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.

Analysis of the Current Situation of Medical Researchers’ Cognition and Attitude towards Ethical Review in China / 中国医学伦理学

Based on the data of a national sampling survey, this paper described and analyzed the understanding, attitude, behavior, and their differences and influencing factors of Chinese medical researchers on ethical review of biomedical research involving human subject. The survey found that researchers with master’s degree or below, working in scientific research institutes or universities, no overseas experience, living in the central region and not serving as committee members have relatively poor acquaintance of "ethical review" ; researchers with the characteristics of male, the younger age, living in the western region, knowing less about "ethical review" , agree more with the view that "ethical review consumes too much time and energy" ; researchers who serve as members of the ethics committee are more likely to participate in scientific research projects that have not passed the ethical review process. Therefore, recommendations are put forward: comprehensively popularizing the training of ethical review, focusing on strengthening the vulnerable groups and regions, strictly implementing ethical review laws and regulations, and strengthening evaluation and supervision, so as to improve the service quality and efficiency of ethical review in multiple directions.

Percepciones sobre la importancia de las ciencias básicas en estudiantes de odontología y medicina

Introducción: El aprovechamiento de los cursos de ciencias básicas puede depender de las percepciones estudiantiles sobre la importancia de estos en su vida profesional, por lo que se hace necesario determinar el grado de importancia que los estudiantes le confieren a este tipo de cursos. Materiales y métodos: Se presentó un cuestionario con 9 declaraciones a 54 estudiantes de odontología y medicina. Las respuestas se pasaron a una escala numérica para su análisis. Se usó una prueba de U de Mann-Whitney con el fin de evaluar diferencias entre estudiantes de ambas facultades. Resultados: Los estudiantes en conjunto mostraron tener una buena opinión de la importancia de las ciencias básicas en la práctica clínica. Se observó también que es mayor la proporción de estudiantes de odontología que consideran que la investigación básica no es útil para su práctica clínica. Conclusión: Los estudiantes consideran las ciencias básicas necesarias para un buen desempeño profesional.

Introduction: The benefit of basic science courses may depend on students' perceptions of the importance of these courses in their professional life, therefore, it's necessary to determine the degree of importance that students give to this type of courses. Materials and methods: A questionnaire with 9 statements was presented to 54 dental and medical students. The responses were converted to a numerical scale for analysis. Using a Mann-Whitney U test, differences between students from both faculties were evaluated. Results: The students showed a good opinion of the importance of basic sciences in clinical practice. It was also observed that the proportion of dental students who consider that basic research is not useful for their clinical practice is higher. Conclusion: Students consider the basic sciences necessary for good professional performance.

Investigaciones biomédicas y psicosociales con enfoque comunitario en Ecuador

Introducción: Varios miembros del Departamento de Investigaciones en Adicciones de la Universidad de Ciencias Médicas de La Habana participaron en el 2020 y 2021 como docentes, asesores y directores de tesis en dos programas de formación académica de estudiantes ecuatorianos: especialización en Medicina Familiar y Comunitaria y maestría en Psicología Clínica (mención en Salud Mental Comunitaria). Objetivo: Describir los resultados del estudio y las investigaciones concluidas en ambos programas de formación académica. Método: Se realizó un estudio descriptivo de corte transversal basado en el análisis de los 69 proyectos de investigación desarrollados. Para la descripción de los resultados se realizó el análisis de contenido del 20 % de las investigaciones. Resultados: El 63,8 % de los estudios fueron investigaciones biomédicas, y el 36,1 % fueron estudios psicosociales. En ambos casos, el contexto social en las comunidades fue de (84,7 %). Entre las investigaciones médicas predominaron las dirigidas al paciente con hipertensión arterial (39,1 %) centradas en la adherencia terapéutica (32,6 %). En los estudios psicológicos predominaron los dirigidos a niños y adolescentes (23,0 %) y a profesionales sanitarios (23,0 %) centradas en las afecciones mentales (19,2 %). Conclusiones: Los proyectos desarrollados concluyeron resultados satisfactorios, se describió con mayor sistematicidad el enfoque comunitario en las investigaciones biomédicas. Se abordaron contenidos relativos a la adherencia terapéutica y las afectaciones a la salud mental. El impacto de la COVID-19 fue valorado como generador de dificultades en niños y adolescentes, profesionales sanitarios y en la población.

Introduction: In 2020 and 2021, the Department of Research on Addiction of Havana University of Medical Sciences participated as teachers, advisors and thesis directors in two academic training programs for Ecuadorian students: specialization in Family and Community Medicine and master's degree in Clinical Psychology with a mention in Community Mental Health. Objective: To describe the results of the study and the research concluded in both academic training programs. Methods: A descriptive cross-sectional study was carried out based on the analysis of the sixty nine research projects established. The content analysis of 20% of the investigations was carried out to describe the results. Results: 63.8% of the studies were biomedical research and 36.1% were psychosocial studies. In both cases, communities was the social context (84.7%). Among the medical investigations, those aimed at the patient with hypertension (39.1%) focused on therapeutic adherence (32.6%) predominated. In the psychological studies, those intended at children and adolescents (23.0%) and health professionals (23.0%) focused on mental disorders (19.2%) prevailed. Conclusions: These projects yielded satisfactory results. The community approach in biomedical research was more systematically described. Contents related to therapeutic adherence and the effects on mental health were addressed. The impact of COVID-19 was assessed as generator of difficulties in children and adolescents, health professionals, and in the population.

Curso de investigación en Atención Primaria de la Salud: experiencia sobre módulo de búsqueda bibliográfica y gestores de citas / Research course in Primary Health Care: experience with the bibliographic search module and citation managers

La Federación Argentina de Medicina Familiar y General apoyó el desarrollo, la difusión y la implementación de una propuesta educativa sobre investigación en atención primaria. Consiste en 4 módulos independientes, destinado para miembros interesados/as, con 2 encuentros virtuales teórico-prácticos, que favorecieran el intercambio de opiniones y experiencias entre colegas. El objetivo del primer módulo fue proporcionar conocimiento, brindar pautas y ofrecer herramientas para la búsqueda bibliográfica y el uso de gestores de citas. Se realizó difusión mediante sociedades y redes sociales. Se incluyó una evaluación individual, que diera cuenta de lectura complementaria y la aplicación práctica de los contenidos. Se llevó a cabo en Junio, con 39 preinscripto/as, mayoritariamente residentes. Hubo 24 participantes efectivos (61%), asistieron 17 y 20 personas respectivamente, y 11 (46%) obtuvieron el certificado de aprobación por responder la consigna en tiempo y forma. En cuanto a los/as asistentes, hubo predominio de mujeres (79%), provenientes de Asociación Metropolitana de Medicina Familiar (25%), Asociación Cordobesa de Medicina Familiar y Comunitaria (16%), Asociación Misionera de Medicina General/Familiar y del Equipo de Salud (16%), Asociación Tucumana de Medicina Familiar, General y Comunitaria (12%), y otras minorías. Expresaron satisfacción, agradecimiento y reconocimiento por la actividad, destacando la buena predisposición de organizadores y equipo docente, la utilidad práctica de la temática, la evidente planificación, y el apoyo político-económico. Esta valiosa experiencia educativa (planteada como necesidad pendiente) resultó exitosa, ya que los/as participantes demostraron un alto nivel de interés, de asistencia de diferentes provincias, y de compromiso. Los certificados emitidos otorgan créditos educativos válidos para la recertificación (AU)

The Federación Argentina de Medicina Familiar y General supported the development, dissemination and implementation of an educational proposal on research in primary care. It consists of 4 independent modules, intended for interested members, with 2 virtual theoretical-practical meetings, which favored the exchange of opinions and experiences among colleagues. The objective of the first module was to provide knowledge, guidelines and tools for bibliographic search and the use of citation managers. Dissemination was carried out through societies and social networks. An individual evaluation was included, to account for complementary reading and the practical application of the contents. It was carried out in June, with 39 pre-registered participants, mostly residents. There were 24 effective participants (61%), 17 and 20 people attended respectively, and 11 (46%) obtained the certificate of approval for answering the instructions in due time and form. As for the attendees, there was a predominance of women (79%), coming from Asociación Metropolitana de Medicina Familiar (25%), Asociación Cordobesa de Medicina Familiar y Comunitaria (16%), Asociación Misionera de Medicina General/Familiar y del Equipo de Salud (16%), Asociación Tucumana de Medicina Familiar, General y Comunitaria (12%), and other minorities. They expressed satisfaction, gratitude, and recognition for the activity, highlighting the good predisposition of the organizers and teaching team, the practical usefulness of the subject matter, the evident planning, and the political-economic support. This valuable educational experience (raised as a pending need) was successful since the participants showed a high level of interest, attendance from different provinces, and commitment. The certificates issued grant educational credits valid for recertification (AU)

Use of appropriate statistical tools in biomedical research: Current trend & status

Background & objectives: Due to lack of appropriate statistical knowledge, published research articles contain various errors related to the design, analysis and interpretation of results in the area of biomedical research. If research contains statistical error, however, costly, it may be of no use and the purpose of the investigation gets defeated. Many biomedical research articles published in different peer reviewed journals may retain several statistical errors and flaws in them. This study aimed to examine the trend and status of application of statistics in biomedical research articles. Study design, sample size estimation and statistical measures are crucial components of a study. These points were evaluated in published original research articles to understand the use or misuse of statistical tools. Methods: Three hundred original research articles from the latest issues of selected 37 journals were reviewed. These journals were from the five internationally recognized publication groups (CLINICAL KEY, BMJ Group, WILEY, CAMBRIDGE and OXFORD) accessible through the online library of SGPGI, Lucknow, India. Results: Among articles assessed under present investigation, 85.3 per cent (n=256) were observational, and 14.7 per cent (n=44) were interventional studies. In 93 per cent (n=279) of research articles, sample size estimation was not reproducible. The simple random sampling was encountered rarely in biomedical studies even though none of the articles was adjusted by design effect and, only five articles had used randomized test. The testing of assumption of normality was mentioned in only four studies before applying parametric tests. Interpretation & conclusions: In order to present biomedical research results with reliable and precise estimates based on data, the role of engaging statistical experts need to be appreciated. Journals must have standard rules for reporting study design, sample size and data analysis tools. Careful attention is needed while applying any statistical procedure as, it will not only help readers to trust in the published articles, but also rely on the inferences the published articles draw.

Fundamentos metodológicos para investigación clínica en estomatología / Methodological basis for clinical research in stomatology

La investigación científica en Odontología es la herramienta clave para generar conocimiento y resolver problemas que conduzcan al desarrollo exponencial y progreso tecnológico de la profesión. A su vez, e indispensable el estudio epidemiológico y etiopatogénico de las enfermedades estomatológicas, factores de riesgo y manifestaciones orales relacionadas a la salud sistémica, para implementar estrategias sanitarias y establecer un adecuado manejo multidisciplinario. La odontología basada en evidencia (OBE) exige al profesional realizar una práctica informada, responsable, actualizada y soportada en una sólida base científica para la toma de decisiones y garantizar resultados altamente predecibles. La mayoría de los estudios clínicos en Odontología se realizan bajo el enfoque cuantitativo utilizando los diseños epidemiológicos; por lo que es necesario identificar la ruta ideal para resolver cada problema científico, la presente revisión comprende las bases metodológicas de investigación en Odontología, la clasificación de tipos de estudio y una perspectiva futura de investigación.

Scientific research in Dentistry is the key tool to generate knowledge and solve problems that lead to the exponential development and technological progress of the profession. At the same time, the epidemiological and etiopathogenic study of stomatological diseases, risk factors and oral manifestations related to systemic health is essential to implement health strategies and establish adequate multidisciplinary management. Evidence-based dentistry (OBE) requires the professional to carry out an informed, responsible, up-to-date practice supported by a solid scientific basis for decision-making and to guarantee highly predictable results. Most of the clinical studies in Dentistry are carried out under a quantitative approach using epidemiological designs; Therefore, it is necessary to identify the ideal route to solve each scientific problem. This review includes the methodological bases of research in Dentistry, the classification of study types and a future research perspective.

Producción científica en Scopus de los institutos de salud especializados públicos de Perú, 2010-2022

Objetivo: Evaluar la producción científica de los institutos de salud de Perú en Scopus, 2010-2022. Métodos : Estudio bibliométrico realizado en Scopus durante septiembre del 2022, en 14 institutos de salud especializados públicos de Perú. Incluimos estudios originales que tuvieran al menos un autor de alguno de los institutos. Resultados : Los institutos incluidos publicaron entre 0 y 347 artículos originales (H-index entre 0 y 51). Los institutos de la ciudad de Lima fueron los que tuvieron mayor producción. En los siete institutos con mayor producción, el porcentaje de artículos con autor corresponsal del instituto evaluado varió entre 22.3% y 36.7%, y el porcentaje de estudios que declararon ser financiados por el instituto varió entre 0% y 11.6%. Conclusión : La producción científica de los institutos evaluados fue heterogénea, a predominio de aquellos ubicados en Lima. Los institutos raramente participaron en el financiamiento de los estudios publicados.

Objective: To evaluate the scientific production of Peruvian health institutes in Scopus, 2010-2022. Methods: We conducted a Bibliometric study in Scopus during September 2022, in 14 public specialized health institutes of Peru. We included original studies with at least one author from one of the institutes. Results: The institutes included published between 0 and 347 original articles (H-index between 0 and 51). The institutes in the city of Lima were the ones with the highest production. In the seven institutes with the highest production, the percentage of articles with a corresponding author from the institute evaluated ranged from 22.3% to 36.7%, and the percentage of studies that reported being financed by the institute ranged from 0% to 11.6%. Conclusion: The scientific production of the evaluated institutes was heterogeneous, with a predominance of those located in Lima. The institutes rarely participated in the financing of the published studies.

Desarrollo de habilidades de investigación en estudiantes y profesores de Salud Pública

Introducción: La investigación es fundamental en la formación académica de los estudiantes de la carrera de Medicina. Objetivo: Identificar habilidades de investigación en estudiantes y profesores del departamento de Salud de la carrera de Medicina. Métodos: Se realizó un estudio transversal descriptivo durante 2023 en el Policlínico Docente Tula Aguilera. Participaron un total de 50 estudiantes de quinto año de la carrera de Medicina que cursaron la asignatura Salud Pública, 15 profesores y 60 personas seleccionadas al azar. Se elaboró una encuesta dirigida a los profesores y estudiantes para identificar deficiencias en las investigaciones. A las 60 personas seleccionadas de manera aleatoria, se les realizó otra encuesta relacionada con infecciones de transmisión sexual. Los datos obtenidos fueron determinados por el programa R los estadígrafos de tendencia central y dispersión, así como la frecuencia absoluta y relativa que se presentaron en tabla y texto. Resultados: Se entrevistaron 50 estudiantes durante el mes de febrero de 2023, se detectaron y detallaron las deficiencias encontradas, igualmente y con el mismo fin se entrevistaron 15 profesores del Departamento de Salud. En otra actividad, el 10 de abril un grupo de 25 estudiantes encuestó a 60 personas sobre las enfermedades de transmisión sexual y reportaron sus hallazgos. Conclusiones: Se identificó el desarrollo de habilidades de investigación en estudiantes y profesores, se profundiza en el tema para lograr una intervención efectiva. Fue posible que los estudiantes llevaran a efecto una investigación en las que aplicaron las habilidades necesarias para esta actividad. Los cursos presenciales y virtuales se enriquecieron con el trabajo.

Introduction : Research is fundamental to the academic training of medical students. Objective: To identify research skills in students and professors of Public Health in the medical degree. Methods: A descriptive study was carried out during 2023 at the University of Medical Sciences of Camagüey and at the Tula Aguilera Teaching Polyclinic. A total of 50 fifth-year medical students who studied public health and their 15 professors and 60 randomly selected people from the communities of the Tula Aguilera Teaching Polyclinic participated. A survey of teachers and students was carried out. A survey related to sexually transmitted infections was carried out on 60 randomly selected people in the community of the Tula Aguilera Teaching Polyclinic. The central tendency and dispersion statistics were determined from the data obtained with the R program, as well as the absolute and relative frequencies that are presented in the table and in the text. Results: 50 students were interviewed during the month of February 2023, the deficiencies found are detected and detailed. Similarly, and for the same purpose, 15 professors from the Department of Health were interviewed. In another activity, on April 10th, a group of 25 students surveyed 60 people about sexually transmitted diseases and reported their findings. Conclusions: The development of research skills in students and teachers was identified and the subject is delved into to achieve an effective intervention. It was possible for the students to carry out an investigation in which they applied the necessary skills for this activity. The face-to-face and virtual courses were enriched with this work.

La relación problema-objetivo-diseño metodológico en el proyecto de investigación: una mirada a través de una situación ejemplo / The problem-objective-methodological design relationship in the research project: a look through an example situation

RESUMEN Las investigaciones relacionadas con factores de riesgo para las enfermedades, así como sobre factores pronósticos de diversos problemas de salud, constituyen propuestas frecuentes de proyectos de trabajos de terminación de la especialidad. En este artículo se ejemplifica, a través de diferentes variantes para la realización de estas investigaciones, la consecución de la imprescindible relación entre el problema de investigación, el objetivo y el diseño metodológico del estudio.

ABSTRACT Research related to risk factors for diseases, as well as prognostic factors for various health problems, are frequent proposals for completion projects in the specialty. This article exemplifies, through different variants for carrying out these investigations, the achievement of the essential relationship between the research problem, the objective and the methodological design of the study.

Ética y negociaciones para el acceso a vacunas: excepcionalismos metodológicos y éticos

Propósito/Contexto. En este artículo se analizan los distintos factores que han afectado el acceso a las vacunas para la prevención de la infección por SARS-CoV-2, con particular atención a los intereses que atraviesan las negociaciones. Se detalla un análisis de los procesos de investigación, producción, contratación, distribución y comercialización de vacunas, así como las normas éticas internacionales que orientan estas prácticas. Metodología/Enfoque. De igual modo, se identifican un marco de excepciones científicas, metodológicas, éticas y legales para la investigación, la producción y la comercialización de vacunas, al tiempo que se ha mantenido y profundizado, sin excepciones, las normas impuestas por el sistema global de mercado en lo referente a protección de propiedad intelectual (Adpic), negociaciones y contratos, defensa de intereses privados y de las empresas. También se pone en evidencia el rol que han tenido los países más ricos, acumulando más dosis de las necesarias, lo cual impactó seriamente en el acceso de los países de bajos ingresos. Resultados/Hallazgos. Se analizan las normas éticas internacionales y los acuerdos realizados por los gobiernos que deberían limitar conductas como estas, evitar sus consecuencias y que no han sido cumplidas. Discusión/Conclusiones/Contribuciones. Se concluye con una propuesta concreta que podría aliviar la situación actual y se incluye una reflexión sobre el impacto en la vida y la salud de los países y los grupos más vulnerables, si el orden internacional sigue regido por el sistema global de mercado en lugar de un nuevo pacto global más justo.

Purpose/Context. This article discusses the various factors that have affected access to vaccines for the prevention of SARS-CoV-2 infection, with particular attention to the interests involved in the negotiations. An analysis of the processes of vaccine research, production, procurement, distribution, and marketing is detailed, as well as the international ethical standards that guide these practices. Methodology/Approach. Similarly, a framework of scientific, methodological, ethi-cal and legal exceptions for research, production and commercialization of vaccines is identified, while the rules imposed by the global market system regarding intellec-tual property protection (TRIPS), negotiations and contracts, defense of private and corporate interests have been maintained and deepened without exceptions. It also highlights the role played by the richest countries, accumulating more doses than necessary, which seriously impacted the access of low-income countries. Results/Findings. The international ethical norms and agreements made by gover-nments that should limit conducts such as these, avoid their consequences and that have not been complied with, are analyzed. Discussion/Conclusions/Contributions. It concludes with a concrete proposal that could alleviate the current situation and includes a reflection on the impact on the life and health of the most vulnerable countries and groups, if the international order continues to be governed by the global market system instead of a new and fairer global agreement.

Finalidade/Contexto. Este artigo discute os vários factores que afectaram o acesso às vacinas para a prevenção da infecção pelo SRA-CoV-2, com especial atenção para os interesses envolvidos nas negociações. Detalha uma análise dos processos de investigação, produção, aquisição, distribuição e comercialização de vacinas, bem como as normas éticas internacionais que orientam estas práticas. Metodologia/Aproximação. Do mesmo modo, é identificado um quadro de excepções científicas, metodológicas, éticas e legais para a investigação, produção e comercialização de vacinas, enquanto as regras impostas pelo sistema de mercado global em termos de protecção da propriedade intelectual (Adpic), negociações e contratos, defesa de interesses privados e empresariais foram mantidas e aprofundadas sem exceções. Salienta também o papel desempenhado pelos países mais ricos, acumulando mais doses do que as necessárias, o que teve um sério impacto no acesso dos países de baixos rendimentos. Resultados/Findings. Normas e acordos éticos internacionais feitos pelos governos que deveriam limitar comportamentos como este e evitar as suas consequências são analisados e não têm sido cumpridos. Discussão/Conclusões/Contribuições. Conclui com uma proposta concreta que poderia aliviar a situação actual e inclui uma reflexão sobre o impacto na vida e saúde dos países e grupos mais vulneráveis, se a ordem internacional continuar a ser regida pelo sistema de mercado global em vez de um novo pacto global, mais justo.

Financiamiento en investigación: ¿qué necesito antes de comenzar a buscar una fuente de financiamiento?: parte 1 / Research funding: what do I need before I start looking for a funding source?: part 1

Esta es la primera parte de un artículo sobre la búsqueda de financiamiento para un proyecto de investigación. Esta entrega resume los principales ítems para tener en consideración a la hora de postularse a una convocatoria. Requerimientos del proceso: 1. Tiempo protegido. 2. Propuesta de investigación sólida. 3. Equipo calificado y con experiencia. 4. Definición y organización de actividades. 5. Cronograma de actividades. 6. Estimación de costos. (AU)

This is the first part of an article about finding funding for a research project. This delivery summarizes the main ítems to take into consideration when applying for a call. Process requirements: 1. Protected time. 2. Strong research proposal. 3. Qualified and experienced team. 4. Definition and organization of activities. 5. Schedule of activities. 6. Cost estimate. (AU)

Biobancos en otorrinolaringología / Biobanks in otolaryngology

Resumen Los biobancos son una innovadora herramienta biotecnológica y un recurso fundamental para el continuo avance en la investigación científica biomédica, y para el advenimiento de la medicina de precisión. Se han desarrollado de forma exponencial durante los últimos 20 años en el mundo, como también a nivel de nuestro país, con la creación de 10 biobancos desde el año 2004. En ellos se almacenan y organizan distintos tipos de muestras biológicas, asociadas a datos epidemiológicos y genéticos de donantes voluntarios. Todos los especímenes almacenados deben ser preservados con estándares de calidad garantizados, a modo de asegurar trazabilidad, integridad y calidad de las muestras. A pesar de que la mantención de un biobanco puede significar altos costos, a fin de cuentas, abaratan costos de los estudios clínicos, dado que es precisamente el biobanco quien se encarga de la obtención de datos y muestras clínicas confiables, permitiendo realizar múltiples estudios a partir de las mismas muestras. A través de este proceso, los biobancos permiten mantener una fuente confiable de recur-sos para la investigación en diversas áreas de la medicina, dentro de ellas la otorrinolaringología. En otorrinolaringología, los biobancos han significado un gran avance, facilitando la investigación en relación con hipoacusia, presbiacusia y tinnitus, así como en el área oncológica. En un futuro, se espera que la comunidad científica haga uso de este recurso, pudiendo expandir su utilidad no solo en el área médica, sino también en otras profesiones de la salud, maximizando así su gigantesco potencial.

Abstract Biobanks are novel biotechnological tools and a fundamental resource for the constant development of biomedical research, as much as for the growing practice of precision medicine. They have proliferated worldwide over the past 20 years and Chile has not been left behind with the creation of 10 bio-banks since 2004. Biobanks store and organize different types of biological samples associated with epidemiological and genetic data from volunteer donors. These samples are stored and preserved under guaranteed quality standards to ensure their traceability, integrity, and quality. Even though the price of maintaining a biobank may seem high, after all, they reduce the costs of research, since biobanks are responsible of the acquisition and storage of data and samples, allowing the performance of multiple studies from the same collection of specimens. In this direction, biobanks grant a constant source of well-founded scientific material for investigation in a wide range of medical fields, such as otolaryngology among them. In otolaryngology, the biobanks have meant a great improvement, facilitating investigations related to deafness, presbycusis, tinnitus and oncology. In the future we hope the scientific community will expand the use this innovative tool over a broader medical field and towards other health-related professions, making the most of its enormous potential.

El objeto y el sujeto en la investigación científica

RESUMEN En este artículo se aborda la unidad dialéctica entre el objeto de estudio y los sujetos de la investigación. Debido a que usualmente, a través del universo y muestra de la investigación, son declarados los sujetos a estudiar, en este trabajo se hace énfasis en la necesidad de declarar explícitamente el objeto a investigar.

ABSTRACT This article presents the dialectical unity between the object of study and the research subjects. Because usually, through the universe and the research sample, the subjects to be studied are declared, this work emphasizes the need to explicitly declare the object to be research.

Exploration on writing features and learning strategies of English biomedical research papers / 中华医学教育探索杂志

Writing and publishing biomedical research papers in English for academic purposes (EAP) has become an essential requirement for medical postgraduates in China. To face this challenge, medical postgraduates need adapt themselves to the local environment of English as a second language and the transformation from writing for examinations to writing for application. This change determines the features of biomedical research papers, including being application-oriented, using clear and concise language, organizing the discourse by specific genre rules, and assessing the quality according to the completion of communicative purposes. Based on these features, students can exploit the learning strategies of choosing a word suited for the style, structuring a sentence according to the logic, creating a paragraph of continuity and one main idea, and composing the discourse in line with the genre. These strategies may help medical postgraduates effectively improve their ability to write biomedical research papers in English.

New consideration for data collection and application of clinical research under the back-ground of ligalization of data administration in China / 中华消化外科杂志

The medical data processed and analyzed in clinical research often contain a large number of personal information. Therefore, researchers should pay attention to the safety management of medical data during clinical research. The Data Security Law of People's Republic of China and the Personal Information Protection Law of People's Republic of China implemented on 1 st September and 1 st November 2021 respectively establish legal basis for data security and personal information protection and point out the direction for medical data security, which indicate that data governance has entered the 'strong regulatory era'. In the process of medical data collection and application of clinical research, respecting and protecting the privacy and safety of patients, ensuring the quality of medical data, safely managing medical data and carrying out high-quality clinical research will be an important test for the collection and application of clinical scientific research data under the new legal background.

Investigation on Construction Status of Biomedical Research Ethics Committee Involving Human Beings in Medical Institutions in Guangzhou / 中国医学伦理学

【Objective:】 To investigate the construction status of biomedical research ethics committee involving human beings in medical institutions in Guangzhou, and to provide the basis for the standardized management of ethics committee. 【Methods:】 The convenience sampling method was conducted to investigate the construction status of biomedical research ethics committee involving human beings in 58 medical institutions in Guangzhou. The SPSS 21.0 statistical software was used to analyze the data, and the chi-square test was used for difference analysis. 【Results:】 58 medical institutions had set up biomedical research ethics committee involving human beings. 50.00% of the ethics committees hired full-time secretaries, 33.96% of the ethics offices were administratively independent, 52.83% of the ethics offices were equipped with full-time staff, 79.17% of the ethics committees submitted paper documents for review, and 48.61% of ethics committees organized training irregularly. Comparison of the management of ethics committees of drug clinical trials and non-drug clinical trials was statistically significant (P<0.05). 【Conclusion:】 The management of ethics committee is generally good, but the standardization construction still needs to be further strengthened. It is recommended to strengthen the discipline construction and informatization construction of ethics committee, standardize the special training of ethics, improve the supervision systems of ethics committee, unify the construction standards of ethics committee, so as to improve the ability of ethics review, and effectively protect the safety, rights and interests of subjects.

Legal Points in Ethical Review of Subjects’ Informed Consent / 中国医学伦理学

Subjects’ informed consent are needed in biomedical research, which has been confirmed by the Civil Code of the People’s Republic of China, Law of the People’s Republic of China on the Promotion of Basic Medical and Health Care, and Law on Doctors of the People’s Republic of China. Due to the professionalism and complexity of the law, researchers often have deficiencies in the use of legal terms, the fulfillment of disclosure obligations and the protection of subjects’ rights and interests when writing informed consent forms. When the ethics committee conducts ethical review on the informed consent form of the subjects, there are some problems such as lack of objective ability or insufficient subjective attention to the above shortcomings of the researchers. By combing the legal points, this paper summarized the correction scheme to provide reference for ethical review.