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.

Exploring the Cultural Origins and Developmental Patterns of Academic Schools in Traditional Chinese Medicine from a Constructivist Perspective / 中医杂志

Using constructivism theory， this study explored the relationship between the "origin" and "flow" of academic schools in traditional Chinese medicine （TCM）， clarified the developmental patterns of schools， and provided insights for the modernization， inheritance， and innovation of current schools. Academic schools originate from different cultural sources， and their differentiation and development are similar to the replication， spread and variation of biological "genes". The theoretical characteristics of constructivism align well with the principles of formation and differentiation of academic schools. The construction of academic thoughts and core diagnostic and therapeutic concepts within each school can be seen as a multilevel unity of self-construction， mutual construction among individuals， and social construction. Firstly， individual medical practitioners choose and inherit from the origins of TCM， integrating personalized understanding， which then differentiates into various schools in the history of academia. Secondly， during the process of cultural inheritance， medical practitioners from different times and regions gradually form academic schools and local medical schools through the method of "tailoring strategies to three categories of etiological factors" and mutual construction among individuals. Finally， in the context of the scientific， standardized， and intelligent development of modern medicine， the further evolution of academic schools needs to follow the evolutionary laws of traditional medicine， combine with the health needs of the new era， adopt a social construction approach， facilitate multi-party participation in the inheritance and innovation of academic thoughts and clinical experiences， and utilize the internet and intelligent technology means to empower modern development.

Analysis on the Current Status and Ethics Review Key Points of Electronic Informed Consent / 中国医学伦理学

Informed consent is one of the key elements to protect the rights and welfare of the patients or research subjects. With the development of electronic information technology, the diversity and convenience brought by the electronization makes the electronic informed consent (E-Consent) come into being. European and American countries have begun to apply E-Consent in the field of clinical trials, established a relatively perfect E-Consent platform and software system, and initially formed the guiding principles and recommendations of E-Consent. However, the implementation of E-Consent is still less in China, and there is no targeted legal basis and guidelines for ethical review. Therefore, this paper explored the implementation potential of E-Consent domestically by analyzing the application scenarios, advantages and disadvantages, and feasibility of E-Consent, and tried to establish the practical ethic review points of E-Consent based on the basic principles of ethical principles, to ensure that clinical trials have an appropriate E-Consent process.

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 Subject Related Costs in Medical Research / 中国医学伦理学

The development of medical research is completed by the cooperation of sponsors, investigators, subjects, and ethics committees. Clinically, it mainly includes clinical trials of medical devices, clinical medicine and new technology research. This paper analyzed the game and the relationship between rights, responsibilities and interests of relevant parties in medical research, combined with the relevant costs and sharing principles involved in medical research, and found that the use of the word "free" in the informed consent is easy to cause misunderstanding and the lack of relevant compensation costs in the informed consent, while the compensation and insurance costs had some problems, such as the imperfect subject compensation mechanism and the insufficient insurance purchase by the sponsor, which can not protect the basic rights and interests of the subjects. Therefore, in order to standardize the cost management of clinical medical research, it is necessary to standardize the process and content of informed consent, strengthen the supervision of medical research process, establish medical research damage compensation fund and research damage insurance system, so as to better protect the rights and interests of subjects.

The Construction and Improvement of the Protection System for the Rights and Interests of Human Subjects in Trial Institutions from the Ethical Perspective: Taking a Hospital in Anhui Province as an Example / 中国医学伦理学

This paper took a hospital in Anhui province as an example, aimed at the problems existing in the protection of human subjects’ rights and interests in China, and put forward relevant suggestions from the ethical perspective. The suggestions included shaping the international vision, playing the core role of ethics committee, strengthening the construction of legal and regulatory protection mechanism, setting up the human research protection committee and actively promoting the construction of subject protection system. These measures will effectively promote the construction and improvement of the rights and interests protection system of human subjects in China.

Quantitative analysis for reform policies of basic medical insurance designated retail pharmacies in China / 中国药房

OBJECTIVE To sort out reform policy for basic medical insurance designated retail pharmacy （referred to as designated retail pharmacy） in China， and to provide reference for the improvement of the policy under the new situation of mutual- aid mechanism for covering outpatient bills. METHODS The policy texts on designated retail pharmacies issued by ministries and commissions of the State Council and departments directly under the State Council were collected from December 1998 to June 2023. The content analysis and social network analysis were adopted to construct a three-dimensional analytical framework based on the policy subject， the policy tool， and the policy process， in order to quantitatively analyze the policies on reforming designated retail pharmacies. RESULTS & CONCLUSIONS The reform policy of designated retail pharmacies can be roughly divided into three stages： germination， exploration and development， and in-depth promotion. The use of policy tools is dominated by environment-oriented tools， and the cooperation network of policy subjects presents a “head-body-tail” chain structure. With the advancement of policy reforms， the number of policy subjects showed a trend of decline followed by growth， the number of policy documents showed an upward trend， emphasizing the use of tools such as the construction of the pharmacist system， the flow of prescriptions， the payment of medical insurance， and the management of “dual-channels” and “outpatient co-ordination”. It is suggested that in terms of policy formulation， all policy subjects should adhere to top-level design， grasp the characteristics of the stage of policy development， and adjust the use of policy tools according to local and timely conditions； we should also strengthen cooperation and communication， improve policy formulation efficiency， achieve policy coordination， and continuously improve policies for designated retail pharmacies.

La lectura en el aula en dos asignaturas de la escuela secundaria: un estudio comparativo / Reading in the classroom in two secondary school subjects: a comparative study / La lecture en classe dans deux enseignements du secondaire: une étude comparative / A leitura na sala de aula em duas disciplinas do ensino médio: um estudo comparativo

Resumen: Este trabajo se propone un análisis comparativo de las actividades de lectura en dos asignaturas del primer año de la educación secundaria argentina: Prácticas del Lenguaje (PDL) y Ciencias Sociales (CS). Se grabaron en audio ocho clases, cuatro de cada uno de los espacios curriculares. Se analizaron de acuerdo con propuestas teóricas preexistentes que permiten segmentar las observaciones en diferentes unidades, caracterizar los tipos y funciones de lecturas y las estrategias promovidas. En las sesiones de PDL fue más frecuente la lectura como actividad típica de aula y se realizó poniendo en juego mayor variedad de estrategias que en CS. La lectura colectiva genuina mental predominó en PDL, mientras que en CS prevaleció la lectura por parte de las profesoras con comentarios. Los resultados permiten introducir reflexiones relativas a las intervenciones docentes en materia de lectura según la asignatura escolar y los distintos desafíos que supone su enseñanza.

Abstract: This study aims to perform a comparative analysis of reading activities in two first-year subjects of secondary school in Argentina: Prácticas del Lenguaje (PDL) [Language and Literature (LAL)] and Ciencias Sociales (CS) [Social Studies (SS)]. Eight lessons were audio-recorded, four from each study area. They were analyzed in accordance with pre-existing theoretical proposals, which made it possible to segment the observations into different units, characterize the types and functions of readings and the strategies promoted. In Language and Literature, reading was a more frequent classroom activity and was carried out with a greater variety of strategies than in Social Studies. Genuine mental collective reading prevailed in Language and Literature, whereas teachers' reading with comments prevailed in Social Studies. The results lead to reflections on different teaching interventions in reading practices according to the school subject and the different challenges involved in teaching them.

Résumé : Cet article propose une analyse comparative des activités de lecture dans deux enseignements de la première année de l'enseignement secondaire argentin : Pratiques du langage (PDL) et Sciences sociales (CS). Huit classes ont été enregistrées en audio, quatre de chacun des espaces du programme. On a analysé selon des propositions théoriques préexistantes qui permettent de segmenter les observations en différentes unités, caractériser les types et fonctions de lectures et les stratégies promues. Dans les sessions PDL, la lecture fût plus fréquente comme activité typique de la classe et elle s'est réalisée en utilisant une plus grande variété de stratégies que dans CS. La véritable lecture collective mentale prédomina en PdL, mais en CS c'est la lecture par les enseignants avec des commentaires qui a prévalu. Les résultats permettent d'introduire des réflexions sur les interventions pédagogiques concernant la lecture selon l'enseignement scolaire, et les différents enjeux que leur enseignement comporte.

Resumo: Este trabalho propõe uma análise comparativa das atividades de leitura em duas disciplinas do primeiro ano do ensino médio argentino: Prática de Linguagem (PDL) e Ciências Sociais (CS). Gravaram-se em áudio oito aulas, quatro de cada um dos espaços curriculares. Analisaram-se de acordo com as propostas teóricas preexistentes as quais permitem segmentar as observações em diferentes unidades, caracterizar os tipos e funções de leituras e as estratégias promovidas. Nas sessões de PDL foi mais frequente a leitura como atividade típica de sala de aula e se realizou investindo a maior variedade de estratégias que nas CS. A leitura coletiva genuína mental predominou na PDL, enquanto que nas CS prevaleceu a leitura por parte das professoras com comentários. Os resultados permitem introduzir reflexões relativas às intervenções docentes em matéria de leitura segundo a disciplina escolar, e os distintos desafios que supõe seu ensino.

Uso y abuso de los criterios de inclusión y exclusión en el proyecto de investigación

Uno de los aspectos metodológicos esenciales de una investigación es la delimitación de los sujetos a estudiar. Este artìculo aborda la tendencia actual a una excesiva e injustificada declaración de los criterios de inclusión y de exclusión en todo tipo de investigación. Se defiende la idea de que una adecuada utilización de las categorías universo y muestra hace innecesaria la declaración de criterios de inclusión y de exclusión en el diseño metodológico de la mayoría de los proyectos de trabajo de terminación de la especialidad que presentan nuestros residentes.

One of the essential methodological aspects of an investigation is the delimitation of the subjects to be studied. This article addresses the current trend towards an excessive and unjustified statement of inclusion and exclusion criteria in all types of research. The idea is defended that an adequate use of the universe and sample categories makes it unnecessary to declare inclusion and exclusion criteria in the methodological design of most of the specialty completion work projects presented by our residents.

Composição de grupo de diálogo sobre o tema gênero e sexualidade nas escolas / Composition of a dialogue group on the theme of gender and sexuality in schools / Composición de un grupo de diálogo sobre el tema de género y sexualidad en las escuelas

Considerando-se os desafios da composição de grupos de diálogos em temas socialmente polêmicos, este estudo teve como objetivo apresentar as estratégias utilizadas para compor um grupo de diálogo a partir da metodologia do Projeto de Conversações Públicas entre pessoas com distintas opiniões sobre a abordagem do tema da diversidade sexual e de gênero nas escolas brasileiras. As transcrições das audiogravações das conversas preparatórias e dos encontros grupais e as anotações de diário de campo compuseram o corpus de análise deste estudo. A análise temática de conteúdo serviu para o destaque das seguintes estratégias consideradas úteis para a composição grupal: 1) Reconhecendo as pessoas envolvidas no conflito; 2) Entrando em contato com pessoas-chave; 3) Recrutando participantes reservas; 4) Pensando formas alternativas de presença no grupo; 5) Reconhecendo quem precisaria estar na conversa; 6) Flexibilidade com relação a entrada de novas/os participantes; 7) Lidando com os estereótipos com relação as/aos facilitadoras/es; 8) Co-construindo estratégias para maior adesão grupal. Esses eixos analíticos foram discutidos a partir da literatura da área.

Considering the challenges of composing dialogue groups in polemic issues, this study aimed to present the strategies used to compose a dialogue group based on the methodology of the Public Conversations Project among people with different opinions on the approach to the topic of sexual and of gender in Brazilian schools. Transcripts of audio recordings of preparatory conversations and group meetings and field diary notes composed the corpus of analysis of this study. The thematic content analysis served to highlight the following strategies considered useful for group composition: 1) Recognizing the people involved in the conflict; 2) Contacting key people; 3) Recruiting reserve participants; 4) Thinking about alternative forms of presence in the group; 5) Recognizing who would need to be in the conversation; 6) Flexibility regarding the entry of new participants; 7) Dealing with stereotypes regarding facilitators; 8) Co-building strategies for greater group membership. The selected material was discussed based on the literature in the area.

Considerando los desafíos de la composición de grupos de diálogo, este estudio tuvo como objetivo presentar las estrategias utilizadas para la composición de un grupo de diálogo basado en la metodología del Proyecto Conversaciones Públicas entre personas con opiniones diferentes sobre el abordaje del tema sexual y de género en las escuelas brasileñas. Transcripciones de grabaciones de audio de conversaciones preparatorias y reuniones grupales y notas del diario de campo componen el corpus de análisis de este estudio. El análisis de contenido temático sirvió para resaltar las siguientes estrategias consideradas útiles para la composición del grupo: 1) Reconocimiento de las personas involucradas en el conflicto; 2) Ponerse en contacto con personas clave; 3) Reclutamiento de participantes de reserva; 4) Pensar en formas alternativas de presencia en el grupo; 5) Reconocer quién debería estar en la conversación; 6) Flexibilidad en la entrada de nuevos participantes; 7) Abordar los estereotipos sobre los facilitadores; 8) Estrategias de co-construcción para una mayor membresía del grupo. El material seleccionado se discutió con base en la literatura en el área.

Urgencias médicas durante el tratamiento estomatológico en los planes de estudio D y E de estomatología / Medical emergencies during oral treatment in the D and E study plans of the dental medicine major

Introducción: El objetivo fundamental de la práctica estomatológica contemporánea es dar solución no solo a aquellas entidades que afectan el aparato estomatognático, sino prevenir y tratar aquellas urgencias médicas que puedan presentarse durante el ejercicio de la profesión. Este propósito solo resulta posible mediante la formación de un estomatólogo con una elevada preparación científico-técnica. Objetivo: Evaluar los contenidos relacionados con las urgencias médicas durante la atención estomatológica en los planes de estudio D y E de la carrera de estomatología. Métodos: Se realizó un análisis documental de los planes de estudio D y E. Durante el cual se revisaron el perfil profesional, los modos de actuación, y los programas de la disciplina integradora Estomatología Integral y de las asignaturas. Asimismo, se valoraron los contenidos relacionados con las urgencias médicas durante la atención estomatológica, el semestre en que se imparte la asignatura, los objetivos, los temas, y el sistema de conocimientos y habilidades. Resultados: Las asignaturas y disciplinas que incorporaron contenidos relacionados con las urgencias médicas durante la atención estomatológica fueron: Operatoria Clínica, Atención Integral a la Familia III, Farmacología y Preparación para la Defensa. El análisis documental realizado y las entrevistas ejecutadas mostraron la existencia de diversos criterios en relación con estos contenidos en las asignaturas abordadas. Conclusiones: Los contenidos relacionados con las urgencias médicas durante la atención estomatológica en los programas de las asignaturas y disciplinas evaluados resultaron limitados e insuficientes, y presentaron algunas deficiencias desde el punto de vista didáctico(AU)

Introduction: The fundamental objective of contemporary oral care practice is to provide solutions not only to those entities that affect the oral apparatus, but also to prevent and treat those medical emergencies that may appear during professional practice. This purpose can be achieved only through the training of an oral physician with a high scientific-technical preparation. Objective: To assess the contents related to medical emergencies during oral care in the D and E study plans of the dental medicine major. Methods: A documentary analysis of the D and E study plans was carried out; the process consisted in reviewing the professional profile, the modes of action and the syllabuses of the integrating discipline Comprehensive Dental Medicine, as well as of the subjects. Likewise, an assessment was carried out of the contents related to medical emergencies during oral care, the semester in which the subject is taught, the objectives, the topics, as well as the system of knowledge and skills. Results: The subjects and disciplines including contents related to medical emergencies during oral care were Clinical Surgery, Comprehensive Family Care III, Pharmacology and Preparation for Defense. The conducted documentary analysis and the performed interviews showed the existence of diverse criterions with respect to these contents in the addressed subjects. Conclusions: The contents related to medical emergencies during oral care in the assessed syllabuses of subjects and disciplines were concluded to be limited and insufficient, as well as presented some deficiencies from the didactic point of view(AU)

Dilemmas and strategies for collaborative governance of medical preventive integration based on SFIC model / 中华医院管理杂志

Promoting medical preventive integration and improving its collaborative mechanism is an inevitable requirement for achieving the transformation of China′s medical and health care system from " disease centered" to " people′s health centered" and providing comprehensive and comprehensive health services for the people.This study established a research framework based on the SFIC model on the basis of clarifying the collaborative subjects of medical preventive integration, sorted out the dilemma of medical preventive integration collaborative governance in China from five aspects, including external environment, starting conditions, facilitative leadership, institutional design and collaborative process.In order to break the dilemma of medical preventive integration and promote collaborative governance among multiple subjects, the authors proposed such optimization strategies, including further improving relevant laws, regulations, and policy systems, filling resource gaps, attracting multiple entities to participate, providing reference for promoting China′s medical preventive integration work.

A quantitative study of regulatory policy texts in China′s healthcare sector from the perspective of policy instruments / 中华医院管理杂志

Objective:To analyze the evolution of China′s national-level healthcare sector regulatory policies between 2003 and 2021, and explore the characteristics and patterns of the use of policy instruments at different stages, for references in policy optimization.Methods:The policy documents related to the regulation of the healthcare sector released by the central government were searched from 2003 to 2021 from the policy document database of the State Council using the keywords " medical" " regulation" and " health" " regulation". Based on the analysis framework of " formulation subject-implementation subject-policy tools", such methods as content analysis, social network analysis, and policy tool analysis were used to analyze policy documents and conduct descriptive analysis of data.Results:A total of 236 policies were included in the study.From 2003 to 2008, according to the time progression, a total of 27 documents were issued, with the State Council as the main formulation subject (77.78%, 21/27), and the government as the main implementation subject (100.00%, 27/27). 191 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 21.46% (41/191), 30.37% (58/191), and 48.17% (92/191). From 2009 to 2017, a total of 48 policies were issued, the formulation subject was mostly the State Council (93.75%, 45/48), and the implementation subject was still mostly the government (100.00%, 48/48), but the proportion of institutions (25.00%, 12/48), industry organizations (43.75%, 21/48) and the society (37.50%, 18/48) has increased. 500 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments were 17.40% (87/500), 32.00% (160/500), and 50.60% (253/500), respectively.From 2018 to 2021, a total of 161 documents were issued, with the formulation subjects featuring multiple subjects (38.51%, 62/161), with a decrease in the percentage of the State Council′s issuance (22.36%, 36/161), and 157 (97.52%) policies were implemented by the government. 1 140 policy tools were used, and the composition ratios of supply-based, demand-based, and environment-based policy instruments being 18.42% (210/1 140), 34.74% (396/1 140), and 46.84% (534/1 140), respectively.Conclusions:From 2003 to 2021, there was an upward trend in the number of policies issued in the field of healthcare sector regulation in China, and the subjects of formulation and implementation were diversified. But the use of different types of policy instruments was uneven.

Main Problems and Ethical Review Points of Subject Recruitment in Drug Clinical Trials / 中国医学伦理学

Drug clinical trials need to recruit suitable subjects to verify the safety and effectiveness of new drugs. Subject recruitment is a very important and challenging link in the whole process of drug clinical trials, and even directly affects the progress and final results of the trials. The medical ethics committee should give full play to the important function of ethical review, carefully review the whole process of subject recruitment from the perspective of science and ethics, and do a good job in the protection of the health and rights of subjects. This paper mainly discussed the basic principles of subject recruitment, the main problems existing in the recruitment process and the key contents of ethical review, so as to provide scientific references and suggestions for standardizing subject recruitment, protecting the rights and interests of subjects, and promoting the efficient and high-quality completion of drug clinical trials.

Protection of Informed Consent Rights for Subjects in Drug Clinical Trials / 中国医学伦理学

The right to informed consent is the basic right of subjects in drug clinical trials. International treaties and domestic laws have successively formed a basic right protection framework, while there are still some problems such as imperfect legal norms and incomplete practical operations. To meet future challenges, it is necessary to further improve legislation, standardize notification procedures, improve notification content, expand dynamic notification methods, and strengthen ethical review, so as to build a standardized and modern system for protecting the right to informed consent of subjects.

Challenges and Thoughts on Improving Subject Protection during the Period of Rapid Development of Biomedical Technology / 中国医学伦理学

With the development of technologies such as gene editing, artificial intelligence, and big data, cutting-edge technologies have brought increasing ethical risks in medical research, and the ability to protect subjects has become increasingly inadequate. However, the current means of ethical governance are relatively weak, the ethical awareness of researchers is not strong, and existing ethical governance methods can no longer meet the needs of new technological developments. Therefore, combined with the Guidelines to Strengthen Governance over Ethics in Science and Technology issued by the General Office of the CPC Central Committee and the General Office of the State Council in March 2022, this paper proposed that subject protection needed to be improved from the following aspects: improving regulations and systems, strengthening the construction of ethics committees, conducting research on ethical governance methods, raising the quality of ethics committees, constructing regional ethics systems, and improving the ethical literacy of researchers. To carry out the above work, it is necessary for the government, ethical professional organizations, research institutions, biomedical enterprises, medical institutions, and the public to explore the "ethical pre-examination" management model with the concept of "prevention", so as to improve the subject protection in the modern society with the continuous development of new technologies.

Reflection on the Current Situation of Pregnant Women’s Participation in Clinical Research from an Ethical Perspective / 中国医学伦理学

Due to the physiological peculiarities of pregnant women, general clinical studies exclude pregnant women. Therefore, there is a lack of evidence of precise medication for pregnant women with diseases worldwide, which poses a significant risk for them to use medication during pregnancy. Whether to include pregnant women as subjects in clinical research has always been a focus of ethical discussion. By providing a broad overview of pregnant women’s participation in clinical research from an ethical perspective, this paper explored the risks and challenges faced by pregnant women’s participation in clinical research, and provided theoretical basis and thinking paths for how to fairly and effectively include pregnant women as subjects and promoting clinical research on pregnant women.

Safety analysis on bioequivalence studies of orally inhaled drug products in healthy Chinese subjects / 中国临床药理学与治疗学

AIM: To investigate the safety of bioequivalence (BE) studies of orally inhaled drug products (OIDPs) conducted by Phase I clinical Research Center of our hospital. METHODS: The safety data were collected from 482 healthy subjects enrolled in 20 OIDPs BE studies in Wuxi People's hospital from 2017 to 2022. The difference of adverse events (AEs) between test preparation and reference preparation were compared, as well as the influence of gender, age, mechanism of drug action and device type on AE were analyzed. RESULTS: A total of 102 cases of AEs were occurred in 77 subjects (16.0%, 77/482), 87 cases of AEs were related to experimental drugs, all AEs were mild or moderate, and no serious adverse events occurred. There was no difference in the incidence of AE between test preparation and reference preparation. In addition, gender, age, mechanism of drug action and device type had no significant effects on AEs. CONCLUSION: In 20 bioequivalence studies of OIDPs, OIDPs were safe and well tolerated in healthy subjects after dosing, and safety features of generic OIDPs and original drug were basically similar.

Analysis of reasons for screening failure of healthy subjects in clinical trials of orally inhaled drug products / 中国临床药理学与治疗学

AIM: To explore the reasons for screening failure of healthy subjects in clinical trials of orally inhaled drug products (OIDPs). METHODS: Screening data of 1 432 healthy subjects who participated in clinical trials of OIDPs were collected. The main reasons for the screening failure, gender differences in screening failure rate and the correlation between age and screening failure rate were summarized and analyzed. RESULTS: The screening failure rate was 72.4 % and increased with age. The failure rate was slightly higher in females than in males. Besides abnormal vital signs (17.3%), abnormal laboratory test results (16.5%) and withdrawal of consent (7.6%), poor venous condition (13.9%), positive for cigarette test results (12.6%) and failure in inhalation training (7.1%) were also the other three main reasons affecting the screening success rate. Abnormal vital signs and poor venous conditions were the primary screening failure reasons for males and females, respectively. CONCLUSION: The screening success rate could be improved by informing fully and communicating effectively, selecting young subjects with strong understanding abilities, and enhancing the training skills of investigators.

Politización del desecho: Tránsitos políticos de lo abyecto en la racionalidad neoliberal / Politicization of Waste: Political Transits of the Abject in Neoliberal Rationality

Resumen Si queremos reconstruir la política y resistirnos a ser gobernados de esta forma por el neoliberalismo, hemos de reconocer nuestra condición precaria, nuestra finitud e, inevitablemente, la necesidad que tenemos de los otros para poder so brevivir. La salida, en consonancia con lo propuesto por Butler, es una política de alianzas que haga frente a la lógica individualizadora contemporánea que inocula la idea de que existen vidas que importan más que otras y que, por tanto, son más dignas de ser vividas y lloradas.

Abstract If we want to reconstruct politics and resist being governed by neoliberalism, in this way, we must recognize our precarious condition, our finitude and, inevi tably, the need we have for others in order to survive. The way out, in line with Butler's proposal, is a policy of alliances, which confronts the contemporary in dividualizing logic that inoculates the idea that there are lives that matter more than others and that, therefore, they are worthier of being lived and mourned.