bluuebunny/crossref_metadata_2025_split huggingface dataset:
Old and New Trial Designs
Authors: Weijer Charles , Hey Spencer Phillips 
Published: December 2022

Abstract
Informed consent and equipoise are key components in the ethical analysis of clinical trials. However, these concepts were developed during a time when “clinical trial” primarily referred to an individually randomized controlled trial. In the twenty-first century, there has been considerable innovation in trial design. Cluster randomized trials, biomarker-stratified or enrichment trials, and multi-arm platform trials are increasingly used. In this chapter, the authors show how each of these innovative designs raises new challenges for understanding and operationalizing ethical judgments regarding consent and equipoise. The features of innovative designs that drive the need for ethical concepts to evolve and adapt differ. In cluster randomized trials, the need to adapt is driven by the broader scope of such trials in terms of interventions and participants; in biomarker-stratified and enrichment designs, it is the complexity of the scientific hypothesis; and in multi-arm platform designs, it is the evolving set of interventions. Despite the sometimes quite dramatic changes to the structure and hypotheses of randomized controlled trials, the ethical concepts of equipoise and consent remain relevant for all randomized controlled trials.
Trade Law in Europe
Authors: Hestermeyer Holger P. 
Published: December 2022

Abstract
The European Union is one of the three largest actors in world trade and one of the world’s most influential regulators. This chapter gives an overview over the European Union’s rules for intra-EU trade, describing the EU customs union and its internal market including the ‘four freedoms’ as well as other EU treaty provisions on the internal market and legislative measures taken to further strengthen the market. It then proceeds to explain the European Union’s external trade policy. Finally, the chapter explains how the United Kingdom withdrew from the European Union and the consequences of this process with regard to both EU-UK trade and UK trade with other states. For readers who are not familiar with the European Union and EU law, the chapter begins with an overview of the EU legal order. Readers familiar with EU law are invited to skip this section.
Eurasian Economic Union and Trade and Investment Liberalization
Authors: Trunk-Fedorova Marina 
Published: December 2022

Abstract
The Eurasian Economic Union is an organization of regional economic integration—a customs union created in line with WTO rules. It maintains, inter alia, a common customs policy and the Eurasian Single Customs Tariff. Although the EAEU is not a WTO Member, a number of its measures have been challenged at the WTO against individual EAEU Member States. The EAEU Treaty provides for the creation of an economic space with free movement of goods, persons, services and capital. It also contains a chapter on investment regulation in the EAEU, which is formulated as a regional agreement on protection of foreign investments.
Trade in Agriculture
Authors: Smith Fiona 
Published: December 2022

Abstract
This chapter reflects on what effects regional trade agreements have on international agricultural trade regulation. It questions the established view that regional trade agreements indicate the further fragmentation of international trade law, and instead proposes a new theoretical perspective grounded on the notion of trade rules’ stability. Focusing on stability reveals new perspectives about how international agricultural trade rules function and why formal regulation seems unable to resolve ongoing political disagreements about the relationship between trade and non-trade values at the WTO. Questions about rules’ stability are not unique to international agricultural trade law and can be extended to reveal new challenges in all areas of international economic law.
Trade Remedies in International Trade
Authors: Perezcano Díaz Hugo 
Published: December 2022

Abstract
Antidumping duties, countervailing duties, and safeguards are trade remedies allowing a country to protect its domestic industry from import competition. Some view them as barriers to trade; others as safety nets that allow States to more confidently agree to greater liberalization. Dumping is defined as the introduction of a product into the commerce of another country at is less than its normal value. The antidumping system is ultimately about price comparability to determine if there is price discrimination. In contrast, subsidies are used to pursue wide-ranging governmental objectives. A subsidy involves the transfer of an economic benefit by government to the recipient’s advantage. Safeguards are measures that temporarily restrict imports that, as a result of unforeseen developments and trade liberalization, are causing or threatening to cause serious injury to domestic producers of like or directly competitive products. Their purpose is to offer protection from import competition so that the domestic industry can make the necessary adjustments that will allow it to compete. Despite their economic inefficiencies, trade remedies play an important role in the world trading system, and will likely do so into the future. That is not to say, however, that the world should be complacent. Trade remedies are not a cure for all trade ailments. They are intended to remedy very particular situations and should be used accordingly. The sheer number of cases involving trade remedies indicates that they have not been. Efforts to progressively discipline them should continue.
Balancing Market and Non-Market Objectives
Authors: Watal Jayashree 
Published: December 2022

Abstract
Lack of access to medicines could be either because they are not available or because even when available, they are not affordable to most patients in a country as the prices are disproportionately high compared to average income levels in the country. The focus of the criticism of the current pharmaceutical innovation model is the alleged use (or misuse) of the intellectual property system that allows the originator to control both the availability and affordability of essential medicines during the patent or market exclusivity term. However, patents are found to be uniquely important to capture profits from innovation in the chemicals and pharmaceutical sectors. In an attempt to balance market and public health objectives, the WTO TRIPS Agreement obliges the acceptance of product and process patents for pharmaceuticals while permitting several solutions, such as compulsory licensing or parallel imports, to attenuate problems of availability and affordability. These TRIPS solutions were the result of hard-fought North-South negotiating battles during the Uruguay Round and have been reiterated in 2001 through the Doha Declaration on the TRIPS Agreement and Public Health. A new TRIPS provision, Article 31bis, permits 100 per cent exports of pharmaceutical production under special compulsory licences to countries that have no manufacturing capacity. Perceived gaps in the TRIPS text are sought to be filled in by the demandeurs for stronger intellectual property protection through provisions in Free Trade Agreements (FTAs), on test-data protection, patent-term extension and patent linkage, among others. Properly balancing market and public health objectives may entail an international agreement in future to encourage differential pricing of patented medicines that would ensure affordable prices in all countries.
Privacy and Data Protection
Authors: Burri Mira 
Published: December 2022

Abstract
Against the background of the centrality of data for contemporary economies, the chapter contributes to a better understanding and contextualization of data protection and its interfaces with global trade law. It looks at existing international, transnational, and selected national frameworks for privacy protection and briefly sketches their evolution. The chapter then explores the application of the WTO rules, which admittedly are in a pre-Internet state, to situations where privacy concerns are affected. Subsequently, the data-related frameworks of FTAs, where most of the new rule-making occurs, are explored. The chapter concludes with an appraisal of the state of affairs and an outlook on the linkages between trade law and data protection in the digital economy.
The Development of the Regulation of International Trade
Authors: McRae Donald 
Published: December 2022

Abstract
International trade regulation based on agreement and the MFN principle has developed from bilateral FCN agreements to a multilateral arrangement under the GATT with diverse ancillary decisions, understandings, and agreements, to its modern form of comprehensive multilateral agreement under the WTO. A critical part of trade regulation has been the role of dispute settlement where under the WTO the Appellate Body became the authoritative decision-maker on the scope or ambit of the obligations under the WTO agreements. However, since the WTO, preferential trade agreements have proliferated at the bilateral, regional, and plurilateral levels, often deepening the areas of obligation from those under the WTO or expanding to new areas not covered by the WTO agreements. Most recently, this has taken the form of a mega-regional arrangement, the TPP, transformed into the CPTPP, characterized by the number of parties and the size of markets and coverage of areas not found in the WTO or other trade agreements, and without a constitutional role being granted to dispute settlement. The future of international trade regulation, given the present economic and political conditions, is uncertain. The comprehensiveness of mega-regulation is a model, but a reinvigoration of the WTO is unlikely. Retrenchment to traditional bilateral or small-scale regional forms of regulation of much narrower scope cannot be ruled out.
Fisheries
Authors: Young Margaret A. 
Published: December 2022

Abstract
Fisheries policy provides fundamental insights for trade lawyers. The scholar and practitioner of international trade law learns from a study of the utilization and trade of marine living resources about common dilemmas: the pressure that trade places on the sustainability of production; the constraints on consumers seeking to discriminate on the basis of ethical sensibilities; the difficulties of norms and institutions interacting with other regimes of international law; and the complexity of overlapping regional and multilateral trade governance, comprising World Trade Organization and regional trade agreements. The COVID19 pandemic adds further challenges. This chapter investigates the dilemmas in three dominant areas: (i) the negotiation of new trade rules, particularly within subsidy disciplines; (ii) the implementation of trade measures on fisheries, such as import bans for fish implicated in ‘illegal, unreported and unregulated’ (IUU) fishing; and (iii) the settlement of trade disputes. Drawing on treaties, case-law and institutional developments, this chapter assesses global and regional regulation of fish production and consumption, including new developments in the blue economy, and provides insight into the role of trade law in modern international governance.
Institutions
Authors: Unterhalter David , Schneidereit Erika 
Published: December 2022

Abstract
This chapter discusses the dispute settlement system of the World Trade Organization (WTO), and dispute settlement under regional and bilateral trade agreements. The WTO dispute settlement system evolved from a system predicated upon consent under the GATT 1947 into a system of compulsory and contentious jurisdiction that results in the adoption of binding resolutions to the disputes of members. The distinctive institutions, principles, rules and practices that comprise this system are given treatment in this chapter. Some emphasis is given to the Appellate Body, the institution born of the Uruguay Round, that was intended to lend stability and certainty to the system. The Appellate Body has attracted praise and criticism. Its principal critic, the United States, has rendered the Appellate Body currently inoperative. The chapter considers these issues and whether the system might be reformed so as to secure its continuation. Finally, the chapter discusses the expansion of bilateral and regional trade agreements, their dispute settlement provisions, and their cohabitation with WTO dispute settlement.
Remedies and Compliance
Authors: Vidigal Geraldo 
Published: December 2022

Abstract
This chapter examines the remedies that prevail in international trade adjudication, often known as ‘prospective’, ‘forward-looking’ or ‘compliance-oriented’. These terms are justified by the lack of awards for reparation for injury in this field, where remedies have evolved to focus not on past injury but on re-establishing conduct that complies with substantive obligations. The primary remedy available to trade adjudicators is an impartial determination of breach, coupled with an instruction for its cessation. These primary remedies are usually accompanied by the possibility of follow-up adjudication on compliance with them, and potentially by the threat of an authorization of retaliation in case of non-cessation of the violation. The authorization to apply regulated retaliation may be considered as a remedy in its own right, available in case the primary remedies prove insufficient to induce compliance. However, authorized retaliation should not be confused with awards for damages or analysed as a functional equivalent to monetary compensation. The practice shows that complainants in trade disputes do not request adjudication seeking retaliation and seldom implement it when authorized to do so. The right to retaliate is not perceived as a benefit in itself, but as an instrument whose threat can be used to induce performance of obligations or a settlement satisfactory to the complainant.
Stakeholders in International Trade Law Dispute Settlement
Authors: Friedbacher Todd , Connolly Katherine 
Published: December 2022

Abstract
This chapter identifies the range of stakeholders in international trade dispute settlement. The community of stakeholders is diverse, and begins with Member states, which have standing to bring disputes, participate in disputes as third parties, and (in the WTO) are the ultimate source of legal authority in the dispute settlement system, through their participation in the Dispute Settlement Body. Industries are the actors who actually engage in trade across borders; they cannot initiate disputes, or participate directly, but their knowledge of how the substantive rules work ‘on the ground’ makes their involvement and cooperation key to a successful dispute, and to making the most out of Members’ legal rights and obligations. Adjudicators are the ‘deciders’, whose independence and impartiality are of fundamental importance to the legitimacy of any dispute settlement system. Accountability of the adjudicators is paramount, and they must both be, and appear to be, independent and impartial in their decision-making. The WTO Secretariat is an important source of institutional support and consistency over time, although also a source of controversy over the appropriate boundaries of its role vis-à-vis the adjudicators. Finally, experts are an often overlooked stakeholder, but increasingly crucial as disputes grow more complex, technical and scientific. Each stakeholder participates in dispute settlement in a different way, for different reasons, and each makes its own contribution to the effective functioning of the various systems.
Alternative Dispute Settlement in the GATT and the WTO
Authors: Porges Amy 
Published: December 2022

Abstract
Governments have settled disputes in the GATT/WTO system not just through formal panel procedures and negotiation, but also through arbitration, mediation, conciliation, good offices, and other alternative dispute resolution (ADR) mechanisms. Trade disputes typically begin in negotiation, and it is negotiation that determines post-litigation outcomes. Parties may seek mediation or other ADR as a substitute or addition to WTO litigation, and they may also use party-controlled arbitration. This chapter provides a history of WTO/GATT ADR and discusses possible use of WTO arbitration in the proposed Multi-Party Interim Appeal Arbitration Arrangement (MPIA) or otherwise.
The Influence of International Trade Law on International Law
Authors: Crawford James , Baetens Freya 
Published: December 2022

Abstract
Numerous commentators have lauded international trade law, and the WTO dispute resolution mechanism in particular, as vehicles for change in international law more generally. In the sense that new rules of international trade law enhance international law, by creating new rights and obligations for the States parties to trade agreements, it is true that international trade law develops international law generally. In preparing the Articles on Responsibility of States for Internationally Wrongful Acts for example, the International Law Commission (ILC) had frequent regard to international trade law and the WTO. However, the influence of international trade law remains curtailed within the wider field of international law, outside the realm of WTO adjudication. Such influence in non-trade areas has been restricted for reasons such as its jurisdictional separateness, its limited relevance as part of the applicable law or even source of interpretation (due to the distinct or ‘sui generis’ character of trade law) and the informal hierarchy of international norms. But, there is room for non-trade-related areas of international law, and associated dispute resolution institutions, to learn from international trade law and in particular from the WTO as an institution.
North American Trade
Authors: Brookfield Robert , Di Pierdomenico Lori 
Published: December 2022

Abstract
On 16 August 2017, Canada, the United States, and Mexico officially launched the ‘re-negotiation’ of the NAFTA, which up until that point had presided over nearly a quarter century of North American trade. US President Trump made it clear that unless drastic changes were made to it, the US would withdraw from the NAFTA. In some respects, it had become clear that an agreement first implemented during the pre-digitalized age, and well-before issues like environment and labour standards were comprehensively addressed within FTAs, was badly in need of changes and modernization. Given its dissatisfaction with the agreement and other issues, the United States was engaging in the politics of breakdown in the rule of law to force change. Once the dust had settled and the new agreement in place, however, it was remarkable in that despite the ringing criticisms, it was clear the NAFTA was mostly left in place, but with a few key improvements, updates, and additions to signal a revised commitment of the Parties to North American trade.
Managing Creativity under Uncertainty
Authors: Zhou Jing 
Published: December 2022

Abstract
Uncertainty permeates the creative process. Managing creativity under uncertainty hence is a fundamental topic for research and management practice. Little prior work has provided a focused and holistic analysis on how uncertainty is related to various aspects of the creative process. In this chapter, the author discusses three aspects of the relation between uncertainty and creativity: uncertainty as an opportunity for creativity, uncertainty in the creative process, and uncertainty in creativity evaluation. The author reviews previous studies in the creativity literature that suggest how to deal with uncertainty in each of these three aspects and evaluates extant work. This review and appraisal underscore the need for greater attention on the role of uncertainty in the creative process than what has been done to date, and suggest exciting directions for future theoretical development and empirical investigation. Overall, the review and discussion provide implications not only for future research but also for management practice.
Samuel Barber’s A Hand of Bridge and Anxieties of the American Middlebrow
Authors: Dupuis Jacques 
Published: December 2022

Abstract
This chapter examines Samuel Barber’s diminutive 1959 opera, A Hand of Bridge, as a case study of American operatic representations of the midcentury middlebrow. The piece’s status as an outlier in Barber’s oeuvre serves as the entry point for a close reading of the opera as an intentioned critique of mid-twentieth-century American culture and, more specifically, middlebrow intellectualism. To shed light on the opera’s particular musical style and au courant topicality, frameworks underpinning Weimar Era Zeitoper are applied to A Hand of Bridge and comparisons are drawn to other American operas that address similar themes. The chapter concludes by considering broader cultural trends of American midcentury anxiety relevant to the opera.
Race, Racism, and Well-Being Impacts on Aboriginal and Torres Strait Islander Peoples in Australia
Authors: Brinckley Makayla-May , Lovett Raymond 
Published: December 2022

Abstract
Race has been (re)constructed over time by those in power to oppress and regulate the lives of Indigenous Peoples and people of color. In settler-colonial states like Australia, race is weaponized to justify settler-colonial violence and to control Indigenous lives. The Indigenous Peoples of Australia have been racialized since first contact, which has resulted in racism and oppression, with present-day implications for health and well-being. To examine the health and well-being impacts of racism exposure, this chapter uses self-report exposure to interpersonal racism and health and well-being outcomes data from Mayi Kuwayu: The National Study of Aboriginal and Torres Strait Islander Wellbeing, an Indigenous designed, led, and governed Australian cohort study. The analysis shows that experiencing interpersonal racism has a range of negative consequences on health and well-being. Aboriginal and Torres Strait Islander People exposed to any level of interpersonal racism have poorer general health and mental health outcomes. Additionally, experiencing any level of interpersonal racism is linked to lower levels of cultural participation. Understanding the history of race and the impacts that racism has on health and well-being is necessary to improve the lives of Aboriginal and Torres Strait Islander Peoples.
Gender and Agency in Digital Religion
Authors: Lövheim Mia 
Published: December 2022

Abstract
Gender has become a prominent theme in research on digital religion, as part of a focus on the particular social, cultural, and embodied context. The most salient issue has been women’s religious agency, in particular within certain gender-traditional communities. The chapter presents three themes emerging in research on gender and digital religion since the year 2000 and discusses how these connect to current approaches to women’s agency within religious studies. The first theme focuses on how digital media enhances women’s agency through expressing religious experiences and connecting to a larger public. The second theme concerns uses of digital media to handle tensions between gender-traditional norms in religious communities, and ideals of gender equality and women’s independence in the wider society. The third theme bring out how digital technology enhances but also challenges women’s agency in new ways. The chapter ends with highlighting critical issues on agency within the area of digital religion that should be attended to in future studies.