This technology slashes across the jurisdiction of many existing regulatory statutes and regulatory agencies, and does so across the globe. Nanotechnology is developing at an enormously rapid rate, perhaps surpassing the capability of any potential regulatory framework to keep pace. Finally, the risks of nanotechnology remain largely unknown, both because of the multitude of variations in the technology and because of the limited applicability of traditional toxicological approaches such as structure-activity relationship to nanotechnology products. (shrink)

Egg freezing has led to heated debates in healthcare policy and bioethics. A crucial issue in this context concerns the distinction between “medical” and “social” egg freezing —contrasting objections to bio-medicalization with claims for oversimplification. Yet such categorization remains a criterion for regulation. This paper aims to explore the “regulatory boundary-work” around the “medical”–”social” distinction in different egg freezing regulations. Based on systematic documents’ analysis we present a cross-national comparison of the way the “medical”–”social” differentiation finds expression in (...) regulatory frameworks in Austria, Germany, Israel, and the Netherlands. Findings are organized along two emerging themes: the definition of MEF and its distinctiveness—highlighting regulatory differences in the clarity of the definition and in the medical indications used for creating it ; and hierarchy of medical over social motivations reflected in usage and funding regulations. Blurred demarcation lines between “medical” and “social” are further discussed as representing a paradoxical inclusion of SEF while offering new insights into the complexity and normativity of this distinction. Finally, we draw conclusions for policymaking and the bioethical debate, also concerning the related cryopolitical aspects. (shrink)

There is a rapidly expanding field of research on social and ethical interactions with nano-scaled sciences and technologies. An important question is: What does social and ethical research actually mean when it is focussed on technological applications that are largely hypothetical, and a field of science spread out across multiple disciplines and lacking unification? This paper maps early literature in the field of research as a way of answering this question. Our aim is to describe how this field is (...) developing in response to its difficult task, and particularly, to comment on the topics of focus and where there is potential for future development. We present four topical categories, labelled Governance, Perception, Science and Philosophy, and use these as a tool to both map the field and to analyse its development. We find a majority of literature currently focused on issues of governance and perception, and offer suggestions for why this might be so. We then discuss cross-category themes of definition, novelty and interdisciplinarity, highlighting diverse positions and a problematic lack of direct debate. Our conclusion is that the field would benefit from more interaction, cross-referencing and creative research across traditional fields of inquiry. (shrink)

Healthcare systems across the globe are struggling with increasing costs and worsening outcomes. This presents those responsible for overseeing healthcare with a challenge. Increasingly, policymakers, politicians, clinical entrepreneurs and computer and data scientists argue that a key part of the solution will be ‘Artificial Intelligence’ (AI) – particularly Machine Learning (ML). This argument stems not from the belief that all healthcare needs will soon be taken care of by “robot doctors.” Instead, it is an argument that rests on the classic (...) counterfactual definition of AI as an umbrella term for a range of techniques that can be used to make machines complete tasks in a way that would be considered intelligent were they to be completed by a human. Automation of this nature could offer great opportunities for the improvement of healthcare services and ultimately patients’ health by significantly improving human clinical capabilities in diagnosis, drug discovery, epidemiology, personalised medicine, and operational efficiency. However, if these AI solutions are to be embedded in clinical practice, then at least three issues need to be considered: the technical possibilities and limitations; the ethical, regulatory and legal framework; and the governance framework. In this article, we report on the results of a systematic analysis designed to provide a clear overview of the second of these elements: the ethical, regulatory and legal framework. We find that ethical issues arise at six levels of abstraction (individual, interpersonal, group, institutional, sectoral, and societal) and can be categorised as epistemic, normative, or overarching. We conclude by stressing how important it is that the ethical challenges raised by implementing AI in healthcare settings are tackled proactively rather than reactively and map the key considerations for policymakers to each of the ethical concerns highlighted. (shrink)

CRISPR germline editing therapies hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny (...) at each stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. (shrink)

In this paper we argue for a naturalistic solution to some of the methodological controversies in regulatory science, on the basis of two case studies: toxicology and health claim regulation. We analyze the debates related to the scientific evidence that is considered necessary for regulatory decision making in each of those two fields, with a particular attention to the interactions between scientific and regulatory aspects. This analysis allows us to identify two general stances in the debate: (...) a) one that argues for more permissive standards of evidence and for methodological pluralism, and b) an opposing one that not only defends strict evidence requirements but also stipulates the use of one particular scientific methodologies for data generation. We argue that the real-world outcomes produced by alternative regulatory options are a vital piece of information that allows for the empirical assessment of these two stances. In particular, this information on outcomes makes it possible to analyze which standards of evidence and scientific methods generate the most useful knowledge as input for regulatory decision making. Our conclusion is that instead of an a priori selection of methodologies and standards, such decisions ought to be based on empirical evidence related to real-world outcomes. (shrink)

In the light of several ongoing antitrust investigations in the E.U. and the U.S., the following research paper analyzes whether ‘big tech’ – same as the big banks – need special regulatory (and economic -political) attention and if so, how an updated form of regulatory policy for the digital era could look like. It does so by utilizing – and reviving – the normative and business -ethical ideals of German ‘neoliberalism’, also known as (classical) ordoliberalism. Especially, Walter Eucken’s (...) work has the potential to inform and enrich the current debate concerning the regulation of big tech. The main goal of the paper is to outline a potentially new regulatory framework – one that combines (and revises) Eucken’s ordoliberalism with the competition policy of the European Union. (shrink)

There has been contentious debate over the years about whether there are morally relevant similarities and differences between the three practices of continuous deep sedation until death, physician-assisted suicide, and voluntary euthanasia. Surprisingly little academic attention has been paid to a comparison of the uses of these practices in the two types of circumstances in which they are typically performed. A comparative domains of ethics analysis methodological approach is used in the paper to compare 1) the use of the three (...) practices in paradigm circumstances, and 2) the use of the practices in paradigm circumstances to their use in non-paradigm circumstances. The analytical outcomes suggest that a bright moral line cannot be demonstrated between any two of the practices in paradigm circumstances, and that there are significant, morally-relevant distinctions between their use in paradigm and non-paradigm circumstances. A thought experiment is employed to illustrate how these outcomes could possibly inform the decisions of hypothetical deliberators who are engaged in the collaborative development of assisted dying regulatory frameworks. (shrink)

Via a historical reconstruction, this paper primarily demonstrates how the societal debate on genetically modified organisms (GMOs) gradually extended in terms of actors involved and concerns reflected. It is argued that the implementation of recombinant DNA technology out of the laboratory and into civil society entailed a “complex of concerns.” In this complex, distinctions between environmental, agricultural, socio-economic, and ethical issues proved to be blurred. This fueled the confusion between the wider debate on genetic modification and the risk assessment of (...) transgenic crops in the European Union. In this paper, the lasting skeptical and/or ambivalent attitude of Europeans towards agro-food biotechnology is interpreted as signaling an ongoing social request – and even a quest – for an evaluation of biotechnology with Sense and Sensibility. In this (re)quest, a broader-than-scientific dimension is sought for that allows addressing the GMO debate in a more “sensible” way, whilst making “sense” of the different stances taken in it. Here, the restyling of the European regulatory frame on transgenic agro-food products and of science communication models are discussed and taken to be indicative of the (re)quest to move from a merely scientific evaluation and risk-based policy towards a socially more robust evaluation that takes the “non-scientific” concerns at stake in the GMO debate seriously. (shrink)

This joint response from the National Research Ethics Advisors' Panel and the Association of Research Ethics Committees has been formulated on the basis of detailed in depth discussion between the two organizations, in consultation with their membership. NREAP is a body that was constituted by the United Kingdom Ethics Committee Authority in order to provide guidance to, and strategic oversight of the NHS Research Ethics Service. AREC represents all sectors of the Research Ethics Committee community and serves to engage in (...) discussion and debate concerning best practice and to serve the best interests of REC membership. (shrink)

Nongovernmental organizations (NGOs) and scientific controversies are often the common denominators in most of the cases that have significantly shaped science and society relationships in the Global South during the past two decades. National and international NGOs and their network have often facilitated the “opening up” of regulatory governance in multiple sectors. This article draws from three cases—the bottled water controversy, the agribiotechnology debates, and the nanotechnology initiatives—and charts out the role of the NGOs and controversies in (re)defining (...) the science-society relationship in India. The three cases illustrate how NGOs and controversies by their presence or absence at various stages of technology development shape the regulation-making exercise and the overall regulatory governance of science and technology. (shrink)

Assisted reproductive technology is a complex medical intervention with many potential social sensitivities. Within this domain, oocyte cryopreservation has emerged as an important research area for preserving female fertility. Against the backdrop of the hotly debated first legal case in China of a single woman wishing to freeze her eggs, and the implementation of the ‘three‐child policy’ in China, there is an urgent need to evaluate policies and address ethical considerations surrounding oocyte cryopreservation for non‐medical reasons. This review examines current (...) policies, explores China's practices and research, and examines the latest ethical challenges surrounding non‐medical oocyte cryopreservation. It develops strategies and recommendations that will be relevant in China and other developing countries seeking to navigate this complex landscape. (shrink)

Via a historical reconstruction, this paper primarily demonstrates how the societal debate on genetically modified organisms (GMOs) gradually extended in terms of actors involved and concerns reflected. It is argued that the implementation of recombinant DNA technology out of the laboratory and into civil society entailed a “complex of concerns.” In this complex, distinctions between environmental, agricultural, socio-economic, and ethical issues proved to be blurred. This fueled the confusion between the wider debate on genetic modification and the risk assessment of (...) transgenic crops in the European Union. In this paper, the lasting skeptical and/or ambivalent attitude of Europeans towards agro-food biotechnology is interpreted as signaling an ongoing social request – and even a quest – for an evaluation of biotechnology with Sense and Sensibility. In this (re)quest, a broader-than-scientific dimension is sought for that allows addressing the GMO debate in a more “sensible” way, whilst making “sense” of the different stances taken in it. Here, the restyling of the European regulatory frame on transgenic agro-food products and of science communication models are discussed and taken to be indicative of the (re)quest to move from a merely scientific evaluation and risk-based policy towards a socially more robust evaluation that takes the “non-scientific” concerns at stake in the GMO debate seriously. (shrink)