This commentary provides a legal analysis of the extent to which changes proposed by scholars to promote care for substance use disorder or other under-treated illnesses through risk adjustment could be implemented administratively, without legislation, in federal risk adjustment systems: Medicare's privatized component, Medicare's pharmaceutical component, and the individual and small group market. As the article explains, federal laws governing risk adjustment provide broad discretion to regulators and can reasonably be interpreted to permit full and final implementation through the administrative (...) process of almost all of the changes that scholars have proposed. (shrink)

Tirana, immediately after it was declared the capital of Albania on 11 February 1920, has undergone many changes in its morphology and city context. The capital is located in the heart of the country. During its lifespan, Tirana has adopted four important regulatory plans starting from 1923. The Western ideologies of the time influenced drastically the city development. The influence of such ideologies was stopped immediately though the imposition of communist ideas, after the Second World War. Rational building forms (...) were created which could be standardized in order to reduce construction costs. Meanwhile, in Western Europe, this current was implemented during the 1920s, as a response to social problems. The communist regime established strict anti-urbanization policy that aims to foster the development of rural areas and the suburban industrial districts in order to control urban growth and demographic mobility. All the regulatory master plans of Tirana, climate data of the city, the actual situation of the specific neighborhood, its orientation toward north, are considered in order to gather information and to implement the correct bioclimatic eco-renovation in the area. A special attention will be given to the underground tunnels which were constructed during the communist regime all over the city (1945–1983) as a response to a hypothetic nuclear attack, in order to shelter the inhabitance against bombing. These reinforced concrete tunnels will serve not only as an area for water collection and recycling strategies but also for cooling with zero energy expenditure for the inhabitants as a consequence of differences in temperature and air pressure. This strategy benefits from the underground air temperature in both seasons (winter and summer). It envisages the handover of these tunnels by the community. Nowadays, such structures are abandoned and denigrated. The realization of these structures required large amounts of money from the state budget. Considering that fact they need to be vitalized and reused, using different methodologies and strategies as part of the city. After the communist regime in the city of Tirana, two other regulatory plans were implemented which observe the city from another perspective, determining and evaluating Tirana’s real values as a city of the future, but not defining yet Tirana as an Ecocity. The ecological potential of Tirana including its outskirts is to be considered. Its flora and fauna are very rich, containing a mixt of species and plants. Regardless, the city of Tirana is suffering from different kinds of pollution such as air and noise pollution which are above EU and WHO norms. Tirana benefits from a Temperate Mediterranean climate. Furthermore, the benefits of the solar radiation are enormous. Unfortunately, nowadays, the city of Tirana is not profiting much from it. This chapter is in search of an overall view of the city of Tirana, and its great potential discovering its underground and upper ground historical secrets. (shrink)

BackgroundThe SARS-COVID-19 pandemic and its associated disease control restrictions have in multiple ways affected families with young children, who may be especially vulnerable to mental health problems. Studies report an increase in perinatal parental distress as well as symptoms of anxiety or depression in children during the pandemic. Currently, little is known about the impact of the pandemic on infants and their development. Infant regulatory problems have been identified as early indicators of child socio-emotional development, strongly associated with maternal (...) mental health and the early parent–infant interaction. Our study investigates whether early parenthood under COVID-19 is associated with more maternal depressive symptoms and with a perception of their infants as having more RPs regarding crying/fussing, sleeping, or eating, compared to mothers assessed before the pandemic.MethodsAs part of a longitudinal study, 65 women who had given birth during the first nationwide disease control restrictions in Northern Germany, were surveyed at 7 months postpartum and compared to 97 women assessed before the pandemic. RPs and on maternal depressive symptoms were assessed by maternal report. Number of previous children, infant negative emotionality, and perceived social support were assessed as control variables.ResultsCompared to the control cohort, infants born during the COVID-19 pandemic and those of mothers with higher depressive symptoms were perceived as having more sleeping and crying, but not more eating problems. Regression-based analyses showed no additional moderating effect of parenthood under COVID-19 on the association of depressive symptoms with RPs. Infant negative emotionality was positively, and number of previous children was negatively associated with RPs.LimitationsDue to the small sample size and cross-sectional assessment, the possibility for more complex multivariate analysis was limited. The use of parent-report questionnaires to assess infant RPs can support but not replace clinical diagnosis.ConclusionsThe pandemic conditions affecting everyday life may have a long-term influence on impaired infant self- and maternal co-regulation and on maternal mental health. This should be addressed in peripartum and pediatric care. Qualitative and longitudinal studies focusing on long-term parental and infant outcomes under ongoing pandemic conditions are encouraged. (shrink)

This article addresses issues of regulatory convergence and Europeanization as they have developed within the agrochemicals sector. Taking the United Kingdom as a case study, the article considers the continuing importance of local and national factors within systems that are ostensibly international and standardized. In particular, the article shows how the embedded social relations of regulatory science in the United Kingdom, including institutional practices, judgments of expertise, and established relationships of trust, result in a “nation centeredness” and divergence (...) of regulatory cultures despite the putative development of a harmonized European framework. It is argued that, as a consequence, the claimed universalism of scientific culture in this area is in tension with the local conditions of its practice and enactment. (shrink)

This article examines the impact of the prevailing state ownership in the Chinese stock market on corporate governance and the financial regulatory system, respectively, as the internal and external monitoring mechanisms to deter corporate fraud and protect investors. In line with the literature that state ownership exaggerates the agency problem, we find that the retained state ownership in privatised firms increases the incidence of regulatory enforcements against fraud. For the state-owned enterprises (SOEs), however, larger state ownership is associated (...) with a lower incidence of enforcement actions. This is attributed to the mutual political affiliation of the fraudulent SOEs and the regulatory commission. A new regulation "Solutions for Listed Firm Checks" promulgated in March 2001 has mitigated this effect by empowering the regulatory commission to increase the severity of regulatory conditions. Our evidence confirms the improvement in the regulatory environment and investor protection in the Chinese stock market brought about by the regulatory reform and development. (shrink)

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

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)

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)

In recent decades, the Organisation for Economic Co-operation and Development has become a powerful forum for trade liberalization and regulatory harmonization. OECD members have worked to reconcile divergent national regulatory approaches, applying a single framework across sovereign states, in effect determining whose knowledge-making practices would guide regulatory action throughout the industrialized world. Focusing on US regulators, industry associations, and environmental groups, this article explores the participatory politics of OECD chemical regulation harmonization in the late 1970s to early (...) 1980s. These efforts were conditioned by differential institutional access and resources among stakeholders who sought to shape regulatory knowledge rules. Facing competing European and US approaches to chemical data—a minimum “base set” of test data versus case-by-case determinations—OECD members chose the European approach in 1980. However, US regulatory politics shifted with the election of President Reagan, prompting industry associations to lobby the US government to block the agreement. Examining the micropolitics of these standards in the making, I demonstrate that while long-term structures advantaged industrial actors, ideological alignment with the US government precipitated their decisive influence. The case illustrates the importance of attending to the distinctive politics of international harmonization and the effects on transnational knowledge-making and regulatory intervention. (shrink)

Studies suggest that reward and emotion are interdependent. However, there are discrepancies regarding the interaction between these variables. Some researchers speculate that the inconsistent findings may be due to different targets being used. Although reward and emotion both affect attention, it is not clear whether their impacts are independent. This study examined the impact of reward anticipation on emotion processing for different targets. A cue-target paradigm was used, and behavior and eye-tracking data were recorded in an emotion or sex recognition (...) task under the conditions of reward and non-reward anticipation. The results showed that when the target was related to the emotional attribute of the stimulus, the reward promoted the processing target information, thereby generating reward-oriented attention. When the target was unrelated to the emotional attributes of the stimulus, the reward did not promote the processing target information, and at the same time, individuals had negative emotional biases toward the emotional faces. The results revealed that, in addition to affecting the attention to emotional faces independently, the target regulated the promotion of reward anticipation to emotional attention and attention bias towards negative stimuli. (shrink)

Evolution has shaped all living organisms on Earth, although many details of this process are shrouded in time. However, it is possible to see, with one's own eyes, evolution as it happens by performing experiments in defined laboratory conditions with microbes that have suitably fast generations. The longest‐running microbial evolution experiment was started in 1988, at which time twelve populations were founded by the same strain ofEscherichia coli. Since then, the populations have been serially propagated and have evolved for tens (...) of thousands of generations in the same environment. The populations show numerous parallel phenotypic changes, and such parallelism is a hallmark of adaptive evolution. Many genetic targets of natural selection have been identified, revealing a high level of genetic parallelism as well. Beneficial mutations affect all levels of gene regulation in the cells including individual genes and operons all the way to global regulatory networks. Of particular interest, two highly interconnected networks—governing DNA superhelicity and the stringent response—have been demonstrated to be deeply involved in the phenotypic and genetic adaptation of these experimental populations. BioEssays 29:846–860, 2007. © 2007 Wiley Periodicals, Inc. (shrink)

According to Regulatory Focus Theory, two systems determine our strategies to pursue goals – the promotion and the prevention system. Individuals with a dominant promotion system focus on achieving gains, i.e., promoters, and individuals with a dominant prevention system focus on avoiding losses, i.e., preventers. Regulatory Fit Theory suggests that a fit between this focus and the situation causes superior performance and makes individuals feel right. We transfer the fit idea to the interaction of dominant regulatory focus (...) with motivational direction. We investigated these interaction effects on individuals’ performance and their experience within creativity workshops. In Study 1, using multi-level analyses, we found that a promotion focus was associated with fluency and a prevention focus with elaborated ideas. This effect was stronger, when preventers also scored high on avoidance motivation. Further, preventers experienced more autonomy support and were more satisfied when they scored high on avoidance. Promoters high on approach motivation reported more autonomy support and more satisfaction than preventers high on approach motivation. For Study 2, we used an experimental design: After measuring regulatory focus, we manipulated approach vs. avoidance motivation in creativity workshops. Using multi-level analyses, we did not find main or interaction effects on fluency or elaboration but we found interaction effects on participants’ experience of the creativity workshop. Preventers were more satisfied when they received the avoidance condition. Promoters reported less autonomy support, lower satisfaction, and more perceived conflicts within their teams in the avoidance condition. (shrink)

This study examined the factors that affect the attitude and behavioral intentions toward electronic sports among students of higher education institutions based on the technology acceptance model. The conditional impact of preventive regulatory focus was analyzed in various aspects developed on the regulatory focus theory. These aspects comprised of perceived usefulness, perceived ease of use, and perceived risk on the attitude toward eSports. Accordingly, data were collected from 293 students of higher education institutions in China's Henan Province, presenting (...) a 54.56% response rate. The PLS-SEM analysis was subsequently implemented to confirm the proposed hypotheses. The empirical findings confirmed the significant positive impact of perceived usefulness and perceived ease of use on the attitude toward eSports. However, perceived risk negatively affected the attitude toward eSports. Meanwhile, the findings on the moderating hypotheses found a negligible impact on preventive regulatory focus. This impact was found explicitly on the perceived usefulness-perceived ease of use link with attitude toward eSports. However, the preventive regulatory focus negatively moderated the perceived risk attitude toward eSports. Finally, the implication and limitations were illustrated at the end of the paper. (shrink)

Focused on evolutionary and continuous human development the global, the regulatory system should be formed in the conceptual (the constant research for the detection, identification and evaluation of global imperatives) and application (development and implementation of activities and coordination tools of influence to ensure the existence of human civilization in a secure politically, economically, socially and environmentally balanced world) planes. On the author's calculations of its formation in functionally complete, holistic view is expected by 2030 due to historically conditioned (...) transformations in the nature of social relations. (shrink)

This paper examines the transformation of environmental regulatory system in Poland during the 1990s. It is a case of institutional transplantation from the past into the present: the place remained constant but the economic and political context rapidly changed over time. Drawing on five case studies of privatized firms, a mailed questionnaire, and policy and institutional analysis, it investigates how Poland developed an effective system for managing industrial pollution while also achieving considerable socioeconomic progress. One key lesson is that (...) considerable and effective evolution of policies can take place during radical shifts in the political-economic context, as long as certain conditions are fulfilled. These include a good “fit” between the approaches taken and the existing modes of conducting societal transactions; wide sharing of certain values among the key societal actors; and continuity in policies and institutions. It also appears that a broad support for the rule of law and due process are crucial. The case of Poland also suggests that, while the developing countries do not necessarily need to reenact the evolution that has taken place among the developed countries during the past three decades, neither can they expect to leapfrog from a highly polluting “dirty” economy to a sustainable economy. The study also suggests that success in the first phase of regulatory system’s transformation—centered around reducing pollution from the energy and manufacturing sectors—is not a predictor of its success in next phase, centered around sustainability issues. The types of institutions, political circumstances, and national capabilities are different for each phase. (shrink)

Biomedical research has a strong impact on a country’s scientific-technological and socioeconomic development. It can make a significant contribution at three different levels: promotion of public health; the exchange of knowledge within the scientific community; and economic/ financial profitability. Africa only attracts ~3.3% of the world’s clinical research. This small proportion is due to, among several factors, the absence of two fundamental aspects: specific robust legislation and capacity for regulatory and ethical evaluation. There are five Portuguese- speaking African countries (...) – Angola, Cabo Verde, Guinea-Bissau, Mozambique and São Tomé and Príncipe. Despite presenting different degrees of clinical research development, these countries show a common serious insufficiency in the minimum conditions necessary for hosting, collaborating or leading biomedical research projects. These countries are also excluded from the support of international organisations for capacity building because of the language barrier. The Biomedical Ethics and Regulatory Capacity Building Partnership for Portuguese-Speaking African Countries project has developed methods to build capacity and partnership through research on national law, comparisons with international standards and by issuing recommendations at a national level. Through collaborative intensive training, trainees are taught to become educators at a national level. This, in turn, creates a sustainable impact at country level. BERC-Luso is a pioneering project, owing to a combination of innovative features. The partnership project: was developed exclusively in Portuguese; involves a large number of African countries, and national and international institutions; has been further enhanced by the diversity and complementarity of its action plans; and has also benefited from a broad participatory methodology based on resolution of recipients’ problems by the recipients themselves. It thus stands out as a model for similar future projects. (shrink)

The development and deployment of medical devices, along with most areas of healthcare, has been significantly impacted by the COVID-19 pandemic. This has had variable ethical implications, two of which we will focus on here. First, medical device regulations have been rapidly amended to expedite approvals of devices ranging from face masks to ventilators. Although some regulators have issued cessation dates, there is inadequate discussion of triggers for exiting these crisis standards, and evidence that this may not be feasible. Given (...) the relatively low evidence standards currently required for regulatory approval of devices, this further indefinite reduction in standards raises serious ethical issues. Second, the pandemic has disrupted the usual operations of device representatives in hospitals, providing an opportunity to examine and refine this potentially ethically problematic practice. In this paper we explain and critically analyse the ethical implications of these two pandemic-related impacts on medical devices and propose suggestions for their management. These include an endpoint for pandemic-related adjustments to device regulation or a mechanism for continued refinement over time, together with a review of device research conducted under crisis conditions, support for the removal and replacement of emergency approved devices, and a review of device representative credentialling. (shrink)

Under the Common Rule, federally-supported activities involving human participants are presumptively required to undergo prospective ethics review if they are “designed to develop or contribute to generalizable knowledge.” However, the “generalizable knowledge” standard is inherently ambiguous; moreover, it is both over- and under-inclusive of the type of activities that warrant prospective ethical oversight. Rather than conditioning prospective ethics review on an ethically irrelevant criterion like the generalizable knowledge standard, this article proposes that prior ethics review should be required when some (...) individuals are exposed to greater-than-minimal risks for the potential benefit of others, at least when the activity in question is conducted or supported by federal agencies. Under such an approach, the fact that an activity constitutes research would be neither necessary nor sufficient to trigger prospective ethical oversight. (shrink)

The evolution of the human brain has resulted in the emergence of higher-order cognitive abilities, such as reasoning, planning and social awareness. Although there has been a concomitant increase in brain size and complexity, and component diversification, we argue that RNA regulation of epigenetic processes, RNA editing, and the controlled mobilization of transposable elements have provided the major substrates for cognitive advance. We also suggest that these expanded capacities and flexibilities have led to the collateral emergence of psychiatric fragilities and (...) conditions. (shrink)

Living systems employ several mechanisms and behaviors to achieve robustness and maintain themselves under changing internal and external conditions. Regulation stands out from them as a specific form of higher-order control, exerted over the basic regime responsible for the production and maintenance of the organism, and provides the system with the capacity to act on its own constitutive dynamics. It consists in the capability to selectively shift between different available regimes of self-production and self-maintenance in response to specific signals and (...) perturbations, due to the action of a dedicated subsystem which is operationally distinct from the regulated ones. The role of regulation, however, is not exhausted by its contribution to maintain a living system’s viability. While enhancing robustness, regulatory mechanisms play a fundamental role in the realization of an autonomous biological organization. Specifically, they are at the basis of the remarkable integration of biological systems, insofar as they coordinate and modulate the activity of distinct functional subsystems. Moreover, by implementing complex and hierarchically organized control architectures, they allow for an increase in structural and organizational complexity while minimizing fragility. Finally, they endow living systems, from their most basic unicellular instances, with the capability to control their own internal dynamics to adaptively respond to specific features of their interaction with the environment, thus providing the basis for the emergence of minimal forms of cognition. (shrink)

Ferroptosis, a form of regulated cell death triggered by lipid hydroperoxide accumulation, has an important role in a variety of diseases and pathological conditions, such as cancer. Targeting ferroptosis is emerging as a promising means of therapeutic intervention in cancer treatment. Polyunsaturated fatty acids, reactive oxygen species, and labile iron constitute the major underlying triggers for ferroptosis. Other regulators of ferroptosis have also been discovered recently, among them the mechanistic target of rapamycin complex 1 (mTORC1), a central controller of cell (...) growth and metabolism. Inhibitors of mTORC1 have been used in treating diverse diseases, including cancer. In this review, we discuss recent findings linking mTORC1 to ferroptosis, dissect mechanisms underlying the establishment of mTORC1 as a key ferroptosis modulator, and highlight the potential of co‐targeting mTORC1 and ferroptosis in cancer treatment. This review will provide valuable insights for future investigations of ferroptosis and mTORC1 in fundamental biology and cancer therapy. (shrink)

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

In an age in which the regulatory state frequently deals with spending, licensing, and employment, the use of allocating powers is perceived as an appealing means by which to prevent discriminatory practices against individuals within illiberal communities. In addition to its easy availability, conditional funding is regarded as both an effective and—in comparison with legal prohibitions—less drastic tool for the prevention of discrimination. Such conditions are thought to be efficient because they increase the relative cost of the discriminatory practice (...) and in doing so create an economical incentive to avoid discrimination. Moreover, these conditions are thought to be less-coercive , because they still allow those subject to them to choose between the more expensive option of discrimination and the cheaper option of non-discrimination. In other words, these conditions are perceived as "Less Drastic Means." In this Article, I will argue that such a perception is false. When applied to the poor such conditionality is not less coercive than prohibitions in criminal law. It is more than reasonable to assume that attempts to rectify this flaw by exempting poor people from conditional funding will render such funding ineffective in preventing discrimination. In the final analysis—when one takes into account both the problem of the commodification of values and the inequality between rich and poor—the use of conditional finding as a means of promoting liberal values will, in most cases, be unjust. If we believe that the antidiscrimination principle has a lexical priority over a parent’s right to educate their children in accordance to their culture, we should choose the path of prohibition and abandon that of conditional funding. (shrink)

Of the many proposals for inferring genetic regulatory structure from microarray measurements of mRNA transcript hybridization, several aim to estimate regulatory structure from the associations of gene expression levels measured in repeated samples. The repeated samples may be from a single experimental condition, or from several distinct experimental conditions; they may be “equilibrium” measurements or time series; the associations may be estimated by correlation coefficients or by conditional frequencies (for discretized measurements) or by some other statistic. This (...) paper describes two elementary statistical difficulties for all such procedures, no matter whether based on Bayesian updating, conditional independence testing, or other machine learning procedures such as simulated annealing or neural net pruning. One difficulty obtains if large numbers of cells are aggregated in a measurement of expression levels from a common population of cells; the other obtains if small numbers of cells are aggregated or if samples are separately aggregated over different populations of cells. (shrink)

An individual’s accountability to oneself leads to self-regulatory behaviour. A field experiment afforded an opportunity to test this relation, given that external accountability conditions were absent. A single group pre-test/post-test design was used to test the hypothesis. A group of full-time resident management students, n ≈ 550, take four meals during the day in the institute mess. As a part of the experiment, food wastage in the form of leftovers on the plates of subjects was measured. As a pre-test, (...) the measurement occurred at two levels. Subjects could see how much they are adding to the total waste by looking at a weighing scale placed under a waste basket, and they could also see the total waste data for each of the four meals for the day and a day earlier displayed at a prominent place. After 105 days, the weighing scale under the basket was removed, and as a post-test measurement, the total waste data for the four meals were noted down for another 72 days. A manipulation test indicated that the experiment has had the desired effect of invoking self-accountability in subjects during the pre-test phase, and diluting it during the post-test phase. Time series analysis of pre-test and post-test data indicated that the wastage data decreased in the pre-test phase. However, the post-test waste data showed an increase over a period of time. The results indicate that accountability conditions like social norms invoke self-accountability cognition leading to self-regulatory behaviours in individuals. (shrink)

This article examines the history of assigning a banned status to medical marijuana; describes the politics of medical marijuana research; provides evidence of the scientifically demonstrated efficacy and safety of Cannabis for certain pathologic conditions; analyzes several vaguely worded state statutes governing the recommendation, distribution, and use of “medical marijuana” that render its use open to abuse; and recommends the development and enforcement of statutory and regulatory reforms that would bring state oversight of this drug into agreement with stringent (...) federal regulation of other controlled substances with proven medical utility. (shrink)

Of the many proposals for inferring genetic regulatory structure from microarray measurements of mRNA transcript hybridization, several aim to estimate regulatory structure from the associations of gene expression levels measured in repeated samples. The repeated samples may be from a single experimental condition, or from several distinct experimental conditions; they may be “equilibrium” measurements or time series; the associations may be estimated by correlation coefficients or by conditional frequencies (for discretized measurements) or by some other statistic. This (...) paper describes two elementary statistical difficulties for all such procedures, no matter whether based on Bayesian updating, conditional independence testing, or other machine learning procedures such as simulated annealing or neural net pruning. One difficulty obtains if large numbers of cells are aggregated in a measurement of expression levels from a common population of cells; the other obtains if small numbers of cells are aggregated or if samples are separately aggregated over different populations of cells. (shrink)

Models of gene regulatory networks have proven useful for understanding many aspects of the highly complex behavior of biological control networks. Randomly generated non-Boolean networks were used in experimental simulations to generate data on dynamic phenotypes as a function of several genotypic parameters. We found that predictive relationships between some phenotypes and quantitative genotypic parameters such as number of network genes, interaction density, and initial condition could be derived depending on the strength of the topological genotype on specific (...) phenotypes. We quantitated the strength of the topological genotype effect on a number of phenotypes in multi-gene networks. For phenotypes with a low influence of topological genotype, derived and empirical relationships using quantitative genotype parameters were accurate in phenotypic outcomes. We found a number of dynamic network properties, including oscillation behaviors, that were largely dependent on genotype topology, and for which no such general quantitative relationships were determinable. It remains to be determined if these results are applicable to biological gene regulatory networks. (shrink)

Living systems employ several mechanisms and behaviors to achieve robustness and maintain themselves under changing internal and external conditions. Regulation stands out from them as a specific form of higher-order control, exerted over the basic regime responsible for the production and maintenance of the organism, and provides the system with the capacity to act on its own constitutive dynamics. It consists in the capability to selectively shift between different available regimes of self-production and self-maintenance in response to specific signals and (...) perturbations, due to the action of a dedicated subsystem which is operationally distinct from the regulated ones. The role of regulation, however, is not exhausted by its contribution to maintain a living system’s viability. While enhancing robustness, regulatory mechanisms play a fundamental role in the realization of an autonomous biological organization. Specifically, they are at the basis of the remarkable integration of biological systems, insofar as they coordinate and modulate the activity of distinct functional subsystems. Moreover, by implementing complex and hierarchically organized control architectures, they allow for an increase in structural and organizational complexity while minimizing fragility. Finally, they endow living systems, from their most basic unicellular instances, with the capability to control their own internal dynamics to adaptively respond to specific features of their interaction with the environment, thus providing the basis for the emergence of minimal forms of cognition. (shrink)

It will be settled out for the open problem of designing an r-order finite-time state observer for reaction-diffusion genetic regulatory networks with time-varying delays. By assuming the Dirichlet boundary conditions, aiming to estimate the mRNA and protein concentrations via available network measurements. Firstly, sufficient F-T stability conditions for the filtering error system have been investigated via constructing an appropriate Lyapunov–Krasovskii functional and using several integral inequalities and convex technique simultaneously. These conditions are delay-dependent and reaction-diffusion-dependent and can be checked (...) by MATLAB toolbox. Furthermore, a method is proposed to design an r-order F-T state observer, and the explicit expressions of observer gains are given. Finally, a numerical example is presented to illustrate the effectiveness of the proposed method. (shrink)

Regulators around the world are coming under pressure from patients, clinicians, and industry groups to streamline the market approval process for highly novel biomedical technologies, including stem cells and regenerative medicine products. The rationale for streamlining this process centers on the perceived failures of regulatory systems to encourage biomedical innovation and provide patients with timely access to potentially beneficial yet experimental therapies. Critics claim that the process of generating scientific evidence in phased clinical trials is too costly, time-consuming, and (...) poorly suited for stem cell–based products that, unlike bio-pharmaceuticals, are intended to engraft into the body for long... (shrink)

Individuals do not have a right to participate in clinical trials. But, they do have a right against being denied participation for inappropriate reasons. Despite the widespread endorsement of these two claims, there has been little discussion regarding which conditions for participation in clinical trials are appropriate and which are inappropriate. The present manuscript attempts to address this gap in the literature. We first describe and then argue against the claim that conditions on enrollment or continued participation are appropriate only (...) when they are needed to answer the scientific question(s) posed by the trial. We then offer an alternative view according to which the appropriateness of conditions depends on whether they help to satisfy the ethical requirements of clinical research. Because these requirements include social value, the present view implies that promoting social value is an acceptable reason to impose conditions on research participation. With this in mind, we explain why it is not coercive to require potential participants to accept conditions on enrollment that promote a trial's social value, even when the participants find those conditions unwelcome. We conclude by evaluating the present proposal's implications for the common practice of requiring participants to agree to the possible use of their leftover biospecimens in a broad range of future research. We argue, contra current regulatory policy, that this practice can be acceptable even when the present trial offers participants the prospect of clinical benefit and the samples are being reserved for future research that is unrelated to the present trial. (shrink)

The problem of finite-time stability of switched genetic regulatory networks with time-varying delays via Wirtinger’s integral inequality is addressed in this study. A novel Lyapunov–Krasovskii functional is proposed to capture the dynamical characteristic of GRNs. Using Wirtinger’s integral inequality, reciprocally convex combination technique and the average dwell time method conditions in the form of linear matrix inequalities are established for finite-time stability of switched GRNs. The applicability of the developed finite-time stability conditions is validated by numerical results.

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

At workplaces where nanomaterials are produced or used, risk assessment and risk management are extremely difficult tasks since there is still limited evidence about the risks of nanomaterials. Measurement methods for nanoparticles are contested and safety standards have not yet been developed properly. To support compliance with the legal obligation of the employer to care for safe workplaces a large number of ‘soft’ regulatory tools have been proposed (e.g. codes of conduct, benchmarks, standards). However, it is not clear whether (...) and under which conditions soft regulation is complied with. This article discusses the potential advantages and drawbacks of soft regulation. It explores compliance issues when exposure measurement devices and other technology-related factors are involved. The exploration of three examples of soft regulation on occupational health and safety (a ministerial recommendation on preliminary exposure benchmarks, a nano-specific guidance of a chemical company and a public–private OHS guideline) shows that the capacity of the regulated parties to comply depends on the availability of appropriate technological devices and methods, technical expertise and other resources. When technological prerequisites are met, compliance is likely to increase. (shrink)

Patients who search for a better treatment, an increased quality of life, or even a chance to preserve life itself may claim to have an interest in accessing investigational medicinal products (IMP), particularly when no validated treatment for their disease or condition exists. For many, awaiting the uncertain and time-consuming process of converting an IMP into an approved drug may not appear a realistic option, as prognoses may be grim and a dramatic outcome may seem hard to avert. Gaining (...) access to an IMP, however, often proves to be a difficult enterprise with a highly uncertain outcome. In addition, the process of seeking access to IMP is surrounded by various ethical issues that will be explored in this article. This paper explores the ethical concerns in two potential tracks of seeking access to IMP for minors: on an individual basis, or collectively, as a patient organisation. In this discourse, several unique ethical and regulatory concerns related to the direct negotiation of access to IMP for minor patients are identified, with a focus on product safety, the recruitment of research subjects, the unnoticed entry of market mechanisms in the recruitment of research subjects, and the sidelining of third parties in the recruitment process. The paper concludes with a concise reflection on the way forward. The quest for access to investigational drugs is particularly relevant to paediatric practice, in which a significant share of the drugs prescribed has never been tested in children or labelled for use in the paediatric population. (shrink)

Homology searches between DNA sequences of evolutionary distant species (phylogenetic footprinting) offer a fast detection method for regulatory sequences. Because of the small size of their genomes, tetraodontid species such as the Japanese pufferfish and green spotted pufferfish have become attractive models for comparative genomics. A disadvantage of the tetraodontid species is, however, that they cannot be bred and manipulated routinely under laboratory conditions, so these species are less attractive for developmental and genetic analysis. In contrast, an increasing arsenal (...) of transgene techniques with the developmental model species zebrafish and medaka are being used for functional analysis of cis regulatory sequences. The main disadvantage is the much larger genome. While comparison between many loci proved the suitability of phylogenetic footprinting using fish and mammalian sequences, fast rate of change in enhancer structure and gene duplication within teleosts may obscure detection of homologies. Here we discuss the contribution and potentials provided by different teleost models for the detection and functional analysis of conserved cis‐regulatory elements. BioEssays 24:564–572, 2002. © 2002 Wiley Periodicals, Inc. (shrink)

This paper examines the role of the consensual model in law and argues that if substantive justice is to be the goal of law, the use of individual choice as a legal criterion for distributive and retributive purposes must be curtailed and made subject to substantive considerations. Substantive justice arguably requires that human rights to life, well-being, and the commodities essential to life and well-being, be given priority whenever a societal decision is made. If substantive justice is a collective societal (...) responsibility, the individual cannot be justly rewarded or punished for his or her choices with respect to life, well-being and essential commodities insofar as these choices are justified or excused by standards of substantive justice. Societal conditions and institutional arrangements should be recognized as grounds for justification and excuse because they may impose limits and constraints on the choices available to an individual that are as unavoidable and compelling as those imposed by chance or by another human being. (shrink)

Current technology and surveillance practices make behaviors traceable to persons in unprecedented ways. This causes a loss of anonymity and of many privacy measures relied on in the past. These de facto privacy losses are by many seen as problematic for individual psychology, intimate relations and democratic practices such as free speech and free assembly. I share most of these concerns but propose that an even more fundamental problem might be that our very ability to act as autonomous and purposive (...) agents relies on some degree of privacy, perhaps particularly as we act in public and semi-public spaces. I suggest that basic issues concerning action choices have been left largely unexplored, due to a series of problematic theoretical assumptions at the heart of privacy debates. One such assumption has to do with the influential conceptualization of privacy as pertaining to personal intimate facts belonging to a private sphere as opposed to a public sphere of public facts. As Helen Nissenbaum has pointed out, the notion of privacy in public sounds almost like an oxymoron given this traditional private-public dichotomy. I discuss her important attempt to defend privacy in public through her concept of ‘contextual integrity.’ Context is crucial, but Nissenbaum’s descriptive notion of existing norms seems to fall short of a solution. I here agree with Joel Reidenberg’s recent worries regarding any approach that relies on ‘reasonable expectations’ . The problem is that in many current contexts we have no such expectations. Our contexts have already lost their integrity, so to speak. By way of a functional and more biologically inspired account, I analyze the relational and contextual dynamics of both privacy needs and harms. Through an understanding of action choice as situated and options and capabilities as relational, a more consequence-oriented notion of privacy begins to appear. I suggest that privacy needs, harms and protections are relational. Privacy might have less to do with seclusion and absolute transactional control than hitherto thought. It might instead hinge on capacities to limit the social consequences of our actions through knowing and shaping our perceptible agency and social contexts of action. To act with intent we generally need the ability to conceal during exposure. If this analysis is correct then relational privacy is an important condition for autonomic purposive and responsible agency—particularly in public space. Overall, this chapter offers a first stab at a reconceptualization of our privacy needs as relational to contexts of action. In terms of ‘rights to privacy’ this means that we should expand our view from the regulation and protection of the information of individuals to questions of the kind of contexts we are creating. I am here particularly interested in what I call ‘unbounded contexts’, i.e. cases of context collapses, hidden audiences and even unknowable future agents. (shrink)

A central goal in regulating direct-to-consumer advertising of prescription pharmaceuticals is to ensure that explicit drug claims are truthful. Yet imagery can also alter viewer attitudes, and the degree to which this occurs in DTCA is uncertain. Addressing this data gap, we provide evidence that positive feelings produced by images can promote favourable beliefs about pharmaceuticals. We had participants view a fictitious anti-influenza drug paired with unrelated images that elicited either positive, neutral or negative feelings. Participants who viewed positive images (...) rated the influenza drug as significantly more effective, safe, and beneficial than did participants who viewed negative images. This effect, known as evaluative conditioning, is well described in experimental social psychology but has not previously been shown with pharmaceuticals. We discuss how evaluative conditioning in DTCA may compromise viewer autonomy, and canvass possible regulatory responses. (shrink)

On what we may call the institutional approach to justice, the most important duty of justice that individuals have is the duty to establish just institutions when they are absent. How should we understand this institutional duty in relation to more personal moral actions, such as taking direct personal action to mitigate institutional failures? Is this institutional duty a necessary responsibility of justice? Is it sufficient? I will discuss this question in the context of climate change: what responsibilities of justice (...) do individual actors have when their state is not complying with an ideal of just emissions? Do they have the duty to do what they reasonably can to reduce their personal direct emissions, perhaps even picking up the slack of non-compliers? Or is their duty of justice primarily that of doing their part to establish a just regulatory framework? I will examine some options of personal responsibility in response to climate change and argue that the most important duty is that of working to bring about better institutions. Taking direct personal action can be helpful, but not when they distract us from working towards institutional reform. (shrink)

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

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

Research shows that trained mentors achieve better results than untrained ones. Their training should particularly address their expectations for their future mentoring. Our study involved 190 preservice teachers, potential mentors of ongoing school mentoring for primary and secondary school students of all grades. They were randomly assigned to one of four conditions in a 2-x-2 between-subjects design of mentoring type (traditional mentoring versus e-mentoring) and mentoring context (non-pandemic versus COVID-19 pandemic). Participants assessed mentoring conducted under these four conditions in terms (...) of its appropriateness for achieving four mentoring program targets: learning, key skills, social targets, and problem coping. Participants were also asked to assess the resources available to achieve each program target. Overall, the potential mentors considered the various conditions to be suitable for achieving the four program targets. They were particularly favorable in their assessment of the possibility for the realization of learning targets. Likewise, they assumed that sufficient resources were available to achieve the targets. However, a repeated-measures MANOVA showed that the potential mentors considered more ambitious targets to be possible in traditional mentoring than in e-mentoring and normal (i.e., pre-pandemic) contextual conditions than during the COVID-19 pandemic. In contrast, they estimated the resources available to achieve the targets to be about the same in the four conditions. This indicates a decoupling of mentoring targets from the consideration of the resources needed to achieve them. This assumption was confirmed in correlation analyses and has implications for mentor training. (shrink)

New discoveries are improving the odds of human cells surviving in host animals, prompting regulatory and funding agencies to issue calls for additional layers of ethical oversight for certain types of human–animal chimeras. Of interest are research proposals involving chimeric animals with humanized brains. But what is motivating the demand for additional oversight? I locate two, not obviously compatible, motivations, each of which provides the justificatory basis for paying special attention to different sets of human–animal chimeras. Surprisingly, the sets (...) of animals that actually get flagged for special scrutiny by research and funding guidelines do not correlate with either of the sets of animals that arise when we think about what is motivating additional oversight. What this shows is that existing research policies and funding guidelines are disconnected from their motivation: the rationale for flagging certain types of human–animal chimeras as requiring special oversight is ignored in execution. (shrink)

In recent years, the fight against money laundering has emerged as a key issue of financial regulation. The Wolfsberg Group is an important multistakeholder agreement establishing corporate responsibility principles against money laundering in a domain where international coordination remains otherwise difficult. The fact that 10 out of the 25 top private banking institutions joined this initiative opens up an interesting puzzle concerning the conditions for the participation of key industry players in the Wolfsberg Group. The article presents a fuzzy-set analysis (...) of seven hypotheses based on firm-level organizational factors, the macro-institutional context, and the regulatory framework. Results from the analysis of these 25 financial institutions show that public ownership of the bank and the existence of a code of conduct are necessary conditions for participation in the Wolfsberg Group, whereas factors related to the type of financial institution, combined with the existence of a black list, are sufficient for explaining participation. (shrink)

The new wave of ‘foundation models’—general-purpose generative AI models, for production of text (e.g., ChatGPT) or images (e.g., MidJourney)—represent a dramatic advance in the state of the art for AI. But their use also introduces a range of new risks, which has prompted an ongoing conversation about possible regulatory mechanisms. Here we propose a specific principle that should be incorporated into legislation: that any organization developing a foundation model intended for public use must demonstrate a reliable detection mechanism for (...) the content it generates, as a condition of its public release. The detection mechanism should be made publicly available in a tool that allows users to query, for an arbitrary item of content, whether the item was generated (wholly or partly) by the model. In this paper, we argue that this requirement is technically feasible and would play an important role in reducing certain risks from new AI models in many domains. We also outline a number of options for the tool’s design, and summarize a number of points where further input from policymakers and researchers would be required. (shrink)

This essay deals with conditions, challenges and perspectives concerning the legal system of the European Union after the Lisbon treaty has entered into force. It starts out by recalling constitutional principles such as primacy, direct effect and consistent interpretation of the European legal order on the one hand and the relationship of cooperation between the Court of Justice and national courts – notably pointing out the importance of the preliminary procedure (Article 267 TFEU) – on the other hand. In addition, (...) characteristics of the legal system of the European Union such as the integration of national legal systems are highlighted. It is accentuated that the legal community of the European Union depends on the acceptance by all 27 Member States. Furthermore, the normative quality of European law-making is discussed as well as the necessity for a sufficient democratic legitimation of European Law. As impressively illustrated by the financial crisis, the European Union is much better equipped with possibilities to effectively fulfil regulatory tasks than any Member State. The author shows developments with regard to European Union citizenship, non-discrimination, the Charter of Fundamental Rights - that is now equipped with binding character – and the vertical distribution of competences between the European Union and the Member States, including explanations relating to subsidiarity requirements and their judicial review. Moreover, challenges to the institutions of the European Union are discussed. (shrink)

Mark Johnson’s work The Meaning of the Body presents John Dewey’s pragmatism and pragmatist aesthetics as the forerunners of the anti-Cartesian embodied enactive approach to human experience and meaning. He rejects the Kantian noncognitive character of aesthetics and emphasizes that aesthetics is the study of the human capacity to experience the bodily conditions of meaning constitution that grows from our bodily conditions of life. Using Mark Johnson’s view as a starting-point, this paper offers the beginning of an enactive approach to (...) aesthetic preference contributing to bringing human aesthetic behavior research closer to the enactive approach to human experience. Following enactive studies on bodily sense-making and embodied emotions, I identify the bodily conditions of meaning constitution in which aesthetic preference is grounded with the subject’s self-regulatory visceral embodied constitution of viable degrees of value of the environmental factors according to her bodily structure. Unlike mainstream aesthetic preference research in empirical aesthetics, I claim that the subject’s aesthetic preference constitution requires the lived experience of the bodily conditions of meaning constitution through the conscious experience of the subjectively aroused lived body. The implausibility of the mind/body dichotomy of current aesthetic preference research is highlighted. (shrink)

Over the last 20+ years, globalization has made international trade and investment more efficient and productive. In the absence of coordinated global regulatory regimes, it has also made multinational corporations (MNCs) impervious to social concerns in the countries where they operate. There is considerable debate in the academic, political, and business arena as to the causes of the apparently inequitable distribution of benefits between labor and capital. Notwithstanding, the relative merits of this debate, and facing tremendous societal pressure, companies (...) have adopted voluntary codes of conduct to ensure that workers making products for them in poor and developing countries are protected from hazardous working conditions and receive wages that meet local laws and market conditions. These codes, however, suffer from a lack of credibility and proof of substantive compliance. A new type of nongovernmental organization (NGO) has emerged that monitors a company's compliance with prespecified standards and provides assurance to the external stakeholders that the company has fulfilled its voluntary obligations. From an historical perspective, this has been an innovative phenomenon where the monitoring organization purports to act as an honest broker to ensure all concerned that the company/industry has fulfilled its obligations. In this article, we undertake a thorough examination of two such organizations, that is, Fair Labor Association, and Social Accountability International, that have played a pioneering role in bridging the gap between societal expectations and corporate performance. We examine their governance structures, operating procedures, monitoring standards, and public disclosure of findings, and above all, their success in improving the level of corporate compliance with their self‐created codes or standards. Unfortunately, our findings and conclusions are disappointing. In our view, the two groups have mostly failed to meet their avowed goals. Rather than using their NGO status to help companies improve their code compliance, they have suffered from managerial capture and have been reduced to corporate apologists. (shrink)