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1.
Rev. enferm. UERJ ; 32: e80274, jan. -dez. 2024.
Article in English, Spanish, Portuguese | LILACS-Express | LILACS | ID: biblio-1554400

ABSTRACT

Objetivo: avaliar os fatores clínicos associados ao bem-estar das mulheres durante o trabalho de parto e parto à luz da bioética principialista e da deontologia. Método: estudo transversal com abordagem quantitativa. Participaram 396 puérperas internadas em um hospital municipal do sudoeste da Bahia, e os dados foram coletados no período de janeiro a maio de 2023, após aprovação do comitê de ética em pesquisa. Os dados foram organizados no software Excel e analisados via SPSS v.25. a partir da regressão logística multinomial. Resultados: a maior parte da amostra apresentou bem-estar com assistência em saúde, mulheres que tiveram parto realizado por profissionais não médicos apresentaram mais chances de níveis de bem-estar "adequado". E mulheres que não tiveram a via de parto cesárea apresentaram aumento de chances de bem-estar. Conclusão: é necessário que os profissionais reflitam sobre suas ações, condicionando-as à humanização no parto, em observância aos princípios bioéticos.


Objective: to evaluate the clinical factors associated with women's well-being during labor and delivery in the light of bioethics principlism and deontology. Method: a cross-sectional study with a quantitative approach was conducted. It involved 396 postpartum women admitted to a municipal hospital in the southwest of Bahia. Data were collected from January to May 2023, after approval from the research ethics committee. The data were tabulated using Excel software and analyzed using SPSS v.25 through Multinomial Logistic Regression. Results: majority of the sample exhibited well-being with health care assistance. Women who underwent delivery performed by non-medical professionals showed higher chances of "adequate" levels of well-being. Additionally, women who did not undergo cesarean delivery showed increased chances of well-being. Conclusion: It is necessary for professionals to reflect on their actions, conditioning them to the humanization of childbirth, according to bioethical principles.


Objetivo: evaluar los factores clínicos asociados al bienestar de la mujer durante el trabajo de parto y parto a la luz de la bioética y la deontología principialista. Método: estudio transversal con enfoque cuantitativo. Incluyó 396 puérperas ingresadas en un hospital municipal del suroeste de Bahía. Recolección de datos de enero a mayo de 2023, con aprobación del comité de ética en investigación. Los datos se tabularon en el software Excel y se analizaron mediante SPSS v.25. utilizando regresión logística multinomial. Resultados: la mayoría de las participantes de la muestra presentó bienestar con la atención para la salud; las que tuvieron partos realizados por profesionales no médicos tenían más probabilidades de tener niveles "adecuados" de bienestar; las que no tuvieron parto por cesárea tenían mayores probabilidades de tener bienestar. Conclusión: es necesario que los profesionales reflexionen sobre sus acciones y las adecuen para humanizar el parto, respetando los principios bioéticos.

2.
Rev. Bras. Odontol. Leg. RBOL ; 11(1): 19-27, 20240601.
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1556119

ABSTRACT

O marketing é uma estratégia de destaque comercial muito utilizada na odontologia, com suas mais variadas modalidades, é uma potente ferramenta, que ao contrário do que é diversas vezes retratado, não se trata apenas de vender, comprar ou comercializar. O objetivo deste trabalho é investigar as violações éticas apresentadas nas publicidades e propagandas de serviços odontológicos na cidade de Santo Antônio de Jesus - Bahia de acordo com o código de ética odontológico (CFO- 118/2012). Os dados foram coletados a partir de uma atenciosa análise de placas, panfletos e outdoors de consultórios odontológicos (pessoa física e/ou jurídica). Estas publicidades e propagandas foram documentadas através de fotografias coletadas por uma única examinadora. Os itens considerados obrigatórios foram registro profissional, nome do profissional e o nome representativo Cirurgião-Dentista, já os itens considerados opcionais avaliados foram logotipo, telefone, E-mail/site, endereço, áreas de atuação, procedimentos e técnicas de tratamento e a expressão "clínico-geral", no quesito infrações foram avaliados itens como cartão de desconto, modalidade de pagamento e aliciamento de pacientes. Verificou-se que apenas 15% dos anúncios apresentavam todos os itens obrigatórios, o item mais encontrado referente aos opcionais foi o Logotipo (48,2%), apenas uma única clínica apresentava itens que continham algum tipo de publicidade com infração ética. O presente estudo constatou que a maior parte das publicidades e propagandas realizadas por clínicas e consultórios odontológicos da cidade de Santo Antônio de Jesus, não seguem todas as normas e diretrizes, desobedecendo as regras básicas propostas


Marketing is a prominent commercial strategy widely used in dentistry, within its diverse modalities; it is a powerful tool, contrary to which is often portrayed, isn't just about selling, buying or marketing. The aim of this paper is investigating the ethical violations viewed on dental services advertisements in the city of Santo Antônio de Jesus - Bahia in accordance with the dental ethics and code of conduct (CFO- 118/2012). The data has been collected as from a careful analysis of advertising boards, flyers and outdoors at dental offices (individuals and/or legal entities). These advertisements were documented through photographs collected by a single examiner. The mandatory items have been considered professional registration, name of the professional and the professional representative name (dentist), while the optional items have been considered logo, phone, E-mail/website, address, activity areas, procedures and treatment techniques and the expression "general practitioner", in relation to infractions, items such as discount card, payment method and patient enticement have been evaluated. It has been found only 15% of the advertisements showed all mandatory items, the most common item was the Logo (48.2%), just a single clinic had some type of item that contained ethical violations advertising. The present article determine that the majority of advertisements carried out by dental clinics in the city of Santo Antônio de Jesus haven´t been followed all regulations, disobeying the basic rules proposals

3.
Rev. Bras. Odontol. Leg. RBOL ; 11(1): 63-71, 20240601.
Article in Portuguese | LILACS-Express | LILACS | ID: biblio-1556125

ABSTRACT

A estabilização protetora tem sido utilizada em procedimentos na área da saúde por décadas para gestão do comportamento, em especial quando as técnicas comunicativas falham. O uso da estabilização tem como objetivo criar um ambiente seguro para a conduta terapêutica, promovendo agilidade nos procedimentos odontológicos, com manutenção da integridade física do paciente e da equipe. Embora apresente benefícios, a sua aplicação é um dilema especialmente em pacientes pediátricos e com necessidades especiais, devido à natureza da restrição física envolvida. O presente trabalho trata-se de uma revisão de literatura integrativa e teve como objetivo descrever os aspectos éticos e legais que envolvem o uso de estabilização protetora no atendimento odontológico. A busca abrangeu estudos desenvolvidos nos últimos 10 anos, pelos descritores "Ética", "Contenção Física", "Odontologia" de acordo com o DeCS e MeSH, além de legislações e normas brasileiras. Na tomada de decisão clínica, os princípios da autonomia, beneficência, não maleficência e justiça devem ser considerados. O consentimento informado, a ponderação dos riscos, benefícios e a informação aos responsáveis são requisitos fundamentais para evitar violações de direitos e preservar a integridade de pacientes e da equipe de cuidado à saúde


Protective stabilization has been used in healthcare procedures for decades to manage behavior, especially when communicative techniques fail. Protective stabilization aims to create a safe environment for therapeutic conduct, promoting efficiency in dental procedures while maintaining the physical integrity of the patient and the staff as well. Despite its benefits, its application poses a dilemma especially with pediatric and patients with special needs, due to the nature of physical restraint involved. The present study is an integrative literature review that aims to describe the ethical and legal aspects surrounding the use of protective stabilization in dental care. The search encompassed studies conducted in the last 10 years, using the descriptors "Ethics," "Physical Restraint," and "Dentistry" according to DeCS and MeSH, as well as Brazilian legislation and regulations. In clinical decision-making, the principles of autonomy, beneficence, non-maleficence, and justice should be considered. Informed consent, weighing risks and benefits, and providing information to guardians are fundamental requirements to prevent rights violations and preserve the integrity of patients and healthcare staff

4.
Invest. educ. enferm ; 42(1): 193-206, 20240408. ilus, tab
Article in English | LILACS, BDENF, COLNAL | ID: biblio-1554634

ABSTRACT

Objective.To investigate the relationship between environmental ethics, spiritual health, and environmental behavior among nursing students . Methods. In this cross-sectional study, 200 iranian students from the Chabahar Nursing School were selected using a simple random sampling method. The data collection tool included a questionnaire on demographic information, knowledge, attitudes and behaviors towards the environment, environmental ethics, and spiritual health. Partial least squares structural equation modeling (PLS-SEM) was utilized to evaluate the conceptual framework in this study. Results. The mean score for environmental ethics among nursing students was 65.73±10.61 out of 100. Most of the students (47%) had desirable environmental ethics. The knowledge structure (ß=0.46) predicted attitude. The attitude structure also predicted environmental behavior (ß=0.28) and spiritual health (ß=0.31). Ultimately, the results showed that spiritual health and environmental ethics predict environmental behavior directly and indirectly (p<0.001). Conclusion. Spiritual health and environmental ethics were strong predictors of environmental behavior. Therefore, it is necessary to take into account not only students' spiritual health but also their ethical behaviors to promote environmental protection behaviors in the future.


Objetivo. Investigar la relación entre la ética ambiental, la salud espiritual y el comportamiento ambiental entre los estudiantes de enfermería. Métodos. En este estudio transversal se seleccionaron 200 estudiantes iraníes de la Escuela de Enfermería de Chabahar mediante un método de muestreo aleatorio simple. La herramienta de recogida de datos incluía un cuestionario sobre información demográfica, conocimientos, actitudes y comportamientos hacia el medio ambiente, ética medioambiental y salud espiritual. Se utilizó el modelo de ecuaciones estructurales por mínimos cuadrados parciales (PLS-SEM) para evaluar el marco conceptual de este estudio. Resultados. La puntuación media en ética medioambiental entre los estudiantes de enfermería fue de 65.73±10.61 sobre 100. El 47% de los estudiantes tenían una ética medioambiental deseable. La estructura de conocimientos (0.46) predijo la actitud. La estructura de la actitud también predijo el comportamiento medioambiental (0.28) y la salud espiritual (0.31). En última instancia, los resultados mostraron que la salud espiritual y la ética medioambiental predicen el comportamiento medioambiental directa e indirectamente (p<0.001). Conclusión. La salud espiritual y la ética medioambiental fueron fuertes predictores del comportamiento medioambiental. Por lo tanto, es necesario tener en cuenta no sólo la salud espiritual de los estudiantes, sino también sus comportamientos éticos para promover conductas de protección del medio ambiente en el futuro.


Objetivo. Investigar a relação entre ética ambiental, saúde espiritual e comportamento ambiental entre estudantes de enfermagem. Métodos. Neste estudo transversal, 200 estudantes da Escola de Enfermagem de Chabahar (Irã) foram selecionados usando um método de amostragem aleatória simples. A ferramenta de coleta de dados incluiu um questionário sobre informações demográficas, conhecimento, atitudes e comportamentos em relação ao meio ambiente, ética ambiental e saúde espiritual. A modelagem de equações estruturais por mínimos quadrados parciais (PLS-SEM) foi usada para avaliar a estrutura conceitual deste estudo. Resultados. A pontuação média sobre ética ambiental entre os estudantes de enfermagem foi de 65.73±10.61 de um total de 100. 47% dos estudantes tinham uma ética ambiental desejável. A estrutura de conhecimento (0.46) previu a atitude. A estrutura da atitude também previu o comportamento ambiental (0.28) e a saúde espiritual (0.31). Por fim, os resultados mostraram que a saúde espiritual e a ética ambiental previram o comportamento ambiental direta e indiretamente (p<0.001). Conclusão. A saúde espiritual e a ética ambiental foram fortes preditores do comportamento ambiental. Portanto, é necessário considerar não apenas a saúde espiritual dos alunos, mas também seus comportamentos éticos, a fim de promover comportamentos de proteção ambiental no futuro.


Subject(s)
Humans , Students, Nursing , Behavior , Attitude , Conservation of Natural Resources , Knowledge
6.
Chinese Medical Ethics ; (6): 811-816, 2024.
Article in Chinese | WPRIM | ID: wpr-1012984

ABSTRACT

As an important carrier of cultivating people with virtue, curriculum aesthetic education combines aesthetic education with professional courses and general courses, and brings it into the whole process of professional talent cultivation. As the core course of medical humanistic education, Medical Ethics not only has natural affinity with aesthetic education, but also has the functions of emotional aesthetic education, rational aesthetic education and human aesthetic education. Through the analysis of aesthetic education points in Medical Ethics, this paper put forward the implementation path to realize the function of the curriculum aesthetic education: exert aesthetic influence on medical students with the help of aesthetic media, guide medical students’ aesthetic attitude, and then make medical students learn to feel, appreciate beauty through practice and sharing ideas, before or after class, online or offline, so as to contribute to the cultivation of high-quality medical talents with lofty aesthetic pursuit and noble-personality cultivation.

7.
Chinese Medical Ethics ; (6): 801-805, 2024.
Article in Chinese | WPRIM | ID: wpr-1012982

ABSTRACT

From an ethical point of view, the ethical characteristics of the consciousness of the Chinese national community contain an ethical starting point based on "love"; ethical path with "people first" as the core; ethical vision for the purpose of "prosperity". The consciousness of the Chinese national community greatly conforms to the teaching objectives and teaching content of medical ethics. Therefore, medical ethics teaching from the perspective of the Chinese national community should implement the fundamental task of helping students develop good morals and enhance the moral quality of "love"; take the "community of doctor-patient destiny" as the starting point of education and build the concept of "people first"; strengthen the country’s sense of responsibility of "prosperity and strength" and establish the mission of "rooting and maintaining health at the grassroots level", build a strong consciousness of the Chinese national community.

8.
Chinese Medical Ethics ; (6): 778-782, 2024.
Article in Chinese | WPRIM | ID: wpr-1012978

ABSTRACT

Formulating codes of ethics for nurses are not only the need of establishing nurses’ professional image and dignity, but also the demand of nursing discipline development. By combing the relevant documents of codes of ethics for nurses at home and abroad, this paper summarized the main contents and application of codes of ethics for nurses, found that codes of ethics for nurses were based on the basic principle of "patient-oriented", discussing the relationship between nurses and patients, collaborators, environment, society, specialty and personal development, and forming the constraint standard for nurses’ behavior in combination with the expectation of local cultural values for nursing industry. The codes of ethics for nurses in China need to further clarify the scope of nursing, formulate behavioral norms in various specialties, and through clinical evaluation, education, management and other aspects to promote its popularization and implementation.

9.
Chinese Medical Ethics ; (6): 687-691, 2024.
Article in Chinese | WPRIM | ID: wpr-1012962

ABSTRACT

The outbreak of major public emergencies is an important practical issue that affects social development and human survival and security. In the face of major public emergencies, college students in the new era must have a strong sense of responsibility and mission. This paper took the formation value of college students’ responsibility ethics as a logical clue, deeply analyzed the subject-object function relationship of college students’ responsibility ethics in major public emergencies, and combined the philosophy of subjectivity to reveal the contradictory connotations of college students’ subjects, that is, the contradictory relationship between spontaneity and consciousness, selfishness and dedication, passivity and initiative, and relyed on the connotation logic of responsibility ethics to promote the sense of responsibility and mission of college students in major public emergencies, so that they can develop to a higher level, thus realizing the ultimate goal of generating the value of responsibility ethics.

10.
Chinese Medical Ethics ; (6): 636-642, 2024.
Article in Chinese | WPRIM | ID: wpr-1012954

ABSTRACT

Vaccine cooperation is an important means to deal with global infectious diseases. However, the cooperation cannot be achieved overnight. Ethical dilemma is one of the obstacles that hinders vaccine cooperation. Reviewing the history, the most successful vaccine collaboration to date has been the global smallpox eradication program. In the process of eradicating smallpox, there were also many ethical dilemmas, including the international pattern of the US-Soviet hegemony, which impacted the mutual help between countries, the ethical disputes of the vaccine itself hindering solidarity and cooperation among actors, and the vaccine coercion adopted to overcome vaccine hesitancy undermining the principle of proportionality among the freedom, equality and efficacy. The ethical dilemmas of vaccine cooperation were resolved by shaping professional and scientific consensus among medical professional groups, reaching consensus on cooperation between leading countries and developing countries, and integrating local culture to improve vaccination methods. Finally, in 1980, the world successfully eradicated smallpox. The case of smallpox eradication provides us lessons for vaccine cooperation against COVID-19 and the construction of a community of common health for mankind today.

11.
Chinese Medical Ethics ; (6): 631-635, 2024.
Article in Chinese | WPRIM | ID: wpr-1012953

ABSTRACT

How medical resources can be fairly distributed in a public health emergency such as COVID-19. There have been mature or comparatively mature studies on this issue in both traditional ethics and contemporary ethics: the traditional ethics has the "maximum happiness principle" represented by utilitarianism, while the contemporary ethics has the new principle doctrine and the medical justice theory, which respectively put forward the methods suitable for the distribution of emergency medical resources, and defended their respective theories from different perspectives. However, when COVID-19 broke out, the actual medical resource distribution methods were still the traditional medical resource distribution methods, but did not use the contemporary mainstream ethical medical distribution approach, which was due to the limitations of the emerging medical ethics distribution theory. Therefore, in order to better provide ethical services to the medical and health field, the contemporary emerging theory of distribution of health care needs to introduce global bioethics, with its tolerance and respect, give full play to its advantages, and improve its shortcomings, so as to solve the problem of medical resources distribution.

12.
Chinese Medical Ethics ; (6): 601-606, 2024.
Article in Chinese | WPRIM | ID: wpr-1012948

ABSTRACT

In order to explore the ethical review experience of organ donation and transplantation after the death of citizens, and provide reference value for medical institutions to carry out corresponding ethical review. By using descriptive research, purpose sampling method and the principle of data saturation, 10 members and secretaries of ethics committee on clinical application of organ transplantation technology were finally selected as respondents for semi-structured interviews. The Colaizzi 7-step analysis method was adopted to analyze, summarize and refine the theme. The results showed that the ethical review experience of organ donation and transplantation after the death of citizens included four themes: the responsibilities of ethics committee, the key points of ethics review, the form of ethics review conference and its advantages and disadvantages, and the construction of the ethics committee of organ transplantation. Therefore, there are defects in the ethical review of organ donation and transplantation in medical institutions at present. These can be remedied by enriching elements of the ethical review following the four principles of medical ethics, refining the laws related to organ donation after citizens’ death, constructing a reasonable and efficient pattern of ethical review conference, and establishing a robust and appropriate operation mode of organ transplantation ethics committee.

13.
Chinese Medical Ethics ; (6): 589-596, 2024.
Article in Chinese | WPRIM | ID: wpr-1012946

ABSTRACT

The ethical governance of science and technology is a kind of practical ethics, which develops in the process of continuously solving the ethical problems and ethical conflicts arising from scientific and technological activities. Ethical governance has common requirements and professional standards. Health-related science and technology activities, including the application of life science and artificial intelligence in health and medical field, make the medical ethical governance face common and unique challenges. The supervision and ethical review should consider the speciality of life science and medical research, and bring the existing ethical review system into full play. However, the focus, emphasis and standards of ethical governance have changed with the application of some technologies (ex. the next-generation sequencing, gene editing, and artificial intelligence). Actions should be taken to strengthen the ethical governance and promote ethics in advance with science and technological implementation in health and medical field. Here in this article, the classified, hierarchical supervision and ethical review strategies are discussed; then some potential effective organization and mechanisms for regional ethics committees are introduced. Promoting the medical education and continuing education of ethical governance of science and technology is also recommended.

14.
Chinese Medical Ethics ; (6): 573-577, 2024.
Article in Chinese | WPRIM | ID: wpr-1012943

ABSTRACT

Ancient traditional Chinese medical ethics thought is a value system with Pre-Qin Confucian benevolence thought as the core. Under the cultivation and regulations of Pre-Qin Confucian benevolence, such as "benevolent love", "taking life as morality" and "self-denial and ritual", ancient Chinese medicine gradually formed the medical ethics ideal of "helping the world and saving people", the medical ethics goal of "life is the most important" and emotion towards patient of "considering others in one’s own place". Learn from the past, cultivate the professional emotion of "saving people and helping the world" of medical staff through example education; using recessive education to guide both doctors and patients to respect their lives, thus creating a social atmosphere of mutual respect between doctors and patients, and advocating doctor-patient communication that apply oneself to others with the help of carrier education; the essence of ancient traditional Chinese medical ethics thought is integrated into the construction of contemporary medical ethics, so as to overcome the problem of medical ethics anomie that life is technicalized and medical services are materialized in today’s medical development, make contemporary medical ethics thought meet the needs of today’s medical development, make medical development return to benevolence and promote the healthy development of medicine.

15.
Chinese Medical Ethics ; (6): 522-527, 2024.
Article in Chinese | WPRIM | ID: wpr-1012934

ABSTRACT

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.

16.
Chinese Medical Ethics ; (6): 508-512, 2024.
Article in Chinese | WPRIM | ID: wpr-1012931

ABSTRACT

In the process of exploring standardized and efficient ethical review models for multi-center drug clinical trials, the ethical review alliance emerged as the times require. Compared with mature ethics committees, higher requirements have been put forward for the "young" ethics committees. By analyzing problems existing in review work of "young" ethics committees in the ethics review alliance, this paper discussed the measures to improve the review quality of "young" ethics committees and promote the standardized and efficient operation of the alliance, and put forward countermeasures and suggestions for improving the homogenization of ethics review and accelerating the clinical research process of innovative drugs.

17.
Chinese Medical Ethics ; (6): 489-493, 2024.
Article in Chinese | WPRIM | ID: wpr-1012927

ABSTRACT

The construction of the scientific and technological ethics management system is crucial to ensure the healthy development of scientific research, and is also the premise and foundation for the scientific and technological innovation and "double first-class" construction of colleges and universities. This paper through the investigation of college life science and medical research ethics committees’ relevant situation, concentrated on the comparative analysis of the construction of ethics training system to identify problems and shortcomings, combined with the work example of Peking University and the current development trend of life science and medical research, some suggestions, including take advantage of the combination of medical services, teaching and research at universities, were put forward to provide possible reference for further updating of the science and technology ethics management in colleges and universities.

18.
Chinese Medical Ethics ; (6): 427-432, 2024.
Article in Chinese | WPRIM | ID: wpr-1012916

ABSTRACT

From January 23, 2020 to May 29, 2021, there were 17,550 clinical research registrations on the China Clinical Trial Registry Platform. The index of clinical research on COVID-19 showed 840 registrations, accounting for 4.79% (840/17 550) of the total registrations. According to the trend chart of epidemic development, 487 clinical research projects of COVID-19 registered from January 23, 2020 to March 18, 2020 were set as the early stage of epidemic discovery in the region, the following 15 months were divided into stable initial stage, stable later stage and the later stage of the first wave of domestic epidemic every five months. The proportion of COVID-19 research projects registered in each stage was 29.80%, 5.87%, 0.76% and 1.15% of all registered projects respectively. The registration ratios of COVID-19 in each clinical stage was 57.98%, 28.81%, 5.95% and 7.26% respectively. Intervention studies were 61.60% (300/487) in the early stage of the epidemic, and most of them were in biological agent and drug therapy, which were 40.49%, 50.00% and 73.77% respectively in the later stages. Stable initial stage biological agent projects decreased. Then the vaccine research program became a focused research program. Among the 58 registration projects involving vaccines, 25 were clinical trials of vaccines in different stages, with the major research units being biopharmaceutical companies. Of the 487 clinical studies registered in the early stage, 10.23%(50/487) were withdrawn, of which 38 were intervention treatment studies, most notably drug studies (17) and blood biological products (16), but they were still registered in the stable initial stage. It is necessary to reflect on the scientific and ethical nature of early COVID-19 clinical trials or research, including whether the three core values of equal respect, help to alleviate pain and fairness can be achieved. Whether the "ethics review meeting should pay special attention to the scientificity, safety, fairness, subject protection, informed consent documents and informed consent process, avoidance of conflicts of interest, etc. of clinical trials or research" has been implemented. Competent government departments at all levels and all clinical medical research institutions should organize evaluation, and then establish an effective evaluation mechanism when new clinical trials or research projects are registered in the future.

19.
Chinese Medical Ethics ; (6): 421-426, 2024.
Article in Chinese | WPRIM | ID: wpr-1012915

ABSTRACT

To ensure the rights and safety of the subjects and improve the quality of clinical trials, the author analyzed and discussed the deviation type and typical cases from 184 cases of protocol violation reviewed by the ethics committee in 56 clinical trials in a tertiary hospital in 2020. Among the 184 cases of violating the protocol, there were 29 major protocol violation cases and its proportion is 16%; 99 cases (54%) violated the GCP principle; 56 cases of other violations of the protocol that require to be reported, accounting for 30%. Through the case analysis of the researcher gave the wrong doses to subjects without following the protocol and drug administration did not conform to the rules, analyzed and discussed from the five perspectives of the research protocol design, the researcher, the clinical trial institution, the sponsor and the ethics committee, and put forward solutions and suggestions, so as to provide reference to improve the compliance of clinical trial protocol, reduce the risk of subjects and protect their rights and safety and ensure the successful progress of clinical trials.

20.
Chinese Medical Ethics ; (6): 357-361, 2024.
Article in Chinese | WPRIM | ID: wpr-1012904

ABSTRACT

Smart healthcare is the outcome of integration and application of the internet, Internet of things (IOT), big data analysis and artificial intelligence (AI) in the medical field. Smart healthcare has been developed rapidly in China. However, smart healthcare has both advantages and risks, thus, it faces challenges and ethical issues in practice. Technological restrictions of smart healthcare increase the risk of privacy disclosure and delayed treatment. Besides, it also induce some ethical issues.Smart healthcare turns the "justice" issue of regional equity into the population equity of medical benefits. In addition, balancing between humanities and science technology should be considered. Smart healthcare should follow the basic ethical principles and the experience of clinical medical ethics. To give full play to the advantages of smart healthcare, the ethical challenges during its development must be regulated at the legal level, and simultaneously governed through ethical norms and guidance.

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