Clinical trials, informed consent, & emergency medicine: A systematic literature review

Background: In the United States, the Food and Drug Administration (FDA) regulates clinical trials. These regulations address good clinical practices as well as human subject protection (FDA, 2012). One of the most important legal and ethical concerns in clinical trials is informed consent. 21 CFR 50 governs human subjects research. Part 50.24 provides an emergency research exception to the informed consent requirement. Research was conducted to determine the appropriateness of this exception, whether the benefit justifies the exception, and its public health significance.^ Methods: A systematic literature review was conducted and articles were identified from peer-reviewed journals.^ Results: There is some variance in opinions regarding the appropriateness of the exception, but the literature reviewed found the study results of these trials justified the waiver.^ Conclusion: The exception to the informed consent requirement is likely appropriate and justified in emergency research when implemented within the specified guidelines.^

Investigating and Understanding Student Learning Outcomes in an Online and Face-to-Face Graduate Level Legal Administration Course: An Embedded Mixed Methods Design

Online education is a new teaching and learning medium with few current guidelines for faculty, administrators or students. Its rapid growth over the last decade has challenged academic institutions to keep up with the demand, while also providing a quality education. Our understanding of the factors that determine quality and effective online learning experiences that lead to student learning outcomes is still evolving. There is a lack of consensus on the effectiveness of online versus face-to-face education in the current research. The U.S. Department of Education conducted a meta-analysis in 2009 and concluded that student-learning outcomes in online courses were equal to and, often times, better than face-to-face traditional courses. Subsequent research has found contradictory findings, and further inquiry is necessary. The purpose of this embedded mixed methods design research study is to further our understanding of the factors that create quality and successful educational outcomes in an online course. To achieve this, the first phase of this study measured and compared learning outcomes in an online and in class graduate-level legal administration course. The second phase of the study entailed interviews with those students in both the online and face-to-face sections to understand their perspectives on the factors contributing to learning outcomes. Six themes emerged from the qualitative findings: convenience, higher order thinking, discussions, professor engagement, professor and student interaction, and face-to-face interaction. Findings from this study indicate the factors students perceive as contributing to learning outcomes in an online course are consistent among all students and are supported in the existing literature. Higher order thinking, however, emerged as a stronger theme than indicated in the current research, and the face-to-face nature of the traditional classroom may be more an issue of familiarity than a factor contributing to learning outcomes. As education continues to reach new heights and developments in technology advance, the factors found to contribute to student learning outcomes will be refined and enhanced. These developments will continue to transform the ways in which we deliver and receive knowledge in both traditional and online classrooms. While there is a growing body of research on online education, the field’s evolution has unsettled earlier findings and posed new areas to investigate.

The Criminalisation of Migration in Europe: A State-of-the-Art of the Academic Literature and Research. CEPS Liberty and Security in Europe No. 61, October 2013

In the last 30 years, a clear trend has come to define modern immigration law and policy. A set of seemingly disparate developments concerning the constant reinforcement of border controls, tightening of conditions of entry, expanding capacities for detention and deportation and the proliferation of criminal sanctions for migration offences, accompanied by an anxiety on the part of the press, public and political establishment regarding migrant criminality can now be seen to form a definitive shift in the European Union towards the so-called ‘criminalisation of migration’. This paper aims to provide an overview of the ‘state-of-the-art’ in the academic literature and EU research on criminalisation of migration in Europe. It analyses three key manifestations of the so-called ‘crimmigration’ trend: discursive criminalisation; the use of criminal law for migration management; and immigrant detention, focusing both on developments in domestic legislation of EU member states but also the increasing conflation of mobility, crime and security which has accompanied EU integration. By identifying the trends, synergies and gaps in the scholarly approaches dealing with the criminalisation of migration, the paper seeks to provide a framework for on-going research under Work Package 8 of the FIDUCIA project.

The Legal Construction of Membership: Nationality Law in Germany and the United States. CES Germany & Europe Working Papers No. 00.5, 2000

The argument of this paper is that several empirical puzzles in the citizenship literature are rooted in the failure to distinguish between the mainly legal concept of nationality and the broader, political concept of citizenship. Using this distinction, the paper analysis the evolution of German and American nationality laws over the last 200 years. The historical development of both legal structures shows strong communalities. With the emergence of the modern system of nation states, the attribution of nationality to newborn children is ascribed either via the principle of descent or place of birth. With regard to the naturalization of adults, there is an increasing ethnization of law, which means that the increasing complexities of naturalization criteria are more and more structured along ethnic ideas. Although every nation building process shows some elements of ethnic self-description, it is difficult to use the legal principles of ius sanguinis and ius soli as indicators of ethnic or non-ethnic modes of community building.

Legal decisions of common law of the United States.

Addressed to Elder Otis Sawyer; concerning legal rights and obligations of trustee or agent for the Shaker community.

Insurgent Testimonies : Witnessing Colonial Trauma in Modern and Anglophone Literature /

This book examines testimony in the works of Rebecca West, Joseph Conrad, E.M. Forster, H.G. de Lisser, V.S Reid, and Ngũgi wa Thiong’o, and argues that disruptions to imperial and national power and the legal and legal responses they inspired shape the formal practices of modernist and Anglophone literature. This title was made Open Access by libraries from around the world through Knowledge Unlatched.

A common-place book of the fifteenth century : containing a religious play and poetry, legal forms, and local accounts /

Spine title: The boke of Brome.

Reflecting on ethical and legal issues in wildlife disease

Disease in wildlife raises a number of issues that have not been widely considered in the bioethical literature. However, wildlife disease has major implications for human welfare. The majority of emerging human infectious diseases are zoonotic: that is, they occur in humans by cross-species transmission from animal hosts. Managing these diseases often involves balancing concerns with human health against animal welfare and conservation concerns. Many infectious diseases of domestic animals are shared with wild animals, although it is often unclear whether the infection spills over from wild animals to domestic animals or vice versa. Culling is the standard means of managing such diseases, bringing economic considerations, animal welfare and conservation into conflict. Infectious diseases are also major threatening processes in conservation biology and their appropriate management by culling, vaccination or treatment raises substantial animal ethics issues. One particular issue of great significance in Australia is an ongoing research program to develop genetically modified pathogens to control vertebrate pests including rabbits, foxes and house mice. Release of any self-replicating GMO vertebrate pathogen gives rise to a whole series of ethical questions. We briefly review current Australian legal responses to these problems. Finally, we present two unresolved problems of general importance that are exemplified by wildlife disease. First, to what extent can or should 'bioethics' be broadened beyond direct concerns with human welfare to animal welfare and environmental welfare? Second, how should the irreducible uncertainty of ecological systems be accounted for in ethical decision making?

Beyond the sphere of the English facial approximation literature: Ramifications of German papers on western method concepts

In the English literature, facial approximation methods have been commonly classified into three types: Russian, American, or Combination. These categorizations are based on the protocols used, for example, whether methods use average soft-tissue depths (American methods) or require face muscle construction (Russian methods). However, literature searches outside the usual realm of English publications reveal key papers that demonstrate that the Russian category above has been founded on distorted views. In reality, Russian methods are based on limited face muscle construction, with heavy reliance on modified average soft-tissue depths. A closer inspection of the American method also reveals inconsistencies with the recognized classification scheme. This investigation thus demonstrates that all major methods of facial approximation depend on both face anatomy and average soft-tissue depths, rendering common method classification schemes redundant. The best way forward appears to be for practitioners to describe the methods they use (including the weight each one gives to average soft-tissue depths and deep face tissue construction) without placing them in any categorical classificatory group or giving them an ambiguous name. The state of this situation may need to be reviewed in the future in light of new research results and paradigms.

Examining moderators of the hindsight bias in the context of civil legal decision -making: Counterfactuals, causal proximity, and self -referencing

The current research sought to clarify the diverging relationships between counterfactual thinking and hindsight bias observed in the literature thus far. In a non-legal context, Roese and Olson (1996) found a positive relationship between counterfactuals and hindsight bias, such that counterfactual mutations that undid the outcome also increased participants’ ratings of the outcome’s a priori likelihood. Further, they determined that this relationship is mediated by causal attributions about the counterfactually mutated antecedent event. Conversely, in the context of a civil lawsuit, Robbennolt and Sobus (1997) found that the relationship between counterfactual thinking and hindsight bias is negative. The current research sought to resolve the conflicting findings in the literature within a legal context. ^ In Experiment One, the manipulation of the normality of the defendant’s target behavior, designed to manipulate participants’ counterfactual thoughts about said behavior, did moderate the hindsight effect of outcome knowledge on mock jurors’ judgments of the foreseeability of that outcome as well as their negligence verdicts. Although I predicted that counterfactual thinking would increase, or exacerbate, the hindsight bias, as found by Roese and Olson (1996), my results provided some support for Robbenolt and Sobus’s (1997) finding that counterfactual thinking decreases the hindsight bias. Behavior normality did not moderate the hindsight effect of outcome knowledge in Experiment Two, nor did causal proximity in Experiment Three. ^ Additionally, my hypothesis that self-referencing may be an effective hindsight debiasing technique received little support across the three experiments. Although both the self-referencing instructions and self-report measure consistently decreased mock jurors’ likelihood of finding the defendant negligent, and self-referencing instructions decreased their foreseeability ratings in studies two and three, the self-referencing manipulation did not interact with outcome knowledge to moderate a hindsight bias effect on either foreseeability or negligence judgments. The consistent pattern of results across the three experiments, however, suggests that self-referencing may be an effective technique in reducing the likelihood of negligence verdicts.^

Examining Moderators of the Hindsight Bias in the Context of Civil Legal Decision-Making: Counterfactuals, Causal Proximity, and Self-Referencing

The current research sought to clarify the diverging relationships between counterfactual thinking and hindsight bias observed in the literature thus far. In a non-legal context, Roese and Olson (1996) found a positive relationship between counterfactuals and hindsight bias, such that counterfactual mutations that undid the outcome also increased participants’ ratings of the outcome’s a priori likelihood. Further, they determined that this relationship is mediated by causal attributions about the counterfactually mutated antecedent event. Conversely, in the context of a civil lawsuit, Robbennolt and Sobus (1997) found that the relationship between counterfactual thinking and hindsight bias is negative. The current research sought to resolve the conflicting findings in the literature within a legal context. In Experiment One, the manipulation of the normality of the defendant’s target behavior, designed to manipulate participants’ counterfactual thoughts about said behavior, did moderate the hindsight effect of outcome knowledge on mock jurors’ judgments of the foreseeability of that outcome as well as their negligence verdicts. Although I predicted that counterfactual thinking would increase, or exacerbate, the hindsight bias, as found by Roese and Olson (1996), my results provided some support for Robbenolt and Sobus’s (1997) finding that counterfactual thinking decreases the hindsight bias. Behavior normality did not moderate the hindsight effect of outcome knowledge in Experiment Two, nor did causal proximity in Experiment Three. Additionally, my hypothesis that self-referencing may be an effective hindsight debiasing technique received little support across the three experiments. Although both the self-referencing instructions and self-report measure consistently decreased mock jurors’ likelihood of finding the defendant negligent, and self-referencing instructions decreased their foreseeability ratings in studies two and three, the self-referencing manipulation did not interact with outcome knowledge to moderate a hindsight bias effect on either foreseeability or negligence judgments. The consistent pattern of results across the three experiments, however, suggests that self-referencing may be an effective technique in reducing the likelihood of negligence verdicts.

Introduction: Exploring the Comparative in Socio-Legal Studies

Among the diverse approaches to comparison in socio-legal studies those that employ qualitative research, richness of detail, and attention to context are the focus of this special issue. The Introduction draws on comparative law and social science literature to argue that comparison amongst studies of laws in contexts can follow different trajectories: the comparison may start from an assumption of similarity—in form, purposes, or context—in order to identify significant differences; or it may identify significant similarity across social and cultural divides. What unites many of the projects of comparison undertaken by qualitative empirical researchers is that the points of relevant comparison are identified within the complexity of the empirical studies at hand; and they are allowed to emerge, or change, as the researcher comes to understand the facts and issues more deeply.

Stumbling Blocks in Empirical Legal Research: Case Study Research

This article examines the main assumptions and theoretical underpinnings of case study method in legal studies. It considers the importance of research design, including the crucial roles of the academic literature review, the research question and the use of rival theories to develop hypotheses and the practice of identifying the observable implications of those hypotheses. It considers the selection of data sources and modes of analysis to allow for valid analytical inferences to be drawn in respect of them. In doing so it considers, in brief, the importance of case study selection and variations such as single or multi case approaches. Finally it provides thoughts about the strengths and weaknesses associated with undertaking socio-legal and comparative legal research via a case study method, addressing frequent stumbling blocks encountered by legal researchers, as well as ways to militate them. It is written with those new to the method in mind.

Law and Literature – a Meaningful Connection

The connection between law and (imaginative) literature can still affect surprisingly. The theme of the present article is to summarize some of the basic features of the movement, which is called „Law and Literature” and to suggest some starting-points with which it is associated. These starting points include, for instance linguistic conception of law, narratology in law or the relations between law and culture. The article offers an overview of the classical approaches connecting law and literature and mentions the reasons for this connection: e.g. cultivation of law and lawyers, improvement of judicial decisions or improvement of legal interpretation. Some of the findings resulting from the joint of law and literature can be used in practice and goes beyond „mere” theory. The article is to be seen as an introduction to the movement of „Law and Literature”, presentation of ideas on which this movement is based and offering the possibility of its further development.

Legal Framework for Cross-Regional Networks: The Case of Services and Migration

Paper prepared by Marion Panizzon and Charlotte Sieber-Gasser for the International Conference on the Political Economy of Liberalising Trade in Services, Hebrew University of Jerusalem, 14-15 June 2010 Recent literature has shed light on the economic potential of cross-border networks. These networks, consisting of expatriates and their acquaintances from abroad and at home, provide the basis for the creation of cross-border value added chains and therewith the means for turning brain drain into brain circulation. Both aspects are potentially valuable for economic growth in the developing world. Unilateral co-development policies operating through co-funding of expatriate business ventures, but also bilateral agreements liberalising circular migration for a limited set of per-sons testify to the increasing awareness of governments about the potential, which expatriate networks hold for economic growth in developing countries. Whereas such punctual efforts are valuable, viewed from a long term perspective, these top-down, government mandated Diaspora stimulation programs, will not replace, this paper argues, the market-driven liberalisation of infrastructure and other services in developing countries. Nor will they carry, in the case of circular labour migration, the political momentum to liberalise labour market admission for those non-nationals, who will eventually emerge as the future transnational entrepreneurs. It will take a combination of mode 4 and infrastructure services openings-cum regulation for countries at both sides of the spectrum to provide the basis and precondition for transnational business and entrepreneurial networks to emerge and translate into cross-border, value added production chains. Two key issues are of particular relevance in this context: (i) the services sector, especially in infrastructure, tends to suffer from inefficiencies, particularly in developing countries, and (ii) labour migration, a highly complex issue, still faces disproportionately rigid barriers despite well-documented global welfare gains. Both are hindrances for emerging markets to fully take advantage of the potential of these cross-border networks. Adapting the legal framework for enhancing the regulatory and institutional frameworks for services trade, especially in infrastructure services sectors (ISS) and labour migration could provide the incentives necessary for brain circulation and strengthen cross-border value added chains by lowering transaction costs. This paper analyses the shortfalls of the global legal framework – the shallow status quo of GATS commitments in ISS and mode 4 particular – in relation to stimulating brain circulation and the creation of cross-border value added chains in emerging markets. It highlights the necessity of adapting the legal framework, both on the global and the regional level, to stimulate broader and wider market access in the four key ISS sectors (telecommunications, transport, professional and financial services) in developing countries, as domestic supply capacity, global competitiveness and economic diversification in ISS sectors are necessary for mobilising expatriate re-turns, both physical and virtual. The paper argues that industrialised, labour receiving countries need to offer mode 4 market access to wider categories of persons, especially to students, graduate trainees and young professionals from abroad. Further-more, free trade in semi-finished products and mode 4 market access are crucial for the creation of cross-border value added chains across the developing world. Finally, the paper discusses on the basis of a case study on Jordan why the key features of trade agreements, which promote circular migration and the creation of cross-border value added chains, consist of trade liberalisation in services and liberal migration policies.