This article provides a concise overview of the history of scholarship on solidarity in Europe and North America. While recent decades have seen an increase in conceptual and scholarly interest in solidarity in North America and other parts of the Anglo-Saxon world, the concept is much more strongly anchored in Europe. Continental European politics in particular have given rise to two of the most influential traditions of solidarity, namely, socialism and Christian ethics. Solidarity has also guided important public instruments and (...) institutions in Europe. Despite the much stronger affinity of continental European societies to solidaristic thinking, we argue that solidarity has much to offer for addressing societal challenges on both sides of the Atlantic and beyond. After proposing a working definition of solidarity that highlights its utility for guiding policy and practice, we give an example of how a solidarity-based perspective can shape instruments for the governance of data use. (shrink)

This article uses recent changes within the Austrian university system to illustrate some general features and dilemmas of organizational design and reform. We focus upon two recent layers of the sediments left by previous and current system reforms: that left by the events of 1968 on continental university systems, and Austria's late conversion to the path taken by the Anglo-American university system since the late 1970s/early 1980s; namely, towards what Marginson and Considine (2000) have called the "enterprise university". These two (...) reform waves are, we argue, neatly reflected in two university laws - UOG 1975 and UG 2002 - which capture with great clarity the spirit of these two policy moments. The Austrian case is thus of interest for two types of reason: first, because of the co-existence of deeply engrained traditions with more recent experiments in organizational democracy (co-determination); secondly, because of the rapidity with which current reforms seek to catch up with what are taken to be international developments in university management. Drawing on arguments advanced by Christopher Hood, Luc Boltanski and Ève Chiapello, and by Albert Hirschman, we seek to draw general conclusions concerning the implications of organizational reform for the management of organizations generally, and of universities in particular. (shrink)

Egg freezing has led to heated debates in healthcare policy and bioethics. A crucial issue in this context concerns the distinction between “medical” and “social” egg freezing —contrasting objections to bio-medicalization with claims for oversimplification. Yet such categorization remains a criterion for regulation. This paper aims to explore the “regulatory boundary-work” around the “medical”–”social” distinction in different egg freezing regulations. Based on systematic documents’ analysis we present a cross-national comparison of the way the “medical”–”social” differentiation finds expression in (...) class='Hi'>regulatory frameworks in Austria, Germany, Israel, and the Netherlands. Findings are organized along two emerging themes: the definition of MEF and its distinctiveness—highlighting regulatory differences in the clarity of the definition and in the medical indications used for creating it ; and hierarchy of medical over social motivations reflected in usage and funding regulations. Blurred demarcation lines between “medical” and “social” are further discussed as representing a paradoxical inclusion of SEF while offering new insights into the complexity and normativity of this distinction. Finally, we draw conclusions for policymaking and the bioethical debate, also concerning the related cryopolitical aspects. (shrink)

There is mounting evidence that non-invasive brain stimulation devices - transcranial direct current stimulation and transcranial magnetic stimulation could be used for cognitive enhancement. However, the regulatory environment surrounding such uses of stimulation devices is less clear than for stimulant drugs—a fact that has already been commercially exploited by several companies. In this paper, the mechanism of action, uses and adverse effects of non-invasive neurostimulation devices are reviewed, along with social and ethical challenges pertaining to their use as cognitive (...) enhancements. Two regulatory approaches that could be used to facilitate responsible use of these devices as products and services are outlined. Apart from establishing the urgently needed comprehensive regulatory framework, they might provide a starting point for establishing long term physiological and social effects of enhancement uses of tDCS and TMS. (shrink)

A recent Organisation for Economic Co-Operation and Development survey demonstrated that an internationalization of genetic laboratory services currently emerged from the rarity of certain genetic abnormalities and from the small of laboratories performing specialized testing. When DNA samples cross national boundaries for genetic testing services to be performed in another country, the heterogeneity of national legal frameworks raises important questions regarding quality of genetic services available internationally.Some aspects of the genetic laboratories’ services are abundantly discussed by the literature, among which (...) most prominent are quality control standards and patients rights. Firstly, a 2003 study identified key distinctions between the different legal frameworks for genetic services. While some countries impose exhaustive regulatory requirements, others favor guidelines for good practices. Moreover, proficiency assessment, clinical validity, retention of laboratory records and test reports are not dealt with uniformly. (shrink)

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 model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated (...) scrutiny at each stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing. (shrink)

Developments in biotechnology present difficult social and ethical challenges that need to be resolved by regulators among others. One crucial problem for regulators of new technologies is to ensure that regulation is both clear and sufficiently flexible to respond to new developments. This is particularly difficult to achieve in contentious fields such as medical biotechnology. In the European Union there is a divergence in the solutions to this problem which has lead to different regulatory frameworks for medical biotechnology. This (...) paper compares and contrasts the British and Dutch regulatory frameworks for the selection of embryos by preimplantation genetic diagnosis as an example of the regulation of medical biotechnology. Some of the outcomes of the regulatory choices and possible reasons behind the divergent frameworks are discussed, such as the ethical outlooks and political systems in these countries. (shrink)

In recent years, the EU legislation on genetically modified crops has come under severe criticism. Among the arguments are that the present legislation is inconsistent, disproportionate, obsolete from a scientific point of view, and vague in terms of its scope. In this paper, the EU GM legislation is analysed based on five proposed criteria: legal certainty, non-discrimination, proportionality, scientific adaptability, and inclusion of non-safety considerations. It is argued that the European regulatory framework does not at present satisfy the (...) criteria of legal certainty, non-discrimination, and scientific adaptability. Two ways of reforming the present legislation toward greater accommodation of the values expressed through the proposed criteria are briefly introduced and discussed. (shrink)

The application of genetic editing techniques for the prevention or cure of disease is a highly promising tool for the future of humanity. However, its implementation contains a number of ethical and legal challenges that should not be underestimated. On this basis, some sectors have already asked for a veto on any intervention that modifies the human germ line, while supporting somatic line editing. In this paper, I will support that this suggestion makes no sense at all, because the somatic/germ (...) line disjunctive has no moral relevance and, therefore, it should not play any role in legal terms. I will provide a number of reasons to hold this assumption, such as the non‐sacred nature of the germ line, the difference between germ line and human genome modification, or the moral importance of the presence of a will to create modified descendants. While doing so, I will provide some examples of the different approaches to germ line editing adopted by different regulations so as to demonstrate that, contrary to what is sometimes stated, a general ban on this practice is not the rule, but the exception. Additionally, I will show how alternative options which currently exist, such as a selective ban based on criteria different to the germ line/somatic line distinction, match better with the need to conciliate research needs and legitimate ethical concerns. Finally, I will introduce some further suggestions to this same purpose. (shrink)

Overall, the deregulation of genetically engineered (GE) crops for commercial cultivation in North America has been a success story. In several cases, however, GE crops have sparked concerns and disagreements among the stakeholders and there are incidences of court lawsuits, including a recent one on glyphosate resistant (GR) alfalfa (Medicago sativa, L.). While GE crops can provide operational benefits to farmers, challenges are looming from commercialization of perennial GE crops. The unique ecology and biology of these crops and GE alfalfa (...) in particular can facilitate adventitious presence (AP) of GE traits and it makes more visible that economic risks for conventional growers and food/feed producers have not been adequately addressed by the GE regulatory system in the United States (US). Asynchronous market approvals and the existence of a number of GE sensitive export markets create uncertainties among the exporters. Policy development in these fields may be helpful for ensuring a broader acceptance and market success of GE agriculture in general. The analysis is focusing on the US, although many diagnosed problems are also relevant to other jurisdictions—in particular if no co-existence policy is in place. (shrink)

There is increasing interest in the EU about the central place of eIdentity (eID) in people’s lives. eID is increasingly seen as a bridge between the commercial viability of models based on large-scale provision of e-services and users’ need for privacy and security in online transactions. This paper examines technological, social and legal developments in the field of eID and asks whether there is the need for a new regulatory framework that both preserves users’ identity and enables the (...) provision of advanced services. Firstly, the paper interprets recent market moves in the eID field as a response to a rising regulatory tide. Secondly, it examines some of the challenges arising from Web2.0, and four emerging socio-legal issues associated with eID—behavioural profiling, social engineering, redlining and other unsocial practices. Thirdly, the paper examines the capacity of the current regulatory framework to absorb this turbulence, and finds it wanting. Finally, it advances a novel model of eID regulation that may help regulators create an identity-preserving, transaction-friendly eID environment. (shrink)

In the UK, regulation of clinical services is being restructured. We consider two clinical procedures, abortion and IVF treatment, which have similar ethical and political sensitivities. We consider factors including the law, licensing, inspection, amount of paperwork and reporting requirements, the reception by practitioners and costs, to establish which field has the greater ‘regulatory burden’. We test them based on scientific, ethical, social, political factors that might explain differences. We find that regulatory burden borne by IVF services is (...) greater than in abortion, but none of the explanatory theses can provide a justification of this phenomenon. We offer an alternative explanation based on regulatory ‘overspill’ from research regulation and policy making, conceptualisation of risk regulation and a high public profile that locks a regulator into self-preservation. (shrink)

The presented paper focuses on the analysis of strategic documents at the level of the European Union concerning the regulation of artificial intelligence as one of the so-called disruptive technologies. In the first part of the article, we outline the basic terminology. Subsequently, we focus on the summarizing and systemizing of the key documents adopted at the EU level in terms of artificial intelligence regulation. The focus of the paper is devoted to issues of personal data protection and cyber security (...) included in these strategic documents. The final part contains recommendations for future research and evaluation of its key features. (shrink)

This paper elucidates and rationalizes the ethical governance system for healthcare AI research, as outlined in the ‘Research Ethics Guidelines for AI Researchers in Healthcare’ published by the South Korean government in August 2023. In developing the guidelines, a four-phase clinical trial process was expanded to six stages for healthcare AI research: preliminary ethics review (stage 1); creating datasets (stage 2); model development (stage 3); training, validation, and evaluation (stage 4); application (stage 5); and post-deployment monitoring (stage 6). Researchers identified (...) similarities between clinical trials and healthcare AI research, particularly in research subjects, management and regulations, and application of research results. In the step-by-step articulation of ethical requirements, this similarity benefits from a reliable and flexible use of existing research ethics governance resources, research management, and regulatory functions. In contrast to clinical trials, this procedural approach to healthcare AI research governance effectively highlights the distinct characteristics of healthcare AI research in research and development process, evaluation of results, and modifiability of findings. The model exhibits limitations, primarily in its reliance on self-regulation and lack of clear delineation of responsibilities. While formulated through multidisciplinary deliberations, its application in the research field remains untested. To overcome the limitations, the researchers’ ongoing efforts for educating AI researchers and public and the revision of the guidelines are expected to contribute to establish an ethical research governance framework for healthcare AI research in the South Korean context in the future. (shrink)

This chapter contains sections titled: What I s Regulation? How Should We Morally Evaluate Regulation? Welfarism; the Pareto Principle; Kaldor‐Hicks Efficiency versus Social Welfare Functions The Two Fundamental Theorems of Welfare Economics and the Market Failure Framework Externalities Public Goods and Monopoly Power The Coase Theorem Information and Paternalism as Rationales for Regulation Regulatory Forms and Regulatory Choice Criteria References.

Genetically engineered animals that are meant for release in the wild could significantly impact ecosystems given the interwoven or entangled existence of species. Therefore, among other things, it is all too important that regulatory agencies conduct entity appropriate, rigorous risk assessments that can be used for informed decision-making at the local, national and global levels about the release of those animals in the wild. In the United States, certain GE animals that are intended for release in the wild may (...) be regulated as new animal drugs by the Food and Drug Administration. This paper argues that the decision to treat them as new animal drugs is attributable to the influence of neoliberalism on the US biotechnology regulatory policy framework. The case is made that there should be public democratic deliberations and decision-making about the values and concerns that should guide the nation’s biotechnology regulatory policy paradigm, including the risk assessment process for GE animals meant for release in the wild. -/- . (shrink)

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

Legal structures may form barriers to, or enablers of, adoption of precision agriculture management with small autonomous agricultural robots. This article develops a conceptual regulatory framework for small autonomous agricultural robots, from a practical, self-contained engineering guide perspective, sufficient to get working research and commercial agricultural roboticists quickly and easily up and running within the law. The article examines the liability framework, or rather lack of it, for agricultural robotics in EU, and their transpositions to UK law, (...) as a case study illustrating general international legal concepts and issues. It examines how the law may provide mitigating effects on the liability regime, and how contracts can be developed between agents within it to enable smooth operation. It covers other legal aspects of operation such as the use of shared communications resources and privacy in the reuse of robot-collected data. Where there are some grey areas in current law, it argues that new proposals could be developed to reform these to promote further innovation and investment in agricultural robots. (shrink)

International regulation of autonomous weapon systems (AWS) is increasingly conceived as an exercise in risk management. This requires a shared approach for assessing the risks of AWS. This paper presents a structured approach to risk assessment and regulation for AWS, adapting a qualitative framework inspired by the Intergovernmental Panel on Climate Change (IPCC). It examines the interactions among key risk factors—determinants, drivers, and types—to evaluate the risk magnitude of AWS and establish risk tolerance thresholds through a risk matrix informed (...) by background knowledge of event likelihood and severity. Further, it proposes a methodology to assess community risk appetite, emphasizing that such assessments and resulting tolerance levels should be determined through deliberation in a multistakeholder forum. The paper highlights the complexities of applying risk-based regulations to AWS internationally, particularly the challenge of defining a global community for risk assessment and regulatory legitimization. (shrink)

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

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

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

Given the multiplicity of codes designed to regulate different stakeholders in terms of promoting good corporate governance, this paper examines areas of conflicts among the various codes and the associated implications for corporate governance practices and regulatory compliances by public-listed Nigerian firms. Using the conflict-signalling theory for developing the conceptual framework, this study examines the proliferation of codes in Nigeria, through a mixed method approach to provide an exploratory account of the implications of corporate governance regulatory multiplicity. (...) Evidence suggests the presence of conflict among the various codes which contributes to reduced compliance by firms and ineffective enforceability by regulatory agencies, which both impede good corporate governance in Nigeria. The findings advance conflict-signalling theory as an important framework for understanding the implications of the conflicts arising from the multiplicity of codes. (shrink)

How are we to appraise new technological developments that may bring revolutionary social changes? Currently this is often done by trying to predict or anticipate social consequences and to use these as a basis for moral and regulatory appraisal. Such an approach can, however, not deal with the uncertainties and unknowns that are inherent in social changes induced by technological development. An alternative approach is proposed that conceives of the introduction of new technologies into society as a social experiment. (...) An ethical framework for the acceptability of such experiments is developed based on the bioethical principles for experiments with human subjects: non-maleficence, beneficence, respect for autonomy, and justice. This provides a handle for the moral and regulatory assessment of new technologies and their impact on society. (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)

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

The prevalence of technology-embedded products, services, and cities, described colloquially as ‘smart’ technologies and ‘smart’ cities, has seen a spate of unprecedented growth in recent years. South Africa (SA) has not been left behind, with smartphones, smart watches, and smart voice-controlled virtual personal assistants such as Amazon’s Alexa now frequently used. But while these technologies hold great promise to revolutionise homes, offices and cities, their adoption poses challenges to individual and collective interests and wellbeing. After demonstrating the legal and ethical (...) difficulties brought about by the introduction of these technologies, this article explores whether SA legislation is sufficiently robust to address these challenges. While the current legislative landscape addresses certain crucial difficulties – such as the safeguarding of personal data by the Protection of Personal Information Act No. 4 of 2013 (‘POPIA’) – it is suggested that the position regulating other aspects of smart technology adoption is, in large part, fragmented and ill-equipped to deal with some of the more pressing legal and ethical questions. Our contention is that, not dissimilar to the issues arising from artificial intelligence-based technological adoption, the extant legislative and regulatory frameworks do not go far enough in addressing the many concerns emerging from recent novel technological design, development, and deployment. Not only do smart technologies give rise to unique challenges, so does their deployment within the Global South and in South Africa, in particular. We suggest that appropriate and effective regulatory reform measures be undertaken in SA to provide better ethical guidance and policy prescriptions buttressed by rigorous regulatory oversight. (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)

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)

The regulation of stem cell research is an issue that has drawn much comment, criticism and even judicial arbitration in recent years. An emerging issue, addressed in this article, is how the fruits of that research-stem cell medicine-are likely to be regulated en route from lab to market. Taking account of the ethical, legal, social and safety issues raised by stem cell medicine and the goals of governance, the article explains the relevant regulatory instruments (e.g. the draft UK Stem (...) Cell Bank Code, the EU Directive on Human Tissue, the EU Directives on medical products and devices, and the Human Tissue Act 2004) and critically examines the framework they provide. (shrink)

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)

Korean biobanks are now adapting to integrate the new paradigm of precision medicine into their fundamental role of promoting health technology. Since the enactment of Bioethics and Safety Act in 2004, the Republic of Korea has developed a regulatory framework that reflects ethical principles. However, the existing regulation of biobanks has recently proven to be limited in responding to newer ethical and legal issues that have arisen. First, as there is an emerging trend for human biospecimens to be (...) stored, managed and distributed as digitalized data, the current role of the Distributive Review Committee may become less important compared to the Data Access Committee. Second, even if public health data is anonymized, the risk of identifiability is growing. This makes a third point relevant, informed consent is crucial to respect the autonomy of patients and research subjects, but current consent rules need to change to reflect the interactive and dynamic communication process, in which information and communication technology plays an increasingly prominent role. Fourth, even though data sharing for research is expected to be altruistic and the sale of human biospecimens and genome data remains prohibited, data sharing practices have become more complicated and are closer to commercial use and commercialization. Given these challenges, there is a pressing need for continuing and deeper deliberation in order to develop a more comprehensive and responsive governance framework. (shrink)

Background: Biomedical research nowadays is increasingly carried out in multinational and multicenter settings. Due to disparate national regulations on various ethical aspects, such as informed consent, there is the risk of ethical compromises when involving human subjects in research. Although the Declaration of Helsinki is the point of reference for ethical conduct of research on humans, national normative requirements may diverge from its provisions. The aim of this research is to examine requirements on informed consent in biomedical research in Germany, (...) Poland, and Russia to determine how each national regulatory framework relates to the provisions of the Declaration of Helsinki. Methods: For this analysis, we conducted a search of the legal databases “Gesetze im Internet” for Germany, “Internetowy System Aktow Prawnych” for Poland, and “ГAPAHT – Garant” for Russia. The search was complemented by a review of secondary literature contained in the databases Google Scholar, PubMed, Polish National Library, and eLibrary ru. We have identified 21 normative regulations containing provisions on informed consent in clinical research in all three countries. The content of these documents was systematically categorized and analyzed. Results: The normative framework in all three countries shows a strong commitment towards the core ethical principles of research envisaged in the Declaration of Helsinki. Nevertheless, provisions on informed consent vary between these three countries. The differences range from the method and language in which information should be provided, through the amount of information required to be disclosed, to the form of documenting consent or withdrawal. In the case of research on vulnerable groups, these differences are particularly visible. Conclusions: The identified differences can negatively impact the ethical conduct of international clinical studies. Attention needs to be paid that flexibilities within national regulations are not misused to undermine the protection of research subjects. Achieving global or regional legislative harmonization might prove impossible. Such lack of legal consensus reinforces the significance of the international ethical agreements. (shrink)

Regulatory offences are a complex phenomenon, presenting problematic aspects both at the level of criminalisation and at the level of enforcement. The literature abounds in works that study the phenomenon. There is, however, an aspect that has remained largely unexplored. It concerns the relationship between the regulatory framework within which the crime occurs and the procedural safeguards that defendants normally enjoy at trial or at the pre-trial stage: defendants tried for regulatory offences are often denied safeguards (...) that are generally considered as important constituents of trial fairness. Relying on a new conceptualisation of regulatory offences, this paper advances a theory that justifies these exceptional rulings. (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)

This paper carries forward the conceptual clarification of normative theories of business ethics ably begun by Hasnas in the January 1998 issue of BEQ. This paper proposes a normatively neutral framework for discussing and assessing such normative theories. Every normative theory needs to address these seven issues: it needs to specify a moral principle that identifies (1) recommended values and (2) the grounds for accepting those values. It also must specify (3) a decision principle that business people who accept (...) the theory can use. It must determine (4) who the normative theory applies to and (5) whose interests need to be considered. It must also outline (6) in what contexts it applies, and (7) what legal and regulatory structures it assumes. Once clarified, this paper applies the framework to the normative versions of stockholder theory, stakeholder theory, and ISCT. It is concluded that ISCT is the most promising normative theory currently under discussion, but that there are some major issues that ISCT has not dealt with yet. (shrink)

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature (...) of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. (shrink)

In the light of several ongoing antitrust investigations in the E.U. and the U.S., the following research paper analyzes whether ‘big tech’ – same as the big banks – need special regulatory (and economic -political) attention and if so, how an updated form of regulatory policy for the digital era could look like. It does so by utilizing – and reviving – the normative and business -ethical ideals of German ‘neoliberalism’, also known as (classical) ordoliberalism. Especially, Walter Eucken’s (...) work has the potential to inform and enrich the current debate concerning the regulation of big tech. The main goal of the paper is to outline a potentially new regulatory framework – one that combines (and revises) Eucken’s ordoliberalism with the competition policy of the European Union. (shrink)

Cell and tissue-based products, such as autologous adult stem cells, are being prescribed by physicians across the world for diseases and illnesses that they have neither been approved for or been demonstrated as safe and effective in formal clinical trials. These doctors often form part of informal transnational networks that exploit differences and similarities in the regulatory systems across geographical contexts. In this paper, we examine the regulatory infrastructure of five geographically diverse but socio-economically comparable countries with the (...) aim of identifying similarities and differences in how these products are regulated and governed within clinical contexts. We find that while there are many subtle technical differences in how these regulations are implemented, they are sufficiently similar that it is difficult to explain why these practices appear more prevalent in some countries and not in others. We conclude with suggestions for how international governance frameworks might be improved to discourage the exploitation of vulnerable patient populations while enabling innovation in the clinical application of cellular therapies. (shrink)

ABSTRACTIt has been estimated that more than 80% of people in Africa use traditional medicine . With the HIV/AIDS epidemic claiming many lives in Africa, the majority of people affected rely on TM mainly because it is relatively affordable and available to the poor populations who cannot afford orthodox medicine. Whereas orthodox medicine is practiced under stringent regulations and ethical guidelines emanating from The Nuremburg Code,1 African TM seems to be exempt from such scrutiny. Although recently there have been calls (...) for TM to be incorporated into the health care system, less emphasis has been placed on ethical and regulatory issues.In this paper, an overview of the use of African TM in general, and for HIV/AIDS in particular, is given, followed by a look at: the relative laxity in the application of ethical standards and regulatory requirements with regards to TM; the importance of research on TM in order to improve and demystify its therapeutic qualities; the need to tailor‐make intellectual property laws to protect traditional knowledge and biodiversity. A framework of partnerships involving traditional healers’ associations, scientists, policy makers, patients, community leaders, members of the communities, and funding organizations is suggested as a possible method to tackle these issues. It is hoped that this paper will stimulate objective and constructive debate that could enhance the protection of patients’ welfare. (shrink)

The growing reliance on non-governmental independent regulators in many social and economic domains, including corporate financial reporting, has brought to the fore concerns over their regulatory accountability. This study looks at one aspect of the regulatory due process-regulatory impact assessment (IA). Drawing on the analytical framework developed by Bovens (Public accountability: a framework for the analysis and assessment of accountability arrangements in the public domain. CONNEX papers, Research Group 2, Democracy and Accountability in the EU, (...) 2006, Eur Law J 13(4): 447–468, 2007), we evaluate the contribution of IA as an instrument for enhancing regulatory accountability in the context of the Financial Reporting Council, an independent regulator for the accountancy profession in the UK. The study’s findings suggest that, despite an increasing level of sophistication in the manner in which IA is used within FRC, the contribution of IA to regulatory accountability remains limited. Specifically, there are concerns as to whether IA is used to achieve a transparent and fair regulatory process or simply to maintain an image of good governance and justify policy decisions that would have been made even in the absence of IA. (shrink)

Computational approaches in systems biology have become a powerful tool for understanding the fundamental mechanisms of cellular metabolism and regulation. However, the interplay between the regulatory and the metabolic system is still poorly understood. In particular, there is a need for formal mathematical frameworks that allow analyzing metabolism together with dynamic enzyme resources and regulatory events. Here, we introduce a metabolic-regulatory network model that allows integrating metabolism with transcriptional regulation, macromolecule production and enzyme resources. Using this model, (...) we show that the dynamic interplay between these different cellular processes can be formalized by a hybrid automaton, combining continuous dynamics and discrete control. (shrink)