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)

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 ability of powerful and well-funded interest groups to steer scientific research in directions that advance their goals has become a significant social concern. This ability is increasingly being recognized in the peer-reviewed literature and in the findings of deliberative expert consensus committees. For example, there is increasing recognition that efforts to address climate change have been stymied in part by a powerful network of conservative foundations, which fund think tanks and other organizations that constitute a “climate change counter movement”. (...) Sociologist Robert Brulle recently found that the total annual income for 91 powerful.. (shrink)

Although developmental biology is an institutionalized discipline, no unambiguous account of what development is and when it stops has so far been provided. In this article, I focus on two sets of developmental molecular mechanisms, namely those underlying the heterochronic pathway in C. elegans and those involving Hox genes in vertebrates, to suggest a conceptual account of animal development. I point out that, in these animals, the early stages of life exhibit salient mechanistic features, in particular in the (...) way mechanisms of genetic regulation occur in the organism. Indeed, these stages are characterized by sequential and irreversible changes in gene expression taking place throughout the organism. A general definition of animal development based on these distinctive features implies that, at least for some animal species, development does not go on throughout the life of the animal, contrary to what has recently been claimed by some biologists and philosophers. Instead, in such species, development encompasses various events occurring sequentially at the beginning of life. (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)

The international context of the last fifty years of modern bioethics have been significant in establishing health-care ethics or bioethics as a common parlance - an ideology of our times, achieving near universal acceptance, with little dissent. Most international health organizations have developed important declarations that have become the credo of their daily practice and long-term commitments. However, in the last decade in particular, bioethicists and other health-care practitioners and scholars have worried about the persistence of health-care inequities and the (...) inadequate realization of bioethics, particularly in low-to-middle income countries. Global bioethics, now well into the new millennium, has entered a regulatory crisis: it needs to confront not just global bioethical commitments around major scientific revolutions such as genomics, but further, a regulatory crisis about the persisting national public law silences and health inequities, especially in low-to-middle income countries. (shrink)

The international context of the last fifty years of modern bioethics have been significant in establishing health-care ethics or bioethics as a common parlance - an ideology of our times, achieving near universal acceptance, with little dissent. Most international health organizations have developed important declarations that have become the credo of their daily practice and long-term commitments. However, in the last decade in particular, bioethicists and other health-care practitioners and scholars have worried about the persistence of health-care inequities and the (...) inadequate realization of bioethics, particularly in low-to-middle income countries. Global bioethics, now well into the new millennium, has entered a regulatory crisis: it needs to confront not just global bioethical commitments around major scientific revolutions such as genomics, but further, a regulatory crisis about the persisting national public law silences and health inequities, especially in low-to-middle income countries. (shrink)

The rapid spread of SARS‐CoV‐2 worldwide has triggered intense activity in the field of biotechnology, leading to the development and regulatory approval of multiple COVID‐19 vaccines in less than 1 year while raising sustained scrutiny as to the ethical issues associated with this process. This article pursues a twofold objective. First, it reconstructs and provides a thorough overview of the different steps, from clinical trial design to regulatory procedures, underpinning the “fast‐tracking” of COVID‐19 vaccine R&D and approval. (...) Second, drawing on a review of published literature, the article identifies, outlines, and analyzes the most ethically challenging aspects related to such process, including concerns around vaccine safety, issues in study design, the enrollment of study participants, and the challenges in obtaining valid informed consent. By scrutinizing relevant aspects of COVID‐19 vaccine development and regulatory processes leading to market authorization, this article ultimately aims to provide a comprehensive overview of the regulatory and ethical issues underpinning the roll‐out of this key pandemic‐containment technology worldwide. (shrink)

The identification of network motifs has been widely considered as a significant step towards uncovering the design principles of biomolecular regulatory networks. To date, time‐invariant networks have been considered. However, such approaches cannot be used to reveal time‐specific biological traits due to the dynamic nature of biological systems, and hence may not be applicable to development, where temporal regulation of gene expression is an indispensable characteristic. We propose a concept of a “temporal sequence of network motifs”, a sequence (...) of network motifs in active sub‐networks constructed over time, and investigate significant network motifs in the active temporal sub‐networks of Drosophila melanogaster. Based on this concept, we find a temporal sequence of network motifs which changes according to developmental stages and thereby cannot be identified from the whole static network. Moreover, we show that the temporal sequence of network motifs corresponding to each developmental stage can be used to describe pivotal developmental events. (shrink)

Cover Photograph: Resolving developmental genetics in the fourth dimension: an illustration (by Kwang‐Hyun Cho himself) of the principle of dynamic network motifs in Drosophila development. Hitherto largely considered in terms of time‐invariant networks, drosophila development is viewed in the article by Man‐Sun Kim, Jeong‐Rae Kim, and Kwang‐Hyun Cho as the result of networks of gene interactions that change during the course of development. Using this paradigm, pivotal developmental events can be correlated with particular changes from one constellation (...) of gene interactions to a different one, and the method allows the identification of certain network motifs that are not identifiable using static approaches. Features article: “Dynamic network rewiring determines temporal regulatory functions in the Drosophila melanogaster development processes”, see pages 505 – 513. (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)

Regulating technologies, innovations and risks is an activity that, as much as scientific research needs proofs and evidence. It is the site of development of a distinct kind of science, regulatory science. This special issue addresses the question of the standards of knowledge governing how we test, assess and monitor technologies and their effects. This topic is relevant and timely in the light of problematics of regulation of innovation, regulatory failure and capture. Given the enormous decisions and (...) stakes regulatory science commends, it becomes crucial to ask where its standards come from and gain credibility, but also what valuations of technology and appreciations of their risks or benefits do they embed, and who controls them? This paper introduces the four contributions comprising the special issue, and outlines a perspective from which to question the construction of regulatory science or, in the terminology adopted here, the authorization and standardization of regulatory knowledge, particularly the role of networks of scientific experts therein. (shrink)

The cerebral cortex controls our most distinguishing higher cognitive functions. Human‐specific gene expression differences are abundant in the cerebral cortex, yet we have only begun to understand how these variations impact brain function. This review discusses the current evidence linking non‐coding regulatory DNA changes, including enhancers, with neocortical evolution. Functional interrogation using animal models reveals converging roles for our genome in key aspects of cortical development including progenitor cell cycle and neuronal signaling. New technologies, including iPS cells and (...) organoids, offer potential alternatives to modeling evolutionary modifications in a relevant species context. Several diseases rooted in the cerebral cortex uniquely manifest in humans compared to other primates, thus highlighting the importance of understanding human brain differences. Future studies of regulatory loci, including those implicated in disease, will collectively help elucidate key cellular and genetic mechanisms underlying our distinguishing cognitive traits. (shrink)

This chapter contains sections titled: What I s Regulation? How Should We Morally Evaluate Regulation? Welfarism; the Pareto Principle; Kaldor‐Hicks Efficiency versus Social Welfare Functions The Two Fundamental Theorems of Welfare Economics and the Market Failure Framework Externalities Public Goods and Monopoly Power The Coase Theorem Information and Paternalism as Rationales for Regulation Regulatory Forms and Regulatory Choice Criteria References.

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)

The financial sector has seen a transformation towards ‘sustainable’ finance particularly in Europe, driven also by unprecedented regulatory reforms. At the same time, many are sceptical about the real impact of these reforms, fearing that they are triggering a paradoxical financialisation of sustainability. Building on recent research on institutional logics and institutional fields formation, we examine changes in the EU regulatory dynamics as characterised by shifts in framing the relationship between sustainability and finance. Deploying a longitudinal approach, consisting (...) of archival data and semi-structured interviews, we explore the development of EU sustainable finance regulation as an extended, interactive and contested process. Specifically, we suggest that regulatory dynamics depend on the hybrid configuration of the social constituencies supporting sustainable finance reforms and on shifts in the overall prevalence of the financial logic in society. Our paper sheds light on the inherent contradictions and limitations of sustainable finance as a means for transformative sustainability reforms. (shrink)

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

The use of preimplantation genetic diagnosis, the powerful technique employed during fertility treatment to select embryos based on their genes, is currently unregulated in the United States—unlike in nearly all other countries where PGD is available. Of course, the analytical quality of the genetic tests, the laboratories where they are performed, and the technicians who carry them out are subject to the Clinical Laboratory Improvement Amendment requirements. And as the Food and Drug Administration prepares to begin regulating laboratory‐developed tests, including (...) many genetic tests, the clinical validity of the tests may also need to be demonstrated. But neither CLIA nor the U.S. Food and Drug Administration is responsible for governing medical practice, and state law and the relevant medical associations have largely fallen silent on the questions of when and why PGD ought to be performed. The result of this regulatory lacuna is that while PGD was originally intended for screening embryos for severe heritable disorders, it is now also employed for a variety of more controversial purposes. (shrink)

In developing countries, banks are simply not present where the majority of poor people live and work. This imposes burdensome access costs on customers who need to travel to distant branches, so the majority of the population opts out from the formal banking system. Banking services can be offered through everyday stores that exist in every community and by new technology, particularly mobile communications networks. Banking regulations, however, impede such possibilities in many developing countries.

In developing countries, banks are simply not present where the majority of poor people live and work. This imposes burdensome access costs on customers who need to travel to distant branches, so the majority of the population opts out from the formal banking system. Banking services can be offered through everyday stores that exist in every community and by new technology, particularly mobile communications networks. Banking regulations, however, impede such possibilities in many developing countries.

Given the multiplicity of codes designed to regulate different stakeholders in terms of promoting good corporate governance, this paper examines areas of conflicts among the various codes and the associated implications for corporate governance practices and regulatory compliances by public-listed Nigerian firms. Using the conflict-signalling theory for developing the conceptual framework, this study examines the proliferation of codes in Nigeria, through a mixed method approach to provide an exploratory account of the implications of corporate governance regulatory multiplicity. Evidence (...) suggests the presence of conflict among the various codes which contributes to reduced compliance by firms and ineffective enforceability by regulatory agencies, which both impede good corporate governance in Nigeria. The findings advance conflict-signalling theory as an important framework for understanding the implications of the conflicts arising from the multiplicity of codes. (shrink)

The paper begins by providing a classification of the regulatory environment within which Business Schools, particularly those in the U.K., operate. The classification identifies mandatory vs. voluntary and prescriptive vs. permissive requirements in relation to the Business and Management curriculum. Three QAA Subject Benchmark Statements relating to Business and Management, the AMBA MBA guidelines, and the EQUIS and AACSB standards are then compared and contrasted with each other. The cognitive and affective learning outcomes associated with business ethics contained in (...) each of these statements are then detailed. The conclusion is that from an international perspective compliance with relevant standards, while requiring due consideration, should be relatively straightforward. From a U.K. perspective, however, the QAA Subject Benchmark Statements provide the most rigorous standards and to meet these will require considerable development on the part of many Business Schools in the U.K. For those academics engaged in this area, however, this represents an opportunity not to be missed. (shrink)

Voice behavior, the extra-role behavior of employees based on their sense of responsibility, plays an important role in organizational development. Research shows that an employee’s voice can have a positive impact on both the quality of decision-making and organizational performance. This study explores the relationship between the prohibitive voice and employees’ safety performance based on the theory of regulatory fit. The study examined 372 employees and their leaders in the Ningxia Hui Autonomous Region of China through a questionnaire (...) survey. A moderated model was constructed, and the SPSS-PROCESS was applied to analyze the data. The study results show that prevention regulatory focus fit strengthened the positive association between the prohibitive voice and safety performance evaluation. This study provides a new perspective in understanding leaders’ evaluation of the prohibitive voice and concludes that the prohibitive voice should be encouraged in organizations as it promotes greater adherence to safety measures and helps reduce organizational development risks. (shrink)

There is a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at (...) least three ethical and policy challenges that have to do with public trust and fair representation. First, the presence of former key industry personnel on review boards could adversely impact the public’s confidence in regulatory decisions about new technology products, including agrifood biotechnologies. Second, the ‘‘revolving door’’ may result in policy decisions about technologies that are biased in favor of industry interests. And third, the ‘‘revolving door’’ virtually guarantees industry a voice in the policy-making process, even though other stakeholders have no assurance that their concerns will be addressed by regulatory agencies. We believe these three problems indicate a failure of regulatory review for new technologies. The review process lacks credibility because, at the very least, it is procedurally biased in favor of industry interests. We argue that prohibiting the flow of personnel between regulatory agencies and industry would not be a satisfactory solution to the three problems of public trust and just representation. To address them, regulatory entities must reject the traditional notion of objectivity. Instead they should adopt the conception of objectivity developed by Sandra Harding and re-configure their regulatory review on the basis of it. That will ensure that a heterogeneous group of stakeholders is at the decision-making table. The fair representation of interests of different constituencies in the review process could do much to inspire warranted public confidence in regulatory protocols and decisions. (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)

In recent decades, the Organisation for Economic Co-operation and Development has become a powerful forum for trade liberalization and regulatory harmonization. OECD members have worked to reconcile divergent national regulatory approaches, applying a single framework across sovereign states, in effect determining whose knowledge-making practices would guide regulatory action throughout the industrialized world. Focusing on US regulators, industry associations, and environmental groups, this article explores the participatory politics of OECD chemical regulation harmonization in the late 1970s to (...) early 1980s. These efforts were conditioned by differential institutional access and resources among stakeholders who sought to shape regulatory knowledge rules. Facing competing European and US approaches to chemical data—a minimum “base set” of test data versus case-by-case determinations—OECD members chose the European approach in 1980. However, US regulatory politics shifted with the election of President Reagan, prompting industry associations to lobby the US government to block the agreement. Examining the micropolitics of these standards in the making, I demonstrate that while long-term structures advantaged industrial actors, ideological alignment with the US government precipitated their decisive influence. The case illustrates the importance of attending to the distinctive politics of international harmonization and the effects on transnational knowledge-making and regulatory intervention. (shrink)

Clp ATPase chaperone proteins are found in procaryotes and eucaryotes. Recently, ClpC of Bacillus subtilis was found to be part of a regulatory switch(1). ClpC, in combination with the MecA and ComS proteins, regulates the activity of a transcription factor, ComK, which is necessary for the development of genetic competence (the ability to bind and take up exogenous DNA). The complex of ClpC:MecA:ComK renders ComK inactive. Interaction between ComS and the ternary complex releases active ComK. This regulatory (...) switch controls ComK activity in response to cell density signals that affect production of ComS. Regulated interaction between Clp ATPases and target proteins might prove to be widespread. (shrink)

Two groups of plant viruses have DNA in their genomes. One group, the caulimoviruses, are non‐integrating retroviruses that package dsDNA in virions. The other group, the geminiviruses, package small circular ssDNA and include the only DNA viruses known with bipartite genomes. The regulation of transcription of these viruses is not well characterized, but recent work is beginning to yield interesting results. Regulatory sequences from these viruses function in cells of species that are not hosts of the virus and are (...) finding use in constitutive expression of chimeric genes in transformed plants. Development of vectors based on plant viruses requires further characterization at the molecular level of viral life cycles. (shrink)

Hindbrain development is orchestrated by a vertebrate gene regulatory network that generates segmental patterning along the anterior–posterior axis via Hox genes. Here, we review analyses of vertebrate and invertebrate chordate models that inform upon the evolutionary origin and diversification of this network. Evidence from the sea lamprey reveals that the hindbrain regulatory network generates rhombomeric compartments with segmental Hox expression and an underlying Hox code. We infer that this basal feature was present in ancestral vertebrates and, as (...) an evolutionarily constrained developmental state, is fundamentally important for patterning of the vertebrate hindbrain across diverse lineages. Despite the common ground plan, vertebrates exhibit neuroanatomical diversity in lineage‐specific patterns, with different vertebrates revealing variations of Hox expression in the hindbrain that could underlie this diversification. Invertebrate chordates lack hindbrain segmentation but exhibit some conserved aspects of this network, with retinoic acid signaling playing a role in establishing nested domains of Hox expression. (shrink)

In 1995, the eyeless (ey) gene was dubbed the “master‐regulator” of eye development in Drosophila. Not only is ey required for eye development, but its misexpression can convert many other tissues into eye, including legs, wings and antennae.(1) ey is remarkable for its ability to drive coordinate differentiation of the multiple cell types that have to differentiate in a very precise pattern to construct the fly eye, and for its power to override the previous differentiation programs of many (...) other diverse tissues. Even more remarkable, the ey homolog Pax6 and homologs of other eye determination genes from Drosophila are also required for eye development in vertebrates,(2,3) prompting reassessment of the evolution of vision throughout the animal kingdom.(4,5) Now Kumar and Moses have published a study that throws a new light on ey function in Drosophila.(6) According to their work, ey becomes a master regulator of eye development much later than previously thought, and is regulated by signalling through the Notch and EGFR signaling pathways. BioEssays 23:763–766, 2001. © 2001 John Wiley & Sons, Inc. (shrink)

Tirana, immediately after it was declared the capital of Albania on 11 February 1920, has undergone many changes in its morphology and city context. The capital is located in the heart of the country. During its lifespan, Tirana has adopted four important regulatory plans starting from 1923. The Western ideologies of the time influenced drastically the city development. The influence of such ideologies was stopped immediately though the imposition of communist ideas, after the Second World War. Rational building (...) forms were created which could be standardized in order to reduce construction costs. Meanwhile, in Western Europe, this current was implemented during the 1920s, as a response to social problems. The communist regime established strict anti-urbanization policy that aims to foster the development of rural areas and the suburban industrial districts in order to control urban growth and demographic mobility. All the regulatory master plans of Tirana, climate data of the city, the actual situation of the specific neighborhood, its orientation toward north, are considered in order to gather information and to implement the correct bioclimatic eco-renovation in the area. A special attention will be given to the underground tunnels which were constructed during the communist regime all over the city (1945–1983) as a response to a hypothetic nuclear attack, in order to shelter the inhabitance against bombing. These reinforced concrete tunnels will serve not only as an area for water collection and recycling strategies but also for cooling with zero energy expenditure for the inhabitants as a consequence of differences in temperature and air pressure. This strategy benefits from the underground air temperature in both seasons (winter and summer). It envisages the handover of these tunnels by the community. Nowadays, such structures are abandoned and denigrated. The realization of these structures required large amounts of money from the state budget. Considering that fact they need to be vitalized and reused, using different methodologies and strategies as part of the city. After the communist regime in the city of Tirana, two other regulatory plans were implemented which observe the city from another perspective, determining and evaluating Tirana’s real values as a city of the future, but not defining yet Tirana as an Ecocity. The ecological potential of Tirana including its outskirts is to be considered. Its flora and fauna are very rich, containing a mixt of species and plants. Regardless, the city of Tirana is suffering from different kinds of pollution such as air and noise pollution which are above EU and WHO norms. Tirana benefits from a Temperate Mediterranean climate. Furthermore, the benefits of the solar radiation are enormous. Unfortunately, nowadays, the city of Tirana is not profiting much from it. This chapter is in search of an overall view of the city of Tirana, and its great potential discovering its underground and upper ground historical secrets. (shrink)

Regulation must target the financial sector, which often funds and profits from environmentally unsustainable development. In an era of global financial markets, the financial sector has a crucial impact on the state of the environment. The long-standing movement for ethically and socially responsible investment (SRI) has recently begun to advocate environmental standards for financiers. While this movement is gaining more adherents, it has increasingly justified responsible financing as a path to be prosperous, rather than virtuous. This trend partly owes (...) to how financial institutions view their legal responsibilities. The business case motivations that now predominantly drive SRI are not sufficient to make the financial sector a means to sustainable development. Some modest legal reforms to improve the quality and extent of SRI have yet to make a tangible difference. A more ambitious strategy to promote SRI for environmental sustainability is possible, based on reforming the fiduciary duties of financial institutions. Such duties, tied to concrete performance standards, could make financiers invest in more ethically responsible ways. Other collateral reforms to financial markets, including improved corporate environmental reporting, are required to promote sustainability. (shrink)

The proteins encoded by the ras proto‐oncogenes play critical roles in normal cellular growth, differentiation and development in addition to their potential for malignant transformation. Several proteins that are involved in the control of the activity of p21ras have now been characterised. p120GAP stimulates the GTPase activity of p21ras and hence acts as a negative regulator of ras proteins. It may be controlled by tyrosine phosphorylation or association with tyrosine phosphorylated proteins. The neurofibromatosis type 1 (NF 1) gene also (...) encodes a potential GTPase activating protein which is likely to be subject to a different control mechanism. Guanosine nucleotide exchange factors for p21ras have now been identified: these may be positive regulators of ras protein function. It appears that p21ras is subject to rapid regulation by several distinct mechanisms which are likely to vary in different cell types; the ras proteins are thereby able to act as very sensitive cellular monitors of the extracellular environment. (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)

Prevention focus is a self-regulatory orientation that serves the need for security, and promotion focus is a self-regulatory orientation that serves the need for growth. From mid-March to early April 2020, did people judge prevention focus to be more useful than promotion focus for responding to COVID-19? Our study tested and showed support for this hypothesis with 401 American and Canadian participants, who we sampled in 100-person waves on the first four Thursdays of the pandemic. For this study, (...) we developed a new measure of the judged usefulness of promotion and prevention focus. Additionally, results showed that the judged usefulness of promotion and prevention focus related positively to support of the psychological needs for autonomy and relatedness, respectively, in responding to COVID-19. Exploratory analyses showed that day-to-day differences in autonomy, competence, and relatedness support and in promotion and prevention focus tended to be small, which is notable given the large-scale changes to social distancing, employment, and media coverage of the virus during this time. Our research could be useful for crafting persuasive advocacy and narrative communications that encourage social distancing to protect others about whom people care most. (shrink)

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

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)

Research in the area of intellectual property (IP) is increasingly relevant to the rapidly growing artificial intelligence (AI) and robotics industries, affecting the legal, business, manufacturing, and healthcare sectors. This contributed volume aims to develop our understanding of the legal and ethical challenges posed by artificial intelligence and robotics technologies and the appropriate intellectual property based legal and regulatory responses. It provides a philosophical and legal framework for considering concepts and principles that relate to the development and use (...) of such technologies at the international, regional, and national levels. The legal discourse in IP concerns the ever-growing AI sector and how businesses can protect their IP and incorporate AI. Moral sentiments often take a back seat to market sentiments, even in shaping the direction of ethical business strategy. This anomaly persists despite growing interest in ethics and IP. Taking an interdisciplinary and diverse perspective, this book enriches the evolving definition and scope of IP literature by focusing on actors, products and regulation that shape the business sector. Considering the gap between theory and practice, this book bridges academic and professional knowledge in unpacking legal, ethical and governance issues in the intellectual property industry. In an effort to include as many viewpoints as possible, contributions have been gathered from diverse fields, including business, ethics, governance, law, philosophy and technology studies. This book will appeal to academics in the field of intellectual property, business ethics, AI, emerging technologies and strategic innovation, as well as practitioners and policy makers. (shrink)

Knowledge on regulatory relations, in for example regulatory pathways in biology, is used widely in experiment design by biomedical researchers and in systems biology. The knowledge has typically either been represented through simple graphs or through very expressive differential equation simulations of smaller sections of a pathway. As an alternative, in this work we suggest a knowledge representation of the most basic relations in regulatory processes regulates, positively regulates and negatively regulates in logics based on a semantic (...) analysis. We discuss the usage of these relations in biology and in artificial intelligence for hypothesis development in drug discovery. (shrink)

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. (...) Given the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling. (shrink)

This paper explores how a particular form of regulation—prior ethical review of research—developed over time in a specific context, testing the claims of standard explanations for such change against more recent theoretical approaches to institutional changes, which emphasize the role of gradual change. To makes its case, this paper draws on archival and interview material focusing on the research ethics review system in the UK National Health Service. Key insights center on the minimal role scandals play in shaping changes in (...) this regulatory setting and how these depend upon the absence of a single coherent profession associated with biomedical research. (shrink)

Cellular differentiation and multicellular development require the programmed expression of coregulated suites of genetic loci dispersed throughout the genome. How do functionally diverse loci come to share common regulatory motifs? A new paper finds that retrotransposons (RTEs) may play a role in providing common regulation to a group of functions expressed during the development of oocytes and preimplantation embryos. Examining cDNA libraries, Peaston et al.1 find that 13% of all processed transcripts in full-grown mouse oocytes contain RTE (...) sequences, mostly from the MT family of retroviral-like elements. Smaller but still significant percentages of RTE sequences are found in cDNA libraries from 2-cell embryos and blastocysts. A quarter of these RTE sequences are at the 5′ ends of chimeric transcripts that also contain exons from endogenous mouse loci. These chimeric transcripts display restricted expression in oocytes and preimplantation embryos and presumably originate from developmentally regulated LTR promoters. Some, but not all, chimeric transcripts encode novel protein products. BioEssays 27:122–125, 2005. © 2005 Wiley Periodicals, Inc. (shrink)

Means–ends decoupling has recently been suggested as one consequence of the problems organizations face in trying to comply with institutional rules in contexts of institutional complexity. Such decoupling is characterized by the adoption, implementation, and scrutiny of particular codes of practice, which tend not to deliver the outcomes they were developed to produce. Recent scholarship focusing on this issue has suggested that such decoupling is a consequence of the trade-off organizations need to make between compliance and goal achievement, most especially (...) when the latter is difficult to evaluate. Although recent scholarship has suggested that this tension might be mitigated by the activities of developers of compliance rules, in this article, we explore how actors internal to organizations, in this case, two charitable organizations, mitigate this tension via nonconformance with particular codes. We focus on how the process of accounting for nonconformance results in the discursive coupling of means and ends as actors creatively develop vocabularies of motive, which respond to anticipated social criticism. (shrink)

Crowdsourced regulation has been discussed to date by legal and social science scholars mainly in the context of legislation and rulemaking, without paying sufficient attention to non-legislative regulatory functions. This article provides a richer theory of crowdsourced regulation which extends to all regulatory functions, focusing on monitoring and enforcement. Regulatory agencies worldwide harness the power of the public using digital platforms to carry out monitoring and enforcement tasks in regulated markets and sectors. For example, agencies operate online (...) complaint databases that invite the public to report mistreatment of consumers and environmental nuisances by regulated firms. Agencies also publish information concerning corporate misbehavior to publicly shame companies into compliance. Crowdsourcing regulatory monitoring and enforcement can help minimize some prominent ailments of the regulatory task, such as poor resources, diminishing deterrence, declining legitimacy, and capture. It can also promote goals and values such as public participation, increased transparency, public trust in regulators, administrative efficiency, and effectiveness in achieving regulatory objectives. However, crowdsourcing regulatory monitoring and enforcement is subject to a new set of legal, administrative, and democratic failures that need to be acknowledged and addressed. The article develops a theory of crowdsourced regulation that supplies justifications and rationales for crowdsourced regulatory monitoring and enforcement, points out its main pitfalls, and normatively evaluates law and policy implications. (shrink)

The prevalence of technology-embedded products, services, and cities, described colloquially as ‘smart’ technologies and ‘smart’ cities, has seen a spate of unprecedented growth in recent years. South Africa (SA) has not been left behind, with smartphones, smart watches, and smart voice-controlled virtual personal assistants such as Amazon’s Alexa now frequently used. But while these technologies hold great promise to revolutionise homes, offices and cities, their adoption poses challenges to individual and collective interests and wellbeing. After demonstrating the legal and ethical (...) difficulties brought about by the introduction of these technologies, this article explores whether SA legislation is sufficiently robust to address these challenges. While the current legislative landscape addresses certain crucial difficulties – such as the safeguarding of personal data by the Protection of Personal Information Act No. 4 of 2013 (‘POPIA’) – it is suggested that the position regulating other aspects of smart technology adoption is, in large part, fragmented and ill-equipped to deal with some of the more pressing legal and ethical questions. Our contention is that, not dissimilar to the issues arising from artificial intelligence-based technological adoption, the extant legislative and regulatory frameworks do not go far enough in addressing the many concerns emerging from recent novel technological design, development, and deployment. Not only do smart technologies give rise to unique challenges, so does their deployment within the Global South and in South Africa, in particular. We suggest that appropriate and effective regulatory reform measures be undertaken in SA to provide better ethical guidance and policy prescriptions buttressed by rigorous regulatory oversight. (shrink)

This study examined the factors that affect the attitude and behavioral intentions toward electronic sports among students of higher education institutions based on the technology acceptance model. The conditional impact of preventive regulatory focus was analyzed in various aspects developed on the regulatory focus theory. These aspects comprised of perceived usefulness, perceived ease of use, and perceived risk on the attitude toward eSports. Accordingly, data were collected from 293 students of higher education institutions in China's Henan Province, presenting (...) a 54.56% response rate. The PLS-SEM analysis was subsequently implemented to confirm the proposed hypotheses. The empirical findings confirmed the significant positive impact of perceived usefulness and perceived ease of use on the attitude toward eSports. However, perceived risk negatively affected the attitude toward eSports. Meanwhile, the findings on the moderating hypotheses found a negligible impact on preventive regulatory focus. This impact was found explicitly on the perceived usefulness-perceived ease of use link with attitude toward eSports. However, the preventive regulatory focus negatively moderated the perceived risk attitude toward eSports. Finally, the implication and limitations were illustrated at the end of the paper. (shrink)