This paper explores some key discrepancies between two sets of normative requirements applicable to the research use of personal data and human biological materials: the data protection regime which follows the application of the European Union General Data Protection Regulation, and the Declaration of Helsinki, CIOMS guidelines and other research ethics regulations. One source of this controversy is that the GDPR requires consent to process personal data to be clear, concise, specific and granular, freely given and revocable and therefore has (...) challenged the concept of ‘broad consent’, which has been widely applied in the context of biobanking. Another source of controversy is the interplay between regulations of research ethics and protection of personal data related to the secondary use of personal data and biological materials. In this case, the GDPR ‘research condition’ provides an alternative to re-consent for the use of previously collected personal data and biological materials. Although the mentioned controversies have been raised in the legal literature, they have not been explicitly addressed from the research ethics perspective. Should consent be regarded as a priority legal basis for personal data processing in health data research? Can broad consent still be a suitable legal ground for biobanking? What should be the role of research ethics provisions that differ from the GDPR standards, and what should be the role and function of research ethics committees in the changing environment of health data research? These are the ongoing controversies to be explored in the paper. (shrink)

This research focuses on how research ethics committee and integrity board members discuss and decide on solutions to case scenarios that involve a dimension of research ethics or integrity in collaborative settings. The cases involved issues around authorship, conflict of interest, disregard of good scientific practice and ethics review, and research with vulnerable populations (children and neonates). The cases were set in a university, a hospital, or a research institute. In the research, we used a deductive qualitative approach with thematic (...) analysis. Twenty-seven research ethics committee and research integrity board members from 16 European countries and one country outside Europe participated. Participants represented natural and life sciences, social sciences, and humanities. They worked on cases involving ethical/integrity issues in six different constellations. Results show that experts apply key elements of ethical decision making, namely identification of ethical issues, stakeholders, guidelines, solutions, and own positionality, in dealing collaboratively with ethics/ integrity problems, and the nature of the application depends on the complexity of the case. Understanding how individuals knowledgeable in research ethics and integrity, in this case, individuals serving on research ethics committees and integrity boards, approach ethical/ moral issues can help to identify strategies that may be useful in the development of research ethics and integrity training for junior researchers who may benefit from learning professional strategies. (shrink)

The upcoming Regulation No 536/2014 on clinical trials on medicinal products for human use, which will replace the current Clinical Trial Directive at the end of 2021, has triggered a significant reform of research ethics committee systems in Europe. Changes related to ethics review of clinical trials in the EU were considered to be essential to create a more favourable environment to conduct clinical trials in the EU. The concern is, however, that the role of the research ethics committees will (...) weaken in at least some of the Member States because the new Regulation allows narrowing down the scope of ethics review as compared with the currently valid Clinical Trial Directive. Although the new Regulation may lead to faster approval procedures for clinical trials, which is especially relevant in the context of pandemics, high-quality ethics reviews integrating methodological aspects of a clinical trial should nevertheless be ensured. To maintain high research ethics standards as well as to foster measures to mitigate potential negative consequences of the reform, it is therefore of vital importance to start debating and sharing the reflections about the potential consequences of these transformations and trends as soon as possible. (shrink)

During the last two decades, national bioethics committees have been established in many countries all over the world. They vary with respect to their structure, composition, and working methods, but the main functions are similar. They are supposed to facilitate public debate on controversial bioethical issues and produce opinions and recommendations that can help inform the public and policy‐makers. The dialogue among national bioethics committees is also increasingly important in the globalized world, where biomedical technologies raise ethical dilemmas that traverse (...) national borders. It is not surprising, therefore, that the committees are established and active in the technologically advanced countries. There have also been a few international capacity‐building initiatives in bioethics that have had a dual task: networking among existing national bioethics committees and helping establish such committees in those countries that still lack them. The problem is that, due to a lack of information, it is not clear what problems and challenges committees face in the transitioning societies often characterized as low‐ and middle‐income countries. (shrink)

Ocherk 1. Voprosy ontologii -- Ocherk 2. Voprosy ėtiki i ėstetiki -- Ocherk 3. Voprosy gnoseologii i aksiologii.

Because the techno-economic paradigm of contemporary conceptualizations of innovation is often taken for granted in the literature, this chapter opens up this self-evident notion. First, the chapter consults the work of Joseph Schumpeter, who can be seen as the founding father of the current conceptualization of innovation as technological and commercial. Second, we open up the concept by reflecting on two aspects of Schumpeter’s conceptualization of innovation, namely its destructive and its constructive aspect, based on findings in the history of (...) innovation. Finally, we synthesize our findings and propose an ontic-ontological conceptualization of innovation as ontogenetic process and outcome with six dimensions—newness, political dimension, economic dimension, temporal dimension, human dimension and risk—that moves beyond its technological and commercial orientation. (shrink)

Research on brain or cognitive/affective processes, culture, social interaction, and structural analysis are overlapping but often independent ways humans have attempted to understand the origins of their evolution, historical, and contemporary development. Each level seeks to employ its own theoretical concepts and methods for depicting human nature and categorizing objects and events in the world, and often relies on different sources of evidence to support theoretical claims. Each level makes reference to different temporal bandwidths (milliseconds, seconds, minutes, hours, days, months, (...) years, decades, and centuries) and focuses on different spatio-temporal activities and controlled and non-controlled stimulus conditions. Biological mechanisms and environmental pressures for survival simultaneously created a gradual intersection and enhancement of cognitive/affective skills, cultural practices, and changes in collaborative social interaction and communicative skills. The evolution of a given level of analysis is assumed to have been incremental and overlapping. These innovative and independent ways humans have learned to characterize their brain or cognitive/affective and social/economic/political life often depend on unexamined, representational re-descriptions or cognitive/affective and socio-cultural devices and forms of communication that facilitate the depiction of practices and beliefs we attribute to respondents or subjects and research colleagues. (shrink)

Russkai︠a︡ t︠erkovʹ i drugie statʹi -- V temnykh religioznykh luchakh.

В книге очерки Владимира Брагинского в жанре ироничного эссе о любви.

Selected Logic Papers, long out of print and now reissued with eight additional essays, includes much of the author's important work on mathematical logic and ...

The article is devoted to the memory of Vyacheslav Semenovich Stepin and Nikita Nikolaevich Moiseev, whose multifaceted work was integrally focused on philosophical, interdisciplinary and transdisciplinary research of the key ideas and principles of universal human-dimensional evolutionism. Other remarkable Russian scientists V.I. Vernadsky, S.P. Kurdyumov, S.P. Kapitsa, D.S. Chernavsky worked in the same tradition of universal evolutionism. While V.I. Vernadsky and N.N. Moiseev had been the originators of that scientific approach, V.S. Stepin provided philosophical foundations for the ideas of those (...) remarkable scientists and thinkers. The scientific legacy of V.S. Stepin and N.N. Moiseev maintained the formation of a new quality of research into the philosophy of science and technology as well as into the philosophy of culture. This new quality is multidimensional and it is difficult to define unambiguously, but we presume the formation of those areas of philosophical knowledge as constructively oriented languages of interdisciplinary and transdisciplinary co-participation of philosophy in the convergent-evolutionary development of scientific knowledge in general. In this regard, attention is paid to V.S. Stepin’s affirmations about non-classical nature of modern social and humanitarian knowledge. Quantum mechanics teaches us that the reality revealed through it is a hybrid construct, or symbiosis, of both mean and object of cognition. Therefore, the very act of cognitive observation constructs quantum reality. Thus, it is very close to the process of cognition in modern sociology and psychology. V.S. Stepin insisted that these principles are applicable to all complex selfdeveloping systems, and such are all “human-dimensional” objects of modern humanities. In all the phases of homeostasis changes, or crises, there is necessarily a share of chaos, instability, uncertainty in the selection process of future development scenarios, which is ineliminably affected by our observation. Therefore, a cognitive observer in the humanities should be considered as a concept of post-non-classical rationality, that is as an observer of complexity. (shrink)

t. 1. Filosofii︠a︡ ; Izbrannye predislovii︠a︡ ; I︠A︡zykoznanie -- t. 2. Filologii︠a︡ ; Vospominanii︠a︡ i nabli︠u︡denii︠a︡ ; Pami︠a︡ti uchiteleĭ i kolleg ; Prilozhenie : A.N. Kolmogorov, semioticheskie poslanii︠a︡.

Formulation of a general model of evolution is presented which is based upon the recognition of the ?biosocial? entity, that is the biosphere and human society, as a component?system. It can be demonstrated that the interactions of the components (moleculas, cells, organisms, ecosystems in the biological realms and people, artifacts and ideas in the societies) have replicative organization. We suggest an explanation for the spontaneous emergence of replicative function and organization, a process called autogenesis. During autogenesis, hierarchical levels of replicative (...) organization emerge and compartmentalization and convergence of replicative information occurs. Questions of the origin and evolution of life are discussed. The replicative paradigm can also be applied to the processes of cultural evolution, in which complex replicative networks of people, ideas, and man?made artifacts show all stages and phenomena of autogenesis. Finally, the present state of evolution of the whole global biosocial system is discussed. (shrink)