Reflexiones sobre la ética de la investigación en Colombia / Reflections on Ethics of Research in Colombia

Resumen Se reflexiona en torno al diseño normativo que regula la investigación en Colombia y las prácticas de los investigadores desde un enfoque ético, abordando asuntos pro blemáticos en las ciencias de la salud, las ciencias sociales y las disciplinas ambien tales, para concluir que se necesita fortalecer el control del Estado en estos temas, la actualización de la normatividad y una mayor formación de los investigadores y miembros de Comités de Ética en investigación, especialmente en: la protección de los participantes, el cuidado de los animales, los conflictos de interés, el manejo de comunidades y de grupos vulnerables, los protocolos comunitarios, el consentimien to informado, la consulta previa, el cuidado de la biodiversidad y el acceso a recursos genéticos.

Abstract This paper reflects on the normative design, which regulates research in Colombia and the practices of researchers from an ethical approach, by addressing critical issues in the health sciences, social sciences, and environmental disciplines, to conclude that it is necessary to strengthen state control in these issues, the updating of the regulations and greater training of researchers and members of Ethics Committees in research , especially in the protection of participants, animal care, conflicts of interest, the management of communities, and vulnerable groups, community pro tocols, informed consent, prior consultation, biodiversity care, and access to genetic resources.

"se eu soubesse, não teria vindo": implicações e desafios da entrevista qualitativa / "si supiera, no estaría aquí": implicaciones y desafíos de la entrevista cualitativa / "if i had known, i wouldn't have come": implications and challenges of qualitative interview

RESUMO Por se tratar de uma técnica que privilegia a investigação do sentido, a entrevista é uma das ferramentas mais utilizadas em pesquisas qualitativas. Faz-se necessária, portanto, uma reflexão sobre seu uso. O objetivo deste artigo é discutir os desafios, para a equipe de pesquisa, na utilização da entrevista qualitativa e seus possíveis impactos à pessoa entrevistada. A análise, sustentada em trechos de entrevistas extraídos de diferentes projetos, debruçou-se sobre dois aspectos: 1. a relação entre pesquisadores e participantes; e 2. possíveis implicações para entrevistados. Discute-se que a entrevista se constitui no campo intersubjetivo pesquisador-participante, com variabilidades e influências contextuais, que estão para além da possibilidade de controle total sobre o processo, evidenciando o papel ativo de ambos no acontecimento da entrevista. A respeito das implicações, observa-se que a entrevista possibilita um momento oportuno para a expressão de experiências não reveladas em outros contextos e que, ao revisitar sua história, a percepção sobre ela e sobre si pode se alterar ao longo da narração. Estes aspectos fazem com que a entrevista seja momento de constituição de sentidos e não de mero relato, o que pode também implicar mobilização de afetos. Diante dessas questões, nota-se que a entrevista pode oferecer, concomitantemente, risco de sofrimento e possibilidade de ressignificação para os participantes. Concluímos que, tanto do ponto de vista ético quanto da viabilidade da pesquisa, é necessário para a condução da entrevista conhecimento teórico-metodológico, acolhimento e empatia, bem como disponibilidade e confiança por parte de quem narra sua história.

RESUMEN Por tratarse de una técnica que privilegia la investigación del sentido, la entrevista es una de las herramientas más utilizadas en investigaciones cualitativas, configurándose necesario la reflexión sobre su uso como instrumento. El objetivo del presente artículo es discutir los desafíos para el investigador en la entrevista cualitativa y posibles impactos para el participante-entrevistado. El análisis, fundamentada en extractos de entrevistas retirados de diferentes proyectos, se centró en dos aspectos: 1. La relación entre investigador y participante y 2. Posibles implicaciones para el entrevistado. Se discute que la entrevista se constituye en el campo intersubjetivo investigador-investigado, con variabilidades e influencias contextuales que están más allá de la posibilidad de control total del investigador sobre el proceso, evidenciando el papel activo de ambos en el acontecimiento de la entrevista. Con respeto a las implicaciones, se observa que la entrevista es oportunidad de expresar experiencias no reveladas en otros contextos y que, al revisar su historia, la percepción del narrador sobre ella y sobre sí mismo puede cambiar. Estos aspectos hacen de la entrevista momento de constitución de sentidos y no mero relato, lo que puede también implicar en la movilización de afectos no elaborados. Ante estas cuestiones, se nota que la entrevista puede ofrecer concomitantemente riesgo de sufrimiento y posibilidad de resignificación para el participante. Concluimos que, tanto desde el punto de vista ético, como de la viabilidad de la investigación, es necesario al entrevistador no sólo el conocimiento teórico-metodológico, sino también acogida y empatía, y por parte del participante, disponibilidad y confianza.

ABSTRACT Since the interview is a technique that favors the investigation of meaning, it is one of the most used tools in qualitative research, requiring a study on its uses. This article aimed to discuss the challenges for the researcher in the use of the qualitative interview and possible implications for the interviewed. Our analysis, based on excerpts from interviews drawn from different research projects, focused on two aspects: 1. The relationship between researcher and participant, and 2. Possible implications for the interviewee. We argue that the researcher-participant intersubjective field constitutes the interview, with contextual variability and influences that preclude the possibility of complete control of the process by the investigator, conferring an active role to both interactors. Concerning the implications for the interviewee, we point out that the interview is an opportunity for the participant to reveal previously untold experiences, and that, by revisiting his/her history; the narrator may change his/her perspective about it and about him/herself. These aspects turn the interview into a moment of sensemaking and not a mere report, which may also imply the mobilization of unelaborated affections. Given these issues, we note that the interview may concomitantly present to the participant the risk of suffering as well as the possibility of making new understandings about their experiences. We conclude that from an ethical point of view, considering as well the viability of the research, the interviewer must display not only the required theoretical and methodological knowledge but also acceptance and empathy, whereas the participant must show availability and trust.

Evaluation of Medical Humanities Course in College of Medicine Using the Context, Input, Process, and Product Evaluation Model.

BACKGROUND: Seoul National University College of Medicine has provided a new educational curriculum on basis of the competency-based curriculum since 2016. The new curriculum included the medical humanities course (MHC) to potentiate humanities of medical students. The present study applied the context, input, process and product (CIPP) evaluation model to the MHC in order to confirm the feasibility of the CIPP model and to improve the MHC by questionnaire survey and analysis of teaching materials. METHODS: This study analyzed the MHC provided to the freshmen in 2016 and to the freshmen and sophomores in 2017 by the CIPP model. Firstly, evaluation criteria and indicators were developed according to the CIPP classification. The materials collected from the course were analyzed by quantitative and qualitative analysis according to the evaluation criteria. In the quantitative analysis, an independent sample t-test was performed to verify the difference in the responses between the students (n = 522) and the professors (n = 22). In addition, content analysis was conducted for qualitative evaluation. RESULTS: There were significant differences in perceptions of MHC between students and professors about the results of almost all objective survey questions through the t-test, such as score 3.64 in students and 4.48 in professors in response to the item of 'provision of appropriate feedback.' As a result of the content analysis, 7 categories and 20 subcategories were derived. There were the most responses to various instructional methods (students, 20%; professors, 21.5%). CONCLUSION: The CIPP evaluation model was acceptable for the MHC analysis. The first task is to raise students' awareness of the MHC in order to improve the MHC quality.

Solidarity and care as relational practices.

Many working in bioethics today are engaging in forms of normative interpretation concerning the meaningful contexts of relational agency and institutional structures of power. Using the framework of relational bioethics, this article focuses on two significant social practices that are significant for health policy and public health: the practices of solidarity and the practices of care. The main argument is that the affirming recognition of, and caring attention paid to, persons as moral subjects can politically motivate a society in three respects. The recognition of solidarity and the attention of care can prompt progressive change toward a democratic willingness: (a) to provide for equal respect for rights and dignity; (b) to provide the social resources and services needed for just health and well-being; and (c) to focus its creativity and wealth on the actualization of potential flourishing of each and all. Solidarity is discussed as a morally developmental stance that moves from standing up for another, standing up with another, and standing up as another. Care is discussed as a morally developmental stance that moves from the attentive rehabilitation of another, attentive companionship with and for another, and attentive commitment to another.

Humanidades e ciência: uma leitura a partir da Bioética de Van Rensselaer (V. R.) Potter / The humanities and the sciences: a reading from Van Rensselaer Potter's Bioethics / Humanidades y ciencia: una lectura a partir de la Bioética de Van Rensselaer Potter

A Bioética surgiu em um momento em que a distância entre a ciência e as humanidades parecia intransponível. Em seu surgimento, a Bioética possuía um apelo para superar essa distância que se revelava fatal para o futuro desenvolvimento da humanidade e para a manutenção das condições de vida nesse planeta. É nesse contexto que V. R. Potter propôs seu conceito original de Bioética como uma integração entre a Biologia e os valores humanos - especialmente a filosofia moral - para orientar a sobrevivência humana. Nesse sentido, o presente texto procurará desenvolver o significado do conceito de Bioética para V. R. Potter e o problema das "duas culturas", isto é, da necessidade de construção de um diálogo entre as humanidades e a ciência, buscando uma convergência da relação ética de todos os saberes em torno do cuidado da vida.(AU)

The rise of Bioethics took place at a time when the gap between the sciences and the humanities seemed insurmountable. The appeal of Bioethics was in its mission of overcoming this distance which was proving to be critical for the future development of humanity and for maintaining the conditions for life on the planet. It was in this context that V. R. Potter put forward his original concept of Bioethics as an integration between Biology and human values - particularly moral philosophy - to guide human survival. In this sense, this paper will seek to develop and clarify the meaning of the concept of V. R. Potter's Bioethics and the problem of "two cultures", namely the need for building a dialogue between the humanities and the sciences, seeking a convergence of the ethical relationships of all knowledge around the idea of caring for life.(AU)

La Bioética surgió en un momento en el que la distancia entre la ciencia y las humanidades parecía insalvable. En su aparición, la Bioética presentaba un clamor para superar esa distancia que se revelaba fatal para el futuro desarrollo de la humanidad y para el mantenimiento de las condiciones de vida en ese planeta. Es en ese contexto que V. R. Potter propuso su concepto original de Bioética como una integración entre la Biología y los valores humanos - especialmente la filosofía moral - para orientar la supervivencia humana. En este sentido, este texto buscará desarrollar el significado del concepto de Bioética para V. R. Potter y el problema de las "dos culturas", es decir, de la necesidad de construcción de un diálogo entre las humanidades y la ciencia, buscando una convergencia de la relación ética de todos los saberes alrededor del cuidado de la vida.(AU)

The Chimes of Freedom: Bob Dylan, Epigrammatic Validity, and Alternative Facts.

This essay brings together work I have done over the past 10 years: on the nature of ethics, on the purpose of ethics, and on its foundations in a way that, I hope, as E.M. Forster put it, connects "the prose and the passion." I deploy lessons learned in this process to identify and face what I believe to be crucial challenges to science and to freedom (as defended by, among others, Cicero, Pete Seeger, Bob Dylan, Thomas Hobbes, John Stuart Mill, and Bertrand Russell). Finally I consider threats to freedom of a different sort, posed by the creation and dissemination of "alternative facts" and by what is sometimes called "super" or "full" artificial intelligence (AI).

Reflexão sobre os aspectos e procedimentos éticos de uma pesquisa com médicos cooperados do Programa Mais Médicos / Reflection on the ethical aspects and procedures of a research with cooperated doctors of The More Physicians Program / Reflexión sobre los aspectos y procedimientos éticos de una investigación con médicos cooperantes del Programa Más Médicos

A questão da ética em pesquisas com seres humanos no Brasil tem sido ainda um dilema, mesmo com a criação da Resolução nº 510/16 do Conselho Nacional de Saúde (CNS). Este artigo faz uma reflexão sobre os aspectos e procedimentos éticos da pesquisa Análise sobre a Formação Profissional e Experiência dos Médicos Cooperados do Programa Mais Médicos no Brasil, que se enquadra na área de Saúde Coletiva, porém utiliza metodologias das Ciências Humanas e Sociais (CHS). Para isto, comparou-se as duas últimas resoluções do CNS com os procedimentos realizados na pesquisa. Embora a nova resolução tenha trazido avanços nas normas éticas brasileiras para as pesquisas nas áreas de CHS, ainda existem lacunas que causam dificuldades para que os pesquisadores enquadrem suas pesquisas nas diretrizes e normas regulamentadoras.(AU)

The issue of ethics in research with humans in Brazil has still been a dilemma, even with the creation of the Resolution 510/16 of the National Health Council (CNS). This paper reflects on the ethical aspects and procedures of the research Analysis of the Professional Training and Experience of the Cooperated Doctors of the More Physicians Program in Brazil, which is part of the Public Health area, but uses Humanities and Social Sciences (HSS) methodologies. To this end, the last two resolutions of the CNS were compared with the procedures performed in the research. Although a new resolution has brought advances in the Brazilian ethical standards for research in HSS areas, there are still gaps that cause difficulties for researchers to frame their research on guidelines and regulatory standards.(AU)

La cuestión de la ética en investigaciones con seres humanos en Brasil continúa siendo un dilema, aun después de la creación de la Resolución n. 510/16 del Consejo Nacional de Salud (CNS). Este artículo hace una reflexión sobre los aspectos y procedimientos éticos de la investigación Análisis sobre la Formación Profesional y Experiencia de los Médicos Cooperantes del Programa Más Médicos en Brasil, que se enmarca en el área de Salud Colectiva; sin embargo, utiliza metodologías de las Ciencias Humanas y Sociales (CHS). Se compararon las dos últimas resoluciones del CNS con los procedimientos realizados en la investigación. Aunque la nueva resolución haya traído avances en las normas éticas brasileras para las investigaciones en las áreas de CHS, aún existen vacíos que ocasionan dificultades para que los investigadores adecuen sus investigaciones en las directrices y normas reguladoras.(AU)

[Ethics and methodology: the importance of promoting, evaluating and implementing education and humanities research in health]. / Ética y metodología: la necesidad de promover, evaluar e implementar la investigación en educación y humanidades en salud.

In this editorial we initially expose the agreements that have set the mechanisms to guarantee safety and fair treatment to human subjects in research. Later on, we offer alternatives from translational and multidisciplinary research to promote education and humanities research in health.

En el presente editorial se exponen, en un primer momento, los acuerdos que han establecido los mecanismos para garantizar la seguridad y el trato digno a las personas sujetas a investigación. Más tarde, se ofrecen alternativas, desde la investigación traslacional y la multidisciplina, para promover en el ámbito de la salud la investigación en educación y las humanidades.

Errata de: Índices antropométricos de crianças assistidas em creches e sua relação com fatores socioeconômicos, maternos e infantis / Erratum to: Anthropometric indices of children treated in daycare centers and the relationship with socioeconomic, maternal and child factors

Errata no artigo: Índices antropométricos de crianças assistidas em creches e sua relação com fatores socioeconômicos, maternos e infantis. edição: volume 21 número 7: 2016, p.2219 correção na p.2230 Doi: 10.1590/1413-81232015217.11712015

Errata no artigo: Resolução nº 510 de 7 de abril de 2016 que trata das especificidades éticas das pesquisas nas ciências humanas e sociais e de outras que utilizam metodologias próprias dessas áreas. na edição: volume 21 número 8: 2016, p.2629 DOI: 10.1590/1413-81232015218.17212016

Errata in article: Anthropometric indices of children treated in daycare centers and the relationship with socioeconomic, maternal and child factors.edição: volume 21 número 7: 2016, p.2219 Doi: 10.1590/1413-81232015217.11712015

Errata in article: Approval of the Resolution governing the ethics of research in social sciences, the humanities, and other disciplines that use methodologies characteristic of these areas: challenges and achievements. na edição: volume 21 número 8: 2016, p.2629 DOI: 10.1590/1413-81232015218.17212016

Humanity and Social Responsibility, Solidarity, and Social Rights.

This article discusses the suggestion of having the notion of solidarity as the foundational value for welfare scheme reforms. Solidarity is an emerging concept in bioethical deliberations emphasizing the need for value-oriented discussion in revising healthcare structures, and the notion has been contrasted with liberal justice and rights. I suggest that this contrast is unnecessary, flawed, and potentially counterproductive. As necessary as the sense of solidarity is in a society, it is an insufficient concept to secure the goals related to social responsibility. The discussion on solidarity is also based on a questionable sense of nostalgia. Furthermore, solidarity and liberal justice share essential objectives concerning welfare schemes; therefore, the question arises whether the proper comparison should in the first place be within justice and solidarity.

Differences in Biases and Compensatory Strategies Across Discipline, Rank, and Gender Among University Academics.

The study of ethical behavior and ethical decision making is of increasing importance in many fields, and there is a growing literature addressing the issue. However, research examining differences in ethical decision making across fields and levels of experience is limited. In the present study, biases that undermine ethical decision making and compensatory strategies that may aid ethical decision making were identified in a series of interviews with 63 faculty members across six academic fields (e.g., biological sciences, health sciences, social sciences) and three levels of rank (assistant professor, associate professor, and full professor) as well as across gender. The degree to which certain biases and compensatory strategies were used in justifications for responses to ethical situations was compared across fields, level of experience, and gender. Major differences were found across fields for several biases and compensatory strategies, including biases and compensatory strategies related to use of professional field principles and field-specific guidelines. Furthermore, full professors tend to differ greatly from assistant and associate professors on a number of constructs, and there were differences in the consistency with which biases and compensatory strategies were displayed within these various groups. Implications of these findings for ethics training and future research are discussed.

Brief report.

Most accounts of the ethical problems facing researchers across a broad spectrum of research fields come from ethicists, ethics committees, and specialists committed to the study of ethics in human research. In contrast, this study reports on the ethical questions that researchers, themselves, report facing in their everyday practice. Fifty-five Swedish researchers contributed 109 examples of ethical dilemmas, conflicts, and problems in research. They were all researchers at the postdoctoral level in the fields of medicine, the humanities, education, and the social sciences, who devoted at least 50 percent of their working hours to research. They reported issues they face before, during, and after gathering data. Their range of issues is broader than generally discussed and points to the importance of researchers' ethical sensitivity.

Humanidades médicas no Reino Unido: uma tendência mundial em educação médica hoje / Medical humanities in the UK: a world trendin medical education today

Este artigo tem por objetivo apresentar uma análise crítica do estado-da-arte da literatura sobre o movimento deintrodução das Humanidades Médicas em Educação Médica no Reino Unido, assim como as percepções e atitudes de estudantes de Medicina, acadêmicos e pesquisadores na área. Para tal foi realizada uma revisão crítica de literatura nas bases Ovid-SP e Scopus para os descritores na língua inglesa ‘medical humanities’, ‘medical education’, ‘humanities’, ‘humanisation’, ‘physicians’, ‘patients’, ‘medical students’, ‘British’, ‘England’, no período de 2000 a 2011, com publicações em língua inglesa e por referência cruzada. Tal pesquisa gerou um resultado de 34 artigos, dos quais 29 encontram-se diretamente referenciados neste texto que mostra a maneira como as Humanidades Médicaspassaram a ser uma florescente disciplina a ser introduzida em Escolas Médicas a partir da década de 1950, paralelamente entre E.U.A. e Reino Unido. Neste panorama, historicizamos as origens do processo de dissolução do ‘bom médico’ e delineamos o caminho por meio do qual o Reino Unido configurou-se como o berço da atual tendência mundial de humanização doscuidados em saúde. Desta maneira, o Reino Unido tem liderado o debate mundial com sua ampla experiência nas Humanidades em Saúde, primeiramente como instrumento de formação éticaem saúde e, mais recentemente, como linha de pesquisa para investigar os efeitos observados na integralidade da formação de médicos produzidos pelos variados modelos de sua implementaçãoem suas Escolas Médicas após a publicação dos Médicos de Amanhã pelo General Medical Council em 1995, cujo objetivo é o de resgatar o ‘good doctor’, o ‘bom médico’, para a prática clínica...

This editorial aims to present a critical analysis of the state-of-the-art literature on the initiative of introduction of the Medical Humanities into Medical Education in the United Kingdom, as well as the perceptions and attitudes of medical students,scholars and researchers in this field. For such purpose, a critical literature review was performed at the online bases Ovid-SP and Scopus for the keywords in the English language ‘medical humanities’, ‘medical education’, ‘humanities’, ‘humanisation’, ‘physicians’, ‘patients’, ‘medical students’, ‘British’, ‘England’,during the period from 2000 to 2011, also collecting publications by cross-referencing. This search produced a result of 34 papers, from which 29 were directly referenced in this work that shows the way through which the Medical Humanities became a flourishing discipline to be introduced in Medical Schools from the 1950’s on, simultaneously in the US and the UK. At this panorama, we historicised the origins of the dissolution process of the ‘good doctor’ and delineated the pathway by which the UK has becomethe focus of a worldwide trend in humanisation of the health care. As such, raising the world debate with the British both wide and effective experience of introduction of the Medical Humanities, firstly as an instrument for the ethical education in health, then, more recently, as a research strength to investigate the observed effects of the integrity in the education od doctors produced by itsseveral formats implementation across the Medical Schools in the UK, after the publication of Tomorrow’s Doctors by the General Medical Council in 1995, whose main aim was to “rescue” the‘good doctor’ back into the healthcare...

Literatura e formação humanística em medicina: o experimento do Laboratório de Humanidades da EPM/UNIFESP / Literature and humanistic education in medicine: the experiment of the Laboratory of Humanities of EPM/UNIFESP

Este artigo descreve, a partir da experiência com uma atividade educacional desenvolvida com alunosde graduação e pós-graduação da EPM-UNIFESP, o Laboratório de Humanidades, a forma como a leiturae discussão de clássicos da literatura universal pode contribuir para o processo de formação humanística ehumanização de futuros médicos e profissionais da saúde em geral. Fundamentado na perspectiva teórica das humanidades e na observação empírica do fenômeno educacional, este estudo aponta a experiência estética ereflexiva a partir da literatura como forma privilegiada de promover a humanização no contexto educacional...

Based on the experience of an educational activity for undergraduate and post graduate students from EPM-UNIFESP, the Laboratory of Humanities, this article aim to describe the way as reading and discussion of literature classics can give humanistic contributions for the medical education. Grounded in the humanities theoretical background and in the empirical observation of educational phenomena, this study shows that aesthetical and reflective experience could be a privileged form to promote “humanization” in the medical education context...

Biopiracy and the ethics of medical heritage: the case of India's traditional knowledge digital library'.

Medical humanities have a central role to play in combating biopiracy. Medical humanities scholars can articulate and communicate the complex structures of meaning and significance which human beings have invested in their ways of conceiving health and sickness. Such awareness of the moral significance of medical heritage is necessary to ongoing legal, political, and ethical debates regarding the status and protection of medical heritage. I use the Indian Traditional Knowledge Digital Library as a case study of the role of medical humanities in challenging biopiracy by deepening our sense of the moral value of medical heritage.

Constructing the Medical Humanities gaze.

In the last few decades genomics has completely reshaped the way in which patients and physicians experience and make sense of illness. In this paper we build upon a real case - namely that of breast cancer genetic testing - in order to point to the shortcomings of the paradigm currently driving healthcare delivery. In particular, we put forward a viable analytical model for the construction of a proper decisional process broadening the scope of medical gaze onto human experience of illness. This model revolves around four main conceptual axes: (i) communicating information; (ii) informing decisions; (iii) respecting narratives; (iv) empowering decision-making. These four kernels, we argue, map precisely onto the main pitfalls of the model presently dealing with genetic testing provision. Medical Humanities, we conclude, ought to play a pivotal role in constructing the environment for competent decision-making, autonomous self-determination and respectful narritivization of one's own life.