The acceleration of the market globalisation process over the last three decades has internationalised clinical research and influenced both the way in which it is funded and the development and application of research practices. In addition, in recent years international multicentre randomised clinical trials have become the model par excellence for research on new medicines. The neoliberal model of globalisation has induced a decline in state power, both with regard to establishing national research for health priorities and to influencing the (...) development of adequate ethical guidelines to protect human beings that participate in multinational research. In this respect, poor and low-income countries, which lack sustainable control and review systems to deal with the ethical and methodological challenges of complex studies conducted by researchers from affluent countries and funded by large multinational pharmaceutical companies, are particularly vulnerable. The aim of the present paper is to explore critically some of the actual and possible ethical pitfalls of globalisation of clinical research and propose mechanisms for turning transnational clinical research into a more cooperative and fairer enterprise. (shrink)

The number of national bioethics commissions has burgeoned since the establishment of the first one in 1983. They provide an arena in which stakeholders with widely differing moral views can discuss, interact and negotiate about controversial matters. The establishment of the Brazilian committee is used as an example of how such bodies can be introduced. If such councils are to be implemented effectively and regarded as legitimate, the society as a whole should be included in the construction of the proposal (...) and represented on the council, the council should have the benefit of specialist advice when that is needed, and the council should be linked to the elected government in an official advisory capacity. The article describes long process of planning and consultation to establish Brazil's National Bioethics Council and of eventually defining its task as advising the president on matters relating to bioethics. (shrink)

The academic literature in research ethics has been marked in the past decade by a much broader focus on the need for the protection of developing communities subjected to international clinical trials. Because of the proximity of the revision of the Declaration of Helsinki, completed in October 2008, most papers have addressed the issue of a double standard of care following the use of placebo. However, other no less important issues, such as interactions between the lifestyles structures of low-income communities (...) and the efficiency of risk-minimising procedures also deserve attention. The purpose of this paper is to discuss forms of uncertainty involved in clinical trials in poor and low-income countries that are not addressed by conventional methods of risk assessment. Furthermore, the increase in size of risks that are identified by conventional assessment methods will be addressed. Besides, the difficulty in properly applying risk-minimising procedures will be discussed. Finally, this paper proposes the involvement of research ethics committees in the risk evaluation process and the establishment of national ethics evaluation systems. (shrink)

The teaching of global ethics can be developed from several points of view. The goals of this education should be to seek respect for plurality and construct a fairer, more equal and more supportive world. The reflections put forward in the present chapter are not only based on the theoretical foundations of ethics and bioethics, but also especially on the geopolitical locus of where the authors live and work, which is the southern hemisphere. The objective of using this artifice was (...) to prevent local negative effects that an intendedly globalized project for teaching ethics might cause. The aim was also to indicate the conceptual bases and practices from which legitimate goals can be defined for this initiative, which can be applied for use in different parts of the world without unilaterality, interpositions, impositions or manipulations. Because of the difficulty in defining goals for teaching global ethics, the present analysis took the reference point of two real themes of the contemporary world: moral imperialism and the point of view of coloniality. Overcoming the distortions and inequities of moral imperialism that are now perceived in the relationships established among different individuals, cultures, countries and regions of the world, combined with coping with situations of coloniality – whether occasional or global – is part of a macro-ethical context that poses an obstacle to construction of non-discriminatory, equal and inclusive global ethics. Considering the barriers against construction of consensuses in this field, the present text proposes the use of education in global ethics as a tool that is applied for opposing situations of moral imperialism and coloniality. Finally, instead of proposing abstract goals that are set aprioristically, this chapter indicates the paradigm of corporeity as a universal marker for what should be sought morally and what should be avoided in education programs regarding global ethics. Thus, this chapter provides a minimal axiological basis upon which it will be possible to establish goals, thereby avoiding educational practices in the field of ethics that will become yet another factual element serving the maintenance of unilateral and hegemonic interests and an unjust global order. (shrink)

The text examines the article 11 of the Universal Declaration on Bioethics and Human Rights of UNESCO that deals with the principle of non-discrimination and non-stigmatization. Both concepts are related to the theme of human dignity, while discrimination is an inherent part of stigma: stigma does not exist if there is no discrimination. In this context, this paper aims to study the relationship between stigma, discrimination and HIV / AIDS. The study argues that to loosen the bonds that hold the (...) subjects that are attached to them is necessary questioning the broader forces - social, cultural, political and economic - that structure stigma, stigmatization and discrimination as social processes directly linked to production and reproduction of structural inequalities. (shrink)

ABSTRACT The bioethics of the so‐called ‘peripheral countries’ must preferably be concerned with persistent situations, that is, with those problems that are still happening, but should not happen anymore in the 21st century. Resulting conflicts cannot be exclusively analysed based on ethical (or bioethical) theories derived from ‘central countries.’ The authors warn of the growing lack of political analysis of moral conflicts and of human indignation. The indiscriminate utilisation of the bioethics justification as a neutral methodological tool softens and even (...) cancels out the seriousness of several problems, even those that might result in the most profound social distortions. The current study takes as a theoretical reference the fact that natural resources (which all of us are) are finite, and that corporeal, pleasurable and painful matters (which affect us all) are relevant. Based on these premises, and on the concept that equity means ‘treating unevenly the unequal’, a proposal of a hard bioethics (or intervention bioethics) is introduced, in defence of the historical interests and rights of economically and socially excluded populations that are separated from the international developmental process. (shrink)

Fundamentos da bioética -- Situações emergentes em bioética -- Situações persistentes em bioética.

t. 1. Dialog s V. V. Davydovym -- t. 2. Nereshennye problemy razvivai︠u︡shchego obrazovanii︠a︡.

Psychiatric examinations in official institutions of the Brazilian government include examinations of individual convicts – some of whom are highly dangerous – carried out by court decision. These individuals are taken handcuffed under police escort from penitentiaries to the examination site. In most Brazilian states, medical examiners or experts adopt the basic procedure of asking the police officers to remove the handcuffs from the convict for the examination to be carried out. This article analyzes, from the bioethical standpoint, the behavior (...) of 49 forensic psychiatrists in eight Brazilian states in relation to procedures adopted as protection measures against any possible danger posed by their examinees. In the context of a developing country, where sophisticated protection means are not available, the practice of keeping convicts handcuffed during such examinations is compared to other measures and more advisable alternatives are discussed from the ethical standpoint. Considering the dilemma between showing minimum respect for the autonomy of examinees and ensuring the security of examiners, the need to adopt equitable procedures based on the recognition of the different needs of examiners and examinees is addressed. (shrink)

Psychiatric examinations in official institutions of the Brazilian government include examinations of individual convicts – some of whom are highly dangerous – carried out by court decision. These individuals are taken handcuffed under police escort from penitentiaries to the examination site. In most Brazilian states, medical examiners or experts adopt the basic procedure of asking the police officers to remove the handcuffs from the convict for the examination to be carried out. This article analyzes, from the bioethical standpoint, the behavior (...) of 49 forensic psychiatrists in eight Brazilian states in relation to procedures adopted as protection measures against any possible danger posed by their examinees. In the context of a developing country, where sophisticated protection means are not available, the practice of keeping convicts handcuffed during such examinations is compared to other measures and more advisable alternatives are discussed from the ethical standpoint. Considering the dilemma between showing minimum respect for the autonomy of examinees and ensuring the security of examiners, the need to adopt equitable procedures based on the recognition of the different needs of examiners and examinees is addressed. (shrink)

Standard models of adolescent risk taking posit that the cognitive abilities of adolescents and adults are equivalent, and that increases in risk taking that occur during adolescence are the result of socio emotional differences in impulsivity, sensation seeking, and lack of self-control. Fuzzy-trace theory incorporates these socio emotional differences. However, it predicts that there are also cognitive differences between adolescents and adults, specifically that there are developmental increases in gist-based intuition that reflects understanding. Gist understanding, as opposed to verbatim-based analysis, (...) generally has been hypothesized to have a protective effect on risk taking in adolescence. Gist understanding is also an essential element of informed consent regarding risks in medical decision- making. Evidence thus supports the argument that adolescents’ status as mature minors should be treated as an exception rather than a presumption, because accuracy in verbatim analysis is not mature gist understanding. Use of the exception should be accompanied by medical experts’ input on the bottom-line gist of risks involved in treatment. (shrink)

Abstract In this chapter, we challenge the presupposed concept of innovation in the responsible innovation literature. As a first step, we raise several questions with regard to the possibility of ‘responsible’ innovation and point at several difficulties which undermine the supposedly responsible character of innovation processes, based on an analysis of the input, throughput and output of innovation processes. It becomes clear that the practical applicability of the concept of responsible innovation is highly problematic and that a more thorough inquiry (...) of the concept is required. As a second step, we analyze the concept of innovation which is self-evidently presupposed in current literature on responsible innovation. It becomes clear that innovation is self-evidently seen as (1) technological innovation, (2) is primarily perceived from an economic perspective, (3) is inherently good and (4) presupposes a symmetry between moral agents and moral addressees. By challenging this narrow and uncritical concept of innovation, we contribute to a second round of theorizing about the concept and provide a research agenda for future research in order to enhance a less naïve concept of responsible innovation. (shrink)

"This book is an augmented and updated translation by the author of Theorie des Subjekts: Subjectiviteat und Identiteat zwischen Moderne und Postmoderne, Teubingen, Francke-UTB, 2010 (3rd ed.)"--Title page verso.

The purpose. Critical social philosophy of education strives to provide a radical critique of existing models of education in the so-called Western models of democracy, creating progressive alternative models. In this context, the proposed integrative metatheory, which is based on classical and modern sources, concepts, aims for a comprehensive understanding and reconstruction of the phenomenon of education. One of the main tasks in the sphere of education’s democratization today, therefore, is to bring to education the results of restructuring and democratization (...) of the society, to reflect changes in conditions of life and thinking, experience and transformation of subjectivity in the context of the technological revolution and globalization. Methodology. The critical social theory, which developed in the framework of contemporary neo-Marxism, indicates the need for a thorough analysis of society, however, unlike other theoretical concepts and research programs in order to analyze not a fixation and a statement of the existing social givens. On the contrary, critical analysis of society involves the identification of existing antagonistic, alienating factors that distort public communication.The subject of social analysis is the whole sphere of human and non-human nature, which interacts a person depend on it, the whole system of relations between society and nature, society and man, which is covered by the historical practice of conscious – "praxis". The representative of "pure science" isn't the learning, research subject. He is a public a person, which is the totality of all social definitions included in society and its constituent individuals. For such a "total subject" Object of interest is not something external; on the contrary, the latter appears as a product of his own activity. The scientific novelty examines trends in educational institutions and models of globalizing society in the context of our particular relationship of education and society, man and the state, and processes. The research and systematic analysis of neoliberal reforms at the level of society in general and education in particular are conducted. It examines substantive, structural and functional characteristics of the concept of «critical social philosophy of education» in the context of institutional tendencies of social life, as well as forms and possibilities of its methodological application. It consider a model of «critical social philosophy of education», as embodied in the programs of social development and learning, which are primarily designed to teach people how to lead an independent and original research themselves, society and knowledge systems. However, it is proved that the models and programs should not be cut off from any individual and the collective system of moral and social values, theoretical and applied training, nor from further use of the acquired values, norms and skills in everyday life, science, or in production, sphere of all social institutions. Conclusions. Critical philosophical, educational, pedagogical-psychological surprisingly theory, its models and concepts seek to redefine public and private and the public mind. Based on these grounds, in the future, it allows philosophy of education to develop a more inclusive philosophical vision of education, to apply directly to the problems of democratization and changes in social relations in the direction of equality and social justice in the field of education. The point of view of socio-philosophical and philosophical-еducational, pedagogical-psychological, normative understanding and social critics also requires the use of active efforts in the reconstruuction of education and society, the social vision of what education and human life can be and what their specific limitations in existing societies. (shrink)

The purpose. Critical social philosophy of education strives to provide a radical critique of existing models of education in the so-called Western models of democracy, creating progressive alternative models. In this context, the proposed integrative metatheory, which is based on classical and modern sources, concepts, aims for a comprehensive understanding and reconstruction of the phenomenon of education. One of the main tasks in the sphere of education’s democratization today, therefore, is to bring to education the results of restructuring and democratization (...) of the society, to reflect changes in conditions of life and thinking, experience and transformation of subjectivity in the context of the technological revolution and globalization. Methodology. The critical social theory, which developed in the framework of contemporary neo-Marxism, indicates the need for a thorough analysis of society, however, unlike other theoretical concepts and research programs in order to analyze not a fixation and a statement of the existing social givens. On the contrary, critical analysis of society involves the identification of existing antagonistic, alienating factors that distort public communication.The subject of social analysis is the whole sphere of human and non-human nature, which interacts a person depend on it, the whole system of relations between society and nature, society and man, which is covered by the historical practice of conscious – "praxis". The representative of "pure science" isn't the learning, research subject. He is a public a person, which is the totality of all social definitions included in society and its constituent individuals. For such a "total subject" Object of interest is not something external; on the contrary, the latter appears as a product of his own activity. The scientific novelty examines trends in educational institutions and models of globalizing society in the context of our particular relationship of education and society, man and the state, and processes. The research and systematic analysis of neoliberal reforms at the level of society in general and education in particular are conducted. It examines substantive, structural and functional characteristics of the concept of «critical social philosophy of education» in the context of institutional tendencies of social life, as well as forms and possibilities of its methodological application. It consider a model of «critical social philosophy of education», as embodied in the programs of social development and learning, which are primarily designed to teach people how to lead an independent and original research themselves, society and knowledge systems. However, it is proved that the models and programs should not be cut off from any individual and the collective system of moral and social values, theoretical and applied training, nor from further use of the acquired values, norms and skills in everyday life, science, or in production, sphere of all social institutions. Conclusions. Critical philosophical, educational, pedagogical-psychological surprisingly theory, its models and concepts seek to redefine public and private and the public mind. Based on these grounds, in the future, it allows philosophy of education to develop a more inclusive philosophical vision of education, to apply directly to the problems of democratization and changes in social relations in the direction of equality and social justice in the field of education. The point of view of socio-philosophical and philosophical-еducational, pedagogical-psychological, normative understanding and social critics also requires the use of active efforts in the reconstruuction of education and society, the social vision of what education and human life can be and what their specific limitations in existing societies. (shrink)

Moral philosophers have often felt the need of a concept which would cover all those cases where we are prevented from achieving our ends through no fault of our own: a criterion for saying when failure is not blameworthy. The deontologists thought we were not to blame for actions done in genuine ignorance of the facts. Kant declared in a famous passage that we were not morally responsible for failures due to the “niggardliness of stepmother nature.” In this article I (...) want to introduce into moral philosophy a new concept for clarifying the failures for which we are not to blame: the notion of scarcity, taken from economic theory. (shrink)

In this article the authors briefly sketch the nature of Brazilian bioethics. Bioethics emerged in Brazil later than in other Western countries and the 1990’s were the most important period for the spread of the discipline in the country. It is in this period that some structural elements of bioethics were established, such as research groups, regulation of Local Research Ethics Committees (Comitês Locais de Ética em Pesquisa – CEP), the creation of the National Commission of Ethics in Research with (...) Human Beings (Comissão Nacional de Ética em Pesquisa com Seres Humanos – CONEP) and the Brazilian Bioethics Society (Sociedade Brasileira de Bioética – SBB). With regard to theoretical work, Brazilian bioethics is clearly an importer of theories from countries central to the studies of bioethics, or, in another words, countries where bioethics first emerged and was established. The most commonly used theory among Brazilian researchers is principlism. (shrink)

It has been hypothesised that the reimbursement system pertaining to radiotherapy is influencing prescription practices for patients with cancer with bone metastases. In this paper, we present and discuss the results of an empirical study that was undertaken on patient records, referred to radiotherapy for the treatment of bone metastases, in a medium-size city, in southern Brazil, during the period of March 2006 to March 2014. Our findings seem to confirm this hypothesis: after a change in the reimbursement method, radiation (...) prescriptions were adapted accordingly, in order to maximise profits. Once such patients become highly vulnerable due to their diagnoses, they also become susceptible to a subtle form of exploitation; physicians let patients believe that more radiation will be better for their health, and they do so despite knowing otherwise, and as it seems, out of pecuniary interests. (shrink)

For millennia, diagnosticians distinguished natural sadness that arose from social circumstances from depressive disorders that were disproportionate to their contexts. In 1980, the DSM-III transformed this tradition through equating depressive disorders with symptoms without regard to context. Nevertheless, it excluded grieving people without especially severe or enduring symptoms from diagnosis. Subsequently, considerable empirical research indicated that bereavement was not unique but a model for all stressor-maintained conditions. Yet, despite the evidence showing that the causes, prognoses, and optimal treatments for context-specific (...) depressions differ from those that aren’t, the DSM-5 removed the bereavement exclusion from the diagnostic criteria for major depression. This article considers the reasons behind this elimination and its implications for the research, labeling, and treatment of depression. (shrink)

The importance of communities in strengthening the ethics of international collaborative research is increasingly highlighted, but there has been much debate about the meaning of the term ‘community’ and its specific normative contribution. We argue that ‘community’ is a contingent concept that plays an important normative role in research through the existence of morally significant interplay between notions of community and individuality. We draw on experience of community engagement in rural Kenya to illustrate two aspects of this interplay: (i) that (...) taking individual informed consent seriously involves understanding and addressing the influence of communities in which individuals’ lives are embedded; (ii) that individual participation can generate risks and benefits for communities as part of the wider implications of research. We further argue that the contingent nature of a community means that defining boundaries is generally a normative process itself, with ethical implications. Community engagement supports the enactment of normative roles; building mutual understanding and trust between researchers and community members have been important goals in Kilifi, requiring a broad range of approaches. Ethical dilemmas are continuously generated as part of these engagement activities, including the risks of perverse outcomes related to existing social relations in communities and conditions of ‘half knowing’ intrinsic to processes of developing new understandings. (shrink)

George V. Walsh examines the differences and similarities between Immanuel Kant and Ayn Rand in the area of metaphysics. He presents Kant's premises and conclusions on the major issues and provides a detailed discussion of Rand's criticisms of Kant. Walsh argues that Rand has seriously misread Kant on several points. Her interpretation—that Kant saw our sensory grasp of the world as "delusion," rather than knowledge—resembles that of Arthur Schopenhauer, except that the latter declares Kant's doctrine worthy of praise instead of (...) condemnation. (shrink)

Following Hartry Field in distinguishing disquotational truth from a conception that grounds truth conditions in a community's usage, it is argued that the notions are materially inequivalent (since the latter allows truth-value gaps) and that both are needed. In addition to allowing blanket endorsements ("Everything the Pope says is true"), disquotational truth facilitates mathematical discovery, as when we establish the Gödel sentence by noting that the theorems are all disquotationally true and the disquotational truths are consistent. We require a more (...) substantial notion, however, if we intend to use truth values and truth conditions in explaining communication by language. (shrink)