ABSTRACT
Resumo O objetivo do estudo é analisar problemas morais e/ou éticos vivenciados por membros de comitês de ética em pesquisa durante suas atividades e as estratégias utilizadas para solucionar esses problemas. Trata-se de pesquisa de abordagem qualitativa, com participação de 39 membros que atuavam em comitês em Salvador/BA, Brasil. Os dados foram coletados em outubro de 2020 por questionário on-line autoaplicado na plataforma Google Forms. Os resultados evidenciaram: vivências de conflitos de interesses e de valores, bem como dilemas; e utilização de trocas de experiências e compartilhamento de ideias e opiniões como estratégias para solucionar esses problemas. Conclui-se que os membros desses comitês vivenciam problemas morais e/ou éticos e buscam solucioná-los por meio de estratégias que favorecem o desenvolvimento de pesquisas conforme critérios éticos e metodológicos adequados.
Abstract The objective of the study is to analyze moral and/or ethical issues experienced by members of research ethics committees when performing their activities and the strategies used to deal with those issues. This is a qualitative study with 39 individuals that participated in committees in Salvador, Bahia, Brazil. Data were collected in October 2020 using a self-administered online questionnaire developed using Google Forms. Results showed that participants underwent conflicts of interests and values, and also faced dilemmas, and the strategies used to deal with those issues were exchanging of experiences and sharing of ideas and opinions. It is concluded that members of such committees experience moral and/or ethical issues and seek to deal with them via strategies that favor the development of research according to appropriate ethical and methodological criteria.
Resumen El objetivo del estudio es analizar los problemas morales o éticos experimentados por los miembros de los comités de ética de investigación durante sus actividades y las estrategias que utilizan para resolver dichos problemas. Se trata de una investigación de enfoque cualitativo, con la participación de 39 miembros que actuaban en comités en Salvador, Bahía, Brasil. Los datos se recopilaron en octubre del 2020 por medio de un cuestionario en línea autoadministrado en la plataforma Google Forms. Los resultados mostraron experiencias de conflictos de intereses y valores, así como dilemas; y el intercambio de experiencias, ideas y opiniones como estrategias para solucionar dichos problemas. Se concluye que los miembros de estos comités experimentan problemas morales o éticos y tratan de solucionarlos mediante estrategias que favorezcan el desarrollo de investigaciones de acuerdo con criterios éticos y metodológicos adecuados.
Subject(s)
Conflict of Interest , Ethics Committees, Research , Ethics, Research , Committee Membership , Prisoner DilemmaABSTRACT
ABSTRACT Objective: to translate, adapt and validate the contents of the Diabetes Medical Management Plan for the Brazilian context. This protocol was developed by the American Diabetes Association and guides the procedure of educators for the care of children and adolescents with diabetes in schools. Method: this methodological study was conducted in four stages: initial translation, synthesis of initial translation, back translation and content validation by an expert committee, composed of 94 specialists (29 applied linguists and 65 health professionals), for evaluation of the translated version through an online questionnaire. The concordance level of the judges was calculated based on the Content Validity Index. Data were exported into the R program for statistical analysis: Results: the evaluation of the instrument showed good concordance between the judges of the Health and Applied Linguistics areas, with a mean content validity index of 0.9 and 0.89, respectively, and slight variability of the index between groups (difference of less than 0.01). The items in the translated version, evaluated as unsatisfactory by the judges, were reformulated based on the considerations of the professionals of each group. Conclusion: a Brazilian version of Diabetes Medical Management Plan was constructed, called the Plano de Manejo do Diabetes na Escola.
RESUMO Objetivo: traduzir, adaptar e validar o conteúdo do Diabetes Medical Management Plan para o contexto brasileiro, protocolo elaborado pela Associação Americana de Diabetes, que orienta a conduta dos educadores para o cuidado das crianças e adolescentes com diabetes mellitus nas escolas. Método: trata-se de estudo metodológico, realizado em quatro etapas: tradução inicial, síntese da tradução inicial, retrotradução e validação de conteúdo por um Comitê de Juízes, composto por 94 especialistas (29 linguistas aplicados e 65 profissionais da área da Saúde), para avaliação da versão traduzida por meio de um questionário online. O nível de concordância dos juízes foi calculado com base no Índice de Validade de Conteúdo. Os dados coletados foram exportados para análise estatística no ambiente R. Resultados: a avaliação do instrumento apresentou boa concordância entre os juízes das áreas da Saúde e Linguística Aplicada, com Índice de Validade de Conteúdo médio de 0,9 e 0,89, respectivamente, e pequena variabilidade do índice entre grupos (diferença inferior a 0,01). Os itens da versão traduzida, avaliados como insatisfatórios pelos juízes, foram reformulados com base nas ponderações dos profissionais de cada grupo. Conclusão: construiu-se uma versão brasileira do Diabetes Medical Management Plan, denominado Plano de Manejo do Diabetes na Escola.
RESUMEN Objetivo: traducir, adaptar y validar el contenido del Diabetes Medical Management Plan para el contexto brasileño, protocolo elaborado por la Asociación de Diabetes Americana, que orienta la conducta de los educadores para el cuidado de niños y adolescentes con diabetes mellitus en las escuelas. Método: se trata de estudio metodológico, realizado en cuatro etapas: traducción inicial, síntesis de la traducción inicial, retrotraducción y validación de contenido por un Comité de Jueces, compuesto por 94 especialistas (29 lingüistas aplicados y 65 profesionales del área de la Salud), para evaluación de la versión traducida por medio de un cuestionario online. El nivel de concordancia de los jueces fue calculado con base en el Índice de Validez de Contenido. Los datos recolectados fueron exportados para ser analizados estadísticamente en el ambiente R. Resultados: la evaluación del instrumento presentó buena concordancia entre los jueces de las áreas de Salud y Lingüística Aplicada, con Índice de Validez de Contenido promedio de 0,9 y 0,89, respectivamente, y pequeña variabilidad del índice entre grupos (diferencia inferior a 0,01). Los ítems de la versión traducida, evaluados como insatisfactorios por los jueces, fueron reformulados con base en las sugestiones de los profesionales de cada grupo. Conclusión: se construyó una versión brasileña del Diabetes Medical Management Plan, denominado Plan de Administración de la Diabetes en la Escuela.
Subject(s)
Humans , Male , Female , Child , Adolescent , Patient Care Planning , Clinical Protocols , Diabetes Mellitus/therapy , School Health Services , Translations , Brazil , Practice Guidelines as Topic , Cultural CharacteristicsABSTRACT
The International Committee of Medical Journal Editors is a leading independent institution providing guidance for the report of biomedical research and health related topics in medical journals. Established in 1978, it is currently constituted by editors of fourteen general medical journals from different countries, plus one representative for the US National Library of Medicine and one representative for the World Association of Biomedical Journal Editors. Since 1978 the Committee provides a document, originally named "Uniform Requirements…", "to help authors, editors, and others involved in peer review and biomedical publishing create and distribute accurate, clear, unbiased medical journal articles". This document has been updated several times and the last version was released in August 2013, now renamed "Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals", available in www.icmje.org and citable as "ICMJE Recommendations". A vast proportion of medical journals, worldwide, have adopted these recommendations as rules. The ICMJE discusses and provides guidance on several relevant aspects including criteria on authorship, peer review, scientific misconduct, conflicts of interest, clinical trials registration, good editorial practices, the relations between editors and journal owners, the protection of individuals subject to medical research, the solvency of electronic publications, among others. The 2013 ICMJE Annual Meeting took place in Santiago, Chile, in November 4 and 5. The photograph shows attendants to the final session.
Subject(s)
Humans , Advisory Committees , Biomedical Research/standards , Editorial Policies , Periodicals as Topic/standards , Publishing/standards , ChileABSTRACT
After a worldwide call for applications that took place in 2009, two medical journals were selected to become new members of the International Committee of Medical Journal Editors (ICMJE): Chinese Medical Journal and Revista Médica de Chile. Both Editors: Getu Zhaori, MD, and Humberto Reyes, MD, respectively, attended the ICMJE Meeting, 12-14 April 2010, in Queenstown, New Zealand. The meeting agenda included several topics that had been studied in advance by the at-tendants: editors or deputy editors of the 14 journals integrating this Committee plus a representative for the U.S. National Library of Medicine and another one for the World Association of Medical Journal Editors (WAME). The Committee agreed in new recommendations tending to safeguard the integrity and transparency of every manuscript published in all journals that adhere to the Uniform Requirements for Manuscripts Submitted to Biomedical Journals (URM). These recommendations will be published shortly in ICMJE member journals. An important issue discussed refers to improvements in the ICMJE Uniform Disclosure Form for Potential Conflicts of Interest, that had some changes, a glossary of terms will be attached to it and the Instructions will be accompanied by translations into the offcial WHO languages as well as other languages used by ICMJE member journals. For our journal it is an honor and a great responsibility to become a member of this highly qualifed Committee, the only journal published in Spanish and the frst one from Latin America.