BackgroundExpanded access is the use of investigational drugs (IDs) outside of clinical trials. Generally it is performed in patients with serious and life-threatening diseases who cannot be treated satisfactorily with authorized drugs. Legal regulations of expanded access to IDs have been introduced among others in the USA, the European Union (EU), Canada and Australia. In addition, in the USA an alternative to expanded access is treatment under the Right-to-Try law. However, the treatment use of IDs is inherently associated with a (...) number of ethically relevant problems.Main textThe objective of this article is to present a coherent framework made up of eight requirements which have to be met for any treatment use of an ID to be ethical. These include a justified need for the use of an ID, no threat to clinical development of the ID, adequate scientific evidence to support the treatment, patient’s benefit as the primary goal of the use of an ID, informed decision of a patient, fair access of patients to IDs, independent review, as well as the dissemination of treatment results.ConclusionsWhile this framework is essentially consistent with the legal regulations of expanded access of the USA, the EU, Canada and Australia, it is substantially wider in scope because it addresses some important issues that are not covered by the regulations. Overall, the framework that we developed minimizes the risks and threats, and maximizes potential benefits to each of the four key stakeholders involved in the treatment use of IDs including patients, doctors, drug manufacturers, and society at large. (shrink)

Most papers included in this special issue were presented at the Fifth International Bioethics Conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.

Traffic research shares a fundamental dilemma with other areas of empirical research in which humans are potentially put at risk. Research is justified because it can improve safety in the long run. Nevertheless, people can be harmed in the research situation. Hence, we need to balance short-term risks against long-term safety improvements, much as in other areas of research with human subjects. In this paper we focus on ethical issues that arise when human beings are directly affected in the performance (...) of research by examining how the ethical requirements in biomedical research can inform traffic research. After introducing the basic ethical requirements on biomedical research, each of the major requirements is discussed in relation to traffic research. We identify the main areas where biomedical research and traffic research differ, and where the ethical requirements from the former cannot easily be transferred to the latter. Finally, we argue that there is a need for systematic studies of the ethics of traffic research and point to some of the issues that need to be addressed. (shrink)

The technological advances of the 20th century resulted in the creation of the Internet and its introduction into everyday life on a global scale. The Internet provides access to information and the sale and purchase of goods. Medications are also subject to trade. Their sale is conducted by online pharmacies and their global turnover amounts to hundreds of billions of dollars. Medications ordered over the Internet are sent by mail all over the world. Considering the events of recent years, we (...) cannot exclude the risk of a terrorist attack through online pharmacies. Terrorists can establish such companies, legally or illegally, or acquire ones already existing. Parcels, which are highly trusted by the customers of online pharmacies, can, for example, be contaminated with dangerous materials. The sale of online medications in the international system is potentially dangerous and requires international regulation. (shrink)

Most papers included in this special issue were presented at the Fifth International Bioethics Conference, “The Ethics of Intellectual Property Rights and Patents,” held in Warsaw, Poland on 23–24 April, 2004.

_The Cinema of Andrzej Wajda: The Art of Irony and Defiance_ Edited by John Orr and Elzbieta Ostrowska Foreword by Andrzej Wajda London: Wallflower Press, 2003 ISBN 1-903364-89-2 227 pages.

The famous theory of undecidable sentences created by Kurt Godel in 1931 is presented as clearly and as rigorously as possible. Introductory explanations beginning with the necessary facts of arithmetic of integers and progressing to the theory of representability of arithmetical functions and relations in the system (S) prepare the reader for the systematic exposition of the theory of Godel which is taken up in the final chapter and the appendix.

This paper analyses whether current explainable AI (XAI) techniques can help to address taxpayer concerns about the use of AI in taxation. As tax authorities around the world increase their use of AI-based techniques, taxpayers are increasingly at a loss about whether and how the ensuing decisions follow the procedures required by law and respect their substantive rights. The use of XAI has been proposed as a response to this issue, but it is still an open question whether current XAI (...) techniques are enough to meet existing legal requirements. The paper approaches this question in the context of a case study: a prototype tax fraud detector trained on an anonymized dataset of real-world cases handled by the Buenos Aires (Argentina) tax authority. The decisions produced by this detector are explained through the use of various classification methods, and the outputs of these explanation models are evaluated on their explanatory power and on their compliance with the legal obligation that tax authorities provide the rationale behind their decision-making. We conclude the paper by suggesting technical and legal approaches for designing explanation mechanisms that meet the needs of legal explanation in the tax domain. (shrink)

The objective of the paper is a presentation and an interpretation of Władysław Stróżewski’s views on aesthetics. Built upon the foundation provided by classical metaphysics, Stróżewski’s aesthetics is simultaneously a continuation of the tradition of phenomenological interpretation of art. Stróżewski extends Roman Ingarden’s aesthetic theory by including the idea of numinous concretion, largely inspired by the works of Rudolf Otto. As a result, this new phenomenological perspective transcends the narrowly understood ‘aesthetics’ of the work of art towards the inherent dimension (...) of the sacred. Moreover, Stróżewski’s scrutiny of the aspect of art that goes beyond the aesthetic reveals an important relationship obtaining between his insights and the theological aesthetics of Hans Urs von Balthasar. Thus Stróżewski’s ideas turn out to be of significance to contemporary aesthetic and theological debates. In particular, he shows the movement of beauty from aesthetic to transcendental, and ultimately towards the sacred, where numinosum is manifested as Mystery. (shrink)

This paper is concerned with n-localization property introduced by Newelski and Rosłanowski in [10] and getting it for CS iterations of forcing notions.

Medical practice is ideally based on robust, relevant research. However, the lack of disease-modifying treatments for Alzheimer’s disease has motivated “innovative practice” to improve patients’ well-being despite insufficient evidence for the regular use of such interventions in health systems treating millions of patients. Innovative or new non-validated practice poses at least three distinct ethical questions: first, about the responsible application of new non-validated practice to individual patients ; second, about the way in which data from new non-validated practice are communicated (...) via the scientific and lay press ; and third, about the prospect of making new non-validated interventions widely available before more definitive testing. We argue that the authors of metabolic enhancement protocols for Alzheimer’s disease have overstated the evidence in favor of these interventions within the scientific and lay press, failing to communicate weaknesses in their data and uncertainty about their conclusions. Such unmeasured language may create false hope, cause financial harm, undermine informed consent, and frustrate the production of generalizable knowledge necessary to face the societal problems posed by this devastating disease. We therefore offer more stringent guidelines for responsible innovation in the treatment of Alzheimer’s disease. (shrink)

In pre-revolutionary Russia, law was criticized from many points of view: in the name of Christ or the name of Marx, in defense of anarchism or of an idealized autocracy, on behalf of the "Russian soul" or of universal progress towards socialism. Examining the rich tradition of hostility to law, Walicki presents those Russian thinkers who boldly challenged this legacy of anti-legal prejudice by developing liberal philosophies of law, vindicating the value of human rights and rule of law. He discusses (...) six leading theorists--Boris Chicherin, Vladimir Soloviev, Leon Petrazycki, Pavel Novgorodtsev, Bogdan Kistiakovsky, and Sergius Hessen--all of whom viewed law in the context of wider philosophical and social problems. (shrink)

The paper consists of two parts, outlined in the title.I. In the historical science time appears as an element of the historian’s workshop. The historian collects source information, evaluates them and assigns respective dates. Only on the ground of thus “processed” sources may he reproduce the past: events and longer development processes, setting them in time. This dated time is understood colloquially as something objective, which runs one way and may be measured.II. A historian who studies the past reality depends (...) on the extent to which those sources are preserved. As a result of their interpretation, with the use of increasingly excellent research methods, he reproduces that reality. He must carry out an ongoing selection of historical facts found. This exposes him to temptations of such selection of those facts so as to adjust the historical knowledge to serve well the national interests, his own political opinions, etc. In this way the historian exerts influence on social awareness, which may consists of various myths and stereotypes, which sometimes lead to negative social behaviors: aggression, chauvinism, etc. Therefore, for researcher honesty’s sake and in the sense of moral responsibility, he must be careful to be as impartial as possible in his work. (shrink)

Natural Deduction Natural Deduction is a common name for the class of proof systems composed of simple and self-evident inference rules based upon methods of proof and traditional ways of reasoning that have been applied since antiquity in deductive practice. The first formal ND systems were independently constructed in the 1930s by G. Gentzen and S. Jaśkowski and … Continue reading Natural Deduction →.

We classify two of Bertrand Russell's theories of events within the point-free ontology. The first of such approaches was presented informally by Russell in ‘The World of Physics and the World of Sense’ (Lecture IV in Our Knowledge of the External World of 1914). Based on this theory, Russell sketched ways to construct instants as collections of events. This paper formalizes Russell's approach from 1914. We will also show that in such a reconstructed theory, we obtain all axioms of Russell's (...) second theory from 1936 and all axioms of Thomason's theory of events from 1989. Russell's work certainly influenced the works of Stanisław Leśniewski, his student Alfred Tarski, and Czesław Lejewski – prominent members of the Lvov-Warsaw School (LWS). We see our work in the tradition of the research of Leśniewski and Tarski. Building on the technical tools developed in this environment and in the spirit of the traditional research of the LWS, we engage here, in particular, with two classic works by Russell on fundamental ontology. (shrink)

The problem of precise characterisation of traditional forms of reasoning applied in mathematics was independently investigated and successfully resolved by Jaśkowski and Gentzen in 1934. However, there are traces of earlier interests in this field exhibited by the members of the Lvov-Warsaw School. We focus on the results obtained by Jaśkowski and Leśniewski. Jaśkowski provided the first formal system of natural deduction in 1926. Leśniewski also demonstrated in some of his papers how to construct proofs in accordance with intuitively correct (...) principles. (shrink)

The aim of the paper is to examine the nature of moral and legal norms in a broader context: first, taking into account logical and methodological assumptions, second, in the perspective of psychology of emotions and legal policy. The basic subject of the research carried out by Leon Petrażycki was represented by law. Originally, it had a psychological character, not an objective, eternal, and unchanging one. To fully understand the genesis and nature of morality and law, Petrażycki addressed the study (...) of mental phenomena, especially emotional experiences. First, however, he developed appropriate rules of logic and scientific methodology. Then he developed a new classification of mental phenomena, among which the fundamental role is played by bilateral emotions. At some stage, emotions begin to cooperate with cognitive processes, first of all with imaginations. Imaginations of acts, such as theft, betrayal, murder, can cause repulsive emotions, and type imaginations, such as truthfulness, charity, justice can evoke apulsive emotions. On the basis of such associations, judgments are created over time, the content of which becomes a basis for fundamental rules of conduct, that is, for norms. There are two fundamentally different types of norms: moral norms and legal norms. The norms of the first type are imperative and represent the nature of validity, while the norms of the second type are imperative-attributive and they also always entitle someone to something, i.e. they give someone a right. This division determines a fundamental difference between morality and law. (shrink)

Książka stanowi wprowadzenie do twórczości Richarda Rorty'ego, a także próbę osadzenia jej na szerszym tle filozofii współczesnej, ze szczególnym uwzględnieniem filozofii postmodernistycznej. Obecne są w niej szersze analizy stanu kultury współczesnej, a także relacje z istotnych koncepcji obecnych we współczesnej humanistyce, bez których nie można zrozumieć ewolucji współczesnej humanistyki i specjalnej roli, jaką odegrała w niej filozofia Richarda Rorty'ego.

“Age of life” is one of the essential characteristics that differentiate people. Age perception is also associated with social justice. The concept of age is defined ambiguously. At the same time, the different age criteria also forms the basis of age differentiation and age discrimination. The population lead to distinctions of age groups, age categories, and generations. Differences between generations also lead to Study in the concepts of intergenerationality, intergenerational justice, and intergenerational policies.

Generational differences in societies are characteristics generally attributed to people’s age that constitute a sociocultural phenomenon. Divisions in the generations differ across nations and extend even to civilizations. Perception and recognition of the different characteristics of each generation affect the cooperation between people in social, political, and economic capacities, and subsequently extend to entities in the public, informal, commercial, and nongovernmental sectors. From the perspective of social justice, it is important to draw attention to how workplace management techniques are used (...) to promote equal opportunities among representatives of various generations. (shrink)

Dowód pierwszej tezy Gorgiasza jest dedukcyjnym wnioskowaniem nie wprost, skon-struowanym przez wielokrotne użycie schematu modus tollens. Te z jego przesłanek, które przyjęte są bez dowodów, są łudząco podobne do niektórych prawd logicznych lub analitycznych. Gdyby rzeczywiście nimi były, w dowodzie musiałyby pojawić się sprzeczności. W czasach Gorgiasza dowód mógł uchodzić za poprawny; możliwość jasnego wskazania i opisania jego defektów poja-wiła się dopiero z wynalezieniem logiki formalnej. Gorgiasz mógł ogłosić swą tezę serio –jako tezę skrajnego nihilizmu metafizycznego –nie obawiając się kompromitacji. (...) Jeżeli dowód jest sofizma-tem, to wśród sofizmatów jest arcydziełem, najwybitniejszym osiągnięciem sofistów w tej dziedzi-nie. (shrink)

Services for single parents constitute a category of child and family services. These services are carried out by public and non-governmental bodies for people who are single parents by the unfortunate events or by their own choice. Individuals come to single parenthood mainly through divorce, separation, birth outside of marriage, child abuse/neglect, death of a partner/widowhood, and adoption.