desde tiempos inmemorables el hombre ha cuestionado el mundo que lo rodea y el porqué de los fenómenos que diariamente observa en la naturaleza, al igual que se ha interesado por estudiar el comportamiento humano y la explicación de las interacciones humanas. En la búsqueda por explicar lo que le rodea, el hombre ha propuesto hipótesis que con el paso del tiempo se han podido verificar o falsear, ese conjunto de conocimientos que se ha logrado confirmar o refutar es lo (...) que se conoce como ciencia y el conjunto de pasos que se siguen para poder confirmarlos es lo que se conoce como método científico. Este artículo busca hacer un análisis de las distintas definiciones de ciencia que se han conocido provenientes de pensadores y filósofos a lo largo de la historia; se realiza un análisis de la categorización de métodos científicos aplicados para la generación de conocimiento y cómo la filosofía aporta para la generación de este. (shrink)

Colombia is the second country with the highest number of internally displaced persons. In the last 10 years, more than 400,000 young people carry, in their life experiences, the title of victims. The psychological and social circumstances that determine the lives of displaced young people in the world are not unknown. Fear, the poor resources for social adaptation available to them, and the possible reproduction of the cycle of violence, represent psychosocial risk factors in the young and displaced population. In (...) this context, the Victims Law in Colombia stipulated various measures of repairment, including Relocation and Return provided the conditions of voluntariness, security, and dignity are present. A hypothesis that well-being will be better in the returnees was set, since they would strengthen the social support networks between neighbors and other victims in their old spaces of life. To test the hypothesis, the scales of Psychological Well-being, Social Well-being, the Satisfaction with Life Scale, and the Psychosocial Trauma Scale were applied to young returnees and relocated in Colombia. The Exploratory and Confirmatory Factor Analysis was performed to extract the general measure of well-being and psychosocial trauma followed by the comparison between the groups. Significance, power, and effect size indicators were obtained, and finally, the partial correlation between the groups was made in relation to psychosocial trauma and well-being. Results showed that returnees have greater well-being and clearer indicators, with respect to that of relocated. In addition, the well-being of returnees has fewer trauma factors, who in turn are quasi-moderated by the situation of return or relocation. (shrink)

Exhumations aim to restore victims’ dignity because they constitute a step towards their individualisation and recognition as members not only of a particular family but of the human family. This article aims to contribute to the critical assessment of how the notion of human dignity and dignification are used in the context of mechanisms of transitional justice, such as exhumations. It focuses on the Colombian case from an interdisciplinary perspective based on socio-legal studies. The research is based on participant observation, (...) interviews, and thematic analysis of the uses of the term dignity and dignification in the texts of the laws and protocols for the exhumations of victims of the armed conflict in Colombia. It explores two dimensions of dignification, which in turn contributes to the understanding of the complex relationship between victims, the state, and institutions of transitional justice. (shrink)

Este estudo problematiza os castigos físicos usados nas escolas, investigando tanto as estratégias utilizadas pelas instâncias de poder, a fim de ordenar as práticas cotidianas, como as táticas utilizadas por professores, gestores e pais para lidarem com os preceitos impostos. Nese ínterim, são denunciadas as tensões existentes nessa relação, mergulhando em práticas, representações e argumentos utilizados nos séculos XIX e XX, tanto para corroborar quanto para proscrever os castigos físicos no espaço escolar. O texto é concluído através de uma reflexão (...) acerca dos castigos como parte da cultura escolar, fazendo referência, também, à distância existente entre as prescrições oficiais e as práticas ordinárias, bem como aos castigos como caminho para educar e civilizar sujeitos. (shrink)

IntroductionCardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in which they (...) have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter.ResultsWe point out the need for strengthening the roles of healthcare personnel as educators and guidance counselors in order to meet the ends of medicine, as well as the need for an ethical discernment that is compatible with our results, namely, that the ethical values developed by healthcare professionals stem from their life history as well as their professional education.ConclusionWe establish the kind of actions, communication skills and empathy that are required to build a stronger patient-healthcare professional relationship, which at the same time improves prognosis, treatment efficiency and therapeutic adhesion. (shrink)

Cardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in which they (...) have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter. (shrink)

En este ensayo se examina de manera crítica el desarrollo de la filosofía analítica y, en particular, de la filosofía analítica latinoamericana. Se propone que esta última adopte un giro político y uno pedagógico con el fin de recuperar su espíritu original y reconectarse con la tradición intelectual latinoamericana. This essay is a critical examination of the development of analytic philosophy and, in particular, of Latin American analytic philosophy. It is argued that the latter ought to adopt a political and (...) pedagogical turn in order to recover its original spirit and to be reconnected to Latin American intelectual tradition. (shrink)

:This article analyzes the criteria for the distribution of healthcare services through different justice theories such as utilitarianism and liberalism, pointing out the problems that arise when providing services to a culturally diverse population. The international epidemiological setting is a favorable one for discussing personal responsibility and luck egalitarianism; however, some provisions have to be made so that healthcare institutions do not treat ethnic, cultural, religious, and linguistic minorities unfairly. The article concludes by proposing that accommodations and culturally sensible attention (...) should be provided when possible, without affecting the equal opportunity of others to access these services. (shrink)

This article discusses the notion of justice from a capabilities approach. We undertake an empirical analysis of the concepts of justice held by healthcare personnel, gleaned from a qualitative analysis of interviews on the subject of ethical dilemmas in everyday practice. The article states that Justice undoubtedly presents a work in progress, which implicates the link between justice as capability and human dignity.We empirically found a contrast between the views of justice based on the patient's own perceptions and those based (...) on the perceptions of healthcare personnel. We establish the kind of actions, communication skills and justice required to build a stronger relationship between patients and healthcare professionals, which would improve prognosis, treatment efficiency and therapeutic adhesion. (shrink)

The purpose of this study is to determine empirically the state of the art of the medical care, when healthcare personal is confronted with ethical dilemmas related with the care they give to the geriatric population. An observational, longitudinal, prospective and qualitative study was conducted by analyzing the correlation between healthcare personnel–patient relationship, and ethical judgments regarding dilemmas that arise in daily clinical practice with geriatric patients. Mexican healthcare personnel with current active practices were asked to write up an ethical (...) dilemma that arose frequently or that had impacted their medical practice. From the narrative input, we were able to draw up a database with 421 dilemmas, and those corresponding to patients 60 years and older were selected (n = 54, 12.8 %). The axiological analysis of the narrative dilemmas of geriatric patients was made using dialectical empiricism. The axiological analysis values found most frequently were classified into three groups: the impact of healthcare, the roles of the physician, and refusal of therapy; the healthcare role of educator, caring for the patients’ life and the risk of imminent death where the values found more often. The persistence and universality of certain dilemmas in geriatrics calls for awareness and requires a good training in the ethical discernment of these dilemmas. This would help to improve substantially the care and the life quality of this population. (shrink)

Drawing on the views of donors and recipients about anonymity in a country that is experiencing a transition towards non-anonymous gamete donation mandated by the Constitutional Court, we explore how the intersection between rights-based approaches and an empirical framework enhances recommendations for ethical policy and healthcare. Between July 2017 and April 2018, 69 donors and 147 recipients, recruited at the Portuguese Public Bank of Gametes, participated in this cross-sectional study. Position towards anonymity was assessed through an open-ended question in a (...) self-report questionnaire, which was subject to content analysis. Preference for an anonymous donation regime was mentioned by 82.6% of donors and 89.8% of recipients; and all those with children. Instead of the rights-based reasoning used by the Constitutional Court, donors highlighted concerns over future relationships and recipients focused on socioethical values linked with the safeguard of safety, privacy and confidentiality. The remaining participants advocated the choice between anonymity or non-anonymity, invoking respect for their autonomy. The complex, diverse ethical views and reasoning of donors and recipients expand a traditionally dichotomous discussion. Their perspectives challenge the transition towards non-anonymity and international guidelines, raising awareness to the need for their involvement in the design of policies to enable choice according to their values and preferences, and of psychosocial counselling responsive to their socioethical concerns and sensitive to their parental status. Empirical frameworks complement rights-based approaches to uphold justice, fairness and equal respect, and to incorporate utility, beneficence and non-maleficence in policymaking and healthcare in the transition towards non-anonymity. (shrink)

IntroductionCardiology is characterized by its state-of-the-art biomedical technology and the predominance of Evidence-Based Medicine. This predominance makes it difficult for healthcare professionals to deal with the ethical dilemmas that emerge in this subspecialty. This paper is a first endeavor to empirically investigate the axiological foundations of the healthcare professionals in a cardiology hospital. Our pilot study selected, as the target population, cardiology personnel not only because of their difficult ethical deliberations but also because of the stringent conditions in which they (...) have to make them. Therefore, there is an urgent need to reconsider clinical ethics and Value-Based Medicine. This study proposes a qualitative analysis of the values and the virtues of healthcare professionals in a cardiology hospital in order to establish how the former impact upon the medical and ethical decisions made by the latter.ResultsWe point out the need for strengthening the roles of healthcare personnel as educators and guidance counselors in order to meet the ends of medicine, as well as the need for an ethical discernment that is compatible with our results, namely, that the ethical values developed by healthcare professionals stem from their life history as well as their professional education.ConclusionWe establish the kind of actions, communication skills and empathy that are required to build a stronger patient-healthcare professional relationship, which at the same time improves prognosis, treatment efficiency and therapeutic adhesion. (shrink)

The psychopathological analysis of hysteria is a victim of narrow conceptualizations. Among these is the inscription of hysteria in the feminine sphere, about body and sexuality, which incentivized conceptual reductionism. Hysteria has been mainly considered a gendered pathology, almost exclusively female, and it has been associated with cultural and/or religious features over time rather than treated as a psychopathological world. Further, hysteria has been dominated by conceptual inaccuracies and indecision, not only in terms of clinical features but also in terms (...) of its definition. For this reason, it seems necessary to “undress” hysteria from this feminization, sexualization, and corporealization with which it has been abundantly clothed over the years. “Undressing” hysteria will make possible a reconfiguring and deconstructing of the explanatory-causal model of Charcot and Freud. However, if we take out this cultural heritage, the stigma accompanying this diagnosis, and the weight of the enormous historical tradition that hysteria carries, the world of hysteria continues to constitute a domain full of complexity and nosographic challenges. Hysteria has been considered a sum of psychological behaviors and states illustrated by drama, mystery, or falsity. The difficulty in understanding the multiple somatic manifestations which characterize this clinical condition created several controversies and much confusion. In the current nosography, the personological component of hysteria has been separated from its symptomatic manifestation, in the Histrionic Personality Disorder and Conversion Disorder categories, respectively. This segmentation by descriptive nosography does contribute to a unitary understanding of the phenomenon and, consequently, of daily clinical practice. Clinical complexity can be grasped and deciphered only if the symptom is inscribed in the patient’s lifeworld and his/her subjective life history. Clinical practice is thus thought of in terms of a structural aggregation of a homogeneous set of phenomena, together constituting a specific way of being in the world. The starting point of this article is the evident modalities characterizing this life-world, taking care not to confuse the point of origin with the point of expression. (shrink)

Esta obra congrega a un grupo de reconocidos filósofos alemanes, argentinos, españoles, venezolanos y colombianos, en torno a la figura del Profesor Dr. Guillermo Hoyos Vásquez. Con aportes en los ámbitos de la fenomenología, la filosofía política y la ética se ofrece al lector especializado, pero también al estudiante de filosofía y al lector interesado en la reflexión filosófica, una serie de escritos de primer orden y de máxima actualidad.

Este estudo problematiza os castigos físicos usados nas escolas, investigando tanto as estratégias utilizadas pelas instâncias de poder, a fim de ordenar as práticas cotidianas, como as táticas utilizadas por professores, gestores e pais para lidarem com os preceitos impostos. Nese ínterim, são denunciadas as tensões existentes nessa relação, mergulhando em práticas, representações e argumentos utilizados nos séculos XIX e XX, tanto para corroborar quanto para proscrever os castigos físicos no espaço escolar. O texto é concluído através de uma reflexão (...) acerca dos castigos como parte da cultura escolar, fazendo referência, também, à distância existente entre as prescrições oficiais e as práticas ordinárias, bem como aos castigos como caminho para educar e civilizar sujeitos. (shrink)

Este estudo investiga as representações construídas acerca da mulherprofessora no processo de feminização do magistério e suas possíveis repercussões na prática pedagógica. Para tanto, além de buscar apoio em pesquisas bibliográficas, foi realizado um garimpo nos periódicos internos das décadas de 30 e 40 (séc. XX) da primeira Escola Normal de Caxias do Sul, inaugurada em 1930, a fim de encontrar discursos que explicitassem como professores, alunos e gestores descreviam as características ideais para atuar na função de educadores infantis. Os (...) resultados apontaram a um forte vínculo entre o papel materno/doméstico e o docente, fazendo menção, também, à educação como dom divino. A comunicação será concluída com uma reflexão acerca das possíveis repercussões dessas representações na prática docente, mostrando como essas constroem formas de ser e agir que, de maneira irreflexiva, convertem-se em danos à prática pedagógica. (shrink)

Resumo: A partir da disseminação das políticas educacionais inclusivas observa-se um aumento de matrículas de estudantes em situação de deficiência no Ensino Superior, elegíveis aos serviços de Educação Especial, no Brasil. Este artigo objetiva analisar os critérios institucionais utilizados para delinear o perfil desses universitários nos dados Censitários da Universidade e, de que modo tais dados comungam com as políticas educacionais inclusivas vigentes. Por conseguinte, buscará compreender como as políticas institucionais da universidade se correlacionam com as do Censo do Ensino (...) Superior e Políticas Educacionais Inclusivas no que refere aos apoios e medidas protetivas de acesso e participação dos estudantes a esta etapa de ensino à população mencionada. Trata-se de um estudo documental balizado na descrição do perfil de universitários da graduação e de pós-graduação, de uma universidade pública paulista no a) anuário institucional, b) formulário de identificação de matrícula de estudantes e, c) das designações desta população, descrita no Censo do INEP. Os resultados demonstraram um descompasso na caracterização dos marcadores que retratam o perfil do público em relação as designações referenciadas na Lei Brasileira de Inclusão. A escassez de práticas institucionais inclusivas dirigidas a este tema, somadas a falta de clareza na compreensão sobre as demandas educacionais específicas, declaradas pelos estudantes contribuem para manter um clima de instabilidade das tratativas de respostas à permanência deste público na universidade investigada. Palavra-chave: Acessibilidade; Deficiência; Ensino Superior; Políticas Educacionais Inclusivas. Policy for the identification of students with SEN at a public Brazilian university Abstract: From the dissemination of inclusive educational policies, there is an increase in enrollment of students with Special Educational Needs (SEN) in Higher Education, users of Special Education services, in Brazil.The article aims to analyze the institutional criteria used to delineate the profile of these university students in the University's Census data and how these data are in line with the current inclusive educational policies. Therefore, it will seek to understand how the university's institutional policies correlate with those of the Higher Education Census and Inclusive Educational Policies regarding support and protective measures to access this stage of education for the population mentioned. This is a documentary study based on the description of the profile of undergraduate and graduate students, of a public university in São Paulo in a) institutional yearbook, b) student enrollment identification form, and c) the designations of this population, described in the INEP Census. The results demonstrated a disparity in the characterization of the markers that portray the public's profile in relation to the designations referenced in the Brazilian Inclusion Law. The shortage of inclusive institutional practices aimed at this theme, added to the lack of clarity in understanding about the especific educational demands, declared by students at the time contribute to maintaining a climate of instability in the treatment of responses to the permanence of this public in the investigated university. Key-words: Accessibility; Disability; Higher Education; Inclusive Educational Policies. Política para la identificación de estudiantes con NEE en una universidad pública brasileña Resumen: El artigo tiene como objetivo analizar los criterios institucionales utilizados para delinear el perfil de estos estudiantes universitarios en los datos del Censo de la Universidad y cómo estos datos están en línea con las políticas educativas inclusivas vigentes. Por lo tanto, le interesará comprender cómo las políticas institucionales de la universidad se correlacionan con las del Censo de Educación Superior y las Políticas Educativas Inclusivas en cuanto a medidas de apoyo y protección para el acceso a esta etapa educativa para la población mencionada. Se trata de un estudio documental basado en la descripción del perfil de estudiantes de grado y posgrado, de una universidad pública de São Paulo en a) anuario institucional y b) formulario de identificación de matrícula y, c) las designaciones de esta población, descritas en Censo del INEP. Los resultados demostraron un desajuste en la caracterización de los marcadores que retratan el perfil del público en relación a las designaciones referenciadas en la Ley de Inclusión brasileña. La escasez de prácticas institucionales inclusivas dirigidas a esta temática, sumada a la falta de claridad en la comprensión de las demandas educativas especificas, declaradas por los estudiantes al momento de su ingreso y / o matrícula, contribuyen a mantener un clima de inestabilidad en el tratamiento de respuestas a la permanencia de este público en la universidad investigada. Palabra-claves: Accesibilidad ; Deficiencia ; Enseñanza superior ; Políticas educativas inclusivas Data de registro: 16/04/2021 Data de aceite: 16/02/2022. (shrink)

Ludwig Wittgenstein hat in seinem späten Werk »Philosophische Untersuchungen« die grammatische Beschreibung unserer lebensweltlichen Handlungen ins Zentrum seiner Überlegungen gestellt. Diese Abkehr von essentialistisch-aristotelischen Wesensdefinitionen in der Philosophie hat bis heute nichts von ihrer Sprengkraft verloren. Mit Habermas sind die »weltkonstituierenden Leistungen« im 20. Jahrhundert auf »grammatische Strukturen« übergegangen. Die Rede des Subjekts von sich selbst erscheint dann in einem neuen Licht: Es ist in einer grammatischen Weise verfasst, im Wissen um die ständige Veränderbarkeit jener Regelsysteme, die durch die Orientierung (...) an grammatischen Standards in die Praxis überführt und dort temporär stabilisiert werden. Erstmals beschreibt der Band die Kategorie der Grammatischen Subjektivität als Erweiterung des Referenzrahmens, innerhalb dessen Menschen von sich sprechen: im Blick auf Themen wie Wissen, Ethik, Politik, die Umstände der Moderne oder den Begriff des Cogito. (shrink)

Aim: Understanding the effects of psychotherapy is a crucial concern for both research and clinical practice, especially when outcome tends to be negative. Yet, while outcome is predominantly evaluated by means of quantitative pre-post outcome questionnaires, it remains unclear what this actually means for patients in their daily lives. To explore this meaning, it is imperative to combine treatment evaluation with quantitative and qualitative outcome measures. This study investigates the phenomenon of non-improvement in psychotherapy, by complementing quantitative pre-post outcome scores (...) that indicate no reliable change in depression symptoms with a qualitative inquiry of patients’ perspectives. Methods: The study took place in the context of a Randomized Controlled Trial evaluating time-limited psychodynamic and cognitive behavioural therapy for major depression. A mixed methods study was conducted including patients’ pre-post outcome scores on the BDI-II-NL and post treatment Client Change Interviews. Nineteen patients whose data showed no reliable change in depression symptoms were selected. A grounded theory analysis was conducted on the transcripts of patients’ interviews. Findings: From the patients’ perspective, non-improvement can be understood as being stuck between knowing versus doing, resulting in a stalemate. Positive changes (mental stability, personal strength and insight) were stimulated by therapy offering moments of self-reflection and guidance, the benevolent therapist approach and the context as important motivations. Remaining issues (ambition to change but inability to do so) were attributed to the therapy hitting its limits, patients’ resistance and impossibility and the context as a source of distress. “No change” in outcome scores therefore seems to involve a “partial change” when considering the patients’ perspectives. Conclusion: The study shows the value of integrating qualitative first-person analyses into standard quantitative outcome evaluation and particularly for understanding the phenomenon of non-improvement. It argues for more multi-method and multi-perspective research to gain a better understanding of (negative) outcome and treatment effects. Implications for both research and practice are discussed. (shrink)

RESUMO O presente ensaio tem como interesse aproximar psicanálise e filosofia, respectivamente a partir de Freud e Ricoeur. Tendo o segundo se dedicado de modo profundo a pensar a obra freudiana, o objetivo é trazer à tona questões sobre a transferência, fenômeno essencial para a clínica psicanalítica, reconhecida por Ricoeur como uma das ideias dominantes em Freud. O intuito é abrir possíveis trajetos para a reflexão, sob mediação da filosofia hermenêutica ricoeuriana, a partir da formulação e da compreensão do conceito (...) de transferência em psicanálise, a fim de pensar como o mesmo poderia contribuir para os estudos filosóficos e políticos sobre memória, enquanto importante categoria para pensar e agir no espaço público. (shrink)

Humanización de los servicios de salud en Iberoamérica: una revisión sistemática de la literatura Humanização dos serviços de saúde na Ibero-América: uma revisão sistemática da literatura Humanization is an ethical imperative that contributes to safeguarding human dignity in harmony with bioethical principles and deontological regulations that govern health care practices. The present study aims to explore the advances in the humanization of Ibero-American health care in the last ten years through a systematic review. Results show that such advances point to (...) understanding the phenomenon based on theoretical approaches, a growing interest in the subject in recent years, and the creation of policies, programs and strategies that should be strengthened from a comprehensive view of the human being. Para citar este artículo / To reference this article / Para citar este artigo Carlosama DM, Villota NG, Benavides VK, Villalobos-Galvis FH, Hernández EL, Matabanchoy SM. Humanización de los servicios de salud en Iberoamérica: una revisión sistemática de la literatura. Pers Bioet. 2019;23:245-262. DOI: https://doi.org/10.5294/pebi.2019.23.2.6 Recibido: 21/06/2019 Aceptado: 04/09/2019. (shrink)

We show a sentence and modal square of opposition and equivalence to be expanded into an hexagon according to oe suggestion from William of Sherwood. This expansión is permittedby two sentence and modal rules.The logical relations of the square allow us to formulate several theorems in order to show a glimpse of the Medieval Logic complexity.

O objetivo do estudo foi investigar a prevalência e motivos do uso de álcool, tabaco e outras drogas por acadêmicos. A amostra foi composta por 560 estudantes, entre 17 e 74 anos ( M = 31,16, DP = 11,10). As substâncias com maior prevalência de uso na vida foram álcool e tabaco. Dentre as drogas ilí..

O presente artigo tem como objetivo chamar a atenção para a historicidade do sujeito, em especial daquele atuante na educação de crianças pequenas. Para tanto, parte do levantamento da trajetória histórica da Educação Infantil no Brasil, analisando os avanços e desafios dessa modalidade educacional. Como foco de debate é discutida a posição da Educação Infantil na sociedade e na cultura e as representações culturais sobre a mulherprofessora no processo de construção de sua identidade profissional. O texto é finalizado abordando as (...) repercussões de tais representações no ser e agir docente e as possibilidades de ação no contexto da formação inicial e continuada, a fim de amenizar tais influências, com vistas à qualidade do trabalho pedagógico. (shrink)

Ethical approval must be obtained before medical research can start. We describe the differences in EA for an pseudonymous, non-interventional, observational European study. Sixteen European national coordinators of the international study on very old intensive care patients answered an online questionnaire concerning their experience getting EA. N = 8/16 of the NCs could apply at one single national ethical committee, while the others had to apply to various regional ECs and/or individual hospital institutional research boards. The time between applying for (...) EA and the first decision varied between 7 days and 300 days. In 9/16 informed consent from the patient was not deemed necessary; in 7/16 informed consent was required from the patient or relatives. The upload of coded data to a central database required additional information in 14/16. In 4/16 the NCs had to ask separate approval to keep a subject identification code list to de-pseudonymize the patients if questions would occur. Only 2/16 of the NCs agreed that informed consent was necessary for this observational study. Overall, 6/16 of the NCs were satisfied with the entire process and 8/16 were unsatisfied. 11/16 would welcome a European central EC that would judge observational studies for all European countries. Variations in the process and prolonged time needed to get EA for observational studies hampers inclusion of patients in some European countries. This might have a negative influence on the external validity. Further harmonization of ethical approval process across Europe is welcomed for low-risk observational studies. Getting ethical approval for low-risk, non-interventional, observational studies varies enormously across European countries. (shrink)