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

This 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)

Background: Over the last several decades, scientists and social groups have frequently raised concerns about politicization or political interference in regulatory science. Public actors (environmentalists and industry advocates, politically aligned public figures, scientists and political commentators, in the United States as well as in other countries) across major political-regulatory controversies have expressed concerns about the inappropriate politicization of science. Although we share concerns about the politicization of science, they are frequently framed in terms of an (...) ideal of value-free science, according to which political and economic values have no legitimate role to play in science. For several decades, work in philosophy of science has identified serious conceptual and practical problems with the value-free ideal. -/- Objectives: Our objectives are to discuss the literature regarding the conceptual and practical problems with the value-free ideal and offer a constructive alternative to the value-free ideal. -/- Discussion: We first discuss the prevalence of the value-free ideal in regulatory science, then argue that this ideal is self-undermining and has been exploited to delay protective regulation. To offer a constructive alternative, we analyze the relationship between the goals of regulatory science and the standards of good scientific activity. This analysis raises questions about the relationship between methodological and practical standards for good science, tensions among various important social goods, and tensions among various social interests. We argue that the aims of regulatory science help to legitimize value-laden choices regarding research methods and study designs. Finally, we discuss how public deliberation, adaptive management, and community-based participatory research can be used to improve the legitimacy of scientists as representatives of the general public on issues of environmental knowledge. -/- Conclusions: Reflecting on the aims of regulatory science—such as protecting human health and the environment, informing democratic deliberation, and promoting the capacities of environmental justice and Indigenous communities—can clarify when values have legitimate roles in regulatory science. (shrink)

While the demands for greater engagement in science in general and regulatory science in particular have been steadily increasing, we still face limited understanding of the empirical resonance of these demands. Against this context, this paper presents findings from a recent study of a potential participatory opening of the German Federal Institute for Risk Assessment, a prominent regulatory scientific organization in the field of risk governance. Drawing upon quantitative surveys of the public and selected professional experts (...) as well as in-depth qualitative expert interviews, we identify a general support for greater engagement in science-based risk assessment. However, we also find significant contestation concerning its potential enactment and its normative and strategic merit. Underlying these contestations, we identify the persistence of a normal view of science and decisionist understanding of risk assessment, which create conflicting legitimacy demands for BfR and other regulatory scientific organizations. Together with concerns about imbalances in the power to participate, especially in highly specialized engagement processes, these pose significant challenges for the institutionalization of more participatory practices. (shrink)

Is there such a thing as a “best scientific methodology” in regulatory science? By examining cases from varying regulatory processes, we argue that there is no best scientific method for generating decision-relevant data. In addition, in regulatory science, the most suitable methodologies often differ from what is considered best practice in knowledge-oriented science. In data generation for regulatory purposes, we are faced with a wide spectrum of preferred methodologies as well as controversy as (...) to methodological choice. What goes by the most adequate scientific method can and will—justifiably and rationally—vary significantly according to context and use. In order to make this argument, we analyze four case studies, two from risk assessment and two from benefit assessment. Our analysis shows that it is the noncognitive objectives of a particular regulatory process that determine what counts as the most appropriate scientific method. We use the concept of bounded rationality to indicate that those methodological choices, despite being context-dependent, can be interpreted as rational. (shrink)

This article examines the regulation of nonsteroidal anti-inflammatory drugs, with particular focus on products approved for marketing in the United Kingdom, while denied marketing approval in the United States on safety grounds, and then subsequently withdrawn from the UK market on those grounds. Using international comparison of regulatory data never before accessed outside government and companies, together with interviews with relevant industry scientists and regulators, the article demonstrates the importance of regulatory expectations, deficits and paradigms. It is argued (...) both that these sociological concepts can be enriched by their application to detailed comparative case study of regulatory science, and that they provide an important policy-relevant framework with which to understand discrepant drug regulatory processes in a sociohistorical context. It is found that regulatory expectations and paradigms may be regarded as mediating factors between political culture and structural interests, on the one hand, and the outcomes of regulatory science, on the other. (shrink)

The US Food and Drug Administration (FDA) is fraught with controversies over the role of values and politics in regulatory science, especially with drugs in the realm of reproductive health. Philosophers and science studies scholars have investigated the ways in which social context shapes medical knowledge through value judgments, and feminist scholars and activists have criticized sexism and injustice in reproductive medicine. Nonetheless, there has been no systematic study of values and gender norms in FDA drug regulation. (...) I focus on three questions about values in regulatory science. First, how have societal values and gender norms shaped the way that the FDA regulates drugs in the realm of reproductive health, specifically with drug labels? Second, what are the ethical, epistemic, and social consequences of these influences on regulation for women and other marginalized groups? Third, which societal values and gender norms ought to influence drug regulation about reproductive health, and how ought this happen? Integrating philosophical analysis with historical archival research and in-depth interviews, I conduct three case studies of drug labeling about reproductive health: (1) the “drug fact” about the mechanism of the morning-after pill; (2) the package inserts for patients about the health risks of oral contraceptives; and (3) the special physician labels made for prescribing drugs to pregnant women. I identify three challenges for the FDA and suggest ways to reduce the influence of sexist values and facilitate feminist alternatives. First, across these cases, I have found that there are many ways in which other concerns in reproductive medicine (such as zygotic life, fetal health, and population control) have devalued women’s health. Second, both knowledge and ignorance xvi about their reproductive health have contributed to women’s oppression, especially poor women and women of color. Finally, by avoiding the epistemic dimensions of ethics, powerful, mostly male parties in medicine (such as doctors, pharmaceutical companies, and religious institutions) have misused “informed consent,” “religious freedom,” and “paternalism” for unethical purposes. For improvement, I suggest extracting sexist values and gender norms from regulatory science that cause epistemic injustices, and I point to success stories for reforming sexism with feminism at the FDA. (shrink)

In this paper we argue for a naturalistic solution to some of the methodological controversies in regulatory science, on the basis of two case studies: toxicology and health claim regulation. We analyze the debates related to the scientific evidence that is considered necessary for regulatory decision making in each of those two fields, with a particular attention to the interactions between scientific and regulatory aspects. This analysis allows us to identify two general stances in the debate: (...) a) one that argues for more permissive standards of evidence and for methodological pluralism, and b) an opposing one that not only defends strict evidence requirements but also stipulates the use of one particular scientific methodologies for data generation. We argue that the real-world outcomes produced by alternative regulatory options are a vital piece of information that allows for the empirical assessment of these two stances. In particular, this information on outcomes makes it possible to analyze which standards of evidence and scientific methods generate the most useful knowledge as input for regulatory decision making. Our conclusion is that instead of an a priori selection of methodologies and standards, such decisions ought to be based on empirical evidence related to real-world outcomes. (shrink)

En este articulo se examina la tradicional caracterización de la filosofía de la ciencia como una disciplina normativa. Se discuten varias concepciones de esta disciplina, cada una de las cuales ofrece una respuesta diferente a la pregunta de si es posible, y cómo, una filosofía de la ciencia genuinamente normativa. De entre esas concepciones, se opta por una forma de naturalismo que se diferencia de otras en la exigeneia de que la normatividad de la filosofía de la ciencia inc!uya la (...) discusión de los objetivos y valores, epistémicos o no, de la ciencia. La necesidad de esta inc!usión se ilustra, finalmente, con el ejemplo de la aetividad conocida como “cicncia reguladora”.This article examines the traditional characterization of the philosophy of science as a normative discipline. Several understandings of this discipline are discussed; each of them offering a different answer to the question whether, and how, a genuinely normative philosophy of science might be possible. Among these views, I choose one variety of naturalism that differs from others in its commitment with the discussion of science’s aims and values, either epistemic or non-epistemic. Finally, the need for this inclusion is illustrated with the example of the so-called “regulatory science”. (shrink)

This paper presents a program of action for the philosophy of regulatory science, based on a general theory of social epistemology. Two candidates are considered. The first one, offered by Alvin Goldman, is not fit for our purposes because it is focused on a veritism incompatible with non‐epistemic aims of regulatory science. The second, championed by Steve Fuller, sociologically investigates the existing means of producing knowledge, to modify them with the goal of obtaining democratic aims through (...) action on a legislative meta‐level. The program has been built upon this procedure, instantiated by the identification, characterization, and modification of epistemic policies. (shrink)

En este articulo se examina la tradicional caracterización de la filosofía de la ciencia como una disciplina normativa. Se discuten varias concepciones de esta disciplina, cada una de las cuales ofrece una respuesta diferente a la pregunta de si es posible, y cómo, una filosofía de la ciencia genuinamente normativa. De entre esas concepciones, se opta por una forma de naturalismo que se diferencia de otras en la exigeneia de que la normatividad de la filosofía de la ciencia inc!uya la (...) discusión de los objetivos y valores, epistémicos o no, de la ciencia. La necesidad de esta inc!usión se ilustra, finalmente, con el ejemplo de la aetividad conocida como “cicncia reguladora”.This article examines the traditional characterization of the philosophy of science as a normative discipline. Several understandings of this discipline are discussed; each of them offering a different answer to the question whether, and how, a genuinely normative philosophy of science might be possible. Among these views, I choose one variety of naturalism that differs from others in its commitment with the discussion of science’s aims and values, either epistemic or non-epistemic. Finally, the need for this inclusion is illustrated with the example of the so-called “regulatory science”. (shrink)

A general criterion for distinguishing between epistemic and non-epistemic values is that the former promotes the attainment of truth whereas the latter does not. Daniel Steel is a proponent of this criterion, although it was initially proposed by McMullin. There are at least two consequences of this criterion; it always prioritizes epistemic values over non-epistemic values in scientific research, and it overlooks the diverse aims of science, especially the aims of regulatory or policy-oriented science. This criterion assumes (...) the lexical priority of truth or lexical priority of evidence. This paper attempts to show a few inadequacies of this assumption. The paper also demonstrates why epistemic priority over non-epistemic values is a problematic stance and how constraining the role of non-epistemic values as ‘tiebreakers’ may undermine the diverse aims of science. (shrink)

Se discuten varias concepciones con respecto al carácter normativo de la filosofía de la ciencia. De entre éstas, se aboga por una forma de naturalismo comprometido con la necesidad de discutir los valores (epistémicos o no) de la ciencia. El ejemplo de la "ciencia reguladora" ilustra esa necesidad.

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

In the 20th century, public health was responsible for most of the 30-year increase in average life expectancy in the United States.1 Most of the significant advances in public health required the combined effort of scientists and attorneys. Scientists identified public health threats and the means of controlling them, but attorneys and policymakers helped convert those scientific discoveries into laws that could change the behavior of industries or individuals at a population level. In tobacco control, public health scientists made the (...) groundbreaking discovery that smoking caused lung cancer, but attorneys and policymakers developed and implemented the policies and litigation strategies that helped reduce smoking rates by more than half over the past 50 years. (shrink)

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

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)

Merleau-Ponty, la passivité et la scienceJe soutiens qu’il y a plus en jeu dans l’intérêt de Merleau-Ponty pour la science qu’une simple dialectique entre disciplines. C’est parce que son évolutionméthodologique le conduit à trouver dans la science un moyen spécifique d’approfondir ses recherches ontologiques, que celle-ci hante de plus en plus sa philosophie. En effet, dans le chapitre « champ phénoménal » de la Phénoménologie de la perception, il est possible de rapprocher certains aspects de son défi méthodologique (...) et l’idée selon laquelle la philosophie tient son origine d’une conscience réflexive, active et autonome dans son ensemble. Je lie cela aux problèmes de la passivité de telle sorte que la science apparaisse comme une façon de saisir la réflexion non pas comme autonome, mais comme une opération du champ phénomenal, comme réflexion radicale. Grâce à l’analyse critique des recherches récentes sur le génome, je montre ensuite commentl’embryologie peut nous aider à conceptualiser la vie comme un champ phénoménal, c’est-à-dire comme un champ qui engendre ce même genre d’opérations qui caractérisent aussi la phénoménalité. Cela nous conduit à voir la phénomenologie non plus comme une réflexion de survol sur les phénomènes, mais plutôt comme une réflexion radicale qui se realise à travers un phénoménalité plus « ancienne », qui appartient à la vie ellemême. Cela ouvre également des perspectives sur quelques problèmes difficiles de la dernière philosophie de Merleau-Ponty; ceux-ci sont abordés d’une manière nouvelle, grâce au rapprochement de sa première philosophie et de la science actuelle.Merleau-Ponty, la passività e la scienzaRitengo che, nell’interesse che Merleau-Ponty rivolge alla scienza, vi sia in gioco qualcosa di più del semplice confronto dialettico con un’altra disciplina. Il motivo è che il suo impegno metodologico finisce per individuare nella scienza una speciale risorsa per l’indagine di quelle profonde questioni ontologiche che investono in modo crescente la sua filosofia. Intendo argomentare tale ipotesi, connettendo dei passi del capitolo di Fenomenologia della percezione “Il campo fenomenico” con la sua sfida metodologica all’idea che la filosofia abbia inizio da una coscienza riflessiva autonoma e interamente attiva. Collego questo alle questioni della passività in un modo che rivela la scienza come una potenziale risorsa per comprendere la riflessione non come autonoma, bensì in quanto operazione di e nel campo fenomenico – come riflessione radicale. Poi, attraverso un’analisi critica dei risultati recenti riguardanti il DNA regolatore, mostrocome l’attuale embriologia può aiutarci a concettualizzare la vita come un campo fenomenico che implicitamente produce i tipi di operazioni rivelatrici distintive della fenomenalità. Questo ci permette di collocare la fenomenologia non semplicemente come una riflessione dall’alto sui fenomeni, ma come una riflessione radicale che opera grazie ad una “più antica” fenomenalità della vita. Questo ci fornisce degli spunti su alcune difficili questioni nella filosofia dell’ultimo Merleau-Ponty, suggerendo un nuovo percorso che giunga a queste combinando il primo periodo della sua filosofia con la scienza recente. (shrink)

Merleau-Ponty, la passivité et la scienceJe soutiens qu’il y a plus en jeu dans l’intérêt de Merleau-Ponty pour la science qu’une simple dialectique entre disciplines. C’est parce que son évolutionméthodologique le conduit à trouver dans la science un moyen spécifique d’approfondir ses recherches ontologiques, que celle-ci hante de plus en plus sa philosophie. En effet, dans le chapitre « champ phénoménal » de la Phénoménologie de la perception, il est possible de rapprocher certains aspects de son défi méthodologique (...) et l’idée selon laquelle la philosophie tient son origine d’une conscience réflexive, active et autonome dans son ensemble. Je lie cela aux problèmes de la passivité de telle sorte que la science apparaisse comme une façon de saisir la réflexion non pas comme autonome, mais comme une opération du champ phénomenal, comme réflexion radicale. Grâce à l’analyse critique des recherches récentes sur le génome, je montre ensuite commentl’embryologie peut nous aider à conceptualiser la vie comme un champ phénoménal, c’est-à-dire comme un champ qui engendre ce même genre d’opérations qui caractérisent aussi la phénoménalité. Cela nous conduit à voir la phénomenologie non plus comme une réflexion de survol sur les phénomènes, mais plutôt comme une réflexion radicale qui se realise à travers un phénoménalité plus « ancienne », qui appartient à la vie ellemême. Cela ouvre également des perspectives sur quelques problèmes difficiles de la dernière philosophie de Merleau-Ponty; ceux-ci sont abordés d’une manière nouvelle, grâce au rapprochement de sa première philosophie et de la science actuelle.Merleau-Ponty, la passività e la scienzaRitengo che, nell’interesse che Merleau-Ponty rivolge alla scienza, vi sia in gioco qualcosa di più del semplice confronto dialettico con un’altra disciplina. Il motivo è che il suo impegno metodologico finisce per individuare nella scienza una speciale risorsa per l’indagine di quelle profonde questioni ontologiche che investono in modo crescente la sua filosofia. Intendo argomentare tale ipotesi, connettendo dei passi del capitolo di Fenomenologia della percezione “Il campo fenomenico” con la sua sfida metodologica all’idea che la filosofia abbia inizio da una coscienza riflessiva autonoma e interamente attiva. Collego questo alle questioni della passività in un modo che rivela la scienza come una potenziale risorsa per comprendere la riflessione non come autonoma, bensì in quanto operazione di e nel campo fenomenico – come riflessione radicale. Poi, attraverso un’analisi critica dei risultati recenti riguardanti il DNA regolatore, mostrocome l’attuale embriologia può aiutarci a concettualizzare la vita come un campo fenomenico che implicitamente produce i tipi di operazioni rivelatrici distintive della fenomenalità. Questo ci permette di collocare la fenomenologia non semplicemente come una riflessione dall’alto sui fenomeni, ma come una riflessione radicale che opera grazie ad una “più antica” fenomenalità della vita. Questo ci fornisce degli spunti su alcune difficili questioni nella filosofia dell’ultimo Merleau-Ponty, suggerendo un nuovo percorso che giunga a queste combinando il primo periodo della sua filosofia con la scienza recente. (shrink)

This joint response from the National Research Ethics Advisors' Panel and the Association of Research Ethics Committees 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 in order to provide guidance to, and strategic oversight of the NHS Research Ethics Service. AREC represents all sectors of the Research Ethics Committee community and serves to engage in (...) discussion and debate concerning best practice and to serve the best interests of REC membership. (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.

Nongovernmental organizations (NGOs) and scientific controversies are often the common denominators in most of the cases that have significantly shaped science and society relationships in the Global South during the past two decades. National and international NGOs and their network have often facilitated the “opening up” of regulatory governance in multiple sectors. This article draws from three cases—the bottled water controversy, the agribiotechnology debates, and the nanotechnology initiatives—and charts out the role of the NGOs and controversies in (re)defining (...) the science-society relationship in India. The three cases illustrate how NGOs and controversies by their presence or absence at various stages of technology development shape the regulation-making exercise and the overall regulatory governance of science and technology. (shrink)

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

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)

ANNOTATION Sardak S.E. Global Regulatory System of Human Resources Development. – Manuscript. Thesis for the Doctor of Economic Science academic degree with major in 08.00.02 – World Economy and international economic relations. – SHEE «Kyiv National Economic University named after Vadym Hetman», Kyiv, 2014. The preconditions and factors of the global economic system with the identified relevant subjects areas and mechanisms of regulation instruments have been investigated. The crucial role of humans in the global economic system as a (...) key factor of production, the main resource, the producer and the consumer of economic and social benefits that are exposed to global threats, problems, challenges, trends and subjects has been confirmed. There have been revealed the causes and consequences of the public institutions transformation under the influence of globalization, which formed a qualitatively new conditions for social and economic development that determine the need for further changes in the areas of conceptual guideline for the management of human resources development, optimization of tasks, state and international institutions activity forms, integration of efforts as for monitoring, planning and forecasting. The modern major instruments and spheres of international cooperation to ensure human development have been determined. The integrated characteristic of human resources and their role in social development both from the standpoint of their use in labour processes and as a medium of civilization and social utility with the help of the categorical classification system organizing and expanding which enables to design and apply the appropriate approaches at all managerial levels have been defined. The necessity and the concept of human resources development in the context of the content of managerial influence identifying (self-development, self-management and external control of development) at different administrative levels that ensures the growth of human capital to the limits of its potential have been analysed. The survey of human activity system aspects in the global world, taking into account the parametrization of the global environment, its structure, management and development have been realized. The formed methodology principles of managerial influence on the development of human resources with scientific schools, hardness degrees, available models, research and providing theoretical and practical implementation peculiarities for groups of countries and territories of the world taken into consideration have been examined. There have been noted civilization and national differences in the forms of managerial influence on the development of human resources, which lead to the formation of human resources development national control systems conditioned by different value public strategic guidelines, especially in relation to social security, education, national management and state migration policy. The current and future requirements for global human resources development which are proposed to be achieved by the development and formalization of global civilizational paradigm of social development due to social coordination interaction have been given. The influence of the institute of state on the human resources development has been evaluated and it has been proved that in the beginning of the XXI century in the global environment the institute of state is the ultimate guarantor of its citizens’ labour ability and vital activity renewal, that makes it the main instrument of managerial influence on human development. The methodology of countries and territories matrix positioning by human development qualitative criteria and population size quantitative parameters which allows to design unified managerial measures as for human resources for similar national economies in the context of global regulatory trends has been proposed. The strategic trends of improvement of human resources development in the national economy, taking into account the differences in the development of human resources in different countries and areas which vary and differ in their focus, content and ways of implementation for such groups. The varying criteria for evaluating the effectiveness of the global impact on human resources development, taking into account the natural, biological, technological, economic, social and management dimensions and the results of human resources development management in social and economic systems at various levels have been revealed. The periodization and the forecast of the global dynamics of human resources development by analyzing and modeling the values of the absolute and relative terms correlation character have been carried out, which enables to make their retrospective and prospective comparison and to find chronological boundaries of qualitatively different periods. The configuration of the human resource development global coordinate system as a set of interrelated principles, components, fields, tools, frameworks, management levels and forms of managerial influence that allows with the help of institutional means to adapt the state of human resources development to a globally varying environment. (shrink)

President Barack Obama ordered federal regulatory agencies to engage in a retrospective regulatory review process in early 2011. This paper reports the initial results of an analysis of participation in the notice and comment process by business and public interest groups. The focus of the analysis is on comments given to the Environmental Protection Agency (EPA). Some attention is given to the EPA’s identification of regulations to be reviewed, as a result of this process.

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)

Regulatory science, which generates knowledge relevant for regulatory decision?making, is different from standard academic science in that it is oriented mainly towards the attainment of non?epistemic (practical) aims. The role of uncertainty and the limits to the relevance of academic science are being recognized more and more explicitly in regulatory decision?making. This has led to the introduction of regulation?specific scientific methodologies in order to generate decision?relevant data. However, recent practical experience with such non?standard methodologies (...) indicates that they, too, may be subject to important limitations. We argue that the attainment of non?epistemic values and aims (like the protection of human health and the environment) requires not only control of the quality of the data and the methodologies, but also the selection of the level of regulation deemed adequate in each specific case (including a decision about which of the two, under?regulation or over?regulation, would be more acceptable). (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)

This article proposes the term “safety logics” to understand attempts within the European Union to harmonize member state legislation to ensure a safe and stable supply of human biological material for transplants and transfusions. With safety logics, I refer to assemblages of discourses, legal documents, technological devices, organizational structures, and work practices aimed at minimizing risk. I use this term to reorient the analytical attention with respect to safety regulation. Instead of evaluating whether safety is achieved, the point is to (...) explore the types of “safety” produced through these logics as well as to consider the sometimes unintended consequences of such safety work. In fact, the EU rules have been giving rise to complaints from practitioners finding the directives problematic and inadequate. In this article, I explore the problems practitioners face and why they arise. In short, I expose the regulatory anatomy of the policy landscape. (shrink)

Aesthetic medicine merges art and medical sciences, focusing on the modification and enhancement of physical appearance through surgical and non-surgical procedures. While it is not globally recognized as a medical specialty, aesthetic medicine has become a cornerstone of medical tourism in several Asian countries, including India, Malaysia, Singapore, South Korea, and Thailand. Despite its popularity, there is notable gap in literature concerning its ethical and regulatory perspective. This study aims to provide a comprehensive analysis of existing regulations and ethical (...) considerations in aesthetic medicine within the context of the selected Asian countries. Given the field’s growth and its potential impact on both domestic and international health practices, this study is significant for healthcare providers, policymakers, and consumers alike. By identifying areas for improvement in current regulatory frameworks, the paper advocates for further examination to ensure that stakeholder rights and well-being are adequately protected. (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)

Inmaculada de Melo-Martín and Kristen Intemann consider whether, from the perspective of the argument from inductive risk, ethical and political values might be logically, epistemically, pragmatically, or ethically necessary in the “core” of scientific reasoning. In each case, they argue that there are significant conceptual problems. In this comment, employing regulatory uses of high-throughput toxicology at the US Environmental Protection Agency as a case study, I respond to some of their claims about the notion of “pragmatic necessity.” I conclude (...) that, while an inductive risk framework has some significant limitations, it is still conceptually and rhetorically valuable. (shrink)

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

This paper examines the transformation of environmental regulatory system in Poland during the 1990s. It is a case of institutional transplantation from the past into the present: the place remained constant but the economic and political context rapidly changed over time. Drawing on five case studies of privatized firms, a mailed questionnaire, and policy and institutional analysis, it investigates how Poland developed an effective system for managing industrial pollution while also achieving considerable socioeconomic progress. One key lesson is that (...) considerable and effective evolution of policies can take place during radical shifts in the political-economic context, as long as certain conditions are fulfilled. These include a good “fit” between the approaches taken and the existing modes of conducting societal transactions; wide sharing of certain values among the key societal actors; and continuity in policies and institutions. It also appears that a broad support for the rule of law and due process are crucial. The case of Poland also suggests that, while the developing countries do not necessarily need to reenact the evolution that has taken place among the developed countries during the past three decades, neither can they expect to leapfrog from a highly polluting “dirty” economy to a sustainable economy. The study also suggests that success in the first phase of regulatory system’s transformation—centered around reducing pollution from the energy and manufacturing sectors—is not a predictor of its success in next phase, centered around sustainability issues. The types of institutions, political circumstances, and national capabilities are different for each phase. (shrink)

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

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

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

Regulatory focus theory is proposed as offering an explanation for the influence of ethical leadership on organizational citizenship behaviors and employee commitments. The prevention focus mindset of an employee is argued to be the mechanism by which an ethical leader influences extra-role compliance behavior as well as normative commitment, whereas the promotion focus mindset of an employee is argued to be the mechanism by which an ethical leader influences extra-role voice behavior as well as affective commitment. Moreover, leader-member exchange (...) is proposed as a moderator of the relationship of ethical leadership to regulatory focus mindsets and employee behavior and commitments. Using the data collected in two waves from 250 working adults, we tested the proposed relationships with moderated mediation bootstrap procedures. The findings generally support the hypothesized relationships and point toward important implications for ethical leadership in work settings. (shrink)

Living systems employ several mechanisms and behaviors to achieve robustness and maintain themselves under changing internal and external conditions. Regulation stands out from them as a specific form of higher-order control, exerted over the basic regime responsible for the production and maintenance of the organism, and provides the system with the capacity to act on its own constitutive dynamics. It consists in the capability to selectively shift between different available regimes of self-production and self-maintenance in response to specific signals and (...) perturbations, due to the action of a dedicated subsystem which is operationally distinct from the regulated ones. The role of regulation, however, is not exhausted by its contribution to maintain a living system’s viability. While enhancing robustness, regulatory mechanisms play a fundamental role in the realization of an autonomous biological organization. Specifically, they are at the basis of the remarkable integration of biological systems, insofar as they coordinate and modulate the activity of distinct functional subsystems. Moreover, by implementing complex and hierarchically organized control architectures, they allow for an increase in structural and organizational complexity while minimizing fragility. Finally, they endow living systems, from their most basic unicellular instances, with the capability to control their own internal dynamics to adaptively respond to specific features of their interaction with the environment, thus providing the basis for the emergence of minimal forms of cognition. (shrink)

By presenting and synthesizing findings on the character of boredom, the article advances a theoretical account of the function of the state of boredom. The article argues that the state of boredom should be understood as a functional emotion that is both informative and regulatory of one's behavior. Boredom informs one of the presence of an unsatisfactory situation and, at the same time, it motivates one to pursue a new goal when the current goal ceases to be satisfactory, attractive (...) or meaningful. Boredom ultimately promotes both movement and the restoration of the perception that one's activities are meaningful and congruent with one's overall projects. (shrink)

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

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