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.

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

In this paper, we want to present the genesis of Stanisław Leśniewski’s mereology. Although ‘mereology’ comes from theword ‘part’, mereology arose as a theory of collective classes. That is why we present the differences between the concepts of being a distributive class and being a collective class. Next, we present Leśniewski’s original mereology from 1927, but with a modern approach. Leśniewski was inspired to create his concept of classes and their elements by Russell’s antinomy. To face it, Leśniewski had to (...) define the concept of being an element of based on the concept of being part of. Leśniewski showed that in his theory, there is no equivalent to Russell’s antinomy. We will show that his solution has nothing to do with the original approach because, in both cases, we are talking about objects of a different kind. Russell’s original antinomy concerned distributive classes, and Leśsniewski’s considerations concerned collective classes. (shrink)

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)

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)

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 →.

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)

Spouses exhibit two kinds of behaviours: protective and transgressive. Protective acts are those aiming to overcome current problems, leading to preserving some balance. Transgressive acts are deliberately overstepping everyday marital reality and doing new things in new ways. They lead to changing the relation with the hope of improving it, but also create the risk of deterioration. The more transgressive behaviours spouses exhibit, the more chances they have to get to know each other and experience the joy of being part (...) of a union. Transgressive tendencies stem from a network personality structure and consist of five psychons: cognitive, instrumental, motivational, emotional, and personal. The success of a marriage is the effect of a specific form of transgressive behaviours in marriage exhibited by both spouses, which is recognizing difficulties as they appear, finding their sources, and taking steps together to overcome them. (shrink)

In terms of psychotransgressionism, personality is a network of five equipollent psychons, the content of which determines the personality’s functioning. The strength and power of the individual psychons underlies the tendency to undertake transgressive actions. In this study, we hypothesized that transgressive spouses are characterized by greater potential strength, greater power of cognitive, instrumental, motivational, emotional, and personal psychons than protective spouses. We operationalized all psychons, created the appropriate research tools, and then studied married couples. Using the Transgression Scale developed (...) by Studenski, we found a group of spouses with higher levels of transgression, and a group of spouses with lower levels of transgression. Transgressive wives are characterized by better knowledge about their husbands’ operational sphere, and are more aware of personal beliefs than protective wives. Similarly, transgressive husbands have greater knowledge of their wives’ operational sphere, stronger cognitive needs, and weaker personal needs than protective husbands. Transgressive husbands are characterized by a positive affective shift and have a greater awareness of personal beliefs than protective husbands. The potential brought into interpersonal relationships by transgressive spouses may create a climate conducive to building a satisfying marital relationship. (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.

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)

Este articulo analiza el proceso de integración del Mercosur en el que participan Argentina, Brasil, Paraguay y Uruguay y sus efectos sobre la ciudadanía política y social. En la primera parte del mismo los autores examinan los rasgos, el contexto de nacimiento y la filos ofía del proceso de integración mercosureño. La segunda parte analiza la evoluciónde la democracia y de la justicia social durante el proceso de integración. Los autores llegan a la conclusión de que el modelo de integración (...) mercosureño no puede contrarrestar la crisis de la democracia y de la justicia social que tienen lugar especialmente en Argentina y Brasil. (shrink)

“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.

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.

The contemporary sociology of morality is a form of descriptive ethics that shrinks away from any sort of prescriptive ethics. Building on the moral philosophies of John Dewey, and also of Alasdair MacIntyre and Paul Ricoeur, and in dialogue with recent work by Stefan Bargheer, this article proposes a more ambitious program of critical social ethics that connects concerns with character and the common good but tempers them with attention to alienation and oppression.

During the global financial crisis of 2007–2009 and the currentCovid-19 debacle, central banks acted quickly, boldly, and effectively. The paper argues that they did so thanks to the lessons learned from the past financial crises, which provided them with opportunities to reconsider their previous beliefs. A case in point is the banking crisis in the United States during the Great Depression of the 1930s that taught central banks to act rapidly and decisively in order to prevent an initial liquidity crisis (...) from escalating into a solvency crisis leading to bankruptcies of banks with potentially disastrous consequences for the entire economy. The paper revisits the consequences of the currency crises of the 1990s, which transformed exchange rate regimes across the world: the EMS one of 1992–1993 that accelerated the launch of the euro, and the Asian one of 1997–1998 resulted in the proliferation of floating exchange rates in emerging economies. (shrink)

I shall outline the topic from a historical perspective, placing the main emphasis on the hundred years’ period spanning 1870–1970.

There are many religions in the human world, and people manifest their religiousness in many different ways. The main problem this paper addresses concerns the possibility of sorting out this complex world of human religiousness by showing that it can be phenomenologically reduced to a few very basic existential attitudes. These attitudes express the main types of ways in which a human being relates to his or herself and the world, independently of the worldview or religion professed by the individual. (...) I use Kierkegaard’s theories of the stages of existence and subjective truth as a model. The theory of the stages of existence provides five basic existential attitudes on the basis of which religious attitudes can develop: spiritlessness, the aesthetic, the ethical, religiousness A, and religiousness B. The theory of subjective truth shows how the concept of truth functions in an ethical and existential sense as the personal truth of an individual engaged in building their religious identity. In turn, I discuss the problem of the relation of Kierkegaard’s philosophy to phenomenology, briefly introduce his concept of subjective truth and the stages of existence, and show how existential attitudes can be transformed into religious ones. I also consider the problem of the demonic as the inverted order of this anthropological and existential model. Finally, I argue that the model developed herein may be useful for further research into the phenomenology of religious attitudes. (shrink)