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.

La COVID-19 como enfermedad profesional: breve análisis de la ley 19873 / COVID-19 as an occupational disease: brief analysis of law 19,873

El artículo se ocupa de analizar la COVID-19 como enfermedad profesional, partiendo de un estudio del concepto de esta última a la luz de nuestro ordenamiento jurídico. Se plantean las posibilidades de considerar esta nueva enfermedad como profesional, no incluida en la lista actualmente vigente sobre las mismas. Luego de analizar la posibilidad de extender el régimen de las enfermedades profesionales contenido en la ley 16.074, el estudio analiza la regulación de la ley 19.873, la que es calificada como restrictiva de la consideración de la COVID-19 como enfermedad. Se contextualiza la legislación nacional en el derecho comprado, donde pueden encontrarse diversas "respuestas" a las consecuencias laborales de la enfermedad.

O placebo e a Declaração de Pachuca: letras mortas? / The placebo and the Declaration of Pachuca: dead letters?

A Confederação Médica Latino-Americana e do Caribe, organização que congrega as entidades congêneres dos países da região, atua em defesa da profissão médica e da saúde da população, guiando-se por documentos internacionais. Em sua Assembleia Geral (Pachuca, México; 2013) foi aprovada a Declaração de Pachuca, com severas críticas à revisão da Declaração de Helsinki ocorrida no Brasil e aos ensaios clínicos que usam placebo em doenças com tratamento definido. O tom duro e enérgico dessa Declaração propõe que entidades-membro denunciem os abusos éticos em todos os foros e aos governantes, e que atuem impedindo o uso do placebo nessas condições. Tais recomendações encontram respaldo no movimento mundial sobre integridade e ética na pesquisa. Conclui-se pela importância do papel educativo dos órgãos de fiscalização ética da medicina, alertando-se os médicos que infringirem essa orientação, a qual também integra o Código de Ética Médica, de que estarão sujeitos a processo ético-profissional...

The Latin American and Caribbean Medical Confederation (CONFEMEL), an organization that brings together related organizations from countries of the region, works on behalf of the medical profession and the population's health guided by international documents. During its General Assembly (Pachuca, Mexico; 2013) the Declaration of Pachuca was approved with strong critics regarding the review of the Declaration of Helsinki that occurred in Brazil and the issue of clinical trials that use placebo in diseases with known treatment. The strong and energetic tone of this Declaration proposes that member entities condemn ethical abuses in all forums and also to administrations so that they engage against the use of placebo in these conditions. These recommendations are supported in the global movement on Integrity and Ethics in Research. The conclusion addresses the importance of the educative role of ethical supervision of Medicine warning physicians who violate these guidelines, which are also incorporated in the Code of Medical Ethics, that they will be subjected to ethical-professional process...

La Confederación Médica Latinoamericana y del Caribe (CONFEMEL), una organización que reúne a instituciones similares de los países de la región, actúa en defensa de la profesión médica y salud de la población, guiándose por los documentos internacionales. En su Asamblea General (Pachuca, México; 2013) se aprobó la Declaración de Pachuca con duras críticas a la revisión de la Declaración de Helsinki que tuvo lugar en Brasil y a los ensayos clínicos que utilizan placebo en enfermedades con tratamiento conocido. El tono duro y enérgico de tal Declaración propone que las entidades-miembros a denunciar los abusos éticos en todos los foros y a los gobernantes, y que actúen impidiendo el uso del placebo en estas circunstancias. Estas recomendaciones se apoyan en el movimiento mundial sobre Integridad y ética en la investigación. Se concluye sobre la importancia del papel educativo de los órganos de supervisión ética da medicina, alertando a los médicos que violen esta norma, que también está contemplada en el Código de Ética Médica, que estarán sujetos a proceso ético-profesional...

Assessing the regulation of the private health sector in the Eastern Mediterranean Region: Yemen

The private health care sector plays an increasingly important role in the health systems of many low and middle-income countries. While most countries in the WHO Eastern Mediterranean Region have passed regulations related to the private health sector, little is known about the regulatory process or its comprehensiveness, effectiveness, institutional capacity and enforcement mechanisms. This report contains the findings of an assessment of the regulation of the private health sector in Yemen. It examines the existing regulatory policy and legislative framework, institutional arrangements, instruments and level of enforcement for private health care within the country. It aims to support the development of evidence-based strategies for the regulation of the private health sector in the countries of the Region

Assessing the regulation of the private health sector in the Eastern Mediterranean Region: Egypt

The private health care sector plays an increasingly important role in the health systems of many low and middle-income countries. While most countries in the WHO Eastern Mediterranean Region have passed regulations related to the private health sector, little is known about the regulatory process or its comprehensiveness, effectiveness, institutional capacity and enforcement mechanisms. This report contains the findings of an assessment of the regulation of the private health sector in Egypt. It examines the existing regulatory policy and legislative framework, institutional arrangements, instruments and level of enforcement for private health care within the country. It aims to support the development of evidence-based strategies for the regulation of the private health sector in the countries of the Region

Standardization of the medical record in plastic surgery

The objective of the present study is to propose a standardization of the medical record for plastic surgery. The record model proposed would work for most plastic surgeons, and could be filled out in an automated and oriented manner by the physician and also allowadaptations according to individual needs. Data on Identification, Chief Complaints, History of Present Illness, Systems Investigation, Personal Background andFamily Background could also be filled out alternatively by the patient him/herself, by using language andexpressions accessible to the lay public, and in order to support the physician more effectively in the case of legal disputes. The record can be viewed quickly and objectively due to the use of figures and diagrams. It has a simple cataloguing and filing system for photographic documents and registered data are numbered in order; so that they may be computerized, making scientific research easier and minimizing data collecting errors. The record model may be used in hospitals, outpatient clinics and individual medical offices. The resolutions of the medical entities that regulate the utilization of Medical Records or Medical Files are also discussed.

Documentação médica: guarda e manuseio dos prontuários médicos / Medical documentation: keeping and handling medical files

Atualmente, realizam-se, no Brasil, mais de 360 milhões de consultas médicas por ano, que geram quantidade imensa de prontuários médicos. Pela legislação brasileira, médicos, clínicas e hospitais são obrigados a manter esses prontuários arquivados por pelo menosdez anos, podendo, a partir desse prazo, ser microfilmados e destruídos. A quantidade de espaço que esses arquivos em papel exigem está tornando os custos cada vez mais elevados. Alguns estabelecimentos tiveram que ampliar ou alugar dependências próprias para arquivo, ocasionando considerável aumento de custos com uma atividade que extrapola os objetivos de um hospital.A partir de agora, os prontuários médicos podem ser elaborados e arquivados com computador. E a guarda dos mesmos poderá ser permanente , sem ocupação de espaço físico. Para garantir a confidencialidade(segredo médico) e a integridade dos dados dos pacientes(uma vez inseridos um dado no sistema, ele não poderá ser alterado), o Conselho Federal de Medicina aprovou normas rígidas para a guarda e o manuseio desses documentos. O sistema de informação utilizado deverá garantir, entre outros requisitos, um rígido controle de acesso aos dados e plena capacidade de recuperação dos registros originais. Cuidados maiores são exigidos nos casos de transmissão de dados do prontuário via internet. Para que possam viabilizar tais transferências, os sistemas deverão incorporar a criptografia assimétrica por chaves(pública e privada), nos termos definidos pela ICP-Brasil(Infra-estrutura de Chaves Públicas Brasileira).A criptografia por chaves garante a autenticidade e a confidencialidade dos documentos eletrônicos, permitindo a transmissão segura pela rede. Certificado fornecido pelo Conselho Federal de Medicina garantirá o valor legal e probante dos prontuários eletrônicos. Os prontuários em suporte de papel que assim permanecem deverão ser armazenados por um período mínimo de vinte anos, contando a partir do último registro...

Analisis de la situación de derechos y responsabilidades de la niñez, adolescencia y juventud

El objetivo del documento es realizar un an lisis sobre la situación de los derechos y responsabilidades de la niñez, adolescencia y juventud en Nicaragua, tomando como eje central la convención sobre los derechos del niño y el código de la niñez y la adolescencia y dem s leyes conexas o relativas con el tema. y elaborar un informe de resultados sobre el cumplimiento en el mbito institucional. En las consideraciones finales anota que los progresos alcanzados en relación al derecho a la salud de niños y adolescentes no han sido de la magnitud y calidad esperada para alcanzar las metas en salud de la cumbre mundial de la infancia y dem s acuerdos asumidos. Aún persisten problemas en las reas relacionadas con la mortalidad materna o perinatal, la calidad y el acceso a los servicios de salud, la atención a la niña y la mujer jóven, la niñez víctima de la violencia, atención del y la adolescente, em embarazo precoz, no deseado, etc. igualmente no hay mecanismos para hacer efectivos los derechos específicos porque el Consejo Nacional de Atención integral de la niñez y la adoelescencia no lo han instaurado por la falta de aprobación de la ley que contiene su organización, entre las principales consideraciones