A perspective on research ethics committees in the Brazilian amazon

This study presents the importance of the Research Ethics Committees (CEP) in the context of the Brazilian North Region, formed by the Amazon rainforest, which is occupied by traditional populations and those constituted by migratory currents. This study aims to analyze the bioethical implications arising from the activities of CEPs in the ethical evaluation of research projects and their essential role in protecting vulnerable populations. The authors seek to highlight the importance of ethics committees in the Amazon and their importance face the modern bioethical values that can contribute to the preservation of one of the most valuable and diverse environments on earth.

Este estudio presenta la importancia de los comités de ética en investigación (CEP) en el contexto de la Región Norte de Brasil, formada por la selva amazónica, ocupada por poblaciones tradicionales y constituida por corrientes migratorias. Este estudio tiene como objetivo analizar las implicaciones bioéticas derivadas de las actividades de los CEP en la evaluación ética de los proyectos de investigación y su papel esencial en la protección de las poblaciones vulnerables. Los autores buscan destacar la importancia de los comités de ética en la Amazonia y su importancia frente a los valores bioéticos modernos que pueden contribuir a la preservación de uno de los ambientes más valiosos y diversos del planeta.

Esse estudo apresenta a importância dos Comitês de Ética em Pesquisa (CEPs) no contexto da Região Norte Brasileira, formada pela floresta amazônica e ocupada por populações tradicionais e aquelas constituídas por correntes migratórias. Esse estudo objetiva analisar as implicações bioéticas que surgem das atividades dos CEPs na avaliação ética de projetos de pesquisa e seu papel fundamental em proteger populações vulneráveis. Os autores procuram enfatizar a importância dos comitês de ética na Amazônia e sua importância face a valores bioéticos modernos, que podem contribuir para a preservação de um dos mais valiosos e diversos ambientes na terra.

Evolution and importance of the Research Ethics Committee, CEP, in higher education institutions: a study in a western Amazonian institution between 2018 to 2022

The Research Ethics Committee (CEP) has become an essential mechanism for social control in Brazilian research involving human subjects, contributing to the development of studies guided by ethical standards and to the protection of research participants. This article analyzes the performance of CEP in Western Amazonian institution, its history, operating conditions, trends, and different aspects between 2018 to 2022. The theoretical framework addresses the history of research involving human subjects, the origins and evolution of bioethics in the international context, bioethics in Brazil, and regulations on the ethical analysis of research. The data were collected through the Brazil Platform and reports from the institution's CEP. The CEP evaluated 865 research protocols, most of which were from Health Sciences. Additionally, it was observed that during 2018 to 2022 the covid-19 pandemic had a negative impact on the number of projects submitted for evaluation to the CEP. The 57% drop in the number of projects registered during 2020/2022 reveals the negative impact of this event on the execution of projects with human participants.

El Comité de Ética en Investigación (CEP) se ha convertido en un mecanismo esencial para el control social en la investigación brasileña con seres humanos, contribuyendo al desarrollo de estudios guiados por normas éticas y a la protección de los participantes en la investigación. Este artículo analiza el desempeño del CEP en la institución amazónica occidental, su historia, condiciones de funcionamiento, tendencias y diferentes aspectos entre 2018 y 2022. El marco teórico aborda la historia de la investigación con seres humanos, los orígenes y la evolución de la bioética en el contexto internacional, la bioética en Brasil y la normativa sobre el análisis ético de la investigación. Los datos se recogieron a través de la Plataforma Brasil y de informes del CEP de la institución. El CEP evaluó 865 protocolos de investigación, la mayoría de los cuales eran de Ciencias de la Salud. Además, se observó que durante 2018 a 2022 la pandemia de covid-19 tuvo un impacto negativo en el número de proyectos presentados para evaluación al CEP. La caída del 57% en el número de proyectos registrados durante 2020/2022 revela el impacto negativo de este evento en la ejecución de proyectos con participantes humanos.

Os Comitês de Ética em Pesquisa (CEPs) tornaram-se um mecanismo essencial para o controle social em pesquisas brasileiras envolvendo sujeitos humanos, contribuindo para o desenvolvimento de estudos regido por padrões éticos e para a proteção de participantes de pesquisas. Esse artigo analisa o desempenho de CEP em instituição da Amazonia Ocidental, sua história, condições operativas, tendências e diferentes aspectos entre 2018 e 2022. O enquadre teórico visa a história da pesquisa envolvendo sujeitos humanos, as origens e evolução da bioética no contexto internacional, bioética no Brasil e regulamentos de análise ética de pesquisa. Os dados foram coletados através da Plataforma Brasil e relatórios do CEP da instituição. O CEP avaliou 865 protocolos de pesquisa, a maioria deles de Ciências da Saúde. Adicionalmente, foi observado que de 2018 a 2022 a pandemia da covid-19 teve um impacto negativo no número de projetos submetidos para avaliação do CEP. A queda de 57% no número de projetos registrados em 2020/2022 revela o impacto negativo desse evento na execução de projetos com participantes humanos.

Engajando crianças em pesquisas científicas: o termo de assentimento no formato de história em quadrinhos / Engaging children in scientific research: the term of assent in the format of comic / Instando a niños en investigaciones científicas: el término de asentimiento en el formato de cómics

O assentimento infantil é uma exigência ética em pesquisas com crianças, porém sua comunicação eficaz tem sido um desafio. Neste relato, descrevemos a construção teórica e metodológica de um termo de assentimento infantil em formato de história em quadrinhos. A experiência foi realizada em uma escola municipal de Teresina, Piauí, com 32 crianças entre oito e dez anos. As etapas consistiram no estudo das questões éticas envolvidas, na construção da arte sequencial, na observação participante, em ajustes na história em quadrinhos e na aplicação e assinatura do termo de assentimento. A experiência resultou em um termo com legibilidade de Flesch de 91,81 sobre as questões éticas na pesquisa com crianças. O assentimento infantil em formato de história em quadrinhos apresentou linguagem acessível, lúdica e legibilidade adequada para comunicar pesquisa com crianças.

Child assent is an ethical requirement in research with children, however effective communication has been a challenge. In this report we describe the theoretical and methodological construction of a child assent term in comic book format. The experience was carried out in a municipal school of Teresina-Piaui with 32 children between eight and ten years old. The steps consisted of the study of ethical issues, the construction of sequential art, in participant observation, in adjustments to the comic strip and in the application and signature of the assent term. The experience resulted in a term with Flesch readability of 91.81 on ethical issues in research with kids. The childish nod in comic book format presented accessible, playful language and adequate legibility to communicate research with children.

El asentimiento infantil es una exigencia ética en investigaciones con niños. Sin embargo, la comunicación eficaz ha sido un desafío. En este relato describimos la construcción teórica y metodológica de un término de asentimiento infantil en formato de cómics. La experiencia ha sido realizada en una escuela municipal de Teresina, Piauí, con 32 niños entre ocho y diez años. Las etapas consistieron en el estudio de las cuestiones éticas, en la construcción del arte secuencial, en la observación participante, en ajustes en los cómics y en la aplicación y firma del término de asentimiento. La experiencia resultó en un término con legibilidad de Flesch de 91,81 sobre las cuestiones éticas en la investigación con niños. El asentimiento infantil en formato de cómics presentó lenguaje accesible, lúdica y legibilidad adecuada para comunicar investigación con niños.

"Cuidados redobrados com a criança"? Reflexões sobre a ciência do vírus Zika (Recife-PE) / "Extended childcare"? Reflections on the science of the Zika virus

Resumo Em 2015, o Brasil foi palco de um evento que despertou a atenção global: a epidemia do vírus da Zika. Esse patógeno chegou aos trópicos trazendo consigo uma novidade para a literatura médica do Zika: o nascimento de crianças com alterações no desenvolvimento fetal oriundas da transmissão vertical do vírus para os fetos. O fenômeno, que foi enquadrado como uma emergência em saúde, passou a ser amplamente estudado e inúmeras pesquisas foram desenvolvidas com as crianças nascidas com alterações associadas ao vírus Zika. Este artigo analisa um conjunto de entrevistas conduzidas em 2022 com cientistas que estiveram diretamente envolvidas na resposta a essa epidemia na Região Metropolitana de Recife. Como as pesquisas foram majoritariamente realizadas com crianças, refletimos, aqui, como essa característica atravessou o fazer científico das pesquisadoras envolvidas. O objetivo principal é promover discussões mais amplas sobre o ato de fazer pesquisa em termos de urgência, direcionando questões acerca das relações científicas, sobretudo entre pesquisadores e participantes (as pesquisadoras do Zika e as crianças diagnosticadas com a síndrome). Um segundo objetivo é pensar como a Antropologia da Criança pode encontrar um terreno fértil de diálogo com outras áreas que se debruçam sobre crianças e as infâncias.

Abstract In 2015, Brazil was the scene of an event that attracted global attention: the Zika virus epidemic. This pathogen arrived in the tropics, bringing with it something new to the Zika medical literature: the birth of children with changes in fetal development resulting from vertical transmission of the virus to fetuses. The phenomenon, which was classified as a health emergency, began to be widely studied and numerous studies were carried out with children born with changes associated with the Zika virus. This article analyzes a set of interviews conducted in 2022 with scientists who were directly involved in the response to this epidemic in the Metropolitan Region of Recife. As the research was mostly carried out with children, we reflect here on how this characteristic permeated the scientific work of the researchers involved. The main objective is to promote broader discussions about the act of carrying out research in terms of urgency, addressing questions about scientific relationships, especially between researchers and participants (Zika researchers and children diagnosed with the syndrome). A second objective is to think about how Child Anthropology can find fertile ground for dialogue with other areas that focus on children and childhood.

Research on ethical dilemmas in scientific research among medical graduate students / 中国医学伦理学

The ethical dilemma in scientific research exists at all stages of the scientific research activities among medical graduate students， mainly involving conflicts of interest， clinical trials， animal experiments， and the relationship between teachers and students. If medical graduate students are in the ethical dilemma in scientific research for a long time， their research activities will be greatly affected. By discussing the connotation， evaluation tools， current situation， influencing factors， and improvement measures of ethical dilemmas in scientific research， this paper proposed some suggestions， such as comprehensively investigating the influencing factors of ethical dilemmas in scientific research， and formulating targeted improvement measures， with a view to helping medical graduate students identify and get rid of ethical dilemmas in scientific research， and promote the stability of research activities.

“Therapeutic misconception” in clinical research / 中国医学伦理学

Therapeutic misconception refers to the misunderstanding of the essence， purpose， and potential benefits of clinical research among patients， who fail to recognize that participating in clinical research does not involve individualized treatment， but rather aims to obtain generalizable scientific knowledge. This paper explored the definition， causes， and impact of clinical research of “therapeutic misconception”， and proposed strategies to address them. By gaining a deeper understanding of “therapeutic misconception”， the quality of informed consent of research participants can be improved， their rights can be protected， and the quality of research can be enhanced.

"Therapeutic misconception"in clinical research / 中国医学伦理学

Therapeutic misconception refers to the misunderstanding of the essence,purpose,and potential benefits of clinical research among patients,who fail to recognize that participating in clinical research does not involve individualized treatment,but rather aims to obtain generalizable scientific knowledge.This paper explored the definition,causes,and impact of clinical research of"therapeutic misconception",and proposed strategies to address them.By gaining a deeper understanding of"therapeutic misconception",the quality of informed consent of research participants can be improved,their rights can be protected,and the quality of research can be enhanced.

Investigation and analysis of the training needs of scientific research ethics among medical graduate students in the context of science and technology ethics governance / 中国医学伦理学

ObjectiveTo investigate the training needs of knowledge of scientific research ethics and ethical review among medical graduate students in Shandong Province， and provide targeted suggestions for carrying out education and training on scientific research ethics for medical graduate students. MethodsA random sampling method was used to conduct a questionnaire survey among 807 medical graduate students from 7 medical colleges and universities in Shandong Province. The data were statistically described and analyzed， and Pearson’s chi-squared test and binary logistic regression were used to analyze the influencing factors. ResultsThere were 94.1% of medical graduate students believed that they “need” to receive training on knowledge of scientific research ethics. Their training needs were ranked as ethical principles of science and technology （75.5%）， the content of ethical review （68.5%）， ethical review process （68.3%）， ethical issues that may be involved in frontier fields （63.6%）， ethics committee system （58.1%）， applied ethical regulation for medical scientific research （55.8%）， and interpretation of relevant ethical documents （42.4%）. The training forms and methods were， in order， online knowledge lectures （67.4%）， academic conferences organized by relevant ethical review organizations （60.3%）， the teaching methods in traditional classrooms （48.8%）， learning by tutors or research groups （48.5%）， conducted by the unit during the internship and work period （26.4%）， and other forms （2.6%）. The results of the regression analysis showed that medical graduate students with experience in project application and ethics course learning have a higher willingness for training needs in scientific research ethics （P<0.05）. ConclusionThe education and training on scientific research ethics among medical graduate students still need improvement， and graduate students have an urgent need for training on scientific research ethics. Schools and hospitals should overall plan and set up a perfect science and technology ethics curriculum system， strengthen the practical training of medical research ethical review， and diversify the ways of scientific research ethics training for medical graduate students， to accelerate the improvement of research ethics literacy of them.

Cognition and Attitude of Chinese Medical Researchers towards Scientific Research Ethics: Based on the Results of a National Sample Survey / 中国医学伦理学

Based on the sampling survey data of 11 164 medical researchers in China, this paper analyzed the understanding, attitude and compliance of medical researchers on scientific research ethics in China. The survey found that although most medical researchers claim to have more understanding of scientific research ethics, the level of understanding of scientific research ethics is not optimistic; the channels to scientific research ethics knowledge are diversified, but the standardized training channels are insufficient; most researchers held the positive attitude toward following the ethical norms, but those male, youth under 35, with senior professional titles, or from northeast China held negative attitude relatively; more than half of the researchers claimed that the supervision of research ethics in China was basically in place, but some people said that the violation of scientific research ethics was common, and some researchers reported that there was a phenomenon of "direct seal consent and reply" in ethical review. Compared with medical institutions, enterprises and universities are the weak links of scientific research ethics training, education and review. Based on the above actuality, it puts forward policy suggestions to strengthen the scientific research ethics training and ethics review requirements.

The Relevant Regulations of Vulnerability in Foreign Biomedical Research Ethics and Its Enlightenment to China / 中国医学伦理学

The advancement of medicine and biotechnology is based on biomedical research. The rights and safety protection of subjects in biomedical research is one of the core issues of research ethics,and the protection of vulnerable subjects should be the top priority importantly,research ethics should provide special protection for vulnerable subjects. Chinese laws and regulations have not yet given a clear definition of the concept of vulnerability,and the content and regulations related to vulnerability are relatively rough and not perfect. By drawing on the main international and foreign research ethics policies and guidelines,introducing the definition of vulnerability,clarifying the source of vulnerability,and applying vulnerability to the process of biomedical research in China. When applying vulnerabilities,one should avoid using the label approach to include people with common characteristics into vulnerable groups,but mainly analyze the types and sources of vulnerability,and includes as many vulnerable subjects of different types as possible to provide them with more comprehensive and adequate protection in biomedical research.

A importância da submissão de pesquisas odontológicas aos comitês de ética: um enfoque à Plataforma Brasil / The importance of dental researches submission to the Ethics Committees: a focus on Brazil Platform

Este trabalho aborda o contexto histórico de avanços na área da pesquisa realizada com seres humanos, e a importância da Bioética nesta evolução. Ao longo da história foram criadas ferramentas de controle social como os Comitês de Ética e Pesquisa para assegurar tanto os direitos individuais, como coletivos, assim mantendo o princípio da dignidade humana e liberdades da população pesquisada. Todavia, os trâmites legais nem sempre atenderam toda a esfera acadêmica, e a legislação por muitas vezes precisou ser ajustada para atender tais necessidades. Atualmente o Brasil utiliza a Plataforma Brasil, uma tecnologia da informação destinada a atender toda a população de pesquisadores, como também o público pesquisado, com o intuito de facilitar o acesso e acompanhamento das solicitações de pesquisas. A Plataforma Brasil representa, assim, um dos maiores avanços na pesquisa brasileira, uma vez que permitiu a unificação das diferentes esferas científicas e contribuiu para o maior controle social dos projetos encaminhados, fornecendo facilidade de acesso ao processo de aprovação da pesquisa

This paper discusses the historical context of advances in the area of research carried out with human beings, and the importance of Bioethics in this evolution. Throughout history, social control tools were created, such as the Ethics and Research Committees, to assure both individual and collective rights, thus maintaining the principle of human dignity and liberties of the research population. However, the legal procedures have not always attended the entire academic sphere, and the legislation has often needed to be adjusted to meet such needs. Brazil currently uses the Brazil Platform, an information technology designed to serve the entire researcher population, as well as the researched public, in order to facilitate access and follow-up of research requests. The Brazil Platform thus represents one of the greatest advances in Brazilian research, since it allowed the unification of the different scientific spheres and contributed to the greater social control of the projects forwarded, providing ease of access to the research approval process

Authors’ conflicts of interest in Nepalese healthcare journals

Most biomedical journals now require authors to declare their conflicts of interest (COI), especially financial ones, before they accept the manuscript for submission. This study aims to examine the COI policies of Nepalese healthcare journals. The sample constituted journals indexed in Nepal Journals Online (NepJOL) as of June 2021. Of the 68 that met our inclusion criteria, 38(55.9%) journals endorsed the COI policy of the International Committee of Medical Journal Editors. Thirty-six (52.9%) journals had a policy for reporting the COI. Financial COI was the only type of COI mentioned. All journals in Nepal are encouraged to request the authors to declare the COI for better transparency.

Enhancing medical ethics education for medical students in clinical research: considerations and strategy analysis / Mejorando la educación ética médica para los estudiantes de medicina en la investigación clínica: consideraciones y análisis de estrategias / Melhorando a educação de ética médica para estudantes de medicina em pesquisa clínica: pensamentos e análise de estratégia

In recent years, the vigorous development of clinical researches carried out by medical schools is inseparable from the effective participation of medical students. However, as the number and categories of clinical research projects that medical students participate in increase, medical ethics related issues gradually occur. This article sorts out the ethical issues that arose in clinical researches, in which medical students participated, analyzes the underlying causes, and proposes solutions for the above-mentioned ethical issues, aiming to provide reference for medical ethics education and research project management for medical schools.

La participación efectiva de los estudiantes de medicina ha contribuido en gran medida al desarrollo exitoso de la investigación clínica en las escuelas de medicina de China en los últimos años. Sin embargo, con el creciente número y tipos de proyectos de investigación clínica en los que participan estudiantes de medicina, las cuestiones éticas se exponen gradualmente. Este trabajo enumera las cuestiones éticas que han surgido en la participación de los estudiantes de medicina en la investigación clínica en los últimos años, analiza las causas subyacentes y propone soluciones a las cuestiones éticas mencionadas anteriormente, con el objetivo de proporcionar referencia para la enseñanza de la ética médica y la gestión de proyectos de investigación para las escuelas de medicina.

A participação efetiva dos estudantes de medicina tem contribuído muito para o próspero desenvolvimento da pesquisa clínica nas escolas médicas da China nos últimos anos. No entanto, com o aumento do número e tipos de projetos de pesquisa clínica dos quais os estudantes de medicina participam, questões relacionadas à ética e à alfabetização são gradualmente expostas. Este artigo lista as questões éticas que surgiram na participação de estudantes de medicina em pesquisas clínicas nos últimos anos, analisa as causas subjacentes e propõe soluções para as questões éticas acima mencionadas, com o objetivo de fornecer referência para o ensino de ética médica e gestão de projetos de pesquisa para escolas médicas.

Ética e integridad académica en la formación doctoral: el caso de los doctorados en educación en las universidades chilenas / Ethics and academic integrity in doctoral training: the case of doctorates in education in Chilean universities / Ética e integridade acadêmica na formação pós-graduada: o caso dos doutorados em educação nas universidades chilenas

El presente artículo analiza, a partir de una revisión documental de planes y programas de curso de los doctorados en Educación activos en Chile, en qué medida y cómo los programas de formación de futuros investigadores en educación doctoral abordan el desafío de integrar la educación ética en su diseño curricular. Mediante un análisis temático de la documentación oficial de los programas se identificaron y analizaron diversos elementos relacionados con ética de la investigación e integridad académica abordados en la formación doctoral, su enfoque prevalente (normativo o de discernimiento ético), su orientación (propositiva o de prevención) y la profundidad con que son tratados esos aspectos. Los resultados muestran que solo un tercio de los actuales programas abordan de manera explícita la formación ética en investigación, y que, en estos casos, su abordaje tiende a subrayar aspectos más formales que de fondo, acotados fundamentalmente al cumplimiento del protocolo de consentimiento informado.

This article analyzes to what extent and how training programs for future researchers in doctoral education address the challenge of integrating ethical training in their curricular design. Based on a documentary review of course plans and postgraduate programs in education active in Chile, the explicit presence of ethical aspects and academic integrity in their training plans was examined. Through a thematic analysis of the official documentation of the programs, we identified and analyzed various elements related to research ethics and academic integrity addressed in doctoral training, their prevalent approach normative or ethical discernment, their orientation proactive or preventive and the depth with which these aspects are treated. The results show that only one-third of the current programs explicitly address ethical training in research and that in these cases, their approach tends to emphasize more formal than substantive aspects, mainly limited to compliance with the informed consent protocol.

O presente artigo analisa, a partir de uma revisão documental de planos e programas de curso dos doutorados em Educação ativos no Chile, em que medida e como os programas de formação de futuros investigadores em educação pós-graduada abordam o desafio de integrar a educação ética em seu plano curricular. Mediante uma análise temática da documentação oficial dos programas se identificaram e analisaram diversos elementos relacionados com ética da investigação e integridade acadêmica abordados na formação pós-graduada, seu enfoque prevalente (normativo ou de discernimento ético), sua orientação (propositiva ou de prevenção) e a profundidade com que são tratados esses aspectos. Os resultados mostram que só um terço dos atuais programas abordam de maneira explícita a formação ética em investigação, e que, nestes casos, sua abordagem tende a ressaltar aspectos mais formais que substanciais, limitados fundamentalmente ao cumprimento do protocolo de consentimento informado.

Investigación científica en el campo de la infancia: consideraciones sobre la aplicabilidad de los requisitos éticos / Scientific research study on childhood: considerations on the applicability of ethical requirements / Pesquisa científica no campo da infância: considerações sobre a aplicabilidade dos requisitos éticos

El artículo aborda un tema particularmente sensible para la investigación científica como lo son los estudios que involucran directamente a niños y niñas. El valor social y la relevancia científica de la investigación en este campo es indudable, sin embargo, su justificación requiere especial detenimiento en las condiciones para el ejercicio de sus derechos antes, durante y después del proceso de investigación. La naturalización de su denominación como "población vulnerable" y el ejercicio de su autonomía relativa, son dos dimensiones principales aquí. El artículo navega por preguntas que no se resuelven aquí precisamente, ¿qué garantías para el proceso efectivo de asentimiento informado?, ¿cómo acompañar en la toma de decisiones sin sustituir al niño y la niña? Sin embargo, sí avanza en la instalación de dilemas y aspectos conceptuales y reflexivos sustantivos en la práctica científica.

The article deals with a particularly sensitive topic for scientific research, such as research studies that directly involve boys and girls. The social value and scientific relevance of research in this field is unquestionable; however, its justification requires special care regarding the conditions of children's rights before, during and after the research process. The naturalization of their denomination as a "vulnerable population" and the exercise of their relative autonomy are the two main dimensions of this study. This paper explores questions that are not answered in it precisely: what guarantees informed consent during the effective process? How to accompany the decision making process without replacing the boy and the girl? However, the study makes progress regarding the setting of substantive conceptual and reflective dilemmas and aspects in scientific practice.

O artigo trata de um tema particularmente sensível para a pesquisa científica, os estudos que envolvem diretamente meninos e meninas. O valor social e a relevância científica da pesquisa neste campo é inquestionável, porém, sua justificativa requer cuidados especiais nas condições de exercício dos direitos da criancas, durante e após o processo de pesquisa. A naturalização de sua denominação como "população vulnerável" e o exercício de sua autonomia relativa são as duas dimensões principais deste paper. O artigo explora por questões que não são aqui resolvidas de forma precisa: quais sao as garantias para o processo efetivo de assentimento informado? Como acompanhar o proceso da tomada de decisões sem substituir o menino e a menina? No entanto, realizamos um avanço na instalação de dilemas e aspectos conceituais e reflexivos substantivos na prática científica.

Los comités de ética de investigación en la Ciudad Autónoma de Buenos Aires: a catorce años de la implementación de la Ley 3301 / Research ethics committees in the Autonomous City of Buenos Aires: 14 years after the implementation of Law 3301

RESUMEN El presente artículo se propone analizar el proceso de implementación de los comités de ética en investigación en la Ciudad Autónoma de Buenos Aires, cuya conformación se observa en el marco de un proceso histórico de implementación de políticas de investigación en salud a nivel nacional y jurisdiccional. Desde un enfoque de investigación cualitativo, observacional y de corte transversal, se realizó un relevamiento de fuentes secundarias de información pública, y entrevistas semiestructuradas y en profundidad a integrantes de los comités de la Ciudad Autónoma de Buenos Aires. Los resultados se presentan agrupados en tres ejes: 1) la conformación de los comités de ética en investigación; 2) procesos de trabajo, haciendo hincapié en el impacto de la pandemia de covid-19; y 3) obstáculos y propuestas, que se focaliza en las mejoras identificadas por sus integrantes.

ABSTRACT This article analyzes the implementation of research ethics committees in the Autonomous City of Buenos Aires, a process that took place in the context of a historical process of implementing health research policies at both the national and jurisdictional levels. Employing a qualitative, observational, and cross-sectional approach, we gathered secondary sources of public information and conducted semi-structured, in-depth interviews with members of the committees in the Autonomous City of Buenos Aires. The results are presented in relation to three aspects: 1) the composition of the research ethics committees; 2) work processes, emphasizing the impact of the COVID-19 pandemic; and 3) obstacles and proposals, that focuses on improvements identified by committee members.

The new requirements and application of Measures for Ethical Review of Life Sciences and Medical Research Involving Human Beings on conflict of interests governance / 中华医学科研管理杂志

Objective:This study aims to critically assess the 2023 updates in the governance of Conflicts of Interests (COIs) as outlined in the Ethical Review Measures for Life Sciences and Medical Research Involving Human Beings. It seeks to delve into the ethical implications of these new mandates and offers concrete strategies for effectively integrating them into ethics review practices.Methods:We conducted a comparative analysis of the COIs-related provisions in the 2016 Ethical Review Measures for Biomedical Research Involving Humans, examining them alongside current trends and challenges in COIs governance and ethics review practices.Results:The study identified key challenges posed by COIs to medical research ethics and addresses three principal areas for normative application: the declaration process for conflicts of interest, enhancing the COIs management framework, and the critical review points for COIs by ethics committees.Conclusions:In light of the international consensus on COIs governance, we advocate for the advancement of conflict of interest management at the institutional level. This includes a focus on informed consent processes, the development of robust systems within medical institutions, and the facilitation of ethical corporate collaborations.

6. Perspectives on Researcher Development / 医学教育

In the new Model Core Curriculum, the objective stated is to "understand the importance of medical research for the advancement of medicine and medical care, and support innovation in medicine through involvement in academic and research activities, developing one's scientific thinking skills." Importantly, scientific background and researcher training education, such as laboratory assignments, are clearly positioned in the Model Core Curriculum and are available to all students. The curriculum consists of five components : Developing a research mindset, Understanding established theories, Conducting Research, Publishing Research, and Research Ethics. In addition, laboratory experience and practical training in basic medicine were also added to the description. Further policy and financial support for researchers will be necessary to increase the number of basic medical researchers in the future.

Análisis de tesis médicas de pregrado en una universidad de Perú, 2011-2020: publicación en revistas indizadas y factores asociados / Analysis of undergraduate medical theses at a Peruvian university, 2011-2020: publication in indexed journals and associated factors

Los factores cuantitativos asociados a la publicación de tesis médicas en el pregrado no han sido lo suficientemente estudiados. Por ello, la investigación describió las tasas de publicación, así como la asociación con las características de las tesis, del asesor y del tesista. Se accedió, de manera virtual, a las tesis médicas de pregrado de la Universidad Nacional de San Agustín de Arequipa, Perú, durante el período 2011-2020. Mediante el análisis de regresión logística múltiple, se evaluó la asociación entre la publicación de la tesis en revistas indizadas (Scopus) y la experiencia previa en publicación en revistas indizadas en Scopus del asesor y del tesista, la unidad de análisis, el tamaño de muestra, diseño de estudio, número de páginas, aprobación por el comité de ética de investigación y el sexo del tesista. De 884 tesis solo 12 (1,5 por ciento) se publicaron; lo que constituye el 1,23 por ciento de las tesis publicadas anualmente, con tendencia constante. La experiencia previa en publicación del asesor se asoció con la colocación de las tesis en revistas indizadas (OR = 8,97 [1,70-42,98]; p = 0,005) y en revistas indizadas a Scopus (OR = 14,64 [1,24-336,11]; p = 0,037). Presentar la aprobación del comité de ética de la institución se asoció con publicar la tesis en revistas indizadas a Scopus (OR = 12,45 [1,06-285,94]; p = 0,050). La publicación de tesis médicas de pregrado en esta universidad es baja y constante. Se asoció con tener un asesor de tesis con experiencia previa en publicaciones en revistas indizadas a Scopus y a tener aprobación por comité de ética. Urge implementar estrategias para aumentar la publicación de tesis(AU)

Quantitative factors associated with the publication of undergraduate medical theses have not been sufficiently studied. Therefore, the research described publication rates, as well as the association with thesis, advisor, and thesis writer characteristics. Undergraduate medical theses from the Universidad Nacional de San Agustín de Arequipa, Peru, during the period 2011-2020 were accessed virtually. Multiple logistic regression analysis was used to evaluate the association between thesis publication in indexed journals (Scopus) and the previous publication experience in indexed journals in Scopus of the advisor and the thesis author, the unit of analysis, sample size, study design, number of pages, approval by the research ethics committee and the gender of the thesis author. Out of 884 theses only 12 (1.5percent) were published; this constitutes 1.23percent of the theses published annually, with a constant trend. The previous publication experience of the advisor was associated with the placement of theses in indexed journals (OR = 8.97 [1.70-42.98]; p = 0.005) and in journals indexed to Scopus (OR = 14.64 [1.24-336.11]; p = 0.037). Presenting the approval of the institution's ethics committee was associated with publishing the thesis in journals indexed to Scopus (OR = 12.45 [1.06-285.94]; p = 0.050). Publication of undergraduate medical theses at this university is low and consistent. It was associated with having a thesis advisor with previous experience in publishing in Scopus-indexed journals and having approval by an ethics committee. There is an urgent need to implement strategies to increase thesis publication(AU)