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.

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.

Termo de assentimento: participação de crianças em pesquisas / Consent forms: the participation of children in research / Formulario de asentimiento: participación de niños en investigaciones

Resumo A Resolução do Conselho Nacional de Saúde 466/2012 estabelece a obrigatoriedade de termo de assentimento para pesquisas realizadas com crianças. No entanto, a resolução apresenta a definição de assentimento livre e esclarecido sem especificar os elementos necessários para o documento. Essa lacuna torna atual e pertinente a abordagem desse tema proposta pelo presente estudo, que tem como objetivo discutir a participação de crianças em pesquisas. Os resultados apresentam um arcabouço teórico a partir do qual se pode refletir sobre a ética em pesquisas com crianças, tendo em vista sua vulnerabilidade, que pode levar a situações irreparáveis. Conclui-se que o tema deve permanecer nos debates acadêmicos e profissionais, pois, além de a realidade ser dinâmica, muitas são as especificidades desse segmento populacional.

Abstract The Resolution 466/2012 of the National Council of Health establishes the term of assent as compulsory for research carried out with children. However, the resolution presents the definition of assent without specifying the terms necessary for the document. This gap makes current and pertinent the approach of this topic by this study, which aims to discuss the participation of children in research. The results present a theoretical framework from which we can reflect on the ethics of Research with children, considering their vulnerability, which can lead to irreparable situations. We conclude that the theme must remain in the academic and professional debates since, on top of being a dynamic reality, this population segment has many specificities.

Resumen La Resolución del Consejo Nacional de Salud 466/2012 brasileño dispone que el término de asentimiento es obligatorio en las investigaciones que involucran a niños. La resolución trae la definición de asentimiento informado, pero no detalla los elementos que deben contener el documento. Con base en esta laguna actual y relevante, este estudio pretende discutir la participación de los niños en investigación. Se presenta un marco teórico desde el cual se reflexiona sobre la ética en la investigación que involucra a niños dada su vulnerabilidad, lo que puede llevar a situaciones irreparables. Se concluye que el tema tiene que seguir en los debates académicos y profesionales, porque, además de que la realidad es dinámica, existen muchas especificidades para esta población.

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.

Cultura de seguridad del paciente en tres hospitales de una subred de Bogotá / Patient's safety culture in three hospitals of a sub-network in Bogotá

Introducción: La seguridad del paciente es un asunto preocupante para la salud pública global y, a su vez, resulta relevante por sus efectos en el propio paciente. Objetivo: Determinar la cultura de seguridad del paciente en los hospitales de una subred de Bogotá, Colombia. Métodos: Estudio cuantitativo, descriptivo, transversal. Previo consentimiento informado se aplicó el cuestionario de la Agency for Healthcare Research and Quality en español a 385 miembros del equipo de salud de la subred que tuvieran contacto directo con el paciente. Se excluyeron aquellos con menos de 3 meses de trabajo en la institución. Se analizaron datos según guía de la Agency for Healthcare Research and Quality. Resultados: El aprendizaje organizacional-mejora continua fue la dimensión de la cultura con mayor porcentaje de respuestas positivas (69 por ciento), seguida del trabajo dentro de las unidades (65 por ciento). El menor número de respuestas positivas se obtuvo en las dimensiones de disponibilidad de personal y respuesta no punitiva al error, ambas con 31 por ciento de respuestas positivas. Los porcentajes de eventos reportados por los respondientes en el último año fueron: ninguno el 52 por ciento, de 1 a 2 el 29 por ciento, de 3 a 5 el 13 por ciento, 6 o más el 7 por ciento. Un 52 por ciento consideró el grado de seguridad como excelente o muy bueno, el 40 por ciento como aceptable y el 8 por ciento como pobre o malo. Conclusiones: Hay una cultura de mejora continua que tiende a constituirse en una fortaleza de cultura de seguridad del paciente, así como el trabajo dentro de las unidades. Además, los asuntos de personal y cultura punitiva frente al error requieren de una atención especial(AU)

Introduction: Patient's safety is an important concern for global public health, and at the same time it is relevant due to its effects in the patient. Objective: Determine the patient's safety culture in hospitals of a sub-network in Bogotá, Colombia. Methods: Quantitative, descriptive, cross-sectional study. With previous informed consent, it was applied a questionnaire of the Agency for Healthcare Research and Quality, in Spanish, to 385 members of the health staff if the sub-network whom have direct contact with the patients. Those with less than 3 months of work in the institution were excluded. Data was analyzed according to the guide of the Agency for Healthcare Research and Quality. Results: Organizational learning - continuous improvement was the dimension with a higher percentage of positive answers (69percent), followed by work within the units (65percent). The smallest number of positive answers was obtained in the dimensions called personal availability and no punitive answer to errors, both with 31percent of positive answers. The percentage of events informed by the respondents in the last year were: none (52percent), 1 to 2 (29percent), 3 to 5 (13percent), 6 or more (7percent). 52percent considered the degree of safety as excellent or very well, 40percent as acceptable and 8percent as poor or bad. Conclusions: There is a culture of continuous improvement that tends to represent strength of the patient's safety culture, as well as the work within the units. In addition, the subjects related to personnel and punitive culture facing errors require a special attention(AU)

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.

Análisis de legibilidad de formatos de consentimiento informado para pruebas genéticas en México / Readability analysis of informed consent forms for genetic tests in Mexico

Resumen Introducción: Es importante conocer si el documento que ampara el consentimiento informado (CI) del paciente a quien se le realizan pruebas genéticas de laboratorio (PGL) es legible y comprensible. Objetivo: Analizar la legibilidad de documentos de CI para pruebas genéticas de laboratorio (PGL) en México. Métodos: Se analizó la legibilidad de 10 formatos de CI libres en internet utilizados para PGL mediante el programa Legible.es; se evaluó índice de Flesh, versión de Fernández Huerta, y la escala INFLESZ. Se contabilizó el número de sílabas, palabras, frases, párrafos y palabras raras, tiempo para leer el documento y años de escolaridad mínima para entenderlo. Resultados: Se identificó que 60 % de los formatos de CI analizados son poco legibles. En promedio, se contabilizaron 3290 sílabas, 1459 palabras, 124 frases, 58 párrafos y 52 palabras raras. El tiempo requerido para la lectura fue de siete minutos y la escolaridad mínima de seis años. Conclusiones: Los formatos de CI analizados tuvieron bajos índices de legibilidad y exceden el número recomendado de palabras. Proponemos un modelo de CI para PGL en México, que cumple con los índices de legibilidad para la correcta comprensión del documento.

Abstract Introduction: Knowing if the document that supports the informed consent (IC) granted by the patient who undergoes genetic laboratory tests is legible and understandable is important. Objective: To analyze the readability of IC documents for laboratory genetic tests (LGT) in Mexico. Methods: Readability of 10 free IC forms on the internet used for LGT was analyzed using the Legible.es program; the Flesh index, Fernández-Huerta version, and the INFLESZ scale were evaluated. The number of syllables, words, phrases, paragraphs and strange words, time to read the document and minimum years of education required to understand it were counted. Results: 60 % of the analyzed IC documents were found to have poor readability. On average, 3,290 syllables, 1,459 words, 124 sentences, 58 paragraphs and 52 strange words were counted. The time required for reading it was seven minutes and minimum level of education to understand it was six years. Conclusions: The analyzed IC forms for LGT have low readability rates and exceed the recommended number of words. We propose an IC model for LGT in Mexico that complies with appropriate readability indexes for a correct understanding of the document.

Deliberaciones éticas ante investigaciones en el área de educación: a propósito de un caso / Ethical deliberations about research in the area of education: about a case

Un equipo investigador liderado por el primer autor de este artículo propuso traducir al español, adaptar transculturalmente y validar un cuestionario para evaluar la competencia de quienes ejercen mentoría en investigación. Dado que no se trataba de una investigación clínica, en un principio, el equipo investigador le restó importancia a la deliberación ética, asumiendo que este tipo de investigación podría estar exceptuada de ser evaluada por un Comité Independiente de Ética. Sin embargo, luego de revisar la bibliografía especializada y de varias sesiones de discusión con expertos en ética de la investigación, la opinión del equipo fue cambiando. Este artículo pretende compartir esta experiencia deliberativa con todo equipo involucrado en investigaciones en educación. (AU)

A research team led by the first author of this article proposed to translate into Spanish, adapt cross-culturally and validate a questionnaire to assess the competence of those who do research mentoring. Since it was not a clinical investigation, initially, the research team downplayed ethical deliberation, assuming that this type of research could be exempted from being evaluated by an Independent Ethics Committee. However, after reviewing the specialized literature and several discussion sessions with experts in research ethics, the opinion of the team changed. This article aims to share this deliberative experience with any team involved in education research. (AU)

Percepciones subjetivas del personal de enfermería sobre la Violencia en el lugar de trabajo, resultados preliminares / Workplace Violence among nursing staff subjective perceptions, preliminary results

ABSTRACT Introduction: Several studies have established the prevalence of workplace violence in the health sector being the nursing staff more likely to experience physical and non-physical violence than other health workers. Objective: Thus, we aimed to research the perceptions of workplace violence in nursing staff in association to type of violence, perpetrators, consequences and protecting measures available in the health institutions. Methods: The study was conducted with a phenomenological method in a major hospital in Quito, Ecuador. N=13/210 professional nurses were selected from a convenience sample and, before starting the discussion, were given information consent forms to sign. The considered selection criteria were being professional, over age 18, and being employers at the hospital as minimum 2 years. The technique selected in data collection was Focus Group Discussion. Results: showed that nursing staff had clarity about what constitutes violence in the workplace such as understanding about the magnitude of the problem, nurses affected by verbal abuse and threats mostly tried to ignore the situation because they considered this to be a typical incident in the workplace, they did not report the situation and it has caused underregistration. The aggressors were mostly staff members, supervisors and relatives of patients. Conclusion: The evidence allowed us to admit that the situation is a significance problem in magnitude and severity. Our recommendations will be oriented toward the implementation of a preventative and minimizing aggression program in the Hospital(AU)

RESUMEN Introducción: Varios estudios han establecido la prevalencia de la violencia en el lugar de trabajo en el sector salud, y es el personal de enfermería quien tiene más probabilidades de sufrirla. Objetivo: Investigar las percepciones de la violencia en el lugar de trabajo en profesionales de la enfermería en asociación con el tipo de violencia, perpetradores, consecuencias y medidas de protección disponibles en las instituciones de salud. Métodos: Estudio fenomenológico en un hospital de especialidades de Quito, Ecuador. N = 13/210 enfermeras profesionales se seleccionaron en una muestra de conveniencia. Antes de comenzar la discusión, se les proporcionaron los formularios de consentimiento informado. Los criterios de selección fueron: ser profesionales, mayores de 18 años y empleadas en el hospital con tiempo mínimo de 2 años. La técnica seleccionada en la recopilación de datos fue Grupo Focal de Discusión. Resultados: El personal de enfermería tenía claridad sobre lo que constituye violencia en el lugar de trabajo, como la comprensión de la magnitud del problema, las enfermeras afectadas por el abuso verbal y las amenazas intentaban ignorar la situación porque consideraban que se trataba de un incidente típico en el lugar de trabajo. No informaron la situación y causó un subregistro. Los agresores eran en su mayoría miembros del personal, supervisores y familiares de pacientes. Conclusión: La evidencia permitió admitir que la situación es un problema de importancia en magnitud y gravedad. Las recomendaciones estarán orientadas a la implementación de un programa preventivo en el hospital(AU)

Students' dietary habits, food service satisfaction, and attitude toward school meals enhance meal consumption in school food service

BACKGROUND/OBJECTIVES: This study aimed to compare student consumption of school meals by school level, to identify the influencing factors of school meal consumption, and to assess improvement needs of school food service among students. SUBJECTS/METHODS: A total of 1,441 elementary, middle, and high school students attending 58 schools in Gyeonggi-do, South Korea participated in the survey in 2015. A questionnaire and informed consent forms for students and legal guardians were sent home and completed responses were returned to the researcher. RESULTS: Approximately 58% of the students perceived the portion sizes of school meals as appropriate and 76.1% consumed almost all or all of the meals served. More elementary and middle school students than high school students consumed almost all or all of the meals (P < 0.001). A regression analysis revealed that the students with a higher dietary behavior score (P < 0.001), higher satisfaction with food service (P < 0.001), a higher environmental protection practice score (P < 0.05), and more positive attitudes toward school meals (P < 0.01) consumed significantly more meals. The provision of foods that taste good and reflecting student opinions on menus were the most important factors for increasing school meal consumption. CONCLUSIONS: To increase consumption of school meals, food service staff should provide students with quality meals and engage students in school food service. Nutrition education that emphasizes healthy eating behaviors and cafeteria environment modification that applies strategies based on behavioral economics can encourage students to consume more school meals.

Protection of Personal Information in Medical Journal Publications / 신경중재치료의학

It aimed to present the definition of personal information based on Korean laws that protect personal information and the process of protection of personal information in journal publishing based on the guidelines of the International Committee of Medical Journal Editors and Committee of Publication Ethics. Two Korean laws relate to the protection of personal information in human subject research: the Personal Information Protection Act and the Bioethics and Safety Act. These laws were enacted to prevent the unauthorized use of Koreans’ personal information including medical information. Personal information can be divided into personally identifiable information including resident registration numbers and sensitive information including health information. To protect personal information in journal publishing, institutional review board (IRB) approval and obtaining informed consent from patients is recommended or mandatory in clinical studies. However, retrospective chart reviews may be exempted from IRB approval, while obtaining informed consent is recommended for all case reports. Journal policies may vary with regard to whether a copy of the informed consent form is collected from authors, since the Committee of Publication Ethics guideline does not specifically recommend collecting it. In discussions of adopting clinical data-sharing policies, transfer of data including nonidentifiable personal information to another country is an unresolved issue. Furthermore, a public data repository site should be established in Korea for data to be deposited. To protect subjects’ privacy and to prevent legal issues potentially arising from privacy concerns, editors and publishers should do their best to publish articles with appropriate oversight on subjects’ personal information.

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.

Consentimiento informado. percepción de pacientes. revisión documental 1995-2013 / Informed consent. patients' perception. documents review, 1995-2013 / Consentimento informado. percepçäo de pacientes. revisäo documental 1995-2013

Resumen Objetivo. Revisar literatura descriptiva y analítica sobre consentimiento informado (CI), publicada entre 1995 y 2013, centrando el interés en los estudios que muestran la percepción de los pacientes en atención clínica. Métodos. El proceso de indagación consistió en la revisión de literatura descriptiva y analítica sobre consentimiento informado, en formatos digitales y en físico, centrando el interés en los estudios que muestran la percepción de los pacientes en atención clínica. Se compiló un total de 78 documentos entre artículos científicos, trabajos de grado, libros y capítulos de libro, publicados entre los años 1995 y 2013. Con estos aspectos de contenido se elaboró una hoja de cálculo (matriz en Excel), con resumen, consideraciones teóricas, metodológicas, observaciones y conclusiones. Resultados. Del total de documentos consultados, solamente dos estudios particularizan sobre un área de atención clínica: la oncología, y apenas algunos tratan la percepción del CI en atención clínica de pacientes. Los demás, son de teoría sobre CI, CI e investigación o se refieren al él en general y versan sobre distintos temas, teniendo en cuenta la percepción de profesionales y expertos. Finalmente, en ningún documento se mencionan posturas teóricas sobre percepción y todos los documentos refieren problemas frente a su aplicación e implementación. En todos los casos, la autonomía se entiende como una expresión de voluntad que requiere ser aplicada, lo cual es determinante para el CI. Conclusiones. Existen pocos estudios de percepción en pacientes y en ninguno se explica qué se entiende por este concepto. Por el contrario, es generalizado en los escritos revisados, lo que evidencia problemas relacionados con la aplicación e implementación del CI.

Summary Objective: To review descriptive and analytical literature on informed consent (IC), published between 1995 and 2013; focusing on studies that show the patients' perception of clinical care. Methods: The investigation process consisted of reviewing descriptive and analytical literature related to informed consent, in both digital and physical formats, while focusing on studies that show the patients' perception of clinical care. A total of 78 documents were compiled, including scientific articles, university theses, complete books, and book chapters, all published between 1995 and 2013. Taking all these into account, a spreadsheet (Excel matrix) was elaborated, including a summary, theoretical considerations, methodologies, observations and conclusions. Results: Of the total number of documents consulted, only two studies specify a clinical care area: oncology, and just a few deal with the perception of IC in clinical patient care. The others are theoretical in their approach to IC, IC and research, or they refer to it in general terms and deal with different topics, taking into account the perception of professionals and experts. Finally, theoretical positions on perceptions are not mentioned in any of the documents, and all the documents refer to problems regarding its application and implementation. In all cases, autonomy is understood as an expression of will that needs to be applied, which is decisive for IC. Conclusions: There are only a few studies of perception in patients and none of them explain what is understood by this concept. On the contrary, IC is generalized in the reviewed writings, which shows problems related to the application and implementation of IC.

Resumo Objetivo. Revisar literatura descritiva e analítica sobre consentimento informado (CI), publicada entre 1995 e 2013, centrando o interesse nos estudos que mostram a percepçäo dos pacientes em atençäo clínica. Métodos. O processo de indagaçäo consistiu na revisäo de literatura descritiva e analítica sobre consentimento informado, em formatos digitais e em físico, centrando o interesse nos estudos que mostram a percepçäo dos pacientes em atençäo clínica. Foi compilado um total de 78 documentos entre artigos científicos, trabalhos de conclusäo de curso, livros e capítulos de libro, publicados entre os anos 1995 e 2013. Com estes aspectos de conteúdo foi elaborada uma folha de cálculo (matriz em Excel), com resumo, considerações teóricas, metodológicas, observações e conclusões. Resultados. Do total de documentos consultados, somente dois estudos particularizam sobre uma área de atençäo clínica: a oncologia, e apenas alguns tratam a percepçäo do CI em atençäo clínica de pacientes. Os demais säo de teoria sobre CI, CI e pesquisa ou se referem ao tema em geral e versam sobre diferentes temas, levando em conta a percepçäo de profissionais e expertos. Finalmente, em nenhum documento se mencionam posturas teóricas sobre percepçäo e todos os documentos referem problemas diante da sua aplicaçäo e implementaçäo. Em todos os casos, a autonomia se entende como uma expressäo de vontade que requer ser aplicada, o que é determinante para o CI. Conclusões. Existem poucos estudos de percepçäo em pacientes e em nenhum se explica que se entende por este conceito. Pelo contrário, é generalizado nos escritos revisados, o que evidencia problemas relacionados com a aplicaçäo e implementaçäo do CI.

How does the patient react after reading the informed consent form of a gynecological surgery? A qualitative study / Como o paciente reage depois de ler o termo de consentimento livre e esclarecido de uma cirurgia ginecológica? Um estudo qualitativo

Abstract Objective To analyze the reaction of women after reading the Informed Consent Form (ICF) before undergoing elective gynecological/urogynecological surgeries. Methods A qualitative study with 53 women was conducted between September 2014 and May 2015. The analysis of the content was conducted after a scripted interview was made in a reserved room and transcribed verbatim.We read the ICF once more in front of the patient, and then she was interviewed according to a script of questions about emotions and reactions that occurred about the procedure and her expectations about the intra- and postoperative period. Results The women had a mean age of 52 years, they were multiparous, and most had only a few years of schooling (54.7%). The majority (60.4%) of them had undergone urogynecological surgeries. Hysterectomy and colpoperineoplasty were themost frequent procedures. Ten women had not undergone any previous abdominal surgery. Fear (34.6%) was the feeling that emerged most frequently from the interviews after reading the ICF, followed by indifference (30.8%) and resignation (13.5%). Nine women considered their reaction unexpected after reading the ICF. Three patients did not consider the information contained in the ICF to be sufficient, and 3 had questions about the surgery after reading the document. Conclusion Reading the ICF generates fear in most women; however, they believe this feeling did not interfere in their decision-making process.

Resumo Objetivo Analisar a reação das mulheres após lerem o Termo de Consentimento Livre e Esclarecido (TCLE) antes de se submeterem a cirurgias ginecológicas/uroginecológicas eletivas. Métodos Um estudo qualitativo com 53 mulheres foi realizado entre setembro de 2014 e maio de 2015. A análise do conteúdo foi feita depois de uma entrevista que seguia um roteiro, que foi realizada em uma sala reservada e transcrita de forma fidedigna. Nós lemos de novo oTCLE na frente da paciente, e depois ela era entrevistada de acordo comumroteiro de questões sobre emoções e reações que ocorreram sobre o procedimento e suas expectativas sobre o período intra e pós-operatório. Resultados As mulheres tinham uma média de 52 anos, eram multíparas, e com poucos anos de educação (54,7%). A maioria (60,4%) já havia realizado cirurgias uroginecológicas. A histerectomia e a colpoperineoplastia foram as cirurgias mais frequentes. Dez mulheres não tinham sido submetidas a nenhum procedimento. O medo (34,6%) foi o sentimento que mais emergiu das entrevistas depois da leitura do TCLE, seguido da indiferença (30,8%) e da resignação (13,5%). Nove mulheres consideraram suas reações inesperadas depois da leitura do TCLE. Três pacientes não consideraram a informação do TCLE suficiente, e outras 3 tiveram dúvidas sobre a cirurgia depois de lerem o documento. Conclusão A leitura do TCLE desperta o medo namaioria dasmulheres; contudo, elas acreditam que este sentimento não interferiu na tomada de decisão relativa ao tratamento.

Ownership of mobile phones and willingness to receive childhood immunisation reminder messages among caregivers of infants in Ondo State, south-western Nigeria

Background. The timely completion of the childhood immunisation schedule for children under the age of 1 year by caregivers is key to reducing the high morbidity and mortality of vaccine-preventable diseases among infantsglobally.Objective. To determine the ownership of mobile phones among caregivers of children under the age of 1 year, their knowledge about immunisation service delivery and willingness to receive childhood immunisation schedule reminder messages in Ondo State, south-western Nigeria.Method. A descriptive cross-sectional study using semi-structured interviewer-administered questionnaires was conducted with 615 caregivers of infants, who brought their children to clinics conducting immunisation in 24 health facilities in rural, semi-urban and urban settlements in Ondo State in December 2014.Results. The mean (standard deviation, SD) age of respondents was 28.49 (6.01) years, 76.7% were Yoruba, 91.4% were married and living with their spouses and 4.2% were single. Mobile phone ownership was 74.5% among rural-based respondents, and 95.8% among urbanbased.Forty-six percent of the respondents had good knowledge of immunisation, vaccine-preventable diseases and vaccination schedules,while 27.5% had poor knowledge. The majority of the respondents (99.7%) were willing to receive childhood immunisation reminder messages on their mobile phones. About 50% of the respondents preferred to receive reminder messages at any time, rather than specific times. The most preferred language for reminders was English (54.5%). Residing in an urban area and having post-secondary education were predictors of mobile phone ownership.Conclusion. The high mobile phone ownership level, and the willingness of caregivers of infants in this study area to receive immunisation schedule reminder messages, is encouraging, and should be optimised to improve routine immunisation uptake. However, caregivers of infants in rural areas need to be provided with mobile phone support, and trained in their usage in order to benefit from such an intervention in childhood immunisation

A Retrospective Study on the Decision to Prohibit Cardiopulmonary Resuscitation in Patients with Premenarcheal Cancer in a University Hospital

OBJECTIVE: Whether to perform cardiopulmonary resuscitation (CPR) or do-not-resuscitate (DNR) is not only a medical problem but also a decision that should be made carefully with self-autonomy in accordance with life values. We conducted a retrospective observational study to identify the characteristics of current CPR and DNR at a practical level. METHODS: We retrospectively analyzed data from medical records with regard to the clinical status of DNR decision in 356 patients with cancer who expired between October 2014 and September 2015 in Soonchunhyang University Bucheon Hospital. RESULTS: DNR was decided significantly more frequently in patients with solid cancers than in patients with hematological cancer (87.7% vs. 71.4%, P=0.003). No other significant factor influenced the DNR decision in this study. The main persons who signed the DNR consent form were mostly sons or daughters (60.7%), never the patients themselves. The median time from the DNR order to death was longer in the ward than in the intensive care unit (ICU; 3.0 days vs. 1.0 days). The mean time from the DNR order to death was 6.6 days (median, 2 days). Among the patients with a DNR order, 110 (36.7%) were hospitalized in the ICU and 73 (24.3%) were treated with ventilator support. CONCLUSION: Most patients expired 6.6 days after DNR permission was given and could not decide their treatment plan by themselves. For better end-of-life care, the sensitive DNR decision with consideration of the individualized environment of the patient for life-sustaining treatment should be settled in Korea.