To what extent, if at all, should a just society adopt public policies that regulate and limit the amount of time people work? Attempts to answer this question face a dilemma: Either, we can adopt a laissez-faire view, according to which governments must refrain from imposing working time policies on the labour market. But this view generates a situation in which many citizens experience deep regret about the balance between work and leisure in their lives. Or, we can (...) endorse an interventionist view that advocates government imposition of working time policies. However, such a view appears to be objectionably perfectionist insofar as it imposes on citizens a particular conception of the ideal balance between work and leisure. This article proposes a way out of this dilemma. It shows that the interventionist view can be defended on the anti-perfectionist grounds that this helps address a collective action problem in the labour market – the working time rat race. Employers often use working time as a proxy for their employees’ productivity and commitment. Those who work particularly long hours are often awarded benefits such as raises or promotions or are spared from dismissals. This makes it individually rational for each worker to work extra hours in an attempt to outcompete colleagues. However, if many workers pursue this strategy, it loses its effectiveness. Workers with preferences for more leisure have a claim to state intervention to remove the rat race when this doesn’t impose disproportionate harm on third parties. (shrink)

Because both emotional arousal and regulation are continuous, ongoing processes, it is difficult, if not impossible, to separate them. Thus, affective dynamics can reveal the regulation of emotion as it occurs in real time. One way that this can be done is through the examination of intra- and interpersonal flexibility or the transitions into and out of affective states. The present article reviews and then expands upon the Flex3 model of real-time dynamic and reactive flexibility, specifying (...) the ways in which individual differences in emotion regulation manifest as differences in flexibility. The differences in results at the real-time scale versus diurnal variability are also discussed within an emotion regulation framework. (shrink)

Understanding time investment while solving problems is central to metacognitive research. By the Diminishing Criterion Model (DCM), time regulation is guided by two stopping rules: a confidence criterion that drops as time is invested in each problem and the maximum time to be invested. This combination generates curved confidence–time associations. We compared the belief that intelligence is malleable, a growth mindset, to the belief that intelligence is fixed, and to neutral control groups. We hypothesized (...) that a growth mindset leads people to selectively invest time in problems carrying the hope of improvement. This extra time makes the curved DCM pattern curvier. In two experiments, participants primed with growth, fixed, or control mindsets solved analogies (Experiment 1) and compound remote associates (Experiment 2). As expected, in both experiments a growth mindset exhibited a curvier confidence–time pattern, while the fixed mindset and control groups replicated previous confidence–time associations. Most additional time was invested in problems with intermediate difficulty levels, suggesting strategic time allocation. The study offers useful measures for delving into factors that affect thinking time allocation. (shrink)

Hedgehog (HH) signaling is a conserved pathway that drives developmental growth and is essential for the formation of most organs. The expression of HH target genes is regulated by a dual switch mechanism where GLI proteins function as bifunctional transcriptional activators (in the presence of HH signaling) and transcriptional repressors (in the absence of HH signaling). This results in a tight control of GLI target gene expression during rapidly changing levels of pathway activity. It has long been presumed that GLI (...) proteins also repress target genes prior to the initial expression of HH in a given tissue. This idea forms the basis for the limb bud pre‐patterning model for regulating digit number. Recent findings indicate that GLI repressor proteins are indeed present prior to HH signaling but contrary to this model, GLI proteins are inert as they do not regulate transcriptional responses or enhancer chromatin modifications at this time. These findings suggest that GLI transcriptional repressor activity is not a default state as assumed, but is itself regulated in an unknown fashion. We discuss these findings and their implications for understanding pre‐patterning, digit regulation, and HH‐driven disease. (shrink)

Recent studies based on next‐generation DNA sequencing have revealed that the female inactive X chromosome is replicated in a rapid, unorganized manner, and undergoes increased rates of mutation. These observations link the organization of DNA replication timing to gene regulation on one hand, and to the generation of mutations on the other hand. More generally, the exceptional biology of the inactive X chromosome highlights general principles of genome replication. Cells may control replication timing by a combination of intrinsic replication (...) origin properties, local chromatin states and global levels of replication factors, leading to a functional separation between the activity of genes and their mutation. (shrink)

The beginning of the twenty-first century saw an apparent change in language in public discourses characterised by the rise of so-called “essentially oxymoronic concepts”, i.e., mainly oxymora and paradoxes. In earlier times, these rhetorical figures of speech were largely reserved for the domain of literature, the arts or mysticism. Today, however, many new technologies and other innovations are contributing to their rise also in the domains of science and of law. Particularly in law, their inherent contradictory quality of combining apparently (...) antagonistic suppositions challenges the traditional dualistic mode of reasoning and binary logic. As reflected in terms like fake news, alternative facts or conspiracy theories, these concepts are seen as a threat to the rule of law and legal certainty and have been described as harbingers of an age of disinformation or post-truth. The challenge posed by these apparently contradictory concepts requires a closer look at the premises that guide our legal thinking and a more integrated theory of the senses and their role in law, as captured by the terms “legal synaesthesia” and “legal semiotics”. It also calls for an inquiry into the mind’s functioning generally and how it processes information in the creative process of decision making, linking thoughts and actions as well as facts and fictions. Based on the qualification of “fake news” as an oxymoron, this article critically examines the deficiencies in a dichotomous distinction between fact and fiction exemplified by information about the pandemic of coronavirus disease 2019 in an attempt to clarify the principal issues for a global regulatory debate regarding “fake news”. (shrink)

As COVID-19 and its variants spread across Australia at differing paces and intensity, the country’s response to the risk of infection and contagion revealed an intensification of bordering practices as a form of risk mitigation with disparate impacts on different segments of the Australian community. Australia’s international border was closed for both inbound and outbound travel, with few exceptions, while states and territories, Indigenous communities, and local government areas were subject to a patchwork of varying restrictions. By focusing on borders (...) at various levels, our research traces how the logics of medico-legal bordering have filtered down from the international to the intra-national, and indeed, into hyper-local spaces. This is not just apparent in the COVID-19 moment but in previous pandemics of 1918 to 1919 influenza and smallpox, in which practices of quarantine and lockdowns were both unevenly distributed and implemented on multiple scales of social organization. An interdisciplinary approach between history and law reveals that human movement during pandemic times in Australia has been regulated in a manner that sees mobility as a risk to public health capable of mitigation through the strict enforcement of borders as a technology of both confinement and exclusion. (shrink)

It has been claimed that the ability to remember the past and the ability to project oneself into the future are intimately related. We sought support for this proposition by examining whether individual differences in dimensions that have been shown to affect memory for past events similarly influence the experience of projecting oneself into the future. We found that individuals with a higher capacity for visual imagery experienced more visual and other sensory details both when remembering past events and when (...) imagining future events. In addition, individuals who habitually use suppression to regulate their emotions experienced fewer sensory, contextual, and emotional details when representing both past and future events, while the use of reappraisal had no effect on either kind of events. These findings are consistent with the view that mental time travel into the past and into the future relies on similar mechanisms. (shrink)

Heterochronic genes control the timing of developmental programs. In C. elegans, two key genes in the heterochronic pathway, lin-4 and let-7, encode small temporally expressed RNAs (stRNAs) that are not translated into protein. These stRNAs exert negative post-transcriptional regulation by binding to complementary sequences in the 3′ untranslated regions of their target genes. stRNAs are transcribed as longer precursor RNAs that are processed by the RNase Dicer/DCR-1 and members of the RDE-1/AGO1 family of proteins, which are better known for (...) their roles in RNA interference (RNAi). However, stRNA function appears unrelated to RNAi. Both sequence and temporal regulation of let-7 stRNA is conserved in other animal species suggesting that this is an evolutionarily ancient gene. Indeed, C. elegans, Drosophila and humans encode at least 86 other RNAs with similar structural features to lin-4 and let-7. We postulate that other small non-coding RNAs may function as stRNAs to control temporal identity during development in C. elegans and other organisms. BioEssays 24:119–129, 2002. © 2002 Wiley Periodicals, Inc. (shrink)

Dysregulation of lipid metabolism is a commonly observed feature associated with metabolic syndrome and leads to the development of negative health outcomes such as obesity, diabetes mellitus, non‐alcoholic fatty liver disease, or atherosclerosis. Time‐restricted feeding/eating (TRF/TRE), an emerging dietary intervention, has been shown to promote pleiotropic health benefits including the alteration of diurnal expression of genes associated with lipid metabolism, as well as levels of lipid species. Although TRF likely induces a response in multiple organs leading to the modulation (...) of lipid metabolism, a majority of the studies related to TRF effects on lipids have focused only on individual tissues, and furthermore there is a lack of insight into potential underlying mechanisms. In this review, we summarize the current insights regarding TRF effects on lipid metabolism and the potential mechanisms in adipose tissue, liver, skeletal muscle, and heart, and conclude by outlining possible avenues for future exploration. (shrink)

The widespread adoption of standard time in Britain took more than fifty years and simple public access to a representation of it took longer still. Whilst the railways and telegraph networks were crucial in the development of standardized time and time-distribution networks, very different contexts existed, from the Victorian period onwards, where time was significant in both its definition and its distribution. The moral drive to regulate and standardize aspects of daily life, from factory work to (...) the sale of liquor, led to time being used as a tool for control. Yet, as a tool, it was problematic, both in its own regulation and in the regulation of its distribution. Companies such as the Standard Time Company, in creating businesses out of time distribution, found themselves at the heart of discussions of time and standards, acting, as they did, as a nexus between the nation's master timekeeper, the Royal Observatory, and London public houses, Lancashire cotton mills and myriad small businesses. We can see this network both literally, in electric wires, clocks, batteries and relays, and metaphorically, transmitting Victorian moral concerns of ‘power’ and ‘intelligence’ between imperial state and individual. Naturally enough, the network itself was as contested as the message it transmitted. (shrink)

We investigated if emotion regulation can be improved through self-regulation training on non-emotional brain regions, as well as how to change the brain networks implicated in this process. During the training period, the participants were instructed to up-regulate their right dorsolateral prefrontal cortex activity according to real-time functional near-infrared spectroscopy neurofeedback signals, and there was no emotional element. The results showed that the training significantly increased emotion regulation, resting-state functional connectivity within the emotion regulation network (...) and frontoparietal network, and rsFC between the ERN and amygdala; however, training did not influence the rsFC between the FPN and the amygdala. However, self-regulation training on rDLPFC significantly improved emotion regulation and generally increased the rsFCs within the networks; the rsFC between the ERN and amygdala was also selectively increased. The present study also described a safe approach that may improve emotion regulation through self-regulation training on non-emotional brain regions. (shrink)

Children’s readiness for school is often threatened by the occurrence of both externalizing and internalizing problems. Previous research has shown that Positive Behavioral Interventions and Supports is particularly effective for fostering children’s behavioral skills and reducing externalizing problems. However, whether PBIS can enhance children’s emotional skills and reduce internalizing problems is less clear. Therefore, TIME-IN was developed, which extends PBIS by also including emotional support systems. It was tested whether TIME-IN was effective for improving emotion regulation and (...) reducing depressive symptoms. Furthermore, it was tentatively explored whether TIME-IN is accompanied by more than natural fluctuations in both children’s externalizing and internalizing problems. The effectiveness of TIME-IN was evaluated in a non-randomized study, in which an intervention group was compared with a matched control group. Both research questions were addressed in a sample consisting of 81 children between 8 and 12 years of age with special educational needs. Questionnaires for teachers, children, and their parents were administered at the beginning and the end of the school year using multi-informant assessment. Only indicative evidence was found for the hypothesis that TIME-IN improved children’s emotion regulation. Practical implications, strengths, and limitations were discussed.Clinical Trial Registration: This work was retrospectively registered at International Standard Registered Clinical/soCial sTudy Number registry ISRCTN54456609. Registered 28 March 2017. (shrink)

It has been claimed that the ability to remember the past and the ability to project oneself into the future are intimately related. We sought support for this proposition by examining whether individual differences in dimensions that have been shown to affect memory for past events similarly influence the experience of projecting oneself into the future. We found that individuals with a higher capacity for visual imagery experienced more visual and other sensory details both when remembering past events and when (...) imagining future events. In addition, individuals who habitually use suppression to regulate their emotions experienced fewer sensory, contextual, and emotional details when representing both past and future events, while the use of reappraisal had no effect on either kind of events. These findings are consistent with the view that mental time travel into the past and into the future relies on similar mechanisms. (shrink)

The House of Lords majority decision in Matthews v. Kent and Medway Towns Fire Authority overturns the narrow interpretation given to key aspects of the Part-Time Workers (Protection of Less Favourable Treatment) Regulations’ core comparator mechanism in the lower tribunals and the Court of Appeal. It is a contextually astute judgment, which recognises the reductionist implications of an overly narrow approach to establishing comparability for the purposes of a less favourable treatment claim on the grounds of part-time work. (...) The positive aspect of this decision remains overshadowed, however, by the fact that this interpretation provides little consolation to the large majority of part-time women workers whose disadvantage and inequality remains outside the scope of the Regulations’ protection. (shrink)

United States federal regulations for pediatric research with no prospect of direct benefit restrict institutional review board (IRB) approval to procedures presenting: 1) no more than "minimal risk" (§ 45CFR46.404); or 2) no more than a "minor increase over minimal risk" if the research is commensurate with the subjects' previous or expected experiences and intended to gain vitally important information about the child's disorder or condition (§ 45CFR46.406) (DHHS 2001). During the 25 years since their adoption, these regulations have helped (...) IRBs balance subject protections with the pursuit of scientific knowledge to advance children's welfare. At the same time, inconsistency in IRB application of these regulations to pediatric protocols has been widespread, in part because of the ambiguity of the regulatory language. During the past decade, three federally-charged committees have addressed these ambiguities: 1) the National Human Research Protections Advisory Committee (NHRPAC) (Washington, DC), 2) the Institute of Medicine (IOM) Committee on the Ethical Conduct of Clinical Research Involving Children (Washington, DC); and 3) the United States Department of Health and Human Services Secretary's Advisory Committee for Human Research Protections (SACHRP) (Washington, DC). The committees have reached similar conclusions on interpretation of language within regulations § § 45CFR46.404 and 406; these conclusions are remarkably consistent with recent international recommendations and those of the original National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (1977) report from which current regulations are based. Drawing on the committees' public reports, this article identifies the ethical issues posed by ambiguities in regulatory language, summarizes the committees' deliberations, and calls for a national consensus on recommended criteria. (shrink)

Researchers have begun to use response times to emotion items as an indirect measure of emotional clarity. Our first aim was to scrutinise the properties of this RT measure in more detail than previously. To be able to provide recommendations as to whether emotional intensity – as a possible confound – should be controlled for, we investigated the specific form of the relation between emotional intensity and RTs to emotion items. In particular, we assumed an inverted U-shaped relation at the (...) item level. Moreover, we analysed the RT measure’s convergent validity with respect to individuals’ confidence in their emotion ratings. As a second aim, we compared the predictive validity of emotional clarity measures with respect to daily emotion regulation. The results of three experience sampling studies showed that the association between emotional intensity and RT followed an inverted U shape. RT was in part related to confidence. Emotional clarity measures were unrelated to reappraisal. There was some evidence that lower emotional clarity was related to a greater use of suppression. The findings highlight that emotional intensity and squared emotional intensity should be controlled for when using the RT measure of emotional clarity in future research. (shrink)

ABSTRACTWhich emotion regulation strategy one uses in a given context can have profound affective, cognitive, and social consequences. It is therefore important to understand the determinants of emotion regulation choice. Many prior studies have examined person-specific, internal determinants of emotion regulation choice. Recently, it has become clear that external variables that are properties of the stimulus can also influence emotion regulation choice. In the present research, we consider whether reappraisal affordances, defined as the opportunities for re-interpretation (...) of a stimulus that are inherent in that stimulus, can shape individuals’ emotion regulation choices. We show that reappraisal affordances have stability across people and across time, and are confounded with emotional intensity for a standardised set of picture stimuli. Since emotional intensity has been shown to drive emotion regulation choice, we construct a context in which emotional intensity is separable from r... (shrink)

Emotion regulation, and in particular cognitive reappraisal. Gross has been booming in theory development and empirical research for the last two decades. A large number of publications have demonstrated the importance of these mechanisms for understanding and promoting well-being and mental health. It is thus timely for Cognition and Emotion to examine the current state of theory in this domain. The resultant invited article, authored by Uusberg, A., Ford, Uusberg, H., and Gross, aims to expand the scope of reappraisal (...) theory by extending their recent reAppraisal model by suggesting different forms of goal commitment and situation construals. Their suggestions are commented on by Kashdan and Goodman from a purpose in life perspective, Ehring, and Woud from a clinical psychopathology perspective. In this editorial, I briefly discuss the lack of specification of the goal construct, which is central to the reappraisal model. Moreover, I point to recent evidence showing that problems may arise because of appraisal biases, in the case of individuals prone to inappropriate evaluations of situations. I suggest that future work in this domain could benefit from increased interaction between theorists and researchers working on appraisal and reappraisal processes. (shrink)

This daily diary study examined the within-person coupling between four emotion regulation strategies and both subjective well-being and perceived stress in daily life of geriatric nurses. Participants (N = 89) described how they regulated their emotions in terms of cognitive reappraisal and suppression. They also indicated their subjective well-being and level of perceived stress each day over three weeks. At the within-person level, cognitive reappraisal intended to increase positive emotions was positively associated with higher subjective well-being and negatively associated (...) with perceived stress. Suppression of the expression of positive emotions was negatively associated with subjective well-being and positively associated with perceived stress. However, cognitive reappraisal intended to down-regulate negative emotions and suppression as a strategy to inhibit the expression of negative emotions were not associated with daily well-being or perceived stress. Off-days were rated as days with higher subjective well-being and lower perceived stress in contrast to working days. At the between-person level, individuals who reported more daily negative affect reported increased suppression of positive emotions, corroborating the within-person findings. Moreover, findings indicated that nurses with more years of experience in the job reported higher subjective well-being and less perceived stress. These results provide insights into important daily emotional processes of geriatric nurses, both at workdays and in their leisure time. (shrink)

In this article, the question is discussed if and how Healthcare Ethics Committees (HECs) should be regulated. The paper consists of two parts. First, authors from eight EC member countries describe the status quo in their respective countries, and give reasons as to the form of regulation they consider most adequate. In the second part, the country reports are analysed. It is suggested that regulation of HECs should be central and weak. Central regulation is argued to be (...) apt to improve HECs’ accountability, relevance and comparability. To facilitate biomedical citizenship and ethical reflection, regulation should at the same time be weak rather than strict. Independence of HECs to deliberate about ethical questions, and to give solicited and unsolicited advice, should be supported and only interfered with by way of exception. One exception is when circumstances become temporary adversarial to ethical deliberation in healthcare institutions. In view of European unification, steps should be taken to develop consistent policies for both Eastern and Western European countries. (shrink)

This special volume of Health Care Analysis is dedicated to a consideration of the status of body parts and products and the roleof law in regulating them. We argue that such a discussion is timely giventhe conflation of technological and academic concerns posed by thecomplex legal framework within which these issues are currentlyaddressed and in the light of debates such as those regardingthe storage of children's organs addressed by inquiries atAlder Hay and Bristol, United Kingdom. The contributors addressspecific legal problems (...) which have been brought before the courts in the UK and other jurisdictions, something which wesuggest is likely to occur with increasing regularity oncethe Human Rights Act 1998 comes into force in October 2000.The issues are also considered on a more theoretical level with papers exploring the role of concepts such as property, donation, commodification and kinship in these debates.While the volume focuses principally upon the manner inwhich these issues have arisen in a UK context, though withreference to certain comparative examples, the concepts discussed here are of more general application acrossother jurisdictions. (shrink)

(2010). Drug Detailing in Academic Medical Centers: Regulating for the Right Reasons, with the Right Evidence, at the Right Time. The American Journal of Bioethics: Vol. 10, No. 1, pp. 21-23.

The ABA has adopted four model policies that address, in one way or another, the issue of foreign lawyer mobility. These policies are the ABA Model Foreign Legal Consultant Rule, which is commonly known as the FLC rule, the ABA Model Rule for Temporary Practice by Foreign Lawyers, which is commonly known as the FIFO rule, ABA Model Rule of Professional Conduct 5.5, which permits foreign lawyers to serve as in-house counsel, and the ABA Model Rule on Pro Hac Vice (...) Admission. All four of the ABA's foreign lawyer mobility recommendations include a requirement that the mobile foreign lawyer is “ subject to effective regulation and discipline by a duly constituted professional body or a public authority .” In other words, these rules set forth requirements regarding the nature of the regulatory system in the foreign lawyer's home jurisdiction. A number of US states have included this requirement in their foreign lawyer mobility provisions, but a number have not. Although the ABA model rules and a number of state rules include this requirement, neither the ABA Model Rules nor any of the state rules have defined what it means for a foreign lawyer to come from a system with “effective regulation and discipline.” Nor is there any evidence that this requirement has been enforced in those states that have included this requirement. This article suggests that the “effective regulation and discipline” requirement has been an elephant in the room that no one has been willing to talk about. The article argues that the time has come to confront this issue head-on. It asserts that either efforts should be undertaken to define and enforce this requirement or that the requirement should be abandoned. The article reviews two “threshold” issues that jurisdictions might want to consider when deciding whether to adopt or retain an “effective regulation and discipline” requirement. It also identifies cross-cultural and cross-professional resources that might be consulted for “benchmarking” purposes if and when US regulators decide to add “meat to the bones” by defining and enforcing the “effective regulation and discipline” requirement found in foreign lawyer mobility provisions. (shrink)

The tendency for emotions to be predictable over time, labelled emotional inertia, has been linked to low well-being and is thought to reflect impaired emotion regulation. However, almost no studies have examined how emotion regulation relates to emotional inertia. We examined the effects of cognitive reappraisal and expressive suppression on the inertia of behavioural, subjective and physiological measures of emotion. In Study 1 (N = 111), trait suppression was associated with higher inertia of negative behaviours. We replicated (...) this finding experimentally in Study 2 (N = 186). Furthermore, in Study 2, instructed suppressors and reappraisers both showed higher inertia of positive behaviours, and reappraisers displayed higher inertia of heart rate. Neither suppression nor reappraisal were associated with the inertia of subjective feelings in either study. Thus, the effects of suppression and reappraisal on the temporal dynamics of emotions depend on the valence and emotional response component in question. (shrink)

The regulation of narcotic medications used in narcotic addiction treatment is unique in medical therapeutics. Physicians who want to use narcotics for this indication must obtain a separate annual registration from the Drug Enforcement Administration. Annual registration is contingent on compliance with both the DEA's security regulations as well as treatment regulations jointly promulgated by the Food and Drug Administration and the National Institute on Drug Abuse.During the last decade, a number of events have occurred that persuaded NIDA that (...) it is time to reevaluate the current method by which the Department of Health and Human Services regulates methadone treatment. As a result of research during the past twenty years, we have learned about the effective components of methadone treatment. In comparison to other available treatment modalities for opioid addiction, methadone treatment is uniquely effective when administered by well-trained medical staffs. (shrink)

The current SARS-CoV-2 crisis raises questions about the challenges faced by nation states and international organisations in offering a coordinated international response to the pandemic, and reveals the great vulnerability of European countries, which are implementing lockdown measures and imposing restrictions on international travel, for the most part on a unilateral basis. Such measures run counter to the prevailing approach of the previous two centuries that developed an international public health space. This article examines the measures adopted by European states (...) in order to contain 19th-century cholera pandemics, which took shape through the development of an international maritime quarantine system, based primarily on the implementation of national regulations and local decision-making. This regime was quickly viewed as ineffective and out of step with liberal ideas that urged a “laissez-faire” approach to public health matters. In its stead, a long-term trend developed towards easing quarantine measures. Nation states supported the internationalisation of the fight against pandemics, which chiefly consisted of externalising quarantine measures to the East in order to eliminate them in Europe. This process was based on a subtle dialectical relationship between the construction of an international public health space and the affirmation of state sovereignty, and continued into the 20th century with the progressive creation of international institutions responsible for advancing global health. (shrink)

Human beings have engaged in animal husbandry and have slaughtered animals for food for thousands of years. During the majority of that time most societies had no animal welfare regulations that governed the care or slaughter of animals. Judaism is a notable exception in that from its earliest days it has included such rules. Among the Jewish dietary laws is a prohibition to consume meat from an animal that dies in any manner other than through the rigorously defined method (...) of slaughter known as shechita. In recent decades more and more attempts have been initiated by governments around the world to either outright ban or to control and modify the practice of shechita. This paper presents the requisite background about shechita and then analyzes the ethics of some of the recent legislation. The analysis includes a rebuttal of the assertion that shechita is an inhumane method of slaughter. It further presents the consequences on the Jewish community of legislation to impose pre-slaughter stunning and explains why such legislation is unethical. The actual effect of labeling laws is discussed and it is shown why such laws are also un-ethical. (shrink)

The regulation of narcotic medications used in narcotic addiction treatment is unique in medical therapeutics. Physicians who want to use narcotics for this indication must obtain a separate annual registration from the Drug Enforcement Administration. Annual registration is contingent on compliance with both the DEA's security regulations as well as treatment regulations jointly promulgated by the Food and Drug Administration and the National Institute on Drug Abuse.During the last decade, a number of events have occurred that persuaded NIDA that (...) it is time to reevaluate the current method by which the Department of Health and Human Services regulates methadone treatment. As a result of research during the past twenty years, we have learned about the effective components of methadone treatment. In comparison to other available treatment modalities for opioid addiction, methadone treatment is uniquely effective when administered by well-trained medical staffs. (shrink)

Contingent reinforcement behavior is generally regarded as one of the key elements of being a “good” leader, yet the question of what happens when this behavior is absent has received little attention in past empirical research. Drawing upon self-regulation theory, we develop and test a model that specifies the effects of leader reward omission on employes’ deviant behavior. Using the data of 230 workers from two manufacturing companies located in South China collected across three time points, we find (...) that leader reward omission is positively associated with deviant behavior. Moreover, the indirect effects of leader reward omission on employes’ deviant behavior are mediated by moral disengagement. Our study also reveals that Machiavellianism can aggravate the positive effect of leader reward omission on moral disengagement, and subsequently exacerbate the indirect effect on employes’ deviant behavior. Taken together, our findings reveal the consequences of leader reward omission, and the importance of examining subordinate self-regulation under the lack of positive reinforcement. (shrink)

The current SARS-CoV-2 crisis raises questions about the challenges faced by nation states and international organisations in offering a coordinated international response to the pandemic, and reveals the great vulnerability of European countries, which are implementing lockdown measures and imposing restrictions on international travel, for the most part on a unilateral basis. Such measures run counter to the prevailing approach of the previous two centuries that developed an international public health space. This article examines the measures adopted by European states (...) in order to contain 19th-century cholera pandemics, which took shape through the development of an international maritime quarantine system, based primarily on the implementation of national regulations and local decision-making. This regime was quickly viewed as ineffective and out of step with liberal ideas that urged a “laissez-faire” approach to public health matters. In its stead, a long-term trend developed towards easing quarantine measures. Nation states supported the internationalisation of the fight against pandemics, which chiefly consisted of externalising quarantine measures to the East in order to eliminate them in Europe. This process was based on a subtle dialectical relationship between the construction of an international public health space and the affirmation of state sovereignty, and continued into the 20th century with the progressive creation of international institutions responsible for advancing global health. (shrink)

Emotions are foremost self-regulating processes that permit rapid responses and adaptations to situations of personal concern. They have biological bases and are shaped ontogenetically via learning and experience. Many situations and events of personal concern are social in nature. Thus, social exchanges play an important role in learning about rules and norms that shape regulation processes. I argue that (a) emotions often are actively auto-regulating—the behavior implied by the emotional reaction bias to the eliciting event or situation modifies or (...) terminates the situation; (b) certain emotion components are likely to habituate dynamically, modifying the emotional states; (c) emotions are typically intra- and interpersonal processes at the same time, and modulating forces at these different levels interact; (d) emotions are not just regulated—they regulate. Important conclusions of my arguments are that the scientific analysis of emotion should not exclude regulatory processes, and that effortful emotion regulation should be seen relative to a backdrop of auto-regulation and habituation, and not the ideal notion of a neutral baseline. For all practical purposes unregulated emotion is not a realistic concept. (shrink)

Regulating clinical trials for testing new drugs is fraught with risk. Misregulation can slow development of innovative and useful new drugs, but in other ways misregulation can foster trials that are inefficient and unethical, driven by commercial rather than scientific ends, and that can harm patients. In this paper, we argue not for more but for better regulation, based on the goal of rapidly producing innovative and safe products that represent significant advances in medical care. Data on industry-funded, late-stage (...) clinical trials demonstrate an urgent need for dramatic changes in how these trials are designed, conducted, and analyzed. On the one hand, current patent rules can dissuade development of innovative new products with smaller markets and press trial designers to create positive results too rapidly. But at the same time, numerous studies show that when the pharmaceutical industry sponsors clinical trials, the results are systematically biased in favor of the sponsor's product, often to the detriment of patients and the public. The reasons for this bias are both complex and unavoidable, and the ways in which clinical trial design, conduct, and reporting can be inappropriately influenced are so varied and nuanced, that efforts to manage this conflict of interest and prevent harms are inevitably unsuccessful. Instead, we conclude such conflict should be avoided and a strong firewall should exist between drug developers and the final stages of clinical testing in humans. All financial support for phase III clinical trials should pass through a public-private partnership organization — perhaps tied to a broader clinical effectiveness research enterprise — which would be charged with designing, funding, and monitoring late-stage human clinical trials of new pharmaceutical products. (shrink)

In March 2021, the Spanish Congress approved the law regulating euthanasia, that regulates both euthanasia and physician-assisted suicide (PAS). In this article, we analyse the Spanish law regulating euthanasia and PAS, comparing it with the rest of the European laws on euthanasia and PAS (Netherlands, Belgium and Luxembourg). Identified strengths of the Spanish law, with respect to other norms, are that it is a law with many safeguards, which broadly recognises professionals’ right to conscientious objection and the specification that it (...) makes on the prior comprehensive care of the patient, including the approach to care dependency. Regarding its shortcomings, the law does not differentiate well between euthanasia and PAS; it barely assigns a role to the healthcare team as a whole (similar to other regulations); it does not clarify the functions of the different professionals involved; it does not detail the specific composition and duration of theevaluation commission; it has not been accompanied by a prior or simultaneous regulation of palliative care; and, lastly, the period of time to implement the law is too short. (shrink)

Research regulation is a timely topic for discussions in bioethics and public health policy. This response to articles in the previous special issue of the Monash Bioethics Review emphasises the importance of having both internal and external controls of human experimentation. Unless both elements are incorporated into research ethics governance frameworks, they will ultimately fail to achieve what should be their primary goal: human subject protection.

Since 2011, the research community had waited with bated breath as regulators contemplated for the first time bringing secondary research with nonidentifiable biospecimens under the Common Rule and dramatically tightening the criteria for waiving consent to biospecimen research. After considerable pushback from both researchers and patients and amid rumors of intractable disagreement among Common Rule agencies, the Final Rule published on the last day of President Obama's administration left out these troubling changes, and there was a collective sigh of (...) relief. Relief is appropriate, but celebration premature: researchers have little reason to avail themselves of the new broad consent option offered in the Final Rule, and the question of whether biospecimens ought to be treated as inherently identifiable has merely been postponed. (shrink)

Objective To obtain information about the similarities and differences in regulating different types of medical research in the European Union .Methods Web searches were performed from September 2009 to January 2011. Notes on pre-determined topics were systematically taken down from the web pages. The analysis relied only on documents and reports available on the web, reflecting the situation at the end of 2010.Results In several countries, regulatory legislation applied only to clinical trials on drugs and medical devices, in other states (...) various types of research were also regulated but by laws different from those concerning trials, and in many countries, some research areas were not controlled by legislation at all. In very few countries was all medical research handled similarly from a legal point of view. The number of research ethics committees in a single country varied from one to 264. Their areas of responsibility, working principles and length of time to grant research permission varied as well as the rules for obtaining informed consent from vulnerable groups. In 10 EU countries, there was no appeal mechanism after a negative decision by an REC. The RECs were not accountable to any organisation in five EU countries.Conclusions There is a need for a fundamental debate regarding whether and which kinds of changes are needed for the further harmonisation of medical research governance in the EU and how cross-country medical research could be facilitated in the future. (shrink)