Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political, legal and cultural, on a global scale. Against this background, this special issue sets out to explore the multifaceted meaning, potential and impact as well as the social praxis of regulatory governance. Under the notions rules, resistance and responsibility the special issue (...) pins out three overall dimensions of regulation and governance thereby providing a theoretical and conceptual framework for grasping the phenomenon of regulatory governance. This is combined with extensive case studies on a number of regulatory governance settings ranging from the World Bank to agricultural reforms carried by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh. (shrink)

Criminal offences and regulatory breaches in using social networking evidence in personal injury litigation Pages 2-7 Current Criminal Law ISSN 1758-8405 Volume 2 Issue 3 March 2010 Author SALLY RAMAGE WIPO 900614 UK TM 2401827 USA TM 3,440.910 Orchid ID 0000-0002-8854-4293 Sally Ramage, BA (Hons), MBA, LLM, MPhil, MCIJ, MCMI, DA., ASLS, BAWP. Publisher & Managing Editor, Criminal Lawyer series [1980-2022](ISSN 2049-8047); Current Criminal Law series [2008-2022] (ISSN 1758-8405) and Criminal Law News series [2008-2022] (ISSN 1758-8421). Sweet & Maxwell (...) (Thomson Reuters) (Licensed Annotator of UK Statutes) in Current Law Statutes Annotated, (2006, 2009, 2010 editions) (sole and separate S&M contracts) for 7 UK Criminal Justice Statutes: UK Safeguarding Vulnerable Persons Act 2006; UK International Development Act 2006; UK Fraud Act 2006; UK Policing and Crime Act 2009, UK Local Democracy Act 2009; UK Bribery Act 2010; and UK Crime and Security Act 2010. Trade Mark SALLY RAMAGE ® 2401827 (2005-2025) in the UK, WIPO Trade Mark SALLY RAMAGE® 900164; USA-(Trade Mark 3,440,910) (2008-2028). WARNING: The doing of an unauthorized act in relation to a copyright work may result in both a civil claim for damages and criminal prosecution. Essentially, Social Network information may not always be admissible in a court of law but may be the door to lead to other, non-contentious evidence. In fact, even illegally obtained evidence may sometimes be admissible evidence, though this is not absolute. Most of the information available on social networking sites will be ‘personal data’. The data controller is the network operator, without whose consent, collecting such information could be an offence, unless it was necessary for the purpose of preventing or detecting crime. (shrink)

Genetically engineered (GE) insects, such as the GE OX513A Aedes aegypti mosquitoes, have been designed to suppress their wild-type populations so as to reduce the transmission of vector-borne diseases in humans. Apart from the ecological and epidemiological uncertainties associated with this approach, such biotechnological approaches may be used by individual governments or the global community of nations to avoid addressing the underlying structural, systemic causes of those infections... We discuss here key ethical questions raised by the use of GE mosquitoes, (...) with the aim of fostering discussion between the public, researchers, policy makers, healthcare organizations, and regulatory agencies at the local, national, and international levels. We affect that goal by outlining a procedural approach to decision-making about the use of the “biotechnology” that goes beyond “community engagement.” The protocol we advocate for entails informed deliberations and decision-making at the community level. It is designed to ensure that the voices of the marginalized and vulnerable groups that would be disproportionately affected by the decision are heard during the community-wide discussions. Moreover, we make the case that the values embedded in the risk assessment should be identified so that the community can make an informed decision about the use of GE insects. In addition, we advocate for the involvement of a variety of actors whose responsibility would be to ensure that the community has the opportunity to make an informed decision based on deliberations about the use of the “biotechnology.”. (shrink)

Vaccination against various diseases has been widely practised for more than a century and on a more limited scale its use in a variety of forms stretches back far longer. During earlier eras disease spread more slowly along shipping lanes on water and traditional transport routes on land. Today, in an era of air transport, contagion spreads far more rapidly. Travelling far more rapidly (indeed instantaneously) is the spread of misinformation that hinders vaccination which can, in the instance of Covid-19, (...) reduce disease impacts, including rates of severe illness and death. This paper explores the ethical issue of informed consent in the context of the contest between personal choice and the greater public welfare. It also makes reference to a number of low, middle and high income countries where vaccine hesitance, and to a lesser extent refusal, has been fed by misinformation on a scale not previously observed but made possible by the proliferation of modern technology. This campaign of ignorance has further undermined trust in governmental health bodies and their attempts to implement quarantine and other measures such as vaccination that had already been damaged by early variations and vacillation in governmental approaches around the globe due in part to a reluctance by some governments to take actions that would have economic repercussions but also by the necessary evolution of their approaches as more became known about the disease and its variants. The paper examines the historical background and the current situation and finds that more must be done to restore or increase trust levels between citizens and governmental authorities, including the dissemination of high quality accurate information in a form relevant to readers/viewers. While potential side-effects of vaccines must be disclosed to ensure informed consent, their incidence should also be clearly communicated (e.g., in vaccine information statements) so that clients/patients are aware that a risk is 1 in 100 or 1in 1000 or 1 in 2 million etc. Governments are urged to learn from their experience and better prepare for inevitable future pandemics to minimise vaccine hesitancy and refusal and maximise its acceptance where evidence is overwhelming as to the benefit to the community. Informed consent is part of the context of efforts to use vaccination to contain or eradicate any disease. Nevertheless, while better information for clients/patients/consumers may reduce vaccine hesitancy/refusal, it is unlikely that it would but eliminate the need for mandating vaccination in some circumstances for the benefit of the broader community, although strict quarantine of those reluctant to accept it is an alternative but one not generally accepted by those reluctant to be vaccinated. The information war is one that needs to be won to increase the voluntary uptake of vaccination in the context of voluntary informed consent. (shrink)

Vaccination against various diseases has been widely practised for more than a century and on a more limited scale its use in a variety of forms stretches back far longer. During earlier eras disease spread more slowly along shipping lanes on water and traditional transport routes on land. Today, in an era of air transport, contagion spreads far more rapidly. Travelling far more rapidly (indeed instantaneously) is the spread of misinformation that hinders vaccination which can, in the instance of Covid-19, (...) reduce disease impacts, including rates of severe illness and death. This paper explores the ethical issue of informed consent in the context of the contest between personal choice and the greater public welfare. It also makes reference to a number of low, middle and high income countries where vaccine hesitance, and to a lesser extent refusal, has been fed by misinformation on a scale not previously observed but made possible by the proliferation of modern technology. This campaign of ignorance has further undermined trust in governmental health bodies and their attempts to implement quarantine and other measures such as vaccination that had already been damaged by early variations and vacillation in governmental approaches around the globe due in part to a reluctance by some governments to take actions that would have economic repercussions but also by the necessary evolution of their approaches as more became known about the disease and its variants. The paper examines the historical background and the current situation and finds that more must be done to restore or increase trust levels between citizens and governmental authorities, including the dissemination of high quality accurate information in a form relevant to readers/viewers. While potential side-effects of vaccines must be disclosed to ensure informed consent, their incidence should also be clearly communicated (e.g., in vaccine information statements) so that clients/patients are aware that a risk is 1 in 100 or 1in 1000 or 1 in 2 million etc. Governments are urged to learn from their experience and better prepare for inevitable future pandemics to minimise vaccine hesitancy and refusal and maximise its acceptance where evidence is overwhelming as to the benefit to the community. Informed consent is part of the context of efforts to use vaccination to contain or eradicate any disease. Nevertheless, while better information for clients/patients/consumers may reduce vaccine hesitancy/refusal, it is unlikely that it would but eliminate the need for mandating vaccination in some circumstances for the benefit of the broader community, although strict quarantine of those reluctant to accept it is an alternative but one not generally accepted by those reluctant to be vaccinated. The information war is one that needs to be won to increase the voluntary uptake of vaccination in the context of voluntary informed consent. (shrink)

COVID-19 vaccination of children has begun in various high-income countries with regulatory approval and general public support, but largely without careful ethical consideration. This trend is expected to extend to other COVID-19 vaccines and lower ages as clinical trials progress. This paper provides an ethical analysis of COVID-19 vaccination of healthy children. Specifically, we argue that it is currently unclear whether routine COVID-19 vaccination of healthy children is ethically justified in most contexts, given the minimal direct benefit that COVID-19 (...) vaccination provides to children, the potential for rare risks to outweigh these benefits and undermine vaccine confidence, and substantial evidence that COVID-19 vaccination confers adequate protection to risk groups, such as older adults, without the need to vaccinate healthy children. We conclude that child COVID-19 vaccination in wealthy communities before adults in poor communities worldwide is ethically unacceptable and consider how policy deliberations might evolve in light of future developments. (shrink)

It is well-known that racism is encoded into the social practices and institutions of medicine. Less well-known is that racism is encoded into the material artifacts of medicine. We argue that many medical devices are not merely biased, but materialize oppression. An oppressive device exhibits a harmful bias that reflects and perpetuates unjust power relations. Using pulse oximeters and spirometers as case studies, we show how medical devices can materialize oppression along various axes of social difference, including race, gender, class, (...) and ability. Our account uses political philosophy and cognitive science to give a theoretical basis for understanding materialized oppression, explaining how artifacts encode and carry oppressive ideas from the past to the present and future. Oppressive medical devices present a moral aggregation problem. To remedy this problem, we suggest redundantly layered solutions that are coordinated to disrupt reciprocal causal connections between the attitudes, practices, and artifacts of oppressive systems. (shrink)

Historically, laws and policies to criminalize drug use or possession were rooted in explicit racism, and they continue to wreak havoc on certain racialized communities. We are a group of bioethicists, drug experts, legal scholars, criminal justice researchers, sociologists, psychologists, and other allied professionals who have come together in support of a policy proposal that is evidence-based and ethically recommended. We call for the immediate decriminalization of all so-called recreational drugs and, ultimately, for their timely and appropriate legal regulation. We (...) also call for criminal convictions for nonviolent offenses pertaining to the use or possession of small quantities of such drugs to be expunged, and for those currently serving time for these offenses to be released. In effect, we call for an end to the “war on drugs.”. (shrink)

Over the last decade, the phenomenon called collaborative economy or sharing economy gained significant dimensions and crossed many sectors of economic and social life, creating new business models. Despite the growing interest, there is no single concept for its definition, manifestations, impacts and business models, while at the same time, digital platforms have allowed its sophisticated development. The seen emergence of sharing economy in Bulgaria brings out the need to study the phenomenon at the national level, its context, development, stakeholders. (...) The aim of this chapter is to shed light on the main manifestations and regulatory issues of the sharing economy in Bulgaria and to discuss its stage of development critically. The first part starts with a review of definition aspects and academic conceptualisation of the sharing economy and key issues. In the second part, aspects of the context and manifestations in the development of the phenomenon are discussed. Then, looking at several national examples of market players, an attempt is made to present the sectoral scope of the sharing economy and its development and to highlight the active stakeholders in the market. The study concludes with a discussion on the policies to be developed at the national level and future research to be carried out in order to catch the potential opportunities and overcome potential barriers. (shrink)

Autism has been defined as a disorder of social cognition, interaction and communication where ritualistic, repetitive behaviors are commonly observed. But how should we understand the behavioral and cognitive differences that have been the main focus of so much autism research? Can high-level cognitive processes and behaviors be identified as the core issues people with autism face, or do these characteristics perhaps often rather reflect individual attempts to cope with underlying physiological issues? Much research presented in this volume (...) will point to the latter possibility, i.e. that people on the autism spectrum cope with issues at much lower physiological levels pertaining not only to Central Nervous Systems (CNS) function, but also to peripheral and autonomic systems (PNS, ANS) (Torres, Brincker, et al. 2013). The question that we pursue in this chapter is what might be fruitful ways of gaining objective measures of the large-scale systemic and heterogeneous effects of early atypical neurodevelopment; how to track their evolution over time and how to identify critical changes along the continuum of human development and aging. We suggest that the study of movement variability—very broadly conceived as including all minute fluctuations in bodily rhythms and their rates of change over time (coined micro-movements (Figure 1A-B) (Torres, Brincker, et al. 2013))—offers a uniquely valuable and entirely objectively quantifiable lens to better assess, understand and track not only autism but cognitive development and degeneration in general. This chapter presents the rationale firstly behind this focus on micro-movements and secondly behind the choice of specific kinds of data collection and statistical metrics as tools of analysis (Figure 1C). In brief the proposal is that the micro-movements (defined in Part I – Chapter 1), obtained using various time scales applied to different physiological data-types (Figure 1), contain information about layered influences and temporal adaptations, transformations and integrations across anatomically semi-independent subsystems that crosstalk and interact. Further, the notion of sensorimotor re-afference is used to highlight the fact that these layered micro-motions are sensed and that this sensory feedback plays a crucial role in the generation and control of movements in the first place. In other words, the measurements of various motoric and rhythmic variations provide an access point not only to the “motor systems”, but also access to much broader central and peripheral sensorimotor and regulatory systems. Lastly, we posit that this new lens can also be used to capture influences from systems of multiple entry points or collaborative control and regulation, such as those that emerge during dyadic social interactions. (shrink)

Theoretical accounts of development exhibit several internal tensions and face multiple challenges. They span from the problem of the identification of the temporal boundaries of development (beginning and end) to the characterization of the distinctive type of change involved compared to other biological processes. They include questions such as the role to ascribe to the environment or what types of biological systems can undergo development and whether they should include colonies or even ecosystems. In this chapter we discuss these conceptual (...) issues, and we argue that adopting an organizational approach may help solve or clarify them. -/- While development is usually identified with the achievement of an adult form with the capability to reproduce and therefore maintain a lineage, adopting the organizational approach may provide a different strategy, which focuses also on the maintenance of the current organization of the organism. By doing so an organizational approach favors a switch in perspective which consists in analyzing how organisms maintain their viability at each moment of development rather than considering them as going through intermediate stages of a process directed toward a specific goal state. This developmental dimension of biological organization has yet to be given a general and detailed analysis within the organizational theoretical perspective, apart from some preliminary attempts. How a biological organization is maintained through a series of radical organizational changes and what these changes are issues that still require clarification. In this chapter we offer the beginnings of such an analysis of developmental transitions, understood as changes in functionality brought forth by regulatory mechanisms in the context of the continued maintenance of organizational viability at every step. (shrink)

My paper builds on the conceptual tools from three interrelated philosophical debates that—as I believe—may help structure important if chaotic discussions about surrogates for living human brains and resolve some practical issues related to regulatory matters. In particular, I refer to the discussions about the “moral precautionary principle” in research ethics (Koplin and Wilkinson 2019); about normative uncertainty in ethics (MacAskill, Bykvist, and Ord 2020), and about the inductive risk problem for animal welfare scientists (Birch 2018). I elucidate (...) upon the possible meanings of the phrase “a too good human brain surrogate” used by Henry T. Greely (2021), and I demonstrate that the evaluation of the practical and regulatory implications of the “goodness” of such surrogates created for research purposes should be sensitive to the possible consequences of two types of errors: the under-attribution and over-attribution of moral status to such beings. Many authors writing about this topic (including Greely 2021, but see also, e.g., Koplin and Savulescu 2019) concentrate only on the first type of error, neglecting the negative consequences of the second type, i.e., over-attribution. (shrink)

Vigorous debate over the moral propriety of cognitive enhancement exists, but the views of the public have been largely absent from the discussion. To address this gap in our knowledge, four experiments were carried out with contrastive vignettes in order to obtain quantitative data on public attitudes towards cognitive enhancement. The data collected suggest that the public is sensitive to and capable of understanding the four cardinal concerns identified by neuroethicists, and tend to cautiously accept cognitive enhancement even as they (...) recognize its potential perils. The public is biopolitically moderate, endorses both meritocratic principles and the intrinsic value of hard work, and appears to be sensitive to the salient moral issues raised in the debate. Taken together, these data suggest that public attitudes toward enhancement are sufficiently sophisticated to merit inclusion in policy deliberations, especially if we seek to align public sentiment and policy. (shrink)

Clinical Ethics Consultations are an important tool for physicians in solving difficult cases. They are extremely common in North America and to a lesser extent also present in Europe. However, there is little data on this practice in Poland. We present results of a survey of 521 physicians practising in Poland concerning their opinion on CECs and related practices. We analysed the data looking at such issues as CECs’ perceived availability, use of CECs, and perceived usefulness of such support. (...) Physicians in our study generally encounter hard ethics cases, even—surprisingly—those who do not work in hospitals. Most physicians have no CEC access, and those that do still do not employ CECs. However, physicians perceive this form of support as useful—even more so among actual users of CECs. We compared these findings with similar studies from other European countries and the North America. We point out peculiarities of our results as compared to those in other countries, with some possible explanations. We hope the results may encourage regulatory debate on the need to formally introduce CECs into the Polish healthcare system. (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)

One of the most prominent ethical concerns regarding emerging neurotechnologies is mental privacy. This is the idea that we should have control over access to our neural data and to the information about our mental processes and states that can be obtained by analyzing it. A key issue is whether this information needs more stringent protection than other kinds of personal information. I will articulate and support the view, underlying recent regulatory frameworks, that mental privacy requires a special treatment (...) because of its relation to relevant aspects of personal identity. It has been suggested that this approach could be supported by the idea that mental privacy constitutes a fundamental psychological dimension of privacy. The connection between this psychological view of privacy and identity can be traced back to Irwin Altman’s idea that privacy is an interpersonal boundary regulation process. However, it is not clear whether this notion of privacy can be associated with a conception of identity that is relevant in contemporary neuroethics. I will suggest that the narrative and relational approach to identity, a prominent view in recent ethical discussions of neurotechnology, lines up with key aspects of Altman’s proposal. I suggest that if mental privacy is an essential component of identity, the latter could be affected by technological mind-reading. (shrink)

Organizations are increasingly finding it challenging to balance economic and environmental performance particularly those that face competitive, regulatory and community pressure. With the increasing pressures for environmental sustainability, this calls for the new formulation of strategies by the manufacturers in order to minimize their products and services negative impact on the environment. Hence, Green Human Resource Management (GHRM) continues to be an important research agenda among the researchers. In Palestine, green issues are new and still developing. Constant study (...) is needed to fully understand and update information regarding this area. Objective: The aim of this paper is to explore the views and level of acceptance of GHRM practices among manufacturing firms in Palestine. Results: Through the use of e-mail survey, 121 responses were obtained to generate the results of the study. The result showed GHRM practices have been practiced to somewhat to a greater extent a firms in Palestine. Findings can be extended to study on the issues in further. Academicians and practitioners can apply this result to their research and business strategies on how to improve sustainable performance and to effectively implement GHRM practices. (shrink)

Research misconduct remains an important problem in health research despite decades of local, national, regional, and international efforts to eliminate it. The ultimate goal of every health research project, irrespective of setting, is to produce trustworthy findings to address local as well as global health issues. To be able to lead or participate meaningfully in international research collaborations, individual and institutional capacities for research integrity are paramount. Accordingly, this paper concerns itself not only with individuals’ research skills but also (...) with institutional and national policies and governance. Such policies and governance provide an ethical scaffold for the production of knowledge and structure incentives. This paper’s operational definition of research therefore draws from Institute of Medicine’s articulation of health research as an inquiry that aims to produce knowledge about the structure, processes, or effects of personal health services; and from an existing health systems framework. The paper reviews the research regulatory environment and the ethics apparatus in Ghana, and describes a project jointly undertaken by Ghanaian researchers in collaboration with New York University to assess the perceived adequacy of current institutional practices, opportunities, and incentives for promoting RI. (shrink)

Since the concept of “nudge” was introduced in 2008 by Thaler and Sunstein, proposing that small interventions based on changes in choice architectures can alter people’s behavior and make it easier for them to achieve their desired goals, the application in public policy of behavioral economics has gained significant attention. This has led to the emergence of different types of policies based on behavioral insights, which have been used in a variety of areas, including health or finance, with the goal (...) of promoting well-being and addressing social and economic issues. After providing a basic theoretical background as a frame of reference to understand gender violence, this study explores the use of tools from the field of behavioral economics as it is applied in public policy. Regulatory (paternalistic) and non-regulatory (libertarian) interventions based on behavioral insights will be considered: nudges, boosts, shoves, budges, or sludge audits, are examined as potential interventions to use in matters related to this type of violence. After evaluating these behavioral policy instruments and their potential effectiveness, the limitations of the behavioral perspective are recognized, and the need for a multifaceted approach to combating gender violence is acknowledged. The article concludes by arguing that public policies addressing gender violence should not only utilize behavioral tools but should also incorporate strategies related to education, legislation, and social norms. (shrink)

The EDPS Ethics Advisory Group (EAG) has carried out its work against the backdrop of two significant social-political moments: a growing interest in ethical issues, both in the public and in the private spheres and the imminent entry into force of the General Data Protection Regulation (GDPR) in May 2018. For some, this may nourish a perception that the work of the EAG represents a challenge to data protection professionals, particularly to lawyers in the field, as well as to (...) companies struggling to adapt their processes and routines to the requirements of the GDPR. What is the purpose of a report on digital ethics, if the GDPR already provides all regulatory requirements to protect European citizens with regard to the processing of their personal data? Does the existence of this EAG mean that a new normative ethics of data protection will be expected to fill regulatory gaps in data protection law with more flexible, and thus less easily enforceable ethical rules? Does the work of the EAG signal a weakening of the foundation of legal doctrine, such as the rule of law, the theory of justice, or the fundamental values supporting human rights, and a strengthening of a more cultural approach to data protection? Not at all. The reflections of the EAG contained in this report are not intended as the continuation of policy by other means. It neither supersedes nor supplements the law or the work of legal practitioners. Its aims and means are different. On the one hand, the report seeks to map and analyse current and future paradigm shifts which are characterised by a general shift from analogue experience of human life to a digital one. On the other hand, and in light of this shift, it seeks to re-evaluate our understanding of the fundamental values most crucial to the well-being of people, those taken for granted in a data-driven society and those most at risk. The objective of this report is thus not to generate definitive answers, nor to articulate new norms for present and future digital societies but to identify and describe the most crucial questions for the urgent conversation to come. This requires a conversation between legislators and data protection experts, but also society at large - because the issues identified in this report concern us all, not only as citizens but also as individuals. They concern us in our daily lives, whether at home or at work and there isn’t a place we could travel to where they would cease to concern us as members of the human species. (shrink)

The debate on whether and how the Internet can protect and foster human rights has become a defining issue of our time. This debate often focuses on Internet governance from a regulatory perspective, underestimating the influence and power of the governance of the Internet’s architecture. The technical decisions made by Internet Standard Developing Organisations that build and maintain the technical infrastructure of the Internet influences how information flows. They rearrange the shape of the technically mediated public sphere, including which (...) rights it protects and which practices it enables. In this article, we contribute to the debate on SDOs’ ethical responsibility to bring their work in line with human rights. We defend three theses. First, SDOs’ work is inherently political. Second, the Internet Engineering Task Force, one of the most influential SDOs, has a moral obligation to ensure its work is coherent with, and fosters, human rights. Third, the IETF should enable the actualisation of human rights through the protocols and standards it designs by implementing a responsibility-by-design approach to engineering. We conclude by presenting some initial recommendations on how to ensure that work carried out by the IETF may enable human rights. (shrink)

This paper addresses global bioethical challenges entailed in emerging viral diseases, focussing on their socio-cultural dimension and seeing them as symptomatic of the current era of globalisation. Emerging viral threats exemplify the extent to which humans evolved into a global species, with a pervasive and irreversible impact on the planetary ecosystem. To effectively address these disruptive threats, an attitude of preparedness seems called for, not only on the viroscientific, but also on bioethical, regulatory and governance levels. This paper analyses (...) the global bioethical challenges of emerging viral threats from a dialectical materialist (Marxist) perspective, focussing on three collisions: (1) the collision of expanding networks of globalisation with local husbandry practices; (2) the collision of global networks of mobility with disrupted ecosystems; and (3) the collision of viroscience as a globalised research field with existing regulatory frameworks. These collisions emerge in a force field defined by the simultaneity of the non-simultaneous. Evidence-based health policies invoke discontent as they reflect the normative logic of a globalised knowledge regime. The development of a global bioethics or macro-ethics requires us to envision these collisions not primarily as issues of benefits and risks, but first and foremost as normative tensions closely entangled with broader socio-economic and socio-cultural developments. (shrink)

I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why RCTs were (...) accepted for regulatory purposes. I contend that their main virtue, from a regulatory viewpoint, is their impartiality, which is grounded in randomisation and fixed rules for the interpretation of the experiment. Thus the question will be whether Bayesian trials can match or exceed the achievements of frequentist RCTs in all these respects. In the second part of the paper, I will first present a quick glimpse of the introduction of Bayesianism in the field of medical experiments, followed by a summary presentation of the basic tenets of a Bayesian trial. The point here is to show that there is no such thing as “a” Bayesian trial. Bayesianism can ground many different approaches to medical experiments and we should assess their respective virtues separately. Thus I present two actual trials, planned with different goals in mind, and assess their respective epistemic, ethical and regulatory merits. In a tentative conclusion, I contend that, given the constraints imposed by our current regulatory framework, impartiality should preside over the design of clinical trials, even at the expense of many of their inferential and ethical virtues. (shrink)

In response to the COVID-19 pandemic, large-scale research and pharmaceutical regulatory processes have proceeded at a dramatically increased pace with new and effective, evidence-based COVID-19 interventions rapidly making their way into the clinic. However, the swift generation of high-quality evidence and the efficient processing of regulatory authorisation have given rise to more specific and complex versions of well-known research ethics issues. In this paper, we identify three such issues by focusing on the authorisation of Molnupiravir, a (...) novel antiviral medicine aimed at reducing the ability of SARS-CoV-2 to multiply in the body, for clinical use by the National Health Service in England and the concomitant testing of Molnupiravir through the large-scale PANORAMIC randomised control trial. By analysing the ways in which the authorisation and clinical use of Molnupiravir complicate standard approaches to clinical equipoise, standard of care, and participant consent in the PANORAMIC randomised control trial we will explain some of ethical implications for clinical trials that aim to study the efficacy and safety of new COVID-19 and other therapeutics when conditional authorisation has already been granted and when such treatments have already been made available to patients by national health providers. (shrink)

New discoveries are improving the odds of human cells surviving in host animals, prompting regulatory and funding agencies to issue calls for additional layers of ethical oversight for certain types of human–animal chimeras. Of interest are research proposals involving chimeric animals with humanized brains. But what is motivating the demand for additional oversight? I locate two, not obviously compatible, motivations, each of which provides the justificatory basis for paying special attention to different sets of human–animal chimeras. Surprisingly, the sets (...) of animals that actually get flagged for special scrutiny by research and funding guidelines do not correlate with either of the sets of animals that arise when we think about what is motivating additional oversight. What this shows is that existing research policies and funding guidelines are disconnected from their motivation: the rationale for flagging certain types of human–animal chimeras as requiring special oversight is ignored in execution. (shrink)

The relevance of the study is the need to reform the educational environment based on the values of inclusion to ensure the accessibility of quality education for all people. The purpose of the study is to justify the need an inclusive culture formation as a culture of acceptance of diversity and mutual understanding. The research problem is the lack of development of an inclusive organizational culture is a barrier to ensuring the availability of quality education in a variety of health (...) limitations and the educational needs of students. The study is based on the analysis of regulatory documents, comparison and generalization of the available approaches in international and Russian theory and practice on the inclusion values issue in the strategy of educational organizations and the formation of an inclusive organizational culture. Results: it was established that the inclusive agenda in education aggravates the problem of the formation of an inclusive organizational culture as a culture of accepting diversity as a value, advantage, significant educational, upbringing, developing resource; staged, the need for a proactive strategy of the formation of intercultural competencies are justified. -/- . (shrink)

Efforts to ban Autonomous Weapon Systems were both unsuccessful and controversial. Simultaneously the need to address the detrimental aspects of AWS development and proliferation continues to grow in scope and urgency. The article presents several regulatory solutions capable of addressing the issue while simultaneously respecting the requirements of military necessity and so attracting a broad consensus. Two much stricter solutions – regional AWS bans and adoption of a no first use policy – are also presented as fallback strategies in (...) case achieving AWS’ compliance with the Laws of Armed Conflict proved elusive. Together, the solutions presented form an outline of a flexible regulatory strategy able to adjust to different technological outcomes and providing a sensible compromise to solve the current deadlock on the AWS issue. (shrink)

This introduction explains the reasons behind this Special issue and discuss the organization and content of it. The difficulty of a genuine dialogue and understanding between economics, law and humanities, seems to be due not only to the fragmentation of reflections on man, but to a real ‘conflict of anthropologies’. What kind of conceptions of man and human values are presupposed by and / or privileged by economics, law, economic approaches to law and social sciences? How and when do these (...) conceptions come into conflict within and between disciplines? How do these conceptions of man and his values influence the conceptions of economics, law and institutions, and vice versa, how do these last conceptions influence the former? What are the normative, regulatory and practical implications of assuming an anthropological and / or axiological perspective instead of another? This Special issue aims at exploring the possibility of finding a common ground for discussion between economics, law and humanities, through the analysis and comparison of both the conceptions of man, human action and values assumed by economics, law and humanities, and their normative implications. The contributions to this Special issue and its organization are outlined at the end of this introduction. (shrink)

In the meantime, critically needed is a comprehensive regulatory framework that enables not only state-owned but also non-state enterprises to be able to issue a wide range of bonds legitimately. This move will certainly pave the way towards a functional corporate bond market and open up the funding channel for enterprises via bond issues.

The COVID-19 pandemic demonstrated the benefits of international data sharing. Data sharing enabled the health care policy makers to make decisions based on real-time data, it enabled the tracking of the virus, and importantly it enabled the development of vaccines that were crucial to mitigating the impact of the virus. This data sharing is not the norm as data sharing needs to navigate complex ethical and legal rules, and in particular, the fragmented application of the General Data Protection Regulation (GDPR). (...) The introduction of the draft regulation for a European Health Data Space (EHDS) in May 2022 seeks to address some of these legal issues. If passed, it will create an obligation to share electronic health data for certain secondary purposes. While there is a clear need to address the legal complexities involved with data sharing, it is critical that any proposed reforms are in line with ethical principles and the expectations of the data subjects. In this paper we offer a critique of the EHDS and offer some recommendations for this evolving regulatory space. (shrink)

Nanotechnology, as with many technologies before it, places a strain on existing legislation and poses a challenge to all administrative agencies tasked with regulating technology-based products. It is easy to see how statutory schemes become outdated, as our ability to understand and affect the world progresses. In this article, we address the regulatory problems that nanotechnology posses for the Food and Drug Administration’s (FDA) classification structure for ‘‘drugs’’ and ‘‘devices.’’ The last major modification to these terms was in 1976, (...) with the enactment of the Medical Device Amendments. There are serious practical differences for a classification as a drug or device in terms of time to market and research. Drugs are classified, primarily, as acting by ‘‘chemical action.’’ We lay out some legal, philosophic, and scientific tools that serve to provide a useful, as well as legally and scientifically faithful, distinction between drugs and devices for the purpose of regulatory classification. These issues we raise are worth the consideration of anyone who is interested in the regulation of nano-products or other novel technologies. (shrink)

In 2000 Bill Joy proposed that the best way to prevent technological apocalypse was to "relinquish" emerging bio-, info- and nanotechnologies. His essay introduced many watchdog groups to the dangers that futurists had been warning of for decades. One such group, ETC, has called for a moratorium on all nanotechnological research until all safety issues can be investigated and social impacts ameliorated. In this essay I discuss the differences and similarities of regulating bio- and nanotechnological innovation to the efforts (...) to regulate nuclear and biological weapons of mass destruction. I then suggest the creation of a global technology regulatory regime to ensure the safe and equitable diffusion of genetic, molecular and information technologies, and point out the principal political obstacles to implementing such a regime. (shrink)

Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods The UCDMC investigative document is (...) reviewed along with standard literature on clinical ethics and clinical data about glioblastoma multiforme (GBM) cancer. Results In this paper I argue that, by tendentiously focusing on policies, regulations, and procedures governing human subjects research, the UCDMC investigation failed to account for the centrality of clinical judgment and clinical ethics pertinent to judicious review of this matter, especially given the unique clinical context of terminally ill patients having exhausted standard care treatment options for glioblastoma multiforme (GBM) cancer. Conclusions The UCDMC investigation raises serious problems for clinicians who are engaged in innovative therapy in the clinical setting, requiring a regulatory framework separate from the normal Institutional Review Board (IRB) process. (shrink)

In Slovenia, the collaborative economy is in the early stages of development. The collaborative economy became a popular topic in 2015 when the government intensified its efforts to initiate a debate on legal reforms that would better accommodate foreign collaborative economy companies in Slovenia. While in 2016, the government was actively working on the topic and eager to start the discussions on legal reform in line with the European agenda for the collaborative economy since 2018, the issue has lost its (...) momentum. After the Act Amending the Hospitality Act was adopted, the government has slowed down its efforts to create a regulatory framework conducive to the needs of the collaborative economy. Nevertheless, the practice is becoming more and more common, with several sharing initiatives surfacing in the past few years. Most collaborative economy services are not yet subject to taxation and regulation, one of the most pressing questions that will have to be answered in Slovenia is how to regulate and tax the collaborative economy. (shrink)

Mehlman and Li offer a framework for approaching the bioethical issues raised by the military use of genomics that is compellingly grounded in both the contemporary civilian and military ethics of medical research, arguing that military commanders must be bound by the two principles of paternal- ism and proportionality. I agree fully. But I argue here that this is a much higher bar than we may fully realize. Just as the principle of proportionality relies upon a thorough assessment of (...) harms caused and military advantage gained, the use of genomic research, on Mehlman and Li’s view, will require an accurate understanding of the connection between genotypes and phenotypes – accurate enough to ameliorate the risk undertaken by our armed forces in being subject to such research. Recent conceptual work in evolutionary theory and the philosophy of biology, however, renders it doubtful that such knowledge is forthcoming. The complexity of the relationship between genotypic factors and realized traits (the so-called ‘G→P map’) makes the estimation of potential military advantage, as well as potential harm to our troops, incredibly challenging. Such fundamental conceptual challenges call into question our ability to ever satisfactorily satisfy the demands of a sufficiently rigorous ethical standard. (shrink)

A growing range of brain-computer interface (BCI) technologies is being employed for purposes of therapy and human augmentation. While much thought has been given to the ethical implications of such technologies at the ‘macro’ level of social policy and ‘micro’ level of individual users, little attention has been given to the unique ethical issues that arise during the process of incorporating BCIs into eHealth ecosystems. In this text a conceptual framework is developed that enables the operators of eHealth ecosystems (...) to manage the ethical components of such processes in a more comprehensive and systematic way than has previously been possible. The framework’s first axis defines five ethical dimensions that must be successfully addressed by eHealth ecosystems: 1) beneficence; 2) consent; 3) privacy; 4) equity; and 5) liability. The second axis describes five stages of the systems development life cycle (SDLC) process whereby new technology is incorporated into an eHealth ecosystem: 1) analysis and planning; 2) design, development, and acquisition; 3) integration and activation; 4) operation and maintenance; and 5) disposal. Known ethical issues relating to the deployment of BCIs are mapped onto this matrix in order to demonstrate how it can be employed by the managers of eHealth ecosystems as a tool for fulfilling ethical requirements established by regulatory standards or stakeholders’ expectations. Beyond its immediate application in the case of BCIs, we suggest that this framework may also be utilized beneficially when incorporating other innovative forms of information and communications technology (ICT) into eHealth ecosystems. (shrink)

This contribution pays special attention to the Italian legal framework concerning the collaborative and sharing economy, with a focus on those economic initiatives which are platform mediated. This choice is due to the importance of the concept of “platform” in the definitions of the CSE provided at both the Italian and the European levels. As highlighted in some studies, most actors of the CSE can be considered not only economic disruptors but also policy disruptors. Thus, the chapter tries to shed (...) light on the difficulties Italian regulators had while dealing with the emergence of these actors, especially in sectors such as food, accommodation, delivery, and transport. Italian policymakers were not able to design new regulatory frameworks to cope with the challenges of CSE, privileging bans or almost total deregulation over the elaboration of innovative rules. Regarding the issue of digital labour, the Italian legislator adopted a partial solution, creating a framework that dualizes the labour market, maybe with the aim of satisfying both digital workers and platforms. Overall, it seems that the Italian ecosystem of the CSE is bound to evolve, especially after the appearance of the health crisis related to the COVID-19. (shrink)

Since the International Agency on Cancer Research’s monograph found glyphosate to be a likely carcinogen, the regulatory focus on the chemical has centred on this determinative criterion for regulatory action. Yet, other pertinent factors, such as the effects of glyphosate on fresh and ground water and ensuing effects on biodiversity, have received less attention as legitimate rationales for regulating the chemical. This underrepresentation prevents a wider policy discussion on the environmental and human health effects of the chemical and (...) fails to disrupt assumptions of path-dependently continuing on agriculture’s chemical treadmill. To avoid ad hoc post hoc chemical regulation, we assess four areas of chemical regulatory oversight in Europe with regard to glyphosate affecting water: (1) the undue emphasis on in laboratorio versus in situ testing; (2) assessing single chemicals (isolated glyphosate) versus admixtures (glyphosate plus surfactants and adjuvants) that are used in practice; (3) the tendency to downplay harms to non-human life; and (4) the lack of policy coherence in the existing regulatory framework. Focusing on European Union regulation of pesticide and water policy affecting aquatic environments, we conclude that issues of measurement and priority have become highly politicised in both science and policy, requiring preventative, precautionary frameworks utilising plural forms of measurement. (shrink)

The term “Complex Systems Biology” was introduced a few years ago [Kaneko, 2006] and, although not yet of widespread use, it seems particularly well suited to indicate an approach to biology which is well rooted in complex systems science. Although broad generalizations are always dangerous, it is safe to state that mainstream biology has been largely dominated by a gene-centric view in the last decades, due to the success of molecular biology. So the one gene - one trait approch, which (...) has often proved to be effective, has been extended to cover even complex traits. This simplifying view has been appropriately criticized, and the movement called systems biology has taken off. Systems biology [Noble, 2006] emphasizes the presence of several feedback loops in biological systems, which severely limit the range of validity of explanations based upon linear causal chains (e.g. gene → behaviour). Mathematical modelling is one the favourite tools of systems biologists to analyze the possible effects of competing negative and positive feedback loops which can be observed at several levels (from molecules to organelles, cells, tissues, organs, organisms, ecosystems). Systems biology is by now a well-established field, as it can be inferred by the rapid growth in number of conferences and journals devoted to it, as well as by the existence of several grants and funded projects.Systems biology is mainly focused upon the description of specific biological items, like for example specific organisms, or specific organs in a class of animals, or specific genetic-metabolic circuits. It therefore leaves open the issue of the search for general principles of biological organization, which apply to all living beings or to at least to broad classes. We know indeed that there are some principles of this kind, biological evolution being the most famous one. The theory of cellular organization also qualifies as a general principle. But the main focus of biological research has been that of studying specific cases, with some reluctance to accept (and perhaps a limited interest for) broad generalizations. This may however change, and this is indeed the challenge of complex systems biology: looking for general principles in biological systems, in the spirit of complex systems science which searches for similar features and behaviours in various kinds of systems. The hope to find such general principles appears well founded, and I will show in Section 2 that there are indeed data which provide support to this claim. Besides data, there are also general ideas and models concerning the way in which biological systems work. The strategy, in this case, is that of introducing simplified models of biological organisms or processes, and to look for their generic properties: this term, borrowed from statistical physics, is used for those properties which are shared by a wide class of systems. In order to model these properties, the most effective approach has been so far that of using ensembles of systems, where each member can be different from another one, and to look for those properties which are widespread. This approach was introduced many years ago [Kauffman, 1971] in modelling gene regulatory networks. At that time one had very few information about the way in which the expression of a given gene affects that of other genes, apart from the fact that this influence is real and can be studied in few selected cases (like e.g. the lactose metabolism in E. coli). Today, after many years of triumphs of molecular biology, much more has been discovered, however the possibility of describing a complete map of gene-gene interactions in a moderately complex organism is still out of reach. Therefore the goal of fully describing a network of interacting genes in a real organism could not be (and still cannot be) achieved. But a different approach has proven very fruitful, that of asking what are the typical properties of such a set of interacting genes. Making some plausible hypotheses and introducing some simplifying assumptions, Kauffman was able to address some important problems. In particular, he drew attention to the fact that a dynamical system of interacting genes displays selforganizing properties which explain some key aspects of life, most notably the existence of a limited number of cellular types in every multicellular organism (these numbers are of the order of a few hundreds, while the number of theoretically possible types, absent interactions, would be much much larger than the number of protons in the universe). In section 3 I will describe the ensemble based approach in the context of gene regulatory networks, and I will show that it can describe some important experimental data. Finally, in section 4 I will discuss some methodological aspects. (shrink)

Status of the national currency of Ukraine exchange rate has been characterized as unstable in recent years. Herewith, the Government has not implemented decisive measures on its stabilization, as a rule, underestimating the importance of the Hryvnia exchange rate stability for the successful economic growth in terms of socio-economic transformations. It should also be noted that in modern conditions among scientific and methodical approaches to the State exchange rate formation mechanisms some uncertainty regarding basic and additional tools for such (...) class='Hi'>regulatory activities allocation is still persist. The problem relevance is exacerbated by the lack of effective policy (coordination between the NBU and the Government actions) regarding the national currency stabilization as an indispensable prerequisite for an effective macroeconomic development. These circumstances determine the importance of factors influencing the national currency exchange rate and its regulation tools research, as well as new organizational and economic mechanisms for the national currency exchange rate in Ukraine stabilization identification. In the emerging market economy conditions formation of the efficient State currency exchange-rate regulation system provides an opportunity not only to stabilize its exchange rate in different socio-economic conditions, but to create the basis for improvement the country economic development as a whole. Given this, the issue of effective tools for the national currency exchange-rate regulation by the state determination is of theoretical, practical and methodological significance. This emphasizes the relevance of further scientific-methodological and practical principles in-depth development for the national currency exchange-rate regulation. (shrink)

Democratic transitions of Eastern countries brought about the need to shifting from eastern into western paradigms. Transitioning into western models of media, more specifically to the public system of broadcasting became a prerequisite for achieving the EU status for Eastern European transitioning countries. It has been twelve years since Albania entered the process of transformation from being a State TV towards becoming a Public Television. The article aims to provide a theoretical framework of public television networks in western countries pointing (...) to the pertaining relationships with their political systems. Using this methodology, the article evaluates the developmental process of RTSH, and traces the evolution of certain fundamental laws to determine that political elites have not put forth any efforts to reform laws to establish self-regulatory instruments and guarantee the media independence as a self regulated institution. Despite international recommendations and internal pressures for change, the practices in the area of public network television services have served the private interest of political parliamentary forces. Using the Hallin and Mancini comparative models for media, we established that efforts towards reformation, the changes of Albanian public television are not guided towards a liberal democratic model; instead they resemble a Mediterranean or polarized system. Political arbitration in choosing key institutions that ensure self regulation and the direction of public service broadcasting reflects similarities with the Italian model of Lottizzazione.However, the design of hybrid laws whose structures and functions do not serve public interests, but instead ensure the interest of political elites, is not a formula that guarantees public service broadcasting. By choosing to pursue the old trend of TVSH’s broadcasting methods, politics is channeling the future of public service broadcasting towards a polarizing model. The approach that would allow a liberalization of Public Service Broadcasting, demands a political emancipation and consensus on this particular issue. For now, the sings of consensus are nowhere to be seen, and as such the fate of public service broadcasting remains in a pending status. One of the main consequences in this process, remains the under informed public that is a vital element in a viable democracy. In this case, society becomes the victim of an autocratic system, perpetually stuck in a vicious cycle against democratic interest. (shrink)

The concept of Sustainable Public Procurement (SPP) has attracted the interests of academics, practitioners, policymakers and the media recently. The interest can be attributed to the strategic role of purchasing and supply chain as a lever for sustainable development. Despite the enormous amount of funds spent on public procurements in South Africa annually, tender irregularities, corrupt practices, non-compliance and lack of knowledge, casts doubts on its role in fostering sustainable development. An in-depth literature review on SPP implementation was adopted to (...) analyse the manner in which sustainability could be realised through regulation, implementation and monitoring compliance of relevant environmental policy instruments. This approach is used to determine how due consideration of sustainable procurement has been used as a tool to enhance social, economic and environmental sustainability. This article notes that in many developed and developing countries, the dare need of technical and management competence, cultural assimilation, high costs of funding sustainable procurement projects and transparency on the part of managers among others are sighted as factors plaguing the growth of sustainable procurement practices in most institutions. Further, this paper puts forth the argument that implementation of sustainable procurement policies alone, will not necessarily help in the achievement of the developmental objectives, but due consideration should be given to capacity building and collaboration with relevant units of government, whilst also integrating social and economic policies, into the formulation of tender documents and selection of suppliers. This paper posits that to overcome these challenges faced by South Africa, it is important that all stakeholders including the government, researchers and other agencies should construct a synergy capable of addressing salient issues for progressive sustainable procurement policies and actions, through the incorporation of sustainable procurement practices into the mainstream of both the public and private organisations through relevant legislations, policies and regulatory frameworks. (shrink)

We subsist under the law where we claim our rights and are obliged to do something enforced. What is a law? The question would be perplexing in history, and one of crucial themes with many lawyers or legal philosophers. As we know, two most important perspectives had earned a universal and historical forge in academics, to say, the natural law and legal positivism. The concept of natural law deals in its primacy for the humanity and natural order which often can (...) be traded as something inviolable or inalienable. The concept has strands in several aspects; (i) its anchor with the civil democratic revolution around 17 and 18 centuries (ii) its supremacy with the new constitutional states (iii) less quality as a realist law from ambiguities and lack of clear definition. The concept of public policy may be related with the social justice, ethics and administration. It generally pursues a justice and desired state of public or community where the tension and conflict always exist between the ruling class and citizens. Historically, the public policy could be mightier to address the society than law where the benevolent Kings or Sovereigns liked to address both their needs and social justice. They may abrogate, more in endowment and divinity, the laws or social customs. The tension between the public power and private interests could be one reason as well as offers a good dualism in understanding the rule of law concept and advent of modern democracy. In this dimension, the King would no longer be divine nor entitled to exercise a plenary power of state rule. Instead, the popular sovereignty in the US democracy or parliamentary type in the UK were to be established to resolve a feudal conflict within the class and society. Lighted to be in vein of influence could arise the two contexts which are a contractarian view and plutocracy desire of the founding fathers. They underlay the mood and philosophical ethos of US revolution. Hence, three concepts as a pillar in private law were sanctified in the very foundation of US constitutional state, sanctity of property right, freedom of contract and due limits for the civil liability. The governmental power should be limited to protect the life and limb of citizens which addressed the Hobbes’ evil, “war against all the rest.” The due process concept was expressed as a fundamental principle of constitution where the human rights are inviolable and inalienable. The separation of powers principle could serve the freedom and wealth of new civil class in the continent, and bicameralism was devised for the check and balance within the federal congress. They see the role of judicial branch is important to preserve their civil interest. Then we can derive some assumptions between the law and public policy. First, a law plays to protect the private interest while the public policy pursues the social justice and mediates the competing interests, “private v. private” and “public v. private.” The civil courts may address a first nature of conflict and the law of takings or regulatory laws may deal with the second aspect. Second, the public or administrative law can shape a legal plane of bureaucracies or public administration, and may guarantee the rule of law ideals. It plays as an enabling authority and, on the other, monitors an arbitrariness and unfairness in the bureaucratic government. In this context, the unresponsive and unfathomable bureaucracy in the Kafka’s could be remedied. Third, for the welfare state in the late 19th and 20th century, a law can well be seen as one of authoritative expression of public policy to redress the evils of capitalist states. Some public laws, such as the Sherman Act classically and Lanham Act recently, may act to regulate the monopoly or oligopoly while other laws were enacted to restore justice between the labor and employers. Through the chapters, the fundamentals of law and public policy will be considered to address their proper status. (shrink)

Some sharing economy firms have adopted a strategy of “regulatory entrepreneurship,” openly violating regulations with the aim of rendering them dead letters. This article argues that in a democracy, regulatory entrepreneurship is a presumptively unethical business strategy. In all but the most corrupt political environments, businesses that seek to change their regulatory environment should do so through the democratic political process, and they should do so without using illegal business practices to build a political constituency. To show (...) this, the article defends a qualified moral obligation for businesspeople to obey the law even in societies that fall short of ideal democracy and that are rife with economic injustice. Owners and managers of successful businesses have strong moral reasons to obey laws concerning resource allocation. Such laws include not only property law, but also tax laws, environmental regulations, and other laws that regulate businesses in competitive markets. The moral reasons to obey such laws apply even to laws that business leaders think unfair or inefficient, provided that the laws in question have reasonable, good faith defenders. (shrink)

International regulation of autonomous weapon systems (AWS) is increasingly conceived as an exercise in risk management. This requires a shared approach for assessing the risks of AWS. This paper presents a structured approach to risk assessment and regulation for AWS, adapting a qualitative framework inspired by the Intergovernmental Panel on Climate Change (IPCC). It examines the interactions among key risk factors—determinants, drivers, and types—to evaluate the risk magnitude of AWS and establish risk tolerance thresholds through a risk matrix informed by (...) background knowledge of event likelihood and severity. Further, it proposes a methodology to assess community risk appetite, emphasizing that such assessments and resulting tolerance levels should be determined through deliberation in a multistakeholder forum. The paper highlights the complexities of applying risk-based regulations to AWS internationally, particularly the challenge of defining a global community for risk assessment and regulatory legitimization. (shrink)

The present study examined relationships between chronic regulatory focus and motivation to improve upon academic outcomes in a sample of individuals varying in degree of hopelessness depression (HD) symptoms. Participants recalled a recent negative academic outcome, completed a measure of regulatory focus, reported their subsequent motivation to improve upon future academic outcomes, and then indicated whether their grades on examinations, assignments, and their GPAs had improved or worsened since the described outcome. Results indicate that degree of HD symptoms (...) positively relates to prevention focus and negatively relates to promotion focus, and the negative relationships between HD symptoms and both motivation and performance outcomes are mediated by (lack of) promotion focus. (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.

The need to better balance the promotion of scientific and technological innovation with risk management for consumer protection has inspired several recent reforms attempting to make regulations more flexible and adaptive. The pharmaceutical sector has a long, established regulatory tradition, as well as a long history of controversies around how to balance incentives for needed therapeutic innovations and protecting patient safety. The emergence of disruptive biotechnologies has provided the occasion for regulatory innovation in this sector. This article investigates (...) the regulation of advanced biotherapeutics in the European Union and shows that it presents several defining features of an adaptive regulation regime, notably institutionalized processes of planned adaptation that allow regulators to gather, generate, and mobilize new scientific and risk evidence about innovative products. However, our in-depth case analysis highlights that more attention needs to be paid to the consequences of the introduction of adaptive regulations, especially for critical stakeholders involved in this new regulatory ecosystem, the capacity and resource requirements placed on them to adapt, and the new tradeoffs they face. In addition, our analysis highlights a deficit in how we currently evaluate the performance and public value proposition of adaptive regulations vis-à-vis their stated goals and objectives. (shrink)

ANNOTATION Sardak S.E. Global Regulatory System of Human Resources Development. – Manuscript. Thesis for the Doctor of Economic Science academic degree with major in 08.00.02 – World Economy and international economic relations. – SHEE «Kyiv National Economic University named after Vadym Hetman», Kyiv, 2014. The preconditions and factors of the global economic system with the identified relevant subjects areas and mechanisms of regulation instruments have been investigated. The crucial role of humans in the global economic system as a key (...) factor of production, the main resource, the producer and the consumer of economic and social benefits that are exposed to global threats, problems, challenges, trends and subjects has been confirmed. There have been revealed the causes and consequences of the public institutions transformation under the influence of globalization, which formed a qualitatively new conditions for social and economic development that determine the need for further changes in the areas of conceptual guideline for the management of human resources development, optimization of tasks, state and international institutions activity forms, integration of efforts as for monitoring, planning and forecasting. The modern major instruments and spheres of international cooperation to ensure human development have been determined. The integrated characteristic of human resources and their role in social development both from the standpoint of their use in labour processes and as a medium of civilization and social utility with the help of the categorical classification system organizing and expanding which enables to design and apply the appropriate approaches at all managerial levels have been defined. The necessity and the concept of human resources development in the context of the content of managerial influence identifying (self-development, self-management and external control of development) at different administrative levels that ensures the growth of human capital to the limits of its potential have been analysed. The survey of human activity system aspects in the global world, taking into account the parametrization of the global environment, its structure, management and development have been realized. The formed methodology principles of managerial influence on the development of human resources with scientific schools, hardness degrees, available models, research and providing theoretical and practical implementation peculiarities for groups of countries and territories of the world taken into consideration have been examined. There have been noted civilization and national differences in the forms of managerial influence on the development of human resources, which lead to the formation of human resources development national control systems conditioned by different value public strategic guidelines, especially in relation to social security, education, national management and state migration policy. The current and future requirements for global human resources development which are proposed to be achieved by the development and formalization of global civilizational paradigm of social development due to social coordination interaction have been given. The influence of the institute of state on the human resources development has been evaluated and it has been proved that in the beginning of the XXI century in the global environment the institute of state is the ultimate guarantor of its citizens’ labour ability and vital activity renewal, that makes it the main instrument of managerial influence on human development. The methodology of countries and territories matrix positioning by human development qualitative criteria and population size quantitative parameters which allows to design unified managerial measures as for human resources for similar national economies in the context of global regulatory trends has been proposed. The strategic trends of improvement of human resources development in the national economy, taking into account the differences in the development of human resources in different countries and areas which vary and differ in their focus, content and ways of implementation for such groups. The varying criteria for evaluating the effectiveness of the global impact on human resources development, taking into account the natural, biological, technological, economic, social and management dimensions and the results of human resources development management in social and economic systems at various levels have been revealed. The periodization and the forecast of the global dynamics of human resources development by analyzing and modeling the values of the absolute and relative terms correlation character have been carried out, which enables to make their retrospective and prospective comparison and to find chronological boundaries of qualitatively different periods. The configuration of the human resource development global coordinate system as a set of interrelated principles, components, fields, tools, frameworks, management levels and forms of managerial influence that allows with the help of institutional means to adapt the state of human resources development to a globally varying environment. (shrink)

Current technology and surveillance practices make behaviors traceable to persons in unprecedented ways. This causes a loss of anonymity and of many privacy measures relied on in the past. These de facto privacy losses are by many seen as problematic for individual psychology, intimate relations and democratic practices such as free speech and free assembly. I share most of these concerns but propose that an even more fundamental problem might be that our very ability to act as autonomous and purposive (...) agents relies on some degree of privacy, perhaps particularly as we act in public and semi-public spaces. I suggest that basic issues concerning action choices have been left largely unexplored, due to a series of problematic theoretical assumptions at the heart of privacy debates. One such assumption has to do with the influential conceptualization of privacy as pertaining to personal intimate facts belonging to a private sphere as opposed to a public sphere of public facts. As Helen Nissenbaum has pointed out, the notion of privacy in public sounds almost like an oxymoron given this traditional private-public dichotomy. I discuss her important attempt to defend privacy in public through her concept of ‘contextual integrity.’ Context is crucial, but Nissenbaum’s descriptive notion of existing norms seems to fall short of a solution. I here agree with Joel Reidenberg’s recent worries regarding any approach that relies on ‘reasonable expectations’ . The problem is that in many current contexts we have no such expectations. Our contexts have already lost their integrity, so to speak. By way of a functional and more biologically inspired account, I analyze the relational and contextual dynamics of both privacy needs and harms. Through an understanding of action choice as situated and options and capabilities as relational, a more consequence-oriented notion of privacy begins to appear. I suggest that privacy needs, harms and protections are relational. Privacy might have less to do with seclusion and absolute transactional control than hitherto thought. It might instead hinge on capacities to limit the social consequences of our actions through knowing and shaping our perceptible agency and social contexts of action. To act with intent we generally need the ability to conceal during exposure. If this analysis is correct then relational privacy is an important condition for autonomic purposive and responsible agency—particularly in public space. Overall, this chapter offers a first stab at a reconceptualization of our privacy needs as relational to contexts of action. In terms of ‘rights to privacy’ this means that we should expand our view from the regulation and protection of the information of individuals to questions of the kind of contexts we are creating. I am here particularly interested in what I call ‘unbounded contexts’, i.e. cases of context collapses, hidden audiences and even unknowable future agents. (shrink)