In the last seven years, close to twenty thousand people have died trying to reach Europe by crossing the Mediterranean Sea. Rescue missions by private actors and NGOs have increased because both national measures and measures by the EU’s border control agency, Frontex, are often deemed insufficient. However, such independent rescue missions face increasing persecution from national governments, Italy being one example. This raises the question of how potential migrants and dissenting citizens should act towards the EU border regime. In (...) contrast to the literature, which mainly addresses migration on the basis of justice requirements, this article focuses on the legitimate authority of the EU’s border regime. Focusing on the legitimacy criteria for states’ claims to regulate migration opens a fruitful normative perspective, given the pervasive disagreement over the content of justice in migration. What reasons for compliance and non-interference does legitimacy supply for potential immigrants and dissenting citizens? And what legitimacy standard may be appropriate for the power that individual states claim over potential immigrants? We argue that, even assuming a minimal legitimacy standard for the state-migrant relationship, the structure of the EU’s border regime exhibits unique features, which cause it to stand in tension with such a standard. By coordinating its Member States’ border regimes, especially through Frontex, the EU claims and exercises power over potential immigrants. However, the asymmetrical delegation of state powers to the EU means that the power involved in regulating European borders is, in core respects, unaccountable. This unaccountability, we argue, is significant for the legitimacy of the EU’s border regime. This article sheds new light on the morality of unauthorised rescue missions by assessing the permissibility of resistance to the EU’s border regime. (shrink)

Even though the Convention for the Protection of Human Rights and Fundamental Freedoms (ECHR) does not explicitly address the rights of asylum seekers and refugees, the case law of the European Human Rights Court (ECtHR) confirms that their rights can be successfully defended under this mechanism. In parallel, in its evolving jurisprudence on asylum the Court of Justice of the European Union (CJEU) refers to the Strasbourg case law, where there is a certain interrelationship between these two jurisdictions, in particular (...) given the recent ECtHR pronouncement on “EU Dublin transfers”. The article aims at evaluating protection available for asylum seekers and refugees under the ECHR, while comparing it with protection of asylum relevant fundamental rights under the EU legal order and the most recent jurisprudence of the CJEU in asylum cases. The authors also analyze which of the two systems is more favourable and what are their limitations. Thus, the article offers to students and practitioners a detailed analysis of ECtHR and CJEU jurisprudence in asylum cases through a comparative perspective, as well as the key problematic aspects arising in both jurisdictions and their junction. The jurisprudence of the ECtHR reveals that despite the most developed protection from expulsion under Article 3 of the ECHR, it does not sufficiently secure status for the concerned persons. Effective remedy requirements under the ECHR allow for filling the gaps of national asylum procedures, while recognition of vulnerability and special status of asylum seekers by the ECtHR assist in addressing still commonly prevailing detention problems of asylum seekers in Europe. In the context of family protection, the recognition of positive obligations by states to reunite the refugee families is still rudimentary, thus, clearly Article 3 protection in expulsion cases takes over Article 8. At the same time, the jurisprudence of the CJEU in asylum cases is still inconsistent, as the court sometimes takes decisions without including human rights into its’ analysis (Kadzoev, Arslan, K.), while in other cases refers to the Charter (MA and others), verifies if its’ own decision is in line with the ECtHR jurisprudence (Elgafaji) or shapes secondary legislation in line with Strasbourg arguments and findings (N.S.). Quite likely, the ECtHR practice will have an important influence on the developments of subsidiary protection in the EU, at least in the context of Articles 2 and 3 of the ECHR, and serve as an important reference for interpretation of various concepts under the EU Qualification and Procedures Directives. The comparative analysis of pros and cons of the two mechanisms demonstrates that the main advantage of the ECtHR is individual justice possibility, which is not yet accessible under CJEU preliminary judgement procedure and its input in developing asylum law concepts, such as non-state agents of persecution, internal protection or even subsidiary protection regime under EU asylum law. Thanks to the ECtHR, the realistic possibility to question the application of certain EU norms has emerged (Dublin Regulation). While the ECtHR does not have such a specific competence over asylum issues as the CJEU and is clearly a slow and seriously overburdened mechanism, the pilot judgement procedure seems to be increasingly capable of providing guidelines to the states concerning systematic problems in their asylum procedures. Thus, both jurisdictions in their own ways contribute to strengthening asylum seekers’ protection while forming a common oasis for these individuals in Europe. (shrink)

Regulation by design (RBD) is a growing research field that explores, develops, and criticises the regulative function of design. In this article, we provide a qualitative thematic synthesis of the existing literature. The aim is to explore and analyse RBD's core features, practices, limitations, and related governance implications. To fulfil this aim, we examine the extant literature on RBD in the context of digital technologies. We start by identifying and structuring the core features of RBD, namely the goals, regulators, regulatees, (...) methods, and technologies. Building on that structure, we distinguish between three types of RBD practices: compliance by design, value creation by design, and optimisation by design. We then explore the challenges and limitations of RBD practices, which stem from risks associated with compliance by design, contextual limitations, or methodological uncertainty. Finally, we examine the governance implications of RBD and outline possible future directions of the research field and its practices. (shrink)

Since the 1980s, there has been a steady growth of interest in the psychological mechanisms that regulate normal emotional experience. In this same period, cognitive-experimental researchers have sought to delineate the information processing biases that characterize emotional disorders. Exciting potential synergies exist between these two areas of investigation. In this article, we consider ways in which reciprocal benefits could be gained by the constructive transfer of theoretical ideas and methodological approaches between emotion regulation researchers and cognitive-experimental investigators. We also discuss (...) how recent innovations within each field can profitably impact upon progress within the other. It is concluded that the overlap in conceptual constructs, and the convergence of complementary investigative techniques, between these two research domains, provide opportunities for creative synthesis that could significantly enrich understanding of normal and abnormal emotion across future years. (shrink)

Music is a stimulus capable of triggering an array of basic and complex emotions. We investigated whether and how individuals employ music to induce specific emotional states in everyday situations for the purpose of emotion regulation. Furthermore, we wanted to examine whether specific emotion-regulation styles influence music selection in specific situations. Participants indicated how likely it would be that they would want to listen to various pieces of music (which are known to elicit specific emotions) in various emotional situations. Data (...) analyses by means of non-metric multidimensional scaling revealed a clear preference for pieces of music that were emotionally congruent with an emotional situation. In addition, we found that specific emotion-regulation styles might influence the selection of pieces of music characterised by specific emotions. Our findings demonstrate emotion-congruent music selection and highlight the important role of specific emotion-regulation styles in the selection of music in everyday situations. (shrink)

The introduction of genomics and biobanking methodologies to the African research context has also introduced novel ways of doing science, based on values of sharing and reuse of data and samples. This shift raises ethical challenges that need to be considered when research is reviewed by ethics committees, relating for instance to broad consent, the feedback of individual genetic findings, and regulation of secondary sample access and use. Yet existing ethics guidelines and regulations in Africa do not successfully regulate (...) research based on sharing, causing confusion about what is allowed, where and when. In order to understand better the ethics regulatory landscape around genomic research and biobanking, we conducted a comprehensive analysis of existing ethics guidelines, policies and other similar sources. We sourced 30 ethics regulatory documents from 22 African countries. We used software that assists with qualitative data analysis to conduct a thematic analysis of these documents. Surprisingly considering how contentious broad consent is in Africa, we found that most countries allow the use of this consent model, with its use banned in only three of the countries we investigated. In a likely response to fears about exploitation, the export of samples outside of the continent is strictly regulated, sometimes in conjunction with regulations around international collaboration. We also found that whilst an essential and critical component of ensuring ethical best practice in genomics research relates to the governance framework that accompanies sample and data sharing, this was most sparingly covered in the guidelines. There is a need for ethics guidelines in African countries to be adapted to the changing science policy landscape, which increasingly supports principles of openness, storage, sharing and secondary use. Current guidelines are not pertinent to the ethical challenges that such a new orientation raises, and therefore fail to provide accurate guidance to ethics committees and researchers. (shrink)

As COVID-19 and its variants spread across Australia at differing paces and intensity, the country’s response to the risk of infection and contagion revealed an intensification of bordering practices as a form of risk mitigation with disparate impacts on different segments of the Australian community. Australia’s international border was closed for both inbound and outbound travel, with few exceptions, while states and territories, Indigenous communities, and local government areas were subject to a patchwork of varying restrictions. By focusing on borders (...) at various levels, our research traces how the logics of medico-legal bordering have filtered down from the international to the intra-national, and indeed, into hyper-local spaces. This is not just apparent in the COVID-19 moment but in previous pandemics of 1918 to 1919 influenza and smallpox, in which practices of quarantine and lockdowns were both unevenly distributed and implemented on multiple scales of social organization. An interdisciplinary approach between history and law reveals that human movement during pandemic times in Australia has been regulated in a manner that sees mobility as a risk to public health capable of mitigation through the strict enforcement of borders as a technology of both confinement and exclusion. (shrink)

Emotions are foremost self-regulating processes that permit rapid responses and adaptations to situations of personal concern. They have biological bases and are shaped ontogenetically via learning and experience. Many situations and events of personal concern are social in nature. Thus, social exchanges play an important role in learning about rules and norms that shape regulation processes. I argue that (a) emotions often are actively auto-regulating—the behavior implied by the emotional reaction bias to the eliciting event or situation modifies or terminates (...) the situation; (b) certain emotion components are likely to habituate dynamically, modifying the emotional states; (c) emotions are typically intra- and interpersonal processes at the same time, and modulating forces at these different levels interact; (d) emotions are not just regulated—they regulate. Important conclusions of my arguments are that the scientific analysis of emotion should not exclude regulatory processes, and that effortful emotion regulation should be seen relative to a backdrop of auto-regulation and habituation, and not the ideal notion of a neutral baseline. For all practical purposes unregulated emotion is not a realistic concept. (shrink)

Emotion regulation has the odd distinction of being a wildly popular construct whose scientific existence is in considerable doubt. In this article, we discuss the confusion about whether emotion generation and emotion regulation can and should be distinguished from one another. We describe a continuum of perspectives on emotion, and highlight how different (often mutually incompatible) perspectives on emotion lead to different views about whether emotion generation and emotion regulation can be usefully distinguished. We argue that making differences in perspective (...) explicit serves the function of allowing researchers with different theoretical commitments to collaborate productively despite seemingly insurmountable differences in terminology and methods. (shrink)

Biological regulation is what allows an organism to handle the effects of a perturbation, modulating its own constitutive dynamics in response to particular changes in internal and external conditions. With the central focus of analysis on the case of minimal living systems, we argue that regulation consists in a specific form of second-order control, exerted over the core regime of production and maintenance of the components that actually put together the organism. The main argument is that regulation requires a distinctive (...) architecture of functional relationships, and specifically the action of a dedicated subsystem whose activity is dynamically decoupled from that of the constitutive regime. We distinguish between two major ways in which control mechanisms contribute to the maintenance of a biological organisation in response to internal and external perturbations: dynamic stability and regulation. Based on this distinction an explicit definition and a set of organisational requirements for regulation are provided, and thoroughly illustrated through the examples of bacterial chemotaxis and the lac-operon. The analysis enables us to mark out the differences between regulation and closely related concepts such as feedback, robustness and homeostasis. (shrink)

Emotion regulation is one of the major foci of study in the fields of emotion and emotional development. This article proposes that to properly study emotion regulation, one must consider not only an intrapersonal view of emotion, but a relational one as well. Defining properties of intrapersonal and relational approaches are spelled out, and implications drawn for how emotion regulation is conceptualized, how studies are designed, how findings are interpreted, and how generalizations are drawn. Most research to date has been (...) conducted from an intrapersonal perspective, and the shortcomings of this approach for understanding emotion regulation are highlighted. The article emphasizes major conceptual and methodological steps required for a fuller description of the process of emotion regulation. (shrink)

Regulation of Regenerative Medicines: A Global Perspective covers regenerative medicine regulations globally where frameworks have been or are being established. Chapters by discipline include manufacturing, supply chain, pharmacology, pharmacokinetics, toxicology, and combination product.

Medicine regulation demands the application of sound medical, scientific, and technical knowledge and skills, and operates within a legal framework. Regulatory functions involve interactions with various stakeholders (e.g., manufacturers, traders, consumers, health professionals, researchers, and governments) whose economic, social, and political motives may differ, making implementation of regulation both politically and technically challenging. This book discusses regulatory landscape globally and the current global regulatory scenario of medicinal products and food products comprehensively.

Depression is a disorder of impaired emotion regulation. Consequently, examining individual differences in the habitual use of emotion-regulation strategies has considerable potential to inform models of this debilitating disorder. The aim of the current study was to identify cognitive processes that may be associated with the use of emotion-regulation strategies and to elucidate their relation to depression. Depression has been found to be associated with difficulties in cognitive control and, more specifically, with difficulties inhibiting the processing of negative material. We (...) used a negative affective priming task to assess the relations among inhibition and individual differences in the habitual use of rumination, reappraisal, and expressive suppression in clinically depressed, formerly depressed, and never-depressed participants. We found that depressed participants exhibited the predicted lack of inhibition when processing negative material. Moreover, within the group of depressed participants, reduced inhibition of negative material was associated with greater rumination. Across the entire sample, reduced inhibition of negative material was related to less use of reappraisal and more use of expressive suppression. Finally, within the formerly depressed group, less use of reappraisal, more use of rumination, and greater expressive suppression were related to higher levels of depressive symptoms. These findings suggest that individual differences in the use of emotion-regulation strategies play an important role in depression, and that deficits in cognitive control are related to the use of maladaptive emotion-regulation strategies in this disorder. (shrink)

Endocrinologists apply the idea of feedback loops to explain how hormones regulate certain bodily functions such as glucose metabolism. In particular, feedback loops focus on the maintenance of the plasma concentrations of glucose within a narrow range. Here, we put forward a different, organicist perspective on the endocrine regulation of glycaemia, by relying on the pivotal concept of closure of constraints. From this perspective, biological systems are understood as organized ones, which means that they are constituted of a set of (...) mutually dependent functional structures acting as constraints, whose maintenance depends on their reciprocal interactions. Closure refers specifically to the mutual dependence among functional constraints in an organism. We show that, when compared to feedback loops, organizational closure can generate much richer descriptions of the processes and constraints at play in the metabolism and regulation of glycaemia, by making explicit the different hierarchical orders involved. We expect that the proposed theoretical framework will open the way to the construction of original mathematical models, which would provide a better understanding of endocrine regulation from an organicist perspective. (shrink)

Mit der rekonstruierenden Textanalyse der Preisschrift über die Fortschritte der Metaphysik (1804) und der drei Kritiken hat der Autor den Begriff der „eigentlichen Metaphysik“ Kants zum Inhalt. Demnach wird die Hauptfrage der kantischen Metaphysik als die Frage nach der Möglichkeit der Erkenntnis von den übersinnlichen Prinzipien der Natur bestimmt. Die Grundmethode zur Kants Antwort auf diese Frage bezeichnet der Autor als „praktische Regulation der Natur“, in der die reine praktische Vernunft ihrem notwendigen Bedürfnis gemäß die reflektierende Urteilskraft dazu leitet, nach (...) dem System der praktisch postulierten Prinzipien (Gott, Freiheit und Unsterblichkeit) eine moralisch-zweckmäßigen Natur zu regulieren. Durch dieses methodische Verfahren zeichnet sich die kantische Metaphysikkonzeption aus, die ihrerseits aber auch auf die aristotelische Tradition zurückbezogen ist. Yuwei Xie promovierte in Philosophie an der Universität Heidelberg und arbeitet derzeit am Philosophischen Seminar der Sun Yat-sen Universität in Guangzhou, China. Seine Forschungsschwerpunkte sind klassische deutsche Philosophie und Phänomenologie. (shrink)

For the purposes of conservation or suppression of species, gene drive technology has significant potential. Theoretically speaking, with the release of even relatively few animals with gene drive systems in an ecosystem, beneficial or harmful genes could be introduced into the entire wild-type population of that species. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. Communities and groups have differing beliefs about nature and its conservation or preservation, as (...) well as concerns about the ecological safety of the eradication, replacement or enhancement of particular species of animals by means of genetic engineering. For all those reasons, the rigorous regulation of insects and other animals with gene drive systems is crucial. In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. (shrink)

This book analyzes the political economy governing energy regulation across the African continent. Presenting case studies that span diverse energy sectors and countries, it provides an overview of their complex political and regulatory frameworks. The book explores emerging technologies and energy markets, highlighting Africa’s preparedness for the energy transition, and sheds light on the pivotal role of cross-border energy trade with regard to energy access. Further, it examines regulators’ influence within regional power pools, as well as their contribution to gender (...) mainstreaming in the energy sector, addressing vital social issues. This book is divided into five parts, the first of which focuses on the political economy of energy regulation. The second part discusses emerging technologies and climate change issues, while the third examines regional energy markets, and regional institutional collaboration. The fourth part features contributions on gender mainstreaming, while part five rounds up the coverage. The book will be of interest to policymakers and investors in Africa, as well as scholars interested in energy regulation and economics. (shrink)

Systematically improving patient safety is of the utmost importance, but it is also an extremely complex and challenging task. This illuminating study evaluates the role of professionalism, regulation and law in seeking to improve safety, arguing that the 'medical dominance' model is ill-suited to this aim, which instead requires a patient-centred vision of professionalism. It brings together literatures on professions, regulation and trust, while examining the different legal mechanisms for responding to patient safety events. Oliver Quick includes an examination in (...) areas of law which have received little attention in this context, such as health and safety law, and coronial law, and contends in particular that the active involvement of patients in their own treatment is fundamental to ensuring their safety. (shrink)

In July 2014, the roboticist Ronald Arkin suggested that child sex robots could be used to treat those with paedophilic predilections in the same way that methadone is used to treat heroin addicts. Taking this onboard, it would seem that there is reason to experiment with the regulation of this technology. But most people seem to disagree with this idea, with legal authorities in both the UK and US taking steps to outlaw such devices. In this paper, I subject these (...) different regulatory attitudes to critical scrutiny. In doing so, I make three main contributions to the debate. First, I present a framework for thinking about the regulatory options that we confront when dealing with child sex robots. Second, I argue that there is a prima facie case for restrictive regulation, but that this is contingent on whether Arkin’s hypothesis has a reasonable prospect of being successfully tested. Third, I argue that Arkin’s hypothesis probably does not have a reasonable prospect of being successfully tested. Consequently, we should proceed with utmost caution when it comes to this technology. (shrink)

PurposeThe purpose of the paper is to provide an overview of the legal implications which may be relevant to the ethical aspects of emerging technologies, to explore the existing situation in the area of legal regulation at EU level, and to formulate recommendations for the lawmakers.Design/methodology/approachThe analysis is based on the premise that the law is supposed to invoke moral principles. Speculative findings are formulated on the basis of analyzing specific emerging technologies; empirical findings are based on a research conducted (...) in the whole legal corpus of the EU.FindingsIn the area of network‐based technologies the already existing and elaborated legal frameworks can be used in an extended manner; artificial intelligence‐based technologies call for alterations in several branches of law; while interface technologies show the difficulty and complexity of regulating interdisciplinary fields. The legal implications of emerging technologies have attracted only a minimal legislative attention in the competent bodies of the EU.Originality/valueThe paper provides a systemic approach towards transmitting ethical norms to the application of emerging technologies through legal regulation, and formulates detailed recommendations in various areas of such technologies. (shrink)

This book traces the historic transformation of institutional review boards (IRBs) from academic committees to compliance bureaucracies. Sarah Babb opens the black box of contemporary IRB decision-making, which is increasingly outsourced to specialized private firms.