La enseñanza de la Ley Nacional de Trasplante como camino ético para la construcción del valor de la atención en salud en Colombia / Education in the National Transplant Law as an ethical pathway for the construction of the health care value in Colombia

Resumen La Ley Nacional de Trasplantes en Colombia, Ley 1805 de 2016, modificó la legislación colombiana en cuanto a cómo se accede a un trasplante de órganos, pero, sobre todo, cambió la figura de donatario y dispuso el término derivado del derecho del consentimiento presuntivo. Este define la hipotética voluntad de una persona de ser donante de órganos como manifestación de solidaridad y beneficencia con otra persona en situación de necesidad y vulnerabilidad relacionada con su salud y las dimensiones que la definen. En el siguiente texto se presentan siete momentos que se consideran hechos fundamentales en la construcción de una cultura del valor de la atención en salud en la política nacional de trasplantes de Colombia.

Abstract The national transplant law in Colombia, Law 1805 of 2016, modified the Colombian legislation regarding how a person accesses an organ transplant, but above all, it changed the donor figure, establishing the term derived from the presumptive consent right. This term implies a person's hypothetical willingness to be an organ donor as a manifestation of solidarity and charity towards another person in a situation of need and vulnerability concerning his/her health and the dimensions that define it. In the following text, seven moments are considered fundamental facts when constructing a culture about the value of healthcare in the national transplant policy in Colombia.

Education in the National Transplant Law as an ethical pathway for the construction of the health care value in Colombia / La enseñanza de la Ley Nacional de Trasplante como camino ético para la construcción del valor de la atención en salud en Colombia.

The national transplant law in Colombia, Law 1805 of 2016, modified the Colombian legislation regarding how a person accesses an organ transplant, but above all, it changed the donor figure, establishing the term derived from the presumptive consent right. This term implies a person's hypothetical willingness to be an organ donor as a manifestation of solidarity and charity towards another person in a situation of need and vulnerability concerning his/her health and the dimensions that define it. In the following text, seven moments are considered fundamental facts when constructing a culture about the value of healthcare in the national transplant policy in Colombia.

La Ley Nacional de Trasplantes en Colombia, Ley 1805 de 2016, modificó la legislación colombiana en cuanto a cómo se accede a un trasplante de órganos, pero, sobre todo, cambió la figura de donatario y dispuso el término derivado del derecho del consentimiento presuntivo. Este define la hipotética voluntad de una persona de ser donante de órganos como manifestación de solidaridad y beneficencia con otra persona en situación de necesidad y vulnerabilidad relacionada con su salud y las dimensiones que la definen. En el siguiente texto se presentan siete momentos que se consideran hechos fundamentales en la construcción de una cultura del valor de la atención en salud en la política nacional de trasplantes de Colombia.

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)

Are face transplant candidates choosing autonomously? A preliminary method to evaluate autonomous choosing in psychosocial and bioethical assessments.

This report proposes a framework for evaluating the validity of informed consent and autonomy in face transplant candidates, taking into account the risk of depression and non-compliance. Traditional factors like decisional capacity, disclosure, comprehension, voluntariness, and agreement are insufficient for assessing valid informed consent in individuals whose self-worth relies on public perception, potentially leading to self-harm if societal worth is undermined. Reliance on self-esteem, rather than inherent personal value, poses risks of depression, poor treatment adherence, and deferential vulnerability. We suggest a qualitative analysis of self-worth, self-esteem, self-trust, and self-respect to better assess the autonomy of face transplant candidates in their decision-making process.

[From physician paternalism to patient autonomy: 25 centuries of history]. / Entre el paternalismo médico y la autonomía de los pacientes: 25 siglos de historia.

From its origins, the doctor-patient relationship accompanied the social and cultural changes that have been modeling different forms of interhuman relationships. However, paternalism remained almost unchanged. Only in the 1970s, hand in hand with postmodern thought and the centrality of ethical, psychological, social and anthropological disciplines, respect for the autonomy of patients began to develop, which constituted the essence of a radical change. "Four models of doctor-patient relationship" are described depending on the objectives of the interaction between the actors, the doctor's obligations and the patient's values. Some particularities are detailed in the decision-making of children and adolescents, the doctrine of the mature minor, and progressive autonomy where the need for informed consent that reflects the autonomy of this age group is evident. It is worth highlighting the importance of communication in the development of a relationship in which the different models can collaborate with a genuine practice of autonomy for patients and their families.

Desde sus orígenes, la relación médico-paciente acompañó los cambios sociales y culturales que han ido modelando diferentes formas vinculares interhumanas. Sin embargo, el paternalismo se mantuvo casi inalterable. Recién en la década del 70, con el pensamiento posmoderno y las disciplinas éticas, psicológicas, sociales y antropológicas, comenzó a desarrollarse el respeto hacia la autonomía de los pacientes. Se describen "cuatro modelos de relación médico-paciente" en función de los objetivos de la interacción entre los actores, las obligaciones del médico y los valores del paciente. Se detallan algunas particularidades en la toma de decisiones de niñas, niños y adolescentes, la doctrina del menor maduro y la autonomía progresiva, que evidencia la necesidad de un consentimiento informado que refleje el reconocimiento de este grupo etario. Es fundamental la comunicación en el desarrollo de una relación en la que los diferentes modelos puedan colaborar con una genuina práctica de la autonomía de los pacientes y sus familias.

Corrigendum: Are face transplant candidates choosing autonomously? A preliminary method to evaluate autonomous choosing in psychosocial and bioethical assessments.

[This corrects the article DOI: 10.3389/frtra.2024.1346667.].

Exploring lived experiences on the usage of removable complete dentures among edentulous patients attending Makerere University Dental Hospital, Kampala, Uganda.

BACKGROUND: Edentulism remains a major disability worldwide, especially among the elderly population, although the prevalence of complete edentulism has declined over the last decades. In Uganda, the prevalence of edentulism in people aged 20 years and above is 1.8%. The therapy for edentulous patients can be realized through the use of conventional removable complete dentures, implant-supported prostheses, and computer-aided design and computer-aided manufacturing (CADCAM), however, the provision of removable complete dentures continues to be the predominant rehabilitation for edentulous patients. However, no published study has explored the lived experiences with removable complete dentures among the Ugandan population. The aim of the present study was to explore patients' lived experiences on the usage of removable complete dentures among Ugandan edentulous patients attending Makerere University Dental Hospital. METHODS: This was a qualitative study approach using purposive sampling. Fifteen (15) respondents were selected across social demographics. Interviews were recorded and transcribed and themes were generated to draw a deeper meaning to the usage of removable complete dentures. A qualitative statistical package, Atlas Ti software was used to generate themes from the interviews followed by an interpretation of the generated data and the results were presented as text and in a table. RESULTS: The reported key positive experiences due to removable complete denture rehabilitation were the improvement in speech, eating ability, regaining good facial appearance, better oral hygiene management, self-esteem and confidence to smile in public, and a feeling of completeness. However, respondents complained of pain and discomfort due to the looseness of dentures, inability to eat certain foods, and regular cleaning of dentures. The respondents did not go through proper informed consent processes before getting removable complete dentures. CONCLUSION: The study found that patients were satisfied with their removable complete dentures rehabilitation due to the positive experiences registered, such as the ability to eat and talk well, and restoration of self-esteem, all of which improved their quality of life. However, they experience pain and discomfort due to the looseness of dentures.

Ethical regulation of biomedical research in Brazil: a quality improvement initiative.

BACKGROUND: Q-CEP (Qualificação dos Comitês de Ética em Pesquisa que compõem o Sistema CEP/Conep) is a nationwide project resulting from a partnership between the Brazilian National Research Ethics Commission (Conep), the Ministry of Health and Hospital Moinhos de Vento (HMV). It was developed to consolidate policy for ethical review of research with human beings in all members of the CEP/Conep System, Brazil's national system of institutional review boards. The aim of this study was therefore to report on the experience and results of the Q-CEP project. METHODS: An observational, retrospective study includes data from the Q-CEP, obtained from visits to all the institutional research ethics committees (RECs) in the country. The actions implemented by Q-CEP were part of a two-step process: (i) training visits to each REC; (ii) development of distance learning modules on strategic topics pertaining to research ethics evaluation. The data presented herein cover step one (training visits), defined by Q-CEP as the diagnostic stage of the project. For a country with social and economics inequalities such as Brazil, this is a particularly important stage; an accurate picture of reality is needed to inform planning of quality improvement strategies. RESULTS: In 2019-2021, Q-CEP visited 832 RECs and trained 11,197 people. This sample covered almost all active RECs in the country; only 4 (0.5%) were not evaluated. Of the 94 items evaluated, 62% did not reach the target of at least 80% compliance and around 1/4 (26%) were below 50% compliance. The diagnostic stage of the process revealed inadequacies on the part of the RECs in their ethical reviews. The analysis of informed consent forms showed compliance in only 131 RECs (15.74%). The description of pending issues made by RECs in their reports was compliant in 19.33% (n = 161). Administrative and operational aspects were also considered inadequate by more than half of the RECs. CONCLUSIONS: Overall, Brazilian RECs showed poor compliance in several aspects of their operation, both in ethics evaluation and in other processes, which justifies additional training. The Q-CEP project is part of a quality improvement policy promoted by the Brazilian Ministry of Health. The data obtained in the diagnostic step of the project have contributed to the qualification and consolidation of one of the world's largest research ethics evaluation systems.

A perspective on research ethics committees in the Brazilian amazon

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.

Diagnóstico humanizado: El paciente en el centro - la comunicación que cura / Diagnóstico humanizado: O paciente no centro - comunicação que cura / Humanized Diagnosis: The pacient at the center - communication that Heals

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.

Fundamentos bioéticos y aspectos prácticos del consentimiento informado en el contexto de la cirugía oncológica

Introducción: El consentimiento informado es un acto importante de la relación médico-paciente, constituye un proceso y un documento médico-legal-bioético trascendente de esta relación. En este sentido, el consentimiento se utiliza como una herramienta que favorece el diálogo y la comprensión durante el tratamiento quirúrgico. Objetivo: Brindar un análisis y actualización del tema desde el contexto de la cirugía oncológica por la importancia de esta temática en la actualidad. Métodos: Se realizó una revisión de la literatura relevante publicada sobre el tema en bases de datos PubMed, SciELO, Google Académico. Se priorizaron los últimos 5 años y los textos escritos en idiomas inglés y español. Se hizo énfasis en las palabras consentimiento, bioética y oncología. Se revisó un total de 35 artículos. Desarrollo: La creciente demanda de terapias novedosas en la medicina, y aún más en la oncología, ha planteado nuevos dilemas éticos para la sociedad. La toma de decisiones en cuestiones de salud es un elemento central de la autonomía. Existen diversos conceptos de entorno al paciente quirúrgico que padece de cáncer. Conclusiones: Aplicar la bioética a la práctica de la oncología permite acceder al escenario donde las decisiones pasan por un análisis ético. Cuando los principios bioéticos son ejercidos como un procedimiento habitual como es el consentimiento informado, la relación médico-paciente refleja acciones dirigidas a favorecer la comunicación, el respeto a la dignidad y el proceso al final de la vida.

Introduction: Informed consent is an important act of the doctor-patient relationship, it is a process and a medical-legal-bioethical document that is transcendent of this relationship. In this sense, consent is used as a tool that favors dialogue and understanding during surgical treatment. Objective: Provide an analysis and update of the topic from the context of oncological surgery due to the importance of this topic today. Methods: A review of the relevant literature published on the subject was carried out in PubMed, SciELO, Google Scholar databases, emphasizing the last 5-years, and in the English and Spanish languages, emphasizing the words consent, bioethics, and oncology. A total of 35 articles were reviewed. Development: The growing demand for novel therapies in medicine and even more in oncology, has raised new ethical dilemmas for society. Decision-making in health matters is a central element of autonomy, there are various concepts related to the surgical patient suffering from cancer. Hence the importance of consent and motivation of this work. Conclusions: Applying bioethics to the practice of oncology allows access to the scenario where decisions go through an ethical analysis. When bioethical principles are exercised as a regular procedure such as informed consent, the doctor-patient relationship reflects actions aimed at promoting communication, respect for dignity and the process at the end of life.

Vulnerabilidade moral entre estranhos morais: limites do princípio da permissão / Moral vulnerability among moral strangers: limits of the principle of permission / Vulnerabilidad moral entre extraños morales: límites del principio de permiso

Resumo Este artigo apresenta uma análise crítica da obra de Tristram Engelhardt, com foco no princípio da permissão. Argumenta-se que, em contextos de intensas desigualdades sociais e negação de direitos, a aplicação da ética de procedimentos baseada apenas no princípio da permissão pode resultar na vulnerabilidade moral de indivíduos e grupos que não compartilham de determinada moralidade. Isso pode levá-los a serem expostos a diferentes formas de negação de direitos, violência, exploração, exclusão e estigmatização. Diante dessa realidade, destaca-se a importância de fortalecer uma bioética comprometida com a defesa da dignidade, da diversidade, dos direitos humanos e da justiça social.

Abstract This article presents a critical analysis of Tristram Engelhardt's work, focusing on the principle of permission. It is argued that, in a context of intense social inequalities and denial of rights, the application of procedural ethics based solely on the principle of permission can result in the moral vulnerability of individuals and groups who do not share a certain morality. This can expose them to different forms of denial of rights, violence, exploitation, exclusion, and stigmatization. Given this reality, the importance of strengthening a bioethics committed to defending dignity, diversity, human rights, and social justice is highlighted.

Resumen Este artículo presenta un análisis crítico de la obra de Tristram Engelhardt, centrándose en el principio de permiso. Se arguye que, en un contexto de intensas desigualdades sociales y negación de derechos, la aplicación de la ética de procedimientos basada solo en el principio de permiso puede generar vulnerabilidad moral en los individuos y grupos que no comparten cierta moralidad. Esto puede llevarlos a verse expuestos a diferentes formas de negación de derechos, violencia, explotación, exclusión y estigmatización. Ante esta realidad, se destaca la importancia de fortalecer una bioética comprometida con la defensa de la dignidad, la diversidad, los derechos humanos y la justicia social.

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.

Consentimento e esclarecimento: dever e direito à informação em odontologia / Consent and clarification: duty and right to information in dentistry / Consentimiento y aclaración: deber y derecho a la información en odontología

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.

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.

Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension.

BACKGROUND: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. OBJECTIVE: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. RESULTS: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. CONCLUSION: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

ANTECEDENTES: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México. OBJETIVO: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo. RESULTADOS: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI. CONCLUSIÓN: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.

When Ethics and the Law Collide: A Multicenter Demonstration Cohort Study of Pre-Exposure Prophylaxis Provision to Adolescent Men Who Have Sex With Men and Transgender Women in Brazil.

PURPOSE: To explore legal and ethical challenges related to adolescents' participation in human immunodeficiency virus (HIV) research that may affect their best interests. METHODS: We analyzed the ethical principles and legal aspects of the participation of 15-17-year-old men who have sex with men and transgender women in the pre-exposure prophylaxis (PrEP) 1519 study, a PrEP demonstration cohort study in three Brazilian cities. The analyses of ethics review committees' (ERCs) evaluations and court decisions followed ethical and human rights principles. An HIV vulnerability score was created, and descriptive statistics and multivariate logistic regression were performed using data from 347 participants. RESULTS: The ERCs evaluated the benefits and risks of research participation, all finding that the benefits outweighed the risks. ERCs deferred responsibility for decisions about waiving parental consent to the judiciary. State courts reached different decisions about waiving parental consent, reflecting variation in recognition of adolescents' evolving capacities and the adolescent as a subject of sexual rights and the primary agent capable of deciding on their health and best interests. The most vulnerable adolescent participants were found in sites where the blanket waiver was in place. DISCUSSION: Judicializing the ethical review process is detrimental to fulfilling the ethical principle of justice and vulnerable adolescents' access to health research. ERCs must be sufficiently independent and autonomous and have the capacity to respect, protect, and help fulfill the rights of participants while ensuring the generation of adequate evidence to inform public health practice.

Hacia la objetividad en la valoración ética: legibilidad como parte de la comprensión de los formatos de consentimiento informado / Towards objectivity in ethical assessment: legibility as part of informed consent form comprehension

Resumen Antecedentes: Se describe la experiencia sobre la legibilidad de los formatos de consentimiento informado (FCI) del Comité de Ética en Investigación del Instituto Nacional de Cancerología de México. Objetivo: Evaluar la legibilidad de una muestra seleccionada aleatoriamente de FCI sometidos para revisión entre el 1 de marzo de 2022 y el 31 de marzo de 2023. Se determinó el número de páginas, el tiempo que el lector invierte para leer el texto y el grado de escolaridad necesario para comprenderlo. Resultados: Más de la mitad de FCI de investigaciones internas mostraron ser algo o muy difíciles de leer, la escolaridad necesaria para comprenderlos fue hasta de 9.9 años y el tiempo de lectura fue corto. Los textos de los FCI de investigaciones internacionales multicéntricas estuvieron dirigidos a un nivel escolar promedio de 5.5 años y tuvieron una legibilidad normal. La mayor parte de los ensayos externos requiere un tiempo de lectura superior a los 60 minutos por FCI. Conclusión: Es necesario disponer de herramientas que den objetividad a la evaluación de los FCI en investigación por parte de los comités de ética y sean indicadores de su comprensión, tales como la legibilidad de los documentos.

Abstract Background: The experience on informed consent form (ICF) readability at the Research Ethics Committee of the National Institute of Cancerology of Mexico (INCan) is described. Objective: To evaluate the readability of a randomly-selected sample of ICFs submitted for review between March 1, 2022 and March 31, 2023. The number of pages, the time the reader takes to read the text and the level of education necessary to understand it were determined. Results: More than half the ICFs from internal investigations were shown to be somewhat or very difficult to read; the level of education required to understand them was up to 9.9 years, and the reading time was short. The ICF texts from international multicenter investigations were aimed at an average education level of 5.5 years and had normal readability. Most ICFs from external trials require a reading time of more than 60 minutes per ICF. Conclusion: It is necessary to have tools that provide objectivity to the evaluation of ICFs under investigation by ethics committees, which should be indicators of their comprehension, such as readability of the documents.

Percepción y prioridades respecto al proceso de consentimiento informado quirúrgico; un análisis mediante métodos mixtos

Objetivo: Identificar las principales preocupaciones antes y después de realizarse un procedimiento quirúrgico, e identificar diferencias basadas en género, edad y nivel de escolaridad. Material y Método: Mediante un muestreo no probabilístico incidental se aplicaron 201 encuestas semiestructuradas a personas en la sala de espera del HSJD. Las respuestas fueron procesadas mediante un análisis mixto donde se organizaron categorías por unidades de significancia y se ordenaron de forma decreciente para luego comparar según edad, género y escolaridad. Resultados: Respecto a los aspectos que las personas consideran relevante conocer previo a la cirugía, 4 categorías concentran el 71 % del total: 1. Riesgos, complicaciones y secuelas, 2. Explicación del procedimiento, 3. Beneficios y pronóstico, 4. Cuidados y evaluaciones previas. En relación con lo que le gustaría que le explicaran después, se prioriza: 1. Conocer los resultados del procedimiento (19,3%), 2. Control, derivaciones y cuidados paliativos (15%), 3. Tiempo de recuperación (13,7%). Diferencias significativas: una mayor necesidad de acompañamiento y explicación de la patología expresada por hombres, el interés por conocer y los aspectos relacionados con funcionalidad postoperatoria en personas entre 18-65 años, el interés de conocer los cuidados y evaluaciones previas, conocer los resultados del procedimiento, los cuidados de la herida y la funcionalidad posoperatoria según nivel educacional. Discusión y conclusión: Existen variaciones significativas en contenido prioritario según edad, género y nivel educacional. Finalmente, el presente artículo proporciona evidencia en cuanto a las principales prioridades de pacientes en el sistema público chileno para el consentimiento informado.

Aim: To identify the main concerns before and after undergoing a surgical procedure, and to identify differences based on gender, age and level of education. Material and Method: 201 semi-structured surveys were administered to people in the waiting room of the HSJD by means of incidental non-probabilistic sampling. The responses were processed by means of a mixed analysis in which categories were organized by units of significance and ordered in decreasing order to then compare according to age, gender and schooling. Results: Regarding the aspects that people considered relevant to know before surgery, 4 categories accounted for 71% of the total: 1. Risks, complications and sequels, 2. Explanation of the procedure, 3. Benefits and prognosis, 4. Prior care and evaluations. In relation to what you would like to have explained to you afterwards, priority is given to: 1. knowing the results of the procedure (19.3%), 2. Monitoring, referrals and palliative care (15%), 3. Recovery time (13.7%). Significant differences: a greater need for accompaniment and explanation of the pathology expressed by men, interest in knowing and aspects related to postoperative functionality in persons between 18-65 years of age, interest in knowing the previous care and evaluations, knowing the results of the procedure, wound care and postoperative functionality according to educational level. Discussion and conclusion: There are significant variations in priority content according to age, gender and educational level. Finally, the present article provides evidence regarding the main priorities of patients in the chilean public system for informed consent.