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)

Consentimento livre e esclarecido em participantes de pesquisa clínica / Free and informed consent in clinical research participants / Consentimiento libre e informado en participantes de investigación clínica

Objetivo: avaliar o processo de consentimento dos participantes de pesquisa clínica. Método: estudo exploratório, retrospectivo e quantitativo, desenvolvido em hospital de referência nacional em oncologia entre maio de 2016 e janeiro de 2017. Foi elaborado formulário e submetido a teste piloto. Utilizou-se o índice de legibilidade de Flesch-Kincaid (ILFK) na avaliação dos Termos de Consentimento Livre e Esclarecido (TCLE). Realizou-se análise descritiva e univariada. Resultados: o cálculo do ILFK revelou que 100% dos TCLEs apresentaram leitura muito difícil. A idade do participante foi estatisticamente significante nas questões sobre ajuda na leitura do TCLE antes da assinatura (p=0,02), dificuldade de leitura do TCLE (p=0,04) e se assinou o TCLE antes de iniciar a participação (p=0,02). A escolaridade apresentou significância quanto à questão sobre indenizações (p=0,02), e o sexo, quanto à questão de ajuda de familiar para a leitura do TCLE (p=0,01). Conclusão: percebeu-se a necessidade em estabelecer padrões que proporcionem tomada de decisão consciente e própria do participante, considerando a escolaridade, necessidades pessoais, crenças e costumes.

Objective: to evaluate the consent process of clinical research participants. Method: exploratory, retrospective and quantitative study, developed in a national reference hospital in oncology between May 2016 and January 2017. Form was prepared and submitted to pilot test. The Flesch-Kincaid readability index (FKRI) was used in the evaluation of the Informed Consent Forms (ICF). Descriptive and univariate analysis was performed. Results: the calculation of the FKRI revealed that 100% of ICFs had very difficult reading. The age of the participant was statistically significant in questions about help in reading the ICF before signing (p=0.02), difficulty reading the ICF (p=0.04) and signed the ICF before starting the participation (p=0.02). Education was significant in relation to the issue of compensation (p=0.02), and sex to the question of family help for reading the ICF (p=0.01). Conclusion: it was perceived the need to establish standards that provide conscious decision making of the participant, considering education, personal needs, beliefs and customs.

Hallazgos incidentales en medicina genómica / Incidental Findings in Genomic Medicine

Las técnicas de Biología Molecular de última generación, como es la secuenciación masiva en paralelo o NGS (Next Generation Sequencing), permite obtener gran cantidad de información genómica, la cual muchas veces va más allá de la detección de una variante patogénica en un gen que explique la patología (hallazgo primario). Es así como surgió desde hace años la discusión internacional respecto a la decisión a tomar frente a los hallazgos secundarios accionables, es decir, aquellos hallazgos de variantes clasificadas como patogénicas o probablemente patogénicas que no están relacionadas con el fenotipo del paciente, pero que tiene alguna medida preventiva o tratamiento posible y, por lo tanto, podría ser de utilidad para la salud del paciente. Luego de revisar la bibliografía internacional y debatir entre los expertos del Hospital de Pediatría Garrahan, se logró establecer una política institucional y reforzar el hecho de que se trata de una disciplina multidisciplinaria. Así, fue posible definir que solo se atenderá las cuestiones relacionadas con la edad pediátrica, dejando para un tratamiento posterior aquellas variantes detectadas en genes que sean accionables en edad adulta. En el Hospital Garrahan, ha sido posible definir claramente cómo proceder frente a los hallazgos secundarios, al adaptar el consentimiento informado a esta necesidad, definiendo cuándo serán informados, y sabiendo que serán buscados intencionalmente en los genes clínicamente accionables enlistados en la última publicación del American College of Medical Genetics and Genomics, siempre y cuando el paciente/padre/tutor lo consienta (AU)

The latest generation of molecular biology techniques, including massive parallel sequencing or NGS (Next Generation Sequencing), allows us to obtain a whealth of genomic information, which often goes beyond the detection of a pathogenic variant in a gene that explains the pathology (primary finding). As a result, an international discussion has arisen over the years regarding the decision-making concerning actionable secondary findings, it means, those findings of variants classified as pathogenic or probably pathogenic that are not related to the patient's phenotype, but which have some possible preventive measure or treatment and, therefore, could be useful for the patient's health. After reviewing the international literature and discussing among the experts of the Hospital de Pediatría Garrahan, an institutional policy was established and the concept that this is a multidisciplinary discipline was reinforced. Consequently, it has been defined that only issues related to children will be addressed, reserving those variants detected in genes that are actionable in adulthood for later treatment. At Garrahan Hospital, we were able to clearly define how to proceed with secondary findings by adapting the informed consent to this need, defining when they will be reported, and knowing that they will be intentionally searched for in the clinically actionable genes listed in the latest publication of the American College of Medical Genetics and Genomics, as long as the patient/parent/guardian consents (AU)

Desafíos clínicos y normativos de la internación forzada en Chile, en virtud de la nueva Ley de Salud Mental / Clinical and regulatory challenges of forced hospitalization in Chile under the new Mental Health Law

Forced hospitalization is a common practice in psychiatry. It involves limiting the patient's freedom of movement in a clinical context without expressing informed consent, causing stress to the family and support network. Thus, forced hospitalization may cause violations, disturbances, or threats to the human rights of a vulnerable population. Considering this clinical reality, the present study seeks to analyze the current law on this subject in Chile compared to the international human rights guidelines. The analysis included a review of legal documents and referenced scientific articles. The new law No. 21,331 establishes a more demanding standard for the origin of forced internment, shortening the distance concerning the human rights guidelines regarding intellectual disability. The incoming development of the regulations mandated by the law could fill in the gaps in several situations that may arise and clarify fuzzy points. The key stakeholders' participation level will be critical in this matter.

Comprensión del consentimiento informado por parte de los pacientes de la Facultad de Odontología de la Universidad de Costa Rica / Understanding of informed consent by patients at the Faculty of Dentistry of the University of Costa Rica

Introducción: El consentimiento informado es el resultado de la evolución de la relación entre las personas profesionales de la salud y sus pacientes o usuarios donde el principio de autonomía está por encima de cualquier otra cosa. Existen muchos artículos sobre el consentimiento informado pero ninguno de los estudios encontrados evaluó si los pacientes realmente lo comprenden. El objetivo de esta investigación fue determinar el nivel de comprensión del consentimiento informado por parte de los pacientes de la Clínica de Exodoncia y Cirugía de la Facultad de Odontología de la Universidad de Costa Rica, en el período agosto a septiembre del 2022, mediante un cuestionario que permitiera correlacionar la comprensión con el nivel de escolaridad. Materiales y métodos: Se realizó un cuestionario a 100 personas dividido en dos partes, una sobre datos sociodemográficos y la otra para establecer la comprensión del consentimiento informado y determinar si el grado de escolaridad tenía relación con la comprensión de este. Resultados: El grupo entre 20 y 30 años fue el mayor, de estos el 51% tuvo estudios universitarios, y aunque la mayoría (98%) refirió conocer el concepto de consentimiento informado, únicamente el 33 % obtuvo las respuestas correctas a las preguntas clínicas realizadas. Conclusiones: A pesar de que los pacientes refieren conocer qué es el consentimiento informado los resultados sugieren una comprensión poco clara de conceptos importantes como complicaciones o reacciones adversas inmediatas o tardías producidas por el efecto de los tratamientos odontológicos o procedimientos quirúrgicos.

Introduction: Informed consent is the result of the evolution of the relationship between health professionals and their patients or users where the principle of autonomy is above anything else. There are many articles on informed consent but none of the studies found assessed whether patients really understand it. The objective of this research was to determine the level of understanding of informed consent by the patients of the Clinic of Oral Surgery of the Faculty of Dentistry of the University of Costa Rica, in the period August to September 2022, by means of a questionnaire that would allow correlating the understanding with the level of schooling. Materials and methods: A questionnaire was administered to 100 people divided into two parts, one on sociodemographic data and the other to establish the understanding of informed consent and to determine whether the level of schooling was related to the understanding of the same. Results: The group between 20 and 30 years of age was the largest, of these 51% had university studies, and although the majority (98%) referred to knowing the concept of informed consent, only 33% obtained the correct answers to the clinical questions asked. Conclusions: Even though patients refer to knowing what informed consent is the results suggest an unclear understanding of important concepts such as complications or immediate or late adverse reactions produced by the effect of dental treatments or surgical procedures.

Acessibilidade do termo de consentimento na pesquisa clínica no Brasil / Accessibility of the consent form in Brazilian clinical research / Accesibilidad al formulario de consentimiento en la investigación clínica en Brasil

Resumo O termo de consentimento livre e esclarecido tem a função de informar o participante de pesquisas clínicas sobre a natureza da pesquisa e seus direitos, formalizando sua decisão de participar. Estudos indicam que esse documento é redigido de modo complexo, comprometendo a autonomia do participante. Para este trabalho, foram redigidos dois termos de consentimento da mesma pesquisa hipotética, com estilos de redação diferentes. Ambos os termos foram analisados pela ferramenta Coh-Metrix Port, que avalia métricas linguísticas e acessibilidade textual. A análise indicou que os textos são complexos e exigem alta escolaridade para serem entendidos. Esses achados reforçam a percepção de que, no Brasil, os termos de consentimento podem ter sua real função comprometida e apontam a importância de modificar sua forma de elaboração.

Abstract The informed consent form informs clinical research patients about the nature of the research and their rights, formalizing their decision to participate; however, studies show that this document is written in a complex manner, compromising patient autonomy. Two consent forms from the same hypothetical research were developed with different writing styles and analyzed by the Coh-Metrix Port tool, which evaluates linguistic metrics and textual accessibility. Results showed that both texts were complex and required high schooling level to be understood. These findings reinforce the perception that consent forms may have their real function compromised and point to the importance of changing its elaboration.

Resumen El formulario de consentimiento informado tiene la finalidad de mostrar la naturaleza de la investigación y sus derechos al participante de la investigación clínica para formalizar su decisión de participar en el estudio. Los estudios indican que la redacción de este documento es compleja, lo que compromete la autonomía del participante. Para este estudio se redactaron dos formularios de consentimiento de una misma investigación hipotética, con diferentes estilos de escritura. Para el análisis de ambos formularios se utilizó la herramienta Coh-Metrix Port, que evalúa las métricas lingüísticas y la accesibilidad textual. Los resultados apuntaron a que los textos son complejos, lo que requiere un alto nivel de educación para su comprensión. Estos hallazgos coinciden que, en Brasil, los formularios de consentimiento pueden tener su finalidad comprometida y señalan la necesidad de modificar su forma de elaboración.

Estratégias para favorecer a compreensão do termo de consentimento pelos participantes de ensaios clínicos: revisão integrativa / Strategies to favor comprehension of the consent form by clinical trial participants: an integrative review / Estrategias para facilitar la comprensión del formulario de consentimiento por parte de los participantes en ensayos clínicos: una revisión integradora

Objetivo: analisar as estratégias utilizadas para favorecer a compreensão de participantes de pesquisas clínicas sobre o termo de consentimento livre e esclarecido, bem como, as bases teóricas em que se apoiam. Métodos: revisão integrativa da literatura realizada no ano de 2019 e atualizada em 2021 em seis bases de dados eletrônicas, adicionada de busca reversa a partir das referências dos artigos incluídos. Resultados: dos 21 artigos selecionados, foram identificadas estratégias de mudanças no conteúdo, da forma de apresentação do termo de consentimento, bem como estratégias multimodais. As estratégias identificadas relacionam-se, em sua maioria, ao referencial tradicional de aprendizagem e resultaram em melhor compreensão por parte dos indivíduos que estavam em processo de obtenção do consentimento para participar de ensaios clínicos, em comparação com as estratégias usuais, mas, para a maioria o patamar de compreensão manteve-se abaixo de 60,0%. Conclusões: as estratégias resultaram na melhora da compreensão geral, porém, com persistência da incompreensão ou compreensão limitada de conceitos fundamentais inerentes à participação em pesquisas clínicas, reforçando que o processo de obtenção do consentimento é um fenômeno complexo e que requer atenção especial dos pesquisadores, na busca de garantir a compreensão adequada das informações, garantindo, de fato, a tomada de decisão esclarecida.

Objective: to analyze the strategies used to favor the comprehension of clinical trial participants about the informed consent form, as well as the theoretical bases on which these are based. Methods: integrative literature review performed in 2019 and updated in 2021 in six electronic databases, plus a reverse search based on references of the included articles. Results: strategies of changing the content and the form of presentation of the consent form, as well as multimodal strategies were identified in the 21 selected articles. The identified strategies are mostly related to the traditional learning framework and resulted in a better understanding by individuals in the process of obtaining consent to participate in clinical trials, compared to the usual strategies. For the most part, the level of comprehension remained below 60.0%. Conclusions: the strategies resulted in an improvement in general understanding, although with persisting misunderstanding or limited understanding of fundamental concepts inherent to participation in clinical trials, reinforcing that the process of obtaining consent is a complex phenomenon that requires special attention from researchers, in the quest to ensure proper understanding of information, and an actually informed decision-making.

Objetivo: analizar las estrategias utilizadas para favorecer la comprensión de los participantes en la investigación clínica sobre el formulario de consentimiento informado, así como las bases teóricas en las que se fundamentan. Métodos: revisión bibliográfica integradora realizada en 2019 y actualizada en 2021 en seis bases de datos electrónicas, además de búsqueda inversa a partir de las referencias de los artículos incluidos. Resultados:de los 21 artículos seleccionados, se identificaron estrategias para modificar el contenido y la forma de presentación del formulario de consentimiento, así como estrategias multimodales. Las estrategias identificadas estaban relacionadas en su mayoría con el marco de aprendizaje tradicional y dieron lugar a una mejor comprensión por parte de las personas que estaban en proceso de obtener el consentimiento para participar en ensayos clínicos, en comparación con las estrategias habituales, pero para la mayoría de ellas el nivel de comprensión se mantuvo por debajo del 60%. Conclusiones: las estrategias resultaron en una mejora de la comprensión general, sin embargo, con la persistencia de incomprensión o comprensión limitada de conceptos fundamentales inherentes a la participación en la investigación clínica, reforzando que el proceso de obtención del consentimiento es un fenómeno complejo que requiere especial atención por parte de los investigadores, en la búsqueda de garantizar la adecuada comprensión de la información, asegurando, de hecho, la toma de una decisión informada

Autonomia da pessoa com problema de álcool: consentimento informado / Autonomy of individuals with alcohol-related disorders: informed consent / Autonomía de la persona con problema relacionado al alcohol: consentimiento informado

Resumo O consentimento livre e esclarecido, como forma de garantir envolvimento e participação em tratamento, é parte da abordagem terapêutica à pessoa com problemas relacionados ao uso de álcool. O valor ético central da autonomia e sua imanência para o consentimento informado apresenta desafios ético-clínicos no caso de pessoa que busca tratamento em situação de coerção, ansiedade ou depressão. Entre abril de 2018 e junho de 2019, conduziu-se estudo observacional longitudinal prospetivo que incluiu 150 pessoas com problemas relacionados ao uso de álcool assistidas em unidade especializada de tratamento. O objetivo foi verificar se o consentimento com interferência de coerção, perturbação de ansiedade ou depressão determina a participação terapêutica. A ausência de coerção judicial e sintomatologia ansiosa e a maior valorização da perceção de autonomia no consentimento informado relacionaram-se com a participação. Propõem-se contributos para reforçar a prática do consentimento informado assente no reconhecimento e promoção da autonomia.

Abstract Informed consent, as a way to ensure involvement and treatment adherence, is part of the therapeutic approach to individuals with alcohol-related disorders. Autonomy, as a core ethical value, and its immanence for informed consent presents ethical-clinical challenges in the case of individuals seeking treatment due to coercion, anxiety, or depression. Between April 2018 and June 2019, a prospective longitudinal observational study was conducted with 150 people with alcohol-related disorders attending a specialized treatment facility. The goal was to verify whether consent obtained under coercion, or influenced by anxiety disorder or depression determines therapeutic participation. Absence of judicial coercion and anxious symptomatology and the greater value placed on perceived autonomy in informed consent were related to participation. The study proposes contributions to strengthen the practice of obtaining informed consent based on the recognition and promotion of autonomy.

Resumen El consentimiento informado, que garantiza comprometimiento y participación en el tratamiento, forma parte del enfoque terapéutico del manejo de la persona con problemas relacionados al consumo de alcohol. El valor ético de la autonomía y su inmanencia para el consentimiento informado tiene desafíos ético-clínicos en el caso de personas que buscan tratamiento en situación de coerción, ansiedad o depresión. Entre abril de 2018 y junio de 2019 se realizó un estudio observacional longitudinal prospectivo con 150 personas con problemas relacionados al consumo de alcohol, asistidas por un centro de tratamiento especializado. Este estudio pretendió confirmar si el consentimiento por coerción, trastorno de ansiedad o depresión influye en la participación terapéutica. La ausencia de coerción judicial y de síntomas ansiosos, así como la mayor autonomía en el consentimiento se relacionaron con la participación. Se proponen aportes para reforzar la práctica del consentimiento informado desde el reconocimiento y promoción de la autonomía.

Dever de informação em medicina: análise de processos judiciais / Disclosure of information in medicine: analysis of judicial cases / El deber de informar en medicina: análisis de las demandas

Resumo Termo de consentimento é a expressão de uma decisão voluntária, tomada após processo informativo, no sentido de aceitar um tratamento considerando riscos, benefícios e possíveis consequências. Este estudo analisou o papel do termo de consentimento em decisões do Tribunal de Justiça do Estado de São Paulo. No período de um ano, realizou-se busca com as palavras-chave "termo de consentimento" e "erro médico", e os dados dos 65 acórdãos estudados foram expostos mediante recursos do programa Excel. Em 15 casos não se utilizou o documento, dos quais 12 demostraram falta do dever de informar. Em 31% dos processos houve condenação do réu e a maioria dos autores que receberam compensação financeira fez jus a indenização por danos morais. As áreas de atuação na medicina que mais figuraram como rés foram cirurgia plástica e ginecologia e obstetrícia. Ficou demonstrada a relevância da aplicação do termo de consentimento e da atuação do perito médico.

Abstract Consent expresses a voluntary decision, taken after disclosure of information, to accept treatment considering risks, benefits, and possible consequences. This study analyzed the role of consent forms in decisions by the São Paulo State Court of Justice. Bibliographic search was conducted using the keywords "consent form" and "medical error." The 65 rulings identified were analyzed using Excel. Of the 15 cases in which patients were not presented with a consent form, 12 showed lack of information disclosure. In 31% of the cases, the defendant was found guilty, and most of the plaintiffs who received financial compensation were awarded moral damages. Plastic surgery, gynecology and obstetrics were the branches that most often featured as defendants. The findings attest the relevant role played by the consent form and the medical expert.

Resumen El formulario de consentimiento expresa una toma de decisión voluntaria al aceptar el tratamiento después de informados los riesgos, beneficios y posibles consecuencias. Este estudio analizó el papel del formulario de consentimiento en las decisiones del Tribunal de Justicia del Estado de São Paulo. Durante un año se realizó una búsqueda con las palabras clave "formulario de consentimiento" y "error médico", y los datos de las 65 demandas se expusieron en el programa Excel. En 15 casos no se utilizó el documento, de los cuales 12 demostraron haber una falla del deber de informar. El 31% de los casos lo condenó al acusado, y la mayoría de los autores que recibieron una compensación económica tenían derecho a indemnización por daño moral. Las áreas de la Medicina que recibieron más demandas fueron la cirugía plástica y la ginecología y obstetricia. Son fundamentales aplicar el formulario y la actuación del perito médico.

Prevalencia de síndrome de Burnout en internos de pediatría de la Universidad Católica del Maule / Burnout Syndrome Prevalence in pediatric interns of the Catholic University of Maule

Burnout syndrome is a public health problem, a pathological entity that affects professionals who work directly with people, such as health professionals. It is currently described as being composed of three dimensions: emotional exhaustion, depersonalization and personal fulfillment, and its evaluation is carried out through the Maslach Burnout Inventory questionnaire. The present study aims to measure, by means of the aforementioned instrument, the prevalence of Burnout Syndrome in pediatric interns of the Universidad Católica del Maule and find out which is the most frequent characteristic that the pathology presents, in relation to the 3 subgroups. It corresponds to a descriptive and cross-sectional study, in which the Maslach Burnout Inventory questionnaire was applied to a sample of 18 pediatric inmates of the Regional Hospital of Talca, together with an informed consent to each participant. The results showed that the burnout syndrome is present in 11,11% of pediatric interns, in addition it was observed that a high percentage manifests alterations in the studied subdimensions, which makes us conclude that attention should be given urgently to this problem, in order to guarantee mental health support to those who need it.

Panel de expertos para la elaboración de un modelo de consentimiento informado de obtención y uso de material audiovisual clínico / Proposal of an informed consent form to obtain audiovisual material from patients

BACKGROUND: An informed consent is mandatory to obtain any clinical audiovisual material from patients. Although there are some documents created for this purpose, there are some barriers for their application, such as the context in which they were created, the language and download availability. AIM: To create a proposal for an informed consent form (ICF) for the capture and different uses for audiovisual material from patients. MATERIAL AND METHODS: A bibliographic search was carried out to obtain different ICFs in Spanish and English, which were subjected to a process of translation, counter-translation and fragmentation. Subsequently, a panel of experts was formed by members of the Chilean Society of Plastic Surgery with extensive experience in social networks. Delphi methodology was applied to reach a consensus about the definitive content of the ICF based on the previously selected fragments. RESULTS: ICFs available for download were identified. The panel was made up of seven Plastic Surgeons and two Delphi rounds were carried out through electronic surveys. At the end of the process, an ICF proposal was obtained for therapeutic, academic or scientific purposes and another for dissemination or education in the mass media. CONCLUSIONS: The proposed ICFs were liberated for their use among health care professionals in Chile, who could use them, provided that they are approved by the local healthcare ethics committees.

Aspectos éticos y recomendaciones para investigación en seres humanos en la era genómica / Ethical aspects and recommendations for human research in the genomic age

Este artículo revisa los principales desafíos éticos que plantea la investigación vinculada al genoma humano a la luz de la bibliografía internacional y entrega recomendaciones sobre su abordaje basada en nuestra experiencia en el Comité de Ética para la Investigación en Seres Humanos de la Facultad de Medicina, Universidad de Chile, incluyendo las regulaciones legales nacionales. Los estándares éticos de la investigación en seres humanos deben extremarse para proteger adecuadamente a los participantes en estudios involucrados con la genómica. Especialmente relevantes en este contexto son: la protección de la confidencialidad y anonimato; la política de entrega de resultados y la posibilidad de retirarse del estudio. Compartir datos resultantes de investigaciones genéticas permite optimizar recursos, otorga mayor transparencia y replicabilidad de los análisis y permite descubrir alteraciones genéticas responsables de enfermedades raras y genes involucrados en enfermedades hereditarias multifactoriales, además de contribuir al diseño de medicina de precisión y de nuevas estrategias terapéuticas. Sin embargo, plantea grandes desafíos: proteger la privacidad y evitar la re-identificación de los voluntarios, la entrega de resultados con asesoría pre y post estudio. Estos aspectos requieren la elaboración de un cuidadoso proceso de consentimiento informado para investigaciones genómicas cuyos componentes principales se analizan en este artículo.

This article reviews the main ethical challenges posed by human genome research in the light of the international literature and provides recommendations on how to approach them based on our experience in the Ethics Committee for Research on Human Subjects of the Faculty of Medicine, University of Chile, including national legal regulations. Ethical standards in human research must be extreme, in order to adequately protect participants in studies involving genomics. Particularly relevant in this context are the protection of confidentiality and anonymity; the policy of delivery of results and the possibility of withdrawing from the study. Sharing data resulting from genetic research optimizes resources, provides greater transparency, and replicability of the analyses and makes it possible to discover genetic alterations responsible for rare diseases and genes involved in multi-factorial hereditary diseases, as well as contributing to the design of precision medicine and new therapeutic strategies. However, it poses great challenges: protecting privacy and avoiding re-identification of volunteers, delivery of results with pre- and post-study counseling. These aspects require the elaboration of a careful informed consent process for genomic research, the main components of which are discussed in this article.

Informed consent in anesthesiology: An exploratory study / El consentimiento informado en anestesiología: un estudio exploratorio / Consentimento informado em anestesiologia: um estudo exploratório

Abstract: In the literature Informed consent (IC) assumptions is well established. However, the different stages and the conditions under which the IC for anesthetic practices is obtained, is scarce. The aim of the present study is to explore the phases and conditions of IC in anesthesiology. Anonymized clinical records of 325 patients submitted to anesthetic procedures at the Institute of Oncology of Porto were analyzed. A total agreement between the anesthetic techniques established in the IC and those performed, was reach with 270 patients. The importance of IC in clinical practice is discussed and an ideal process for IC is argued.

Resumen: El consentimiento informado (CI) está bien establecido en la literatura. Sin embargo, la información sobre las diferentes fases y condiciones en las que se obtiene el CI para las prácticas anestésicas es escasa. El objetivo del presente estudio es explorar las fases y condiciones de obtención de la CI en anestesiología. Se analizaron las historias clínicas anónimas de 325 pacientes sometidos a procedimientos anestésicos en el Instituto de Oncología de Oporto. Se alcanzó una concordancia total entre las técnicas de anestesia establecidas en el CI y las realizadas con 270 pacientes. Se defiende la importancia del CI en la práctica clínica y se discute un proceso ideal para obtenerlo.

Resumo: Na literatura o Consentimento Informado (CI) é bem estabelecido. Contudo, a informação sobre as diferentes fases e as condições em que o CI para práticas anestésicas é obtido, é escassa. O objetivo do presente estudo é explorar as fases e condições da obtenção do CI em anestesiologia. Foram analisados os registos clínicos anónimos de 325 pacientes submetidos a procedimentos anestésicos no Instituto de Oncologia do Porto. Foi alcançado um acordo total entre as técnicas anestésicas estabelecidas no CI e as realizadas, com 270 pacientes. A importância do CI na prática clínica é defendida e discute-se um processo ideal para a obtenção do CI.

La comunicación en el consentimiento informado / Communication in the informed consent

Introducción. El consentimiento informado es un elemento importante en la relación médico-paciente, que involucra la trasmisión de un mensaje. En este contexto, se describe la teoría de la comunicación implícita en un consentimiento informado, las barreras para una transmisión adecuada del mensaje, la responsabilidad en la comunicación y los requisitos para el logro de estos propósitos. El objetivo fue analizar de forma reflexiva los procesos de comunicación surtidos y necesarios durante su diligenciamiento, con algunas propuestas factibles de implementar. Discusión. El proceso comunicativo implica evaluar la calidad, el contexto, la intencionalidad, la pedagogía y la recepción-emisión del mensaje. La naturaleza de la actividad quirúrgica requiere el perfeccionamiento de la comunicación como una competencia necesaria en los cirujanos. Se señalan oportunidades de mejoramiento para una adecuada ejecución de esta habilidad no técnica, habitualmente no contemplada en la formación médica. Conclusiones. El consentimiento informado es un acto que trasciende a la transmisión de la información y es el resultado de un proceso complejo, que involucra habilidades comunicativas. Su efectividad se deriva de una toma de decisiones respaldada por el entendimiento claro de la situación y del procedimiento a efectuar. Existen puntos críticos durante su realización que podrían ser objeto de intervenciones futuras, desde esta perspectiva comunicativa.

Introduction. Informed consent is an important element in the doctor-patient relationship, which involves the transmission of a message. In this context, the theory of communication required in an informed consent, the barriers for an adequate transmission of the message, the responsibility in the communication, and the requirements for the achievement of these purposes are described. The objective is to reflexively analyze the assorted and necessary communication processes during its completion, with some feasible proposals to implement. Discussion. The communicative process implies evaluating the quality, the context, the intentionality, the pedagogy and the reception-emission of the message. The nature of the surgical activity requires the improvement of communication as a necessary skill in surgeons. Opportunities for improvement are pointed out for an adequate execution of this non-technical skill, usually not contemplated in medical training. Conclusions. Informed consent is an act that transcends the transmission of information and is the result of a complex process that involves communication skills. Its effectiveness derives from decision-making supported by a clear understanding of the situation and the procedure to be implemented. There are critical points during its realization that could be the object of future interventions from this communicative perspective.

Los biodatos del expediente clínico odontológico en México: análisis jurídico y bioético / The biodata of the dental clinical record in Mexico: legal and bioethical analysis

Objetivo: analizar los biodatos que integran el expediente clínico odontológico desde el derecho mexicano y la bioética. Métodos: hermenéutica analógica aplicada a los documentos jurídicos y bioéticos que determinan los biodatos mínimos constitutivos de los expedientes clínicos estomatológicos en México. Resultados: jurídicamente se identificaron los biodatos y se categorización en función de su naturaleza (antecedentes heredo-familiares, antecedentes personales patológicos y no patológicos, padecimiento actual e interrogatorio por aparatos y sistemas) y de los datos personales sensibles (datos: personales, identificativos, laborales, patrimoniales, académicos, de tránsito y migración, de salud, biométricos, de características físicas, y, especialmente, protegidos). Conclusiones: el análisis de la aplicación de los principios bioéticos a los biodatos del expediente clínico odontológico identificó como medidas mínimas las siguientes: la existencia de consentimiento(s) informado(s); el buen tratamiento de los biodatos; el correcto tratamiento y manejo de seguridad de las bases de datos que contengan un expediente o un conjunto de ellos y la bioseguridad del material biológico y genético en biobancos.

Objective: To analyze the biodata that make up the dental clinical record from Mexican law and bioethics. Methods: Analogical hermeneutics applied to the legal and bioethical documents that determine the minimum biodata constituting the stomatological clinical records in Mexico. Results: Legally, biodata were identifed and categorized according to their nature (inherite-family history, pathological and non-pathological personal history, current condition and questioning by devices and systems) and according to sensitive personal data (data: personal, identifcation, labor, patrimonial, academic, transit and migration, health, biometric, physical characteristics, and especially protected). Conclusion: The analysis of the application of Bioethical principles to the biodata of the dental clinical record identifed as minimun measures: the existence of informed consent(s), the good treatment of the biodata, good treatment and security of the databases that contain a fle or a set them, the biosecurity of biological and genetic material in biobanks.

Lineamientos para la implementación de la autoprueba en la detección de la infección por el virus de la inmunodeficiencia humana / Guidelines for the implementation of auto-testing in the detection of human immunodeficiency virus infection

Este documento describe las directrices para la implementación de la autoprueba como una intervención adicional de la prevención combinada para la detección del VIH, en los establecimientos de salud públicos y no públicos que brindan servicios de prevención del VIH (AU)