Regulatory governance frameworks have become essential building blocks of world society. From supply chains to the regimes surrounding international organizations, extensive governance frameworks have emerged which structure and channel a variety of social exchanges, including economic, political, legal and cultural, on a global scale. Against this background, this special issue sets out to explore the multifaceted meaning, potential and impact as well as the social praxis of regulatory governance. Under the notions rules, resistance and responsibility the (...) special issue pins out three overall dimensions of regulation and governance thereby providing a theoretical and conceptual framework for grasping the phenomenon of regulatory governance. This is combined with extensive case studies on a number of regulatory governance settings ranging from the World Bank to agricultural reforms carried by the International Transitional Administrations (ITAs) in Kosovo and Iraq as well as global supply chains and their impact on the garment industry in Bangladesh. (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)

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)

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)

The web is increasingly inhabited by the remains of its departed users, a phenomenon that has given rise to a burgeoning digital afterlife industry. This industry requires a framework for dealing with its ethical implications. We argue that the regulatory conventions guiding archaeological exhibitions could provide the basis for such a framework.

Fake news is a topic that we all know well, and that continues to play a prominent role in the social harms besieging the globe today. From the recent storming of the Capitol Hill in the United States to the siege of Red fort over Farm-laws in India, online disinformation via social media platforms was the main driving force catapulting the protestors far and wide. In the backdrop of such social harms, this Research Article examines the epistemic, legal and (...) class='Hi'>regulatory discourse surrounding the disinformation bubble in India and asks for the deployment of ‘Lessig’s Decentred Regulatory Model’ — the potential Framework solution to regulate social media platforms in order to curb the menace of ‘fake news’. (shrink)

As the world grapples with the urgent need for sustainable development, the transition towards green energy stands as a critical imperative. Financing this transition poses significant challenges, requiring innovative approaches that align financial objectives with environmental sustainability goals. This review presents a conceptual framework for leveraging data-driven techniques in sustainable finance to facilitate the transition towards green energy. The proposed framework integrates principles of sustainable finance with advanced data analytics to enhance decision-making processes across the financial ecosystem. At its core, (...) the framework emphasizes the importance of harnessing vast datasets related to energy production, consumption, environmental impact, and financial performance. By leveraging machine learning algorithms and predictive modeling techniques, financial stakeholders can gain deeper insights into the risks and opportunities associated with green energy investments. Key components of the framework include data collection and aggregation, risk assessment, impact measurement, and investment optimization. Data sources range from traditional financial indicators to environmental metrics, social impact assessments, and geopolitical factors. Through comprehensive data analysis, financial institutions can assess the long-term viability and sustainability of green energy projects, while also evaluating potential social and environmental impacts. Risk assessment methodologies within the framework consider both financial risks, such as market volatility and regulatory uncertainty, and non-financial risks, such as climate change impacts and community resilience. By integrating these factors into risk models, investors can make more informed decisions that mitigate potential losses and maximize returns. Furthermore, impact measurement tools enable stakeholders to quantify the environmental and social benefits of green energy investments. By tracking metrics such as carbon emissions reduction, energy efficiency improvements, and job creation, investors can assess the contribution of their portfolios towards broader sustainability objectives. Finally, the framework incorporates investment optimization strategies that align financial goals with environmental objectives. Through portfolio diversification, asset allocation, and innovative financial instruments such as green bonds and impact investing funds, financial institutions can allocate capital more efficiently towards green energy projects. The conceptual framework presented herein offers a systematic approach to integrating data-driven methodologies into sustainable finance practices. By leveraging advanced analytics and comprehensive datasets, financial stakeholders can drive the transition towards green energy while simultaneously achieving financial returns and positive environmental outcomes. (shrink)

This paper critically revises the organisational account of teleology, which argues that living systems are first and foremost oriented towards a goal: maintaining their own conditions of existence. It points out some limitations of this account, mainly in the capability to account for the richness and complexity of biological systems and their purposeful behaviours. It identifies the reason of these limitations in the theoretical grounding of this account, specifically in the too narrow notion of closure of constraints, focused on self-production. (...) It proposes to ground an organisational account of biological teleology in the capability of living system not just to produce and replace their parts, but to control their own internal dynamics and behaviours in such a way as to maintain themselves. This theoretical framework has two advantages. It better captures the distinctive features of biological organisations and consequently the richness and active nature of their purposeful behaviours. By doing so, it makes it possible to apply this framework beyond minimal theoretical models to real biological cases. (shrink)

We apply Ken Wilber's Integral Theory to AI governance, demonstrating its ability to systematize diverse approaches in the current multifaceted AI governance landscape. By analyzing ethical considerations, technological standards, cultural narratives, and regulatory frameworks through Integral Theory's four quadrants, we offer a comprehensive perspective on governance needs. This approach aligns AI governance with human values, psychological well-being, cultural norms, and robust regulatory standards. Integral Theory’s emphasis on interconnected individual and collective experiences addresses the deeper aspects of AI-related (...) issues. Additionally, we propose using Integral Theory as a methodology for literature reviews to overcome the fragmented understanding often seen in traditional reviews of AI governance. (shrink)

An increasing number of financial services (FS) companies are adopting solutions driven by artificial intelligence (AI) to gain operational efficiencies, derive strategic insights, and improve customer engagement. However, the rate of adoption has been low, in part due to the apprehension around its complexity and self-learning capability, which makes auditability a challenge in a highly regulated industry. There is limited literature on how FS companies can implement the governance and controls specific to AI-driven solutions. AI auditing cannot be performed in (...) a vacuum; the risks are not confined to the algorithm itself, but rather permeates the entire organization. Using the risk of unfairness as an example, this paper will introduce the overarching governance strategy and control framework to address the practical challenges in mitigating risks AI introduces. With regulatory implications and industry use cases, this framework will enable leaders to innovate with confidence. (shrink)

Since the sharing economy is a rather new phenomenon, there is still no official definition of it in the legal framework of Croatia. The continuous development of sharing economy started a few years after the 1998 global and domestic economic crisis stroked Croatia. Namely, a total of eight platforms in the sectors of transportation, accommodation, finance, and online skills could be identified. The total market share of these platforms amounts to estimated market revenue of roughly 106 million EUR. When compared (...) to the other EU Member States, it could be noticed that Croatia falls within the group of countries with a below-average performance by a number of platforms per 1 million population, as well as in the level of revenues compared to national GDP. Figures that are more promising can be detected regarding the collaborative economy’s contribution to national employment, which positions Croatia within the EU average. Future studies should explain in greater depth how the sharing economy poses several new challenges for regulators in Croatia and countries across the EU. In particular, policymakers must comprehend the big picture and provide regulatory guidelines to manage the long-term changes in job markets, public safety, competition, and digital trust. (shrink)

The dominant legal and regulatory approach to protecting information privacy is a form of mandated disclosure commonly known as “notice-and-consent.” Many have criticized this approach, arguing that privacy decisions are too complicated, and privacy disclosures too convoluted, for individuals to make meaningful consent decisions about privacy choices—decisions that often require us to waive important rights. While I agree with these criticisms, I argue that they only meaningfully call into question the “consent” part of notice-and-consent, and that they say little (...) about the value of notice. We ought to decouple notice from consent, and imagine notice serving other normative ends besides readying people to make informed consent decisions. (shrink)

Over time, research programs focusing on the processes that underlie dissonance and regret diverged to the point that the present literature only occasionally draws explicit connections between regret and consistency seeking processes. One of our aims in this chapter is to reestablish the connection between regret and consistency within the context of a theory that examines two independent factors that critically interact to enhance or diminish regret. The first of these is opportunity, which includes both perceptions of past opportunities to (...) make alternative choices and future opportunities to take corrective actions, and the second is mitigation, which is the ability to justify one's actions or otherwise engage regulatory processes that allow for the diminishment of regret. We examine both opportunity and mitigation separately before describing how the two may interact to elicit differential experiences of regret. (shrink)

The current ethical and regulatory framework for research is often charged with burdening investigators and impeding socially valuable research. To address these concerns, a growing number of research ethicists argue that informed consent should be adapted to the risks of research participation. This would require less rigorous consent standards in low-risk research than in high-risk research. However, the current discussion is restricted to cases of research in which the risks of research participation are outweighed by the potential clinical benefits (...) for the individual research participant. Furthermore, current proposals do not address the worry that risk-adapted informed consent may result in enrolling participants into research without their autonomous authorization. In this paper, we show how the standard view of informed consent – consent as autonomous authorization – can be adapted to risk even when the research does not have a favourable risk-benefit profile for the participant. Our argument has two important implications: first, it implies that current and proposed consent standards are not adequately calibrated to risk and, second, that consent standards also need to be adapted to factors other than risk. (shrink)

Typically, fair machine learning research focuses on a single decision maker and assumes that the underlying population is stationary. However, many of the critical domains motivating this work are characterized by competitive marketplaces with many decision makers. Realistically, we might expect only a subset of them to adopt any non-compulsory fairness-conscious policy, a situation that political philosophers call partial compliance. This possibility raises important questions: how does partial compliance and the consequent strategic behavior of decision subjects affect the allocation outcomes? (...) If k% of employers were to voluntarily adopt a fairness-promoting intervention, should we expect k% progress (in aggregate) towards the benefits of universal adoption, or will the dynamics of partial compliance wash out the hoped-for benefits? How might adopting a global (versus local) perspective impact the conclusions of an auditor? In this paper, we propose a simple model of an employment market, leveraging simulation as a tool to explore the impact of both interaction effects and incentive effects on outcomes and auditing metrics. Our key findings are that at equilibrium: (1) partial compliance by k% of employers can result in far less than proportional (k%) progress towards the full compliance outcomes; (2) the gap is more severe when fair employers match global (vs local) statistics; (3) choices of local vs global statistics can paint dramatically different pictures of the performance vis-a-vis fairness desiderata of compliant versus non-compliant employers; (4) partial compliance based on local parity measures can induce extreme segregation. Finally, we discuss implications for auditors and insights concerning the design of regulatory frameworks. (shrink)

One of the most prominent ethical concerns regarding emerging neurotechnologies is mental privacy. This is the idea that we should have control over access to our neural data and to the information about our mental processes and states that can be obtained by analyzing it. A key issue is whether this information needs more stringent protection than other kinds of personal information. I will articulate and support the view, underlying recent regulatory frameworks, that mental privacy requires a special (...) treatment because of its relation to relevant aspects of personal identity. It has been suggested that this approach could be supported by the idea that mental privacy constitutes a fundamental psychological dimension of privacy. The connection between this psychological view of privacy and identity can be traced back to Irwin Altman’s idea that privacy is an interpersonal boundary regulation process. However, it is not clear whether this notion of privacy can be associated with a conception of identity that is relevant in contemporary neuroethics. I will suggest that the narrative and relational approach to identity, a prominent view in recent ethical discussions of neurotechnology, lines up with key aspects of Altman’s proposal. I suggest that if mental privacy is an essential component of identity, the latter could be affected by technological mind-reading. (shrink)

As autonomous systems rapidly become ubiquitous, there is a growing need for a legal and regulatory framework that addresses when and how such a system harms someone. There have been several attempts within the philosophy literature to define harm, but none of them has proven capable of dealing with the many examples that have been presented, leading some to suggest that the notion of harm should be abandoned and “replaced by more well-behaved notions”. As harm is generally something that (...) is caused, most of these definitions have involved causality at some level. Yet surprisingly, none of them makes use of causal models and the definitions of actual causality that they can express. In this paper, which is an expanded version of the conference paper Beckers et al. (Neurips, 2022), we formally define a qualitative notion of harm that uses causal models and is based on a well-known definition of actual causality. The key features of our definition are that it is based on contrastive causation and uses a default utility to which the utility of actual outcomes is compared. We show that our definition is able to handle the examples from the literature, and illustrate its importance for reasoning about situations involving autonomous systems. (shrink)

I will open the first part of this paper by trying to elucidate the frequentist foundations of RCTs. I will then present a number of methodological objections against the viability of these inferential principles in the conduct of actual clinical trials. In the following section, I will explore the main ethical issues in frequentist trials, namely those related to randomisation and the use of stopping rules. In the final section of the first part, I will analyse why RCTs were accepted (...) for regulatory purposes. I contend that their main virtue, from a regulatory viewpoint, is their impartiality, which is grounded in randomisation and fixed rules for the interpretation of the experiment. Thus the question will be whether Bayesian trials can match or exceed the achievements of frequentist RCTs in all these respects. In the second part of the paper, I will first present a quick glimpse of the introduction of Bayesianism in the field of medical experiments, followed by a summary presentation of the basic tenets of a Bayesian trial. The point here is to show that there is no such thing as “a” Bayesian trial. Bayesianism can ground many different approaches to medical experiments and we should assess their respective virtues separately. Thus I present two actual trials, planned with different goals in mind, and assess their respective epistemic, ethical and regulatory merits. In a tentative conclusion, I contend that, given the constraints imposed by our current regulatory framework, impartiality should preside over the design of clinical trials, even at the expense of many of their inferential and ethical virtues. (shrink)

As Christian List (2021) has recently argued, the increasing arrival of powerful AI systems that operate autonomously in high-stakes contexts creates a need for “future-proofing” our regulatory frameworks, i.e., for reassessing them in the face of these developments. One core part of our regulatory frameworks that dominates our everyday moral interactions is blame. Therefore, “future-proofing” our extant regulatory frameworks in the face of the increasing arrival of powerful AI systems requires, among others things, that (...) we ask whether it makes sense to extend our blaming practices to these systems. In the paper, we argue for the admittedly surprising thesis that this question should be answered in the affirmative: contrary to what one might initially think, it can make a lot of sense to blame AI systems, since, as we furthermore argue, many of the important functions that are fulfilled by blaming humans can also be served by blaming AI systems. The paper concludes that this result gives us a good pro tanto reason to extend our blame practices to AI systems. (shrink)

The European project European and Latin American Systems of Ethics Regulation of Biomedical Research Project (EULABOR) has carried out the first comparative analysis of ethics regulation systems for biomedical research in seven countries in Europe and Latin America, evaluating their roles in the protection of human subjects. We developed a conceptual and methodological framework defining ‘ethics regulation system for biomedical research’ as a set of actors, institutions, codes and laws involved in overseeing the ethics of biomedical research on humans. This (...) framework allowed us to develop comprehensive national reports by conducting semi-structured interviews to key informants. These reports were summarised and analysed in a comparative analysis. The study showed that the regulatory framework for clinical research in these countries differ in scope. It showed that despite the different political contexts, actors involved and motivations for creating the regulation, in most of the studied countries it was the government who took the lead in setting up the system. The study also showed that Europe and Latin America are similar regarding national bodies and research ethics committees, but the Brazilian system has strong and noteworthy specificities. (shrink)

During the current financial crisis, the need for an alternative to a laissez-faire ethics of capitalism (the Milton Friedman view) becomes clear. I argue that we need an order ethics which employs economics as a key theoretical resource and which focuses on institutions for implementing moral norms. -/- I will point to some aspects of order ethics which highlight the importance of rules, e.g. global rules for the financial markets. In this regard, order ethics (“Ordnungsethik”) is the complement of the (...) German conception of “Ordnungspolitik” which also stresses the importance of a regulatory framework. This framework is needed not to tame the market, but to make it more profitable in the long run. -/- The conception of order ethics relies heavily on contractarianism, especially on James Buchanan’s work. Unlike many other conceptions of ethics, it does not start with an aim to achieve, but rather with an account of what the social world – in which ethical norms have to be implemented – is like. Our social world is different from the pre-modern one. Pre-modern societies played zero-sum games in which people could only gain significantly at the expense of others. And the types of ethics that we are still used to today have been developed within these pre-modern societies. -/- Modern societies, by contrast, can be characterised – by economists and other social theorists alike – as societies with continuous growth. This growth has only been made possible by the modern competitive market economy which enables everyone to pursue his own interests within a carefully devised institutional system. In this system, positive sum games are played, which makes it in principle possible to improve the position of every individual at the same time. Most kinds of ethics, however, resulting from the conditions of pre-modern societies, ignore the possibility of win-win-situations and instead require us to be moderate, to share, to sacrifice, as this would have been functional in zero-sum games. These conceptions distinguish – in more or less strict ways – between self-interest and altruistic motivation. Self-interest, more often than not, is ultimately seen as something evil. -/- Such an ethics cannot be functional in modern societies. Ethical concepts lag behind. Within zero-sum games, it was necessary to call for temperance, for moderate profits, or for a condemnation of lending money at interest. Within positive-sum games, however, the morally desired result of a social process cannot be brought about by changes in motivation, by switching from ‘egoistic’ to ‘altruistic’ motivation. The second theoretical element introduced by order ethics is the distinction between actions and rules, which was already mentioned. Traditional ethics concerns actions: It calls directly for changes in behaviour. This is a consequence of pre-modern conditions as reconstructed before: People in the pre-modern world were only able to control their actions, not so much however the conditions of their actions. In particular, rules like laws, constitutions, social structures, the market order, and also ethical norms have remained stable for centuries. In modern societies, this situation has changed entirely. The rules governing our actions have increasingly come under our control. -/- In this situation, ethics has to focus on rules. Morality must be incorporated in incentive-compatible rules. Direct calls for changes in behaviour without changes in the rules lead only to an erosion of compliance with moral norms. Individuals that continue to behave ‘morally’ will be singled out, because the incentives have not been changed. Moral norms which are to be justified cannot require people to abstain from pursuing their own advantage. People abstain from taking ‘immoral’ advantages only if adherence to ethical norms yields greater benefits over the planned sequence of actions than defection in the single case. Thus ‘abstaining’ is not abstaining in the long run, it is rather an investment in expectations of long-term benefits. By adhering to ethical norms, I become a reliable partner for interactions. The norms do indeed constrain my actions, but they simultaneously expand my options in interactions. And people consent to rules only if these rules hold greater advantages for them, at least in the long run. -/- In general, ethics cannot require people to abandon their individual calculation of advantages. However, it may suggest improving one’s calculation, by calculating in the long run rather than in the short run, and by taking into account the interests of our fellows, as we depend on their acceptance for reaching an optimal level of well-being, especially in a globalized world full of interdependence. -/- The problem of implementation can now be placed at the beginning of a conception of order ethics, justified with reference to the conditions of modern societies I have sketched. Under the conditions of pre-modern societies, an ethics of temperance had evolved that posed simultaneously the problems of implementation and justification. The implementation of well-justified norms or standards could then be regarded as unproblematic, because the social structures allowed for a direct face-to-face enforcement of norms. Pre-modern societies not only favored an ethics of temperance, they also had the instrument of face-to-face-sanctions within their smaller and non-anonymous communities. This instrument is no longer functional in modern anonymous societies, and so we have to face up to the problem of implementation right at the start of our ethical conception. Simultaneously, an order ethics relies on the implementation of sanctions for enforcing incentive-compatible rules. In modern societies, rules and institutions, to a large extent, must fulfil the tasks that were, in pre-modern times, fulfilled by moral norms, which in turn were sanctioned by face-to-face sanctions. Norm implementation in modern societies thus works by setting adequate incentives in order to prevent the erosion of moral norms, which would happen if ‘moral’ actors were systematically threatened with exploitation by other, less ‘moral’ actors. -/- This conception of order ethics is then elaborated further in the area of business ethics. -/- . (shrink)

This paper addresses global bioethical challenges entailed in emerging viral diseases, focussing on their socio-cultural dimension and seeing them as symptomatic of the current era of globalisation. Emerging viral threats exemplify the extent to which humans evolved into a global species, with a pervasive and irreversible impact on the planetary ecosystem. To effectively address these disruptive threats, an attitude of preparedness seems called for, not only on the viroscientific, but also on bioethical, regulatory and governance levels. This paper analyses (...) the global bioethical challenges of emerging viral threats from a dialectical materialist (Marxist) perspective, focussing on three collisions: (1) the collision of expanding networks of globalisation with local husbandry practices; (2) the collision of global networks of mobility with disrupted ecosystems; and (3) the collision of viroscience as a globalised research field with existing regulatory frameworks. These collisions emerge in a force field defined by the simultaneity of the non-simultaneous. Evidence-based health policies invoke discontent as they reflect the normative logic of a globalised knowledge regime. The development of a global bioethics or macro-ethics requires us to envision these collisions not primarily as issues of benefits and risks, but first and foremost as normative tensions closely entangled with broader socio-economic and socio-cultural developments. (shrink)

In The Future of Human Nature, Jürgen Habermas raises the question of whether the embryonic genetic diagnosis and genetic modification threatens the foundations of the species ethics that underlies current understandings of morality. While morality, in the normative sense, is based on moral interactions enabling communicative action, justification, and reciprocal respect, the reification involved in the new technologies may preclude individuals to uphold a sense of the undisposability of human life and the inviolability of human beings that is necessary for (...) their own identity as well as for reciprocal relations. Engaging with liberal bioethics and Catholic approaches to bioethics, the article clarifies how Habermas’ position offers a radical critique of liberal autonomy while maintaining its postmetaphysical stance. The essay argues that Habermas’ approach may guide the question of rights of future generations regarding germline gene editing. But it calls for a different turn in the conversation between philosophy and theology, namely one that emphasizes the necessary attention to rights violations and injustices as a common, postmetaphysical starting point for critical theory and critical theology alike. In 2001, Jürgen Habermas published a short book on questions of biomedicine that took many by surprise.[1] To some of his students, the turn to a substantive position invoking the need to comment on a species ethics rather than outlining a public moral framework was seen as the departure from the “path of deontological virtue,”[2] and at the same time a departure from postmetaphysical reason. Habermas’ motivation to address the developments in biomedicine had certainly been sparked by the intense debate in Germany, the European Union, and internationally on human cloning, pre-implantation genetic diagnosis, embryonic stem cell research, and human enhancement. He turned to a strand of critical theory that had been pushed to the background by the younger Frankfurt School in favor of cultural theory and social critique, even though it had been an important element of its initial working programs. The relationship of instrumental reason and critical theory, examined, among others, by Max Horkheimer, Theodor W. Adorno, and Herbert Marcuse and taken up in Habermas’ own Knowledge and Interest and Theory of Communicative Action became ever-more actual with the development of the life sciences, human genome analysis, and genetic engineering of human offspring. Today, some of the fictional scenarios discussed at the end of the last century as “science fiction” have become reality: in 2018, the first “germline gene-edited” children were born in China.[3] Furthermore, the UK’s permission to create so-called “three-parent” children may create a legal and political pathway to hereditary germline interventions summarized under the name of “gene editing.”In this article, I want to explore Habermas’ “substantial” argument in the hope that philosophy and theology become allies in their struggle against an ever-more reifying lifeworld, which may create a “moral void” that would, at least from today’s perspective, be “unbearable”, and for upholding the conditions of human dignity, freedom, and justice. I will contextualize Habermas’ concerns in the broader discourse of bioethics, because only by doing this, his concerns are rescued from some misinterpretations.[1] Jürgen Habermas, The Future of Human Nature.[2] Ibid., 125, fn. 58. 8[3] Up to the present, no scientific publication of the exact procedure exists, but it is known that the scientist, Jiankui He, circumvented the existing national regulatory framework and may have misled the prospective parents about existing alternatives and the unprecedented nature of his conduct. Yuanwu Ma, Lianfeng Zhang, and Chuan Qin, "The First Genetically Gene‐Edited Babies: It's “Irresponsible and Too Early”," Animal Models and Experimental Medicine ; Matthias Braun, Meacham, Darian, "The Trust Game: Crispr for Human Germline Editing Unsettles Scientists and Society," EMBO reports 20, no. 2. (shrink)

In the meantime, critically needed is a comprehensive regulatory framework that enables not only state-owned but also non-state enterprises to be able to issue a wide range of bonds legitimately. This move will certainly pave the way towards a functional corporate bond market and open up the funding channel for enterprises via bond issues.

Introduction In 2013, Dr. J. Muizelaar and Dr. R. Schrot, two neurosurgeons at the University of California Davis Medical Center (UCDMC), were found guilty of research misconduct due to failure to comply with institutional policies as well as Food and Drug Administration (FDA) regulations governing human subjects research. At issue here, however, is the difference between research and innovative therapy in the clinical setting of patient care where clinical judgment is reasonably to be privileged. Methods The UCDMC investigative document is (...) reviewed along with standard literature on clinical ethics and clinical data about glioblastoma multiforme (GBM) cancer. Results In this paper I argue that, by tendentiously focusing on policies, regulations, and procedures governing human subjects research, the UCDMC investigation failed to account for the centrality of clinical judgment and clinical ethics pertinent to judicious review of this matter, especially given the unique clinical context of terminally ill patients having exhausted standard care treatment options for glioblastoma multiforme (GBM) cancer. Conclusions The UCDMC investigation raises serious problems for clinicians who are engaged in innovative therapy in the clinical setting, requiring a regulatory framework separate from the normal Institutional Review Board (IRB) process. (shrink)

Ethical concerns in e-social science are often raised with respect to privacy, confidentiality, anonymity and the ethical and legal requirements that govern research. In this article, the authors focus on ethical aspects of e-research that are not directly related to ethical regulatory framework or requirements. These frameworks are often couched in terms of benefits or harms that can be incurred by participants in the research. The authors shift the focus to the sources of value in terms of which (...) benefits or harms are understood in real social situations. A central claim of this paper is that the technologies that are used for research are not value neutral, but serve to reinforce some values at the expense of others. The authors discuss databases, modelling and simulation, network analysis as examples of technologies which affect the articulation of values. A view of e-social science as a techno-scientific constellation of researchers, technologies and society, in which values are always already embedded, is put forward as a basis for a view of ethics as reflexive and active engagement, conducted with awareness. Methodological pluralism and proactive openness are also proposed as responses to this view of the ethical dimensions of e-social science. (shrink)

Evidence from jurisdictions that allow assisted dying is frequently used in the debate about assisted dying in the UK, since it provides important information about how assisted suicide and voluntary euthanasia work in practice. However, in order to interpret these data meaningfully, it is essential that they are understood in the context of the different legal and regulatory frameworks in operation in these countries. -/- The Commission on Assisted Dying has commissioned this expert briefing paper in order to (...) help unpick these complexities, and identify evidence for the effectiveness of the various legal safeguards that have been employed in jurisdictions that allow assisted dying. In the briefing paper the authors identify and explain the features of the legal regimes that regulate assisted dying in four target jurisdictions: the Netherlands, Belgium, Oregon and Switzerland. -/- They explore the evidence for the effectiveness of individual safeguards in each of these regimes in turn. Then they evaluate the evidence for the effectiveness of each safeguard, drawing on a detailed examination of the evidence, and, where possible, make recommendations on how these regimes could implement and regulate assisted dying more effectively. (shrink)

This contribution pays special attention to the Italian legal framework concerning the collaborative and sharing economy, with a focus on those economic initiatives which are platform mediated. This choice is due to the importance of the concept of “platform” in the definitions of the CSE provided at both the Italian and the European levels. As highlighted in some studies, most actors of the CSE can be considered not only economic disruptors but also policy disruptors. Thus, the chapter tries to shed (...) light on the difficulties Italian regulators had while dealing with the emergence of these actors, especially in sectors such as food, accommodation, delivery, and transport. Italian policymakers were not able to design new regulatory frameworks to cope with the challenges of CSE, privileging bans or almost total deregulation over the elaboration of innovative rules. Regarding the issue of digital labour, the Italian legislator adopted a partial solution, creating a framework that dualizes the labour market, maybe with the aim of satisfying both digital workers and platforms. Overall, it seems that the Italian ecosystem of the CSE is bound to evolve, especially after the appearance of the health crisis related to the COVID-19. (shrink)

This article suggests theoretical and methodological approach to corporate control system formation in Eastern Europe (case study of Ukraine). It considers historical and controversial aspects of corporate control implementation and suggests the systematization of subjects and objects in terms of corrective actions and outlines of corporate relations. Existing types of corporate control in Ukraine have been investigated on the basis of legal and regulatory framework and corporate practice. The article suggests measures in respect of management of the corporate control (...) system development, based on the improvement of certain components of corporate control implementation and structural peculiarities. (shrink)

Internal audit, management review, and account reconciliation are popular tools for combating corporate fraud, but whistle-blowing is the most prevalent. Whistle-blowers frequently fear reprisal from coworkers and bosses. That is why they require protection and support. Many international organizations have advocated that countries adopt regulatory frameworks for protecting whistle-blowers. Therefore, the current study investigates the notion of whistle-blowing to compare it to Public Interest Disclosure Act 2017 of Pakistan, which was enacted. It identifies the influence of legal and (...) ethical cultural norms in organizations on whistle-blowing behaviour. (shrink)

In general, CEO turnover has been researched widely following numerous studies in developed countries. Nevertheless, the determinants of CEO turnover are still unclear in transition countries of which the legal and regulatory framework are weak and financial systems and corporate govemance are underdeveloped. Therefore, examining determinants of CEO turnover in Vietnam, a transition country, helps to provide more evidence on the efficiency and effectiveness of corporate governance in transition countries. Furthermore, the examination helps to define weaknesses, and it, therefore, (...) could provide guidance to improve corporate governance in Vietnamese enterprises. (shrink)

In Slovenia, the collaborative economy is in the early stages of development. The collaborative economy became a popular topic in 2015 when the government intensified its efforts to initiate a debate on legal reforms that would better accommodate foreign collaborative economy companies in Slovenia. While in 2016, the government was actively working on the topic and eager to start the discussions on legal reform in line with the European agenda for the collaborative economy since 2018, the issue has lost its (...) momentum. After the Act Amending the Hospitality Act was adopted, the government has slowed down its efforts to create a regulatory framework conducive to the needs of the collaborative economy. Nevertheless, the practice is becoming more and more common, with several sharing initiatives surfacing in the past few years. Most collaborative economy services are not yet subject to taxation and regulation, one of the most pressing questions that will have to be answered in Slovenia is how to regulate and tax the collaborative economy. (shrink)

Since the International Agency on Cancer Research’s monograph found glyphosate to be a likely carcinogen, the regulatory focus on the chemical has centred on this determinative criterion for regulatory action. Yet, other pertinent factors, such as the effects of glyphosate on fresh and ground water and ensuing effects on biodiversity, have received less attention as legitimate rationales for regulating the chemical. This underrepresentation prevents a wider policy discussion on the environmental and human health effects of the chemical and (...) fails to disrupt assumptions of path-dependently continuing on agriculture’s chemical treadmill. To avoid ad hoc post hoc chemical regulation, we assess four areas of chemical regulatory oversight in Europe with regard to glyphosate affecting water: (1) the undue emphasis on in laboratorio versus in situ testing; (2) assessing single chemicals (isolated glyphosate) versus admixtures (glyphosate plus surfactants and adjuvants) that are used in practice; (3) the tendency to downplay harms to non-human life; and (4) the lack of policy coherence in the existing regulatory framework. Focusing on European Union regulation of pesticide and water policy affecting aquatic environments, we conclude that issues of measurement and priority have become highly politicised in both science and policy, requiring preventative, precautionary frameworks utilising plural forms of measurement. (shrink)

The concept of Sustainable Public Procurement (SPP) has attracted the interests of academics, practitioners, policymakers and the media recently. The interest can be attributed to the strategic role of purchasing and supply chain as a lever for sustainable development. Despite the enormous amount of funds spent on public procurements in South Africa annually, tender irregularities, corrupt practices, non-compliance and lack of knowledge, casts doubts on its role in fostering sustainable development. An in-depth literature review on SPP implementation was adopted to (...) analyse the manner in which sustainability could be realised through regulation, implementation and monitoring compliance of relevant environmental policy instruments. This approach is used to determine how due consideration of sustainable procurement has been used as a tool to enhance social, economic and environmental sustainability. This article notes that in many developed and developing countries, the dare need of technical and management competence, cultural assimilation, high costs of funding sustainable procurement projects and transparency on the part of managers among others are sighted as factors plaguing the growth of sustainable procurement practices in most institutions. Further, this paper puts forth the argument that implementation of sustainable procurement policies alone, will not necessarily help in the achievement of the developmental objectives, but due consideration should be given to capacity building and collaboration with relevant units of government, whilst also integrating social and economic policies, into the formulation of tender documents and selection of suppliers. This paper posits that to overcome these challenges faced by South Africa, it is important that all stakeholders including the government, researchers and other agencies should construct a synergy capable of addressing salient issues for progressive sustainable procurement policies and actions, through the incorporation of sustainable procurement practices into the mainstream of both the public and private organisations through relevant legislations, policies and regulatory frameworks. (shrink)

Background: Besides regulatory learning skills, learning also requires students to relate to their social context and negotiate it as they transition and adjust to medical training. As such, there is a need to consider and explore the role of social and cultural aspects in student learning, particularly in problem-based learning, where the learning paradigm differs from what most students have previously experienced. In this article, we report on the findings of a study exploring first-year medical students’ experiences during the (...) first semester of an undergraduate problem-based learning medical program at an African medical school. Method: We employed a qualitative case study approach using in-depth interviews with 23 first-year medical students. Participants ranged in age from 18 to 25 years. All students were bi/multilingual (some spoke three to five languages), with English as the learning language. We conducted an inductive thematic analysis to systematically identify and analyze patterns in the data using the Braun and Clarke framework. Results: Before medical school, students worked hard to compete for admission to medical school, were primarily taught using a teacher-centered approach, and preferred working alone. At the beginning of medical school, students found it challenging to understand the problem-based learning process, the role of the case, speaking and working effectively in a group, managing a heavy workload, and taking increased responsibility for their learning. By the end of the first semester, most students were handling the workload better, were more comfortable with their peers and facilitators, and appreciated the value of the problem-based learning approach. Conclusions: Our study highlights the importance of interrogating contextual sociocultural factors that could cause tension when implementing problem-based learning in non-western medical schools. Adjustment to problem-based learning requires a conceptual and pedagogic shift towards learner-centered practice, particularly concerning self direction, the role of the case, and collaborative learning. As such, there is a need to develop and implement research informed learning development programs that enable students to reflect on their sociocultural beliefs and practices, and enhance their regulatory learning competence to optimize meaningful and early engagement with the problem based learning process. (shrink)

Abstract: As the integration of Artificial Intelligence (AI) continues to permeate various sectors, the legal domain stands on the cusp of a transformative era. This research paper delves into the multifaceted relationship between AI and the law, scrutinizing the profound implications and innovative applications that emerge at the intersection of these two realms. The study commences with an examination of the current landscape, assessing the challenges and opportunities that AI presents within legal frameworks. With an emphasis on efficiency, accuracy, (...) and accessibility, AI technologies are reshaping traditional legal processes, ranging from document analysis and contract review to predictive legal analytics. Furthermore, the paper scrutinizes the ethical considerations and potential biases inherent in AI algorithms, exploring the delicate balance between technological advancements and the preservation of legal principles such as fairness, accountability, and transparency. The research also delves into the evolving role of legal professionals in navigating and overseeing AI applications, emphasizing the importance of responsible AI deployment. Drawing on case studies and real-world examples, this paper showcases instances where AI has already demonstrated its efficacy in legal contexts, highlighting successful implementations and identifying areas for improvement. The discussion extends to the evolving regulatory landscape, as legal systems grapple with the need to adapt and establish frameworks that ensure the responsible and ethical use of AI technologies. In conclusion, this research contributes to the growing discourse on the dynamic interplay between AI and the legal domain. By illuminating the potential benefits, ethical considerations, and regulatory challenges, it provides a comprehensive overview for legal practitioners, policymakers, and technologists alike, fostering a nuanced understanding of the evolving landscape where artificial intelligence intersects with the law. (shrink)

In July 2014, the roboticist Ronald Arkin suggested that child sex robots could be used to treat those with paedophilic predilections in the same way that methadone is used to treat heroin addicts. Taking this onboard, it would seem that there is reason to experiment with the regulation of this technology. But most people seem to disagree with this idea, with legal authorities in both the UK and US taking steps to outlaw such devices. In this paper, I subject these (...) different regulatory attitudes to critical scrutiny. In doing so, I make three main contributions to the debate. First, I present a framework for thinking about the regulatory options that we confront when dealing with child sex robots. Second, I argue that there is a prima facie case for restrictive regulation, but that this is contingent on whether Arkin’s hypothesis has a reasonable prospect of being successfully tested. Third, I argue that Arkin’s hypothesis probably does not have a reasonable prospect of being successfully tested. Consequently, we should proceed with utmost caution when it comes to this technology. (shrink)

The weaponizing of scientific expertise to oppose regulation has been extensively studied. However, the relevant studies, belonging to the emerging discipline of agnotology, remain focused on the analysis of empirical corruption: of misinformation, doubt mongering, and other practices that cynically deploy expertise to render audiences ignorant of empirical facts. This paper explores the wrongful deployment of expertise beyond empirical corruption. To do so, I develop a broader framework of morally subversive expertise, building on recent work in political philosophy (Howard, 2016). (...) Expertise is subversive if it sets up its audience to fail morally, either intentionally or negligently. I distinguish three modes of subversive expertise: empirical subversion (the focus of agnotology), normative subversion and motivational subversion. Drawing on these distinctions, I offer a revisionary account of the Trump Administration’s regulatory science as a case study. I show that the Trump Administration’s use of expertise to dismantle climate regulation, contra the standard charge, cannot be explained using the resources of agnotology alone: the Administration produced highly reliable climate assessments, detailing the risks of climate change, candidly admitting the harms of its proposed policies, and still successfully deployed these findings to justify massive climate deregulation. The lesson of the analysis is that dismissing the expertise that underpins climate deregulation as empirically corrupt ‘anti-science’ both obscures its actual role in the politics of climate change and understates its wrongfulness: it misses the breadth of the assault on moral agency that sustains climate injustice. (shrink)

Although religious belief is often claimed to help with physical ailments including pain, it is unclear what psychological and neural mechanisms underlie the influence of religious belief on pain. By analogy to other top-down processes of pain modulation we hypothesized that religious belief helps believers reinterpret the emotional significance of pain, leading to emotional detachment from it. Recent findings on emotion regulation support a role for the right ventrolateral prefrontal cortex, a region also important for driving top-down pain inhibitory circuits. (...) Using functional magnetic resonance imaging in practicing Catholics and avowed atheists and agnostics during painful stimulation, here we show the existence of a context-dependent form of analgesia that was triggered by the presentation of an image with a religious content but not by the presentation of a non-religious image. As confirmed by behavioral data, contemplation of the religious image eneabled the religious group to detach themselves from the experience of pain. Critically, this context-dependent modulation of pain specifically engaged the right VLPFC, whereas group-specific preferential liking of one of the pictures was associated with activation in the ventral midbrain. We suggest that religious belief might provide a framework that allows individuals to engage known pain-regulatory brain processes. (shrink)

The advent of Generative AI, particularly through Large Language Models (LLMs) like ChatGPT and its successors, marks a paradigm shift in the AI landscape. Advanced LLMs exhibit multimodality, handling diverse data formats, thereby broadening their application scope. However, the complexity and emergent autonomy of these models introduce challenges in predictability and legal compliance. This paper analyses the legal and regulatory implications of Generative AI and LLMs in the European Union context, focusing on liability, privacy, intellectual property, and cybersecurity. It (...) examines the adequacy of the existing and proposed EU legislation, including the Artificial Intelligence Act (AIA), in addressing the challenges posed by Generative AI in general and LLMs in particular. The paper identifies potential gaps and shortcomings in the EU legislative framework and proposes recommendations to ensure the safe and compliant deployment of generative models. (shrink)

This article reviews research on counterfactual, social, and temporal comparisons and proposes a Reflection and Evaluation Model (REM) as an organizing framework. At the heart of the model is the assertion that 2 psychologically distinct modes of mental simulation operate during comparative thinking: reflection, an experiential (“as if”) mode of thinking characterized by vividly simulating that information about the comparison standard is true of, or part of, the self; and evaluation, an evaluative mode of thinking characterized by the use of (...) information about the standard as a reference point against which to evaluate one’s present standing. Reflection occurs when information about the standard is included in one’s self-construal, and evaluation occurs when such information is excluded. The result of reflection is that standard–consistent cognitions about the self become highly accessible, thereby yielding affective assimilation; whereas the result of evaluation is that comparison information is used as a standard against which one’s present standing is evaluated, thereby yielding affective contrast. The resulting affect leads to either an increase or decrease in behavioral persistence as a function of the type of task with which one is engaged, and a combination of comparison-derived causal inferences and regulatory focus strategies direct one toward adopting specific future action plans. (shrink)

In this paper, we assess the impact of extended reality technologies as they relate to sexual forms of harassment. We begin with a brief history of the nature of sexual harassment itself. We then offer an account of extended reality technologies focusing specifically on psychological and hardware elements most likely to comprise what has been referred to as “the metaverse”. Although different forms of virtual spaces exist (i.e., private, semi-private, and public), we focus on public social metaverse spaces. We do (...) this to better explain how the concept of sexual harassment must be adjusted to such spaces and how approaches aimed at mitigating harassment must be sensitive to the type of metaverse spaces users utilize. We then offer a typology of sexual harassment for the metaverse focusing on three distinct forms of sexual harassment: (1) invariant (2) mixed variance or modified and (3) unique or metaverse specific. Although existing normative and legal frameworks may function well with respect to the first and, possibly, second forms of harassment, we argue such frameworks will not helpfully address metaverse-specific harassment. Ultimately, the changing nature of privately owned public spaces (POPS) which metaverses are likely to represent pose distinct ethical and regulatory challenges. (shrink)

Healthcare systems across the globe are struggling with increasing costs and worsening outcomes. This presents those responsible for overseeing healthcare with a challenge. Increasingly, policymakers, politicians, clinical entrepreneurs and computer and data scientists argue that a key part of the solution will be ‘Artificial Intelligence’ (AI) – particularly Machine Learning (ML). This argument stems not from the belief that all healthcare needs will soon be taken care of by “robot doctors.” Instead, it is an argument that rests on the classic (...) counterfactual definition of AI as an umbrella term for a range of techniques that can be used to make machines complete tasks in a way that would be considered intelligent were they to be completed by a human. Automation of this nature could offer great opportunities for the improvement of healthcare services and ultimately patients’ health by significantly improving human clinical capabilities in diagnosis, drug discovery, epidemiology, personalised medicine, and operational efficiency. However, if these AI solutions are to be embedded in clinical practice, then at least three issues need to be considered: the technical possibilities and limitations; the ethical, regulatory and legal framework; and the governance framework. In this article, we report on the results of a systematic analysis designed to provide a clear overview of the second of these elements: the ethical, regulatory and legal framework. We find that ethical issues arise at six levels of abstraction (individual, interpersonal, group, institutional, sectoral, and societal) and can be categorised as epistemic, normative, or overarching. We conclude by stressing how important it is that the ethical challenges raised by implementing AI in healthcare settings are tackled proactively rather than reactively and map the key considerations for policymakers to each of the ethical concerns highlighted. (shrink)

The CRISPR system for gene editing can break, repair, and replace targeted sections of DNA. Although CRISPR gene editing has important therapeutic potential, it raises several ethical concerns. Some bioethicists worry CRISPR is a prelude to a dystopian future, while others maintain it should not be feared because it is analogous to past biotechnologies. In the scientific literature, CRISPR is often discussed as a revolutionary technology. In this paper we unpack the framing of CRISPR as a revolutionary technology and contrast (...) it with framing it as a value-threatening biotechnology or business-as-usual. By drawing on a comparison between CRISPR and the Ford Model T, we argue CRISPR is revolutionary as a product, process, and as a force for social change. This characterization of CRISPR offers important conceptual clarity to the existing debates surrounding CRISPR. In particular, conceptualizing CRISPR as a revolutionary technology structures regulatory goals with respect to this new technology. Revolutionary technologies have characteristic patterns of implementation, entrenchment, and social impact. As such, early identification of technologies as revolutionary may help construct more nuanced and effective ethical frameworks for public policy. (shrink)

The Adverse Outcome Pathway (AOP) concept is a knowledge assembly and communication tool to facilitate the transparent translation of mechanistic information into outcomes meaningful to the regulatory assessment of chemicals. The AOP framework and associated knowledgebases (KBs) have received significant attention and use in the regulatory toxicology community. However, it is increasingly apparent that the potential stakeholder community for the AOP concept and AOP KBs is broader than scientists and regulators directly involved in chemical safety assessment. In this (...) paper we identify and describe those stakeholders who currently—or in the future—could benefit from the application of the AOP framework and knowledge to specific problems. We also summarize the challenges faced in implementing pathway-based approaches such as the AOP framework in biological sciences, and provide a series of recommendations to meet critical needs to ensure further progression of the framework as a useful, sustainable and dependable tool supporting assessments of both human health and the environment. Although the AOP concept has the potential to significantly impact the organization and interpretation of biological information in a variety of disciplines/applications, this promise can only be fully realized through the active engagement of, and input from multiple stakeholders, requiring multi-pronged substantive long-term planning and strategies. (shrink)

The United States Fish and Wildlife Service in Alaska, USA, conducted a species status assessment for a petition to list the Alexander Archipelago wolf (Canis lupus ligoni) under the Endangered Species Act in 2020-2022. This federal undertaking could not be adequately prepared without including the knowledge of Indigenous People who have a deep cultural connection with the subspecies. Our objective is to communicate the authoritative expertise and voice of the Indigenous People who partnered on the project by demonstrating how their (...) knowledge contributed to the species status assessment. The Indigenous knowledge applied in the assessment is the cultural and intellectual property of those who have shared it. We employed rapid appraisal research to expeditiously develop a preliminary and qualitative understanding of Indigenous People's cultural and ecological knowledge of Alexander Archipelago wolves. We used semi-directed interviewing and inductive coding from grounded theory for text analysis. Indigenous knowledge contributed to the agency's understanding of the Alexander Archipelago wolf in Southeast Alaska and helped the agency with their classification decision. Indigenous research partners explained the rich cultural significance and position of wolves in Tlingit society and described human–wolf relationships and ecological interactions. The agency used a single-species assessment approach based in species ecology and conservation biology, whereas the Indigenous wolf experts applied a multi-species, community ecology approach based in a sociocultural context of balance and respect. The Indigenous wolf experts successfully addressed knowledge gaps identified by the agency. The partners were challenged by a short regulatory timeframe that did not allow for comprehensive study of Indigenous knowledge and constrained review and feedback by Indigenous experts. The United States Fish and Wildlife Service learned that its assessment framework was not designed to account for an Indigenous worldview. To level the playing field, the agency and Indigenous experts should discuss how to co-develop an assessment framework that equitably applies both perspectives. (shrink)

Are universities justified in trying to regulate student use of cognitive enhancing drugs? In this article I argue that they can be, but that the most appropriate kind of regulatory intervention is likely to be voluntary in nature. To be precise, I argue that universities could justifiably adopt a commitment contract system of regulation wherein students are encouraged to voluntarily commit to not using cognitive enhancing drugs. If they are found to breach that commitment, they should be penalized by, (...) for example, forfeiting a number of marks on their assessments. To defend this model of regulation, I adopt a recently-proposed evaluative framework for determining the appropriateness of enhancement in specific domains of activity, and I focus on particular existing types of cognitive enhancement drugs, not hypothetical or potential forms. In this way, my argument is tailored to the specific features of university education, and common patterns of usage among students. It is not concerned with the general ethical propriety of using cognitive enhancing drugs. (shrink)

Research misconduct remains an important problem in health research despite decades of local, national, regional, and international efforts to eliminate it. The ultimate goal of every health research project, irrespective of setting, is to produce trustworthy findings to address local as well as global health issues. To be able to lead or participate meaningfully in international research collaborations, individual and institutional capacities for research integrity are paramount. Accordingly, this paper concerns itself not only with individuals’ research skills but also with (...) institutional and national policies and governance. Such policies and governance provide an ethical scaffold for the production of knowledge and structure incentives. This paper’s operational definition of research therefore draws from Institute of Medicine’s articulation of health research as an inquiry that aims to produce knowledge about the structure, processes, or effects of personal health services; and from an existing health systems framework. The paper reviews the research regulatory environment and the ethics apparatus in Ghana, and describes a project jointly undertaken by Ghanaian researchers in collaboration with New York University to assess the perceived adequacy of current institutional practices, opportunities, and incentives for promoting RI. (shrink)

This contribution explores disability rights protection in Inter-American States within the framework of the OAS and in the context of the obligations established under the CIADDIS and the CRPD. Following the classical division between ‘primary’ and ‘secondary’ rules, the contribution first sketches key regulatory initiatives in the area of disability rights and second considers compliance and enforcement mechanisms. Along these lines, the first section illustrates similarities and differences between the CIADDIS and the CRPD and, within this framework, essential regional (...) regulatory initiatives. The second section assesses disability rights in select countries, based on periodic reports under the CIADDIS and CRPD. The section examines the four largest countries by population in the region, notably, the United States of America (US), Mexico, Brazil and Colombia. The third section explores the enforcement of disability rights via key cases before the Inter-American Commission on Human Rights (IAComHR) and the Inter-American Court of Human Rights (IACtHR). The purpose is providing a comprehensive understanding of disability rights in the region and identifying key regulatory problems and ways forward. (shrink)

A large proportion of the total global burden of disease is caused by emergency medical conditions. Emergency care research is essential to improving emergency medicine but this research can raise some distinctive ethical challenges, especially with regard to (1) standard of care and risk–benefit assessment; (2) blurring of the roles of clinician and researcher; (3) enrolment of populations with intersecting vulnerabilities; (4) fair participant selection; (5) quality of consent; and (6) community engagement. Despite the importance of research to improve emergency (...) care in low-income and middle-income countries (LMICs) and the widely acknowledged ethical challenges, very little has been written on the ethics of emergency care research in LMICs. This paper examines the ethical and regulatory challenges to conducting emergency care research with human participants in LMICs. We outline key challenges, present potential solutions or frameworks for addressing these challenges, and identify gaps. Despite the ethical and regulatory challenges, conducting high-quality, ethical emergency care research in LMICs is possible and it is essential for global health. (shrink)