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.

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

ABSTRACT 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.

Processo de obtenção de consentimento livre e esclarecido para pessoas analfabetas em procedimentos de saúde / Process for obtaining informed consent for illiterate people in healthcare procedures

O Termo de Consentimento Livre e Esclarecido (TCLE) é um documento que faz parte do processo de obtenção da anuência de pacientes ou de participantes de pesquisa, para garantir seus direitos e atribuir seus deveres. Caso o TCLE contenha um texto complexo, ele restringirá, de certa forma, a liberdade de decisão de indivíduos analfabetos. Objetivo: avaliar a percepção de analfabetos sobre o conhecimento do TCLE e suas formas de manifestação de anuência para procedimentos de saúde. Material e método: trata-se de uma pesquisa transversal quali-quantitativa, cuja coleta de dados foi realizada com alunos da Educação de Jovens e Adultos (EJA) por meio de entrevista gravada após leitura de um TCLE modelo. Os resultados qualitativos foram analisados segundo a Técnica de Análise de Conteúdo, proposta por Bardin. Os quantitativos foram analisados pelo teste qui-quadrado e por análise de regressão logística por meio do software JAMOVI. Resultados: participaram da pesquisa 32 alunos. Os dados obtidos mostraram que o conhecimento prévio acerca do TCLE era baixo (34,37%), apenas 46,87% dos participantes compreenderam o documento, sendo 38% da 4ª etapa da EJA. Quase todos os participantes entenderam os benefícios em aplicar o TCLE nas práticas clínicas e 75% informaram que imagens facilitariam a compreensão do documento. Conclusão: concluiu-se que baixas habilidades de alfabetização afetam diretamente a autonomia para anuência em TCLE. A dificuldade na compreensão do TCLE pode estar relacionada aos elementos textuais, como o tamanho da fonte, utilização de termos difíceis e apresentação de um texto extenso contendo muitas informações

The Informed Consent (IC) is a document that is part of the process for obtaining the consent of patients or research participants, to guarantee their rights and assign their duties. The IC, by containing a complex text, restricts, in some way, the freedom of decision of illiterate individuals. Objective: to evaluate the perception of illiterate individuals on the knowledge of the IC and their forms of expression of consent to health procedures. Material and method: this is a quali-quantitative cross-sectional study, whose data collection was carried out with students of Youth and Adult Education (YAE) by means of recorded interview after reading an IC model. The qualitative results were analyzed according to the Content Analysis Technique, proposed by Bardin. Quantitative results were analyzed applying the Chi-square test and logistic regression analysis using the JAMOVI software. Results: 32 students participated in the research. The data obtained showed that the previous knowledge about the ICF is low (34.37%), only 46.87% of the participants understood the document, 38% of them from the 4th stage of YAE. Almost all participants understood the benefits in applying the IC in clinical practices and 75% claimed that images would facilitate understanding of the document. Conclusion: It was concluded that low literacy skills directly affect the autonomy to consent using the IC. The difficulty in understanding the IC may be related to textual elements, such as font size, use of difficult terms, and presentation of an extensive text containing a lot of information

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.

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.

The importance of applying the statement of assent to children and adolescents: a qualitative study / La importancia de la aplicación del término de consentimiento para niños y adolescentes: un estudio cualitativo / A importância da aplicação do termo de assentimento para crianças e adolescentes: um estudo qualitativo

Objective. To describe the importance of the Statement of Assent for children and adolescents invited to participate in a clinical study and their main reactions to its explanation. Methods. This is an exploratory descriptive qualitative study of 17 children and adolescents, who were invited to participate in a clinical study in the field of oncology in a hospital located in Rio de Janeiro (Brazil). Data were analyzed using thematic analysis. Results. Two thematic units were generated after data interpretation: signing the statement of assent, in which participants felt their main role when faced with the possibility of expressing their agreement or not to take part in the study; and understanding of the study, when they showed that they understood the steps of the study by asking pertinent questions to clarify their doubts. Children and adolescents understood the steps of the study contained in the Statement of Assent, were interested and asked questions to clarify their doubts about the study. Conclusion. The Statement of Assent was important for participants understanding the study and having autonomy over their participation. As the statement strengthened the main role of children and adolescents in the research process, the conclusion was that its use in studies involving the pediatric population should be encouraged.

Objetivo. describir la importancia del Formulario de Consentimiento Informado para los niños y adolescentes invitados a participar en un estudio clínico aleatorizado y sus principales reacciones a su explicación. Métodos. se trata de una investigación exploratoria descriptiva con abordaje cualitativo, realizada con 17 niños y adolescentes, quienes fueron invitados a participar de un estudio clínico en el área de oncología en un hospital ubicado en Río de Janeiro (Brasil). A los datos se les realizó análisis temático. Resultados. Luego de la interpretación de los datos, se generaron 2 unidades temáticas: la firma del formulario de consentimiento y la comprensión del estudio. Los niños y adolescentes entendieron las etapas del estudio contenidas en la firma del Término de Asentimiento y se interesaron, haciendo preguntas para aclarar sus dudas sobre la investigación. Conclusión. El consentimiento informado era importante para que los participantes entendieran la investigación y tuvieran autonomía sobre su participación. Al potenciar el protagonismo de los niños y adolescentes en el proceso de investigación, recomendamos que debe fomentarse su uso en los estudios con población pediátrica.

Objetivo. Descrever a importância do Termo de Assentimento para crianças e adolescentes convidados a participar de um estudo clínico e suas principais reações quanto à explicação do mesmo. Métodos. Trata-se de uma pesquisa do tipo descritiva exploratória com abordagem qualitativa, realizada com 17 crianças e adolescentes, que foram convidados a participar de um estudo clínico na área da oncologia em um hospital localizado no Rio de Janeiro (Brasil). Os dados foram analisados empregando-se a análise temática. Resultados. Após a interpretação dos dados, foram geradas 2 unidades temáticas: a assinatura do termo de assentimento em que os participantes se sentiram protagonistas frente a possibilidade de expressarem a concordância ou não em participar da pesquisa, e a compreensão sobre o estudo quando elas mostraram que entenderam as etapas do estudo fazendo perguntas pertinentes para esclarecer suas dúvidas. As crianças e adolescentes compreenderam as etapas do estudo que constavam no Termo de Assentimento e tiveram interesse, fazendo perguntas para esclarecer suas dúvidas com relação à pesquisa. Conclusão. O termo de assentimento foi importante para os participantes compreenderem sobre a pesquisa e para terem autonomia sobre sua participação. Por potencializar o protagonismo de crianças e adolescentes no processo de pesquisar conclui-se que seu uso em estudos que envolvem a população pediátrica deve ser incentivado.

Patients' understanding of "informed consent" in plastic surgery

SUMMARY OBJECTIVE To assess the patient's understanding of the informed consent form before and after plastic surgery. METHODS This was a prospective analytical descriptive study that utilized a questionnaire on informed consent before and after plastic surgery procedures. RESULTS Comprehension of informed consent was higher before surgery than after surgery (p=0.016; question 15). The higher the scholarity, the higher the comprehension (s=0.151; p=0.045) before surgery (question 4). For the other questions, it was not possible to find a difference in the pattern of understanding and in the association with the educational attainment level after surgery (s=0.180; p=0.046; question 1). CONCLUSIONS: The patients' level of comprehension of the details, outcomes, possible complications, and postoperative evolutions of surgical procedures, as stated by the informed consent form, is high.

Consentimento por telefone: otimização do recrutamento de participantes de pesquisas / Telephone consent: optimizing the recruitment of research participants / Consentimiento por teléfono: optimización del reclutamiento de participantes de investigaciones

Resumo O consentimento informado objetiva proteger a autonomia de potenciais participantes de pesquisas, fornecendo as informações necessárias para a decisão sobre participar ou não. Este estudo relata uma experiência de processo de consentimento informado via telefone. Houve sucesso no contato telefônico com mais de 90% das pacientes elegíveis; 1,16% entenderam as informações fornecidas, mas não aceitaram participar da pesquisa; e 0,70% recusaram dar o consentimento por telefone e pediram que o termo de consentimento fosse enviado por correio. Participaram do estudo mulheres de todas as regiões do país. A maioria tinha algum procedimento marcado em um dos hospitais pesquisados para pelo menos 62 dias após a data da ligação. Os resultados mostram que o consentimento por telefone pode ser um método alternativo de recrutamento de pacientes, tendo em vista a alta taxa de adesão dos participantes e a redução no tempo de coleta de dados.

Abstract Informed consent aims to protect the autonomy of potential research participants, providing the information necessary to make the right decision. This study reports the experience of collecting the informed consent via telephone from individuals. Telephone contact was successfully achieved for more than 90% of the participants; 1.16% understood the survey, but did not accept to participate; and 0.70% refused to provide telephone consent and required a consent form by mail. Women from all regions of Brazil participated and most had some procedure in the hospital at least 62 days after the date of the call. The results show that telephone consent can be an alternative method of recruiting patients given the high rate of acceptance of the participants and time gains in data collection.

Resumen El consentimiento informado tiene como objeto proteger la autonomía de los posibles participantes de investigaciones, proporcionándoles la información necesaria para que decidan si aceptan o no participar. Este estudio relata una experiencia de proceso de consentimiento informado por teléfono. El contacto telefónico se realizó con éxito con más del 90% de los participantes; el 1,16% entendió la información suministrada, pero no aceptó participar en la investigación; y el 0,70% se negó a otorgar el consentimiento por teléfono y solicitó que se le enviara el formulario de consentimiento por correo. Participaron en el estudio mujeres de todas las regiones de Brasil. La mayoría de las participantes tenía algún procedimiento programado en uno de los hospitales investigados al menos 62 días después de la fecha de la llamada telefónica. Los resultados muestran que el consentimiento por teléfono puede ser un método alternativo para reclutar a los pacientes, una vez que hubo una alta tasa de adherencia de los participantes y reducción en el tiempo para la recopilación de datos.

Calidad de los formatos escritos del consentimiento informado en pacientes graves / Quality of written forms of informed consent in critically ill patients

RESUMEN Fundamentación: el consentimiento informado es un proceso cuyo objetivo es el respeto a la autonomía del paciente y consta de la aceptación verbal y escrita de una intervención médica, después que el médico le haya informado de forma adecuada. Objetivo: evaluar la calidad de los formatos escritos de consentimiento informado en pacientes graves. Métodos: se realizó un estudio descriptivo trasversal con 335 formatos escritos del consentimiento informado aplicados a familiares y pacientes ingresados en la Unidad de Cuidados Intensivos del Hospital Joaquín Albarrán Domínguez, La Habana, Cuba, del 30 de septiembre de 2017 al 22 de septiembre de 2018. Se realizó la prueba de Chi cuadrado a las frecuencias de los cumplimientos. Fue significativo un valor de p ≤ 0,05. Resultados: aunque el predominio de los formatos escritos fue en pacientes con perfil clínico, los mejores documentos fueron los de perfil quirúrgico. El cumplimiento de los datos generales de los formatos escritos fue adecuado, sin embargo, los formularios del perfil clínico, no cumplieron adecuadamente con la información respecto a los procederes médicos, fue pobre la evacuación de las dudas respecto a la condición médica de los pacientes. En ningún caso se solicitó el autorizo para investigaciones médicas ni se entregó copia del documento escrito a los interesados. Conclusiones: la calidad de los formatos fue mala, aún hay que mejorar la calidad de la información e implementar de manera habitual la solicitud para investigaciones médicas y mecanismos que faciliten la entrega de una copia del documento escrito.

ABSTRACT Background: Informed Consent is the acceptance of a medical intervention by a patient, in a free, voluntary and conscious way, after the doctor has informed him of the nature of the intervention, risks, benefits and alternatives. Objective: to assess the quality of structure and content of the informed consent forms in severe patients. Methods: cross-sectional retrospective descriptive study was carried out with 335 IC written forms applied to family members and/or patients admitted to the Intensive Care Unit of the Joaquín Albarrán Domínguez Hospital, Havana, Cuba, from September 30, 2017 to September 22, 2018. The Chi-square test was performed the frequencies of compliance. A value of p ≤ 0.05 was significant. Results: predominantly, the written formats in patients with a clinical profile complied with the completion of the document and the best were those of surgical profile. In compliance with the general data in the IC written format, there was an adequate compliance, in the forms of the clinical profile, they did not comply with writing the name and description of medical procedures. There was no consent forms to authorize medical researches and it was not delivered a copy of the written document to the interested persons. Conclusions: the quality of the formats was bad, we still have to improve the information offered, clarify the doubts, as well as the request for authorization for medical research and implement mechanisms that facilitate the delivery of a copy of the written document.

Termos de esclarecimento e responsabilidade à luz da bioética de intervenção / Terms of clarification and accountability in the light of intervention bioethics / Formularios de esclarecimiento y responsabilidad a la luz de la bioética de intervención

Resumo No Brasil, o acesso aos medicamentos do Componente Especializado da Assistência Farmacêutica, no âmbito do Sistema Único de Saúde, ocorre mediante preenchimento e entrega do termo de esclarecimento e responsabilidade nas farmácias especializadas. Estes termos visam a obtenção do consentimento informado do paciente no que diz respeito ao tratamento medicamentoso oferecido. O estudo avaliou-os à luz do referencial teórico da bioética de intervenção com ênfase na garantia da autonomia do paciente e na sua proteção como ente vulnerável. Embora haja dispositivos que resguardem sua privacidade e forneçam informações relevantes para seu empoderamento na relação com o médico, os termos carecem de medidas protetivas nos casos em que ocorrem efeitos indesejáveis. Cabe, portanto, ao Estado fortalecê-los para garantir verdadeira autonomia dos pacientes, balizar sua vulnerabilidade e assegurar medidas de proteção em casos de episódios adversos.

Abstract In Brazil, access to medicines of the Specialized Pharmaceutical Care Program, within the scope of the Brazilian Unified Health System, depends on filling out and delivering the Clarification and Responsibility Form at specialized pharmacies. These forms are intended to obtain the patient´s informed consent concerning the medication being offered. The study evaluated them in the light of the theoretical reference of intervention bioethics, with emphasis on guaranteeing patient autonomy and protection as a vulnerable entity. Though the forms studied consider patient privacy and provide them with information relevant to their empowerment in dealing with doctors, the term lacks enough protective measures in cases where undesirable effects occur. Therefore, it is a State responsibility to strengthen them to guarantee true autonomy for patients, to identify their vulnerability and to ensure protective measures in cases of adverse event.

Resumen En Brasil, el acceso a los medicamentos del Componente Especializado de la Asistencia Farmacéutica, en el ámbito del Sistema Único de Salud, tiene lugar mediante diligenciamiento y entrega del Formulario de Esclarecimiento y Responsabilidad en las farmacias especializadas. Estos documentos procuran la obtención del consentimiento informado del paciente respecto del tratamiento medicamentoso a ser ofrecido. Este estudio los evaluó a la luz del marco teórico de la bioética de intervención con énfasis en la garantía de la autonomía del paciente y en su protección como ente vulnerable. Aunque haya dispositivos que resguarden la privacidad del paciente y proporcionen informaciones relevantes para su empoderamiento en la relación con el médico, los formularios carecen de medidas de protección en los casos de ocurrencia de efectos indeseables. Le compete, por lo tanto, al Estado fortalecerlos para garantizar una verdadera autonomía de los pacientes, demarcar su vulnerabilidad, y asegurar medidas de protección en casos de episodios adversos.

Actualidad del deber de informar en Chile / The duty to inform in the Chilean legislation

The new Chilean regulation about patients' rights and duties is generating a significant change in the information that health care professionals must provide to their patients. This issue will gravitate on medical liability. If this duty is accomplished incorrectly, professionals would fall into an illicit act and become liable to lawsuits and compensations to patients. This article provides a panoramic view about the grounds and content of the duty to inform and how judges are regulating the issue.

El consentimiento informado en clínica: inquietudes persistentes / Informed consent in clinical practice: persistent doubts

Informed consent is the core aspect of the patient-physician relationship. Since its beginnings, clinical bioethics was opposed to the authoritarian paternalism characteristic of medicine since the 19th century. The informed consent was developed to provide patients with sufficient information to allow autonomous decisions when faced with medical diagnostic and therapeutic alternatives. In spite of bioethics’ effort to perfect informed consent, the discipline has been unable to avoid informed consent from becoming an impersonal and administrative procedure. Even though the major goal of this procedure is to provide sufficient information to allow patients an objective weighting of benefits and risks of medical practice, the uncertainties of medicine make full disclosure unattainable. Collecting more information finally leads to indecision and ultimate trust in medical advice. The clinical encounter is fundamentally a fiduciary relationship, and bioethics ought to accept that its main objective is to strengthen the trust bond that is essential to the clinical encounter. This goal may become incompatible with the quest for unlimited autonomy. Patients often will only require information as long as they distrust that medical institutions and their professionals are considering their interests and needs. The main proposal of this article is to temper bioethics’ insistence on autonomy, and accept that patients essentially seek to be protected and cared for. Informed consent ought to relent its efforts at full autonomy to the benefit of trustworthiness in medicine, and trust in clinical practice.

O Termo de Consentimento e as pendências identificadas na apreciação ética pelo CEP-FHEMIG / The Informed Consent and the disputes identified in ethics examination by CEP-FHEMIG

INTRODUÇÃO: O Termo de Consentimento Livre e Esclarecido (TCLE) é peça fundamental na elaboração de uma pesquisa envolvendo seres humanos e expressa todas as garantias éticas e humanas do pesquisador frente ao voluntário. Por sua importância o TCLE é fonte de atenção pormenorizada dos Comitês de Ética em Pesquisa (CEP) e fonte recorrente de pendências. OBJETIVO: Levantar todas as causas de pendências de projetos de pesquisa apreciados no CEP-FHEMIG, nos últimos 30 meses, ressaltando as falhas relacionadas ao TCLE. MÉTODOS: Estudo retrospectivo, no qual foram analisados os projetos de pesquisa que tramitaram no CEP-FHEMIG no período de fevereiro de 2012 a julho de 2014. Foram coletados dados relacionados ao resultado do 1º parecer, causas de pendências e pendências relacionadas ao TCLE. RESULTADOS: Foram apreciados 280 projetos, com o seguinte Parecer: Aprovados 239 (85,4%), Pendentes 37 (13,2%), Não aprovados 03 (1,1%), Retirado 01 (0,4%). Dentre os 37 estudos com Parecer Pendente foram contabilizadas 126 pendências. Estas diferentes pendências foram agrupadas em 03 grandes categorias: Pendência Documental 08 (6,3%), Pendência sobre o Projeto 55 (43,7%) e Pendência sobre o TCLE 63 (50,0%). CONCLUSÃO: Erros na elaboração do TCLE ainda são as principais causas de pendências na apreciação ética de um projeto de pesquisa pelo CEP-FHEMIG.

The Informed Consent Form (ICF) is a fundamental piece on the elaborationof research with human beings and it contains all the ethics safeties and guaranties for the voluntaries chosen to participate in the project. Because of its importance, the informed consent is given a special attention by the Research Ethics Committee (REC) and is required for the approval of the project. Objectives: raise all causes search projects pending at FHEMIG's REC in recent 30 months, highlighting the flaws related to the ICF.Methods: This is a retrospective study in which the research projects in FHEMIG's REC were evaluated from February 2012 to July 2014. Results: 280 projects are assessed with the following opinion: Approved 239 (85.4%), Pending 37 (13.2%), and Not Approved 03 (1.1%), Withdrawn 01 (0.4 percent). Among the 37 Pending Studies were accounted 126pending. These pending were grouped into 03 categories: 08 (6.3%) of Document Pending, Pending on the Project 55 (43.7%) and Pending on the ICF 63 (50.0%). Conclusion: Errors in the preparation of ICF are still the main causes of pending in the ethical assessment of a research project by CEP-FHEMIG.

La obligación de informar al paciente: Cuestiones sobre el derecho a ser informado / The obligation to inform the patient: Issues on the right to be informed

This article aims to analyze, from a legal perspective, the boundaries of the obligation imposed on health care providers to inform the patient. This requirement originated and was developed as an ethical issue. However, with the newly approved law regulating the rights and duties of patients, the obligation to inform can be viewed from prisms and principles that differ from those governing medical ethics. With this purpose, we will focus on the comparative experience, which will allow us to evaluate the responsibility of health care providers when this duty is breached. We will try to answer the following questions: Which medical information must be informed to the patient? When should the doctor inform the patient? In which form should this information be provided?.

Understanding of Technical Terms and Contents of Informed Consent Forms for Sedative Gastrointestinal Endoscopy Procedures

PURPOSE: This was a cross-sectional study designed to evaluate the subjective understanding of technical terms and contents of the informed consent forms given to patients about to undergo conscious sedative upper gastrointestinal endoscopy. METHODS: A group of conveniently selected 180 patients, who were undergoing sedative endoscopy were recruited in the endoscopy procedure room in a tertiary hospital from June to July 2011. Data were collected with a structured questionnaire. RESULTS: The average number of terms exposed was 8.12 out of 10 items, the average number of terms understood well by the patients was 5.53 out of 10 items, and the average number of right answers was 3.30 out of 5 items, and the percent of correct answers ranged from 26.1% to 90.0%. The exposure to terms differed by gender, education, and previous exposure to sedative endoscopy procedures. The number of "understanding of the terms well" responses differed according to age and previous exposure to sedative endoscopy procedures, and the correct answer rate was differed by education. CONCLUSION: The understanding of the terms and knowledge about the procedures were disappointing. Therefore, sufficient explanations should be provided to the patients. While the informed consent was taken by doctors, the level of understanding should be monitored by nurses. In particular, subjects who did not have any previous experience with endoscopy procedures showed relatively lower level of understanding. We recommend that medical terms should be replaced with more common and nontechnical words in consent forms.

O consentimento informado: Qual o seu real valor na prática médica? / Informed consent: what is it real value in medical practice?

Trata-se de um artigo que comenta sobre a real importância do Termo de Consentimento Informado na prática médica. Este documento tem sido cada vez mais usado como uma prática defensiva, a fim de constituir provas para defesa de um eventual processo judicial de responsabilidade médica, desvirtuando assim a idéia original, que seria a de respeitar a autonomia do paciente e delimitar a responsabilidade médica. O documento tem como objetivo mostrar que o médico cumpriu com seu dever de informar. Seu grande valor reside nos casos onde existam riscos de danos irreversíveis ao paciente. Conclui-se, porém, que um prontuário bem elaborado onde se inclui o registro das informações que foram transmitidas, bem como o grau de participação dos pacientes e seus familiares nas decisões terapêuticas, também deve ter valor ético e jurídico semelhante do TCI.

This is an article that talks about the real importance of Informed Consent (IC) in medical practice. This document has been increasingly used as a defensive practice, in order to provide evidence to the defense of any lawsuit of medical responsibility, thus distorting the original idea, which would be to respect patient autonomy and delimit medical liability. The document aims to show that the doctor complied with his duty to inform. Its great value lies in cases where there is a risk of irreversible damage to the patient. We conclude, however, that a well-documented chart, which includes the recording of information that was provided and the degree of participation of patients and their families in treatment decisions, should also have legal and ethical value similar to the IC's.

Recomendações para o processo de obtenção do consentimento na pesquisa com seres humanos realizada no Hospital de Clínicas de Porto Alegre: [revisão] / Hospital de Clínicas de Porto Alegre directives for the informed consent process in human experimentation: [review]

São apresentadas recomendações institucionais para o processo de consentimento em pesquisas envolvendo seres humanos, especialmente para a elaboração e aplicação do Termo de Consentimento Livre e Esclarecido. Estas recomendações visam esclarecer os pesquisadores, com ênfase nos critérios utilizados pelo Comitê de Ética em Pesquisa do Hospital de Clínicas de Porto Alegre na avaliação de projetos, sobre aspectos fundamentais que devem ser levados em consideração quando da elaboração e obtenção do consentimento de potenciais participantes de um projeto de pesquisa.

Institutionals directives are proposed for the informed consent process in research involving human beings, especially for the development and implementation of the Informed Consent Form. These recommendations aim to clarify the researchers, using the Research Ethics Committee of Hospital de Clinicas de Porto Alegre in project review, on key aspects that must be taken into account when preparing and obtaining the consent of the prospects participants in a research project.

O uso do termo de consentimento livre e esclarecido na prática médica / The use of the free and clarified consent term in medical practice

Este artigo analisa a aplicação do termo de consentimento livre e esclarecido (TCLE) na prática dos médicos que trabalham no Hospital Universitário (HU) da Universidade Federal de Sergipe, localizado na cidade de Aracaju. A pesquisa que originou o trabalho verificou aatribuição de importância à aplicação do TCLE na prática médica. Foram entrevistados cinco médicos do HU, bem como analisados 72 prontuários de pacientes internos, de acordo com a bioética, a legislação e a doutrina brasileiras. Concluiu-se que apesar de visto como importante, o TCLE só é utilizado em dois serviços naquela unidade, apesar dos avanços da responsabilidade civil médica no Brasil.

Principais falhas na elaboração do TCLE dos projetos tramitados no CEP-FHEMIG nos últimos 24 meses / The most commons flaws on the elaboration of the informed cosent of the projects that were auditioned in CEP-FHEMIG in the last 24 months

INTRODUÇÃO: O Termo de Consentimento Livre e Esclarecido (TCLE) é peça fundamental na elaboração de uma pesquisa envolvendo seres humanos e expressa para o participante todas as garantias éticas e humanas do pesquisador junto ao voluntário. Por sua importância o TCLE é fonte de atenção detalhada dos Comitês de Ética em Pesquisa (CEP) e é determinante para aprovação do início das pesquisas. OBJETIVOS: Levantar as principais falhas detectadas na elaboração do TCLE dos projetos apreciados pelo CEP-FHEMIG, nos últimos 24 meses. MATERIAL: Trata-se de um estudo retrospectivo, no qual foram analisados os projetos de pesquisa que tramitaram no CEP-FHEMIG no período de setembro de 2008 a agosto de 2010. RESULTADOS: Foram analisados 193 projetos de pesquisa, sendo que 39,9% deste receberam o parecer de pendências por diversos motivos, porém a causa mais comum de pendências foram as inadequações do TCLE (38%). As principais falhas na elaboração do TCLE foram: Linguagem inadequada (23%), não disponibilização de contatos telefônicos para esclarecimento de dúvidas (15%), não apresentavam os riscos e benefícios da pesquisa (13,9%), projetos sem envio do TCLE (13,4%), não esclareciam o objetivo do estudo (7,5%), não mencionavam no TCLE os procedimentos a serem realizados (6,4%), falha não relatada no parecer (6,4%), erros de formatação (5,9%), não relatavam no TCLE as garantias do sujeito da pesquisa (5,9%) e sem relato de custo ou remuneração para o voluntário (2,7%). CONCLUSÕES: As principais causas de pendência estão diretamente relacionadas a falhas encontradas no TCLE, em especial as falhas presentes na linguagem do documento.(AU)

The informed consent is a fundamental piece on the elaboration of research with human beings and it contains all the ethics safeties and guaranties for the voluntaries chosen to participate in the project. Because of its importance, the informed consent is given a special attention by the Research Ethics Committee (REC) and is required for the approval of the project. OBJECTIVES: This study aims to assess the aspects of the research projects sent to CEP-FHEMIG, especially the difficulties related to the informed consent. MATERIALS: This is a retrospective study in which the research projects in CEP-FHEMIG were evaluated from November 2008 to August 2010. RESULTS: 193 research projects were analyzed, 39.9% of those were held up for various reasons. However the most common hold up was related to problems on the informed consent (38%). The most common mistakes related to the informed consent were: inappropriate grammar and language (23%) , did not have the phone info necessary to clear possible doubts (15%), did not show the risks and benefits of the research (13.9%), did not send the informed consent (13.4%), did not explain the objectives of the project (7.5%), did not mention the procedures of the research in the informed consent (6.4%), did not have the exact problem identified on their files (6.4%), were not properly formatted (5.9%), did not included the rights of the subject of the research (5.9%) and did not show that there was no costs or payment to the patients (2.7%). CONCLUSIONS: Most hold ups are related to flaws encountered on the informed consent, mainly on the grammar and language of the document.(AU)

Avaliação auditiva no recém-nascido e suas implicações éticas: [revisão] / Hearing evaluation on newborn babies and its ethical implications: [review]r

O estudo tem por finalidade examinar a produção bibliográfica que investigou o uso do teste das emissões otoacústicas em recém-nascidos realizado em hospitais, dando ênfase à aprovação do referido artigo junto ao Comitê de Ética em Pesquisa. O método constitui-se numa revisão bibliográfica de artigos nacionais publicados em revistas brasileiras. A busca se deu por meio de bancos de dados da Biblioteca Virtual em Saúde (BVS) (http://www.bireme.br), e site de busca (http://www.google.com.br), referentes aos anos de 2004 a 2006, usando os descritores emissões otoacústicas e triagem auditiva ou expressões equivalentes em neonatos, em hospitais. Outro meio foi a busca manual nas listas de referências dos artigos selecionados. Após aplicação dos critérios de inclusão, foram selecionados nove artigos em cinco tipos de revistas. A citação da aprovação do Comitê de Ética e assinatura do termo de consentimento livre e esclarecido pelo responsável estiveram presentes na grande maioria dos artigos, demonstrando a preocupação e respeito dos pesquisadores da área para com o sujeito participante no estudo.

The study has as purpose to examine the bibliographic production that investigates the use of the test of otoacoustic emissions in newborn babies done in hospitals. It gives emphasis in the approval of the mentioned article along the Research Ethics Committee. The method consists on bibliographic revision of national articles published in Brazilian journals. The research was realized in databases of the virtual library in health (http://www.bireme.br) and at the search engine Google (http://www.google.com.br), considering the period of 2004 to 2006. The key words used were: otoacoustic emissions and hearing triage or equivalent expressions in newborn babies in hospitals. Another source was the manual search in reference lists of the selected articles. After the application of the inclusion rules, nine articles were selected in five different journals. The citation of the approval of the Ethics Committee and the signature of the Free Consent Term, which were cleared by the responsible, were present in the majority of the articles and it demonstrates the concern and respect of the researchers of this area with the participant citizen on the study.