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)

The logic of genetic discovery has changed little over time, but the focus of biology is shifting from simple genotype–phenotype relationships to complex metabolic, physiological, developmental, and behavioral traits. In light of this, the traditional reductionist view of individual genes as privileged difference‐making causes of phenotypes is re‐examined. The scope and nature of genetic effects in complex regulatory systems, in which dynamics are driven by regulatory feedback and hierarchical interactions across levels of organization are considered. This review argues (...) that it is appropriate to treat genes as specific actual difference‐makers for the molecular regulation of gene expression. However, they are often neither stable, proportional, nor specific as causes of the overall dynamic behavior of regulatory networks. Dynamical models, properly formulated and validated, provide the tools to probe cause‐and‐effect relationships in complex biological systems, allowing to go beyond the limitations of genetic reductionism to gain an integrative understanding of the causal processes underlying complex phenotypes. (shrink)

Focused on evolutionary and continuous human development the global, the regulatory system should be formed in the conceptual (the constant research for the detection, identification and evaluation of global imperatives) and application (development and implementation of activities and coordination tools of influence to ensure the existence of human civilization in a secure politically, economically, socially and environmentally balanced world) planes. On the author's calculations of its formation in functionally complete, holistic view is expected by 2030 due to historically (...) conditioned transformations in the nature of social relations. (shrink)

Interspecific comparisons reveal remarkable diversity in patterns of gene expression, even among closely related species. Combinatorial regulatory mechanisms could facilitate the evolution of this diversity. However, the high degree of interdependence characteristic of combinatorial networks would represent a major constraint on evolution and might generate many features that have no direct adaptive value.

This paper examines the transformation of environmental regulatory system in Poland during the 1990s. It is a case of institutional transplantation from the past into the present: the place remained constant but the economic and political context rapidly changed over time. Drawing on five case studies of privatized firms, a mailed questionnaire, and policy and institutional analysis, it investigates how Poland developed an effective system for managing industrial pollution while also achieving considerable socioeconomic progress. One key lesson (...) is that considerable and effective evolution of policies can take place during radical shifts in the political-economic context, as long as certain conditions are fulfilled. These include a good “fit” between the approaches taken and the existing modes of conducting societal transactions; wide sharing of certain values among the key societal actors; and continuity in policies and institutions. It also appears that a broad support for the rule of law and due process are crucial. The case of Poland also suggests that, while the developing countries do not necessarily need to reenact the evolution that has taken place among the developed countries during the past three decades, neither can they expect to leapfrog from a highly polluting “dirty” economy to a sustainable economy. The study also suggests that success in the first phase of regulatory system’s transformation—centered around reducing pollution from the energy and manufacturing sectors—is not a predictor of its success in next phase, centered around sustainability issues. The types of institutions, political circumstances, and national capabilities are different for each phase. (shrink)

This book develops a new naturalist theory of reason and scientific knowledge from a synthesis of philosophy and the new sciences of complex adaptive systems.

This study's objective is to explore the psychological defense mechanisms of Ukrainian service members as a regulatory system for personality stabilization that influences combat mission effectiveness. The study was carried out during 2019–2020. The respondents were 270 military personnel of the ground forces, who had gained experience in the Anti-Terrorist Operation hostilities in the East of Ukraine in 2017–2020. We used psychodiagnostic methods such as the Lifestyle Index by Plutchik, Kellerman, and Conte; Lazarus’s Coping Test; and Leontiev’s Meaningful (...) Life Orientations Test. Our work confirmed our research hypothesis that psychological defense mechanisms as part of the regulatory system of personality stabilization predetermine the effectiveness of the combat missions performed by military personnel of special branches. Military psychologists can use the results during their official training (psychological training and psycho-corrective measures) in order to acquire among the troops the required effectiveness in combat. Defense mechanisms will also contribute to the observance of military ethics, not least when faced with military immorality on the part of adversaries. (shrink)

The transition of gene switch induced by external noises and external signals is investigated in the genetic regulatory system. Results show that the state-to-state transition of gene switch as well as resonant behaviors, such as the explicit coherence resonance, implicit coherence resonance and control parameter coherence biresonance, can appear when noises are injected into the genetic regulatory system. The ECR is increased with the increase of the control parameter value when starting from the supercritical Hopf bifurcation (...) parameter point, and there exists a critical control parameter value for the occurrence of ECR. However, the ICR is decreased as the control parameter value is increased when starting from the subcritical Hopf bifurcation point. In particular, the coherence of ECR is higher and more sensitive to noise than that of ICR. When an external signal is introduced into the system, the enhancement or suppression of the CPCBR and the number of peaks strongly depend on the frequency and amplitude of the external signal. Furthermore, the gene regulation system can selectively enhance or decrease the noise-induced oscillation signals at preferred frequency and amplitude of an external signal. (shrink)

Over the past three decades, two separate federal regulatory structures have emerged, each seeking to assure separate aspects of the integrity and ethics of research conducted using federal funding. One set of regulations is described in the Public Health Service Policies on Research Misconduct and relates to research misconduct, defined as consisting of fabrication of data or results, falsification of data and results, or plagiarism, in accordance with the federal‐wide definition adopted by the Office of Science and Technology Policy. (...) The second set of regulations, set forth in the Department of Health and Human Services regulations on the protection of human subjects (known as the “Common Rule”), prescribes a set of ethical and procedural protections for research involving human subjects.These two sets of research regulations are distinguished from each other by having different foci of enforcement, priorities of protection, oversight officials, oversight procedures, seizure of evidence, standards of proof, expectations of privacy, and appeal procedures for researchers who are subject to adverse findings and penalties. These differences are significant and fundamental. They complicate the process of compliance for institutions and researchers, who are expected to adhere to both sets of standards for the same federally funded research activities in research with human subjects. Compliance is especially complicated when suspected violations of both sets of standards must be investigated and resolved concurrently. This document represents an effort to provide institutions and individuals with practical suggestions as they try to comply with both sets of regulations. (shrink)

While analysing constitutions of various countries in the legal literature, usually not only the form and the content but also the structure of the constitution is discussed. The structure of the constitution is an internal organisational order of the norms of the constitution. Although every state has a unique structure of their constitution, however, certain regularities can be discerned. The analysis of the structure of various constitutions leads to a conclusion that normally each constitution consists of the following standard structural (...) parts: the preamble, the main part, the final, transitional or additional provisions, in some constitutions there can also be annexes. The article ascertains that most of the constitutions begin with the introductory part, the preamble. Only the constitutions of several countries (e.g. Norway, the Netherlands, Belgium, Italy, Greece) contain no preamble. After analysing the preambles of the Lithuanian Constitutions adopted in 1918-1940, the Lithuanian Constitution of 1992, the Constitution of the United States of America of 1787, the Constitution of Federal Republic of Germany of 1949, and the constitutions of several Central and Eastern European countries (the Constitution of the Republic of Estonia of 1992, the Constitution of Czech Republic of 1992 and the Constitution of the Republic of Poland of 1997) it is stated that a preamble is considered as an inseparable part of an official text of a constitution. The preamble reflects the historical context and the circumstances of the adoption of a constitution, names the goals of the constitutional regulation, fortifies the values to be attained, declares the key political principles or even the fundamental human rights and freedoms, etc. Often the preamble reveals the methods of adoption of a constitution. The preamble is an important structural part of the constitution that helps to understand the established constitutional regulation. The principles enshrined in it can be considered as significant argument for the constitutional justice institutions while solving the case of whether the law or any other legal act in question contradicts with the constitution. While interpreting and applying the constitution as a single act, its separate sections, clauses or certain provisions it is necessary to take the content of the preamble into account, since no text of the constitution shall be interpreted in a way to contradict the statements of the preamble and its spirit. The preamble is not only a category of a political, ideological or philosophical nature, it undoubtedly has the legal burden, therefore it is considered to have legal validity. Constitutions usually do not contain any particular preamble amendment procedures. The preambles are characterised to have the so-called higher style; they are usually formulated not in compliance with the requirements of legal technique. Therefore, they differ from other constitutional provisions that are usually set out in official writing style according to certain rules of legal technique. (shrink)

Professor Hooker’s mind is not unlike a telescope: it sees farther than the rest of us. Never mind the chromatic aberration that attends his higher magnifications; the present volume is a book of vision, and it will profit any reader to see the philosophical universe through Hooker’s well-turned lens.

Using the case of food safety governance reform in Japan between 2001 and 2003, this paper examines the relationship between science and trust. The paper explains how the discovery of the first BSE positive cow and consequent food safety scandals in 2001 politicized the role of science in protecting the safety of the food supply. The analysis of the Parliamentary debate focuses on the contestation among legislators and other participants over three dimensions of risk science, including “knowledge,” “objects,” and “beneficiaries.” (...) The metaphor of “seven samurai” and the relationally situated roles of “samurai,” “bandits,” and “beneficiaries” are used to show that in the process of policy making certain moral and ethical expectations on a new expert institution for food safety were contested and negotiated to frame responsibilities and commitments of social actors for creating the food system based on trust. (shrink)

Criminal liability for acts committed by AI systems has recently become a hot legal topic. This paper includes three different contributions. The first contribution is an analysis of the extent to which an AI system can satisfy the requirements for criminal liability: accomplishing an actus reus, having the corresponding mens rea, possessing the cognitive capacities needed for responsibility. The second contribution is a discussion of criminal activity accomplished by an AI entity, with reference to a recent case involving an (...) online bot, the Random Darknet Shopper. This discussion will provide the context for the analysis of commonalities and differences between criminal activities by humans and by artificial systems. The third contribution concerns the evaluation of different ways of addressing criminal activities by AI systems in a regulatory perspective. (shrink)

This paper explores two main methods, employed for the analysis of regulatory law, empirical and systems-theoretical approaches. These two approaches are often portrayed in the literature as very different, mainly for two reasons. First, it is contended by some authors that systems-theoretical approaches—in contrast to empirical approaches—do not see a role for individuals in shaping social reality and regulatory law as one aspect of it. This paper, however, claims that systems-theoretical accounts do provide for human agency while empirical (...) accounts have limitations in their analysis of the role of ‘real individuals’ in shaping regulatory law. The paper argues that both empirical and systems-theoretical approaches need to provide a deeper analysis of the notion of ‘the individual’. This requires taking into account how ‘feeling rules’ influence the management of emotions. Secondly, empirical and systems-theoretical approaches are portrayed as distinct because they are considered as employing different methodologies. While systems theory involves speculative grand theory, empirical approaches are based on specific techniques of empirical data collection and analysis. This paper argues, however, that systems-theoretical ideas on how knowledge about the social world can be generated are close to qualitative empirical approaches, which stress the relativity and subjectivity of the meaning systems of the particular actors studied. (shrink)

Institutional review board delays may hinder the successful completion of federally funded research in the U.S. military. When this happens, time-sensitive, mission-relevant questions go unanswered. Research participants face unnecessary burdens and risks if delays squeeze recruitment timelines, resulting in inadequate sample sizes for definitive analyses. More broadly, military members are exposed to untested or undertested interventions, implemented by well-intentioned leaders who bypass the research process altogether. To illustrate, we offer two case examples. We posit that IRB delays often appear in (...) the service of managing institutional risk, rather than protecting research participants. Regulators may see more risk associated with moving quickly than risk related to delay, choosing to err on the side of bureaucracy. The authors of this article, all of whom are military-funded researchers, government stakeholders, and/or human subject protection experts, offer feasible recommendations to improv... (shrink)

The sodium cotransport systems comprise an important group of transport proteins which are involved in the transport of a variety of organic and inorganic solutes across the cellular membrane of animal cells. These systems play a central role in a wide variety of cellular and biochemical processes. We summarize here the current state of knowledge regarding the variety, structure and regulation of this important group of membrane proteins.

This article uses recent changes within the Austrian university system to illustrate some general features and dilemmas of organizational design and reform. We focus upon two recent layers of the sediments left by previous and current system reforms: that left by the events of 1968 on continental university systems, and Austria's late conversion to the path taken by the Anglo-American university system since the late 1970s/early 1980s; namely, towards what Marginson and Considine (2000) have called the "enterprise (...) university". These two reform waves are, we argue, neatly reflected in two university laws - UOG 1975 and UG 2002 - which capture with great clarity the spirit of these two policy moments. The Austrian case is thus of interest for two types of reason: first, because of the co-existence of deeply engrained traditions with more recent experiments in organizational democracy (co-determination); secondly, because of the rapidity with which current reforms seek to catch up with what are taken to be international developments in university management. Drawing on arguments advanced by Christopher Hood, Luc Boltanski and Ève Chiapello, and by Albert Hirschman, we seek to draw general conclusions concerning the implications of organizational reform for the management of organizations generally, and of universities in particular. (shrink)

Living systems employ several mechanisms and behaviors to achieve robustness and maintain themselves under changing internal and external conditions. Regulation stands out from them as a specific form of higher-order control, exerted over the basic regime responsible for the production and maintenance of the organism, and provides the system with the capacity to act on its own constitutive dynamics. It consists in the capability to selectively shift between different available regimes of self-production and self-maintenance in response to specific signals (...) and perturbations, due to the action of a dedicated subsystem which is operationally distinct from the regulated ones. The role of regulation, however, is not exhausted by its contribution to maintain a living system’s viability. While enhancing robustness, regulatory mechanisms play a fundamental role in the realization of an autonomous biological organization. Specifically, they are at the basis of the remarkable integration of biological systems, insofar as they coordinate and modulate the activity of distinct functional subsystems. Moreover, by implementing complex and hierarchically organized control architectures, they allow for an increase in structural and organizational complexity while minimizing fragility. Finally, they endow living systems, from their most basic unicellular instances, with the capability to control their own internal dynamics to adaptively respond to specific features of their interaction with the environment, thus providing the basis for the emergence of minimal forms of cognition. (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)

Living systems employ several mechanisms and behaviors to achieve robustness and maintain themselves under changing internal and external conditions. Regulation stands out from them as a specific form of higher-order control, exerted over the basic regime responsible for the production and maintenance of the organism, and provides the system with the capacity to act on its own constitutive dynamics. It consists in the capability to selectively shift between different available regimes of self-production and self-maintenance in response to specific signals (...) and perturbations, due to the action of a dedicated subsystem which is operationally distinct from the regulated ones. The role of regulation, however, is not exhausted by its contribution to maintain a living system’s viability. While enhancing robustness, regulatory mechanisms play a fundamental role in the realization of an autonomous biological organization. Specifically, they are at the basis of the remarkable integration of biological systems, insofar as they coordinate and modulate the activity of distinct functional subsystems. Moreover, by implementing complex and hierarchically organized control architectures, they allow for an increase in structural and organizational complexity while minimizing fragility. Finally, they endow living systems, from their most basic unicellular instances, with the capability to control their own internal dynamics to adaptively respond to specific features of their interaction with the environment, thus providing the basis for the emergence of minimal forms of cognition. (shrink)

It is argued that fundamental to Piaget's life works is a biologically based naturalism in which the living world is a nested complex of self-regulating, self-organising (constructing) adaptive systems. A structuralist-rationalist overlay on this core position is distinguished and it is shown how it may be excised without significant loss of content or insight. A new and richer conception of the nature of Piaget's genetic epistemology emerges, one which enjoys rich interrelationships with evolutionary epistemology. These are explored and it is (...) shown how a regulatory systems evolutionary epistemology may be embedded within genetic epistemology. (shrink)

This article addresses issues of regulatory convergence and Europeanization as they have developed within the agrochemicals sector. Taking the United Kingdom as a case study, the article considers the continuing importance of local and national factors within systems that are ostensibly international and standardized. In particular, the article shows how the embedded social relations of regulatory science in the United Kingdom, including institutional practices, judgments of expertise, and established relationships of trust, result in a “nation centeredness” and divergence (...) of regulatory cultures despite the putative development of a harmonized European framework. It is argued that, as a consequence, the claimed universalism of scientific culture in this area is in tension with the local conditions of its practice and enactment. (shrink)

In the future systems of ambient intelligence will include decision support systems that will automate the process of discrimination among people that seek entry into environments and to engage in search of the opportunities that are available there. This article argues that these systems must be subject to active and continuous assessment and regulation because of the ways in which they are likely to contribute to economic and social inequality. This regulatory constraint must involve limitations on the collection and (...) use of information about individuals and groups. The article explores a variety of rationales or justifications for establishing these limits. It emphasizes the unintended consequences that flow from the use of these systems as the most compelling rationale. (shrink)

This Article examines the regulatory state through the lens of evolving political economy, arguing that a significant reconstruction is now underway. The ongoing shift from an industrial mode of development to an informational one has created existential challenges for regulatory models and constructs developed in the context of the industrial economy. Contemporary contests over the substance of regulatory mandates and the shape of regulatory institutions are most usefully understood as moves within a larger struggle to chart (...) a new direction for the regulatory state in the era of informational capitalism. A regulatory state optimized for the information economy must develop rubrics for responding to three problems that have confounded existing regulatory regimes: platform power — the power to link facially separate markets and/or to constrain participation in markets by using technical protocols; infoglut — unmanageably voluminous, mediated information flows that create information overload; and systemic threat — nascent, probabilistically-defined harm to be realized at some point in the future. Additionally, it must develop institutions capable of exercising effective oversight of informationera activities. The information-era regulatory models that have begun to emerge are procedurally informal, mediated by networks of professional and technical expertise that define relevant standards, and financialized. Such models, however, also have tended to be both opaque to external observation and highly prone to capture. New institutional forms that might ensure their legal and political accountability have been slow to develop. (shrink)

The notion of validity fulfils a crucial role in legal theory. In the emerging Web 3.0, Semantic Web languages, legal ontologies, and normative multi-agent systems are designed to cover new regulatory needs. Conceptual models for complex regulatory systems shape the characteristic features of rules, norms, and principles in different ways. This article outlines one of such multilayered governance models, designed for the CAPER platform, and offers a definition of Semantic Web Regulatory Models . It distinguishes between normative-SWRM (...) and institutional-SWRM. It also compares existing principles in privacy by design, linked open data , legal information institutes , and online dispute resolution . The article concludes by proposing the notion of Relational Law to summarize the ethical dimension of SWRM. Ethics are the only regulatory way to constitute a global space, out of the jurisdictional public domain set by national, international, or transnational law, and opposed to the private one. (shrink)

The article explores the problems of the legal status of the regulatory authorities in the energy sector of Ukraine in the context of the administrative reform currently taking place in the Ukraine and the fulfillment of the EU requirements in this sphere. Based on the analysis of the EU legislation, in particular Directive 2009/72/EC of the European Parliament and the Council of 13 July 2009 concerning common rules for the internal market in electricity and repealing Directive 2003/54/EC and Directive (...) 2009/73/EC of the European Parliament and the Council of 13 July 2009 concerning common rules for the internal market in natural gas and repealing Directive 2003/55/EC, and the experience of Ukraine in the field of energy regulation, the author of this article supports granting the special legal status to the national regulatory authorities in the energy sector of Ukraine and their separation from the system of state executive bodies, however, recommends to stipulate in the Constitution of Ukraine the provisions, regarding the organizational legal form and the establishment procedure of such bodies, the appointment and dismissal procedure for their management and members, the peculiarities of the relations of these bodies with the President of Ukraine, the Parliament of Ukraine and the Government of Ukraine. (shrink)

Centralised, compliance-focused approaches to research ethics have been normalised in practice. In this paper, we argue that the dominance of such systems has been driven by neoliberal approaches to governance, where the focus on controlling and individualising risk has led to an overemphasis of decontextualised ethical principles and the conflation of ethical requirements with the documentation of ‘informed consent’. Using a UK-based case study, involving a point-of-care-genetic test as an illustration, we argue that rather than ensuring ethical practice such compliance-focused (...) approaches may obstruct valuable research. We call for an approach that encourages researchers and research communities—including regulators, ethics committees, funders and publishers of academic research—to acquire skills to make morally appropriate decisions, and not base decision-making solely on compliance with prescriptive regulations. We call this ‘ethical preparedness’ and outline how a research ethics system might make space for this approach. (shrink)

Nanoscience has enabled the understanding of organisation of the atomic and molecular world. Due to the unique chemical, electronic and magnetic properties nanomaterials have wide applications in the chemical, manufacturing, medical sector etc., Single walled carbon nanotubes, buckyballs, ZnSe quantum dots, TiO 2 nanoparticle based products are nearing commercialisation. Research is on-going worldwide on suitable delivery systems for nanomaterial based drugs. Nanomaterials are highly reactive in biological systems due to the large surface area. While the benefits of nanomaterials are evident (...) there are studies which indicate the potential risk to biological systems. Substances known to be harmless in bulk can be potentially toxic in certain fibrous and nanoparticle form. Risk assessment studies with nanomaterials largely focus on mouse models. There are very few studies on their effects on aquatic species and plants which form the largest in the productivity chain with respect to the ecological pyramid. This study reviews the research done worldwide in the area of risk assessment of nanomaterials, particularly the effects on aquatic and plant systems. Risk assessment is the foundation for regulatory decision making. A general comparison of the regulatory regime in nanotechnology is performed to understand the extent of development. (shrink)

The presented paper focuses on the analysis of strategic documents at the level of the European Union concerning the regulation of artificial intelligence as one of the so-called disruptive technologies. In the first part of the article, we outline the basic terminology. Subsequently, we focus on the summarizing and systemizing of the key documents adopted at the EU level in terms of artificial intelligence regulation. The focus of the paper is devoted to issues of personal data protection and cyber security (...) included in these strategic documents. The final part contains recommendations for future research and evaluation of its key features. (shrink)

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the (...) aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. (shrink)

First paragraph: The awesome range of Heike Jung’s work—over different aspects of criminal law, different jurisdictions and traditions, different disciplines and languages—makes life both easier and harder for contributors to his Festschrift: easier, because one can choose almost any criminal law topic and be confident that it will connect to his work; harder (for those with the British vices of monolingualism and intellectual parochialism), since one’s paper will display the linguistic, jurisdictional or intellectual limitations that Heike Jung’s work so impressively (...) transcends. In an attempt to overcome some of those limitations, I will discuss a topic that concerns criminal trials and the scope of the criminal law, through the distinction between crimes (Straftaten) and ‘regulatory offences’ (Ordnungswidrigkeiten) which is more often formally drawn in Germany and other continental European systems than in English law. (shrink)

First paragraph: The awesome range of Heike Jung’s work—over different aspects of criminal law, different jurisdictions and traditions, different disciplines and languages—makes life both easier and harder for contributors to his Festschrift: easier, because one can choose almost any criminal law topic and be confident that it will connect to his work; harder (for those with the British vices of monolingualism and intellectual parochialism), since one’s paper will display the linguistic, jurisdictional or intellectual limitations that Heike Jung’s work so impressively (...) transcends. In an attempt to overcome some of those limitations, I will discuss a topic that concerns criminal trials and the scope of the criminal law, through the distinction between crimes (Straftaten) and ‘regulatory offences’ (Ordnungswidrigkeiten) which is more often formally drawn in Germany and other continental European systems than in English law. (shrink)

This commentary provides a legal analysis of the extent to which changes proposed by scholars to promote care for substance use disorder or other under-treated illnesses through risk adjustment could be implemented administratively, without legislation, in federal risk adjustment systems: Medicare's privatized component, Medicare's pharmaceutical component, and the individual and small group market. As the article explains, federal laws governing risk adjustment provide broad discretion to regulators and can reasonably be interpreted to permit full and final implementation through the administrative (...) process of almost all of the changes that scholars have proposed. (shrink)

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

The literature has suggested that to understand the diffusion of unethical conduct in the workplace, it is important to investigate the underlying processes sustaining engagement in misbehaviour and to study what occurs during vocational education. Drawing on social-cognitive theory, in this study, we longitudinally examined the role of two opposite dimensions of the self-regulatory moral system, regulatory self-efficacy and moral disengagement, in influencing academic cheating behaviour. In addition, in line with the theories highlighting the bidirectional relationship between (...) cognitive processes and behaviour, we aimed to also examine the reciprocal influence of behaviour on these dimensions over time. Overall, no previous studies have examined the longitudinal interplay between these variables. The sample included 866 nursing students who were assessed three times annually from the beginning of their vocational education. The findings from a cross-lagged model confirmed that regulatory self-efficacy and moral disengagement have opposite influences on cheating behaviour, that regulatory self-efficacy negatively influences not only the engagement in misconduct but also the justification mechanisms that allow the divorce between moral standards and action, and that moral disengagement and cheating behaviour reciprocally support each other over time. Specifically, not only did moral disengagement influence cheating behaviour even when controlling for its prior levels, but also cheating behaviour affected moral disengagement one year later, controlling for its prior levels. These findings suggest that recourse to wrongdoing could gradually lead to further normalising this kind of behaviour and morally desensitising individuals to misconduct. (shrink)

All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical and Regulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing (...) the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)

It is argued that neoliberal political ideology has redefined the regulatory state to have greater convergence of interests and goals with the pharmaceutical industry than previously, particularly regarding acceleration and cost reduction of drug development and regulatory review. Consequently, the pharmaceutical industry has been permitted to set the agenda about how shorter term and cheaper alternative carcinogenicity testing systems are investigated for validity. The authors contend that, with the tacit approval of the neoliberal regulatory state, the commercial (...) interests of the pharmaceutical industry framed the process and interpretation of validating these new test systems, thereby influencing what counts as knowledge about the carcinogenic status of new pharmaceuticals. While such alternative tests were occasioned by “molecularization,” the framing of their validation was not determined by technoscientific logic or a lack of standards of validation, but by the sociopolitical goals of the controlling institutions. Indeed, a different validation process could have been conducted had the priority been to develop carcinogenicity testing in the interests of public-health protection. While the resulting validation indicated that the short-term alternative tests posed small risks to the commercial interests of pharmaceutical firms, they provided little reassurance that patients would not be exposed to greater risks than before from undetected carcinogens. (shrink)

This open access contributed volume examines the ethical and legal foundations of (future) policies on recommender systems and offers a transdisciplinary approach to tackle important issues related to their development, use and integration into online eco-systems. This volume scrutinizes the values driving automated recommendations - what is important for an individual receiving the recommendation, the company on which that platform was received, and society at large might diverge. The volume addresses concerns about manipulation of individuals and risks for personal autonomy. (...) From a legal perspective, the volume offers a much-needed evaluation of regulatory needs and lawmakers’ answers in various legal disciplines. The focus is on European Union measures of platform regulation, consumer protection and anti-discrimination law. The volume will be of particular interest to the community of legal scholars dealing with platform regulation and algorithmic decision making. By including specific use cases, the volume also exposes pitfalls associated with current models of regulation. Beyond the juxtaposition of purely ethical and legal perspectives, the volume contains truly interdisciplinary work on various aspects of recommender systems. (shrink)

This article examines the impact of the prevailing state ownership in the Chinese stock market on corporate governance and the financial regulatory system, respectively, as the internal and external monitoring mechanisms to deter corporate fraud and protect investors. In line with the literature that state ownership exaggerates the agency problem, we find that the retained state ownership in privatised firms increases the incidence of regulatory enforcements against fraud. For the state-owned enterprises (SOEs), however, larger state ownership is (...) associated with a lower incidence of enforcement actions. This is attributed to the mutual political affiliation of the fraudulent SOEs and the regulatory commission. A new regulation "Solutions for Listed Firm Checks" promulgated in March 2001 has mitigated this effect by empowering the regulatory commission to increase the severity of regulatory conditions. Our evidence confirms the improvement in the regulatory environment and investor protection in the Chinese stock market brought about by the regulatory reform and development. (shrink)

This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the ‘Research Ethics Guidelines for AI Researchers in Healthcare’ published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (stage 6). Researchers (...) identified similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers’ ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future. (shrink)

In this paper, we compare the two Global Reporting Initiative reporting standards, G3.1, and the most current version G4.0. We do this through the lens of political corporate social responsibility theory, which describes the broadened understanding of corporate responsibility in a globalized world building on Habermas’ notion of deliberative democracy and ethical discourse. As the regulatory power of nation states is fading, regulatory gaps occur as side effects of transnational business. As a result, corporations are also understood to (...) play a “political role” to fill regulatory gaps and contribute to a global governance system by voluntarily engaging in self-regulation. Such corporate political action, however, is not always legitimate as it suffers from a democratic deficit. Consistent with scholars in the field of political CSR, this paper argues that only by means of communication and discourse can this drawback be avoided. That is why CSR reporting and guidelines for standardizing the disclosed CSR information is key for political CSR. By comparing the GRI standards from a political CSR perspective, one can see whether these often-used reporting guidelines fulfill the communicative requirements and whether they are adequate tools to face the challenges of the twenty-first century. We present results from a theory-derived and criteria-driven comparison of the two guidelines. Indication of the effectiveness of voluntary self-regulation is, for example, important considering the 2014 directive of the European Union to make CSR reporting mandatory. We offer a guideline-based view on current CSR theory as well as CSR reporting practice. We discuss implications for CSR theory, particularly the appropriateness of deliberation in the Habermasian sense, which is the basis of political CSR theory. We do so by introducing the notion of “uncommitted deliberation” with regard to the refined concept of materiality in GRI 4.0, which induces subjectivity and reduces data-driven comparability. Finally, we address the limitations of this research as well as research questions for future studies. (shrink)

We give in this paper indications about the dynamical impact coming from the main sources of perturbation in biological regulatory networks. First, we define the boundary of the interaction graph expressing the regulations between the main elements of the network . Then, we search what changes in the state values on the boundary could cause some changes of states in the core of the system . After, we analyse the role of the mode of updating on the asymptotics (...) of the network, essentially on the occurrence of limit cycles . Finally, we show the influence of some topological changes on the dynamical behaviour of the system. (shrink)

The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of (...) the American Society of Law, Medicine & Ethics to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief. (shrink)

The capacity to treat pain has never been greater; but, as you will read in the articles that follow, the problem of undertreated and neglected pain in the United States persists. Deep-seated perceptions and practices undergird this strong and well-documented pattern of neglect. Among the reasons frequently noted for the inadequacy of treatment for pain, however, is that the legal system actually penalizes effective interventions to relieve pain while it leaves neglect of pain unthreatened. It is the mission of (...) the American Society of Law, Medicine & Ethics to explore areas, such as this one, where developments in medicine directly encounter the law and, in turn, create ethical issues for clinicians, regulators, patients, and lawyers.This special issue of the Journal of Law, Medicine & Ethics is part of a multi-year project in which ASLME, with the wonderful support of the Mayday Fund, has worked to address legal and regulatory barriers to effective pain relief. (shrink)