Study on the Protection of the Rights and Interests of Tumor Subjects in Clinical Trials in the Prevention and Control of the COVID -19 / 中国医学伦理学

The outbreak of the COVID -19 has had a big impact on the implementation of clinical trials of tumor drugs and the prevention and control measures such as traffic control and home isolation has caused clinical trials couldn’t proceed normally, so the protection of tumor subjects in clinical trials faces many new challenges. Based on Western and Chinese policies and guidelines on the management of clinical trials during the COVID -19, this paper expounded the impacts of the COVID -19 on tumor patients and tumor clinical trials, analyzed the challenges faced by the protection of tumor subjects in the prevention and control of the COVID -19, and then protected tumor subjects from aspects of optimizing the allocation of health resources, improving non-face-to-face informed consent procedures, strengthening subject visit management, and enhancing clinical trial safety evaluation. It is hoped that these optimization measures can face the future and continue to protect subjects after the end of the epidemic or in new public health emergencies.

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.

Research on the Moral Responsibility of Face Recognition and Medical Diagnosis / 中国医学伦理学

The application of face recognition technology is gradually expanding to the medical field. It has been initially used in the medical diagnosis of endocrine diseases and genetic syndrome. This technology is expected to be used for the screening of genetic syndrome and endocrine diseases, shortening the delay period of disease diagnosis and helping the staging of endocrine diseases. However, this technology also has some moral risks, such as the risk of personal information security disclosure, the challenge to the future of mankind and the division of moral responsibility. This paper reflected on the dilemma of moral responsibility in the application of face recognition and medical diagnosis, and explored the two basic problems of "who is the subject of moral responsibility" and "the specific division of moral responsibility of different moral subjects" in face recognition and medical diagnosis. Finally, some suggestions on the moral responsibility in face recognition and medical diagnosis are put forward. The first is to determine the role of face recognition and medical diagnosis as an auxiliary category, and doctors are still the main medical subject; the second is to build the responsibility ethics mechanism and laws and regulations, the establishment of the responsibility system of face recognition and medical diagnosis is inseparable from the joint action of law and ethics.

The Harm of Shame to Self and Its Way out from the Perspective of Bioethics / 中国医学伦理学

Psychological research results confirmed that the negative impact of shame on self often causes psychological diseases, and shame does not always related to ethical value. People with serious sense of shame will lead to negative evaluation and overall negation to themselves, and the sense of shame accompanied by great pain will cause great harm to individuals. To realize the sublimation of shame, the ethical orientation of its self cognitive schema and evaluation method must be changed, from the orientation of "transforming self and reaching perfection" to the position of "caring for self and accepting imperfect self" . To tap the positive value of shame, individuals must avoid hurting themselves and then care for themselves. "The principle of not harming life" and "do not denying people’s ethical subject status" are the bottom line of the ethical value of shame.

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.

Onde está o sujeito? Reflexões sobre o materialismo e a dialética / Where's the subject? Reflections on materialism and dialectics / ¿Dónde está el sujeto? Reflexiones sobre el materialismo y la dialéctica

Buscamos uma análise acerca dos desdobramentos da questão do sujeito à luz das diversas críticas que a ela se levantaram nos anos pós-estruturalistas e diante da ascensão do neoliberalismo como ideologia dominante em todo o mundo. Relegada como questão metafísica da modernidade, ou como resíduo do cientificismo positivista, a categoria de sujeito tem sido notadamente objeto de desconstrução, ou, quando não, de simples rejeição. Se apoiando sobre um duplo questionamento, de sua possível pertinência para o pensamento psicológico e filosófico atual, como dos possíveis atores da transformação social diante das transformações sofridas que o capitalismo tardio impõe à categoria de proletariado, através do pensamento de Alain Badiou e Slavoj Zizek, tentamos afastar a tendência linguística que hoje pauta grande parte das análises sobre o sujeito e os processos subjetivos para tentar apontar a importância de uma teoria das verdades que renove as bases ontológicas do pensamento e a visão sobre a dialética materialista. Uma teoria do sujeito assentada sobre um conceito de verdade se mostra assim um potencial para repensar o homem enquanto criador. (AU)

We seek an analysis of the developments surrounding the issue of the subject in light of various critiques that have emerged in the post-structuralist years and in the face of the rise of neoliberalism as the dominant ideology worl-dwide. Relegated as a metaphysical question of modernity or as a residue of positivist scientism, the category of the subject has notably been a target of deconstruction, or, when not, outright rejection. Grounded in a dual inquiry into its possible relevance for current psychological and philosophical thought, as well as the potential actors of social transformation in the face of the changes imposed by late capitalism on the proletariat category, through the prospectives of Alain Badiou and Slavoj Zizek, we attempt to move away from the linguistic trend that currently guides a significant portion of analyses on the subject and subjective processes. Our aim is to emphasize the importance of a theory of truths that renews the ontological foundations of thought and the perspective on dialectical materialism. A theory of the subject anchored in a concept of truth thus proves to be a potential avenue for rethinking man as a creator. (AU)

Buscamos un análisis del desarrollo del tema del sujeto a la luz de las diversas críticas que surgieron en los años postestructuralistas y ante el surgimiento del neoliberalismo como ideología dominante a nivel mundial. Relegada como cuestión metafísica de la modernidad, o como residuo del cientificismo positi-vista, la categoría de sujeto ha sido notablemente objeto de deconstrucción o, cuando no, de simple rechazo. Partiendo de un doble cuestionamiento, de su posible relevancia para el pensamiento psicológico y filosófico actual, como de los posibles actores de la transformación social frente a las transforma-ciones que el capitalismo tardío impone a la categoría de proletariado, a través del pensamiento de Alain Badiou y Slavoj Zizek , intentamos quitar la tendencia lingüística que hoy guía la mayoría de los análisis sobre el tema y los procesos subjetivos para intentar señalar la importancia de una teoría de las verdades que renueve las bases ontológicas del pensamiento y la mirada sobre la dialéctica materialista. Una teoría del sujeto basada en un concepto de verdad muestra así un potencial para repensar al hombre como creador. (AU)

Do Discurso Capitalista Neoliberal ao Sujeito como Inapropriável / From the Neoliberal Capitalist Discourse to the Subject as Unappropriable / Del Discurso Capitalista Neoliberal al Sujeto como Inapropiable

Por meio da formalização lacaniana da teoria dos discursos e do discurso do capitalista, objetivamos localizar os modos de operação presentes na racionalidade neoliberal. Partimos da introdução de uma nova modalidade de laço social, que parece travar as possibilidades de funcionamento do quarto de giro e opera sob o psiquismo aos moldes de uma produção ilimitada, reduzindo o desejo à dimensão da demanda. Esse movimento realiza uma manobra de captura da subjetividade por meio do supereu e passa a se orientar por horizontes forjados pelo neoliberalismo. A empreitada do discurso do capitalista se assemelha a um "crime perfeito", a qual tem como meta o apagamento de qualquer rastro que sirva como uma orientação desejante. Apostamos na inscrição do desejo por meio do ato de escuta como estratégia de localização de representações possíveis. Assim evita-se a consumação de um crime perfeito e trata-se de uma operação com um resto inassimilável pela economia de mercado. É na medida em que esse resto pode ser acolhido por meio de uma escuta que se inscreve a possibilidade de produção não apenas de uma coordenada pautada no desejo bem como de uma estratégia política frente ao ilimitado dos mercados contemporâneos.

Through Lacan's formalization of the theory of discourses and the discourse of the capitalist, we aim to locate the operation modes present in neoliberal rationality. We start from the introduction of a new modality of social bond, which seems to block the working possibilities of a quarter spin and operates under the psyche in the mold of an unlimited production, reducing desire to the dimension of demand. This movement captures the subjectivity through the superego and begins to be guided by horizons forged by neoliberalism. The endeavor of the capitalist discourse resembles the "perfect crime", which has as its goal the erasure of any trace that serves as a desiring orientation. We bet on the inscription of desire through the act of listening as a strategy for locating possible representations. In this way, the consummation of a perfect crime is avoided and it is turns to be about an operation with a leftover that cannot be assimilated by the market economy. It is to the extent that this remainder can be welcomed through listening that the possibility of producing not only a coordinate based on desire, but also a political strategy in the face of the unlimited nature of contemporary markets is inscribed.

Por medio de la formalización lacaniana de la teoría de los discursos y del discurso del capitalista, pretendemos ubicar los modos de operación presentes en la racionalidad neoliberal. Partimos de la introducción de una nueva modalidad de vínculo social, que bloquea las posibilidades de trabajo del rotación y opera bajo el psiquismo en el molde de una producción ilimitada, reduciendo el deseo a la demanda. Este movimiento captura la subjetividad a través del superyó y comienza a guiarse por horizontes forjados por el neoliberalismo. La obra del discurso capitalista se asemeja al "crimen perfecto", que tiene como fin borrar cualquier rastro de orientación deseante. Apostamos por la inscripción del deseo a través del acto de escuchar como estrategia de localización de posibles representaciones. De esta forma se evita la consumación de un delito perfecto y se trata de una operación con un resto que no puede ser asimilado por la economía de mercado. Es en la medida en que este resto puede ser acogido a través de la escucha que se inscribe la posibilidad de producir no sólo una coordenada basada en el deseo, sino también una estrategia política frente a la naturaleza ilimitada de los mercados contemporáneos.

Análisis crítico del programa de la asignatura Genética Médica de la disciplina Investigaciones Diagnósticas / A Critical Analysis of the Syllabus for the Subject Medical Genetics of the Discipline Diagnostic Research

Introducción: El programa de estudio es una formulación hipotética de los aprendizajes que se pretenden lograr en el educando. Constituye una herramienta fundamental de trabajo docente. Objetivo: Exponer un análisis crítico del programa de estudio de la asignatura Genética Médica en la carrera de medicina, a partir de lo normado en el reglamento vigente para el trabajo docente-metodológico. Métodos: Se realizó una revisión bibliográfica para desarrollar un análisis crítico del programa de la asignatura genética médica, en la que se consideraron artículos publicados entre 2012 y 2022. La búsqueda fue realizada en Google académico, Dialnet, SciELO y Redalyc en septiembre de 2022. Las palabras clave utilizadas fueron: programas, genética, asignatura, disciplina y proceso docente-educativo. Dentro de este marco se incluyeron todos los artículos cubanos publicados; no hubo restricción en cuanto al idioma. Se consultaron 50 artículos, de estos 11 fueron seleccionados. Se excluyeron aquellos no relacionados con la educación médica superior. Resultados: Se orientó metodológicamente la inclusión de aspectos encaminados a la promoción de salud; fomentar las habilidades comunicativas; reformular los objetivos, incluyendo en su estructura los elementos esenciales; realizar un cambio en el orden de impartir el contenido, con modificaciones, además, en el nivel de profundidad y con aporte de un enfoque preventive; y declarar adecuadamente los valores, la rectificación de la cantidad de horas del fondo de tiempo y la actualización de la bibliografía. Conclusiones: Las insuficiencias encontradas en el análisis efectuado identificaron las áreas vulnerables hacia donde deben dirigirse las principales acciones encaminadas a aumentar la calidad del proceso docente educativo y reflejaron la necesidad de su reevaluación(AU)

Introduction: The syllabus is a hypothetical formulation of the learning aspects intended to be achieved in the student. It is a fundamental tool for teaching. Objective: To present a critical analysis of the syllabus for subject Medical Genetics in the medical major, based on the current regulations for the teaching-methodological work. Methods: A literature review was carried out to develop a critical analysis of the syllabus of the subject Medical Genetics, considering articles published between 2012 and 2022. The search was performed in Google Scholar, Dialnet, SciELO and Redalyc in September 2022. The keywords used were programas [syllabuses], genética [genetics], asignatura [subject], disciplina [discipline] and proceso docente-educativo [teaching-educational process]. This framework included all published Cuban articles; there were not any language-related restrictions. Fifty articles were consulted, 11 of which were selected. Those not related to higher medical education were excluded. Results: The methodological orientation was to include aspects aimed at health promotion, to encourage communicative skills, to reformulate the objectives (including the essential elements in their structure), to make a change in the order of teaching (with modifications also in the level of depth and contributing with a preventive approach), as well as to state the values adequately, to rectify the number of hours within the available time fund, to update the bibliography. Conclusions: The insufficiencies found through the performed analysis permitted to identify the vulnerable areas towards the main actions should be directed if aimed at increasing the quality of the educational teaching process, apart from reflecting their need to be reassessed(AU)

Esboços para uma teoria do sujeito: com Badiou e a psicanálise / Outlines for a theory of the subject: with Badiou and psychoanalysis / Essais pour une théorie du sujet: avec Badiou et la psychanalyse

Partindo-se do pressuposto de que, com Descartes, a questão que subjaz na constituição da modernidade é o que seria o sujeito, este texto se propõe a explorar desdobramentos sobre essa questão tendo como referência teorizações de Alain Badiou e algumas concepções básicas que aprendemos a ler na psicanálise. Ele procura demonstrar os impasses que encontramos ao tentarmos estabelecer formalizações sobre o sujeito, impasses esses que estariam na constituição do homem moderno. Trabalha também interseções e implicações dessas formalizações paradoxais com conceitos igualmente caros à psicanálise, como os de sintoma, corpo e verdade, assim como ressonâncias que poderíamos desdobrar entre a tipologia formal do sujeito proposta por Badiou e formalizações sobre esse tema que poderíamos depreender da leitura das obras de Freud e Lacan.

Based on the assumption that with Descartes the question that underlies the constitution of modernity is what the subject would be, this text proposes to explore developments on this issue with Alain Badiou's theorizations as a reference and some basic concepts that we learn to read in psychoanalysis. He tries to demonstrate the impasses that we find when we try to establish formalizations about the subject, impasses that would be in the constitution of modern humans. It also works on the intersections and implications of these paradoxical formalizations with concepts equally dear to psychoanalysis such as symptom, body, and truth, as well as resonances that we could unfold between the formal typology of the subject proposed by Badiou and formalizations on this theme that we could infer from reading the works by Freud and Lacan.

Sur la base de l'hypothèse que, avec Descartes, la question qui sous-tend la constitution de la modernité est ce qui serait le sujet, ce texte propose d'explorer les développements sur cette question ayant pour référence des théorisations d'Alain Badiou et quelques concepts de base que nous apprenons à lire en psychanalyse. Il essaie de démontrer les impasses que nous trouvons lorsque nous essayons d'établir des formalisations sur le sujet, des impasses qui seraient dans la constitution de l'homme moderne. Il travaille également sur les intersections et implications de ces formalisations paradoxales avec des concepts tout aussi chers à la psychanalyse, tels que les symptômes, le corps et la vérité, ainsi que les résonances que nous pourrions déployer entre la typologie formelle du sujet proposée par Badiou et les formalisations sur ce thème que nous pourrions déduire de la lecture des travaux de Freud et de Lacan.

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.

"Lá onde Isso era, [eu] devo devir": comentário sobre a Lição 21 do Seminário 6, de Lacan / Là où C'était, [je] dois devenir": commentaire de la leçon 21 du Séminaire 6 de Lacan / "Where Id was, [I] must become": commentary on Lesson 21 of Lacan's Seminar 6

O presente trabalho é um comentário da Lição 21 do Seminário sobre O desejo e sua Interpretação de Jacques Lacan. Nessa lição, intitulada. A forma do corte, Lacan percorre a ideia de que a psicanálise se interessa pelo efeito-sujeito, indicando-a a partir da expressão freudiana " Wo Es war, soll Ich werden" e de seus desenvolvimentos a propósito da noção de fantasia, o que inclui o objeto a. O texto percorre essas noções para pensar o trabalho que se realiza numa análise

Cet article est un commentaire de la leçon 21 du séminaire de Jacques Lacan sur Le désir et son interprétation. Dans cette leçon, intitulée La forme de la coupure, Lacan développe l'idée que la psychanalyse s'intéresse à l'effet-sujet, en l'indiquant à partir de l'expression freudienne " Wo Es war, soll Ich werden" et de ses développements sur la notion de fantasme, qui inclut l'objet a. Le texte passe en revue ces notions afin de réfléchir au travail qui s'opère dans une analyse

This paper is a commentary on Lesson 21 of Jacques Lacan's Seminar on "Desire and its Interpretation". In this lesson, entitled "The form of the cut", Lacan goes through the idea that psychoanalysis is interested in the subject-effect, indicating this from the Freudian expression "Wo Es war, soll Ich werden" and its developments with regard to the notion of fantasy, which includes the object a. The text goes through these notions in order to think about the work that takes place in an analysis

Repercussões sociais/culturais e psíquicas da linguagem escrita na aprendizagem do sujeito / Social/cultural and psychic repercussions of written language on the subject's learning

A linguagem escrita é uma ferramenta básica em nossa Cultura, pois ela permite resgatar e transmitir o patrimônio cultural através da História da Humanidade. Considera-se fundamental compreendê-la integralmente, levando em conta aspectos relacionados às quatro habilidades básicas: ler, escrever, falar e escutar, como fundamentado por Kenneth Goodman (1977) e Condemarin (1992). Aprender a ler e escrever é um "rito de passagem" que demanda experiências formais e informais, dentro e fora do contexto escolar. A produção da linguagem escrita abre espaço para a singularização, isto é, possibilita expressar e identificar-se aos valores e conceitos que contribuem para a formação individual e coletiva. Sendo considerada a "espinha dorsal da escolarização", muitas das queixas de Dificuldades de Aprendizagem podem ser relacionadas à sua fragilidade, tendo repercussões na constituição do sujeito aprendente. Este artigo tenta descrever a amplitude do que envolve a queixa escolar referente à produção de linguagem de maneira integral e integrada, apresentando enfoques teóricos que fundamentam a Psicopedagogia Dinâmica no que diz respeito ao desenvolvimento da linguagem.

Written language is a basic tool in our Culture, as it allows to rescue and transmit cultural heritage through the history of humanity. It is considered fundamental to fully understand it, considering aspects related to the four basic skills: reading, writing, speaking, and listening, as founded by Kenneth Goodman (1977) and Mabel Condemarin (1992). Learning to read and write is a "rite of passage" that requires formal and not formal experiences, both within and outside the school context. The production of written language opens space for singularization, that is, it makes it possible to express and identify oneself to the values and concepts that contribute to individual and collective formation. Being considered the "backbone of schooling", many of the complaints of Learning Difficulties can be reactivated to its fragility, having repercussions on the constitution of the learning subject. This article tries to describe the breadth of what involves the school complaint regarding the production of language in an integral and integrated way, presenting important theoretical approaches to broaden this reflection. presenting theoretical approaches that underlie Dynamic Psychopedagogy regarding language development.

Scientific supervision and subject-oriented development of China clinical research / 中国胸心血管外科临床杂志

@#At the end of 2022, the National Medical Products Administration (NMPA), in conjunction with the National Cancer Center, Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College raised for the first time the important issue of clinical research globally: whether the source of the death time of clinical trials based on the simple follow-up records is credible, and proposed a consensus document on the source of the death time of clinical trials. The results were published in The Lancet Regional Health-Western Pacific, which attracted wide attention and recognition from the international industry. This is the first time that the China consensus on quality standards for clinical research has been ahead of the U.S. Food and Drug Administration and other international colleagues. The NMPA has been leading China in promoting the scientific development of clinical research, so as to constantly establish and improve the scientific regulatory system and ecological system, and promote China's full integration into the global pharmaceutical research and development system. China clinical research institutions and the whole industry are also gradually from standardized development to scientific development, high-quality development process. In this study, we summarized the scientific and subject-oriented development of China clinical research industry in recent years, and continuously strengthened the international competitiveness of China pharmaceutical industry. It is suggested that scientific thinking model should be used to deal with the normative problems in clinical research and promote the development of medical model to scientific model.

Analysis and discussion on the subject complaint in clinical drug trials / 中华医学科研管理杂志

Objective:By exploring the management of subject complaints by the ethics committee, to identify and correct the problems that damage the rights of subjects in clinical drug trials, in order to improve the ability of the ethics committee of protecting the rights and interests of the subjects.Methods:We conducted a retrospective analysis of 13 cases of subject complaints accepted by the Ethics Committee of Peking University People′s Hospital from January to December 2021, analyzed the causes of complaints, and proposed countermeasures and suggestions.Results:Problems exist in the subject complaints regarding the payment of compensation, investigators′ communication attitude and skills, subjects′ understanding bias, etc.Conclusions:The ethics committee should attach great importance to subject complaints, adopt a closed-loop management process, carry out hierarchical management, strict ethical review, improve the ability of continuous supervision, conduct targeted training for investigators, and provide counseling services for subjects, to improve the communication between investigators and subjects, effectively reduce and avoid the occurrence of complaints. Relevant functional departments of medical and health institutions should work together to protect the rights and interests of the subjects.

Operation and Reflection on Exemption from Ethical Review / 中国医学伦理学

Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans. "Exemption from ethical review" was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023. To implement the exemption from ethical review within the permitted scope of laws and regulations, and to protect the privacy and rights of research participants when utilizing their data information and biological samples, multiple factors need to be considered, including the person responsible for exemption from ethical review, the conditions for exemption from ethical review, and the specific process for exemption from ethical review. As with other review procedures, exemption from ethical review also required the development of corresponding systems, implementation of responsibilities, and reliance on the construction of subject protection systems. It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.

Analysis on Legal Relationship Based on a Typical Case of Medical Device Clinical Trial / 中国医学伦理学

Guaranteeing the rights and safety of subjects is an important responsibility of all participants in the medical devices clinical trial, including medical institutions, sponsors and researchers. The legal disputes caused by serious adverse events in the clinical trial of medical devices are characterized by complex legal relationships, great difficulty in handling, and many points of dispute. Based on a typical case of medical device clinical trials, this paper discussed the litigation subject qualification, the treatment of contract breach and tort in medical device clinical trial, analyzed the responsibility of different subjects, and provided constructive suggestions on the risk management of medical device clinical trial.

Supervision of Electronic Informed Consent in International Clinical Research and Its Implications for China / 中国医学伦理学

At present, China is still in the exploratory stage in the field of electronic informed consent (eIC), and relevant policies, regulations and application guidelines have not yet been established and improved. While the traditional informed consent supervision system is difficult to meet the needs of the innovative development of eIC, such as subject privacy and data security. Through sorting out and analyzing the legal norms and construction system of eIC supervision in Europe and the United States, combined with the current development status, problems, and challenges of eIC in China, this paper targeted proposed the path to construct the supervision of eIC in clinical research in China from the aspects of restricting the signing form and process of eIC, adjusting the ethical review paradigm of eIC, enhancing the strength of eIC ethical review, improving the construction of eIC legal system, and strengthening the training of relevant researchers.

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.

Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives / 中西医结合学报

Delivery of acupuncture in the setting of a clinical trial is a unique practice that diverges significantly from the delivery of acupuncture in a real-world clinical setting. Research acupuncturists, particularly those trained in traditional Chinese medicine (TCM), are often required to set aside valued precepts of traditional care, including diagnosing imbalances, individualizing treatment, and forging a therapeutic relationship with patients. TCM-trained acupuncturists express mixed feelings about participating in clinical trials. Many are eager to play a vital role in the advancement of acupuncture science and appreciate the need for strict protocol adherence to minimize bias. However, the acupuncturist(s) may also have concerns about clinical trial methodology, including but not limited to the delivery of a control condition, e.g., sham acupuncture. Investigators should anticipate certain questions and even a level of resistance to the requirements of research among acupuncturists and be prepared to address them. This manuscript presents a brief review of the subjective experience of the research acupuncturist within the available scientific literature as it pertains to the delivery of active and sham clinical research protocols. Our goals are to better understand the perspectives of acupuncturists who may participate in clinical research, so that their concerns may be addressed in study design and methodology. To that end, we suggest the creation of a novel training program specifically for clinical trial acupuncturists, intended for qualified TCM- and Western-trained practitioners, that would help to standardize the research acupuncturist's role and help to strengthen the design and execution of acupuncture studies. Please cite this article as: Anastasi JK, Capili B, Neumaier J, Hackett L. Delivery of acupuncture in clinical trials: Research acupuncturists' perspectives. J Integr Med. 2023; 21(4):315-319.

O ensino das lutas na formação de professores de Educação Física: uma perspectiva a partir da dialética sujeito-objeto e da experiência docente / The teaching of martial arts in physical education teacher training: a perspective from the subject-object dialectic and teaching experience / La enseñanza de las artes marciales en la formación del profesor de Educación Física: una perspectiva desde la dialéctica sujeto-objeto y la experiencia docente

RESUMO O objetivo do presente artigo é refletir a respeito dos lugares de objeto em que o conteúdo de lutas pode ocupar na experiência formativa de professores de Educação Física. Para este fim, este artigo traça um diálogo entre as noções de sujeito e objeto a partir da Filosofia de Theodor W. Adorno, no contexto da prática docente no ensino superior. Nessa perspectiva, a teoria crítica de Adorno contribui para a percepção da necessidade de pensamento e autonomia na formação de professores, observando que não é possível a concepção de um sujeito na prática sem a consideração da alteridade dos objetos em questão.

ABSTRACT The aim of this paper is to reflect on object places that martial arts contents can occupy in experience during physical education teacher training. To this end, I will consider Theodor W. Adorno's notions of subject and object interacting with teaching practice in higher education. In this perspective, Adorno's critical theory adds to the perception of the need for thought and autonomy in teacher training, observing that it a subject of practice without considering the otherness of the object in question is not possible .

RESUMEN El objetivo de este artículo es reflexionar sobre los lugares de objeto que pueden ocupar los contenidos de artes marciales en la experiencia de formación de profesores de Educación Física. Para ello, dialogo con las nociones de sujeto y objeto en la Filosofía de Theodor W. Adorno, interactuando con la práctica docente en la educación superior. En esta perspectiva, la teoría crítica de Adorno contribuye a la percepción de la necesidad del pensamiento y la autonomía en la formación docente, constatando que no es posible un sujeto de práctica sin considerar la alteridad de los objetos en cuestión.