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)

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)

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)

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)

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)

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)

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)

Children and individuals with developmental disabilities compared to typical participants are disadvantaged not only by virtue of being vulnerable to risks inherent in research participation but also by the higher likelihood of exclusion from research altogether. Current regulatory and ethical guidelines although necessary for their protection do not sufficiently ensure fair distributive justice. Yet, in view of disproportionately higher burdens of co-occurring physical and mental disorders in individuals with DD, they are better positioned to benefit from research by equitable (...) participation. Greater elucidation of this ethical dilemma is called for by researchers, institutional review boards, and funding agencies to urgently redress the imbalance. This article discusses many of the regulatory principles to ensure better research participation of children and individuals with DD: human rights, validity, distributive justice, beneficence/nonmaleficence, and autonomy. (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.

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)

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)

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)

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)

The paper is intended to focus on peculiarities of nanomedicine and the importance of social concerns implicated, in order to understand if existing regulations are appropriate to maintain its safety or if a new ad hoc regulatory framework is needed. Consideration of social challenges will underline the crucial role of medical ethics in regulatory discussion.

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)

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)

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.

It is clear that where a disease affects men and women differently, research on potential therapies or cures should include both men and women and should examine whether the therapy is effective and safe for both sexes. In this paper we consider whether there is an appropriate role for law in regulating to ensure an examination of these sex- and gender-specific aspects in health research. We consider the relative advantages and disadvantages of pursuing a regulatory approach to achieving gender (...) equity in the field of women’s health by exploring first, the meaning of gender equity, and second, the regulatory mechanisms that might be best suited to promoting the goal of gender equity. Within our examination of different regulatory forms and mechanisms, we also interrogate the shift from gender-neutral provisions relating to sex in favor of generalized notions of fairness that remove any specific consideration of sex. (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)

Robots are slowly, but certainly, entering people's professional and private lives. They require the attention of regulators due to the challenges they present to existing legal frameworks and the new legal and ethical questions they raise. This paper discusses four major regulatory dilemmas in the field of robotics: how to keep up with technological advances; how to strike a balance between stimulating innovation and the protection of fundamental rights and values; whether to affirm prevalent social norms or nudge social (...) norms in a different direction; and, how to balance effectiveness versus legitimacy in techno-regulation. The four dilemmas are each treated in the context of a particular modality of regulation: law, market, social norms, and technology as a regulatory tool; and for each, we focus on particular topics? such as liability, privacy, and autonomy? that often feature as the major issues requiring regulatory attention. The paper then highlights the role and potential of the European framework of rights and values, responsible research and innovation, smart regulation and soft law as means of dealing with the dilemmas. (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)

This paper investigates the determinants of regulatory compliance in corporate organizations. Exploiting a unique enforcement and reporting framework for insider trading in Italy, we present three main findings. First, board governance, such as chief executive–chairman duality and the proportion of non-executive directors, does not increase the propensity of firms to comply with regulation. Second, family firms and firms with a high degree of separation of ownership from control are most likely to comply with regulation. Third, corporate ethos is more (...) important in predicting regulatory compliance than explicit corporate governance structures. (shrink)

The cis-regulatory hypothesis is one of the most important claims of evolutionary developmental biology. In this paper I examine the theoretical argument for cis-regulatory evolution and its role within evolutionary theorizing. I show that, although the argument has some weaknesses, it acts as a useful example for the importance of current scientific debates for science education.

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)

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)

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

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

Efforts by governments, firms, and patients to deliver pioneering drugs for critical health needs face a challenge of diminishing efficiency in developing those medicines. While multi-sectoral collaborations involving firms, researchers, patients, and policymakers are widely recognized as crucial for countering this decline, existing incentives to engage in drug development predominantly target drug manufacturers and thereby do little to stimulate collaborative innovation. In this mini review, we consider the unexplored potential within pharmaceutical regulations to create novel incentives to encourage a diverse (...) set of actors from the public and private spheres to engage in the kind of collaborative knowledge exchange requisite for fostering enhanced innovation in early drug development. (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)

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

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

Complex cognitive processes like concept learning involve a mixture of redundant explicit and implicit processes that are active simultaneously. This aspect of cognitive architecture creates difficulties in determining the influence of consciousness on processing. We propose that the interaction between an individual's regulatory focus and the reward structure of the current task influences the degree to which explicit processing is active. Thus, by manipulating people's motivational state and the nature of the task they perform, we can vary the influence (...) of conscious processing in cognitive performance. We demonstrate the utility of this view by focusing on studies in which people acquire new perceptual concepts by learning to classify them. This technique will allow us to better tease apart the roles of explicit and implicit processing in a variety of cognitive tasks. (shrink)

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

The goal of this paper is to examine the impact of leadership and promotion regulatory focus on employees’ willingness to engage in unethical pro-organizational behavior . Building from a person–situation interactionist perspective, we investigate the interaction of leadership style and how leaders frame messages, as well as test a three-way interaction with promotion focus. Using an experimental design, we found that inspirational and charismatic transformational leaders elicited higher levels of UPB than transactional leaders when the leaders used loss framing, (...) but not gain framing. Furthermore, followers’ promotion regulatory focus moderated this relationship such that the effect held for followers with low promotion focus, but not for individuals with high promotion focus. Our findings extend the understanding of UPB, offer theoretical mechanisms to explain when this behavior occurs, and contribute to leadership theory and research on ethical decision making. (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)

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

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)

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)

We investigate the regulatory sanctions imposed on independent directors for their firms’ financial frauds in China. These regulatory sanctions are prima-facie evidence of significant lapses in business ethics. During the period 2003–2010, 302-person-time independent directors were penalized by the regulator, and the two stock exchanges. We find that the independent directors with accounting experiences are more likely to be penalized by the CSRC, though they do not suffer more severe penalties than do the other sanctioned independent directors. We (...) also find that independent directors suffer less severe penalties than do the insider directors. These results are consistent with the hypothesis that the sanctions on independent directors are tied to their assumed ethical and legal responsibilities. Following a regulatory sanction, penalized independent directors experience a significant decline in the number of other board seats held. However, they can gain board seats in better quality firms. We find that interlocked firms that share penalized independent directors with the fraud firm do not suffer from a valuation decline. Overall, our results suggest that regulatory sanctions have not triggered further sanctions on the penalized directors in the labor market but they have, instead, created a disincentive for these directors to serve on the company boards of high-risk firms. (shrink)

U.S. regulations do not afford consistent protections to human research subjects. One complaint is that they focus on federally sponsored research, with private research covered only if it falls under the jurisdiction of the Food and Drug Administration. This paper examines a deeper problem: Even when the regulations do apply, they still do not afford consistent standards of protection. The U.S. Common Rule and related FDA regulations lack a workable regulatory control mechanism.

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.

How do we respect the legitimate privacy interests of individuals and communities about whom data relate while maximizing data’s utility as a fundamental resource? Pyrrho, Cambraia and de Vasconcel...

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)

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)

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)

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)