bluuebunny/crossref_metadata_2025_split huggingface dataset:
Standalone Regulatory Agreements for Product-Development Collaborations in the Medical Products Industry
Authors: Wilhelm Mary E , Pire-Smerkanich Nancy , Richmond Frances J 
Published: May 2024

Abstract
Background
Medical-product companies often outsource research and manufacturing needs to contracting or partnering organizations but then must manage a challenging patchwork of regulatory activities. A standalone regulatory agreement could clarify the relationships and responsibilities between companies working jointly on a single regulated product. This study explored the need for and current use of standalone regulatory agreements.

Methods
A survey instrument was developed using an implementation framework and disseminated to mid- to senior-level employees and consultants for sponsor and vendor companies in the medical products sector.

Results
Of 294 respondents, about half, primarily from companies with more than 200 employees, were familiar with standalone regulatory agreements, and half of this subgroup had moved forward to implement them. Such agreements were considered beneficial to clarify regulatory roles and responsibilities, standardize regulatory expectations between the companies, and stimulate earlier discussion about joint regulatory strategies. However, the development of regulatory agreements appears challenged by the fact that such agreements are not required by regulatory agencies overseeing medical products and have no standardized templates, agency or industry guidance. Respondents whose organizations do not now use regulatory agreements either had not considered or did not see a need for a standalone agreement.

Conclusions
Standalone regulatory agreements are becoming more common but are not yet implemented fully by most companies. Their usefulness and content appeared to depend upon the type of partner, the complexity of the relationship and the availability of internal expertise and support.
Examining spatial and socioeconomic disparities in internet resilience during extreme weather events: a case study of Hurricane Harvey and Winter Storm Uri
Authors: Gupta Yuvraj , Liu Zhewei , Mostafavi Ali 
Published: May 2024

AbstractThe resilience of internet service is crucial for ensuring consistent communication, situational awareness, facilitating emergency response in our digitally-dependent society. However, due to empirical data constraints, there has been limited research on internet service disruptions during extreme weather events. To bridge this gap, this study utilizes observational datasets on internet performance to quantitatively assess the extent of internet disruption during two recent extreme weather events. Taking Harris County in the United States as the study region, we jointly analyzed the hazard severity and the associated internet disruptions in the context of two extreme weather events. The results show that the hazard events significantly impacted regional internet connectivity. There exists a pronounced temporal synchronicity between the magnitude of disruption and hazard severity: as the severity of hazards intensifies, internet disruptions correspondingly escalate, and eventually return to baseline levels post-event. The spatial analyses show that internet service disruptions can happen even in areas that are not directly impacted by hazards, demonstrating that the repercussions of hazards extend beyond the immediate area of impact. This interplay of temporal synchronization and spatial variance underscores the complex relationships between hazard severity and Internet disruption. Furthermore, the socio-demographic analysis suggests that vulnerable communities, already grappling with myriad challenges, face exacerbated service disruptions during these hazard events, emphasizing the need for prioritized disaster mitigation strategies and interventions for improving the resilience of internet services. To the best of our knowledge, this research is among the first studies to examine the Internet disruptions during hazardous events using a quantitative observational dataset. The insights obtained hold significant implications for city administrators, guiding them towards more resilient and equitable infrastructure planning.
The Member States in the EU Food System: National Regulatory Options for Sustainable Food Offer, Food Consumption and Food Environments
Authors: Schebesta Hanna 
Published: May 2024

AbstractThe Framework for Sustainable Food Systems law will either not be published at all or after a long delay. Whereas the first part of the article constructs an empirical and theoretical underpinning about why the EU Member States should therefore act on food sustainability, the second part focuses on what legal measures Member States can take.In the first part, leaning on food systems thinking, we argue that in the absence of EU action in the matter, the Member States remain the most potent lever for taking regulatory action on addressing sustainability in the food system.In the second part, the article provides an exploratory study of potential national legal instruments for making domestic food systems more sustainable, with an emphasis on the regulation of offer and consumption of foods and food environments. The article discusses the following legal instruments in the context of EU law and Member States’ room for action, with examples from a comparative perspective: public procurement purchasing by governments, product composition requirements, fiscal measures, non-fiscal pricing instruments, labelling & certification, marketing, and the regulation of private and public food environments. The article further concludes that it may prove useful to better enshrine the food sustainability paradigm in law at national level.
Hegel's Philosophy of History and the Postcolonial Realization of Concrete Bildung
Authors: Hofmann Christian 
Published: May 2024

AbstractHegel's Philosophy of History can be characterized as Eurocentric and one finds in it many problematic passages, and even racist statements, as well as a legitimization of colonialism which is presented as a means of education (Bildung). Nevertheless, this article argues that it is possible to reject such judgements and at the same time hold on to the basic intention of Hegel's theories of freedom and Bildung. While the concept of freedom as self-determination is certainly applied in a Eurocentric manner by Hegel in his Philosophy of History, this concept is not Eurocentric at its core. To understand this ‘core’, one has to go back to Hegel's logic of the concept, which finally leads me to a concept of ‘concrete Bildung’. The struggles for self-determination of the colonized peoples must be understood in terms of a further development of the realization of the concept of freedom. If one wants to think Hegel's Philosophy of History meaningfully beyond Hegel's own time, one is inevitably led to the necessity of a liberation of the colonized, for there is a need for a further extension of the consciousness of freedom that actually is inclusive. This demand is contained in Hegel's thought itself, but it still remains abstract with him and must therefore be developed beyond him.
Dividends of the Colour Line: Slaveholder Indemnities and the Philosophy of Right
Authors: Cross Ciaran 
Published: May 2024

AbstractIn notes to Hegel's Rechtsphilosophie lectures, written around the time of Haiti's 1825 ‘ransom’—the 150 million francs demanded by France to indemnify former slave and plantation owners—we find an uncanny remark. Hegel appears to report on a different ransom, a compensated abolition of slavery in North America that never happened, anticipating an application of the Fifth Amendment's takings clause that US legal scholarship routinely fails to mention. In view of Alan Brudner's enlistment of Hegel as the philosopher ‘uniquely’ able to understand the Fifth Amendment's requirement for compensation for expropriations—a ‘constitutional essential for liberalism’—this paper explores the meaning of these passages in the historical context of the legal abolitions of Hegel's time: feudalism and slavery. The slaveholder indemnities were clearly the unjust ‘dividends’ of the colour line, but their legal foundations and developments in US thought of the nineteenth century also usefully illustrate takings law's foreclosure of political and social transformation through the securitization of value. Reading these histories and Hegel's comments alongside the critical interventions of the black radical tradition, I suggest that Hegel's curious remarks on compensated takings suggest not only a critical divergence from Brudner's understanding of ‘dialogic community’, but a crucial limitation in his field of analysis which pivoted on the denigration of black sovereignty. This paper thus suggests an understanding of US takings law through the shifting understandings of the term ‘ransom’—which for abolitionists such as Frederick Douglass signified not a resolution of slavery, but rather the threat of its perpetuation—and Douglass's elaboration of the pathology of the colour line.
Past! Future! In Extreme!: Looking for Meaning in the “New Romantics,” 1978–82
Authors: Worley Matthew 
Published: May 2024

AbstractFirst used in 1980, “new romantics” was a term applied to describe a British youth culture recognized initially for its sartorial extravagance and penchant for electronic music. Closely associated with the Blitz nightclub in London's Covent Garden (as well as milieus elsewhere in the UK), new romantics appeared to signal a break from the prescribed aesthetics and sensibilities of punk, rejecting angry oppositionism for glamour and aspiration. In response, cultural commentators have often sought to establish connections between new romantism and the advent of Thatcherism and “the 1980s.” This article challenges such an interpretation, offering a more complex analysis of new romanticism rooted in nascent readings of postmodernism. It also shifts our understandings of the periodization of postwar British history and the concept of “popular individualism,” arguing that youth culture provides invaluable insight both to broader processes of sociocultural change and to the construction of the (post)modern self.
Do Physicians Have a Duty to Support Secondary Use of Clinical Data in Biomedical Research? An Inquiry into the Professional Ethics of Physicians
Authors: Jungkunz Martin , Köngeter Anja , Winkler Eva C. , Schickhardt Christoph 
Published: May 2024

AbstractSecondary use of clinical data in research or learning activities (SeConts) has the potential to improve patient care and biomedical knowledge. Given this potential, the ethical question arises whether physicians have a professional duty to support SeConts. To investigate this question, we analyze prominent international declarations on physicians’ professional ethics to determine whether they include duties that can be considered as good reasons for a physicians’ professional duty to support SeConts. Next, we examine these documents to identify professional duties that might conflict with a potential duty of physicians to support SeConts.
Diversion to Treatment when Treatment is Scarce: Bioethical Implications of the U.S. Resource Gap for Criminal Diversion Programs
Authors: Arıtürk Deniz , Easter Michele M. , Swanson Jeffrey W. , Swartz Marvin S. 
Published: May 2024

PrécisDespite significant scholarship, research, and funding dedicated to implementing criminal diversion programs over the past two decades, persons with serious mental illness and substance use disorders remain substantially overrepresented in United States jails and prisons. Why are so many U.S. adults with behavioral health problems incarcerated instead of receiving treatment and other support to recover in the community? In this paper, we explore this persistent problem within the context of “relentless unmet need” in U.S. behavioral health (Alegría et al., 2021).
Addressing Bioethical Implications of Implementing Diversion Programs in Resource-Constrained Service Environments
Authors: Korchmaros Josephine D. , Hall Kevin 
Published: May 2024

AbstractThe opioid epidemic demands the development, implementation, and evaluation of innovative, research-informed practices such as diversion programs. Aritürk et al. have articulated important bioethical considerations for implementing diversion programs in resource-constrained service environments. In this commentary, we expand and advance Aritürk et al.’s discussion by discussing existing resources that can be utilized to implement diversion programs that prevent or otherwise minimize the issues of autonomy, non-maleficence, beneficence, and justice identified by Aritürk et al.
A Public Option for Clinical Trials? Lessons from Convalescent Plasma
Authors: Roy Victor , Ross Joseph S. , Ramachandran Reshma 
Published: May 2024

AbstractThe case of clinical trials for convalescent plasma during COVID-19 illustrates important lessons for realizing public sector approaches to biomedical research and development. These lessons, centering on mission, transparency, and spillover effects, can be translated to wider efforts to develop a “public option” for clinical trials.
Teaching Global Health Law: Preparing the Next Generation for Future Challenges
Authors: Gostin Lawrence O. , Bosha Sarah L. , Meier Benjamin Mason 
Published: May 2024

AbstractFollowing from sweeping law reforms across the global health landscape, there is a need to prepare the next generation to advance global health law to ensure justice for a healthier world. Educational programs across disciplines have increasingly incorporated the field of global health law, with new courses examining the law and policy frameworks that apply to the new set of public health threats, non-state actors, and regulatory instruments that structure global health. Such interdisciplinary training must be expanded throughout the world to prepare future practitioners to strengthen global health law — ensuring a foundation for global health in legal studies and law and global health studies. Meeting this imperative for global health law teaching — establishing academic courses and textbooks on global legal responses to shared health threats — will be necessary to support students to address the global health challenges of the future.
Battling Environmental Racism in Cancer Alley: A Legislative Approach
Authors: Garofalo Megan Resener 
Published: May 2024

AbstractThis Paper argues that to protect at-risk communities — and all Americans — from the deadly effects of environmental racism, Congress must pass the Environmental Justice for All Act. The Act is intended to “restore, reaffirm, and reconcile environmental justice and civil rights.” It does so by restoring an individual’s right to sue in federal court for discrimination based on race, ethnicity, or national origin regardless of intent under the Civil Rights Act of 1964, strengthening the National Environmental Policy Act, and providing economic incentives focused on environmental justice.
Church Against State: How Industry Groups Lead the Religious Liberty Assault on Civil Rights, Healthcare Policy, and the Administrative State
Authors: Wuest Joanna , Last Briana S. 
Published: May 2024

AbstractIndustry-funded religious liberty legal groups have sought to undermine healthcare policy and law while simultaneously attacking the rights of sexual and gender minorities. Whereas past scholarship has tracked religiously-affiliated healthcare providers’ growing political power and attendant transformations to legal doctrine, our account emphasizes the political donors and visionaries who have leveraged religious providers and the U.S. healthcare system’s delegated structure to transform social policy and bureaucratic agencies more generally.
Enacting Relational Public Health: Federally Qualified Health Centers During the COVID-19 Pandemic
Authors: Pacia Danielle , Crane Johanna , Neuhaus Carolyn , Berlinger Nancy , Fabi Rachel 
Published: May 2024

PrécisFederally Qualified Health Centers (FQHCs) proved to be critical points of access for people of color and other underserved populations during the COVID-19 pandemic, administering 61% of their COVID-19 vaccinations to people of color, compared to the 40% rate for the overall United States’ vaccination effort. To better understand the approaches and outcomes of FQHCs in pandemic response, we conducted semi-structured interviews with FQHC health care providers and outreach workers and analyzed them using an inductive qualitative methodology.
Pre-Mortem Interventions for the Purpose of Organ Donation: Legal Approaches to Consent
Authors: Taillieu Renée , Weiss Matthew J. , Harvey Dan , Murphy Nicholas , Weijer Charles , Chandler Jennifer A 
Published: May 2024

PrécisThe administration of Pre-Mortem Interventions (PMIs) to preserve the opportunity to donate, to assess the eligibility to donate, or to optimize the outcomes of donation and transplantation are controversial as they offer no direct medical benefit and include at least the possibility of harm to the still-living patient. In this article, we describe the legal analysis surrounding consent to PMIs, drawing on existing legal commentary and identifying key legal problems. We provide an overview of the approaches in several jurisdictions that have chosen to explicitly address PMIs within codified law. We then provide, as an example, a detailed exploration of how PMIs are likely to be addressed in one jurisdiction where general medical consent law applies because there is no specific legislation addressing PMIs — the province of Ontario in Canada.
A new post-LOME (Late Ordovician Mass Extinction) recovery brachiopod fauna from South China
Authors: Huang Bing , Candela Yves , Shi Kaiyan , Rong Jiayu 
Published: May 2024

AbstractFollowing the Late Ordovician Mass Extinction event, brachiopod faunas were in a phase of recovery during the late Rhuddanian (early Silurian), documented by a drastic turnover of Ordovician-type to Silurian-type faunas. In this study, we present a recovery brachiopod fauna, from the Niuchang Formation (late Rhuddanian-based graptolite zonation) at the Wanzi section of Zhenxiong in northeastern Yunnan Province, South China. The fossils include 26 species assigned to 25 genera, with a dominance of strophomenides and orthides, but also a diverse suite of atrypides and pentamerides, which exhibit compositional differences compared to the earlier Edgewood–Cathay fauna. The emergence of a more typical Silurian brachiopod fauna suggests a delayed community turnover after the Late Ordovician Mass Extinction event. The shallowing marine environment trend evinced in the brachiopod assemblages in the section indicates a balance between the global transgression and the regional Qianzhong Uplift, which provided a stable environment for the brachiopod recovery. The presence of diverse pentamerides, including the earliest species of the large-shelled genus Sinostricklandiella, suggests early diversification of this clade in South China.
A bidirectional LSTM-based morphological analyzer for Gujarati
Authors: Baxi Jatayu , Bhatt Brijesh 
Published: May 2024

AbstractMorphological analysis is a crucial preprocessing stage for building the state-of-the-art natural language processing applications. We propose a bidirectional LSTM (long short-term memory)-based approach to develop the morphological analyzer for the Gujarati language. Our morph analyzer predicts a root word and the morphological features for the given inflected word. We have experimented with two different methods for label representation for predicting morphological features: the monolithic representation method and the individual label representation method. We have also created the gold morphological dataset of 16,234 unique words for the Gujarati language. The dataset contains morpheme splitting and grammatical feature information for each inflected word. Due to the change in the label representation technique in the proposed model, the accuracy of the present baseline system is improved by a large margin. The proposed system performs very well across the POS categories without the knowledge of language-specific suffix rules.
An online method for ship trajectory compression using AIS data
Authors: Liu Zhao , Yuan Wensen , Liang Maohan , Zhang Mingyang , Liu Cong , Liu Ryan Wen , Liu Jingxian 
Published: May 2024

Abstract
Vessel trajectories from the Automatic Identification System (AIS) play an important role in maritime traffic management, but a drawback is the huge amount of memory occupation which thus results in a low speed of data acquisition in maritime applications due to a large number of scattered data. This paper proposes a novel online vessel trajectory compression method based on the Improved Open Window (IOPW) algorithm. The proposed method compresses vessel trajectory instantly according to vessel coordinates along with a timestamp driven by the AIS data. In particular, we adopt the weighted Euclidean distance (WED), fusing the perpendicular Euclidean distance (PED) and synchronous Euclidean distance (SED) in IOPW to improve the robustness. The realistic AIS-based vessel trajectories are used to illustrate the proposed model by comparing it with five traditional trajectory compression methods. The experimental results reveal that the proposed method could effectively maintain the important trajectory features and significantly reduce the rate of distance loss during the online compression of vessel trajectories.
Optimizing insurance risk assessment: a regression model based on a risk-loaded approach
Authors: Landsman Zinoviy , Shushi Tomer 
Published: May 2024

AbstractRisk measurement and econometrics are the two pillars of actuarial science. Unlike econometrics, risk measurement allows taking into account decision-makers’ risk aversion when analyzing the risks. We propose a hybrid model that captures decision-makers’ regression-based approach to study risks, focusing on explanatory variables while paying attention to risk severity. Our model considers different loss functions that quantify the severity of the losses that are provided by the risk manager or the actuary. We present an explicit formula for the regression estimators for the proposed risk-based regression problem and study the proposed results. Finally, we provide a numerical study of the results using data from the insurance industry.
FINITARY UPPER LOGICISM
Authors: JACINTO BRUNO 
Published: May 2024

AbstractThis paper proposes and partially defends a novel philosophy of arithmetic—finitary upper logicism. According to it, the natural numbers are finite cardinalities—conceived of as properties of properties—and arithmetic is nothing but higher-order modal logic. Finitary upper logicism is furthermore essentially committed to the logicality of finitary plenitude, the principle according to which every finite cardinality could have been instantiated. Among other things, it is proved in the paper that second-order Peano arithmetic is interpretable, on the basis of the finite cardinalities’ conception of the natural numbers, in a weak modal type theory consisting of the modal logic
$\mathsf {K}$
, negative free quantified logic, a contingentist-friendly comprehension principle, and finitary plenitude. By replacing finitary plenitude for the axiom of infinity this result constitutes a significant improvement on Russell and Whitehead’s interpretation of second-order Peano arithmetic, itself based on the finite cardinalities’ conception of the natural numbers.