Ética en investigación: desafíos durante la pandemia / Research ethics: challenges during the pandemic

Durante la pandemia de Covid-19 los hospitales pediatricos se vieron menos afectados, debido a la menor infección en niños, y sus recursos fueron reasignados en distintas tareas.. El Comité de Ética en Investigación del Hospital General de Niños Pedro de Elizalde presenta los distintos procedimientos implementados en esta emergencia, para sostener diferentes investigaciones, y que les permitió una rápida respuesta a esta situación.

Saúde e pesquisa científica com seres humanos: a conformação dos danos decorrentes e o modelo brasileiro de fiscalização / Health and scientific research with human beings: the conformation of the resulting damages and the brazilian method of inspection / Salud e investigación científica con seres humanos: la conformación de los daños resultantes y el modelo brasileño de fiscalización

Objetivo: Este artigo objetiva analisar o ordenamento jurídico brasileiro às pesquisas envolvendo seres humanos no tocante aos danos à saúde decorrentes dos experimentos, com fundamento na Resolução nº 466/2012 do Conselho Nacional de Saúde. Metodologia: Realizou-se pesquisa de natureza bibliográfica, em livros e artigos da área jurídica, em legislações ordinárias e resoluções relacionadas, bem como em artigos publicados em periódicos da área de Saúde. Resultados: Os danos decorrentes dos experimentos devem ser cuidadosamente evitados e, se ocorrerem, deve o participante da pesquisa ser indenizado. Conclusão: Eventuais danos decorrentes dos experimentos devem ser evitados e observados durante todo o curso da pesquisa, iniciando-se com a assinatura do Termo de Consentimento Livre e Esclarecido pelo participante e perpassando pela fiscalização pelo Comitê Nacional de Ética e Pesquisa e pelas Comissões de Ética em Pesquisa. É essencial que o acompanhamento e a fiscalização sejam feito de forma mais próxima, obstando e ressarcindo a ocorrência de eventuais danos, além de garantir a regularidade do processo de consentimento realizado no projeto

Objective: This article objectives to analyze the legal treatment and the procedure adopted by Brazil on clinical research with basis on the Resolution nº 466/2012 from National Health Council towards the occurrence of damages due to the project. Methodology: The research was carried out in nature bibliographical references, in books and articles of the legal area, in ordinary legislations and related resolutions, as well as in articles published in periodicals of the Health area. Results: Damages must be avoided and, when occurring, must provide also an compensation to those who were harmed. Conclusion: Any damages resulting from the experiments should be avoid and noted during the curse of the project, since the moment of the informed consent's signature to the stage of inspection from the National Ethics and Research Committee and Research Ethics Committees. The completion of a closest monitoring is essential to prevent this damages and to indemnify the participant. Furthermore, it guarantees that the process of consent is being held on a satisfactory form

. Objetivos: Trabajo destinado al análisis jurídico de la protección conferida por el ordenamiento brasileño a las investigaciones involucrando a seres humanos en lo que se refiere a los daños a la salud derivados de los experimentos, con base en la Resolución 466/2012 del Consejo Nacional de Salud. Metodología: Se realizó investigación de naturaleza bibliográfica, en libros y artículos del área jurídica, en legislaciones ordinarias y resoluciones relacionadas, así como en artículos publicados en periódicos del área de Salud. Resultados: Los daños resultantes de los experimentos deben ser cuidadosamente evitados y, si ocurren, el participante de la investigación debe ser indemnizado. Conclusión: Eventuales daños resultantes de los experimentos deben ser evitados y observados durante todo el curso de la investigación, iniciándose con la firma del Término de Consentimiento Libre y Esclarecido por el participante y pasando por la fiscalización por el Comité Nacional de Ética e Investigación y por las Comisiones de Ética en Investigación. Es esencial que el seguimiento y la fiscalización se haga de forma más cercana, obstaculizando y resarciendo la ocurrencia de eventuales daños, además de garantizar la regularidad del proceso de consentimiento realizado en el proyecto

Estructura y funcionamiento de los comités de ética en investigación de la Ciudad Autónoma de Buenos Aires y el Gran Buenos Aires / Structure and functioning of research ethics committees in the Autonomous City of Buenos Aires and Greater Buenos Aires

En función de los escasos estudios publicados sobre los comités de ética en investigación (CEI) de Argentina, este trabajo tiene como objetivo describir la estructura y funcionamiento de los CEI de instituciones de la Ciudad Autónoma de Buenos Aires y el Gran Buenos Aires. Con ese fin, se realizó un estudio descriptivo, cuali-cuantitativo, a partir de la aplicación de una encuesta entre marzo y julio de 2012. La muestra quedó conformada por 46 CEI. El 40% de sus miembros eran médicos y la distribución por sexo y edad se adecuaba a la normativa. Se encontraron falencias en la cantidad de metodólogos, representantes de la comunidad, abogados y miembros externos a las instituciones, falta de personal administrativo y de lugar fijo para las reuniones, presupuestos escasos para gastos y poco entrenamiento en ética de la investigación. Algunos de los encuestados reportaron problemas de relación con la institución y los investigadores, y con el tiempo disponible para realizar la tarea.

Given the few existing studies on research ethics committees (RECs) in Argentina, this paper aims to describe the structure and functioning of institutional RECs in the Autonomous City of Buenos Aires and Greater Buenos Aires. A descriptive, qualitative and quantitative research study was carried out using a survey conducted between March and July 2012. The sample was made up of 46 RECs. Forty percent of committee members were doctors and the age and sex distribution met standards. Inadequate numbers of methodologists, community representatives, lawyers and members external to the institution were identified, as well as shortcomings regarding administrative staff, fixed locations for meetings, budgets adequate to expenditures and training in research ethics. Some of those surveyed reported problems in their relationship with the institution and with researchers, in addition to difficulties regarding the time available to perform tasks.

O Núcleo de Apoio ao Pesquisador e o Comitê de Ética em Pesquisa: uma estratégia de fomento à pesquisa na Fundação Hospitalar do Estado de Minas Gerais / Researcher Support Centre and the Research Ethics Committee: a strategy of research promotion in Hospital Foundation of Minas Gerais

Introdução: Como integrante do Sistema Único de Saúde, a Fundação Hospitalar do Estado de Minas Gerais (Fhemig) considera estratégico o desenvolvimento da pesquisa para qualificação profissional e melhoria da assistência à saúde. O Núcleo de Apoio ao Pesquisador, já completamente implantado, e os Comitês de Ética em Pesquisa trabalham nessa perspectiva. Objetivos: Descrever os projetos de pesquisa cadastrados na Fhemig. Métodos: Realizou-se análise descritiva dos projetos submetidos ao Núcleo de Apoio ao Pesquisador e aos Comitês de Ética em Pesquisa da Fhemig, em 2010-2011. Resultados: Dos 330 projetos de pesquisa avaliados, 243 foram considerados adequados para se desenvolver nas Unidades da Rede Fhemig. Desses, 164 (50%) foram aprovados após um único parecer favorável por parte dos profissionais do Núcleo de Apoio ao Pesquisador e 79 (24%) foram aprovados após atender as recomendações quanto às questões metodológicas, principalmente. O Comitê de Ética em Pesquisa da Fhemig avaliou 196 projetos de pesquisa e o do Hospital Eduardo de Menezes avaliou 41 sendo que nenhum projeto de pesquisa foi reprovado. No entanto, a maior deles apresentou inadequações quanto ao Termo de Consentimento Livre e Esclarecido (54,3%). Conclusões: O grande número de projetos aprovados na primeira submissão ao Núcleo de Apoio ao Pesquisador indica uma maior qualidade desses projetos no biênio. O Núcleo de Apoio ao Pesquisador tem cumprido sua função de apoio aos pesquisadores em seus projetos de pesquisa.

Introduction: Hospital Foundation of Minas Gerais (Fhemig), member of Unified Health System, considers strategic the research development for qualifying professionals and improve health assistance. The Researcher Support Centre, now completely implanted, and the Research Ethics Committees work based in this perspective. Objectives: To describe research projects registered in Fhemig. Methods: Descriptive analysis of projects registered in the Researcher Support Centre and the Research Ethics Committees from Fhemig, were done in 2010-2011. Results: 243 out of 330 research projects analyzed were considered appropriate to develop in the Fhemig Network Units. Out of those, 164 (50%) were approved after only one favorable feedback from professionals of the Researcher Support Centre and 79 (24%) after complying with, mostly, of the methodological recommendations. Fhemig's Research Ethics Committee evaluated 196 projects and Eduardo de Menezes' Hospital Ethics Committee evaluated 41. None them was reproved. However, most of them presented inadequacies on their Term of Informed Consent (54,3%). Conclusions: The great number of approved projects in the first submission to the Research Support Centre indicates a higher quality of such projects in the couple of years. The Research Support Centre has reached its role in supporting researchers in their research projects.(AU)

Protocolo de pesquisa: o desafio do aprimoramento ético / Research protocol: the challenge of ethical improvement

O trabalho analisa protocolos de pesquisas no âmbito universitário submetidos nos últimos três anos ao Comitê de Ética em Pesquisa da Escola Superior de Ciências da Santa Casa de Misericórdia de Vitória (CEP/Emescam). Este CEP avalia 200 projetos/ano. Os dados foram restritos ao título dos projetos e número de sujeitos. Os achados foram agrupados conforme a Biblioteca Virtual de Saúde (BVS). As pesquisas concentram-se nas categorias saúde do trabalhador; aleitamento materno, saúde materna e da mulher; adolescência, criança e idoso. Economia, indicadores de saúde, alta complexidade e ciência e tecnologia estão ausentes. Considerando que a preferência pela área temática advém da familiaridade com o tema, os dados levantados foram comparados com a experiência dos pesquisadores, registrada na Plataforma Lattes. Sabe-se que hoje as pesquisas são resultado dos esforços passados dos pesquisadores e conhecer o cenário atual da pesquisa acadêmica é importante para planejar o futuro da pesquisa em saúde no país.

Reasons for resubmission of research projects to the research ethics committee of a University Hospital in São Paulo, Brazil

INTRODUCTION: It is important to know the reasons for resubmitting research projects to the Research Ethics Committee in order to help researchers to prepare their research projects, informed consent forms and needed research documentation. OBJECTIVES: To verify the reasons for resubmitting projects that were previously rejected by the Ethics Committee. METHOD: This is a cross-sectional study that evaluated research projects involving human beings. Research projects were submitted in 2007 to the Research Ethics Committee of the Hospital das Clínicas, Faculdade de Medicina da Universidade de São Paulo. RESULTS: One thousand two hundred and fifty six research projects were submitted to the ethics committee and the average time for evaluating the research projects and related documents until a final decision was reached was 49.95 days. From the total, 399 projects were reviewed in 2 or more meetings until a final decision was reached. Of these, 392 research projects were included in the study; 35 projects were subsequently excluded for involving animals. Among the research projects included, 42.5 percent concerned research with new drugs, vaccines and diagnostic tests, 48.5 percent consisted of undergraduate students' research projects, 68.9 percent of the research had no sponsorship, and 97.5 percent were eventually approved. The main reasons for returning the projects to the researchers were the use of inadequate language and/or difficulty of understanding the informed consent form (32.2 percent), lack of information about the protocol at the informed consent form (25.8 percent), as well as doubts regarding methodological and statistical issues of the protocol (77.1 percent). Other reasons for returning the research projects involved lack of, inaccuracy on or incomplete documentation, need of clarification or approval for participation of external entities on the research, lack of information on financial support. CONCLUSION: Among the ...

Current Status of the Institutional Review Boards in Korea: Constitution, Operation, and Policy for Protection of Human Research Participants

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.