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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 theregulatoryinstitutions 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)

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The article analyses the legal status of the natural gas marketregulatoryinstitutions 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)

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There are at least four important, institutional obstacles to whistle-blowing toregulatoryinstitutions. First,regulatoryinstitutions are often systematically understaffed and do not have the resources needed to adequately process whistle-blowing cases. Second, regulators who process whistle-blowing cases are often systematically inexperienced and do not understand the strategic importance of whistle-blowing cases. Third, regulators are often under systemic pressure from the politicians who appoint them to ignore whistle-blowing cases relevant to their sources of financial and/or ideological (...) political support. Fourth, there are high systemic risks to whistle-blowers who blow the whistle toregulatoryinstitutions. Nonetheless, understanding how theinstitutions and obstacles operate can help us understand what types of whistle-blowing methods can be used to navigate around the obstacles and within theregulatoryinstitutions. In addition, sometimes whistle-blowing methods can help reformregulatoryinstitutions. (shrink)

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We investigate two under-explored factors in mitigating the risk of corporate fraud andregulatory enforcement against fraud, namely institutional investors and political connections. The role of institutional investors in the effective monitoring of a firm’s management is well established in the literature. We further observe that firms that have a large proportion of their shares held by institutional investors have a lower incidence of enforcement actions against corporate fraud. The importance of political connections for enterprises, whether in a developed (...) market such as the United States or an emerging market such as China, has been established by previous studies. However, we find evidence of another positive effect of political connections: they may reduce the incidence of enforcement action against corporate fraud. We also find that political connections play a more significant role in reducingregulatory enforcement incidents against non-state-owned enterprises and firms in weaker legal environments, whereas institutional ownership plays a more important role in reducingregulatory enforcement incidents against state-owned enterprises. (shrink)

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

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An amendment to this paper has been published and can be accessed via the original article.

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

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This Article examines theregulatory state through the lens of evolving political economy, arguing that a significant reconstruction is now underway. The ongoing shift from an industrial mode of development to an informational one has created existential challenges forregulatory models and constructs developed in the context of the industrial economy. Contemporary contests over the substance ofregulatory mandates and the shape ofregulatoryinstitutions are most usefully understood as moves within a larger struggle to (...) chart a new direction for theregulatory state in the era of informational capitalism. Aregulatory state optimized for the information economy must develop rubrics for responding to three problems that have confounded existingregulatory regimes: platform power — the power to link facially separate markets and/or to constrain participation in markets by using technical protocols; infoglut — unmanageably voluminous, mediated information flows that create information overload; and systemic threat — nascent, probabilistically-defined harm to be realized at some point in the future. Additionally, it must developinstitutions capable of exercising effective oversight of informationera activities. The information-eraregulatory models that have begun to emerge are procedurally informal, mediated by networks of professional and technical expertise that define relevant standards, and financialized. Such models, however, also have tended to be both opaque to external observation and highly prone to capture. New institutional forms that might ensure their legal and political accountability have been slow to develop. (shrink)

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A number of high-profile mislabeling incidents have led to many studies exploring the decision-making processes that firms make around performing illegal acts. However, it remains unclear why the proportion of firms conducting these acts constantly fluctuates and never disappears. Therefore, this study investigated this by carrying out a longitudinal analysis of food labeling in the Taiwanese rice industry. Drawing on the institutional isomorphism theory, it was found that the degree of mislabeling is negatively correlated with both the level of control (...) of inspection regulations and public attention toward food regulations, and positively correlated with the previous proportion of firms mislabeling their products. Thus, there is a feedback loop betweenregulatory control, public attention, and the amount of mislabeling, with the amount of mislabeling not only being affected by the former degree ofregulatory control, public attention, and mislabeling, but also modifying the future status of each of these. These findings further our understanding of the causal effects of illegal actions in the institutional agricultural environment. (shrink)

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Human Biological Materials (HBMs) are an invaluable resource in biomedical research.ObjectiveTo determine if researchers and a Research Ethics Committee (REC) at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries.Study DesignEthically approved retrospective cross‐sectional descriptive audit.ResultsOf the 1305 protocols audited, 151 (11.57%) fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors (90) were from the USA (p = 0.0001). The principle investigators (PIs) in all 151 protocols informed the (...) REC of their intent to store HBMs. Only 132 protocols informed research participants (P< 0.0001). In 148 protocols informed consent (IC) was obtained from research participants, 116 protocols (76.8%) solicited broad consent compared to specific consent (32; 21.2%) [p< 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p< 0.0001]. More protocols informed the REC (90) than the research participants (67) that HBMs would be exported (p = 0.011). Export permits (EPs) and Material Transfer Agreements (MTAs) were not available in 109 and 143 protocols, respectively.ConclusionsResearchers and the REC did not adequately address the inter‐related ethical andregulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

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With the ongoing coronavirus disease 2019 pandemic, technological, socio-political, and institutional changes have led to a “new normal” competitive landscape, firms must make longer-term strategic changes to deal with short-term discontinuities and great uncertainties to acquire sustainable advantage. Based onregulatory focus theory and upper echelons theory, this study explores the relationship between CEOregulatory focus and corporate strategic change and examines the moderating effects of analysts’ optimism bias in earning forecasts. The study uses data from A-share-listed companies (...) in China during 2010–2018. We find that CEO promotion focus is positively associated with strategic change, while CEO prevention focus is negatively associated with strategic change. We also find analysts’ optimism bias in earning forecasts would moderate these relationships. (shrink)

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Human Biological Materials are an invaluable resource in biomedical research. Objective To determine if researchers and a Research Ethics Committee at a South African institution addressed ethical issues pertaining to HBMs in collaborative research with developed countries. Study Design Ethically approved retrospective cross-sectional descriptive audit. Results Of the 1305 protocols audited, 151 fulfilled the study's inclusion criteria. Compared to other developed countries, a majority of sponsors were from the USA . The principle investigators in all 151 protocols informed the REC (...) of their intent to store HBMs. Only 132 protocols informed research participants . In 148 protocols informed consent was obtained from research participants, 116 protocols solicited broad consent compared to specific consent [p< 0.0001]. In 105 cases a code was used to maintain confidentiality. HBMs were anonymised in 14 protocols [p< 0.0001]. More protocols informed the REC than the research participants that HBMs would be exported . Export permits and Material Transfer Agreements were not available in 109 and 143 protocols, respectively. Conclusions Researchers and the REC did not adequately address the inter-related ethical andregulatory issues pertaining to HBMs. There was a lack of congruence between the ethical guidelines of developed countries and their actions which are central to the access to HBMs in collaborative research. HBMs may be leaving South Africa without EPs and MTAs during the process of international collaborative research. (shrink)

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

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ANNOTATION Sardak S.E. GlobalRegulatory 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 publicinstitutions 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 internationalinstitutions 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 globalregulatory 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)

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

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This article addresses issues ofregulatory 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 ofregulatory science in the United Kingdom, including institutional practices, judgments of expertise, and established relationships of trust, result in a “nation centeredness” and divergence (...) ofregulatory 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)

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

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The National Institutes of Health (NIH) invests over $37 billion per year in support of research to improve human health. All research funded by NIH that involves human subjects is subject toregulatory oversight, requiringinstitutions to staff and manage Institutional Review Boards (IRBs). IRB members, chairs, and the many associated human subjects protections oversight professionals who support the work of the IRB must navigate complex federal regulations issued by multiple agencies. This book is the industry standard reference (...) work for the research oversight community, providing comprehensive, understandable interpretations of the regulations, clear descriptions of the ethical principles on which the regulations are based, and practical best-practices guidelines for effectively implementingregulatory oversight. (shrink)

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

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

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Event studies are vital analytical tools used to gauge if unusual investment returns result from events within defined time frames. This article explores events marked by the disclosure of administrative penalties imposed on South African publicly traded financialinstitutions between 2011 to 2021 due to non-compliance with regulations. Results reveal statistically significant abnormal returns occur in at least 70% of cases, with negative events like fines correlating with negative returns. The findings emphasise the impact ofregulatory fines on (...) the performance of listed financialinstitutions. Banks are advised to monitor and manage conduct risk systematically and carefully. (shrink)

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The quality of a research study application sends a distinct signal to the institutional review board (IRB) about the skills, capacities, preparation, communication, experience, and resources of its authors. However, efforts to research and define IRB application quality have been insufficient. Inattention to the quality of an IRB application is consequential because the application precedes IRB review, and perceptions of quality between the two may be interrelated and interdependent. Without a clear understanding of quality, IRBs do not know how to (...) define quality and researchers do not know how to achieve quality. This position has not been systematically studied to date, and future research could provide much-needed empirical validation. This paper lays the conceptual groundwork for future investigation into what constitutes quality in an IRB application. It includes a landscape review of multidisciplinary research on quality, as well as a discussion of quality frameworks analogous to research with human participants that exist in the published literature. It also examines the background and significance of federal research regulations,regulatory burdens, researchers’regulatory literacy, and the roles and responsibilities of IRB professionals within this ecosystem. (shrink)

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This paper examines the transformation of environmentalregulatory 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 andinstitutions. 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 ofregulatory 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 ofinstitutions, political circumstances, and national capabilities are different for each phase. (shrink)

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Boston Medical Center/Boston University Medical Campus recently reduced certain requirements for human subjects research where this could be done without adversely affecting the rights and welfare of participants, in anticipation of changes in the Final Common Rule. Modifications affected exempt and expedited categories, approval periods, ceding review, Quality Improvement/Quality Assessment activities, and some requirements for pregnant women, prisoners, and children. This case study may assist otherinstitutions in responding to the Final Common Rule.

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This paper discusses the varieties of capitalism in transitional societies in Latin America and Central / Eastern Europe. The intended purpose of these transitions from semi-closed import-substituting economies in the first case and state socialist ones in the second was to institutionalize open-market economies. Twenty or thirty years later, there is a variety of types of capitalism in these countries, which I classify into three: open-market, neo-mercantilist, and anemic. The question for sociology is whether these quite different variants represent temporary (...) stages or distortions in the same process of transition or whether, on the contrary, they may institutionalize as discrete forms of peripheral capitalism. Neither standard “legacy” argu­ments nor institutionalist theories offer satisfactory answers to this question. The multiple modernities approach, on the other hand, is more appropriate as a theoretical perspective, but it has not produced yet specific propositions applicable to this question. My paper makes two claims. First, the successful transfer ofinstitutions depends on the congruence between theseinstitutions and the broader institutional framework of the recipient economies, a point not developed by institutionalist theories. I offer a hypothesis in this regard: Two critical nodes of congruence are theregulatory and extractive capacity of the state and the strength of civil society. Second, market capitalism (as liberal democracy as well) is a complex institution, and some of its components “travel” more easily across societies and institutional frameworks, and therefore are easier to institutionalize. This is the source of the hybrid variants. (shrink)

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In recent decades, the Organisation for Economic Co-operation and Development has become a powerful forum for trade liberalization andregulatory harmonization. OECD members have worked to reconcile divergent nationalregulatory approaches, applying a single framework across sovereign states, in effect determining whose knowledge-making practices would guideregulatory 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 shaperegulatory 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, USregulatory 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 andregulatory intervention. (shrink)

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It is argued that neoliberal political ideology has redefined theregulatory state to have greater convergence of interests and goals with the pharmaceutical industry than previously, particularly regarding acceleration and cost reduction of drug development andregulatory 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 neoliberalregulatory 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 controllinginstitutions. 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)

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This study examines the direct impact of three dimensions of the institutional environment on managerial attitudes toward the natural environment and the direct influence of the latter on the environmental sustainability orientation (ESO) of small firms. We contend that when the institutional environment is perceived by owner–managers as supportive of sound natural environment management practices, they are more likely to develop a positive attitude toward natural environment issues and concerns. Such owner–manager attitudes are likely to lead to a positive and (...) proactive orientation of their firms toward environmental sustainability. The study uses survey data from 166 small manufacturing firms located in three Philippine cities. First, the study develops and tests the measurement models to examine the validity of the constructs representing the firm’s institutional environment, managerial attitudes toward the natural environment and the ESO of firms. Second, the study develops and tests the structural models examining the institutional environment–managerial attitudes–ESO linkages. Multi-sample invariance structural model analysis shows the mediating role of managerial attitudes in the institutional environment–ESO nexus. The findings show that ESO is a construct comprising three dimensions: knowledge of environmental issues, sustainable practices and commitment toward environmental sustainability. The cognitive,regulatory and normative elements of the institutional environment are strongly linked to positive managerial attitudes toward environmental sustainability, which in turn, positively influences the firm’s overall ESO. Managerial attitudes play a mediating role in the institutional environment–ESO linkages. The managerial, practical, research and policy implications of the research findings are discussed. (shrink)

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Concentrated attention on institutional investors' activism has been perceived in the last few decades and further intensified in the post‐Enron era. A new area of particular significance that has emerged is institutional investors' growing awareness and practice of socially responsible investment (SRI). This article starts by reviewing the importance of institutional investor activism and the historical implication of SRI. Significantly, various elements that give rise to the growth of SRI in the modern business world are considered in detail. It is (...) recognized that, although current empirical evidence suggests ambiguous effects of SRI, the positive impact of institutional investors' activism on SRI is likely to have been undermined due to the underdevelopment of evaluation systems, and SRI should stand out as a good investment option for its joint financial and societal concerns. Nevertheless, obstructions still exist in the exercise of investor activism and the pursuit of SRI strategy, which implies that, at least in the near future, SRI strategy will remain as a minor investment trend for institutional investors in Anglo‐American countries. Additionalregulatory methods and awarding schemes are, therefore, expected to motivate institutional investors' activism on SRI, and subsequently to promote global sustainability. (shrink)

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All investigators funded by the National Institutes of Health are now required to receive training about the ethics of clinical research. Based on a course taught by the editors at NIH, Ethical andRegulatory Aspects of Clinical Research is the first book designed to help investigators meet this new requirement. The book begins with the history of human subjects research and guidelines instituted since World War II. It then covers various stages and components of the clinical trial process: designing (...) the trial, recruiting participants, ensuring informed consent, studying special populations, and conducting international research. Concluding chapters address conflicts of interest, scientific misconduct, and challenges to the IRB system. The appendix provides sample informed consent forms. This book will be used in undergraduate courses on research ethics and in schools of medicine and public health by students who are or will be carrying out clinical research. Professionals in need of such training and bioethicists also will be interested. (shrink)

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With the expansion of multinational corporations (MNCs), the alarming upsurge in widely publicized and notable corporate scandals involving MNCs in emerging markets has begun to draw both academic and managerial attention to look beyond home market practices to the pressing concern of CSR in emerging markets. Previous studies on CSR have focused primarily on Western markets, reserving limited discussions in addressing the issue of MNC attitudes and CSR practices in their emerging host markets abroad. Despite this incongruity in academic response (...) to CSR in emerging markets, managers of multinational companies continue to face mounting and most often conflicting pressures to weigh among multiple strategic CSR responses in emerging markets. Such a task is often further complicated by the complexity of varying business norms and standards,regulatory environments, and stakeholder demands for CSR across national boundaries. With such a challenge in mind, I attempt to examine the explanatory factors in leading MNCs, otherwise recognized for accountability and integrity in their home markets, to employ inconsistent or negligent practices under CSR pressure in Chinese emerging economy. Preliminary findings reveal that discrepancies exist in how MNCs perform in CSR in home countries versus in host countries. While MNCs do have much to improve, the institutional environment in the emerging market, including the legal framework and the ethical culture, also needs to be improved by the host country governments, the industry associations, and local firms. Meanwhile, media interest and journalists, NGOs, third party monitors, industry stakeholders as well as consumer advocacy groups can raise the visibility of MNC's contradictory practices between their origin nations and countries with emerging economies and offer the pressures and incentives for MNCs to amend their ethical short-comings. This article also suggests implications for both theory and practice. (shrink)

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The notion of validity fulfils a crucial role in legal theory. In the emerging Web 3.0, Semantic Web languages, legal ontologies, and normative multi-agent systems are designed to cover newregulatory needs. Conceptual models for complexregulatory systems shape the characteristic features of rules, norms, and principles in different ways. This article outlines one of such multilayered governance models, designed for the CAPER platform, and offers a definition of Semantic WebRegulatory Models . It distinguishes between normative-SWRM (...) and institutional-SWRM. It also compares existing principles in privacy by design, linked open data , legal information institutes , and online dispute resolution . The article concludes by proposing the notion of Relational Law to summarize the ethical dimension of SWRM. Ethics are the onlyregulatory way to constitute a global space, out of the jurisdictional public domain set by national, international, or transnational law, and opposed to the private one. (shrink)

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As social media becomes increasingly popular, human subjects researchers are able to use these platforms to locate, track, and communicate with study participants, thereby increasing participant retention and the generalizability and validity of research. The use of social media; however, raises novel ethical andregulatory issues that have received limited attention in the literature and federal regulations. We review research ethics and regulations and outline the implications for maintaining participant privacy, respecting participant autonomy, and promoting researcher transparency when using (...) social media to locate and track participants. We offer a rubric that can be used in future studies to determine ethical and regulation-consistent use of social media platforms and illustrate the rubric using our study team’s experience with Facebook. We also offer recommendations for both researchers and institutional review boards that emphasize the importance of well-described procedures for social media use as... (shrink)

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This paper provides an exploratory comparative assessment of the institutional pressures influencing corporate social responsibility in a developed country, UK, vs. a developing country, Brazil, based on a survey of different actors. Information on sustainability concerns, organizational strategies and mechanisms of pressure was collected through interviews with environmentalregulatory agencies, financialinstitutions, media and non-governmental organizations. Our results confirm that the more advanced awareness and CSR responsiveness in the UK is a consequence of a predominance of coercive and (...) normative forces on the organizational field. The institutional forces tend to build a Brazilian organizational field that is relational based and risk intensive. The findings lend support to the view that CSR responses are unlikely to be easily transformed into uniform standardized practices across the globe. This paper contributes to a collective understanding of the organizational field and a common template for CSR in the context of developed and developing countries. (shrink)

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In transitional economies, the governing central authorities impose heavyregulatory burdens on firms, which results in great costs for business in terms of time, resources, and other constraints. However, quality assurance through decentralizedinstitutions (such as private certified management standards) is rapidly becoming more prevalent. This study examines the contingent implications that such decentralizedinstitutions have for centralized regulation by focusing on the relationship between international certifications andregulatory 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 andregulatory 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 withregulatory 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)

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Regulatory impact assessment (RIA) is seen as a tool for increasing evidence-based policy making and as such it is being integrated into decision-making procedures on a wide range of issues. Based on systematic consultation, clear criteria for policy choice, and economic analysis of how costs and benefits impact on a wide range of affected parties, this tool operates by using scientific knowledge and technical analysis rather than political considerations. Scientific knowledge can be used to achieve instrumental learning (Radaelli, 2009, (...) OECD), policy change (Sabatier, 1999), to impact on decision making (Caplan, 1979; C.H.Weiss, 1999) but also to seek legitimacy from the policy environment (Edelman, 1985; Schrefler, 2010). This article suggests an analytical framework for analysing RIA documents with insight from knowledge utilization theories. We argue that in order to better understand the RIA itself, we need to look at institutional factors as well. The combination of institutional context variables and variables for RIA document content analysis which make up worldviews in this framework provide the basis for the document analysis and exploration of RIA in its context. (shrink)

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Background Victoria was the first Australian state to legalize voluntary assisted dying (elsewhere known as physician-assisted suicide and euthanasia). Someinstitutions indicated they would not participate in voluntary assisted dying. The Victorian government issued policy approaches forinstitutions to consider Objective To describe and analyse publicly available policy documents articulating an institutional objection to voluntary assisted dying in Victoria. Methods Policies were identified using a range of strategies, and those disclosing and discussing the nature of an institutional objection (...) were thematically analysed using the framework method. Results The study identified fifteen policies from nine policymakers and developed four themes: (1) extent of refusal to participate in VAD, (2) justification for refusal to provide VAD, (3) responding to requests for VAD, and (4) appeals to state-sanctionedregulatory mechanisms. While institutional objections were stated clearly, there was very little practical detail in most documents to enable patients to effectively navigate objections in practice. Conclusion This study demonstrates that despite having clear governance pathways developed by centralized bodies (namely, the Victorian government and Catholic Health Australia), manyinstitutions’ public-facing policies do not reflect this guidance. Since VAD is contentious, laws governing institutional objection could provide greater clarity andregulatory force than policies alone to better balance the interests of patients and non-participatinginstitutions. (shrink)

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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 onregulatory 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 ofregulatory 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)

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While the demands for greater engagement in science in general andregulatory 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 prominentregulatory 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 otherregulatory 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)

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Technology regulation is one of the most important public policy issues facing society and governments at the present time, and further clarity could improve decision making in this complex and challenging area. Since the rise of the internet in the late 1990s, a number of approaches to technology regulation have been proposed, prompted by the associated changes in society, business and law that this development brought with it. However, over the past decade, the impact of technology has been profound and (...) the associated issues for government have extremely challenging, ranging across cyber security, artificial intelligence, and many other areas. To that end, this article introduces a Theory of Institutional Technology Actors and Norms (TITAN), a normatively informed and institutionally-based account of technology regulation. It focuses on the moral and legal (includingregulatory) rights and responsibilities of the relevant actors and seeks to inform the development of regulation that is both fit for purpose, rights compliant and fair for all concerned. The account incorporates the perspectives of four key categories of groups in society: producers of technology, users of technology, government regulators, and normative policy shapers. (shrink)

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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 (...) thisregulatory setting and how these depend upon the absence of a single coherent profession associated with biomedical research. (shrink)

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The past two decades have witnessed the emergence of corporateassociation- and standards-based forms of environmental selfregulation. Private environmental governance is commonly presented as being a market-driven phenomenon. Firms seek to manage their environmental impacts as a means of achieving cost-based or differentiation-based advantages. Yet, these innovations are necessarily embedded in theregulatory policies andinstitutions of nation states and thus subject to the dynamics ofregulatory change. Historically, economic crises have stimulated significantregulatory changes that have, (...) more often than not, resulted in an expansion of public regulation and a diminution of self-regulation. This Article considers the ramifications of the global financial crisis for the development of private environmental governance. (shrink)

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Conflicts between labor unions and nongovernmental organizations often impede private laborregulatory attempts to protect worker rights at supplier factories. Based on a study of a failed privateregulatory attempt for Swedish garment retailers, we contribute to existing research into union–NGO relations by demonstrating how conflict arises because unions and NGOs act upon different institutional logics. We also contribute to the institutional logics perspective by challenging the current emphasis on either coexistence or conflict among multiple logics, and showing (...) the heterogeneity in how multiple logics manifest on a local level, how this could shift over time, and suggesting an empirically derived typology of manifestations of multiple logics. (shrink)

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Food safety has become a major development challenge and a key influence on the strategic behavior of food companies. The study seeks to analyze the effect of perceived institutional pressures on the governance of food safety and the effect this may have on food safety performance in emerging food supply chains. The research develops a conceptual framework that links perceived institutional pressures, degree of food manufacturer-supplier relationships, food safety practices, and food safety output. The hypothesized relationships were tested in the (...) Middle Eastern context, where food safety concerns are rising. Accordingly, a survey was carried out to collect data from food quality/safety managers representing 94 food processors across Lebanon. The study finds that perceived institutional pressures have a direct and strong effect on the degree of integration in the agro-food supply chain, and such an integration, in turn, increases the intensity of food safety practices and food safety performance. However, in the absence of strong manufacturer-supplier relationships, perceived institutional pressures do not lead to improved food safety performance. The study suggests that long-term food manufacturer-supplier relationship is necessary if agro-food chain actors are to respond to establishedregulatory demands, industry practices, and social norms. (shrink)

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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 onregulatory 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 ofregulatory 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)

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