National governments have signed and ratified over three thousand International Investment Agreements (IIAs), which for the first time give multinational firms standing to sue host governments in international arbitration tribunals. IIAs have led to a host of high-profile and controversial legal disputes that have led to claims that investor state arbitration may be impeding governments in their ability to regulate and to protect their citizens’ well-being, a phenomenon known as “regulatory chill.” To understand the normative implications of (...) class='Hi'>regulatory chill, I analyze investor state arbitration over tobacco in Australia and Latin America. I examine legislative discussions over possible regulatory changes in Australia and Uruguay, the two cases that have faced disputes over tobacco laws, as well as in Latin American countries that provide access to the legislative debates and had legislative initiatives that sought to strengthen tobacco legislation. These cases demonstrate that tobacco packaging laws in a number of countries have been delayed or reduced as a result of fears of potential arbitration among the government and legislators. This regulatory chill is normatively problematic as it suggests that states may be giving up more of their regulatory authority than they initially believed they would have to under IIAs. (shrink)

Chilling Effects occur when the risks surrounding a speech restriction inadvertently deter speech that lies outside the restriction’s official scope. Contrary to the standard interpretation of this phenomenon I show how speech deterrence for individuals can sometimes, instead of suppressing discourse at the group level, intensify it – with results that are still unwelcome, but crucially unlike a ‘chill’. Inadvertent deterrence of speech may, counterintuitively, create a Heating Effect. This proposal gives us a promising explanation of the intensity of (...) public debate on topics for which there is, simultaneously, evidence of people self-censoring, for fear of breaching speech restrictions. It also helps to pinpoint two problems with existing theoretical analyses of the Chilling Effect: (i) in how they construe the relation between individual- and group-level discursive phenomena; and (ii) how they characterize the distinctively wrongful nature of inadvertent speech deterrence. (shrink)

People's sense of being subject to digital dataveillance can cause them to restrict their digital communication behavior. Such a chilling effect is essentially a form of self-censorship in everyday digital media use with the attendant risks of undermining individual autonomy and well-being. This article combines the existing theoretical and limited empirical work on surveillance and chilling effects across fields with an analysis of novel data toward a research agenda. The institutional practice of dataveillance—the automated, continuous, and unspecific collection, retention, and (...) analysis of digital traces—affects individual behavior. A mechanism-based causal model based on the theory of planned behavior is proposed for the micro level: An individual's increased sense of dataveillance causes their subjective probability assigned to negative outcomes of digital communication behavior to increase and attitudes toward this communication to become less favorable, ultimately decreasing the intention to engage in it. In aggregate and triggered through successive salience shocks such as data scandals, dataveillance is accordingly hypothesized to lower the baseline of free digital communication in a society through the chilling effects mechanism. From the developed theoretical model, a set of methodological consequences and questions for future studies are derived. (shrink)

Research on musical chills has linked the response to multiple musical features; however, there exists no study that has attempted to manipulate musical stimuli to enable causal inferences, meaning current understanding is based mainly on correlational evidence. In the current study, participants who regularly experience chills ( N = 24) listened to an original and manipulated version of three pieces reported to elicit chills in a previous survey. Predefined chills sections were removed to create manipulated conditions. The effects of these (...) manipulations on the chills response were assessed through continuous self-reports, and skin conductance measurements. Results show that chills were significantly less frequent following stimulus manipulation across all three pieces. Continuous measurements of chills intensity were significantly higher in the chills sections compared with control sections in the pieces; similar patterns were found for phasic skin conductance, although some differences emerged. Continuous measurements also correlated with psychoacoustic features such as loudness, brightness and roughness in two of the three pieces. Findings are discussed in terms of understanding structural and acoustic features and chills experiences within their local music contexts, the necessity of experimental approaches to musical chills, and the possibility of different features activating different underlying mechanisms. (shrink)

Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body in Europe and a (...) key player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European Medicines Agency’s main expert committee, this article aims to analyze how regulatory knowledge is defined and then transformed into regulatory decisions. First, it describes the main characteristics of European medicines regulation and the historical definition of what can count as “objective” evidence on the safety and efficacy of medicines. Second, it demonstrates that experts use many different types of knowledge in building their opinions: the results of studies, but also knowledge about firms’ past and present strategies, about patients’ needs and future behavior, about the state of research and clinical practices, and about legal and policy-making issues. Third, it explains why, in spite of the various forms of knowledge involved, experts manage to produce consensual opinions on medicines and why these opinions are considered genuine decisions in the sector. (shrink)

On paper, the Russians left Communism behind at a single stroke of the pen. But within their walls and inside their heads the great majority of them remain material and mental prisoners of the Soviet period, whose tattered remnants still ensure - albeit with increasing difficulty - everyday life and survival. As for the Chinese, they continue to celebrate the glory of Mao in the most official fashion. But within their walls and deep within themselves, they are now decidedly elsewhere.

The revised Common Rule includes a new option for the conduct of secondary research with identifiable data and biospecimens: regulatory broad consent. Motivated by concerns regarding autonomy and trust in the research enterprise, regulators had initially proposed broad consent in a manner that would have rendered it the exclusive approach to secondary research with all biospecimens, regardless of identifiability. Based on public comments from both researchers and patients concerned that this approach would hinder important medical advances, however, regulators decided (...) to largely preserve the status quo approach to secondary research with biospecimens and data. The Final Rule therefore allows such research to proceed without specific informed consent in a number of circumstances, but it also offers regulatory broad consent as a new, optional pathway for secondary research with identifiable data and biospecimens. In this article, we describe the parameters of regulatory broad consent under the new rule, explain why researchers and research institutions are unlikely to utilize it, outline recommendations for regulatory broad consent issued by the Secretary's Advisory Committee on Human Research Protections, and sketch an empirical research agenda for the sorts of questions about regulatory broad consent that remain to be answered as the research community embarks on Final Rule implementation. (shrink)

A defense of imprecise credences (and other imprecise doxastic attitudes).

Singapore, a highly affluent island city-state located in Southeast Asia, has increasingly leveraged new assisted reproductive technologies (ART) to overcome its dismal fertility rates in recent years. A new frontier in ART is preimplantation genetic testing (PGT) for polygenic risk scores (PRS) to predict complex multifactorial traits in IVF (in vitro fertilisation) embryos, such as type 2 diabetes, cardiovascular diseases and various other characteristics like height, intelligence quotient (IQ), hair and eye colour. Unlike well-known safety risks with human genome editing, (...) there are negligible risks with PGT-P, because there are no man-made genetic modifications that can be transmitted to future generations. Nevertheless, the current efficacy of using PGT-P to select IVF embryos for either increased or decreased probability of developing specific polygenic traits is still far from certain. Hence, the regulatory safeguards proposed here will be based on the assumption that the efficacy of this new technology platform has already been validated. These include: (1) restricting the application of PGT-P only for prevention of clinically relevant polygenic disease traits, (2) securely blocking patients’ access to the raw genomic DNA sequencing data of their IVF embryos, (3) validating diagnosis of polygenic disease traits in the prospective parents/grandparents of IVF embryos, and restricting PGT-P only for preventing specifically diagnosed polygenic disease traits and (4) mandating rigorous and comprehensive genetic counselling for IVF patients considering PGT-P. There is an urgent and dire need to prevent abuse of the PGT-P technique, as well as protect the interests and welfare of patients if its clinical application is to be permitted in the country. (shrink)

Co‐option of the eye developmental gene regulatory network may have led to the appearance of novel functional traits on the wings of flies and butterflies. The first trait is a recently described wing organ in a species of extinct midge resembling the outer layers of the midge's own compound eye. The second trait is red pigment patches on Heliconius butterfly wings connected to the expression of an eye selector gene, optix. These examples, as well as others, are discussed regarding (...) the type of empirical evidence and burden of proof that have been used to infer gene network co‐option underlying the origin of novel traits. A conceptual framework describing increasing confidence in inference of network co‐option is proposed. Novel research directions to facilitate inference of network co‐option are also highlighted, especially in cases where the pre‐existent and novel traits do not resemble each other. (shrink)

Regulatory agencies in the United States have relied increasingly on consensus-based decision processes to build public support for their policies. If they are well-designed and managed effectively, consensus-based processes may increase support for an agency’s policies and enhance its institutional legitimacy. But poorly-designed processes may lead to a consensus trap, in which an agency commits to making decisions based on a consensus the participants will never be able to achieve. Two recent initiatives of the U.S. Environmental Protection Agency - (...) negotiated rule making and the Common Sense Initiative - suggest factors that may be associated with more and less sucessful consensus-based processes. (shrink)

In law school we often focus on the importance of carefully crafting statutory and regulatory language. Textual ambiguities or sloppiness can significantly impair the efficacy of laws and regulations. Just as important as meticulous drafting, however, is the government’s ability to enforce its rules. In the absence of adequate enforcement resources, the government’s regulatory initiatives may well fail. The ability to promote public welfare depends as much on regulatory compliance as it does on the text of the (...) regulations themselves. (shrink)

Approaches to induce tumor differentiation often result in manageable and therapy‐naïve cellular states in cancer cells. This transformation is achieved by activating pathways that drive tumor cells away from plasticity, a state that commonly correlates with enhanced aggression, metastasis and resistance to therapy. Here, we discuss signaling pathways, epigenetics and non‐coding RNAs as three main regulatory levels with the potential to drive tumor differentiation and hence as potential targets in differentiation therapy approaches. The success of an effective therapeutic regimen (...) in one cancer, however, does not necessarily sustain across cancer types; a phenomenon largely resulting from heterogeneity in the genetic and physiological landscapes of tumor types necessitating an approach designed for each cancer's unique genetic and phenotypic build‐up. (shrink)

This timely book examines the interaction of health research and regulation with law through empirical analysis and the application of key anthropological concepts to reveal the inner workings of human health research. Through ground-breaking empirical inquiry, Regulatory Stewardship of Health Research explores how research ethics committees (RECs) work in practice to both protect research participants and promote ethical research.This thought-provoking book provides new perspectives on the regulation of health research by demonstrating how RECs and other regulatory actors seek (...) to fulfil these two functions by performing a role of 'regulatory stewardship'. This involves guiding researchers through stages of research approval, as well as seeking to maximise benefits for participants and society while minimising risks. Arguing that participant protection and research promotion should rightly be treated as twin objectives for health research regulators, this book asserts that there is a need for more overt recognition of the importance and function of the deliberative space in which RECs can negotiate the risks relevant to a research application.This book is a key resource for academics and students interested in health research and regulation, and the dynamic interaction of ethics and the law. Regulators and policy-makers will also find it to be an insightful and illuminating text for the practical insights that it reveals about research governance in action. (shrink)

This article examines the way in which public controversies affect regulatory science. It describes the controversy that unfolded in Europe around the use of the ninety-day rat-feeding tests for the risk assessment of genetically modified plants. This type of test had been criticized for almost two decades by toxicologists, nongovernmental organizations, and industry alike for its inability to capture the specific health effects of GM plants. But GM risk assessment experts showed great reluctance to move toward a more systematic (...) use of other tests, such as chronic two-year studies or toxicogenomic techniques, and made sure that official guidance continues to recommend the use of the ninety-day rat-feeding study. The article shows that these tactics of standardization are a defining feature of regulatory science, and a resource for toxicity experts to defend their authority and credibility against competing expertises that arise during controversies. (shrink)

President Obamas recent memorandum calling for an overhaul of White House regulatory policies provides an opportunity to revisit our reliance on cost-benefit analysis as a fundamental regulatoryprinciple.

The concepts of regulation and homeostasis are of frequent use but lack a single universally accepted definition. Here we propose a definition of theregulatory strength andhomeostatic strength, which allow to assess the importance of a regulatory pathway in a quantitative fashion.

In this article, we hypothesize that the level of environmentally oriented noncompliance regulatory fines and penalties levied on companies and on their industry counterparts will be associated with the development of an environmental infrastructure and practices within these companies. We find that the presence of these regulatory actions is associated with the likelihood of companies reporting environmental policies and activities and with the presence of a separate board of directors’ committee that monitors company environmental concerns. Our findings suggest (...) that environmental regulatory pressure may serve as a driver of environmental action but is not its only determinant. (shrink)

This paper addresses recent calls to study the role of the state in private regulation. Integrating current scholarship on the state as a catalyst of private regulatory regimes with prior literature on regulatory failure and self-regulation, it identifies and problematizes unsettled assumptions used as a starting point by this growing body of research. The case study traces the evolution of public debates and the interaction of different regulatory initiatives dealing with corporate social responsibility issues in Canada’s mining (...) industry. Findings reveal the conditions under which the state is more likely to encourage firm-level, fragmented initiatives than facilitate and promote industry-wide regulatory strengthening and consolidation. I discuss the need for greater analytical precision regarding the variation in regulatory policy preferences across time and branches of government and the interaction between public and private regulatory initiatives. The conclusion outlines suggested areas for future research as well as the likely outcome of Canada’s current CSR policy framework. (shrink)

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

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)

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)

Both experimental and therapeutic uses of the new reproductive technologies have been governed not by the medical ideology of the best interests of patients and their children, but by the market ideology of profit maximization under the guise of "reproductive liberty." Government in our constitutional, democratic society has the authority and obligation to make and enforce reasonable regulations to manage the new reproductive market in order to protect the interests of the public, prospective parents, and their future children. The "cloning" (...) debate provides a useful opportunity to compare and contrast the competing regulatory models of the free market, professional guidelines, and government restrictions. (shrink)

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)

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

I want to sound a warning note and suggest some changes that are needed in the practice of ethical review. It is easy to assume that with a policy as high-minded as the policy of reviewing research on human beings, the only difficulties will be the obstacles put in its way by recalcitrant and unreformed paries: by the special-interest groups affected. But this is not always true of high-minded policies and it is not true, in particular, of the policy of (...) reviewing research. Ethical review is endangering valuable research on human beings and, moreover, it is endangering the very ethic that is needed to govern that research. And this is not anyone's fault, least of all the fault of any special-interest groups. The problem is that the process of ethical review has been driven by an institutional dynamic that is not in anyone's control and this dynamic is now driving us, willy nilly, on to some very stony ground. My argument is developed in four sections. In the next section, section two, I look at a model of policy-making which identifies a reactive, institutional dynamic that lies at the origin of certain policy intitiatives. In the third section I argue that this model fits the appearance and development of the ethical review of human research, showing how the process of review has been motored by a dynamic of step-by-step reaction to chilling tales of abuse. In the fourth section I look at the predictions of the future development of ethical review that the extrapolation of that model yields. And then in the fifth and.. (shrink)

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

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

How do “international” epistemic communities shape regulatory contests between transnational firms and civil society organizations in the Global South? With the establishment of the World Trade Organization, member states committed to basing trade-restrictive national regulations on science-based “international” standards set by “international” standard-setting bodies. Yet we know little about how the WTO regime has shaped the operation of epistemic communities within standard-setting bodies and, in turn, how standard-setting bodies articulate with national policy-making processes in the Global South. Building on (...) work in the new political sociology of science, I argue that neoliberal globalization and the establishment of the WTO have created incentives for Western epistemic communities to at once cast themselves as “international” under the WTO regime and orient their scientific agendas toward the priorities of transnational firms. Moreover, this transformation of epistemic communities has created opportunities for transnational firms facing contentious policy environments in the Global South to effectively outsource regulatory decision-making to “international” epistemic communities that can claim legal status under the WTO regime. Empirically, I focus on the case of one Western epistemic community—the Association of Analytical Communities International—and its claim to epistemic jurisdiction over pesticide residue standards for soft drinks in India. (shrink)

This article examines the nature of interpretation in regulation. Drawing on the work of Ronald Dworkin it considers two alternative theses of regulatory interpretation; the conversational thesis and the constructive thesis. The conversational thesis, which seems to find support in several contemporary writings on the use of rules in public administration, perceives regulatory interpretation as a method of interpretation that resembles the interpretation that people deploy in the course of a conversation in their attempt to understand and communicate (...) with their co-discussants. The constructive thesis describes regulatory interpretation as a dialectical practice whose ultimate objective is to meet the demand for new and better interpretations in accordance with the public standards that best justify regulatory practice. It will be argued that the constructive thesis offers a more appealing account of regulatory interpretation because it is better placed to accommodate two apparently conflicting intuitions with respect to interpretation in the regulatory domain. The first one is the idea that the meaning of regulatory provisions must not be entirely contingent on the beliefs and/or preferences of those conducting the interpretation, for otherwise interpretation collapses into a cynical game of rent-seeking and regulatory capture. The second intuition is that regulatory interpretation must be procedurally efficient. (shrink)

The globalization of securities markets has resulted in a rapid increase in securities transactions that cut across the national borders of more than one country. Individual country regulators cannot avoid the question of how regulatory authority should be allocated for such transactions. Rather, they continue with the present territorial regime, which allocates regulatory authority based on the location of a particular transaction and the effects associated with the transaction. This article assesses a range of alternate responses to globalization. (...) Some have argued that a company’s home country should regulate all transactions in the company’s securities regardless of location. Others have argued for increased harmonization across different country securities regulatory regimes. The article instead contends that giving issuers a greater degree of freedom to select among the securities regulatory regimes of different countries will result in both more desirable levels of investor protections as well as increased social welfare. Arguments have been raised against a move toward greater issuer choice in securities regulation. The article responds to such criticism, pointing out that the present territorial regime suffers from even greater flaws. (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)

Anticipation plays a role in language comprehension. In this article, we explore the extent to which verb sense influences expectations about upcoming structure. We focus on change of state verbs like shatter, which have different senses that are expressed in either transitive or intransitive structures, depending on the sense that is used. In two experiments we influence the interpretation of verb sense by manipulating the thematic fit of the grammatical subject as cause or affected entity for the verb, and test (...) whether readers’ expectations for a transitive or intransitive structure change as a result. This sense‐biasing context influenced reading times in the postverbal regions. Reading times for transitive sentences were faster following good‐cause than good‐theme subjects, but the opposite pattern was found for intransitive sentences. We conclude that readers use sense‐contingent subcategorization preferences during on‐line comprehension. (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)

Two major regulatory changes are affecting the provision of undergraduate legal education in England and Wales. On the one hand, the Qualifying Law Degree is being deregulated, meaning law schools are free to make significant changes to how and what they teach. On the other hand, higher education in England has seen a significant overhaul through the creation of the Office for Students, which treats students as consumers. Now more than ever, law schools need to ask themselves existential questions (...) which will not only test their continued relevance or indeed viability within the ‘market’ for higher education, but also the status of the discipline of law as a whole. The regulatory landscape may indeed present a significant threat, but it is also an opportunity to reflect on what law schools are for, and consequently what changes could result from the academic freedom that comes with deregulation. Whilst different law schools will interpret their mission differently, they should caution against either generalised inertia or succumbing to an outcomes-oriented provision that simply prepares students for the new Solicitors Qualifying Examination. Instead, law schools will find their proper purpose in critical reflection and academic self-grounding, providing undergraduate students with a ‘question everything’ mentality, and showing them that law is something to be experienced and not merely learnt. (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)

The generation of patterns and the diversity of cell types in a multicellular organism require differential gene regulation. At the heart of this process are enhancers or cis‐regulatory modules (CRMs), genomic regions that are bound by transcription factors (TFs) that control spatio‐temporal gene expression in developmental networks. To date, only a few CRMs have been studied in detail and the underlying cis‐regulatory code is not well understood. Here, we review recent progress on the genome‐wide identification of CRMs with (...) chromatin immunoprecipitation of TF‐DNA complexes followed by microarrays (ChIP‐on‐chip). We focus on two computational approaches that have succeeded in predicting the expression pattern driven by a CRM either based on TF binding site preferences and their expression levels, or quantitative analysis of CRM occupancy by key TFs. We also discuss the current limits of these methods and highlight some of the key problems that have to be solved to gain a more complete understanding of the structure and function of CRMs. (shrink)

American policymakers delegate the administration of many welfare programs to states, where officials implement them in increasingly diverse ways. Welfare state scholarship has little to say about this subnational policy divergence, and it portrays the complexity of delegated governance as a barrier to nonelite legislative influence. Drawing on an ethnographic study of one state’s Medicaid program, this article shows that delegated governance offers ample opportunity for nonelite influence and policy divergence, but through regulatory governance rather than legislative advocacy. Medicaid (...) is opaque to politicians, whose inability to monitor program details creates conditions of bureaucratic autonomy and even activism: health-care agency personnel sequence regulatory tweaks to protect and expand entitlements. But budget cuts, outsourcing, and fraught provider relations also deprive bureaucrats of street-level know-how, and bureaucrats depend on beneficiaries’ advocates who selectively illuminate a path to reform. A full rendering of subnational divergence in American federalism requires attention to underexamined factors such as bureaucratic activism, agency advocacy, and regulatory governance. (shrink)

This paper examines ethical violations committed by Certified Public Accountants in Puerto Rico in the 2002–2010 period and the related disciplinary actions taken by the local regulatory bodies. The institutional settings for the accounting profession in PR are different from those of the United States. Ethical complaints are investigated by the PR Society of CPAs and evaluated based on the Code of Professional Conduct of the American Institute of Certified Public Accountants, although most CPAs in PR are not affiliated (...) with the AICPA. Our study is based on data provided by the PR Society of CPAs that is not publicly available. We examine the association between the occurrence of the ethical violations and certain variables such as gender, type of practice performed by the CPA, and whether the CPA participates in a peer review program. Results of a multiple correspondence analysis suggest that not being a member of the AICPA, practicing as a sole practitioner, and not participating in a peer review program seem to be more associated with the occurrences of ethical violations by CPAs. We compare our findings with prior research on ethical infractions committed by CPAs in the United States and find some differences attributable to the institutional settings in PR. Overall, our results suggest the importance of codes of conduct in the accounting profession and compliance with such ethical guidelines by practicing accountants. (shrink)

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

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

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)

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.