This work examines the development and performance of federal independent regulatory bodies in Canada in the period up to 1979, with particular attention to the operation of legislative schemes that include executive review and appeal powers. The author assesses the impact of the exercise of these powers on the administrative law process, and proposes new models for the generation, interpretation, implementation, review, and enforcement of regulatory policy. The study includes a series of representative case studies based on (...) documentation and extensive interviews with individuals drawn from government, agencies, and other parties, including counsel for public interest groups. This enables author, writing from her experience as a participant-observer embedded in the public interest legal sector, to draw on the experiences and perspectives of a broad range of participants in the regulatory process, including but not limited to those dealing with the regulated energy, transportation, communications, and foreign investment sectors. Legal principles identified as emergent in leading judicial decisions in administrative law are used to assess the powers and practices used in executive reviews and appeals. The author finds those powers and practices to be flawed and proposes changes. The proposed models are designed to accord with emerging legal principles and avoid flaws of the types identified in the review and appeal provisions. This work, written under contract with the Administrative Law Project of the Law Reform Commission of Canada, formed one part of a comprehensive study of administrative law at the federal level in Canada. (shrink)

This paper examines the creation of independent agencies within the EU, such as the European Environment Agency and the European Central Bank. Majone and others have argued the case for European regulatory agencies. Such agencies can provide for continuity, expertise, accountability and effective authority – in short, an institutionalisation of responsibility. Against this optimism, I argue that a dilemma of institutional design naturally arises from the agencies’ situation in the EU. On the one side, (...) we risk creating powerful agencies that institutionalise monomania– that is, agencies that single-mindedly and all-too-effectively pursue narrow agendas, inadequately checked by other bodies. On the other, we are also likely to encounter relatively impotent agencies which institutionalise schizophrenia– that is, agencies that must scout around for audience and support, and hence are unable to act effectively. (shrink)

In all countries where health care access is considered a social right, regulation is both a tool of performance improvement as well as an instrument of social justice. Both social (equity in access) and economical (promoting competition) regulation are at stake due to the nature of the good itself. Different modalities of regulation do exist and usually new regulatory cycles include the creation of stronger regulatory agencies. Indeed, health care regulation is rising steadily in most developed countries (...) as a consequence of the introduction of the New Public Management perspective to provide essential public goods.Health care is delivered by different organisations with very different cultural backgrounds—public and private (profit and non-profit)—that should be accountable for their decisions. Control by regulatory agencies is instrumental to accomplish this goal. However, there is some dispute with regards the degree of regulatory autonomy. The objective of this paper is to determine if independent regulatory agencies (IRAs) are effective in carrying out health care regulation. The authors apply Walshe’s analytical framework to the Regulatory Authority of Health (Portugal) to answer the question if independent regulation works.In conclusion, the two year experience of the Regulatory Authority of Health is important not only because the primary goals of independent regulation were achieved but also because this authority is now a full partner in the health care sector. However, independent agencies need to develop strong mechanisms of accountability because good regulatory governance is the paradigm of this institutional innovation. (shrink)

The increasing costs of healthcare delivery led to different political and administrative approaches trying to preserve the core values of the welfare state. This approach has well documented weaknesses namely with regard to healthcare rationing. The objective of this paper is to evaluate if independent healthcare regulation is an important tool with regard to the construction of fair processes for setting limits to healthcare. Methodologically the authors depart from Norman Daniels’ and James Sabin’s theory of accountability for reasonableness and (...) try to determine if new regulatory models—namely independent agencies—perform better with regard to the public disclosure of the reasons and rationales of healthcare rationing. In publicly financed healthcare systems independent regulation is an important tool to assure fair and reasonable procedures of prioritising services. In accordance with the principle of public accountability, independent regulatory agencies are particularly well suited to assure publicity of the decision-making processes, relevance of the rationale involved and particularly mechanisms for challenge and dispute resolution regarding limit setting decisions. It follows that independent healthcare regulation could be regarded not only as an instrument for performance improvement but also as a tool of social justice. The authors conclude by stating that accountability for reasonableness should be regarded as a landmark of any healthcare reform. And therefore regulators have the social task of assuring that the rationales for limit-setting decisions are clearly accessible to the public. (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)

The formation of the chaplaincy movement in the context of the formation of independent Ukraine (after 1991) required the solution of a number of issues, primarily of a conceptual nature. The initiators of the restoration of chaplaincy faced the underestimation of the chaplaincy factor, the risks of transferring interfaith disputes to the military environment. In fact, it was a question of finding their own model of chaplaincy service, which would provide an optimal model for organizing the work of chaplains. (...) The authors propose to divide the development of the chaplaincy movement in independent Ukraine into three stages, which differ not only chronologically but also in their characteristics. The first stage (1991-2005) was characterized by a rethinking of the role and place of religion in the activities of the Armed Forces of Ukraine. The idea of a chaplaincy service was revived primarily on the basis of the volunteer movement. Volunteers also encouraged churches to form appropriate structures that would be responsible for chaplaincy work. At this stage, the driving force behind the formation of the chaplaincy movement was the unstable informal ties between church and security forces in Ukraine. With the advent of the first legal acts that regulated the search for optimal models for creating the chaplaincy institute, the second stage of development of the chaplaincy movement in Ukraine began. It lasted from 2006 to 2013. During this time, regulations were developed and implemented that institutionalized the relationship between the Ministry of Defense of Ukraine and the country's largest churches and religious organizations. The third stage began with the beginning of the Russian Federation's attack on Ukraine in 2014 and continues to this day. The annexation of Crimea and the outbreak of hostilities in eastern Ukraine created the need to sharply increase the number of chaplains and to legalize them in military institutions. Already in 2015-2016, the formation of the state regulatory framework of the chaplaincy institute began and staff positions of chaplains in military units were introduced. On the other hand, there has also been a qualitative growth in the theoretical and practical training of chaplains and their material support. These processes show that the establishment of the institute of military chaplaincy in Ukraine has actually taken place. In each period, the authors highlight the problematic issues that government agencies and religious organizations addressed in organizing the chaplaincy movement. Particular attention was paid to the attempts of activists to form their own model of chaplaincy ministry and the problematic issues of improving the quality of chaplains' training. In particular, it was pointed out that the best way for Ukraine is to organize separate chaplaincy faculties in the country's higher educational institutions to train specialists at the level of world standards. (shrink)

This essay explains how to use the calculus of consent framework to think more rigorously about self-governance, and applies this framework to the issue of evaluating federal regulatory agencies. Robust political economy is the idea that institutions should be designed to work well even under weak assumptions about decision-makers’ knowledge and benevolence. I show how the calculus of consent can be used to analyze both incentives and knowledge problems. The calculus is simultaneously a theory of self-governance and a (...) tool for robust political economy analysis. Applying this framework to the case of public administration leads to the conclusion that private goods (such as medicine) tend to be over-regulated, public goods tend to be under-regulated (such as enabling too much pollution), and regulatory agencies tend to be over-centralized (and should in most cases either be replaced with certification markets or moved to state level). (shrink)

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

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

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

The lack of economic sustainability of most healthcare systems and a higher demand for quality and safety has contributed to the development of regulation as a decisive factor for modernisation, innovation and competitiveness in the health sector. The aim of this paper is to determine the importance of the principle of public accountability in healthcare regulation, stressing the fact that sunshine regulation—as a direct and transparent control over health activities—is vital for an effective regulatory activity, for an appropriate supervision (...) of the different agents, to avoid quality shading problems and for healthy competition in this sector. Methodologically, the authors depart from Kieran Walshe’s regulatory theory that foresees healthcare regulation as an instrument of performance improvement and they articulate this theory with the different regulatory strategies. The authors conclude that sunshine regulation takes on a special relevance as, by promoting publicity of the performance indicators, it contributes directly and indirectly to an overall improvement of the healthcare services, namely in countries were citizens are more critical with regard to the overall performance of the system. Indeed, sunshine regulation contributes to the achievement of high levels of transparency, which are fundamental to overcoming some of the market failures that are inevitable in the transformation of a vertical and integrated public system into a decentralised network where entrepreneurialism appears to be the predominant culture. (shrink)

(1990). Arts councils as organized anarchies and de facto regulatory agencies: Some comments on the bureaucratization of artistic production. World Futures: Vol. 28, Cross-Cultural Dialogue, pp. 217-223.

This study examines the influence of board independence on firm agency cost among listed firms in Bangladesh, which feature concentrated ownership and high insider representation on corporate boards. This study uses three measures of agency cost: the ‘expense ratio’, the ‘Q-free cash flow interaction’ and the ‘asset utilization ratio’. The finding of the study is that board independence can reduce the firm agency cost only under ‘asset utilization ratio’ measure of agency cost. These findings are robust to several robustness tests. (...) Furthermore, the non-linearity tests suggest that the benefit of outside independent directors is generally plausible as a factor controlling agency costs in the case of a medium level of board independence. Overall, these findings do not reject the validity of agency theory, supporting the Anglo-American orthodoxy promoting outside independent directors as good monitors. (shrink)

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

The National Institute for Health and Clinical Excellence (hereafter NICE) was created in 1998 to give guidance on which treatments should be provided by the British National Health Service, and to whom. So it has a crucial role as an agent of distributive justice. In this paper I argue that it is failing to adequately explain and justify its decisions in the public arena, particularly in terms of distributive justice; and that this weakens its legitimacy, to the detriment of the (...) National Health Service as a whole. I argue that this failure arises from the fact that NICE works within the frameworks of positivist science and liberal ethics, largely to the exclusion of other perspectives. This narrowness of view prevents NICE from properly connecting with the range of moral concerns represented in the population. I argue for NICE’s deliberations to become more inclusive, both in terms of epistemology, and also in terms of ethical perspectives. And I suggest a range of perspectives that could usefully be included. Finally I offer a framework of structures, philosophies and discussion process that will enable competing perspectives to be debated fairly and productively in this process. (shrink)

We investigate the regulatory sanctions imposed on independent directors for their firms’ financial frauds in China. These regulatory sanctions are prima-facie evidence of significant lapses in business ethics. During the period 2003–2010, 302-person-time independent directors were penalized by the regulator, and the two stock exchanges. We find that the independent directors with accounting experiences are more likely to be penalized by the CSRC, though they do not suffer more severe penalties than do the other sanctioned (...) independent directors. We also find that independent directors suffer less severe penalties than do the insider directors. These results are consistent with the hypothesis that the sanctions on independent directors are tied to their assumed ethical and legal responsibilities. Following a regulatory sanction, penalized independent directors experience a significant decline in the number of other board seats held. However, they can gain board seats in better quality firms. We find that interlocked firms that share penalized independent directors with the fraud firm do not suffer from a valuation decline. Overall, our results suggest that regulatory sanctions have not triggered further sanctions on the penalized directors in the labor market but they have, instead, created a disincentive for these directors to serve on the company boards of high-risk firms. (shrink)

Pharmaceutical paternalism is the normative stance upheld by pharmaceutical regulatory agencies like the US Food and Drug Administration. These agencies prevent patients from accessing treatments declared safe and ineffective for the patient’s good without their consent. Libertarian critics of the FDA have shown a number of significant flaws in regulatory paternalism. Against these objections, I will argue that, in order to make an informed decision about treatments, a libertarian patient should request full disclosure of the uncertainty (...) about an experimental treatment. But pharmaceutical markets, on their own, are not a reliable source of information about such uncertainty. And companies have the power to capture any independent expert who may assess it. Therefore, the libertarian is better off deferring on an independent regulatory body the assessment of the pharmaceutical risks, constraining access to treatments until tested. (shrink)

In this article, we look at the contested role of in-house lawyers in regulated organisations in the financial sector. A recent Financial Conduct Authority consultation on whether to designate the head of legal of banks, insurance companies and other financial firms as ‘Senior Managers’ and the decision which flowed from it, reflected a flawed view of lawyers as a neutral technocracy of mere legal technicians; we show how the FCA’s decision is potentially damaging to the public interest and failed to (...) take into account that in-house lawyers are often important decision-makers and influencers within their organisations. We put the case for an alternative view; that in-house lawyers are professionals, with agency that requires them to act in accordance with ethical norms and means they should be made more accountable for their conduct. (shrink)

American policymakers delegate the administration of many welfare programs to states, where officials implement them in increasingly diverse ways. Welfare state scholarship has little to say about this subnational policy divergence, and it portrays the complexity of delegated governance as a barrier to nonelite legislative influence. Drawing on an ethnographic study of one state’s Medicaid program, this article shows that delegated governance offers ample opportunity for nonelite influence and policy divergence, but through regulatory governance rather than legislative advocacy. Medicaid (...) is opaque to politicians, whose inability to monitor program details creates conditions of bureaucratic autonomy and even activism: health-care agency personnel sequence regulatory tweaks to protect and expand entitlements. But budget cuts, outsourcing, and fraught provider relations also deprive bureaucrats of street-level know-how, and bureaucrats depend on beneficiaries’ advocates who selectively illuminate a path to reform. A full rendering of subnational divergence in American federalism requires attention to underexamined factors such as bureaucratic activism, agency advocacy, and regulatory governance. (shrink)

This article examines conflicts of interest in the context of scientific research related to regulation or litigation. The article defines conflicts of interest, considers how conflicts of interest can impact research, and discusses different strategies for dealing with conflicts of interest. While it is not realistic to expect that scientific research related to regulation or litigation will ever be free from conflicts of interest, society should consider taking some practical steps to minimize the impact of these conflicts, such as requiring (...) full disclosure of information required for independent evaluation of research, prohibiting financial relationships between regulatory agencies and the companies they regulate, and banning payments to expert witnesses for specific research results, testimony or legal outcomes. (shrink)

This paper explores versions of agency or manipulability theories of causation and argues that they are unacceptable both for the well-known reasons of their anthropomorphism, limited scope, and circularity and because they are subsumed by an alternative "independence" theory of causation, which is free of these difficulties.

Many mental phenomena involve thinking about people who do not exist. Imagined characters appear in planning, dreams, fantasizing, imaginary companions, bereavement hallucinations, auditory verbal hallucinations, and as characters created in fictional narratives by authors. Sometimes these imagined persons are felt to be completely under our control, as when one fantasizes about having a great time at a party. Other times, characters feel as though they are outside of our conscious control. Dream characters, for example, are experienced by dreamers as autonomous (...) entities, and often do things that frighten and surprise dreamers. Some imagined persons, such as characters in fiction, start off under conscious control of the author, but over time, can appear to gain an illusion of independent agency. I propose an explanation for different autonomy attributions: characters are by default non-autonomous, unless their personalities are well-practiced. Characters become autonomous because modeling their thinking has become automatized, like many other well-practiced activities. (shrink)

The objective of this paper is to present a legal theory of agency selection. The theory posits why certain legal forms of agency are chosen when agencies are created by the executive branch of government. At the core of the theory is the idea that the executive branch chooses agency forms that strike a politically optimal balance between maximising its control while minimising its legal and political accountability for agency activities. This optimal balance is determined on an issue by (...) issue basis. As such, the rise of the regulatory state has provided a means by which the executive branch of government has been able to strategically choose to divest itself of and minimise its legal accountability for the administration of government while, at the same time, maintaining effective political control of the administrative arm of government. (shrink)

This book argues that the negotiation of agency is central not only to the experience of war but also to its representation in cultural expressions, ranging from a notion of disablement, expressed in victimization, immobilization, traumatization, and death, to enablement, expressed in the perpetration of heroic, courageous, skillful, and powerful actions of assertion and dominance. In order to illustrate this thesis, it provides a comprehensive analysis of literary representations of the American War of Independence from 1775, the beginning of the (...) war, up until roughly 1860, when the Civil War marked a decisive historical turning point. As the first national war, it has an unquestionably exemplary status for the development of American conceptions of war. The in-depth study of exemplary texts from a variety of genres and by authors like Thomas Paine, Benjamin Franklin, James Fenimore Cooper, Catharine Sedgwick, William Gilmore Simms, and Herman Melville, demonstrates that the overall character of Revolutionary War literature presents the war as a forum in which collective and individual agency is expressed, defended, and cultivated. It uses the military environment in order to teach the values of discipline and self-subordination to a communal good, which are perceived as basic principles of a Republican virtue to guide the actions of the autonomous individual in a popular democracy. (shrink)

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically (...) from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention has adopted guidelines that require Common Rule review for “research” but not “practice” activities. (shrink)

Insulators play a central role in subdividing the chromosome into a series of discrete topologically independent domains and in ensuring that enhancers and silencers contact their appropriate target genes. In this review we first discuss the general characteristics of insulator elements and their associated protein factors. A growing collection of insulator proteins have been identified including a family of proteins whose expression is developmentally regulated. We next consider several unexpected discoveries that require us to completely rethink how insulators function (...) (and how they can best be assayed). These discoveries also require a reevaluation of how insulators might restrict or orchestrate (by preventing or promoting) interactions between regulatory elements and their target genes. We conclude by connecting these new insights into the mechanisms of insulator action to dynamic changes in the three‐dimensional topology of the chromatin fiber and the generation of specific patterns of gene activity during development and differentiation. (shrink)

We argue that the transition from unicellular to multicellular systems raises important conceptual challenges for understanding agency. We compare several MC systems displaying different forms of collective behavior, and we analyze whether these actions can be considered organismically integrated and attributable to the whole. We distinguish between a ‘constitutive’ and an ‘interactive’ dimension of organizational complexity, and we argue that MC agency requires a radical entanglement between the related processes which we call “the constitutive-interactive closure principle”. We explain in detail (...) that this is not possible without a regulatory center functionally integrating the two dimensions, and we also argue that, in turn, this type of regulation would not be possible without a special type of organization between the cells required for the development and maintenance of systems capable of integrated behavior. (shrink)

No one questions the importance of protecting human subjects of research, but over the past few years dissatisfaction has surfaced with the manner in which the protection is conferred by the federal regulatory system referred to as “The Common Rule. ” Some of the criticism surfaces in print. Some bubbles out anecdotally in conversations among researchers, with complaints about the review process being virtually inevitable whenever the topic arises. Like those in other disciplines that differ more or less dramatically (...) from the world of clinical medical research around which the Common Rule was conceptualized, public health researchers, particularly those working in official public health agencies, have experienced some tension and difficulty in adapting to the rules. The Centers For Disease Control and Prevention has adopted guidelines that require Common Rule review for “research” but not “practice” activities. (shrink)

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

There has been much debate whether computers can be responsible. This question is usually discussed in terms of personhood and personal characteristics, which a computer may or may not possess. If a computer fulfils the conditions required for agency or personhood, then it can be responsible; otherwise not. This paper suggests a different approach. An analysis of the concept of responsibility shows that it is a social construct of ascription which is only viable in certain social contexts and which serves (...) particular social aims. If this is the main aspect of responsibility then the question whether computers can be responsible no longer hinges on the difficult problem of agency but on the possibly simpler question whether responsibility ascriptions to computers can fulfil social goals. The suggested solution to the question whether computers can be subjects of responsibility is the introduction of a new concept, called “quasi-responsibility” which will emphasise the social aim of responsibility ascription and which can be applied to computers. (shrink)

The aim of this exploratory paper is to review an under-appreciated parallel between group agency and artificial intelligence. As both phenomena involve non-human goal-directed agents that can make a difference to the social world, they raise some similar moral and regulatory challenges, which require us to rethink some of our anthropocentric moral assumptions. Are humans always responsible for those entities’ actions, or could the entities bear responsibility themselves? Could the entities engage in normative reasoning? Could they even have rights (...) and a moral status? I will tentatively defend the (increasingly widely held) view that, under certain conditions, artificial intelligent systems, like corporate entities, might qualify as responsible moral agents and as holders of limited rights and legal personhood. I will further suggest that regulators should permit the use of autonomous artificial systems in high-stakes settings only if they are engineered to function as moral (not just intentional) agents and/or there is some liability-transfer arrangement in place. I will finally raise the possibility that if artificial systems ever became phenomenally conscious, there might be a case for extending a stronger moral status to them, but argue that, as of now, this remains very hypothetical. (shrink)

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

Many ethicists writing about automated systems attribute agency to these systems. Not only that; they seemingly attribute an autonomous or independent form of agency to these machines. This leads some ethicists to worry about responsibility-gaps and retribution-gaps in cases where automated systems harm or kill human beings. In this paper, I consider what sorts of agency it makes sense to attribute to most current forms of automated systems, in particular automated cars and military robots. I argue that whereas it (...) indeed makes sense to attribute different forms of fairly sophisticated agency to these machines, we ought not to regard them as acting on their own, independently of any human beings. Rather, the right way to understand the agency exercised by these machines is in terms of human–robot collaborations, where the humans involved initiate, supervise, and manage the agency of their robotic collaborators. This means, I argue, that there is much less room for justified worries about responsibility-gaps and retribution-gaps than many ethicists think. (shrink)

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

Brazil is the biggest market for pesticides in the world. In the registration process, a pesticide must be authorized by the Institute of the Environment, Health Surveillance Agency and Ministry of Agriculture. Evaluations follow a package of toxicological studies submitted by the companies and also based on the Brazilian law regarding pesticides. We confronted data produced by private laboratories, submitted to the Institute of the Environment for registration, with data obtained from scientific databases, corresponding to mutagenicity, carcinogenicity and teratogenicity of (...) pesticides. All studies submitted by the companies were carried out by private laboratories. From 247 pesticide formulations analyzed, none showed positive results for mutagenicity, carcinogenicity or teratogenicity. From 574 articles in the scientific literature, 84% published by public laboratories showed positive results, while 79% of those showing negative results came from private laboratories. There is an ethical concern about a conflict of interest between public/independent laboratories and private laboratories that produce data for registering pesticides. We demonstrated that there is a clear contradiction between public and private laboratories. Brazilian regulatory authorities have approved the registration of pesticides based almost exclusively on the monographs provided by the pesticide industry, because the use of scientific articles or information from the independent literature is strongly belittled by the industry. Pesticide companies argue that scientific articles cannot be trusted. Also, according to the industry, pesticide registration cannot be refused based on results from scientific articles. Thus, the registration of pesticides with mutagenic, carcinogenic and teratogenic risks has been approved in Brazil. (shrink)

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

This article examines the artistic potential of forms of image-making that involve registering the features of real objects using mind-independent processes. According to skeptics, these processes limit an agent’s intentional control over the features of the resultant “automatic images,” which in turn limits the artistic potential of the work, and the form as a whole. I argue that this is true only if intentional control is understood to mean that an agent produces the features of the work by their (...) own bodily movements alone. Not only is this an unrealistic standard to uphold, but I show that a definition of intentional control based on the skeptic’s position does not prohibit an agent from realizing the features of an image by means beyond their own actions. An agent can exercise intentional control over the features of an image if they successfully anticipate the effect that the remote consequences of their actions will have on these. This, I argue, entails that to exert intentional control over the features of an image is to exercise “creative agency,” which is a species of executive agency. Consequently, I defend the idea that the origin of automatic images in creative agency grounds their artistic significance. (shrink)

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

Medicines regulators have generally adopted a scientistic view of medicines evaluation, which they present as an exercise that should—and indeed can—be purely “objective,” based only on knowledge produced through validated research protocols. The growing body of social science literature analyzing the regulation of medicines has questioned this pretense of objectivity and underlined the socio-political construction of evidence on the risks and benefits of medicines. But while the European Medicines Agency has become the dominant regulatory body in Europe and a (...) key player at world level, very few studies have investigated its actual practices. Based on interviews with European regulators, but also on direct observations of several meetings of the European Medicines Agency’s main expert committee, this article aims to analyze how regulatory knowledge is defined and then transformed into regulatory decisions. First, it describes the main characteristics of European medicines regulation and the historical definition of what can count as “objective” evidence on the safety and efficacy of medicines. Second, it demonstrates that experts use many different types of knowledge in building their opinions: the results of studies, but also knowledge about firms’ past and present strategies, about patients’ needs and future behavior, about the state of research and clinical practices, and about legal and policy-making issues. Third, it explains why, in spite of the various forms of knowledge involved, experts manage to produce consensual opinions on medicines and why these opinions are considered genuine decisions in the sector. (shrink)

In spite of its everyday connotations, the term independence as republicans understand it is not a celebration of individualism or self-reliance but embodies an acknowledgement of the importance of personal and social relationships in people’s lives. It reflects our connectedness rather than separateness and is in this regard a relational ideal. Properly understood, independence is a useful concept in addressing a fundamental problem in social philosophy that has preoccupied theorists of relational autonomy, namely how to reconcile the idea of individual (...) human agency with the inevitable and necessary influence of other people, both directly and indirectly. I derive my account from the work of Mary Wollstonecraft and Catharine Macaulay, whose contributions have remained largely overlooked by current republican theorists. I have three purposes in this chapter. First, I set out the relational character of independence. Secondly, I outline a republican approach to the problem of structural social threats to agency. Finally, I hope to establish the basis for a fruitful dialogue between republicans and relational autonomy theorists on the requirements and dynamics of individual agency and freedom in oppressive social situations. I identify three distinctive features of the internal logic of freedom as independence that give it a relational character: it always locates the person within a community; there is a mediating role played by the notion of arbitrariness in connecting individual and collective perspectives; a causal relationship exists linking each person’s freedom as independence such that that the dependence of one class of persons jeopardizes the independence of the whole community. (shrink)

This chapter contains sections titled: Introduction Action and Passivity Capability/Incapability and Need Choice, Rationality, Freedom/Constraint Independence and Dependency References Further reading.

Self-regulatory processes have predominantly been linked to the study of academic achievement in terms of learning behavior, cognitive engagement, and specific academic performance measures. If poorly regulated, academic behavior can have repercussions on social adaptation. Motivational processes constitute the other key element in ensuring successful regulation, as studies indicate that self-regulation can effectively influence achievement outcomes if learners have positive beliefs about their personal ability to negotiate difficulties and work towards the desired learning outcomes. This book takes a critical (...) look at the role of self-regulatory processes and personal agency beliefs in academic and social self-regulatory functioning, providing the reader with theoretical understanding of the issues and lending empirical support to the relevance of these processes in the East Asian educational context. In this way, the study explores the extent to which self-regulation and personal agency beliefs can offer an alternative explanation for the academic performance of students. (shrink)

The paper considers three questions. First, what is the connection between economics and agency? It is argued that causation and explanation in economics fundamentally depend on agency. So a philosophical understanding of economic explanation must be sensitive to an understanding of agency. Second, what is the connection between agency and causation? A causal view of agency-involving explanation is defended against a number of arguments from the resurgent noncausalist tradition in the literature on agency and action-explanation. If agency is fundamental to (...) economic explanation, it is argued, then so is causation. Third, what is the connection between causal explanation and the natural sciences? It is argued that, though the explanations given in economics and other social sciences are causal explanations, they are different in kind from the causal explanations of the natural sciences. On the one hand, then, the causal explanations of the social sciences are irreducible to those found in the natural sciences. On the other hand, the causal relations described by the social sciences are not completely autonomous; they do not float free of, or operate independently from, the causal relations charted by the natural sciences. (shrink)