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

This paper is an examination of how research ethics committees have evolved from being advisory committees to more formal regulatory authorities. It is argued that the role of ethics committees should be broader than simple ethical review. Inconsistency in outcome should not be taken to signal failure. Procedural fairness is of the utmost importance. Nor should ethics committees be seen to diminish the ethical responsibilities of researchers themselves.

The pursuit of unproven stem cell-based interventions is an emerging issue that raises various concerns. Physicians play different roles in this market, many of which engage their legal, ethical and professional obligations. In Canada, physicians are members of a self-regulated profession and their professional regulatory bodies are responsible for regulating the practice of medicine and protecting the public interest. They also provide policy guidance to their members and discipline members for unprofessional conduct.

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)

Regulatory authorities have advised smokers who would not or could not quit smoking to switch to lower tar cigarettes. Smoking such cigarettes was seen as a means of reducing the harm caused by smoking, but not as offering a ‘safe’ smoking option. Correspondingly manufacturers have been required to place tar and nicotine information on packet labels and/or advertisements. This paper explores the possibility that the conventional format for conveying tar and nicotine information could be responsible for the belief, held (...) by a significant proportion of smokers, that some brands of lower tar cigarettes are absolutely ‘safe’. To deal with this situation it is suggested that changes should be made to health warnings, and tar and nicotine communications. Proposed changes to the latter are evaluated in terms of their ethical and public health implications. The authors conclude that brand specific warnings and a classification of cigarettes as either ‘Very Dangerous’ or ‘Dangerous’, is best suited to reconciling consumer needs for information with the public health objectives of reducing the harm caused by smoking. (shrink)

In “Potential Subjects’ Responses to an Ethics Questionnaire in a Phase I Study of Deep-Brain Stimulation in Early Parkinson’s Disease,” Finder, Bliton, Gill, Davis, Konrad, and Charles undertake informed consent research on what they describe as a Phase I trial of deep brain stimulation (DBS) for Parkinson’s disease. We argue that the authors should have more carefully characterized the nature of the DBS study at the start of their clinical study.

The theoretical rationale was the author’s Functional Model of Health, where health is construed as a function of creative coping with stress. Participants in the study were 141 patients with blood cancer treated with bone marrow transplantation at the Hematology Clinic, Jagiellonian University Collegium Medicum. Besides a standardized interview the following instruments were used: STAI by Spielberger, CISS and CHIP by Endler and Parker, and SOC-29 by Antonovsky. Health status was operationalized using 10-point self-rating scales to assess the patients’ perceived (...) health and sense of calmness, while their objective health was rated by a medical expert - hematologist. In the statistical analyses significant correlations were found between stress level and the patients’ subjective health. The following variables predicted stress intensity: anxious personality, distraction coping strategy, female sex, and sense of meaningfulness. Subjective health predictors of leukemia patients are: objective health, level of stress, by the patient’s sense of meaningfulness and focusing on negative emotions. To promote patients’ health moreover, their sense of meaningfulness in life and in being active should be supported and enhanced. (shrink)

The Human Fertilization and Embryology Authority policy on permitting ova provision for research purposes breaches good regulatory practice in being inconsistent, unaccountable and untargeted. This article will illustrate how these breaches have resulted in a policy which is unfair to ova providers who wish to contribute to stem cell research and undermines the intentions behind the policy's very inception. (This article is based on a paper entitled Appropriate Recompense for Oocytes in Stem Cell Research presented at the Stem (...) Cells: Hope or Hype debate, North West Genetics Knowledge Park, Manchester in May 2007.). (shrink)

The article analyses the legal status of the natural gas market regulatory institutions in Lithuania and in the member states of the European Union. First, the authors assess the most important elements of the legal status of the natural gas market regulators in the EU member states, namely, the degree of autonomy (type of institution, appointment and dismissal procedures of management, duration of the terms of office, sources of funding) and the measures aimed at ensuring accountability, transparency, and prevention (...) of conflicts of interest. Second, the legal status of the National Control Commission for Prices and Energy, which carries out functions of regulation and control of the natural gas sector in Lithuania, is examined. Finally, the authors conclude that the imperfections in the regulation of the legal status of the Commission result in several negative effects and provide reasoned proposals regarding the improvement of the legal status of the Commission. (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)

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)

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)

In this article, the authors explore the impact of a potential future regulatory decision by FDA whether or not to continue its enforcement discretion policy allowing physicians to perform, and stool banks to sell, stool product for fecal microbiota transplantation as a treatment for recurrent Clostridium Difficile infection without an Investigative New Drug application. The paper looks at the Agency's regulatory options in light of the current gut microbiota based products that are in the FDA pipeline for drug (...) approval and the potential impact and repercussions of their approval on FDA action. In laying out FDA's options we consider the implications of market exclusivity and off-label use of newly approved drugs. Ultimately, we explore the potential impact of FDA's decision on patients, research, and innovation. (shrink)

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

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

Governments, institutions, and brands try various intervention strategies for countering growing cyberbullying, but with questionable effectiveness. The authors use hypocrisy induction, a technique for subtly reminding consumers that they have acted contrary to their moral values, to see whether it makes consumers more willing to support brand-sponsored anti-cyberbullying CSR campaigns. Findings demonstrate that hypocrisy induction evokes varying reactions depending on regulatory focus, mediated by guilt and shame. Specifically, consumers who have a dominant promotion (prevention) focus feel guilt (shame), which (...) motivates them to overcome their discomfort by supporting (avoiding) an anti-cyberbullying campaign. Moral regulation is drawn as a theoretical underpinning to explain various consumer reactions to hypocrisy induction, the moderating role of regulatory focus, and mediating role of guilt and shame. The research contributes to the literature and provides practical implications by explaining when and why brands can use hypocrisy induction to persuade consumers to support social causes through the lens of moral regulation theory. (shrink)

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

Pharmaceutical promotion is a negative influencing force for prescribing. However, very few regulatory initiatives are taken to overcome this unwarranted influence. The present research was conducted in such context with an attempt to review the regulatory documents related to pharmaceutical promotion in Bangladesh including Code of Pharmaceutical Marketing Practices (CPMP), and to compare CPMP with different global guidelines. The studied guidelines demonstrate effort to regulate promotion, though that varies to a great extent, particularly in enforcement aspects. Clearly defined (...) ethical and legal prohibitions, provisions of punishment for violations and entrusted agency with defined authority are crucial. (shrink)

Political theorists have recently sought to replace the liberal, contractual theory of the firm with a political view that models the authority relation of employee to firm, and its appropriate regulation, on that of subject to state. This view is liable to serious difficulties, however, given existing discontinuities between corporate and civil authority as to their coerciveness, entry and exit conditions, scope, legal standing, and efficiency constraints. I here inspect these, and argue that, albeit in some cases significant, (...) such discontinuities fail to undermine the firm/state analogy, either because they are not significant enough to do so or because the particular trait on which they hinge is not decisive for how authority, in the state and in the firm, should be regulated to be legitimate. A pro tanto requirement exists, I thus argue, that corporate authority be held to regulatory norms comparable to those legitimate states abide by, including civil liberties, rule-of-law constraints, and accountability to subjects. (shrink)

The article is devoted to the study of the phenomenon of ideology in the context of its normative and regulatory function. The author's contribution to the further knowledge of the ideology was the following main conclusions. The emergence of ideology as a regulatory mechanism was primarily due to the transition from a traditional society to a modern one. Ideology is an attribute of modern society, since it acts as an intermediary between a person and social reality, determining and (...) regulating the activities of all people and relations between them in any sphere of society. In the XIX – first half of the XX centuries political ideology in its theoretical form dominated. As a regulatory mechanism, it functioned alongside religion, morality, and law, complementing them. In the second half of the XX – XXI centuries, as a result of the third STR, ideology in an ordinary and practical form became widespread. It began to replace the traditional regulatory mechanisms, surpassing them in the degree of influence on public consciousness and becoming the main mechanism of social regulation. (shrink)

This paper discusses some models purported to legitimise a European supranational legal order. In particular, the author focuses on an application of the so‐called regulatory model to the complex structure of the European Community and the European Union. First of all, he tackles the very concept of legitimacy, contrasting it with both efficacy and efficiency. Secondly, he summarises the most prominent positions in the long‐standing debate on the sources of legitimation for the European Community. Thirdly, in this perspective, he (...) analyses several, sometimes contradictory, notions of the rule of law. His contention is that we can single out five fundamental notions of the rule of law and that some but not all of them are incompatible with or oppose democracy. Finally, the paper addresses the regulatory model as a possible application of the rule of the law to the European supranational order. The conclusion is that the regulatory model should be rejected if it is presented as an alternative to classical democratic thought, though it might be fruitful if reshaped differently and no longer assessed from a functionalist standpoint of deliberation. (shrink)

Whistleblower bounty schemes that pay individuals a cash “bounty” for surfacing information about illegal conduct have rapidly gained public and scholarly attention, fueling calls to install a bounty approach across numerous regulatory areas, from workplace safety, environmental protection, and civil rights to political corruption, immigration, and antitrust. Yet despite the enthusiasm, bounty regimes have remained confined to the fraud context. This Article uses this fact as a jumping off point and, looking across the regulatory state, aims to answer (...) some basic questions about bounty regimes that have thus far eluded sustained scholarly attention: What features of a given regulatory area make it more or less conducive to a bounty approach? Given this, how might existing bounty regimes be revised? And if bounty regimes were to break out of the fraud area, where might they most profitably spread? It offers some initial answers to these questions by constructing a simple framework that shows how two features of the regulatory environment - the directness of the harm to be regulated and the determinacy of the legal mandate to be implemented - structure the choice among competing bounty approaches. These aspects of regulatory context, I argue, map onto the two most vexing challenges facing regulatory architects weighing a bounty mechanism or choosing among competing designs: optimizing the quantity and quality of information revelation and maintaining public control over the elaboration of legal mandates. The framework brings into relief some of the fault-lines in the growing scholarly debate about the optimal use and design of bounty schemes, including the choice between a simple cash-for-information scheme and a more elaborate qui tam scheme in which whistleblowers are vested with independent enforcement authority via a private right of action. It also yields a rough regulatory roadmap showing where existing bounty schemes might be revised and also the areas to which a bounty approach might be usefully exported. (shrink)

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

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

Religious associations sometimes seek to provide services and goods to the public using religious values that discriminate on grounds otherwise prohibited by law and public values. 'Group pluralists' support these efforts by highlighting the importance of shielding group authority from state overreach and protecting a robust associational life within democratic contexts. By contrast, 'liberal statists' insist on the state's final authority over societal groups and the need to protect individuals from arbitrary group power. This paper defends a third (...) approach to group authority called relational pluralism. Relational pluralism is skeptical that the state can resolve group conflicts fully and fairly and recognizes that too much state interference in group life weakens democratic relations. At the same time, it recognizes that groups can rarely act independently of other groups, including the regulatory state. Instead, groups rely on being empowered by other groups and often also by the state to carry out their projects. Group authority is nearly always 'relational' in that it depends on the cooperation of other groups. The paper sketches out a relational pluralist approach to understanding group authority and explains its democratic virtues. It shows how the approach can illuminate otherwise underappreciated features of conflicts about authority. (shrink)

In transitional economies, the governing central authorities impose heavy regulatory burdens on firms, which results in great costs for business in terms of time, resources, and other constraints. However, quality assurance through decentralized institutions (such as private certified management standards) is rapidly becoming more prevalent. This study examines the contingent implications that such decentralized institutions have for centralized regulation by focusing on the relationship between international certifications and regulatory burdens. As two prominent features of the institutional environment in (...) emerging economies, the threat of competition from the informal sector and corruption may influence the relationship between international certifications and regulatory burdens. These features are therefore examined in terms of their moderating roles. The study draws on institutional and signaling theories to interpret data from a survey conducted by the World Bank in China in 2012. The empirical results show that international certification is negatively associated with regulatory burdens. This relationship is strengthened by the threat of competition from the informal sector, but mitigated by a corrupt business environment. Our study contributes to the institutional literature and to research on international certifications, and it has implications for both business management and governmental policy. (shrink)

The wide and complex range of technologies produced and used in the contemporary societies has challenged the analysis from the different fields of social sciences. In this sense, in order to elaborate a study that aim at understanding the relationship between technological progress and the ongoing institutional changes that mark the capitalist societies, we believe it is necessary to adopt an interdisciplinary approach combining methodologies from Economics and Sociology fields. Therefore, this study proposes the development of an interdisciplinary dialogue between (...) the economic sociology of Pierre Bourdieu and the evolutionary economics developed by authors such as Giovanni Dosi, Sidney Winter, Richard Nelson and Bhaven Sampat. In doing so, we intend to demonstrate that a theory guided by Marx’s historical materialism, as it is the case of evolutionary economics, can be enriched by a materialist theory of symbolic, such as that of Pierre Bourdieu. In searching the comprehension of the complementarity between material and symbolic forces, this study addresses the conflictual process surrounding the formulation of the regulatory institutions to the biotechnology sector in Brazil over the last two decades. More precisely, through a case study, we seek to demonstrate that the convergence of discourses and interests between prestigious scientific organizations and the multinational companies that control the agrobiotechnology industry has been relevant to allow this new technological paradigm to make progress. Finally, we raise some questions concerning this alliance between business and science and the conflicts that revolve around the rapid expansion of the genetically modified crops worldwide. (shrink)

In this book, Professor McGarity reveals the complex and problematic relationship between the 'regulatory reform' movements initiated in the early l970s and the United States' federal bureaucracy. Examining both the theory and application of 'regulatory reform' under the Reagan administration, the author succeeds in offering both a relevant analysis and critique of 'regulatory reform' and its implementation through bureaucratic channels. Using several case studies from the early Reagan years, this book describes the clash of regulatory cultures (...) resulting from the President's attempt to incorporate 'regulatory analysis' into the bureaucratic decision-making process. Yet while McGarity recognizes the limitations of regulatory analysis, he concludes with suggestions for enhancing its effectiveness. This book could be used not only as a textbook for political science and government courses but also for graduate applications in public policy and public administration. (shrink)

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

The biopsychosocial model of challenge and threat posits that resource and demand appraisals interact in situations of acute stress to determine affective responses, and concomitant physiological responses, motivation, and decisions/behaviors. Regulatory approaches that alter appraisals to regulate challenge and threat affective states have the potential to facilitate coping. This reply clarifies the conceptualization of one such regulatory approach, arousal reappraisal, and suggests avenues for future research. However, it is important to note that arousal reappraisal is not a “silver (...) bullet” for improving stress outcomes, nor should this strategy be expected to positively impact all individuals. More work is needed to better elucidate how psychological and biological stress processes interact to shape health. (shrink)

In this paper the author argues that the Academy of Medical Sciences's ‘Review of the regulation and governance of medical research’ has produced a set of muddled recommendations that could increase complexity and uncertainty in research governance rather than reduce it. Issues discussed in the paper include the additional legal burden placed upon the newly proposed Health Research Agency by the plan for a National Research Governance Service and its system of centralized permissions, the consequences that this may have for (...) the research ethics committees in the discharge of their legal duty, and the unanswered questions surrounding the TGN1412 incident. (shrink)

The articles in this special issue of Environmental Values have a shared significance. In one way or another, all of them reflect contemporary concerns about issues of trust, risk, uncertainty, and the cultural shaping of science.These are matters of mounting significance for the politics of the environment in countries like Britain, and indeed for politics more generally, as we have seen in a succession of recent controversies. The Brent Spar oil platform farrago, the hugely costly BSE-CJD upsets, the continuing uproars (...) around genetically modified plants and foods ­ central in all of these have been challenges to the political authority of official patterns of scientifically-backed reassurance, concerning the impacts of deep and open-ended trajectories of technological transformation.To understand what is likely to be at stake in such matters for the politics of industrial democracies in the 21st century, there is now an urgent need to develop richer pictures than those currently dominant, of the cultural and epistemological architecture on which our regulatory institutions have been coming to rely. The contributions to this special issue can be pictured as building blocks in such a process.The present article offers a complementary perspective ­ one grounded in a degree of more hands-on personal experience of related matters. (shrink)

Weapons of both defense and offense have grown steadily in their effectiveness—especially since the industrial revolution. The mass destruction of humanity, by parts or in whole, became reality with the advent of toxic agents founded on chemistry and biology or nuclear weapons derived from physics. The military’s new non-combat roles, combined with a quest for non-lethal weapons, may change the picture in regard to conventional defense establishments but are unlikely to deter bellicose tyrants or the new terrorists from using the (...) unlimited potential of today’s and tomorrow’s arsenals. The author addresses the issues that are raised by this developing situation with the intent of seeking those ethics that will enable us to survive in a future and uncertain world. (shrink)

When fertility centers dispose of embryos, how should this be done? Current regulatory guidelines by the Human Fertilisation and Embryology Authority state that, when terminating the development of human embryos, a clinic should act with sensitivity, taking account of the embryo’s “special status” and respecting the interests of the gamete providers and recipients. As yet, it is unclear as to how and to what extent this achieved within fertility clinics in the UK. Resultantly, this paper examines the largely (...) undocumented domain of embryo disposal practice. By undertaking an empirical study into policy and procedure and noting divergence in clinic practice, it then comments on the ethical implications of these protocols for patients and practitioners. Specifically, this paper argues for a more holistic approach to embryo disposal. An approach that effectively meets the requirements of the lab, is respectful of the “special status” of the human embryo, and, perhaps most importantly, reflects the multifaceted needs of the patient. (shrink)

Academic-researcher-led public engagement and consultation on new biotechnology provides information about new biotechnology to the public, and solicits their attitudes, beliefs and understanding about the technology. A burden associated with the democratic ideals of transparency and accountability encourages researchers to provide accurate information to the public. Less recognized is their role as actual, or perceived, authorities to provide new knowledge and to make policy or regulatory decisions. This paper focuses on the first of these two – the conflation between (...) expertise on the subject of the engagement and the authority to represent that subject in an engagement process. While expertise, or at least accuracy in portraying expert knowledge, is consistent with transparency and accountability, it is argued here that authority in the representation of expert knowledge may be inconsistent with the intent of public engagement and consultation. (shrink)

Studies on the conservation of the inferred transcriptional regulatory network of prokaryotes have suggested that specific transcription factors are less‐widely conserved in comparison to their target genes. This observation implied that, at large evolutionary distances, the turnover of specific transcription factors through loss and non‐orthologous displacement might be a major factor in the adaptive radiation of prokaryotes. However, the recent work of Hershberg and Margalit1 suggests that, at shorter phylogenetic scales, the evolutionary dynamics of the bacterial transcriptional regulatory (...) network might exhibit distinct patterns. The authors find previously unnoticed relationships between the regulatory mode (activation or repression), the number of regulatory interactions and their conservation patterns in γ‐proteobacteria. These relationships might be shaped by the differences in the adaptive value and mode of operation of different regulatory interactions. BioEssays 29:625–629, 2007. © 2007 Wiley Periodicals, Inc. (shrink)

In a new era of regulatory oversight, the US Supreme Court upended traditional Chevron deference to agency interpretations of ambiguous Congressional provisions in Loper in June 2024. Federal courts were instructed to make their own assessments of statutory authorities amid an onslaught of public health agency challenges surfacing nationally. Even so, SCOTUS may be eyeing further limits on agency powers despite clear and substantial repercussions for the health of the nation.

This joint response from the National Research Ethics Advisors' Panel (NREAP) and the Association of Research Ethics Committees (AREC) has been formulated on the basis of detailed in depth discussion between the two organizations, in consultation with their membership. NREAP is a body that was constituted by the United Kingdom Ethics Committee Authority (UKECA) in order to provide guidance to, and strategic oversight of the NHS Research Ethics Service. AREC represents all sectors of the Research Ethics Committee (REC) community (...) and serves to engage in discussion and debate concerning best practice and to serve the best interests of REC membership. (shrink)

ABSTRACTRecent research suggests that obedience in the Milgram paradigm is underpinned by stress vulnerability and inhibitory control over pain sharing. Because self-regulatory fatigue induction is a suited method to investigate the influence of inhibitory control on behaviour, participants were randomly assigned to a High vs. Low self-regulatory condition. Heart rate variability was collected during 5-min baseline and continuously during the experimental procedure. Prior to the experiment, participants completed an online survey assessing right-wing authoritarianism, a well-known predictor of obedience. (...) Using the Immersive Video Milgram Obedience Experiment, we found that lower resting HRV predicted higher destructive obedience, that low self-regulatory inhibition reduced destructive obedience, that the well-established influence of RWA on destructive obedience was suppressed in the presence of SRF. Implic... (shrink)

This paper demonstrates how the UK’s Advertising Standards Authority governs advertising ethics with and on behalf of its members and stakeholders. Drawing on an archive of 310 non-commercial adjudication reports, we highlight the substantive norms and procedural mechanisms through which the ASA governs advertising complaints alleging offence and/or harm. Substantively, the ASA precludes potential normative transgressions by publishing, disseminating, consulting upon, and updating detailed codes of advertising conduct. Procedurally, the ASA adjudicates between allegations and justifications of offence and harm (...) on a received complaint-by-complaint basis, often upon consequentialist grounds. Such consequentialism, we claim, has the effect of normalizing power imbalances between the ASA’s members, on the one hand, and wider stakeholders, on the other hand. The paper argues that, in the context of UK advertising, what Michel Foucault called the right ‘to be or not to be governed like that’ is enjoyed by relatively few subjects. Having demonstrated how UK advertising practices are governed, the paper closes with suggestions as to how they might be governed otherwise. (shrink)

Both law and medicine rely on self-regulation and codes of professionalism to ensure duties are performed in a competent, ethical manner. Unlike physicians, however, judges are lawyers themselves, so judicial oversight is also self-regulation. As previous literature has highlighted, the hesitation to report a cognitively-compromised judge has resulted in an “opensecret” amongst lawyers who face numerous conflicts of interest.Through a case study involving a senior judge with severe cognitive impairment, this article considers the unique ethical dilemmas that cognitive specialists may (...) encounter when navigating duties to patient, society, and the medical profession, without clear legal guidance.Systemic self-regulatory inadequacies in the legal profession are addressed, as well as challenges that arise when trying to preserve the trust and dignity of an incapacitated patient who must fulfill special duties to society.Ultimately, because of their unique neurological expertise and impartial assessments, we submit that allowing cognitive specialists to submit their assessments to an internal judiciary board may act as an additional check and balance to ensure the fair and competent administration of justice. (shrink)

This book presents an interdisciplinary exploration of digital sovereignty in China, which are addressed mainly from political, legal and historical point of views. The text leverages a large number of native Chinese experts among the authors at a time when literature on China’s involvement in internet governance is more widespread in the so-called “West”. Numerous Chinese-language documents have been analysed in the making of this title and furthermore, literature conceptualising digital sovereignty is still limited to journal articles, making this one (...) of the earliest collective attempts at defining this concept in the form of a book. Such characteristics position this text as an innovative academic resource for students, researchers and practitioners in international relations (IR), law, history, media studies and philosophy. (shrink)

In contrast to many countries, the political debates in the Netherlands on reproductive technologies and embryo research have paid particular attention to the issue of health risks to women. This article focuses on the question to what extent the discourse of gender has contributed to shaping the space for embryonic research in this country. The author argues that in the policy arena flexible conceptualizations of risks and burdens to women and of the identities of embryos have been crucial in drawing (...) and maintaining a discursive boundary between the domains of medically assisted reproduction and embryo research. The author shows that feminist intervention challenging this discursive strategy has had an impact on the present regulation of research. However, the main weakness of this temporary and partial feminist success is the virtual absence of a public debate on the meaning and desirability of embryo research. (shrink)

Disputes over agriculture and foodproduction have occurred against a background ofdisputed authority with regard to governments,experts, and single issue pressure groups. Consumershave intervened in quite significant ways with manyaltering their buying patterns. The conventionalassessment of consumer ``preferences'''' throughaggregated purchases fails to reflect the ethicalnature of significant numbers of purchase decisions.Nevertheless, consumers seem to offer a wider basis onwhich to consider ethical issues. The author proposesthat a valuable inclusion of consumer opinion in thedebates would require a move away from neo-classicaleconomics (...) and the selective inclusion of consumeropinion to unravel the complexity of (aggregated)consumer behavior. It is argued that Hirschman''sframework of ``exit, voice, and loyalty'''' is a moreappropriate tool for the understanding of ethics infood consumption. (shrink)

In this article, I identify the peculiar challenges of current regulation in the UK to assess the safety of new medical devices. Not only is there a limited role for the regulatory authority in assessing their safety, but also no clinical investigation might be needed before many new devices can be marketed for use in populations across the European Union. As a lay member of a committee flagged to review research involving medical devices, I describe some of the (...) difficulties we face in this regard as well as recent developments designed to raise regulatory standards. (shrink)

In all countries where health care access is considered a social right, regulation is both a tool of performance improvement as well as an instrument of social justice. Both social (equity in access) and economical (promoting competition) regulation are at stake due to the nature of the good itself. Different modalities of regulation do exist and usually new regulatory cycles include the creation of stronger regulatory agencies. Indeed, health care regulation is rising steadily in most developed countries as (...) a consequence of the introduction of the New Public Management perspective to provide essential public goods.Health care is delivered by different organisations with very different cultural backgrounds—public and private (profit and non-profit)—that should be accountable for their decisions. Control by regulatory agencies is instrumental to accomplish this goal. However, there is some dispute with regards the degree of regulatory autonomy. The objective of this paper is to determine if independent regulatory agencies (IRAs) are effective in carrying out health care regulation. The authors apply Walshe’s analytical framework to the Regulatory Authority of Health (Portugal) to answer the question if independent regulation works.In conclusion, the two year experience of the Regulatory Authority of Health is important not only because the primary goals of independent regulation were achieved but also because this authority is now a full partner in the health care sector. However, independent agencies need to develop strong mechanisms of accountability because good regulatory governance is the paradigm of this institutional innovation. (shrink)

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 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)