The Endangered Species Act (ESA) can impose significant limitations on what landowners may do with their property, especially as it pertains to development. These restrictions imposed by the ESA are part of a larger controversy about the reach of the “Takings Clause” of the Fifth Amendment, which says that private property shall not be taken for public use without just compensation. The question this paper addresses is whether these restrictions require compensation. The paper develops a position on the general (...) question of compensation for regulatory takings and applies it to the ESA. The main argument concludes that compensation should be paid. It is based on the proposition that the goods provided by regulatory takings are typically public goods, and on a principle of fairness, which holds that compensation should be paid when those who benefit from a regulatory taking pay virtually nothing and those who pay receive hardly any benefit. It is argued that this principle is implicit in many of the Court's rulings on regulatory takings. (shrink)

When state regulations prevent owners from certain uses of their property, is this action of the state a taking of property which requires compensation? One way of answering this problem, within a framework viewing property as a bundle of rights, is to inquire into whether the incident of use is an essential element of the bundle making up the property. Given the difficulties with figuring out what is essential and what is not, I propose an alternative solution, which does not (...) give up the bundle-of-rights framework, but which, while assuming all incidents to be equally essential, it concentrates, instead, upon the legal entitlements conveying those incidents. I begin by arguing that while the incident of possession may be expressed by a right to exclude, the incident of use is expressed by a Hohfeldian liberty, and then I consider the consequences of this argument for the question of regulatory takings. I argue that while the liberty to use does not render the incident of use meaningless (at least, insofar as regulation of property use is concerned), there is nonetheless a significant distinction between transgressing a right and transgressing a liberty, and this implies that what it takes for an infringement of the right to exclude to be translated into a taking of the (whole) property is less than what it takes for the infringement of the liberty to use to be translated into a taking of property. As I show in the paper, we can achieve this result either by means of an argument from ‘constitutional residue’ or by means of an argument from the specification of constitutional rights. (shrink)

The public debate on recombinant DNA research has ended even though significant issues of public interest remain undecided or untouched. The reason for the termination of other than muted public discussion is not simply the removal of an initial fear of catastrophic biohazards. With the cessation of public debate over such hazards came also the dissolution of most public forums. The ends to which recombinant DNA research and development ought to be directed are not matters of public debate. With the (...) transfer of basic research knowledge to the private sector, that sector's proprietary interests and ownership prerogatives effectively deny any continued public participation in charting the future of genesplicing technology and its application. (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)

The regulation of stem cell research is an issue that has drawn much comment, criticism and even judicial arbitration in recent years. An emerging issue, addressed in this article, is how the fruits of that research-stem cell medicine-are likely to be regulated en route from lab to market. Taking account of the ethical, legal, social and safety issues raised by stem cell medicine and the goals of governance, the article explains the relevant regulatory instruments (e.g. the draft UK Stem (...) Cell Bank Code, the EU Directive on Human Tissue, the EU Directives on medical products and devices, and the Human Tissue Act 2004) and critically examines the framework they provide. (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)

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)

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)

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)

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 paper targets an orphan topic in research ethics, namely the so called principle of the primacy of the human being, which states that the interests of the human subject should always take precedence over the interests of science and society. Although the principle occupies the central position in the majority of international ethical and legal standards for biomedical research, it has been commented in the literature mainly in passing. With a few notable exceptions, there is little in-depth discussion about (...) the meaning and role of the principle. Several authors note that the principle is vogue, ambiguous and apparently conflicting with the accepted practice of conducting non-beneficial research on individuals unable to give consent. There are opinions that it is just “a vacuous figure of speech” and should be abandoned. This paper argues that the primacy principle is far from being “a vacuous figure of speech”, rather it should be seen as a threefold concept: a fundamental interpretative rule, a procedural rule, and a substantive rule aimed at protecting research subjects from instrumental treatment and unacceptable risks. This interpretation tracks back to the principle regulatory and normative origins in the Declaration of Helsinki of 1975, but also acknowledges changes in research ethics and practice, which took place at the turn on the twentieth and twenty-first centuries. Thus, the proposed reading of the principle is not only original, but also historically grounded and normatively fruitful. It provides a fresh and ethically rich perspective on extensively debated, but still controversial problem of an upper limit of permissible risks in non-beneficial studies. (shrink)

On January 18, 2011, President Obama signed Executive Order 13563, Improving Regulation and Regulatory Review, which instructs federal regulators to do the following: coordinate their agencies activities to simplify and harmonize rules that may be overlapping, inconsistent, or redundant; determine whether the present and future benefits of a proposed regulation justify its potential costs (including taking into account both quantitative and qualitative factors); increase participation of industry, experts, and the public (“stakeholders”) in the formal rule‐making process; encourage the use (...) of warnings, default rules, disclosure requirements, and provisions of information to the public as an alternative to traditional “command‐and‐control” rule‐making restricting consumer choice; and mandate a government‐wide review of all existing administrative rules to remove outdated regulations. Executive Order 13563 includes a qualitative “values” provision to be considered in the required cost–benefit analysis, which can potentially counteract the alleged regulatory reform rationale of President Obama. Furthermore, in Executive Order 13563, President Obama established a deadline of May 18, 2011, for all executive branch agencies to submit their plans to streamline their rulemaking operations and repeal those “overlapping, inconsistent, or redundant” rules. These two issues, along with complementary regulatory review proposals being discussed in the U.S. Congress, are evaluated in this essay. (shrink)

CRISPR germline editing therapies hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny (...) at each stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. (shrink)

An individual’s accountability to oneself leads to self-regulatory behaviour. A field experiment afforded an opportunity to test this relation, given that external accountability conditions were absent. A single group pre-test/post-test design was used to test the hypothesis. A group of full-time resident management students, n ≈ 550, take four meals during the day in the institute mess. As a part of the experiment, food wastage in the form of leftovers on the plates of subjects was measured. As a pre-test, (...) the measurement occurred at two levels. Subjects could see how much they are adding to the total waste by looking at a weighing scale placed under a waste basket, and they could also see the total waste data for each of the four meals for the day and a day earlier displayed at a prominent place. After 105 days, the weighing scale under the basket was removed, and as a post-test measurement, the total waste data for the four meals were noted down for another 72 days. A manipulation test indicated that the experiment has had the desired effect of invoking self-accountability in subjects during the pre-test phase, and diluting it during the post-test phase. Time series analysis of pre-test and post-test data indicated that the wastage data decreased in the pre-test phase. However, the post-test waste data showed an increase over a period of time. The results indicate that accountability conditions like social norms invoke self-accountability cognition leading to self-regulatory behaviours in individuals. (shrink)

This Article examines what form the public/private distinction takes in contemporary legal consciousness. It proposes that while the public/ private distinction is still an important component of contemporary legal consciousness, the content of each sphere, their stability as distinct spheres, and their interaction with each other have significantly changed. This transformation occurred primarily due to the rise of the regulatory state and the increased visibility of the interconnectedness of the spheres due to public ordering of private activity in an (...) age of widespread privatization. The current state of the distinction challenges courts, when these are asked by petitioners to define the proper scope of the spheres and decide on their boundaries. The Article critically examines the Israeli High Court of Justice decision in a prison privatization case, as a case that reflects the mismatch between the traditional understanding of the public/private distinction and a much messier reality in which the private and public spheres keep changing, and intermingling in new ways. (shrink)

Drawing on an analysis of complaint files that we conducted for the Irish Medical Council, this paper offers three possible explanations for the gap between the ubiquity of official commitments to taking patients’ complaints seriously and medical professional regulators’ dismissal—as not warranting an inquiry—of the vast majority of complaints submitted by members of the public. One explanation points to the “regulatory illiteracy” of many complainants, where the remit and threshold of seriousness of regulators is poorly understood by the general (...) public. Another points to possible processes of “institutional epistemic injustice” that unjustly undermine the credibility of certain complainants, such as those with low levels of formal education. A third explanation highlights the marginalization of the general public from “symbolic power” to define what matters in medical professional regulation. The paper is offered in a spirit of ideas in progress and raising questions rather than definitive insights into the regulatory process. (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)

In lieu of an abstract, here is a brief excerpt of the content:Garrison on Beauty in Artworks as a Response to Regulatory PowerA Focus on Butler and KantKelly Coble (bio)As Garrison concedes, critical theory and Confucian philosophy will strike many of his readers as unlikely interlocutors. One would be hard-pressed to find two intellectual traditions more historically and culturally remote, and at least at first glance, more antithetical in their stances on authority and cultural power. In Reconsidering the Life (...) of Power Garrison prosecutes a brilliant case against these appearances, bringing these traditions into sustained and productive conversation. He is able to do so successfully by steadfastly refraining from a style of intercultural philosophy that would force these traditions into abrupt conversation—an errand that would involve stripping each tradition of the cultural and historical circumstances that give it life (p. 31). Instead, Garrison delineates a vast, rhizomatic network in which these traditions can be observed interacting and intersecting, displaying "intriguing similarities as well as informative divergences" (p. 50). Tracing such a network is a daunting task, demanding one bring to bear (i) an elegant, accessible rhetorical style; (ii) redoubtable scholarly erudition: the book features close readings of texts by European philosophers from Kant to Foucault and Butler, Confucius and major figures in the classical Confucian tradition, and leading contemporary scholars of (and in) Confucian philosophy; and not least (iii) an original argument breathing fresh life into the many texts, old and new, under examination.In what follows I offer a summary of a large part of that argument and offer critical comment on a small part of it. As Garrison's title indicates, the book can profitably be read as a sympathetic development of, and critical response to, Butler's account of the psychodynamics of power as developed, [End Page 821] above all, in their 1997 The Psychic Life of Power. Of course, what sets Garrison's endeavor apart from the standard commentary is the use he makes of Confucian insights. One impetus for his doing so is recognition of fertile common ground. The poststructuralist, psychoanalytic, queer-theoretical tradition of which Butler is a major contributor shares with the Confucian tradition a "particular insight into how the relational self arises discursively through naming, ritual, and performance" (p. 49).On what grounds, then, does Butler's account of power merit a critical response, according to Garrison, and how do Confucian insights help shape that response? The point de départ of Butler's 1997 book is Foucault's affiliated notions of assujettissement ("subjection" or "subjugation") and subjectivation (in English as in French). "Subjectivation" is Foucault's coinage for the complex process responsible at once for the formation and maintenance of subjects and their subjection and subordination, a para-doxical achievement that is a hallmark of panoptic regulatory power. As Butler observes, subjection signifies "the way regulatory power maintains subjects in subordination by producing and exploiting the demand for continuity, visibility, and place."1 (We note that Butler's influential account of the performativity of gender also draws heavily on this concept of subjectivation.) In their 1997 book Butler gives systematic attention to the following dynamic: subjects depend on the subordinating effects of regulatory power for their existence, giving them an existential stake in, and concomitant desire for, their own subordination. Building on the Foucauldian thesis that the "psychic operation of the norm offers a more insidious route for regulatory power than explicit coercion," Butler proceeds through Hegel's "unhappy consciousness" and Nietzsche's "bad conscience" to an original reading of Freud's melancholia.2 As in Hegel and Nietzsche, so also in Freud, Butler observes, the ego is said to "turn back upon itself," taking itself "not only as an object of love, but of aggression and hate as well."3 And as in Hegel and Nietzsche, so also in Freud, this idea of a turn from the object to the ego that produces the ego, Butler observes, both defies intelligibility and describes a scene of failure. In Butler's words, "The turn from the object to the ego can never quite be accomplished," and as a result the subject "is haunted by an inassimilable remainder, a melancholia that marks the limits of subjectivation."4So far, Garrison... (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)

Cognitive enhancement takes many and diverse forms. Various methods of cognitive enhancement have implications for the near future. At the same time, these technologies raise a range of ethical issues. For example, they interact with notions of authenticity, the good life, and the role of medicine in our lives. Present and anticipated methods for cognitive enhancement also create challenges for public policy and regulation.

ABSTRACTThis article takes an interdisciplinary lens to the treatment of regulatory capture . RC ensues when government bureaucrats, regulators, and public sector agencies receive adverse publicity for ceasing to serve the wider collective public interest. The work is divided into four sections. The first takes the point of view of each of the participants in the capture situation and provides an overview of the three variations on the RC story. Each subsequent section focuses on a version of the story. (...) RC 1, the libertarian free market version celebrates capture as inevitable and desirable. RC 2, the regulators' communitarian take on capture places it in the context of a cycle story with regulators dutifully doing the public's shifting will. In the RC 3 version, the public finds it difficult to piece together a coherent version of the morally charged narrative. The article concludes with a discussion of the relevance of each of these three versions of RC in order to understand dominant–submissive relationships between business and government. (shrink)

Just as a stream of genetically modifiedcrops looked set to be approved for commercialproduction in the European Union, the approvalprocedure appears to have become bogged down onceagain by disagreements among and within member states.Old controversies have resurfaced in new forms. Theintractability of the issues suggests that theregulatory procedure has had too narrow a focus,leaving outside its boundary many of the morefundamental aspects that cause people in the EuropeanUnion most concern. Regulators have come underconsiderable pressure to ensure their risk assessmentdecisions are (...) soundly science-based. Ethical issueshave been deemed to lie beyond the scope of theregulatory procedure, as a matter to be consideredseparately by professional ethicists. Yet it has beensuggested that all environmental controversies at rootinvolve disputes about fundamental ethical principles.This paper examines how the ethical issues arecurrently suppressed or sidelined. It discusses how anappreciation of systems thinking and a check on thevalues that underpin decisions, using boundary testingquestions, might contribute to a more constructiveregulatory dialogue, with ethical issues considered asintegral in a way that takes better account ofpeople's concerns. (shrink)

Objective To evaluate the questions asked during the informed consent process by adult and adolescent participants as well as their parents in five interventional regulatory studies conducted at our center from 2018 to 2019. Methods The study protocol was approved by Institutional Ethics Committee [EC/OA-116/2019]. Consent narratives in the source documents for the studies were evaluated. Questions asked were classified as per Indian Council of Medical Research’s (ICMR) guidelines (2017). We evaluated total number of questions, nature of questions and (...) whether there was an association between education, gender, phase of trials, physician taking consent and number questions being asked. Results A total of five studies that had N = 297 consent narratives were evaluated. Narratives of n = 284 adult participants/Guardians and of n = 13 children were analysed. A total of 374 questions were asked of which children asked only 10 questions. A total of 131/284 (40%) of the participants did not ask any question. Among the participants who asked questions, the majority132/171 (77%) participants asked about risks related to investigational products followed by questions related to study procedures 83/171 (49%). Participants/guardians with higher education (relative to those who were educated upto the secondary school and primary school) and those who consented for Phase III studies (relative to Phase I studies) asked significantly more questions (p < 0.0001). Conclusion A majority of the queries were related to the risks associated with the investigational products. Educational status and the Phase of the trial were found to be significantly associated with the number of questions being asked. (shrink)

Anticorruption regulators delegate to organizations part of the responsibility for deterring corruption in the form of ethics and compliance programs (ECPs), also referred to as compliance programs, ethics programs, and integrity programs. From this anticorruption perspective, organizations are expected to design and implement programs that comply with general criteria established by regulators to achieve a specific social goal—reducing corruption. This integrative review examines how different communities of practice analyze ECPs in their role as anticorruption mechanisms. Based on a conceptualization of (...) ECP derived from theories of regulation, the review integrates the fragmented literature at the intersection of ECPs and corruption and uncovers connections across communities of practice to propose new insights and research directions. To achieve this objective, the review proposes a process-oriented anticorruption multi-level integrative framework that (1) situates ECPs in the anticorruption process that originated them and (2) identifies the areas where cross-fertilization of ideas from different communities of practice can contribute to redirecting future research. The review concludes with a research agenda that can help advance knowledge applicable to ECPs as anticorruption mechanisms and to other self-regulatory initiatives against grand societal challenges. (shrink)

This article highlights the current controversies around stem cell research and its application in clinical medicine. It aims to discuss the ethical concerns around how corporate involvement is corrupting the ethical progression in this field of research. The author appeals to medical and scientific communities to take cognisance of current practices and to facilitate the regulation of new stem cell therapies being advertised to the public.

The paper examines the issue of corporate social responsibility against the backdrop of its self-regulatory posture. Using the African experience as a case study, the paper observes that the activities of multinationals show very clearly that they are grossly irresponsible despite their professed self-regulation. Instead, the multinationals have created an image of terror due to their deep-rooted involvements in human rights abuses, environmental degradation, tax evasion, bribery, market manipulation, and other forms of unethical practices, notwithstanding their so-called self-regulation. The (...) paper concludes by advocating the establishment of a broad-based United Nations Global Business Regulatory Agency to fully take charge of corporate regulation in the global business terrain. (shrink)

Major hallmarks of Alzheimer's disease include brain deposition of the amyloid-beta peptide , which is proteolytically cleaved from a large Abeta precursor protein by beta and gamma- secretases. A transmembrane aspartyl protease, beta-APP cleaving enzyme , has been recognized as the beta-secretase. We review the structure and function of the BACE1 protein, and of 4129 bp of the 5'-flanking region sequence of the BACE1 gene and its interaction with various transcription factors involved in cell signaling. The promoter region and 5'-untranslated (...) region contain multiple transcription factor binding sites, such as AP-1, CREB and MEF2. A 91 bp fragment is the shortest region with significant reporter gene activity and constitutes the minimal promoter element for BACE1. The BACE1 promoter contains six unique functional domains and three structural domains of increasing sequence complexity as the "ATG" start codon is approached. Notably, the BACE1 gene promoter contains basal regulatory elements, inducible features and sites for regulation by various important transcription factors. Herein, we also discuss and speculate how the interaction of these transcription factors with the BACE1 promoter can modulate synaptic plasticity, neuronal apoptosis and oxidative stress, which are pertinent to the pathogenesis and progression of AD. (shrink)

In the early 1970s, the idea of precaution—of heeding rather than ignoring scientific evidence of harm when there is uncertainty, and taking action that errs on the side of safety—was so appealing that the US Congress used it as the basis of the toxics provisions of the Clean Water Act of 1972, the federal Environmental Protection Agency based its proposals for implementing those provisions on it, and the courts frequently tended toward it when resolving conflicts over the implementation of pollution (...) control law. In other words, precaution was written into toxic water pollutant control law and was beginning to be written into policy and regulations. By 1976, the tables were completely turned. The EPA abandoned the safety-providing approach in the implementation of the law, even though the law required it, and adopted a risk-taking approach in the creation of standards for the vast majority of toxic water pollutants. The article examines how this change was brought about. It builds on recent work on undone science as an obstacle to regulation and contributes to the development of an account of the creation of the regulatory system, with both its achievements and its limitations. (shrink)

:A norm of equal treatment is cited regularly in the American jurisprudence of property “takings” under the Fifth and Fourteenth Amendments to the Constitution, as a benchmark of fair treatment of owners. According to an increasingly prevalent version of this equality norm, courts should look to parity of treatment among property owners in investigating whether particular regulations “take” property. This essay argues, however, that such an equality norm is misplaced, and that courts should judge fairness by the criterion of (...) expectation—including reasonable expectations of regulation.A norm of equality becomes problematic in the face of the economic theory of the evolution of property. This theory posits that as resources become more congested, their uses carry increasing common pool costs or “externalities”—a scenario that should predictably result in more stringent resource management—up to and including the establishment of regulatory regimes as well as property rights themselves. This evolutionary pattern, however, places earlier and later resource users in different positions vis-à-vis both common pool externalities and regulatory responses, and their different temporal positions fragment the meaning of equal treatment and destabilize it as a jurisprudential norm. This essay argues that while equal treatment may be a benchmark for special or invidious cases, like those relating to civil rights, the great bulk of takings cases involve regulatory responses to congesting resources, where a norm of equal treatment breaks down. Thus, in seeking fair treatment, takings jurisprudence should downplay equality and instead look to the understanding of property as a basis of expectations—but those expectations should include the anticipation of reasonable regulatory responses to resource congestion. (shrink)

In this article, we look at the contested role of in-house lawyers in regulated organisations in the financial sector. A recent Financial Conduct Authority consultation on whether to designate the head of legal of banks, insurance companies and other financial firms as ‘Senior Managers’ and the decision which flowed from it, reflected a flawed view of lawyers as a neutral technocracy of mere legal technicians; we show how the FCA’s decision is potentially damaging to the public interest and failed to (...) take into account that in-house lawyers are often important decision-makers and influencers within their organisations. We put the case for an alternative view; that in-house lawyers are professionals, with agency that requires them to act in accordance with ethical norms and means they should be made more accountable for their conduct. (shrink)

Research to date provides only limited insights into the processes of abusive supervision, a form of unethical leadership. Leaders’ vulnerable narcissism is important to consider, as, according to the trifurcated model of narcissism, it combines entitlement with antagonism, which likely triggers cognitive and affective processes that link leaders’ vulnerable narcissism and abusive supervision. Building on conceptualizations of aggression as a self-regulatory strategy, we investigated the role of internal attribution of failure and shame in the relationship between leaders’ vulnerable narcissism (...) and abusive supervision. We found across three empirical studies with supervisory samples from Germany and the United Kingdom (UK) that vulnerable narcissism related positively to abusive supervision (intentions), and supplementary analyses illustrated that leaders’ vulnerable (rather than grandiose) narcissism was the main driver. Study 1 (N = 320) provided correlational evidence of the vulnerable narcissism-abusive supervision relationship and for the mediating role of the general proneness to make internal attributions of failure (i.e., attribution style). Two experimental studies (N = 326 and N = 292) with a manipulation-of-mediator design and an event recall task supported the causality and momentary triggers of the internal attribution of failure. Only Study 2 pointed to shame as a serial mediator, and we address possible reasons for the differences between studies. We discuss implications for future studies of leaders’ vulnerable narcissism as well as ethical organizational practices. (shrink)

Decentralized clinical trials (DCTs) have the potential to advance the conduct of clinical trials, but raise several ethical issues, including obtaining valid informed consent. The debate on the ethical issues resulting from digitalization is predominantly focused on direct risks relating to for example data protection, safety, and data quality. We submit however, that a broader view on ethical aspects of DCTs is needed to touch upon the new challenges that come with the DCT practice. Digitalization has impacts that go beyond (...) its direct purposes, by shaping behaviors, experiences, social relations, and values. We examine four elements of the informed consent procedure that are affected by DCTs, while taking these soft impacts of technologies into account: (i) informing participants and testing understanding, (ii) freedoms in relation to responsibilities and burdens, (iii) trust in participant-researcher relations, and (iv) impacts on the concept of privacy. Our analysis reveals that a broad view is key for optimal conduct of DCTs. In addition, it provides insight into the ethical impacts of DCTs on informed consent. Technologies such as DCTs potentially have profound impacts which are not immediately addressed by the existing regulatory frameworks, but nonetheless important to recognize. These findings can guide future practices of DCTs to foster the important values of clinical research in this novel approach for conducting clinical trials. (shrink)

Innovative organizing strategies in the labor movement are being driven by the realization that labor law is of virtually no help in helping workers exercise their rights. Unions are increasingly designing strategies that go beyond traditional workplace tactics and draw on a wide range of social actors and relationships in an effort to find and harness new leverage sources. Service Employees International Union Local 1199 Florida provides one such example. 1199 Florida has a multilayered, multifaceted organizing strategy that attempts to (...) surmount the obstacles of employer resistance and weak labor laws by mobilizing a range of allies and engaging political and regulatory actors. (shrink)

The pipeline model framework proposed by Char et al. makes a timely contribution to the literature in allowing one to take a step back and consider machine learning healthcare app...

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)

Narratives surrounding ionizing radiation have often minimized radioactivity’s impact on the health of human and non-human animals and the natural environment. Many Cold War research policies, practices, and interpretations drove nuclear technology forward by institutionally obscuring empirical evidence of radiation’s disproportionate and low-dose harm—a legacy we still confront. Women, children, and pregnancy development are particularly sensitive to exposure from radioactivity, suffering more damage per dose than adult males, even down to small doses, making low doses a cornerstone of concern. Evidence (...) of compounding generational damage could indicate increased sensitivity through heritable impact. This essay examines the existing empirical evidence demonstrating these sensitivities, and how research institutions and regulatory authorities have devalued them, willingly sacrificing health in the service of maintaining and expanding nuclear technology. Radiation’s disproportionate impacts should now be the research and policy focus, as society is poised to make crucial and long-lasting decisions regarding climate change mitigation and future energy sources. (shrink)

This study uses a Corpus Assisted Discourse Studies methodology to provide the first systematic analysis of how trust is discursively constructed in crypto-drug markets. The data come from two purpose-built corpora. One comprises all the forum messages posted on the flag ship crypto-drug market Silk Road during the years in which it traded on the hidden net. The other corpus comprises all the reports published by the United Nations Office on Drugs and Crime during the same period. Our analysis of (...) trust focuses on the identities of those buying and selling drugs. The findings reveal that the Silk Road community members regularly discussed vendors’ identities alongside a continuum of trust–risk calculation, explicitly identifying both ‘good’ and ‘bad’ practices and hence engaging in self-regulatory discourses, and mainly constructed drug users’ identities in relation to values of expertise, integrity and benevolence. The findings also suggest that hard law enforcement activity, such as crypto-drug market closure, may encourage technological innovation within these markets. Moreover, our results show a disconnect between the discursive reality of the policy-making documents we examined and the very crypto-drug markets that they seek to legislate. (shrink)

Drawing on case studies from the modern era of pharmaceutical regulation in the UK, US and Europe, I examine how the extent and distribution of trust between regulators, the pharmaceutical industry, and the medical profession about drug testing and monitoring influences knowledge and regulatory judgements about the efficacy and safety of prescription drugs. Introducing the concepts of ‘acquiescent’ and ‘investigative’ norms of regulatory trust, I demonstrate how investigative norms of regulatory trust—which deter pharmaceutical companies from assuming that (...) their data analyses will be accepted without independent de-construction—drive up bioethical and regulatory standards of drug assessment in the interests of health. By contrast, acquiescent norms of regulatory trust, which are associated with industrial capture and professional closure of interests, promote permissive standards allowing patients to take pharmaceuticals with greater risks to health and less evidence of therapeutic efficacy. (shrink)

Alternative cleavage and polyadenylation (APA) can diversify coding and non‐coding regions, but has particular impact on increasing 3′ UTR diversity. Through the gain or loss of regulatory elements such as RNA binding protein and microRNA sites, APA can influence transcript stability, localization, and translational efficiency. Strikingly, the central nervous systems of invertebrate and vertebrate species express a broad range of transcript isoforms bearing extended 3′ UTRs. The molecular mechanism that permits proximal 3′ end bypass in neurons is mysterious, and (...) only beginning to be elucidated. This landscape of neural 3′ UTR extensions, many reaching unprecedented lengths, may help service the unique post‐transcriptional regulatory needs of neurons. A combination of approaches, including transcriptome‐wide profiling, genetic screening to identify APA factors, biochemical dissection of alternative 3′ end formation, and manipulation of individual neural APA targets, will be necessary to gain fuller perspectives on the mechanism and biology of neural‐specific 3′ UTR lengthening. (shrink)

The Endangered Species Act of 1973 is America's strongest environmental law. Its citizen-suit provision—permitting “any person” whomsoever to sue on behalf of a threatened or endangered species—awards implicit intrinsic value, de facto standing, and operational legal rights to listed species. Accordingly, some cases had gone forward in the federal courts in the name of various listed species between 1979 and 2004, when the Ninth Circuit Court of Appeals ruled that animals could not sue in their own name. Because the Supreme (...) Court has interpreted its habitat destruction as the “taking” of a listed species, some have argued that enforcement of the ESA's critical-habitat-protection provision is a “regulatory taking” of private property without just compensation, contrary to the Fifth Amendment of the Constitution. The courts have not agreed. The ESA citizen-suit provision appears to waive federal-court standing requirements devolved from Article III of the U.S. Constitution, creating much confusion and mutually contradictory rulings. A series of cases reconciles the ESA's citizen-suit provision with the particularized and concrete “injury-in-fact” standing requirements devolved from Article III. (shrink)

This book surveys the leading modern theories of property - Lockean, libertarian, utilitarian/law-and-economics, personhood, Kantian and human flourishing - and then applies those theories to concrete contexts in which property issues have been especially controversial. These include redistribution, the right to exclude, regulatory takings, eminent domain and intellectual property. The book highlights the Aristotelian human flourishing theory of property, providing the most comprehensive and accessible introduction to that theory to date. The book's goal is neither to cover every (...) conceivable theory nor to discuss every possible facet of the theories covered. Instead, it aims to make the major property theories comprehensible to beginners, without sacrificing accuracy or sophistication. The book will be of particular interest to students seeking an accessible introduction to contemporary theories of property, but even specialists will benefit from the book's lucid descriptions of contemporary debates. (shrink)

Reigning regulatory frameworks for biomedical research impose on researchers and research ethics committees an obligation to protect research participants from risks that are unnecessary, disproportionate to potential research benefits, and non-minimized. Where the research has no potential to produce results of direct benefit to the subjects and the subjects are unable to give consent, these requirements are strengthened by an additional condition, that risks should not exceed a certain minimal threshold. In this article, I address the question of whether (...) there should be limits of permissible risks in non-therapeutic research involving competent and healthy subjects. Some commentators argue that competent and informed individuals should have a right to participate even in extremely risky research and that research ethics committees should never reject studies because they are too dangerous. To use David Shaw's expression, competent volunteers should have ‘a right to participate in high-risk research’. I argue that this idea is ill-founded, as it does not take into account the social mission and complex collaborative nature of research practice as well as the inequity of power between researchers and subjects. Imposition of limits on permissible risks for healthy volunteers is justified by the need to protect research enterprise and the need to protect the weaker party, namely the subjects. Also, I suggest that the best way to set boundaries on research risks is to leave the judgment of risk acceptability to research ethics committees. (shrink)

Taking advantage of the China’s recent anti-corruption campaign, we attempt to examine the effect of public governance on a firm’s incentive to commit fraud. Using enforcement actions data from the Chinese Securities Regulatory Commission (CSRC) from 2004 to 2014, we find that, due to enhanced public governance, firms are less likely to commit fraud in the post-campaign period than in the pre-campaign period. We further show that the effect of public governance is more evident in privately held listed firms, (...) in firms with weak legal environment, and in firms in areas with poor local economies. In addition, we find that older CEOs respond less actively to the public governance caused by anti-corruption regulations. This paper offers clear policy implications for business ethics by indicating that public governance provides external monitoring of corporate decisions. (shrink)

We take a fresh look at the concerns about credit card pricing and empirically investigate whether the Credit CARD Act of 2009 has been successful in addressing those concerns. The rational choice theory of credit card pricing, which posits that issuers use back-end fees to adjust the price of credit to reflect new information about borrowers’ credit risk, predicts that issuers will respond to the Act by using alternative ways to price risk. In contrast, the behavioral economics theory, which posits (...) that issuers use back-end fees because they are not salient to consumers, predicts that issuers will respond by increasing unregulated non-salient prices. If the market is competitive, we argue that the CARD Act should also result in increases in some salient, up-front prices. But we show that if issuers have market power, reductions in non-salient fees may not result in concomitant increases in salient charges. We test these predictions using two datasets on credit card contract terms before and after the CARD Act rules went into effect. We find that the rules have substantially reduced the back-end fees directly regulated by the Act, including late fees and over-the-limit fees. However, unregulated contract terms, such as annual fees and purchase interest rates, have changed little. Post-CARD Act, consumers continue to face high long-term prices and low short-term prices, and imperfectly rational consumers still find it difficult to understand the cost of credit card borrowing. We thus consider potential improvements to the regulatory framework. We argue that improved disclosures that present to consumers the aggregate cost of credit under the contract, based on information about the borrower’s likely use of credit, would improve consumer outcomes. Furthermore, we suggest that regulators, rather than focusing on prices that are “too high,” should consider limiting the ability of issuers to charge introductory teaser interest rates that are in a sense “too low. (shrink)

Taking notice of race is both risky and inevitable, in medicine no less than in other endeavors. On the one hand, race can be a useful stand-in for unstudied genetic and environmental factors that yield differences in disease expression and therapeutic response. Attention to race can make a therapeutic difference, to the point of saving lives. On the other hand, racial distinctions have social meanings that are often pejorative or worse, especially when these distinctions are cast as culturally or biologically (...) fixed. I argue in this essay that we should start with a presumption against racial categories in medicine, but permit their use when it might prolong lives or meaningfully improve health. Use of racial categories should be understood as an interim step; follow-up inquiry into the factors that underlie race-correlated clinical differences is important both to improve the efficacy of clinical care and to prevent race in itself from being misunderstood as a biological determinant. If we pursue such inquiry with vigor, the pernicious effects of racial categories on public understanding can be managed. But perverse market and regulatory incentives create the danger that use of race will be “locked-in,” once drugs or other therapies are approved. These incentives should be revisited. (shrink)

The article examines the possibilities of using the mechanisms of public-private partnership when implementing the projects on urban agglomerations development. Specific features of the urban agglomerations development are identified. They are based on combining the efforts of the territorial communities and aimed at implementing joint projects by attracting the appropriate resources, which allows to obtain an agglomeration effect and ensure the improvement of the quality of life of the population. It was proved that to implement joint projects on the basis (...) of using the mechanisms of public-private partnership it is necessary to attract private investors. The experience of using the mechanisms of public-private partnership in Ukraine is analyzed in two directions: by region and by type of activity. It was found that a significant part of projects with using public-private partnership mechanisms in the sphere of life support for large cities and agglomerations is carried out in the form of a concession. Concession allows to attract financial resources needed for the implementation of the development projects due to the ability to manage property over a long period of time, and also helps to prevent a monopolistic increase in the cost of services. The necessity of expanding the use of mechanisms of public-private partnership when implementing joint projects on the development of life support sphere for urban agglomerations was substantiated. Undoubtedly, it will be of great interest for private investors. In particular, it is the improvement of the tariff setting and tariff regulation policy, a strict control over the targeted use of funds, the transparency and economic certainty of costs, the balance of economic interests and the responsibility of those people who take part in the implementation of public-private partnership projects. Here, the scheme of the formation and implementation of joint projects on public-private partnership is presented that includes the observance of certain principles, the use of appropriate regulatory, economic and organizational methods, as well as the support of the economic security through risk management. Scientific approaches to improving the regulatory support for the use of public-private partnership mechanisms have been generalized, and the directions for making changes in the current legislation have been determined. The above measures will contribute to increased use of public-private partnership mechanisms when implementing joint projects aimed at developing the sphere of life support for urban agglomerations. (shrink)

Self-regulatory processes have predominantly been linked to the study of academic achievement in terms of learning behavior, cognitive engagement, and specific academic performance measures. If poorly regulated, academic behavior can have repercussions on social adaptation. Motivational processes constitute the other key element in ensuring successful regulation, as studies indicate that self-regulation can effectively influence achievement outcomes if learners have positive beliefs about their personal ability to negotiate difficulties and work towards the desired learning outcomes. This book takes a critical (...) look at the role of self-regulatory processes and personal agency beliefs in academic and social self-regulatory functioning, providing the reader with theoretical understanding of the issues and lending empirical support to the relevance of these processes in the East Asian educational context. In this way, the study explores the extent to which self-regulation and personal agency beliefs can offer an alternative explanation for the academic performance of students. (shrink)

Taking into account the historic transitions and progressions in agricultural science, this article examines the emergence of the phenomenon of agricultural biotechnology. It identifies pivotal sites of tension between agricultural biotechnology and alternative approaches to agriculture. The article identifies two distinct sources of contemporary social tension around agricultural science. First, it identifies the epistemological fault line and examines how the latter is promoted by intellectual property. Second, it spotlights the gene-wandering syndrome—a byproduct of genetic modification—and evaluates its impact on the (...) escalating tension in our agricultural communities. Drawing from recent court decisions in Canada, the article recognizes the present urgency for a better jurisprudence and practical regulatory policy on aspects of agricultural biotechnology to mediate current tensions in those communities. It argues that judicial and policy response must be predicated on recognition of agro-epistemic pluralism and an understanding of broader socioeconomic impact of agro-biotechnology on alternative forms of agriculture. (shrink)

In an instant classic paper ; 2002: 179–182) biologist Yuri Lazebnik deplores the poor effectiveness of the approach adopted by biologists to understand and “fix” biological systems. Lazebnik suggests that to remedy this state of things biologist should take inspiration from the approach used by engineers to design, understand, and troubleshoot technological systems. In the present paper I substantiate Lazebnik’s analysis by concretely showing how to apply the engineering approach to biological problems. I use an actual example of electronic circuit (...) troubleshooting to ground the thesis that, in engineering, the crucial phases of any non-trivial troubleshooting process are aimed at generating a mechanistic explanation of the functioning of the system, which makes extensive recourse to problem-driven qualitative reasoning possibly based on cognitive artifacts applied to systems that are known to have been designed for function. To show how to translate these findings into biological practice I consider a concrete example of biological model building and “troubleshooting”, aimed at the identification of a “fix” for the human immune system in presence of progressing cancer, autoimmune disease, and transplant rejection. The result is a novel immune system model—the danger model with regulatory cells— and new, original hypotheses concerning the development, prophylaxis, and therapy of these unwanted biological processes. Based on the manifest efficacy of the proposed approach, I suggest a refocusing of the activity of theoretical biologists along the engineering-inspired lines illustrated in the paper. (shrink)