Mucopolysaccharidosis type I (MPS I) is a rare lysosomal storage disorder treated with bone marrow transplantation or enzyme replacement therapy with laronidase, a high-cost orphan drug. Laronidase was approved by the US Food and Drug Administration and the European Medicines Agency in 2003 and by the Brazilian National Health Surveillance Agency in 2005. Many Brazilian MPS I patients have been receiving laronidase despite the absence of a governmental policy regulating access to the drug. Epidemiological and treatment data concerning MPS I (...) are scarce. This study aims to present a demographic profile of Brazilian patients with MPS I, describe the routes of access to laronidase in Brazil, and discuss associated ethical issues relating to public funding of orphan drugs. (shrink)

The coronavirus disease 2019 pandemic is altering dynamics in academia, and people juggling remote work and domestic demands – including childcare – have felt impacts on their productivity. Female authors have faced a decrease in paper submission rates since the beginning of the pandemic period. The reasons for this decline in women’s productivity need to be further investigated. Here, we analyzed the influence of gender, parenthood and race on academic productivity during the pandemic period based on a survey answered by (...) 3,345 Brazilian academics from various knowledge areas and research institutions. Productivity was assessed by the ability to submit papers as planned and to meet deadlines during the initial period of social isolation in Brazil. The findings revealed that male academics – especially those without children – are the least affected group, whereas Black women and mothers are the most impacted groups. These impacts are likely a consequence of the well-known unequal division of domestic labor between men and women, which has been exacerbated during the pandemic. Additionally, our results highlight that racism strongly persists in academia, especially against Black women. The pandemic will have long-term effects on the career progression of the most affected groups. The results presented here are crucial for the development of actions and policies that aim to avoid further deepening the gender gap in academia. (shrink)

Introduction: Variation across research ethics boards in conditions placed on access to medical records for research purposes raises concerns around negative impacts on research quality and on human subject protection, including privacy.Aim: To study variation in REB consent requirements for retrospective chart review and who may have access to the medical record for data abstraction.Methods: Thirty 90-min face-to-face interviews were conducted with REB chairs and administrators affiliated with faculties of medicine in Canadian universities, using structured questions around a case study (...) with open-ended responses. Interviews were recorded, transcribed and coded manually.Results: Fourteen sites required individual patient consent for the study to proceed as proposed. Three indicated that their response would depend on how potentially identifying variables would be managed. Eleven sites did not require consent. Two suggested a notification and opt-out process. Most stated that consent would be required if identifiable information was being abstracted from the record. Among those not requiring consent, there was substantial variation in recognising that the abstracted information could potentially indirectly re-identify individuals. Concern over access to medical records by an outside individual was also associated with requirement for consent. Eighteen sites required full committee review. Sixteen allowed an external research assistant to abstract information from the health record.Conclusions: Large variation was found across sites in the requirement for consent for research involving access to medical records. REBs need training in best practices for protecting privacy and confidentiality in health research. A forum for REB chairs to confidentially share concerns and decisions about specific studies could also reduce variation in decisions. (shrink)

BackgroundThe amount of research utilizing health information has increased dramatically over the last ten years. Many institutions have extensive biobank holdings collected over a number of years for clinical and teaching purposes, but are uncertain as to the proper circumstances in which to permit research uses of these samples. Research Ethics Boards (REBs) in Canada and elsewhere in the world are grappling with these issues, but lack clear guidance regarding their role in the creation of and access to registries and (...) biobanks.MethodsChairs of 34 REBS and/or REB Administrators affiliated with Faculties of Medicine in Canadian universities were interviewed. Interviews consisted of structured questions dealing with diabetes-related scenarios, with open-ended responses and probing for rationales. The two scenarios involved the development of a diabetes registry using clinical encounter data across several physicians' practices, and the addition of biological samples to the registry to create a biobank.ResultsThere was a wide range of responses given for the questions raised in the scenarios, indicating a lack of clarity about the role of REBs in registries and biobanks. With respect to the creation of a registry, a minority of sites felt that consent was not required for the information to be entered into the registry. Whether patient consent was required for information to be entered into the registry and the duration for which the consent would be operative differed across sites. With respect to the creation of a biobank linked to the registry, a majority of sites viewed biobank information as qualitatively different from other types of personal health information. All respondents agreed that patient consent was needed for blood samples to be placed in the biobank but the duration of consent again varied.ConclusionParticipants were more attuned to issues surrounding biobanks as compared to registries and demonstrated a higher level of concern regarding biobanks. As registries and biobanks expand, there is a need for critical analysis of suitable roles for REBs and subsequent guidance on these topics. The authors conclude by recommending REB participation in the creation of registries and biobanks and the eventual drafting of comprehensive legislation. (shrink)

The second half of the 1940s left its mark on the history of Soviet scholarship [nauka] as a special period in the interrelations between scholarship and society, as a time of direct encroachment on the development of scholarship by the totalitarian state. This direct ideological diktat over the activity of scholars [uchenye] took the form of scholarly [nauchnye] discussions, as they were called. They were an expression of the striving of Party-bureaucratic structures to unify the development of knowledge and to (...) impose like-mindedness on the basic directions of scholarly activity. References to the philosophical discussion, the Lysenko session of the Lenin All-Union Academy of Agriculture [VASKhNIL], the intrusion into the development of physics and chemistry, the discussions on issues of linguistics, physiology, etc., have become commonplace and have entered the textbooks, although the extent to which they have been studied varies. (shrink)

In the article the problem of transformation of the information received by the user on the Internet into his knowledge is investigated. The paper uses the main special scientific and logical research methods used in the social and humanitarian sciences. At the same time, the methods of systematic and value-worldview analysis of the phenomena of the spiritual world of a person are distinguished by the degree of significance, which allow us to study the problem of the dialectic of knowledge and (...) information on the Internet not in isolation, but in connection with the main phenomena of the spiritual life of people, taking into account the priority of value-worldview structures. The goal of the work is to find a priority factor that provides a higher degree of accuracy in the transformation of information from the Internet into human knowledge. It is shown that the nature of the world wide web to a certain extent complicates the process of translating information coming to a person into his knowledge. It is concluded that the condition for the transformation of information received by the user on the Internet is the cognitive activity of a person, due primarily to the development of its value and ideological sphere. If the cognizing person has sufficiently developed and stable value – ideological foundations of personality, he successfully realizes himself as a developing subject, an active participant in knowledge. On the contrary, insufficiently stable value-worldview sphere can lead to passive perception of information by the individual, adaptation to reality, simplification of personality. Information from the Internet in the most adequate form is transformed into a person’s knowledge on the basis of his own cognitive activity, in the presence of intellectual and volitional capabilities for verifying the information available on the Network. (shrink)

Рассматриваются актуальные проблемы философской антропологии, проводится анализ парадоксов и противоречий, возникающих при изучении человека, тех кардинальных сдвигов в культуре, которые открыли новые стороны человеческого бытия. Для студентов.

Gender is known to be a term used to define the sociocultural form of the existence of gender: man and woman act not as natural definitions but as sociocultural phenomena. If gender is determined on the basis of physical, organic and psychophysiological characteristics, then, unlike it, gender is derived from the social, cultural and historical features of human being. Human behavior in society and how it is perceived in it and defines gender as a social gender. Gender is thus one (...) of the ways of social stratification of a society that, in combination with such socio-demographic factors as race, nationality, class, age, organizes the system of social hierarchy. Because gender is not a natural thing but a social construct, it implies self-awareness and self-determination. Gender has always been and remains a meaningful term. In the social sciences, "gender" has become more narrowly defined, denoting "social gender", that is, socially determined roles, identities and spheres of activity of men and women, which depend not on biological sexual differences, but on the social organization of society. Central to gender studies is the problem of social inequality between men and women. (shrink)

It is known that antiquity understood man as an organic part of the cosmos, which occupies the highest place among natural beings. Instead, the Middle Ages led man beyond the limits of cosmic natural life, proclaiming, on the one hand, an invisible connection with the transcendent God, and, on the other, humiliating the complete dependence caused by his fall upon Divine grace. The Middle Ages are about the discovery of the "inner man", who in the cosmos does not meet anything (...) and know the depths of which can only be obtained by the supernatural light of grace [Haydenko P.P. Evolution of the concept of science.- M., 1980.- C. 409, 425]. Self-knowledge, like the knowledge of God, medieval philosophical thought subordinated the religious task of saving the soul. She transferred the center of gravity of ethics from the sphere of knowledge to the sphere of faith, giving priority to freedom rather than reason - which led to the assertion of man as an active subject of action as opposed to the objectively contemplative attitude of antiquity. Such activity of the subject, despite its purely religious orientation, subsequently played an important role in the formation of the identity of the Renaissance individual. (shrink)

Violence is a natural human state, a natural means of communication between one individual and another and it will remain so as long as society is in the stage of its "animal" evolution, as long as man in the mass remains, as Nietzsche put it, a "superchimpanzee." Violence is natural, and goodness and altruism are artificial; one must make a great effort to be good. To be good is an art. There are no laws that make us love one another. (...) But there are laws according to which we must fear or hate, or try to subjugate others. These are the laws of nature. (shrink)

The transition from self-consciousness as the unhappy consciousness to reason as the critique of idealism is among the most important in Hegel’s Phenomenology of Spirit. Yet this transition is implicit and not readily discernible. This paper investigates whether we can discover and describe any roadblock that the unhappy consciousness is able to knock down, or despite which it is able to maneuver, and so become reason; or whether the unhappy consciousness arrives at an impassable dead end and either manages to (...) create a detour around it or just begins again, unexplained and unexplainably, almost ex nihilo, as reason; or whether, despite its implicitness, there exists a continuous, tenable, and unimpeded path from self-consciousness to reason. (shrink)

The term 'Machiavellianism', used to designate a tough politics knowing no ethical barriers, entered firmly into circulation as far back as the sixteenth century. It was the negative reaction to the maxims in The Prince that defined the initial attitude toward Machiavelli's doctrine, and the internal polemic with this initial assessment has spawned an endless stream of literature endeavoring to justify in one way or other the ill-starred secretary of the Florentine Republic. In sheer number of publications, pro-Machiavelli views exceed (...) anti-Machiavelli views by many times. And yet questions remain; the original negative reaction is not eradicated, just as the striving for apologetics is not eradicated. (shrink)