BackgroundCORE (Clarity and Openness in Reporting: E3-based) Reference (released May 2016 by the European Medical Writers Association [EMWA] and the American Medical Writers Association [AMWA]) is a complete and authoritative open-access user’s guide to support the authoring of clinical study reports (CSRs) for current industry-standard-design interventional studies. CORE Reference is a content guidance resource and is not a CSR Template.TransCelerate Biopharma Inc., an alliance of biopharmaceutical companies, released a CSR Template in November 2018 and recognised CORE Reference as one of (...) two principal sources used in its development.MethodsThe regulatory medical writing and statistical professionals who developed CORE Reference conducted a critical review of the TransCelerate CSR Template. We summarise our major findings and recommendations in this communication. We also re-examined and edited the Version 1 CORE Reference Terminology Table that we first published in 2016, and we present this as Version 2 in this communication.ResultsOur major critical review findings indicate that opportunities remain to refine the CSR Template structure and instructional text, enhance content clarity, add web links to referenced guidance documents, improve transparency to support the broad readership of CSRs, and develop supporting resources.The CORE Reference ‘Terminology Table’ Version 2 includes estimand as a defined term and an adaptation of the original ‘worked study example’ to incorporate the recently evolved concept of ‘estimands’.ConclusionsAs TransCelerate’s CSR Template represents an important milestone in authoring CSRs, we offer CSR authors advice and recommendations on its use, similarities, and differences with CORE Reference and advise them to consider shared interpretations between the two.RegistrationCORE Reference is registered with the EQUATOR Network. The TransCelerate CSR Template is not registered with any external organisation to the knowledge of the authors of this paper. (shrink)

Pietraszewski asserts that social psychological research on groups is too vague, tautological, and dependent on intuitions to be theoretically useful. We disagree. Pietraszewski's contribution is thought-provoking but also incomplete and guilty of many of the faults he attributes to others. Instead of rototilling the existing knowledge landscape, we urge for more integration of new and old ideas.

Management practitioners and scholars have worked diligently to identify methods for ethical decision making in international contexts. Theoretical frameworks such as Integrative Social Contracts Theory (Donaldson and Dunfee, 1994, Academy of Management Review 19, 252–284) and more recently the Global Business Citizenship Approach [Wood et al., 2006, Global Business Citizenship: A Transformative Framework for Ethics and Sustainable Capitalism. (M. E. Sharpe, Armonk, NY)] have produced innovations in practice. Despite these advances, many managers have difficulty implementing these theoretical concepts in daily (...) practice. Using the example of recent decisions by internet service providers Google, Yahoo, and MSN regarding censorship requirements in China, we offer six heuristic questions to help managers to resolve cross-cultural ethical conflicts in which the firm’s way of doing business differs from the practice in the host country. Recognizing that companies can take different approaches to law and ethics (Paine, 1994, Harvard Business Review 72(2), 107–117), our aim is to provide a management decision process to deal with demands or opportunities for engaging in questionable business practices in a host country. (shrink)

Cross cultural ethical conflicts are a major challenge for managers of multinational corporations (MNEs) when an MNE''s business practices and a host country''s practices differ. We develop a set of decision principles to help MNE managers deal with these conflicts and illustrate with examples of ethical conflicts faced by MNEs doing business in contemporary Russia (DeGeorge, 1994). We discuss the generalizability of the principles by comparing them to the Donaldson (1989) and Buller and Kohls (1997) decision models. Finally we discuss (...) changes in the cross cultural ethical problems facing MNE managers and offer suggestions for future corporate and academic work on these problems. (shrink)

Cross cultural ethical conflicts are a major challenge for managers of multinational corporations (MNEs) when an MNE's business practices and a host country's practices differ. We develop a set of decision principles to help MNE managers deal with these conflicts and illustrate with examples of ethical conflicts faced by MNEs doing business in contemporary Russia (DeGeorge, 1994). We discuss the generalizability of the principles by comparing them to the Donaldson (1989) and Buller and Kohls (1997) decision models. Finally we discuss (...) changes in the cross cultural ethical problems facing MNE managers and offer suggestions for future corporate and academic work on these problems. (shrink)

Recent corporate legal and ethical meltdowns suggest that avoiding such harms to companies and to society requires a significant culture change within the organization. This paper addresses the issue of what it takes to change a corporate culture. While conventional wisdom may suggest that a change requires only the institution of an ethics office with proper reporting paths and an ethics code, such an approach is only a beginning. Many large corporations, especially those in danger of legal and ethical catastrophes, (...) need to undertake multiple initiatives to generate a new culture that manifests new values and new vocabularies. A cultural change accomplished by changing large numbers of personnel is expensive in financial and human terms. One component of a less costly approach is to tell new and different stories within the corporation because stories establish the cultural DNA that gives organizations, families, and individuals their identities. Such changes in individual firms, however, are influenced by the ideological assumptions within which and under which the industry and the society operates. (shrink)

Management practitioners and scholars have worked diligently to identify methods for ethical decision making in international contexts. In this paper we offer sixheuristic questions to help corporate managers resolve cross-cultural ethical conflicts involving questionable business practices in a host country. Our aim is to provide practical guidance for discussion within a firm on whether or not to do business the firm’s way, the host’s way or refrain from doing business there (the highway).

We have synthesized a 582,970-base pair Mycoplasma genitalium genome. This synthetic genome, named M. genitalium JCVI-1.0, contains all the genes of wild-type M. genitalium G37 except MG408, which was disrupted by an antibiotic marker to block pathogenicity and to allow for selection. To identify the genome as synthetic, we inserted "watermarks" at intergenic sites known to tolerate transposon insertions. Overlapping "cassettes" of 5 to 7 kilobases (kb), assembled from chemically synthesized oligonucleotides, were joined by in vitro recombination to produce intermediate (...) assemblies of approximately 24 kb, 72 kb ("1/8 genome"), and 144 kb ("1/4 genome"), which were all cloned as bacterial artificial chromosomes in Escherichia coli. Most of these intermediate clones were sequenced, and clones of all four 1/4 genomes with the correct sequence were identified. The complete synthetic genome was assembled by transformation-associated recombination cloning in the yeast Saccharomyces cerevisiae, then isolated and sequenced. A clone with the correct sequence was identified. The methods described here will be generally useful for constructing large DNA molecules from chemically synthesized pieces and also from combinations of natural and synthetic DNA segments. 10.1126/science.1151721. (shrink)

As part of a multifactorial approach to address weak incentives for innovative antimicrobial drug development, market entry rewards are an emerging solution. Recently, the Duke-Margolis Center for Health Policy released the Priority Antimicrobial Value and Entry Award proposal, which combines a MER with payment reforms, transitioning from volume-based to “value-based” payments for antimicrobials. Here, the PAVE Award and similar MERs are reviewed, focusing on further refinement and avenues for implementation.

Hastings Center Report, Volume 52, Issue S1, Page S83-S88, March‐April 2022.

Technology has expanded genomic research and the complexity of extracted gene-related information. Health-related genomic incidental findings pose new dilemmas for nurse researchers regarding the ethical application of disclosure to participants. Consequently, informed consent specific to incidental findings is recommended. Critical Social Theory is used as a guide in recognition of the changing meaning of informed consent and to serve as a framework to inform nursing of the ethical application of disclosure consent in genomic nursing research practices.

Theorists about love typically downplay the scale of persistent and possibly intractable disagreement about love. Where they have considered such disagreements at all, they have tended to treat them as an example of the lack of clarity surrounding the concept of love, a problem which can be resolved by philosophical analysis. In doing so, they invariably slip into prescriptive mode and offer moral injunctions in the guise of conceptual analyses.This article argues for philosophical modesty. I propose that the starting point (...) of any coherent philosophical investigation of love must be a willingness to take our disagreements seriously. These disagreements stem from profound moral differences: we disagree about love inasmuch as we disagree about how we should properly treat one another.With a series of examples drawn from philosophy, literature and real life I attempt to illustrate some of the disagreements that arise in relation to erotic love. Drawing upon the work of Wittgenstein, Friedrich Waissman and W.B. Gallie, I suggest that any robust theory of love needs to take account of its contestable nature and the integral role it plays in our moral life. (shrink)

We review the observational foundations of the ΛCDMΛCDM model, considered by most cosmologists as the standard model of cosmology. The Cosmological Principle, a key assumption of the model is shown to be verified with increasing accuracy. The fact that the Universe seems to have expanded from a hot and dense past is supported by many independent probes . The explosion of detailed observations in the last few decades has allowed for precise measurements of the cosmological parameters within Friedman–Lemaître–Robertson–Walker cosmologies leading (...) to the ΛCDMΛCDM model: an apparently flat Universe, dominated by a cosmological constant, whose matter component is dominantly dark. We describe and discuss the various observational probes that led to this conclusion and conclude that the ΛCDMΛCDM model, although leaving a number of open questions concerning the deep nature of the constituents of the Universe, provides the best theoretical framework to explain the observations. (shrink)

In this paper we show how the dynamics of the Schrödinger, Pauli and Dirac particles can be described in a hierarchy of Clifford algebras, \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}${\mathcal{C}}_{1,3}, {\mathcal{C}}_{3,0}$\end{document}, and \documentclass[12pt]{minimal} \usepackage{amsmath} \usepackage{wasysym} \usepackage{amsfonts} \usepackage{amssymb} \usepackage{amsbsy} \usepackage{mathrsfs} \usepackage{upgreek} \setlength{\oddsidemargin}{-69pt} \begin{document}${\mathcal{C}}_{0,1}$\end{document}. Information normally carried by the wave function is encoded in elements of a minimal left ideal, so that all the physical information appears within the algebra itself. The state of the quantum process can be (...) completely characterised by algebraic invariants of the first and second kind. The latter enables us to show that the Bohm energy and momentum emerge from the energy-momentum tensor of standard quantum field theory. Our approach provides a new mathematical setting for quantum mechanics that enables us to obtain a complete relativistic version of the Bohm model for the Dirac particle, deriving expressions for the Bohm energy-momentum, the quantum potential and the relativistic time evolution of its spin for the first time. (shrink)

23 pages, no figure. Proceedings of "Philosophical Aspects of Modern Cosmology" held in Granada, Spain, 22-23 Sept. 2011. Studies in History and Philosophy of Modern Physics ; doi:10.1016/j.shpsb.2013.02.002.

Until a few years ago, the works of Thomas Reid were known only by specialists in the history of philosophy, and, insofar as people did think at all about Reid and his school of common sense philosophy, it was generally thought that Kant had been right in dismissing them as naive thinkers who did not really understand what philosophical skepticism was all about. This attitude about Reid changed very rapidly in recent years. More and more people now realize that Reid (...) was one of the most important British philosophers, and that his works are full of deep insights that have only recently been rediscovered. (shrink)

The object of this article is to examine the letter from which Plutarch quotes in the above passage from the twenty-eighth chapter of his life of Alexander; to attempt to prove, particularly by a comparison of the letter with the Sidypafifia sent in 319 B.C. by Polyperchon to the Greek cities, that it is a genuine part of Alexander's correspondence; and further to consider what light the letter, if genuine, throws upon the person of Alexander himself.

The object of this article is to examine the letter from which Plutarch quotes in the above passage from the twenty-eighth chapter of his life of Alexander; to attempt to prove, particularly by a comparison of the letter with the Sidypafifia sent in 319 B.C. by Polyperchon to the Greek cities, that it is a genuine part of Alexander's correspondence; and further to consider what light the letter, if genuine, throws upon the person of Alexander himself.

Describes the life and influence of B. Brecht. Offers useful explanations of several key concepts Brecht employed, and revised over his career, including: gestus, Verfremdung, and Verfremdungseffekt.

A. H. Sommerstein has recently directed our attention away from the belaboured topic of the essential and original structure of Old Comedy to the more productive question of how the extant plays of Aristophanes are shaped. He begins with the question of the source of ‘the five-act principle, standard in Menandrian comedy’ . Correctly looking to the chorus as the key element in articulating a play's form, Sommerstein finds that the five-act format already dominates the shape of Old Comedy, although (...) he argues that the number of acts ranges from four to seven and that only in the fourth century do the acts become about the same length. His analysis is largely correct, I think, but it is in danger of being ignored because his criteria are not objective and have not been applied systematically. Thus, B. Zimmermann has more recently described the structure of Aristophanic comedy as free. (shrink)

A. H. Sommerstein has recently directed our attention away from the belaboured topic of the essential and original structure of Old Comedy to the more productive question of how the extant plays of Aristophanes are shaped. He begins with the question of the source of ‘the five-act principle, standard in Menandrian comedy’. Correctly looking to the chorus as the key element in articulating a play's form, Sommerstein finds that the five-act format already dominates the shape of Old Comedy, although he (...) argues that the number of acts ranges from four to seven and that only in the fourth century do the acts become about the same length. His analysis is largely correct, I think, but it is in danger of being ignored because his criteria are not objective and have not been applied systematically. Thus, B. Zimmermann has more recently described the structure of Aristophanic comedy as free. (shrink)

In an otherwise convincing article Mr. T. P. Wiseman argues that this passage ‘seems to mean that L. Memmius and Q. Pompeius were principes, i.e. outstanding orators, and that they were not among those who spoke in their own defence in 90 B.C.’. But he rightly refuses to believe that Cicero can have intended this, since, apart from other considerations, it is clear from Cicero's previous references to Memmius and Pompeius that he did not consider them to be outstanding orators.

In an otherwise convincing article Mr. T. P. Wiseman argues that this passage ‘seems to mean that L. Memmius and Q. Pompeius were principes, i.e. outstanding orators, and that they were not among those who spoke in their own defence in 90 B.C.’. But he rightly refuses to believe that Cicero can have intended this, since, apart from other considerations, it is clear from Cicero's previous references to Memmius and Pompeius that he did not consider them to be outstanding orators.

The modern use of algebra to describe geometric ideas is discussed with particular reference to the constructions of Grassmann and Hamilton and the subsequent algebras due to Clifford. An Einstein addition law for nonparallel boosts is shown to follow naturally from the use of the representation-independent form of the geometric algebra of space-time.