Termo de consentimento livre e esclarecido e sua relação com os procedimentos de preenchimento labial / Free and informed consent terms and its relationship with lip filling procedures

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)

Prevalence of different variations of non-consented care during the childbirth process in Mexico by geographical regions: comparing ENDIREH survey data from 2016 to 2021.

INTRODUCTION: Non-consented care, a form of obstetric violence involving the lack of informed consent for procedures, is a common but little-understood phenomenon in the global public health arena. The aim of this secondary analysis was to measure the prevalence and assess change over time of non-consented care during childbirth in Mexico in 2016 and 2021, as well as to examine the association of sociodemographic, pregnancy-, and childbirth-factors with this type of violence. METHODS: We measured the prevalence of non-consented care and three of its variations, forced sterilization or contraception, forced cesarean section, and forced consent on paperwork, during childbirth in Mexico for 2016 (N = 24,036) and 2021 (N = 19,322) using data from Mexico's cross-sectional National Survey on the Dynamics of Household Relationships (ENDIREH). Weighted data were stratified by geographical regions. We performed adjusted logistic regression analyses to explore associations. RESULTS: The national prevalence of non-consented care and one of its variations, pressure to get a contraceptive method, increased from 2016 to 2021. A decrease in the prevalence was observed for forced contraception or sterilization without knowledge, forcing women to sign paperwork, and non-consented cesarean sections nationally and in most regions. Women between the ages of 26 and 35 years, married, cohabiting with partner, living in urban settings, who do not identify as Indigenous, and who received prenatal services or gave birth at the Mexican Institute of Social Security (IMSS) facilities experienced a higher prevalence of non-consented care. Being 26 years of age and older, living in a rural setting, experiencing stillbirths in the last five years, having a vaginal delivery, receiving prenatal services at IMSS, or delivering at a private facility were significantly associated with higher odds of reporting non-consented care. CONCLUSION: While a decrease in most of the variations of non-consented care was found, the overall prevalence of non-consented care and, in one of its variations, pressure to get contraceptives, increased at a national and regional level. Our findings suggest the need to enforce current laws and strengthen health systems, paying special attention to the geographical regions and populations that have experienced higher reported cases of this structural problem.

Informed Consent and Digit Replantation: Current State and Recommendations for Ethical Patient Care.

The importance of informed consent and the value of shared decision-making in hand surgery are well-established and particularly critical in the setting of digit amputation when considering replantation. Informed consent requires an understanding of not only the immediate and long-term risks and benefits of surgery, as well as the risks and alternatives involved, but also the capacity of the patient to make a medical decision. However, patients who have acutely sustained a disfiguring trauma are often in distress and may not fully process the consent discussion. Digit replantation is an "elective emergency"-the decision must be made immediately but is not lifesaving-which poses a difficult dilemma: are surgeons acting in patients' best interests by pursuing replantation if we engage those patients in informed consent discussions when they may not have capacity? This article explores the relevant bioethical principles associated with digit replantation, summarizes updated literature regarding informed consent and shared decision-making, and provides recommendations for patient education materials to standardize informed consent discussions for surgeons approaching patients at this unique intersection of considering revision amputation versus replantation.

[Key considerations in the process of assent in children and adolescents: an integrative review]. / Consideraciones claves en el proceso de asentimiento en niños, niñas y adolescentes: revisión integrativa.

The participation of children and adolescents in research requires bioethical measures to safeguard their autonomy and well-being through the application of the informed consent process. OBJECTIVE: To critically analyze the factors involved in the process of assent/consent in children and adolescents in research. METHODOLOGY: Integrative review of scientific evidence carried out between April and June 2023, from manuscripts published between 2014 and 2023 in Web of Science, PubMed, CUIDEN, and CINAHL databases, using the descriptors Process Assessment OR Assent AND Informed Consent AND Bioethics AND Minors OR Child OR Children AND adolescent OR teenage AND Pediatrics AND Research. Twenty primary articles were found, and the results were subjected to content analysis. RESULT: Three categories were identified: shared consent/assent; child-specific factors for giving assent (age of the child to give assent and autonomy of the child to give assent), and key aspects of the assent process (assent form format; assent form content, and context for applying the assent process). CONCLUSIONS: The assent process is a key tool for legal and ethical compliance with the rights of children and adolescents in clinical trial participation. In addition to favoring participation in informed decision-making together with the parents, it is also an instance where the participant's competencies, capacity for understanding, and autonomy are valued.

Bioética em odontologia: autonomia dos pacientes em clínicas de ensino / Bioethics in dentistry: patient autonomy in teaching clinics / Bioética en odontología: la autonomía del paciente en los centros docentes

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.

Ética de las nuevas inteligencias: Memorias de las ponencias 2do Congreso de Ética en Investigación / Ethics of new intelligences: Reports of the presentations 2nd Congress of Research Ethics

Memoria de las ponencias del 2do Congreso de Ética en Investigación, realizado en la Ciudad de Buenos Aires en septiembre de 2023, y organizado por el Comité Central de Ética en Investigación del Ministerio de Salud de esta ciudad. Se presentan las ponencias del congreso, organizadas en los capítulos: Inteligencia Artificial y Datos en la investigación; Conducta responsable en investigación e integridad científica; y Mecanismos alternativos para la instrumentación del consentimiento informado en investigaciones en salud.

Análise clínica da atividade de trabalho de agentes funerários no nordeste brasileiro / A clinical activity analysis of funeral agents' work in the brazilian northeast / Análisis clínico de la actividad laboral de agentes funerarios en el nordeste de Brasil

Especializados na gestão dos processos da morte e do morrer, os agentes funerários são uma categoria profissional indispensável na sociedade contemporânea. Estudar esses profissionais, marcados por alto grau de invisibilidade social, torna-se extremamente relevante, sobretudo concebendo-os como sujeitos ativos no processo de análise de sua atividade. Nesse sentido, este artigo teve como objetivo analisar a atividade de trabalho de agentes funerários a partir das contribuições teórico-metodológicas da Clínica da Atividade. Para o desenvolvimento desta pesquisa-intervenção foram realizadas 23 observações participantes no local de trabalho, 15 entrevistas individuais e seis entrevistas em grupo, mediadas pelo uso da técnica de Instruções ao Sósia, com agentes funerários que trabalham em um grande grupo funerário no interior do nordeste brasileiro. A análise da atividade de trabalho nos levou à compreensão de que o fazer desses trabalhadores é muito mais do que lidar meramente com o corpo inerte, sem vida, mas demanda deles alto grau de habilidades para lidar com suas emoções e prestar apoio às famílias enlutadas. O gênero profissional da atividade dos agentes funerários fornece importantes maneiras desses trabalhadores se portarem. Diante das imprevisibilidades e impedimentos presentes nas rotinas de trabalho, cada agente funerário age de um jeito, estiliza seu fazer, mas há aqueles modos de agir que são compartilhados, o que permite a construção do modo coletivo do agir profissional, tornando a atividade do agente funerário uma constante mescla do coletivo e do singular.(AU)

Specialized in the management of death processes, funeral agents are an indispensable professional category in contemporary society. It is extremely relevant to study these professionals who endure a high degree of social invisibility, especially by considering them as active subjects in the process of analyzing their own activities. Thus, this study aimed to analyze the work activity of funerary agents using the theoretical-methodological contributions of Clinical Activity. To develop this research-intervention, 23 participant-observations at their workplace, 15 individual interviews, and six group interviews, mediated by the use of the Instructions to the Double technique were carried out with funeral agents who work in a large funeral group in the inner Brazilian northeast. The analysis of work activity led us to understand that these workers' job prescriptions exceeds dealing with inert lifeless bodies. These workers have a high demand of socio-emotional skills, especially to cope and support grieving families. The professional genre in funeral agents' activity provide important ways for these workers to behave. As a result of the unpredictability and impediments in their work routines, funerary agents find their own way to meet the demands of work. However, their shared conducts enable them to construct the collective mode of professional action, making funerary agents' activity a constant mixture of collective and singular contributions.(AU)

Especializados en la gestión de los procesos de la muerte y del morir, los agentes funerarios son una categoría profesional indispensable en la sociedad contemporánea. Estudiar estos profesionales, caracterizados por el alto grado de invisibilidad social, se convierte en algo extremamente relevante, principalmente considerándolos como sujetos activos en el proceso de análisis de su actividad. En este sentido, este artículo tuvo como objetivo analizar la actividad laboral de agentes funerarios a partir de las contribuciones teórico-metodológicas de la Clínica de la Actividad. Para el desarrollo de esta investigación-intervención fueron realizadas 23 observaciones participantes en el local de trabajo, 15 encuestas individuales y seis grupales, mediadas por el uso de la técnica de instrucción al doble, con agentes funerarios que trabajan en un grupo funerario en el interior del Nordeste de Brasil. El análisis de la actividad laboral destaca que estos profesionales desempeñan una labor que va más allá del cuerpo inerte, sin vida, que les requiere un alto grado de habilidades para lidiar con las emociones y fornecer apoyo a las familias en duelo. El tipo profesional de la actividad de los agentes funerarios les proporciona a estos trabajadores importantes modos de portarse. Ante lo imprevisible y las dificultades en sus rutinas de trabajo, cada agente funerario actúa a su manera, pero hay modos de actuar compartidos, lo que permite la construcción del modo colectivo del actuar profesional, transformando la actividad del agente funerario en una constante mezcla entre lo colectivo y lo singular.(AU)

Introducción al Capítulo III: El consentimiento informado en la era digital: Desafíos éticos y tecnológicos en medicina e investigación / Introduction to Chapter III: Informed consent in the digital age: Ethical and technological challenges in medicine and research

El consentimiento (CI) es un proceso dinámico y continuo en el cual la progresión de la información se establece mediante un diálogo esclarecedor entre las partes interesadas. Este, se basa en el respeto mutuo entre los profesionales y los pacientes o los posibles participantes en una investigación. (COPILOT IA, 2024) Numerosos tratados de ética médica y de investigación, publicados en libros, conferencias y medios electrónicos, abordan los distintos modelos, usos y metodologías para obtener y proporcionar un consentimiento informado. Si en la actualidad buscamos el término 'consentimiento informado' en Google, obtenemos más de 32.000.000 de resultados en varios idiomas. Esto demuestra que el tema se discute ampliamente en distintos ámbitos y desde diferentes perspectivas, lo que puede ayudarnos a comprender el proceso con mayor profundidad. En la era digital, el uso del consentimiento informado ha cobrado gran relevancia, especialmente en el ámbito de la investigación. Las herramientas digitales facilitan que los pacientes comprendan los detalles de una intervención y acepten mediante su firma electrónica. Sin embargo, resulta crucial garantizar que el contenido no se altere después de la firma y que el documento pueda recuperarse para demostrar autenticidad e integridad. (AU)

Integración del aviso de privacidad al formulario del consentimiento Informado en un hospital escuela / Integration of the privacy notice to the informed consent form in a teaching hospital

Las instituciones de salud que se dedican a la enseñanza y las que realizan investigación clínica deben incluir un aviso de privacidad de la información del paciente; de la privacidad y protección de datos personales en el formulario del consentimiento informado. El aviso de privacidad aclara el uso que se les da a los datos que se recaban en las instituciones de salud y cómo garantizan la protección, confidencialidad y privacidad de los datos personales. (AU)

Algunos interrogantes a la no presencialidad y la mediación tecnológica en el proceso de consentimiento informado / Some questions regarding non-presence and mediation technology in the informed consent process

Frente a los grandes desafíos que se nos presenta con los avances tecnológicos nos interrogamos sobre la posibilidad del uso de las nuevas tecnologías para la obtención del consentimiento informado. Sin perder de vista la necesidad de agilizar estos procedimientos pero puesta la mirada en el sujeto, parte de la investigación, ¿se protege su dignidad y su autonomía con el uso de estas nuevas formas? O pensarlo de modo contrario, ¿con el tradicional procedimiento de consentimiento informado, se protege al sujeto que participa en el proyecto de investigación? (AU)

El consentimiento Informado en la era de las tecnologías de información y comunicación / Informed consent in the age of information and communication technologies

Introducción: La emergencia sanitaria evidenció una carencia de alternativas para la toma del consentimiento informado (CI) en investigaciones biomédicas. Algunos países elaboraron nuevas normativas, utilizando tecnologías de información y comunicación (TICs) para obtener consentimiento. Materiales y métodos: se revisó bibliografía de los últimos 3 años y las normativas vigentes, argentinas e internacionales, sobre modalidades del CI en investigación biomédica. Resultados: Las investigaciones sobre comprensión, legibilidad y longitud de la información de los formularios de CI muestran que debe mejorarse la presentación al sujeto para su correcta comprensión. En EEUU se utilizan TICs para informar y obtener CI, resguardando la autonomía del sujeto por la intervención de un testigo. Las normas de la República Argentina sólo aprueban el proceso por escrito. Conclusiones:La emergencia por COVID-19 ha planteado desafíos para investigar. Se requiere mayor estudio sobre la adecuación de contenidos de CIs para investigaciones, y revisión de las normativas nacionales. (AU)

Necesidad de información preoperatoria en pacientes intervenidos en el servicio de otorrinolaringología / Need for preoperative information in patients undergoing surgery in the Otorhinolaryngology Department

Resumen Objetivo: determinar las necesidades de información en el preoperatorio de los pacientes atendidos en el servicio de otorrinolaringología del Hospital Nacional Arzobispo Loayza de Lima, Perú. Métodos: investigación de tipo descriptiva y de corte transversal. Se estudiaron 127 pacientes quirúrgicos del servicio de otorrinolaringología. Se utilizó un cuestionario de demandas de información y conocimiento de los pacientes en cuanto a su derecho de decidir una cirugía; contiene preguntas referentes a la descripción de la técnica quirúrgica, complicaciones y riesgos que conlleva la cirugía. Se utilizó una muestra no probabilística por conveniencia, así como el análisis de los datos, el cual se realizó con el paquete estadístico SPSS en versión 25. Para evaluar la correlación entre variables se empleó la prueba chi-cuadrado. Resultados: participaron 127 pacientes, más de 75% de ellos deseaban conocer más información sobre su enfermedad y el tratamiento quirúrgico, 90% manifestaron el deseo de tener una explicación de cómo se realizará la cirugía, 85% necesitaban conocer las complicaciones frecuentes, 20% deseaba ignorar la información sobre posibilidad de muerte. Los adultos jóvenes y el grupo con educación superior demandaban más información (p<0.05), no presentaron diferencias respecto al sexo, salvo en la necesidad de conocer el riesgo de muerte a causa de la cirugía, a favor del sexo femenino (p<0,05). Conclusiones: la mayoría de los pacientes necesitan una información detallada durante la evaluación preoperatoria, principalmente en los grupos de adultos jóvenes y con educación superior. Los médicos debemos brindar información suficiente, clara y con expectativas reales, respetando la autonomía del paciente en la toma de decisiones.

Abstract Aim: To determine the informational needs of preoperative patients being attended at the Otorhinolaryngology Service of the Hospital Nacional Arzobispo Loayza of Lima, Peru. Methods: Using cross-sectional descriptive research, 127 surgical patients from the Otorhinolaryngology Service were studied. A questionnaire asked what information and knowledge the patients had when exercising their right to decide surgery. It contained questions concerning the description of the surgical technique, complications, and risks involved in the surgery. A non probability sample by convenience was used and the data analysis was performed with the SPSS statistical package in version 25 and the chisquare test was used to evaluate the correlation between variables. Results: 127 patients participated, more than 75% of patients wanted to know more information about their disease and the surgical treatment, 90% stated that they needed an explanation of how the surgery would be performed, 85% wanted to know the common complications, and 20% wanted to ignore the possibility of death. Young adults and the group with higher education demanded more information (p<0.05). Concerning sex, there were no differences between the men and women in their answers other than the females needing to know the risk of death due to surgery (p<0.05). Conclusions: Most patients need detailed information during the preoperative evaluation, especially young adults and those with higher education. Physicians should provide sufficient, clear information with realistic expectations, respecting the patient's autonomy in decision-making.

[Ethical aspects in the assent of adolescents to participate in research]. / Aspectos éticos en el asentimiento de los adolescentes para participar en investigaciones.

OBJECTIVE: to describe the ethical aspects to be considered in the consent of adolescents to participate in research. MATERIAL AND METHOD: A narrative review was conducted in the scientific databases PUBMED and BVS, between 2010-2021, the search was conducted in English, and MeSH and DeCS descriptors were used, obtaining a total sample of 12 articles selected for analysis. RESULTS: Age was commonly used instead of directly assessing the ability to understand the issues and make an informed decision about participating in research. This ability is influenced by age, context, and development. Adolescent decision-making is substantially different in the presence of peers. A balance is needed between recognizing the emerging autonomy in adolescents, their differential developmental rhythms, and their not yet fully mature response to personal risk. CONCLUSIONS: It is necessary to generate responses and strategies that safeguard both safety and respect for adolescents, focusing on the characteristics of both the age group and the individual, unifying valid mechanisms for determining the capacity to consent, integrating criteria from the sciences regarding cognition, maturation and development, psychology and ethics.

Shared decision-making and specific informed consent in patients with aortic aneurysms.

OBJECTIVE: To analyze the refusal rate of elective aortic aneurysm surgery in asymptomatic patients after the presentation of a detailed informed consent form followed by a meeting where patient and their families can analyze each item. METHODS: We conducted a retrospective analysis of 49 patients who had aneurysms and were offered surgical treatment between June 2017 and February 2019. The patients were divided into two groups: the Rejected Surgery Group, which was composed of patients who refused the proposed surgical treatment, and the Accepted Surgery Group, comprising patients who accepted the proposed surgeries and subsequently underwent them. RESULTS: Of the 49 patients, 13 (26.5%) refused surgery after reading the informed consent and attending the comprehensive meeting. We observed that patients who refused surgery had statistically smaller aneurysms than those who accepted surgery (9% versus 26%). These smaller aneurysms were above the indication size, according to the literature. CONCLUSION: One-quarter of patients who were indicated for elective surgical repair of aortic aneurysms rejected surgery after shared decision-making, which involved presenting patients with an informed consent form followed by a clarification meeting for them and their families to analyze each item. The only factor that significantly influenced a rejection of the procedure was the size of the aneurysm; patients who rejected surgery had smaller aneurysms than those who accepted surgery. Up to 26% of patients with aortic aneurysms refused surgical repair. The proposed technique, whether open or endovascular, did not influence patients' decisions. Patients with smaller aneurysms were more likely to refuse aortic aneurysm treatment.

Prioritizing women's choices, consent, and bodily autonomy: From a continuum of violence to women-centric reproductive care.

Obstetric violence is a product of medical institutions' failure to prioritize women-centric reproductive care. Through interviews with local activists and leaders in Oaxaca, Mexico, as well as analysis of primary and secondary sources, we find that women-centric reproductive care is hindered by three barriers that are a part of a continuum of violence. These barriers include the cultural and religious norms surrounding reproductive care, the medical community and medical profiteers' opposition to combatting obstetric violence, and the state's resistance to women's human rights policy changes. Shifting to a women-centric reproductive care model requires: the life of the woman to be prioritized in reproductive care, the criminalization of obstetric violence, improved training for the medical community, reduced monetary incentives for unnecessary cesarean sections, and the respectful inclusion of indigenous and midwife knowledge and practices. Our study's theoretical and empirical contributions add to the scholarly research regarding the systemic causes of obstetric violence and the care ethic required for transformative change. Our recommendations can be applied across contexts with locally developed and culturally inclusive models of women-centric reproductive care.