Everybody recognizes that most of the problems in medical ethics arise, these days, from innovations in medical technology. We would not have had to lay down laws or ethical guidelines about assisted reproduction had it not been for the new technology of in vitro fertilization, which produced the first IVF baby in 1978. We would not be currently anxious about the ethics of possible human cloning, had it not been for the production in Edinburgh of Dolly, the lamb (...) whose birth resulted from the removal of a mammary gland cell from an adult sheep. So the question is whether there is some research into developing technology that is too dangerous, that will lead to consequences too dramatic for humanity, for the research itself to be permitted. Should there be control over what technological innovation should be permitted? (shrink)

Ensuring fairness is a capital issue in any sporting competition. However, fairness is a complex concept. We seek here to offer an analysis of the construction and upholding of fairness within comp...

Stem cell technology is an emerging science field; it is the unique regenerative ability of the pluripotent stem cell which scientists hope would be effective in treating various medical conditions. While it has gained significant advances in research, it is a sensitive subject involving human embryo destruction and human experimentation, which compel governments worldwide to ensure that the related procedures and experiments are conducted ethically. Based on face-to-face interviews with selected Malaysian ethicists, scientists and policymakers, the objectives and effectiveness (...) of the current Guideline for Stem Cell Research and Therapy are examined. The study’s findings show that the guideline is rather ineffective in ensuring good ethical governance of the technology. A greater extent of unethical conduct is likely present in the private medical clinics or laboratories offering stem cell therapies compared with the public medical institutions providing similar services, as the latter are closely monitored by the governmental agencies enforcing the relevant policies and laws. To address concerns over malpractices or unethical conduct, this paper recommends a comprehensive revision of the current stem cell guideline so that adequate provisions exist to regulate the explicit practices of the private and public stem cell sectors, including false advertising and accountability. The newly revised Malaysian stem cell guideline will align with the Guidelines for Stem Cell Research and Clinical Translation of the International Society for Stem Cell Research containing secular but universal moral rules. However, a regulatory policy formulated to govern the technology remains the main thrust of empowering the guideline for compliance among the stakeholders. (shrink)

Today, a rights-based approach to technology regulation is central to national and international law-making. A human-rights-based approach would involve viewing technology from the prism of human rights objectives and principles. A more specific turn would be to evaluate their impact on specific rights, namely the right to life, right to peaceful assembly, right to development, right to redressal, rights against discrimination, right to education, etc. Normative frameworks have emerged to further protect human rights from technology-based harms. (...) This paper covers a few conceptual and institutional considerations highlighted in seminal works from scholars and international human rights institutions. To name a few; (1) technology and discriminatory challenges (2) design and use of technology (3) digital divide amongst countries (4) duty of actors, (5) neoliberal technologies, (6) the use of prohibitions and remedies, and (7) the emergence of new human rights. Much of the advocacy and rights-based interventions around the globe are attentive to technology’s challenges to human rights. The abovementioned considerations define the core of the international normative framework, which is often advanced to protect human rights from technology-based harms. (shrink)

This book brings together papers given at a symposium which took place in Melbourne, Australia in 2001. Like any such collection, the chapters vary in quality and in substance. Some authors have chosen to analyse one issue in considerable depth, while others attempt a broad overview of regulations in different regions of the world. Julian Savulescu, for example, confines himself to the complex question of whether gamete providers’ freedom to dispose of their unwanted embryos should take priority over infertile couples’ (...) interests in using these surplus embryos in treatment. In contrast, Jothi Kumar surveys the regulation of assisted reproductive technology throughout Asia in a mere four pages of text. In general, contributions of the first type tend to be more successful; attempts to summarise something as complex as the regulation of assisted reproductive technology across a whole continent can be difficult for the reader to digest, and inevitably offer little by way of analysis.A further problem bedevils any new publication in this fast moving area of medical law and ethics. Although providing a “snapshot” of regulation in 2001 is undoubtedly an interesting and worthwhile project, a book such as this risks being out of date before it is even published. As a result, the more discursive chapters which concentrate on especially novel or controversial ethical dilemmas are likely to be of use and interest for longer than those which describe the regulatory status quo. Certainly, Savulescu’s chapter on the public interest in embryos, and Giuliana Fuscaldo’s contribution on …. (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)

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)

Louis Charland's ‘Technological reason and the regulation of emotion’ focuses on a specific area, that of the emotions, in which he sees a problematic dominance of the technical attitude. He argues that our technologically oriented psychiatry has taken an instrumentalist approach to regulation of emotion that severely limits and distorts the role of emotion in psychiatric practice. A prominent example is the exclusion of moral judgments and values, emotion-laden aspects of experience, from psychotherapy because they do not fit (...) the technical model. To illustrate his point, Charland both contrasts the modern notion of emotion with the traditional notion of passion, and our contemporary practice of technically regulated emotion with the ‘moral treatment’ of the nineteenth century. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a “bottleneck” develops (...) upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a “bottleneck” develops (...) upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

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)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). If a (...) “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic. (shrink)

This article addresses the data protection and product safety regulatory models currently applied to consumer-facing health technologies. It explains how the design and structures of existing data protection and safety regulation in the U.S. have resulted in exceptionally thin protection for the users of consumer-facing devices and products that rely on or that facilitate consumer collection or aggregation of health and wellness data. It also examines some appealing legislative alternatives to the current thin model used in the U.S. and (...) suggests a framework for prioritizing ameliorative regulation. To better understand existing regulatory models, their deficiencies, and how they should be reformed, the article employs an analytical model describing these regulatory systems across two axes. The vertical axis describes the quantity or depth of regulation, such as, for example, the strictness of the rules imposed by the regulatory model. The horizontal axis describes the reach of the regulation, the behaviors, products, or industries to which the regulation applies. (shrink)

In order to responsibly protect certain cherished values, for instance, human or environmental health, privacy, or ‘human dignity’, societies see a need for oversight, guidance and regulation of de...

Contra mercantile propaganda, technology is "humanized" to the extent that it satisfies or at least permits satisfaction of basic human needs or enhancements. To assess a technology's contribution to humanization requires (1) rejection of the primacy of the machine (cyborg model) and commitment to primacy of the human being (prosthesis model) in man/machine relations, and (2) insistence on the responsibility of managers for consequences of their technology-related decisions. Such decisions are appropriate in this respect to the extent (...) that they help meet basic human needs rather than artificially engendered needs. Meta-evaluation requires active citizen participation in government regulation of technology. (shrink)

The scale and asymmetry of commercial technology firms’ power over people through data, combined with the increasing involvement of the private sector in public governance, means that increasingly, people do not have the ability to opt out of engaging with technology firms. At the same time, those firms are increasingly intervening on the population level in ways that have implications for social and political life. This creates the potential for power relations of domination, and demands that we decide (...) what constitutes the legitimacy to act on the public. Business ethics and private law are not designed to answer these questions, which are primarily political. If people have lost the right to disengage with commercial technologies, we may need to hold the companies that offer them to the same standards to which we hold the public sector. This paper first defines the problem and demonstrates that it is significant and widespread, and then argues for the development of an overarching normative framework for what constitutes non-domination with regard to digital technologies. Such a framework must involve a nuanced idea of political power and accountability that can respond not only to the legality of corporate behaviour, but to its legitimacy. (shrink)

This paper discusses the notion of using international shipping legislation to provide healthcare technologies to inhabitants of a country on a ship in international waters based just outside the country’s border. This allows technologies that would otherwise be unavailable, regulated or banned to the citizens of a particular nation to be available, just offshore. This is because in international waters ships are governed by the laws of their home nation not those they are nearby. We focus on the example suggested (...) recently in the UK of “sperm ships”, flying Danish flags to circumvent IVF regulation in the UK. While we acknowledge that this general strategy could be used to do good by providing healthcare where it would not be otherwise available, it also provides a significant challenge to the effective sovereignty of the state and its ability to regulate healthcare technologies for the benefit of its citizens. We discuss this challenge to the regulation of healthcare and suggest a few tentative solutions. (shrink)

Xenotransplantation - the transfer of living tissue between species - has long been heralded as a potential solution to the severe organ shortage crisis experienced by the United Kingdom and other 'developed' nations. However, the significant risks which accompany this biotechnology led the United Kingdom to adopt a cautious approach to its regulation, with the establishment of a non-departmental public body - UKXIRA - to oversee the development of this technology on a national basis. In December 2006 UKXIRA (...) was quietly disbanded and replaced with revised guidance, which entrusts the regulation of xenotransplantation largely to research ethics committees. In this article we seek to problematize this new regulatory framework, arguing that specialist expertise and national oversight are necessary components of an adequate regulatory framework for a biotechnology which poses new orders of risk, challenges the adequacy of traditional understandings of autonomy and consent, and raises significant animal welfare concerns. We argue for a more considered and holistic approach, based on adequate consultation, to regulating biotechnological developments in the United Kingdom. (shrink)

In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools. In August 2016, the US Food and Drug Agency (...) (FDA) approved the uncaged field trial of a GE Aedes aegypti mosquito in Key Haven, Florida. The FDA’s decision was based on its assessment of the risks of the proposed experimental public health research project. The FDA is considered a global regulatory standard setter. So, its approval of the uncaged field trial could be used by proponents of GE mosquitoes to urge countries in the global South to permit the use of those bio-technologies. -/- From a public health ethics perspective, this paper evaluates the FDA’s 2016 risk assessment of the proposed uncaged field trial of the GE mosquito to determine whether it qualified as a realistic risk evaluation. -/- The FDA’s risk assessment of the proposed uncaged field trial did not proximate the conditions under which the GE mosquitoes would be used in regions of the global South where there is a high prevalence of mosquito-borne diseases. -/- Given that health and disease have political-economic determinants, whether a risk assessment of a product is realistic or not particularly matters with respect to interventions meant for public health problems that disproportionately impact socio-economically marginalized populations. If ineffective public health interventions are adopted based on risk evaluations that do not closely mirror the conditions under which those products would actually be used, there could be public health and ethical costs for those populations. (shrink)

Ethical decision-making in public health rarely involves simply avoiding a bad choice in favor of a good choice. Instead, it requires policymakers to strike a balance among conflicting goals that are all good—goals such as the health of populations and individuals, knowledge gained through scientific research, autonomy, social justice, and the efficient use of limited resources. This balance can be elusive, and perfect examples are the legal instruments governing dual-use research, a term describing scientific endeavors meant to produce beneficial knowledge (...) or technology, but that could also be misapplied. Dual-use research of concern policies were implemented... (shrink)

Regulatory agencies aim to protect the public by moderating risks associated with innovation, but a good regulatory regime should also promote justified public trust. After introducing the USDA 2020 SECURE Rule for regulation of biotech innovation as a case study, this essay develops a theory of justified public trust in regulation. On the theory advanced here, to be trustworthy, a regulatory regime must (1) fairly and effectively manage risk, must be (2) “science based” in the relevant sense, and (...) must in addition be (3) truthful, (4) transparent, and (5) responsive to public input. Evaluated with these norms, the USDA SECURE Rule is shown to be deeply flawed, since it fails appropriately to manage risk, and similarly fails to satisfy other normative requirements for justified trust. The argument identifies ways in which the SECURE Rule itself might be improved, but more broadly provides a normative framework for the evaluation of trustworthy regulatory policy-making. (shrink)

In 2018, the Chinese scientist He Jiankui presented his research at the Second International Summit on Human Genome Editing in Hong Kong. While it was intended that he facilitate a workshop, he was instead called on to present his research in heritable human genome editing, where he made the announcement that he had taken great strides in advancement of his research, to the extent that he had gene-edited human embryos and that this had resulted in the live births of two (...) children. While his research ethic and methodology was interrogated, he insisted that two children, twin girls, had been born healthy and that there was another pregnancy (at the time) where birth of a third gene edited child would be imminent. This announcement generated a ripple effect in the scientific community and exposed the gaps in regulation and absence of law relating to the technology. This resulted in a flurry of activity and conversation around regulation of the technology, which scientists stated was not ready for human trials. This article reviews the Third Summit which was held in London in March 2023 and comments on the latest developments in the regulation of heritable human genome editing. (shrink)

There are certain kinds of risk for which governments, rather than individual actors, are increasingly held responsible. This article discusses how regulatory institutions can ensure an equitable distribution of risk between various groups such as rich and poor, and present and future generations. It focuses on cases of risk associated with technological and biotechnological innovation. After discussing various possibilities and difficulties of distribution, this article proposes a non-welfarist understanding of risk as a burden of cooperation.

Like all technologies, nanotechnology will inevitably present risks, whether they result from unintentional effects of otherwise beneficial applications, or from the malevolent misuse of technology. Increasingly, risks from new and emerging technologies are being regulated at the international level, although governments and private experts are only beginning to consider the appropriate international responses to nanotechnology. In this paper, we explore both the potential risks posed by nanotechnology and potential regulatory frameworks that law may impose. In so doing, we also (...) explore the various rationales for international regulation including the potential for cross-boundary harms, sharing of regulatory expertise and resources, controlling protectionism and trade conflicts, avoiding a “race to the bottom” in which governments seek economic advantage through lax regulation, and limiting the “nano divide” between North and South. Finally, we examine some models for international regulation and offer tentative thoughts on the prospects for each. (shrink)

Since the first draft of the human genome was published in 2001, DNA sequencing technology has advanced at a remarkable pace. Launched in 1990, the Human Genome Project sought to sequence all three billion base pairs of the haploid human genome, an endeavor that took more than a decade and cost nearly three billion dollars. The subsequent development of so-called “next generation” sequencing methods has raised the possibility that real-time, affordable genome sequencing will soon be widely available. Currently, NGS (...) methods can be used to sequence up to 60 billion base pairs per day. Whole-genome sequencing costs an estimated $5,000-10,000, with that number predicted to fall to $1000 in the near future.In the past few years, the availability of high-throughput NGS methods has led to a proliferation of potential and actual clinical applications for NGS. NGS therefore has the potential to usher in the long-awaited era of personalized medicine. (shrink)

Developments in biotechnology present difficult social and ethical challenges that need to be resolved by regulators among others. One crucial problem for regulators of new technologies is to ensure that regulation is both clear and sufficiently flexible to respond to new developments. This is particularly difficult to achieve in contentious fields such as medical biotechnology. In the European Union there is a divergence in the solutions to this problem which has lead to different regulatory frameworks for medical biotechnology. This (...) paper compares and contrasts the British and Dutch regulatory frameworks for the selection of embryos by preimplantation genetic diagnosis as an example of the regulation of medical biotechnology. Some of the outcomes of the regulatory choices and possible reasons behind the divergent frameworks are discussed, such as the ethical outlooks and political systems in these countries. (shrink)

The use of genetic technologies within the equine industries has become increasingly common since the horse genome was published in 2009 (Wade et al. 2009). Testing for genes coding for disease in...

There is much we do not know about nanotechnology. Despite its tremendous promise, nanotechnology today is mostly forecast and fervent hope. Predictions that spending on nanotechnology will increase from current levels of $13 billion to more than $1 trillion by 2015 are no more than that – simply predictions. Hopes that nanotechnology will be an essential part of solving the globe's energy, food, and water problems should be tempered by recalling a century of revolutionary technologies that failed to live up (...) to their early promise such as nuclear energy, supersonic airplanes, or gene therapy. Many other questions continue to nip at nanotechnology's heels, not the least of which are debates about what is and is not technically feasible. Despite these uncertainties, we can have complete confidence in one aspect of nanotechnology's future – it will be subject to a host of regulations. (shrink)

A primer on legal issues relating to cyberspace, this textbook introduces business, policy and ethical considerations raised by our use of information technology. With a focus on the most significant issues impacting internet users and businesses in the United States of America, the book provides coverage of key topics such as social media, online privacy, artificial intelligence, and cybercrime as well as emerging themes such as doxing, ransomware, revenge porn, data-mining, e-sports and fake news. The authors, experienced in journalism, (...) technology and legal practice, provide readers with expert insights into the nuts and bolts of cyber law. Cyber Law and Ethics: Regulation of the Connected World provides a practical presentation of legal principles, and the book is essential reading for non-specialist students dealing with the intersection of the internet and the law. (shrink)

This article is dedicated to methodological questions in ethical regulation of neuroresearch. Neuroethics has emerged recently within the framework of the neuro-trend in modern technoscience; its regulatory capabilities are yet to be discovered. Sciences that study human brain and behavior orient towards existing institutions of ethical regulation, which do not consider the complexity and specificity of the emerging threats and risks. The author examines the circumstances for formation of the research ethics and points of intersection with neuroethics. Research (...) ethics is viewed as a part of bioethics, which not only assessed the potential harm for the examinees, but also the social and anthropological consequences of scientific and technological development. The author provides a “narrow” understanding of research ethics as a system of rules within the framework of particular disciplines, and as a clinical research practice. Based on the historically established ethical regulation of clinical research and the forming beneath our eyes rules of modification of human genome and artificial intelligence, the author demonstrates contradictions and trends of the separate regulatory systems, which should be taken into account to prevent risks in neuroresearch and prediction of social implications of the spread of neurotechnologies. Ethical examination became a part of a complex system of international control of clinical research, which leads to fading of the value component aimed at protection of research subjects. The author underlines two factors that form the types of harm peculiar to neuroresearch: orientation towards technological realization and vulnerability of mental sphere as a subject of research. The conclusion is made on inefficiency of application of the calculation of harm/advantage in ethical assessment of neuroresearch. Leaning on the experience of bioethics, neuroethics requires development of the own systems of rules that would become the institutions of neuroethical regulation. For preventing formalization of ethical control, it is essential to advance extensive socio-humanistic assessment of new achievements in neuroscience, as well as neuroethical education for the scientists. (shrink)

The development of genetic engineering and its plausible consequences raises a level of controversy that can be identified at the level of public rather than scientific debate. Opposition to genetic engineering may manifest itself in rejection of the technology overall, or rejection of specific aspects of the technology, where public attitudes may be defined by a complex set of perceptions incorporating risk, benefit, control, and ethical concerns.One hundred and seventy six members of the public responded to questionnaires about (...) genetic engineering that were framed in terms of either food production or medical application. The first section assessed perceived risks, benefits, and control of genetic engineering where the targets of the potential application and the location of control were varied. The second section assessed the relationship between objections to application of the technology to different types of organisms (plants, microorganisms, animals, or human genetic material). Questions were directed at either perceived risk or ethical objections. The applications of genetic engineering were seen as riskier and less beneficial when applied to food production than medicine, although perceived control was independent of application. Optimistic bias was observed. Ethical and risk related objections were greater for applications to food than to medicine, and again dependent on the type of organism manipulated. The transfer of genetic material between “dissimilar” types of organism (for example, between plants and animals) were not associated with greater risk or ethical concern than transfers between “similar” types of organism (for example, between animals and animals). The public requirement for legislative control was also dissociated into risk or ethical objections to the technology, and found to be greater for risk-related concerns, although ethical considerations were also important. (shrink)

This paper explores the analytical relevance of Foucault's notion of biopower in the context of regulating and managing non-human lives and populations, specifically those animals that are the focus of livestock breeding based on genetic techniques. The concept of biopower is seen as offering theoretical possibilities precisely because it is concerned with the regulation of life and of populations. The paper approaches the task of testing the 'analytic mettle' of biopower through an analysis of four policy documents concerned with (...) farm animal genetics: the UK's National Scrapie Plan (2003); the UK National Action Plan on Farm Animal Genetic Resources (2006); the Agriculture and Environment Biotechnology Committee's report on Animals and Biotechnology (2002); and the Farm Animal Welfare Council's report on the Welfare Implications of Animal Breeding and Breeding Technologies in Commercial Agriculture (2004). Of interest is whether and how the four policy case studies articulate a form of biopower in relation to human-livestock animal relations in the context of genetic approaches to livestock breeding, and how biopower is variably expressed in relation to the different policy issues addressed. In concluding, the paper considers the overall applicability and relevance of biopower in the context of regulating animal lives within livestock breeding, highlighting both possibilities and limitations, and offers suggestions for taking forward research on livestock populations from a neo-Foucaultian perspective. (shrink)

Abstract:There is a role for regulatory oversight over new genetic technologies. Research must ensure the rights of human subjects, and all medical products and techniques should be ensured to be safe and effective. In the United States, these forms of regulation are largely the purview of the National Institutes of Health and the Food and Drug Administration. Some have argued, however, that human genetic therapies require new regulatory agencies empowered to enforce cultural norms, protect against hypothetical social harms, or (...) ensure that the human genome remains unchanged. Focusing on the United States, this essay will briefly review these arguments and argue that the current limited regulatory role over human gene therapies is sufficient to protect public health, bodily autonomy, and reproductive freedom. (shrink)

This article contributes to research on the regulation of technological risks in the form of a case study of the Baltic Sea ferry traffic. The analysis suggests that the social systemic features of an industry heavily influence the relationship between technological failures and risk regulation. The study augments recent work on how regulations affect the handling of technological risks and how failures influence regulatory arrangements. These issues have already been studied in the context of aviation, auto, chemical, nuclear (...) power, and railway industries, but not in shipping. As an extension to previous literature, the authors also explore how different regulatory organizations in this industry act in relation to risks and how they influence each other in risk regulation activities. The study highlights the indirect relationships between technological failures and risk regulation arrangements. It also underlines the influence of the involved actors on the regulatory responses to technological failures. (shrink)

The transport of messenger RNAs (mRNAs) from the nucleus to cytoplasm is an essential step in the gene expression program of all eukaryotes. Recent technological advances in the areas of RNA‐labeling, microscopy, and sequencing are leading to novel insights about mRNA biogenesis and export. This includes quantitative single molecule imaging (SMI) of RNA molecules in live cells, which is providing knowledge of the spatial and temporal dynamics of the export process. As this information becomes available, it leads to new questions, (...) the reinterpretation of previous findings, and revised models of mRNA export. In this review, we will briefly highlight some of these recent findings and discuss how live cell SMI approaches may be used to further our current understanding of mRNA export and gene expression. (shrink)

Technology assessment (TA) is an important instrument for the regulation of innovation. From the perspective of sociology of knowledge, the regulatory process can be understood as a complex interplay between different forms of knowledge. The prevailing instruments of TA, expertise and participation, are both facing difficulties in dealing with the limits and impasses of regulatory knowledge in the realm of innovation. Nevertheless, as is argued in this article, reflexive forms of TA offer a good, if not the only, (...) answer to the question of how we can deal with the contradictions and paradoxes involved in the regulation of innovation. (shrink)

The past few years have brought significant breakthroughs in understanding human genetics. This knowledge has been used to develop ‘polygenic scores’ which provide probabilistic information about the development of polygenic conditions such as diabetes or schizophrenia. They are already being used in reproduction to select for embryos at lower risk of developing disease. Currently, the use of polygenic scores for embryo selection is subject to existing regulations concerning embryo testing and selection. Existing regulatory approaches include ‘disease-based' models which limit embryo (...) selection to avoiding disease characteristics, and 'laissez-faire' or 'libertarian' models, under which embryo testing and selection remain unregulated. We introduce a novel 'Welfarist Model' which limits embryo selection according to the impact of the predicted trait on well-being. We compare the strengths and weaknesses of each model as a way of regulating polygenic scores. Polygenic scores create the potential for existing embryo selection technologies to be used to select for a wider range of predicted genetically influenced characteristics including continuous traits. Indeed, polygenic scores exist to predict future intelligence, and there have been suggestions that they will be used to make predictions within the normal range in the USA in embryo selection. We examine how these three models would apply to the prediction of non-disease traits such as intelligence. The genetics of intelligence remains controversial both scientifically and ethically. This paper does not attempt to resolve these issues. However, as with many biomedical advances, an effective regulatory regime must be in place as soon as the technology is available. If there is no regulation in place, then the market effectively decides ethical issues. (shrink)

This well‐researched book will be of immense value to the person who will someday write the full story of broadcast regulation in the United States. That story still needs to be written; although in this book the facts are all presented, the story behind the facts is not.Well, actually, not quite all the facts are here either. For example, similar problems tackled in other countries such as Canada, even before the United States began looking into them, aren't even mentioned. (...) True, the title of the book specifies that it is limited to the United States, but to understand the regulations presented we should certainly have some knowledge of how others had attacked the same problem.More important, Hugh Slotten totally ignores the personalities of the people involved. This is a tremendously important consideration, for to understand what happened we must know something about the motives of the people who made the decisions, and since many of the motives were hidden under layers of varying complexity and political beliefs we would like to know something about the personalities of the players. Someone at the Johns Hopkins Press evidently noticed the problem, but the only attempt at fixing it was to lie blatantly on the bookjacket: “His [Slotten's] discussion of the early years of radio examines powerful personalities—including navy secretary Josephus Daniels and commerce secretary Herbert Hoover.” But there is no discussion at all of the personalities of these men. Daniels is mentioned in only two sentences, neither of which touches on him as a person, and although Hoover occurs in several more, nothing of his “personality” is thrown in.Lee De Forest is another example. On page 4 he is identified as the inventor of the audion . On page 61 we read of his “invention” [sic] of that device. Why the quotation marks around “invention”? Did he or didn't he invent it? Actually, there is a good story to be told about that, but you won't read it here. De Forest played an active role in the regulation controversies, and this role is made clear in the book. But precisely because of this, wouldn't it be interesting to know that De Forest was arrested and went to trial for crooked stock manipulation in connection with the audion? The only hint at such activities is Slotten's statement that De Forest was a “maverick.” Wouldn't that one word make you want to know more about him, if only to evaluate his quoted remarks on governmental interference and regulations?Other matters of interest are passed by, as when on page 48 we read: “Decisions about who should receive licenses … could … be based on such qualitative issues as the character of broadcasts … and the educational benefits.” What a can of worms this opens up! Or should open up. Is the government going to censor broadcasting by denying licenses to stations that publicize alternative methods of government, such as communism? How about religious or ethnic controversies: will these be deemed “educational” or subversive? Is the government, through its licensing powers, going to let the public hear only what it wants it to hear, à la Goebbels and Germany? Well, we'll never know, for this particular can is not opened by the author; after this one mention, the subject is never broached again.In summary, if you are actively researching this field, Slotten's book is a must for you. But the full story of radio and television regulation in the United States is still to be written. (shrink)

This paper presents an introductory overview of the main issues that the digitalisation of industrial enterprises known as Industry 4.0 raises for social sciences. First, it will show that this technological transition—which, however, is unfinished and is seen to be in continuity with the so-called “third industrial revolution”—cannot be interpreted with reference to a deterministic approach. It can be analysed more usefully as a range of decisions affecting the industrial policies of national states, the conception and design of machines, their (...) adoption in production processes and finally their use by operators. Second, certain aspects of Industry 4.0 of special concern in terms of organisation of work processes will be analysed on various scales. Finally, we will explain various hypotheses that social and economic research is developing with regard to the new technologies’ controversial effects on employment. (shrink)

The beginning of the twenty-first century saw an apparent change in language in public discourses characterised by the rise of so-called “essentially oxymoronic concepts”, i.e., mainly oxymora and paradoxes. In earlier times, these rhetorical figures of speech were largely reserved for the domain of literature, the arts or mysticism. Today, however, many new technologies and other innovations are contributing to their rise also in the domains of science and of law. Particularly in law, their inherent contradictory quality of combining apparently (...) antagonistic suppositions challenges the traditional dualistic mode of reasoning and binary logic. As reflected in terms like fake news, alternative facts or conspiracy theories, these concepts are seen as a threat to the rule of law and legal certainty and have been described as harbingers of an age of disinformation or post-truth. The challenge posed by these apparently contradictory concepts requires a closer look at the premises that guide our legal thinking and a more integrated theory of the senses and their role in law, as captured by the terms “legal synaesthesia” and “legal semiotics”. It also calls for an inquiry into the mind’s functioning generally and how it processes information in the creative process of decision making, linking thoughts and actions as well as facts and fictions. Based on the qualification of “fake news” as an oxymoron, this article critically examines the deficiencies in a dichotomous distinction between fact and fiction exemplified by information about the pandemic of coronavirus disease 2019 in an attempt to clarify the principal issues for a global regulatory debate regarding “fake news”. (shrink)