Moving forward rapidly in the clinical research phase, uterus transplantation may be a future treatment option for women with uterine factor infertility, which accounts for three per cent of all infertility in women. This new method of treatment would allow women, who currently rely on gestational surrogacy or adoption, to gestate and birth their own genetic offspring. Since uterus transplantation carries significant risk when compared with surrogacy and adoption as well as when compared with other organ transplants, it requires greater (...) justification because its goals are quality of life, not life-saving, in their scope. It is important to address questions regarding the physical, psychosocial and ethical risks and benefits of uterus transplantation for all three parties involved—the patient, the donor and the potential child—as well as discuss the regulatory implications as research on uterus transplantations moves forward. (shrink)

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

The market for cosmetic surgery tourism is growing with an increase in people travelling abroad for cosmetic surgery. While the reasons for seeking cosmetic surgery abroad may vary the most common reason is financial, but does cheaper surgery abroad carry greater risks? We explore the risks of poorly regulated cosmetic surgery to society generally before discussing how harm might be magnified in the context of cosmetic tourism, where the demand for cheaper surgery drives the market and makes surgery accessible for (...) increasing numbers of people. This contributes to the normalisation of surgical enhancement, creating unhealthy cultural pressure to undergo invasive and risky procedures in the name of beauty. In addressing the harms of poorly regulated surgery, a number of organisations purport to provide a register of safe and ethical plastic surgeons, yet this arguably achieves little and in the absence of improved regulation the risks are likely to grow as the global market expands to meet demand. While the evidence suggests that global regulation is needed, the paper concludes that since a global regulatory response is unlikely, more robust domestic regulation may be the best approach. While domestic regulation may increase the drive towards foreign providers it may also have a symbolic effect which will reduce this drive by making people more aware of the dangers of surgery, both to society and individual physical wellbeing. (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)

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA (...) policy, we argue, does not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

A great deal has been made of the question of whether nano-materials provide a unique set of ethical challenges. Equally important is the question of whether they provide a unique set of regulatory challenges. In the last 18 months, the US Environmental Protection Agency has begun the process of trying to meet the regulatory challenge of nano using the Toxic Substances Control Act (1976)(TSCA). In this central piece of legislation, ‘newness’ is a critical concept. Current EPA (...) policy, we argue, does not adequately (or ethically) deal with the novelty of nano. This paper is an exploration of how to do a better job of accounting for nanomaterials as ‘new.’ We explore three alternative ways that nanomaterials might be made to fall under the TSCA regulatory umbrella. Since nanomaterials are of interest precisely because of the exciting new properties that emerge at the nano-scale, each of these three alternatives must meet what we call the ‘novelty condition’ and avoid what we call the ‘central paradox’ of existing regulatory policy. Failure to meet either of these conditions is a moral failure. We examine both the strengths and weaknesses of each alternative in order to illuminate the conceptual, practical, and moral challenges of novelty. (shrink)

International surrogacy is an increasingly common phenomenon and an important global health challenge. Legal rules are a key consideration for the participants in international surrogacy arrangements. In some cases the law can help to resolve the complex issues that arise in this context, but it is important to consider the role played by law in contributing to the complex conflicts that such arrangements can generate.

Lawyers tend to look to the law to resolve disputes and to create certainty about the rights and responsibilities of parties to relationships. There is a particularly acute need for certainty in the context of global trade in surrogacy services, both because of the number of parties who may be involved in creating familial relationships and because of the vulnerabilities created as a result of surrogacy arrangements. Participants in the Global Health Challenges conference were invited to consider to what (...) extent law is implicated in global health challenges — both in terms of how law might help to resolve the challenges, and, how law might contribute to or create these challenges. (shrink)

RESUMEN: En la era de las tecnologías digitales, el Derecho se enfrenta al objetivo de afrontar la protección de los datos personales en un universo global donde las fronteras se diluyen y el principio de territorialidad ha dejado de tener aplicación. Este trabajo pretende plantear el reto que supone, para el ordenamiento jurídico español, la adaptación a la nueva regulación europea en esta materia.ABSTRACT: At the digital´s technologies age, Law faces with the aim to address the personal data protection in (...) a global universe where blurring the borders, and the territoriality principle has ceased to be applied. This paper aims to poset he challenge that supposes, to the Spanish legal system, the adaptation to the new European Union regulation on this matter.PALABRAS CLAVE: universo digital, protección de datos personales, reglamento europeo, constitución española, conflictos de competenciaKEYWORDS: digital universe, personal data protection, european regulation, spanish constitution, competence´s conflicts. (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)

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

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

Polyphosphate (polyP) is a ubiquitous biomolecule thought to be present in all cells on Earth. PolyP is deceivingly simple, consisting of repeated units of inorganic phosphates polymerized in long energy‐rich chains. PolyP is involved in diverse functions in mammalian systems—from cell signaling to blood clotting. One exciting avenue of research is a new nonenzymatic post‐translational modification, termed lysine polyphosphorylation, wherein polyP chains are covalently attached to lysine residues of target proteins. While the modification was first characterized in budding yeast, recent (...) work has now identified the first human targets. There is significant promise in this area of biomedical research, but a number of technical issues and knowledge gaps present challenges to rapid progress. In this review, the current state of the field is summarized and existing roadblocks related to the study of lysine polyphosphorylation in higher eukaryotes are introduced. It is discussed how limited methods to identify targets of polyphosphorylation are further impacted by low concentration, unknown regulatory enzymes, and sequestration of polyP into compartments in mammalian systems. Furthermore, suggestions on how these obstacles could be addressed or what their physiological relevance may be within mammalian cells are presented. (shrink)

This Article examines what form the public/private distinction takes in contemporary legal consciousness. It proposes that while the public/ private distinction is still an important component of contemporary legal consciousness, the content of each sphere, their stability as distinct spheres, and their interaction with each other have significantly changed. This transformation occurred primarily due to the rise of the regulatory state and the increased visibility of the interconnectedness of the spheres due to public ordering of private activity in an (...) age of widespread privatization. The current state of the distinction challenges courts, when these are asked by petitioners to define the proper scope of the spheres and decide on their boundaries. The Article critically examines the Israeli High Court of Justice decision in a prison privatization case, as a case that reflects the mismatch between the traditional understanding of the public/private distinction and a much messier reality in which the private and public spheres keep changing, and intermingling in new ways. (shrink)

Increasingly, models have been highlighted that not only disadvantage society but those whom the model was originally designed to benefit. An increasing number of legal challenges around the world illustrates this. A surge of recent work has focussed on the technical, legal or regulatory challenges but not necessarily the real-world day to day challenges for practitioners such as data collection or fairness by design. Since the publication of the Holstein et al.’s study in 2019, additional legislation, (...) regulation and multiple bodies have been created to address practitioner challenge. This study asks what, if anything, has improved for practitioners between 2019 and 2022. Study 1 conducts an investigation into real-world needs within industry and asks whether practitioners are now able to mitigate challenges in a more robust manner. A further pilot study on the perception of AI examines whether perception of AI impacts practitioner work. The results show increasing and continuing interdisciplinary issues. Where increased regulation and legislation might have seemed reasonable, the result for practitioners is indecision and overwhelm. Based on these findings, we highlight directions for future research in this area. The most problematic area being human factors. (shrink)

In April 2018, Japan’s first law regulating clinical research went into effect. The law aimed to strengthen regulations on research integrity and conflicts of interest, which had been limited under existing administrative guidelines; the law also provided stipulations for legal penalties. The scope of the new regulations, however, is limited entirely to studies that evaluate unapproved drugs or the off-label use of approved drugs, and those that receive funding from companies. On the other hand, the law’s application brings numerous complications, (...) including the establishment of new review committees, troublesome procedures for transitioning studies that are currently underway, and ambiguities about the scope of what constitutes best efforts. Thus, the change has led to substantial strain and confusion in the field. This paper offers an overview of the law and its background, and discusses its future prospects from the practical standpoint of managing ethics committees and providing research ethics support in the field. (shrink)

This Article examines the regulatory 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 for regulatory models and constructs developed in the context of the industrial economy. Contemporary contests over the substance of regulatory mandates and the shape of regulatory institutions are most usefully understood as moves within a larger struggle to (...) chart a new direction for the regulatory state in the era of informational capitalism. A regulatory state optimized for the information economy must develop rubrics for responding to three problems that have confounded existing regulatory 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 develop institutions capable of exercising effective oversight of informationera activities. The information-era regulatory 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)

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.

Last month, a fifty-eight-year old man developed bleeding into his cheek and oozing from sites where previously he had had blood samples drawn. This bleeding was caused by disseminated intravascular coagulation, a complication of colon cancer that had spread to his liver and lungs. This complication occurred even though he was on chemotherapy for the cancer. In the hospital, he received transfusions and was administered medicine to stop the bleeding. However, his condition did not improve. He developed more bruises. When (...) he tried to go to the bathroom without assistance, he fell, struck his head, requiring stitches, and developed a black, swollen eye. The patient, a successful businessman, had already overcome another type of cancer—lymphoma—through chemotherapy, twenty-five years ago. In a few days, this dynamic individual who expected to start experimental chemotherapy now saw his quality of life deteriorate steadily.We talked about more chemotherapy, about hospice, and about withholding attempts at resuscitation if his heart should stop. (shrink)

Last month, a fifty-eight-year old man developed bleeding into his cheek and oozing from sites where previously he had had blood samples drawn. This bleeding was caused by disseminated intravascular coagulation, a complication of colon cancer that had spread to his liver and lungs. This complication occurred even though he was on chemotherapy for the cancer. In the hospital, he received transfusions and was administered medicine to stop the bleeding. However, his condition did not improve. He developed more bruises. When (...) he tried to go to the bathroom without assistance, he fell, struck his head, requiring stitches, and developed a black, swollen eye. The patient, a successful businessman, had already overcome another type of cancer—lymphoma—through chemotherapy, twenty-five years ago. In a few days, this dynamic individual who expected to start experimental chemotherapy now saw his quality of life deteriorate steadily.We talked about more chemotherapy, about hospice, and about withholding attempts at resuscitation if his heart should stop. (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 a “revolving door” between federal agencies and the industries regulated by them. Often, at the end of their industry tenure, key industry personnel seek employment in government regulatory entities and vice versa. The flow of workers between the two sectors could bring about good. Industry veterans might have specialized knowledge that could be useful to regulatory bodies and former government employees could help businesses become and remain compliant with regulations. But the “revolving door” also poses at (...) least three ethical and policy challenges that have to do with public trust and fair representation. First, the presence of former key industry personnel on review boards could adversely impact the public’s confidence in regulatory decisions about new technology products, including agrifood biotechnologies. Second, the ‘‘revolving door’’ may result in policy decisions about technologies that are biased in favor of industry interests. And third, the ‘‘revolving door’’ virtually guarantees industry a voice in the policy-making process, even though other stakeholders have no assurance that their concerns will be addressed by regulatory agencies. We believe these three problems indicate a failure of regulatory review for new technologies. The review process lacks credibility because, at the very least, it is procedurally biased in favor of industry interests. We argue that prohibiting the flow of personnel between regulatory agencies and industry would not be a satisfactory solution to the three problems of public trust and just representation. To address them, regulatory entities must reject the traditional notion of objectivity. Instead they should adopt the conception of objectivity developed by Sandra Harding and re-configure their regulatory review on the basis of it. That will ensure that a heterogeneous group of stakeholders is at the decision-making table. The fair representation of interests of different constituencies in the review process could do much to inspire warranted public confidence in regulatory protocols and decisions. (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)

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 and Regulatory 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)

Although much has been learned about hereditary mechanisms since Gregor Mendel’s famous experiments, gene concepts have always remained vague, notwithstanding their central role in biology. During over hundred years of genetic research, gene concepts have often and dynamically changed to accommodate novel experimental findings, without ever providing a generally accepted definition of the ‘gene.’ Yet, the distinction between ‘regulatory genes’ and ‘structural genes’ has remained a common theme in modern gene concepts since the definition of the operon-model. This distinction (...) is now challenged by recent findings which suggest that, at least in eukaryotes, structural genes may in many situations have a regulatory function that is independent of the function of the gene product (protein or non-coding RNA molecule). This brief paper discusses these new findings and some possible implications for the notion of the ‘regulatory gene.’. (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)

In this paper, we compare the two Global Reporting Initiative reporting standards, G3.1, and the most current version G4.0. We do this through the lens of political corporate social responsibility theory, which describes the broadened understanding of corporate responsibility in a globalized world building on Habermas’ notion of deliberative democracy and ethical discourse. As the regulatory power of nation states is fading, regulatory gaps occur as side effects of transnational business. As a result, corporations are also understood to (...) play a “political role” to fill regulatory gaps and contribute to a global governance system by voluntarily engaging in self-regulation. Such corporate political action, however, is not always legitimate as it suffers from a democratic deficit. Consistent with scholars in the field of political CSR, this paper argues that only by means of communication and discourse can this drawback be avoided. That is why CSR reporting and guidelines for standardizing the disclosed CSR information is key for political CSR. By comparing the GRI standards from a political CSR perspective, one can see whether these often-used reporting guidelines fulfill the communicative requirements and whether they are adequate tools to face the challenges of the twenty-first century. We present results from a theory-derived and criteria-driven comparison of the two guidelines. Indication of the effectiveness of voluntary self-regulation is, for example, important considering the 2014 directive of the European Union to make CSR reporting mandatory. We offer a guideline-based view on current CSR theory as well as CSR reporting practice. We discuss implications for CSR theory, particularly the appropriateness of deliberation in the Habermasian sense, which is the basis of political CSR theory. We do so by introducing the notion of “uncommitted deliberation” with regard to the refined concept of materiality in GRI 4.0, which induces subjectivity and reduces data-driven comparability. Finally, we address the limitations of this research as well as research questions for future studies. (shrink)

Abstract -/- The Crisis and Disaster Management process (CDMP) is composed of several clearly defined phases. Strategic risk assessment; preparation and planning, effective response and recovery, and post-crisis evaluation. It is essential for those facing such threats to understand, appreciate, and implement the appropriate responses for each phase. Public service organizations, or PSOs, are increasingly charged with additional duties and responsibilities that historically were not part of their original purview. PSOs are currently forced to operate within an environment of increasing (...) political unrest and social chaos. Events of international magnitude now impact the domestic environment. These organizations must deal with negative media, hostile public backlash, increased scrutiny, and calls for greater accountability. Service organizations are currently faced with increasing political and social chaos, with widespread civil unrest, domestic and international threats of terrorism, human trafficking and illegal migration, public health emergencies, natural disasters, and diverse climate-related challenges. These conditions have fostered additional layers of responsibility to already overburdened first responders and their civil support partners. The consequences are significant. These previously mentioned burdens are further compounded by budgetary constraints, greater regulatory compliance, and organizational accountability. In other words, agencies and departments are expected to do more with less, much more with much less. -/- DOI: 10.5772/intechopen.108408. (shrink)

Clinical research ethics consultation has emerged in the last 15 years as a service to those involved in the conduct of clinical research who face challenging issues for which more than one course of action may be justified. To respond to a growing field and need for opportunities to share knowledge and experience, the Clinical Research Ethics Consultation Collaborative, established in 2014, holds monthly webinars for its 90 members to present their most challenging cases to each other and engage in (...) substantive discussion. Every year, the group selects the four most interesting cases with accompanying commentaries for publication in the American Journal of Bioethics. This timely book brings together these cases and commentaries under a range of common themes for the first time, creating a permanent collection in book format that encourages and supports readers to gain a better understanding of the ethical challenges that they may face, and providing them with a convenient and reflective resource to reference in their own deliberations. Key Features- Comprehensive collection of cases and commentaries, chosen to reflect the range of issues faced by clinical researchers and oversight committees and illustrate the diversity of analysis that can arise. Supplemented by short introductions to each section. Focus on ethical rather than regulatory issues. Essential Reading for graduate students in bioethics and post-doctoral bioethics fellows, and useful for all participants in training grants that are funded by either NIH or NSF Presenting challenging cases to stimulate reflection, the book provides invaluable guidance to clinicians in training and in practice and to investigators, bioethics consultants, regulators, and oversight bodies. (shrink)

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)

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

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a (...) “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration and, second, the scheduling decisions made by the Drug Enforcement Administration. If a (...) “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin and began marketing it as an analgesic. (shrink)

There is little doubt that the development and commercialisation of nanotechnologies is challenging traditional state-based regulatory regimes. Yet governments currently appear to be taking a non-interventionist approach to directly regulating this emerging technology. This paper argues that a large regulatory toolbox is available for governing this small technology and that as nanotechnologies evolve, many regulatory advances are likely to occur outside of government. It notes the scientific uncertainties facing us as we contemplate nanotechnology regulatory matters and (...) then examines the notion of regulation itself, suggesting new ways to frame our understanding of both regulation and the regulatory tools relevant to nanotechnologies. By drawing upon three different conceptual lenses of regulation, the paper articulates a wide range of potential regulatory tools at hand. It also focuses particularly on the ways various tools are currently being used or perhaps may be employed in the future. The strengths and weaknesses characterising these tools is examined as well as the different actors involved. The paper concludes that we will increasingly face debate over what is likely to work most effectively in regulating nano technologies, the legitimacy of these different potential approaches, and the speed at which these different regimes may be employed. (shrink)

Organizations increasingly rely on algorithm-based HR decision-making to monitor their employees. This trend is reinforced by the technology industry claiming that its decision-making tools are efficient and objective, downplaying their potential biases. In our manuscript, we identify an important challenge arising from the efficiency-driven logic of algorithm-based HR decision-making, namely that it may shift the delicate balance between employees’ personal integrity and compliance more in the direction of compliance. We suggest that critical data literacy, ethical awareness, the use of participatory (...) design methods, and private regulatory regimes within civil society can help overcome these challenges. Our paper contributes to literature on workplace monitoring, critical data studies, personal integrity, and literature at the intersection between HR management and corporate responsibility. (shrink)

Those who write about pain management have focused almost entirely on delivery issues, paying essentially no attention to the federal regulatory challenges that affect the development of pain relief technologies — namely, pharmaceuticals and medical devices indicated for analgesic uses. The academic literature is strangely devoid of any sophisticated discussion of the difficulties that attend, first, the product approval decisions of the Food and Drug Administration (FDA) and, second, the scheduling decisions made by the Drug Enforcement Administration (DEA). (...) If a “bottleneck” develops upstream, it could have serious repercussions downstream — without pain relief technologies, the issues of access that have preoccupied previous commentators would have little practical consequence.The modern pharmaceutical industry traces its origins back more than a century, around the time that the German company Bayer first synthesized aspirin (acetylsalicylic acid) and began marketing it as an analgesic. (shrink)

In addition to ethical aspects Citizen Science projects also involve social, economic and—not least—regulatory challenges that arise from their very openness and opportunities for participation. So...