The European framework surrounding clinical trials on medicinal products for human use is going to change as demonstrated by the large debate at European institutional level. One of the major challenges is to overcome the lack of harmonisation of clinical trial procedures among countries. This aspect is gaining more and more importance, considering the increasing number of multicentre and multinational studies. In this work, the actual European rules governing the Clinical Trial Application have been analysed throughout the different steps including (...) the registration of the trial in the European database; the preparation of documents to be submitted and their contents; the preparation of documents related to the information and consent process; the submission to competent bodies. Specific issues related to paediatric research and trials involving non EU/EEA countries have been addressed as well. Results reveal that the European legislation offers a well defined set of European rules covering different aspects of a Clinical Trial Application. However, these are not suitable to meet the challenges from multicentre and multinational clinical studies. A stronger set of rules, such as is available in a composite European Regulation has been adopted and is expected to harmonise practices and enable sponsors to carry out well conducted trials. But will the new regulation overcome the existing criticisms of Directive 2001/20/EC? (shrink)

We present a reference model for finding evidence of discrimination in datasets of historical decision records in socially sensitive tasks, including access to credit, mortgage, insurance, labor market and other benefits. We formalize the process of direct and indirect discrimination discovery in a rule-based framework, by modelling protected-by-law groups, such as minorities or disadvantaged segments, and contexts where discrimination occurs. Classification rules, extracted from the historical records, allow for unveiling contexts of unlawful discrimination, where the degree of burden over protected-by-law (...) groups is evaluated by formalizing existing norms and regulations in terms of quantitative measures. The measures are defined as functions of the contingency table of a classification rule, and their statistical significance is assessed, relying on a large body of statistical inference methods for proportions. Key legal concepts and reasonings are then used to drive the analysis on the set of classification rules, with the aim of discovering patterns of discrimination, either direct or indirect. Analyses of affirmative action, favoritism and argumentation against discrimination allegations are also modelled in the proposed framework. Finally, we present an implementation, called LP2DD, of the overall reference model that integrates induction, through data mining classification rule extraction, and deduction, through a computational logic implementation of the analytical tools. The LP2DD system is put at work on the analysis of a dataset of credit decision records. (shrink)

This paper explores taste fragmentalism, a novel approach to matters of taste and faultless disagreement. The view is inspired by Kit Fine’s fragmentalism about time, according to which the temporal dimension can be constituted—in an absolute manner—by states that are pairwise incompatible, provided that they do not obtain together. In the present paper, we will apply this metaphysical framework to taste states. In our proposal, two incompatible taste states (such as the state of rhubarb’s being tasty and the state of (...) rhubarb’s being distasteful) can both constitute reality in an absolute manner, although no agent can have joint access to both states. We will then develop a formalised version of our view by means of an exact truthmaker semantics for taste assertions. Within this framework—we argue—our linguistic and inferential practices concerning cases of faultless disagreement are elegantly vindicated, thus suggesting that taste fragmentalism is worth of further consideration. (shrink)

Dans la mythologie grecque, Prométhée - le 'prévoyant' - déroba le feu aux dieux et le transmit aux hommes. Zeus, courroucé par ce transfert technologique, condamna Prométhée à un châtiment itéré à l'identique, à l'infini, algorithmique. Le problème que pose l'ancien mythe est celui des limites de la connaissance. En termes modernes, jusqu'à quel point pouvons-nous transformer la nature sans une connaissance des conséquences de nos actions sur elle? Cette question nous pousse à analyser les limites des sciences : à (...) une techno-science devenue toujours plus invasive, la science répond en se donnant à elle-même des limites"--Page 4 of cover. (shrink)

Sceptical Paths gathers a variety of innovative studies that inquire into the presence and function of sceptical elements, strategies, and approaches in various traditions throughout Ancient, Medieval, Modern, and contemporary philosophy. Special at.

The moving spotlight account (MS) is a view that combines an eternalist ontology and an A-theoretic metaphysics. The intuition underlying MS is that the present time is somehow privileged and experientially vivid, as if it were illuminated by a moving spotlight. According to MS-theorists, a key reason to prefer MS to B-theoretic eternalism is that our experience of time supports it. We argue that this is false. To this end, we formulate a new family of positions in the philosophy of (...) time, which differ from MS in that, intuitively, they admit a plurality of moving spotlights. We argue that these ‘deviant’ variants of MS cannot be dismissed as conceptually incoherent, and that they are as well-supported by our experience as is MS. One of these variants, however, is consistent with the B-theory. Thus, if our experience of time supports MS, then it supports the B-theory as well. (shrink)

Open futurism is the indeterministic position according to which the future is ‘open’, i.e., there is now no fact of the matter as to what future contingent events will actually obtain. Many open futurists hold a branching conception of time, in which a variety of possible futures exist. This paper introduces two challenges to branching-time open futurism, which are similar in spirit to a challenge posed by Fine to tense realism. The paper argues that, to address the new challenges, open (...) futurists must adopt an objective, non-perspectival notion of actuality and subscribe to an A-theoretic, dynamic conception of reality. Moreover, given a natural understanding of “actual future”, it is perfectly sensible for open futurists to hold that a unique, objectively actual future exists, contrary to a common assumption in the current debate. The paper also contends that recognising the existence of a unique actual future helps open futurists to avoid potential misconceptions. (shrink)

Artefacts do not always do what they are supposed to, due to a variety of reasons, including manufacturing problems, poor maintenance, and normal wear-and-tear. Since software is an artefact, it should be subject to malfunctioning in the same sense in which other artefacts can malfunction. Yet, whether software is on a par with other artefacts when it comes to malfunctioning crucially depends on the abstraction used in the analysis. We distinguish between “negative” and “positive” notions of malfunction. A negative malfunction, (...) or dysfunction, occurs when an artefact token either does not or cannot do what it is supposed to. A positive malfunction, or misfunction, occurs when an artefact token may do what is supposed to but, at least occasionally, it also yields some unintended and undesirable effects. We argue that software, understood as type, may misfunction in some limited sense, but cannot dysfunction. Accordingly, one should distinguish software from other technical artefacts, in view of their design that makes dysfunction impossible for the former, while possible for the latter. (shrink)

Das Buch enthält die Einführung in die Lektüre sowie den Textkommentar zu den der Analyse der Grundsätze der Modalität gewidmeten "Postulaten des empirischen Denkens überhaupt". Untersucht wird Kants gesamte Theorie der Modalbegriffe (Möglichkeit - Unmöglichkeit, Dasein - Nichtsein, Notwendigkeit - Zufälligkeit) seit Mitte der 1750er Jahre bis zur Kritik der reinen Vernunft. Die Postulate sind nach Kant nicht objektiv, sondern subjektiv-synthetisch: Der Gegenstand der Erfahrung, welcher zunächst anhand der objektiv-synthetischen Funktionen der Quantität, Qualität und Relation bestimmt wird, lässt sich nun (...) in seinem Verhältnis zum setzenden Subjekt betrachten. Die Postulate thematisieren jedoch nicht - hier liegt die konstitutive Charakteristik dieser synthetischen Urteile a priori - das Subjekt selbst, sondern das Objekt als solches und die Objektivität überhaupt. Wie diese Untersuchung zeigt, antwortet Kant erst hier - nicht in den viel diskutierten Deduktionskapiteln oder in den anderen Grundsatzkapiteln - auf die Frage "Was ist ein Objekt?" und bezieht zugleich Stellung gegenüber anderen philosophischen Theorien der Objektivität des 18. Jahrhunderts: Rationalismus, Empirismus, Idealismus, Skeptizismus. (shrink)

CHAPTER Structure and function In physical systems made by a large number of basic constituents one can observe collective properties which find their ...

Computing, today more than ever before, is a multi-faceted discipline which collates several methodologies, areas of interest, and approaches: mathematics, engineering, programming, and applications. Given its enormous impact on everyday life, it is essential that its debated origins are understood, and that its different foundations are explained. On the Foundations of Computing offers a comprehensive and critical overview of the birth and evolution of computing, and it presents some of the most important technical results and philosophical problems of the discipline, (...) combining both historical and systematic analyses. -/- The debates this text surveys are among the latest and most urgent ones: the crisis of foundations in mathematics and the birth of the decision problem, the nature of algorithms, the debates on computational artefacts and malfunctioning, and the analysis of computational experiments. By covering these topics, On the Foundations of Computing provides a much-needed resource to contextualize these foundational issues. -/- For practitioners, researchers, and students alike, a historical and philosophical approach such as what this volume offers becomes essential to understand the past of the discipline and to figure out the challenges of its future. (shrink)

While there has been increased attention to emotions and institutions, the role of denial and repression of emotions has been overlooked. We argue that not only the expression and the feeling of emotions, but also their control through denial contribute to stabilize institutional orders. The role denial plays is that of avoiding the emergence of disruptive emotions that might motivate a challenge to the status quo. Reflecting on the example of the livestock industry, we propose a theoretical model that identifies (...) seeds for change in denied emotional contradictions in an inte- gration of the cultural-relational and issue-based conceptions of organi- zational fields. (shrink)

Riprendendo quanto George Edward Moore scrive a proposito del concetto di “bene” (“good”), Hans Kelsen sostiene che il concetto di “dovere” (“Sollen”) sia un concetto semplice, un concetto ultimo, e in quanto tale né definibile, né analizzabile. Questa tesi di Kelsen sembra essere smentita dalle ricerche che sono state condotte parallelamente da Georg Henrik von Wright e Amedeo Giovanni Conte a partire dagli anni '80 del XX secolo. Von Wright e Conte hanno, infatti, distinto dal concetto di “dovere deontico” (“deontic (...) Ought”), il dovere par excellence, altre specie di dovere che essi considerano categorialmente irriducibili al concetto di dovere deontico come il “dovere tecnico” (“technical Ought”) e il “dovere anankastico”. È proprio all'indagine di queste due specie di dovere adeontico che è dedicato il libro Anankastico in deontica. (shrink)