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Introdução: Na medida em que envelhecemos os lábios estreitam-se, ocasionando perda de volume e contorno e como forma de minimizar este efeito fisiológico o preenchimento labial de escolha utilizado é o ácido hialurônico. É possível perceber efeitos adversos advindos do emprego deste material, e pelo fato da informação ao paciente ser assegurada pelo Código de Defesa do Consumidor e pelo fato da necessidade dos Cirurgiões-Dentistas terem de esclarecer seus pacientes, o Termo de Consentimento Livre e Esclarecido tornase necessário. Objetivo: identificar, por meio de aplicação de questionário, a percepção de profissionais que trabalham com Harmonização Orofacial em relação a necessidade do emprego do Termo de Consentimento Livre e Esclarecido (TCLE). O questionário apresentou 6 perguntas objetivas, que foram disponibilizadas na plataforma Google Forms®. Material e Método: os dados obtidos foram tabulados em uma planilha eletrônica do programa Microsoft Excel e após analisados descritivamente através de tabelas de frequência, porcentagens e gráficos estatísticos. Resultados: dentre os entrevistados foi constatado que a maioria, 87,5% dos especialistas em Harmonização Orofacial realizam o procedimento de preenchimento labial em sua rotina clínica, e 12,5% não. Conclusão: no presente estudo identificamos que os especialistas realizam o emprego do TCLE, em sua maioria, porém, alguns destes ainda negligenciam o seu uso(AU)
Introduction: As we age, the lips become thinner and to minimize this effect, the lip filler used is hyaluronic acid. It is possible to notice adverse effects arising from the use of this material, and it is extremely important that Dental Surgeons have to clarify their patients, the Free and Informed Consent Form becomes necessary. Objective: to identify, through the application of a questionnaire, the perception of professionals who work with Orofacial Harmonization in relation to the need to use the Free and Informed Consent Form (TCLE). The questionnaire presented 6 objective questions, which were made available on the Google Forms® platform. Materials and Methods: the data obtained were tabulated in a Microsoft Excel spreadsheet and then analyzed descriptively using frequency tables, percentages and graphs. Results: among those interviewed, it was found that the majority, 87.5% of specialists in Orofacial Harmonization perform the lip filling procedure in their clinical routine, and 12.5% do not. With the high percentage of 59.4%, it was possible to verify that the majority of professionals perform 1 to 3 procedures per month; 31.3% perform 4 to 9 procedures per month; and 9.4% of 10 or more monthly procedures. Conclusion: in the present study it was possible to identify that the majority of specialists in Orofacial Harmonization use the informed consent form, however, some of them still neglect its use(AU)
Sujets)
Consentement libre et éclairé , Formulaires de consentement , Produits de comblement dermiqueRésumé
This study presents the importance of the Research Ethics Committees (CEP) in the context of the Brazilian North Region, formed by the Amazon rainforest, which is occupied by traditional populations and those constituted by migratory currents. This study aims to analyze the bioethical implications arising from the activities of CEPs in the ethical evaluation of research projects and their essential role in protecting vulnerable populations. The authors seek to highlight the importance of ethics committees in the Amazon and their importance face the modern bioethical values that can contribute to the preservation of one of the most valuable and diverse environments on earth.
Este estudio presenta la importancia de los comités de ética en investigación (CEP) en el contexto de la Región Norte de Brasil, formada por la selva amazónica, ocupada por poblaciones tradicionales y constituida por corrientes migratorias. Este estudio tiene como objetivo analizar las implicaciones bioéticas derivadas de las actividades de los CEP en la evaluación ética de los proyectos de investigación y su papel esencial en la protección de las poblaciones vulnerables. Los autores buscan destacar la importancia de los comités de ética en la Amazonia y su importancia frente a los valores bioéticos modernos que pueden contribuir a la preservación de uno de los ambientes más valiosos y diversos del planeta.
Esse estudo apresenta a importância dos Comitês de Ética em Pesquisa (CEPs) no contexto da Região Norte Brasileira, formada pela floresta amazônica e ocupada por populações tradicionais e aquelas constituídas por correntes migratórias. Esse estudo objetiva analisar as implicações bioéticas que surgem das atividades dos CEPs na avaliação ética de projetos de pesquisa e seu papel fundamental em proteger populações vulneráveis. Os autores procuram enfatizar a importância dos comitês de ética na Amazônia e sua importância face a valores bioéticos modernos, que podem contribuir para a preservação de um dos mais valiosos e diversos ambientes na terra.
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Este texto plantea la importancia de confeccionar protocolos de diagnóstico humanizado que permitan a los profesionales de la salud brindar información sobre patologías y/o discapacidades de manera clara y veraz, humana y delicadamente, facilitando su recepción por parte del paciente y su familia. El diagnóstico humanizado no forma parte únicamente de un protocolo de "urbanidad" en el vínculo médico paciente: es parte integrante y relevante del procedimiento o tratamiento. Este abordaje exige una mirada interdisciplinar. En esta temática hay elementos que se vinculan a lo médico científico; lo jurídico legislativo jurisprudencial y lo político.
Ao longo deste texto, discute-se a importância da elaboração de protocolos diagnósticos humanizados que permitam aos profissionais de saúde fornecerem informações sobre patologias e/ou incapacidades de forma clara e verdadeira, ao mesmo tempo em que humanizada e delicada, facilitando seu acolhimento pelo paciente e sua família. O diagnóstico humanizado não é apenas parte de um protocolo de "civilidade" na relação médico-paciente, mas parte integrante e relevante do procedimento para realizar o tratamento de uma doença ou deficiência. Essa abordagem requer uma abordagem interdisciplinar. Nessa disciplina há elementos que se vinculam ao médico-científico; as esferas jurídica, legislativa e política.
Throughout this text, the importance of creating humanized diagnostic protocols is discussed. These should allow healthcare professionals to provide clear and truthful information about pathologies and/or disabilities in a humane and delicate manner, facilitating their understanding by the patient and their family. Humanized diagnosis is not just part of a "politeness" protocol in the doctor-patient relationship, but an integral and relevant part of the procedure for treating a disease or disability. This approach requires an interdisciplinary perspective, as there are elements that are linked to the strictly medical-scientific, legal-legislative-jurisprudential, and political aspects of this topic.
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Droit SanitaireRésumé
Donation after death is the most important ethical principle to carry out organ donation after citizens’ death. The newly-revised <i>Regulations on Human Organ Donation and Transplantation</i> does not define death, and avoids the key question of “whether to recognize brain death”. Certain legal risks or damages to the rights and interests of donors may exist in organ donation. Death is an inevitable part of human life. It is necessary to establish specific criteria, which is also the only approach, to define death in any era. Death criteria are established based on the view of death, and restricted by the development level of productive forces and other social factors. The determination of death criteria hugely varies between China and the West. To standardize organ donation and transplantation and promote high-quality development of organ donation, medical staff must adhere to the principle of pure motivation, take informed consents as the premise, respect the donors' and their close relatives' rights to choose their own death criteria, strictly follow the death judgment procedures and operating norms, and ensure the scientificity, accuracy and fairness of death determination.
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Whether children can exercise their medical decision-making power has always been a controversial topic in law and ethics, and it is also the focus of attention of people from all walks of life. In this regard, combined with the problems existing in the exercise of children’s medical decision-making power, such as conflict with the right to life and health, insufficient guarantee of the right to informed consent system, and the legal guardian’s exercise of children’s medical decision-making power may not be in the best interests of children. This paper discussed the dilemma and feasibility of children’s exercise of medical decision-making power from three aspects: children’s right to life and health, the evaluation of informed consent and medical decision-making ability, and the thinking of children’s informed consent and medical decision-making ability, and pointed out that children who are able to make self-determination should be fully endowed with legal medical decision-making power, so as to ensure their best interests in medical clinic.
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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.
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In order to understand the status quo of ethical review of clinical research on the defecation function of patients with rectal cancer after sphincter-preserving surgery, analyze its causes and put forward corresponding suggestions, to arouse researchers’ attention to ethical review in subsequent relevant clinical studies. The ethical review of literatures related to the defecation function of patients with rectal cancer after sphincter-preserving surgery published on CNKI in recent 10 years was sorted out and summarized. The results showed that the ethical review of clinical research papers on defecation function of patients with rectal cancer after sphincter-preserving surgery was not optimistic. We should strengthen the ethical training of researchers, improve the ethical awareness of researchers, strictly implement the ethical norms of paper publication, strengthen the ethical requirements of manuscript contracts, perfect the ethical review system, and pay attention to the examination and supervision of informed consent, so as to promote the construction of ethical examination and approval norms of clinical research documents.
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Based on the characteristics of qualitative research, such as openness, flexibility, interaction and subjectivity, this paper discussed the related ethical challenges and responsibilities faced by institutional ethics committees and researchers in ethical review, informed consent, privacy protection and researchers’ influence in the application of medical and health fields. Ethics committees need to adopt review standards suitable for qualitative research characteristics and improve their review ability. Researchers need to consider from the perspective of research participants, improve their scientific ability and ethical awareness in the whole process of design, data collection, analysis and reporting, truly respect and protect the rights and interests of research participants, and finally produce valuable research evidence.
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Trials within cohorts (TwiCs) are design methods derived from randomized controlled trials (RCTS). They have been widely used in chronic disease areas such as tumors and cardiovascular diseases. The basis of the TwiCs design is a prospective cohort of specific diseases. When RCTS need to be implemented, some patients meeting the inclusion and exclusion criteria are randomly sampled from the cohort to receive "trial interventions", while the remaining patients in the cohort who meet the inclusion and exclusion criteria continue to receive conventional treatment as control groups. By comparing the efficacy differences between the intervention measures of the trial group and the control group, the efficacy of intervention measures was evaluated. Within the cohort, the same process could be repeated to carry out multiple RCTS, so as to evaluate different intervention measures or compare the efficacy of different doses or timing of interventions. Compared with classical RCTS, TwiCs make it easier to recruit patients from the cohort and have higher external validity, providing a new research paradigm for improving the efficiency and applicability of RCTS in clinical practice. However, TwiCs may also face the challenge of poor compliance of patients in the cohort. Researchers need to take effective measures to control these patients in the design and operation of TwiCs. This article focused on the methodological key points during the implementation of TwiCs, including multi-stage informed consent (patients are informed of consent at three stages: entering the cohort, entering the trial group, and after the trial), randomization procedures (only random sampling of patients from the cohort to receive "trial interventions"), sample size calculation, and statistical analysis methods. The article also compared the differences between TwiCs and traditional RCTS and illustrated TwiCs research design and analysis with examples, so as to provide new research ideas and methods for clinical researchers.
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Regarding biological samples, compared to the Measures of Ethical Review of Biomedical Research Involving Humans, the newly released Measures of Ethical Review of Life Science and Medical Research Involving Humans updated the definitions, clarified the scope, defined the responsibilities of the subject, as well as emphasized the management system, ethical review, and informed consent. By comparing and analyzing the current management status of biological samples at home and abroad, it was found that there were still many problems in the management and ethical review of biological samples in China, such as a chaotic management system of biological samples, unclear responsible entities for management, lack of widely recognized management standards of biological samples in the industry, absence of ethics committee, the non-standard ethical review, the inadequacy or inability to implement informed consent, and the difficulty in providing feedback on research results. Therefore, it is recommended to establish a standardized management system of biological samples, conduct a standardized and effective ethical review, as well as sufficient and necessary informed consent, in order to comply with the requirements of the Measures of Ethical Review of Life Science and Medical Research Involving Humans on biological samples, and enhancing the quality of the management of biological samples in China.
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The shared decision marking between doctors and patients is a moral requirement,which stems from the basic rights of medical staff to accept patients or their families,such as autonomy,informed consent and choice.In order to achieve the shared decision marking between doctors and patients,medical staff and patients play different roles.The task of medical staff is to introduce professional knowledge and specific experience,provide patients with multiple recommendations for diagnosis and treatment choices,and the task of patients is to choose treatment plans recognized in the shared decision marking based on their understanding of medical and ethical knowledge such as treatment goals,health values,and basic rights.From the ethical perspective,based on the shared decision marking between doctors and patients,this study deeply analyzes its ethical significance.Centering on the basic requirements of ethics,this study explores various practical models such as the doctor-patient joint participation model,the doctor-patient-family joint participation model,the doctor-nurse-patient joint participation model,the high-risk case conversation model of medical intervention,and the multidisciplinary team collaboration model from multiple perspectives and depths,to further promote the implementation of the shared decision marking between doctors and patients and to provide some reference basis.
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Therapeutic misconception refers to the misunderstanding of the essence, purpose, and potential benefits of clinical research among patients, who fail to recognize that participating in clinical research does not involve individualized treatment, but rather aims to obtain generalizable scientific knowledge. This paper explored the definition, causes, and impact of clinical research of “therapeutic misconception”, and proposed strategies to address them. By gaining a deeper understanding of “therapeutic misconception”, the quality of informed consent of research participants can be improved, their rights can be protected, and the quality of research can be enhanced.
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ObjectiveTo investigate and analyze case reporting ethical review and patient informed consent reports published in the comprehensive journals of clinical medicine in China in 2022. MethodsAccording to the data from the 2022 Edition of the Chinese Science and Technology Journal of the Citation Reports (Extended Version),the case reports published in comprehensive journals of clinical medicine in 2022 were selected as the research objects.The information on ethics and patient informed consent was extracted from the case reports that met the selection criteria,and Microsoft Excel 2021 and SPSS 21.0 were used to sort out and analyze the data. ResultsA total of 587 case reporting articles were published in the 42 included journals in 2022,of which 36 (6.13%) reported on science and technology ethics and/or informed consent.Case reports reporting on science and technology ethics and/or informed consent mostly came from the key magazine of China technology (88.89% Vs.65.88%),and the proportion of manuscripts involving science and technology ethics on the official website of the journal was relatively high (86.11% Vs.63.88%),and the difference was statistically significant (P<0.01). ConclusionThe proportion of case reports of science and technology ethics and/or informed consent in journals of comprehensive discipline classification of clinical medicine was relatively low.Currently,most international journals are required to obtain the informed consent of patients or legal guardians before publishing case reports.Compared with this,there are still certain gaps in China,which need to be paid great attention to.
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Resumo Estudos acerca do consentimento informado de paciente no âmbito da odontologia são escassos e apresentam divergências, evidenciando a necessidade de aprofundar o conhecimento sobre definições, dinâmica, atos normativos, jurisprudência e limites de responsabilidade diante de fatores diversos e riscos inerentes à profissão. Por meio de revisão bibliográfica que incluiu estudos indexados nas bases de dados SciELO e LILACS, bem como livros-texto, buscou-se definir o que se entende por consentimento livre e esclarecido do paciente, distinguir diferentes tipos e destacar a denominada "escolha esclarecida", considerando que a atividade do cirurgião-dentista é classificada como serviço e é regulamentada pela Constituição Federal de 1988, Código de Defesa do Consumidor, Código Civil e leis especiais. Diante disso, busca-se verificar se é possível melhorar a obtenção do consentimento informado do paciente, transformando-a em processo de escolha esclarecida que considere tratamentos adequadamente indicados cuja finalidade principal é a saúde.
Abstract Studies on informed patient consent in the field of dentistry are scarce and present divergences, highlighting the need to deepen knowledge about definitions, dynamics, normative acts, case law and limits of responsibility in the face of diverse factors and risks inherent to the profession. From a bibliographic review that included studies indexed in the SciELO and LILACS databases, as well as textbooks, this study aimed to define what is meant by a patient's free and informed consent, distinguish different types and highlight the so-called "informed choice," considering that the activity of the dental surgeon is classified as a service and is regulated by the 1988 Federal Constitution of Brazil, the Consumer Defense Code, the Civil Code and special laws. The aim is to see if it is possible to improve the process of obtaining informed consent from patients, transforming it into a process of informed choice that takes into account appropriately indicated treatments whose main purpose is health.
Resumen Los estudios del consentimiento informado del paciente en odontología son escasos y presentan divergencias, lo que revela la necesidad de profundizar en el conocimiento en definiciones, dinámicas, actos normativos, jurisprudencia y límites de responsabilidad frente a diversos factores y riesgos relacionados a la profesión. A partir de una revisión bibliográfica en las bases de datos SciELO y LILACS, y en libros, se buscó definir qué se entiende por consentimiento informado del paciente, distinguir diferentes tipos e identificar la llamada "decisión aclarada", considerando que la actividad del cirujano dental está clasificada como un servicio y reglamentada por la Constitución Federal de 1988, el Código de Defensa del Consumidor, el Código Civil y leyes especiales. Se busca identificar si es posible mejorar el consentimiento informado al convertirlo en un proceso de obtención de decisión aclarada que considere adecuadamente los tratamientos cuya principal finalidad sea la salud.
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Resumo Este artigo foi desenvolvido com o objetivo de analisar o respeito ao princípio da autonomia na assistência aos pacientes atendidos em clínicas odontológicas de ensino, do ponto de vista de professores e alunos. Com esse propósito, foram estudadas duas faculdades públicas do estado do Rio de Janeiro. Os dados das pesquisas foram obtidos por meio da realização de entrevistas individuais e grupos focais com alunos do último ano da graduação, entrevistas com professores e observação participante. Os resultados revelaram que os atendimentos nas instituições de ensino analisadas por vezes não contemplam o respeito ao princípio da autonomia dos pacientes. A formação profissional observada reproduz o modelo hegemônico de educação tecnicista e é regida pelo estabelecimento de uma relação paternalista entre profissionais e pacientes, o que contribui para uma constante, e indesejável, violação dos direitos dos pacientes.
Abstract This article analyzes the respect for patient autonomy in dental teaching clinics as perceived by professors and students. Data were obtained by means of individual interviews and focus groups with senior students, teachers interviews and participant observation in two public state universities. Results showed that care provision at the analyzed educational institutions oftentimes does not include respect for patient autonomy. The observed professional training reproduces the hegemonic technicist education and is informed by a paternalistic physician-patient relation that contributes to a constant and undesirable violation of patient rights.
Resumen Este artículo tiene el objetivo de analizar el respeto al principio de autonomía en la atención a los pacientes de los centros odontológicos docentes desde el punto de vista de profesores y estudiantes. Para ello, se analizaron dos universidades públicas del estado de Río de Janeiro. Los datos de la investigación se obtuvieron de entrevistas individuales y grupos focales realizadas a estudiantes en el último año de graduación, de entrevistas a docentes y observación participante. Los resultados revelaron que la atención en los centros educativos analizados, en ocasiones, no incluyen el respeto al principio de autonomía de los pacientes. La formación de los profesionales reproduce el modelo hegemónico tecnicista y se rige por el establecimiento de una relación paternalista entre los profesionales y los pacientes, lo que contribuye a una constante e indeseable violación de los derechos de los pacientes.
Sujets)
Formation des Ressources en Santé Humaine , Consentement libre et éclairé , Sens moralRésumé
Informed consent is an important medical ethical principle,which has been widely applied in clinical treatment and medical research.However,it is not fully applicable in epidemic prevention and control.The public characteristics of the technical means and governance measures of epidemic prevention and control have led to the lack of some elements of informed consent or changes in ethical standards.The principle of informed consent plays an important role in safeguarding individual rights and interests,therefore its practical value can't be ignored.One of the solutions is to redefine the connotation and practice path of informed consent,including emphasizing the combination of group-informed and individual-informed in the informed process,as well as grasping the boundaries of autonomy,and clarifying the way and scope of legal consent in the process of consent,so as to construct a paradigm of informed consent principles applicable to epidemic prevention and control work.
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Informed consent is an important ethical symbol in clinical research,and researchers have the responsibility to fully inform participants of the research information before conducting clinical research.However,it is difficult to obtain complete informed consent form participants or their guardians within a narrow treatment time period in clinical research conducted in emergency situations.Currently,in addition to traditional general informed consent,there are also reality-accepted informed consent,including exemption of informed consent,broad informed consent,and deferred informed consent.By introducing the origin and development process of deferred informed consent in clinical research,this paper sorted out the current application status of deferred informed consent,proposed the prerequisites for applying deferred informed consent in emergency situations,and explored the issues that need to be noted during the application process of deferred informed consent.It is hoped to provide an ethical defense and ethical procedure for the application of deferred informed consent in clinical research in emergency situations.
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Therapeutic misconception refers to the misunderstanding of the essence,purpose,and potential benefits of clinical research among patients,who fail to recognize that participating in clinical research does not involve individualized treatment,but rather aims to obtain generalizable scientific knowledge.This paper explored the definition,causes,and impact of clinical research of"therapeutic misconception",and proposed strategies to address them.By gaining a deeper understanding of"therapeutic misconception",the quality of informed consent of research participants can be improved,their rights can be protected,and the quality of research can be enhanced.
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Objective:Investigating the content and signing status of the informed consent form for surgery,as well as the signing status of the power of attorney to understand the current implementation of informed consent for surgery in medical institutions.Methods:A stratified random sampling method was used to investigate the signing status of surgical consent and power of attorney on 276 surgical records from a tertiary A hospital in the first half year of 2022.Results:The signatures of both patients and doctors were relatively complete.The medical teams had provided sufficient information to patients regarding the main preoperative diagnosis,surgical name,possible complications during or after the surgery,and surgical risks.However,there was inadequate information on the patient's own high-risk factors,as well as alternative treatment plans and their advantages and disadvantages.The signing of surgical consent and power of attorney signed by non-patients was not standardized.Conclusion:The implementation of informed consent for surgery in medical institutions is relatively good,but there are still some shortcomings.Medical institutions can ensure the implementation of informed consent by strengthening legal and regulatory training,clarifying the scope of authorization,strengthening the surgeon's notification and signing,as well as implementing supervision and inspection,so as to protect the unity of rights and obligations of doctors and patients,effectively avoid medical risks,and promote the construction of a harmonious doctor-patient relationship.
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The privacy problem of facial recognition technology is that commercial companies obtain people's facial information without the consent of individuals and use facial information to infringe on the privacy of individuals. The importance of human privacy in facial recognition technology is reflected through facial ethics, which requires others to perform corresponding obligations to individuals, such as oral care. Through the analysis of the privacy issues of facial recognition technology, it is found that the two elements of "without personal informed" and "without personal consent" together form the basis for commercial companies to violate personal privacy. The principle of informed consent includes the principle of informed and the principle of consent, which is derived from the principle of informed consent in medical ethics. This paper improves the principles of informed consent in medicine and ethics to better address facial recognition privacy issues.
El problema de la privacidad en la tecnología de reconocimiento facial es que las empresas comerciales obtienen información facial de las personas sin el consentimiento de éstas y utilizan la información facial para vulnerar la privacidad de las personas. La importancia de la privacidad de las personas en la tecnología de reconocimiento facial se refleja a través de la ética facial, que exige que otros cumplan las obligaciones correspondientes con los individuos, como el cuidado bucal. A través del análisis de los problemas de privacidad de la tecnología de reconocimiento facial se descubre que los dos elementos de "sin información personal" y "sin consentimiento personal" juntos forman la base para que las empresas comerciales violen la privacidad personal. El principio de consentimiento informado incluye el de información y el de consentimiento, que se deriva del principio de consentimiento informado de la ética médica. Este artículo mejora los principios del consentimiento informado en medicina y ética para abordar mejor los problemas de privacidad del reconocimiento facial.
A questão da privacidade na tecnologia de reconhecimento facial é que as companhias comerciais obtém informações faciais das pessoas sem seu consentimento e usam informação facial para infringir sua privacidade. A importância da privacidade humana na tecnologia de reconhecimento facial é refletida através da ética facial, que exige que se cumpram obrigações correspondentes para com os indivíduos, da mesma forma como com cuidados orais. Através da análise de aspectos de privacidade na tecnologia de reconhecimento facial, encontrou-se que os dois elementos "sem informação pessoal" e "sem consentimento pessoal" juntos, formam a base para companhias comerciais violarem a privacidade pessoal. O princípio do consentimento informado inclui o princípio de informação e o princípio de consentimento, os quais derivam do princípio do consentimento informado em ética médica. Esse artigo melhora os princípios do consentimento informado em medicina e ética para melhor incluir aspectos de privacidade no reconhecimento facial.