Trascendencia de los Comités de Ética de Investigación en Seres Humanos en el Ecuador / Research Ethics Committees of Human Beings in Ecuador

INTRODUCCIÓN. Los Comités de Ética de Investigación en Seres Humanos deben proteger la dignidad, los derechos, el bienestar y la seguridad de los sujetos investigados; evalúan aspectos éticos, metodológicos y jurídicos de los protocolos de investigación, competencia otorgada por el ente sanitario del país que ameritó observar si se cumplió. OBJETIVO. Evaluar la situación de los Comités de Ética de Investigación en Seres Humanos, basados en la percepción del cursillista, la normativa, las repercusiones y consecuencias para mantener su condición activa y su trascendencia. MATERIALES Y MÉTODOS. Estudio descriptivo, transversal y ambispectivo con un universo de 1 327 profesionales del área de la salud y una muestra de 385 encuestados que expresaron su percepción sobre trece Comités de Ética de Investigación en Seres Humanos a nivel nacional, con revisión bibliográfica nacional e internacional, se excluyeron los suspendidos. Se aplicó encuesta validada online, período abril a octubre de 2019. Data analizada en Excel y SPSS versión 23. RESULTADOS. El 76,92% Comités de Ética de Investigación en Seres Humanos fueron de la ciudad de Quito. Los cursillistas percibieron que el 64,16%, no trascendieron en su labor; desconocieron que: la Dirección Nacional de Inteligencia de la Salud, cuestionó el nombramiento de algún miembro un 97,14%; el cuestionamiento estuvo basado en la norma vigente un 79,48%; sobre la aprobación del plan anual de capacitación en investigación, 2019, un 95,06%; el plan anual de capacitación específico un 77,40%, y no recibieron directrices ni retroalimentación en temas de capacitación en calidad de investigador, un 90,39%. Además, percibieron que los Comités fueron responsables de capacitar otros Comités de ética de Investigación en Seres Humanos, un 81,82% y a los investigadores, un 85,71%; que deben elaborar el plan anual de educación específica para los miembros del comité, un 89,35%. CONCLUSIÓN. Se identificó entre los problemas que los investigadores casi no los conocen y hay necesidad de actualizar la norma que afectó el funcionamiento. Los justificativos para mantener la condición activa no se cumplieron, se evidenció la necesidad de asesoría para los comités por parte de las autoridades competentes, sin lograr conformación consolidada con actores y repercutió en su trascendencia.

INTRODUCTION. The Research Ethics Committees on Human Beings must protect the dignity, rights, well-being and safety of the research subjects; evaluate ethical, methodological and legal aspects of the research protocols, a competence granted by the health entity of the country that merited see if it is done. OBJECTIVE. Evaluate the situation of the Ethics Committees for Research in Human Beings, based on the perception of the trainee, the regulations, the repercussions and consequences to maintain their active condition and their transcendence. MATERIALS AND METHODS. Descriptive, cross-sectional and ambispective study with a universe of 1,327 professionals in the health area and a sample of 385 respondents who expressed their perception of thirteen Research Ethics Committees on Human Beings at the national level, with national and international bibliographic review. those suspended were excluded. An online validated survey was applied, from April to October 2019. Data analyzed in Excel and SPSS version 23. RESULTS. 76.92% Human Research Ethics Committees were from the city of Quito. The trainees perceived that 64,16%, did not transcend in their work; they did not know that: the National Directorate of Health Intelligence, questioned the appointment of a member 97,14%; the questioning was based on the current norm 79,48%; on the approval of the annual research training plan, 2019, 95,06%; the specific annual training plan 77,40%, and did not receive guidelines or feedback on training issues as a researcher, 90,39%. In addition, they perceived that the Committees were responsible for training other Human Beings Research Ethics Committees, 81,82% and the researchers, 85,71%; that they must prepare the annual specific education plan for the members of the committee, 89,35%. CONCLUSION. It was identified among the problems that the researchers hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance. hardly know them and there is a need to update the norm that affected the operation. The justifications to maintain the active condition were not fulfilled, the need for advice for the committees by the competent authorities was evidenced, without achieving a consolidated conformation with actors and had repercussions on its importance.

Melhorando a qualidade do processo de revisão por pares: instruções para os revisores da GGA / Improving the quality of peer review: GGA instructions for reviewers

A revisão por pares (peer review) é parte essencial e indissociável do processo editorial e de publicação acadêmica, contribuindo para a validação dos textos submetidos para revistas biomédicas. Boas revisões melhoram sobremaneira a qualidade dos manuscritos publicados e, por conseguinte, a reputação, o valor e a relevância da revista para os leitores. Este artigo especial incluiu as principais recomendações do Conselho Editorial da revista Geriatrics, Gerontology and Aging aos seus atuais e futuros revisores, almejando a contínua evolução dos padrões de qualidade do processo de revisão por pares adotado pelo periódico. Além de discorrer sobre a importância e tipos de processos de revisão, como se dão o fluxo editorial e a seleção dos revisores, apresentamos recomendações gerais e específicas para a condução de um bom parecer.

Peer review is an essential and integral part of the editorial and academic publication process that contributes to validate manuscripts submitted to biomedical journals. A good review can greatly improve the quality of published manuscripts, thereby improving the journal's reputation, value, and relevance to the reader. This special article includes the main recommendations of the editorial board of Geriatrics, Gerontology and Aging to its current and future reviewers, aiming at a continuous improvement of quality standards in the peer review process used by the journal. In addition, the importance and types of review processes are discussed, as well as the editorial flow and selection of reviewers, and general and specific recommendations are presented for carrying out good reviews.

Ampliação e politização do conceito internacional de bioética / Expansion and politicization of the international concept of bioethics

A América Latina e o Brasil, particularmente, tiveram importante papel na recente ampliação e politização da agenda bioética internacional, fundamentada na Declaração Universal sobre Bioética e Direitos Humanos da Unesco. O presente estudo faz um breve histórico deste processo, relacionando os problemas éticos contemporâneos com a atual crise econômica e sociopolítica mundial, que justificam a necessidade de mudanças concretas no campo da ética aplicada. Analisando certas situaçães nas quais a bioética vem falhando ou não se manifestando como deveria, mostra a urgência de se passar a analisar de modo distinto os conflitos morais constatados hodiernamente. O objetivo da discussão é revisar algumas concepçães conservadoras da bioética que evitam desnudar os reais problemas relacionados com as desigualdades sociais, propondo novos referenciais teóricos e metodológicos de atuação futura para a mesma. Conclui sugerindo algumas medidas e mudanças - epistemológicas e práticas - necessárias ao enfrentamento das questães bioéticas daqui para a frente.