Relación Transversal, Vertical y Sagital en Sujetos con Deformidad Facial Candidatos a Cirugía Ortognática / Transverse, Vertical and Sagittal Relationship in Subjects with Facial Deformity Candidates for Orthognathic Surgery

RESUMEN: El objetivo de este estudio fue evaluar la relación entre la clase esqueletal sagital y las condiciones transversales o verticales en sujetos con deformidad facial sin presencia de asimetría facial; Se realizó un análisis cefalomét rico de la clase esqueletal sagital, transversal y vertical en 115 sujetos con indicaciones de cirugía ortognática. Se consideró algunos datos del análisis cefalométrico de Steiner y el análisis cefalométrico de Ricketts en sentido sagital para determinar la clase esqueletal facial. A nivel transversal se determinó la dimensión transversal facial, dimensión transversal maxilar y dimensión transversal mandibular. A nivel vertical se determinó la dimensión vertical oclusal y dimensión vertical total. Al comparar las mediciones transversales y verticales entre sujetos de sexo femenino y masculino, se observó que los hom- bres presentaban mayores dimensiones que las mujeres (p=0,0001) en todos los análisis realizados. Los sujetos clase III presentaron mayor dimensión transversal facial (p=0,0002) y transversal mandibular (p=0,001) que los sujetos clase II. Además, se observó que los sujetos clase III presentaban mayor dimensión vertical total (p=0,002) que los sujetos clase II; Es posible concluir que existe características faciales transversales y verticales que se pueden relacionar con la posición sagital de las estructuras maxilo-mandibulares.

ABSTRACT: The aim of this study is to evaluate the relationship between sagittal skeletal class and transverse or vertical conditions in subjects with facial deformity without presence of facial asymmetry; A comparative study was conducted between the results of the cephalometric analysis of the sagittal, transverse and vertical skeletal class in 115 subjects with indications for orthognathic surgery. The Steiner cephalometric analysis in the sagittal direction was used to determine the facial skeletal class and the Ricketts cephalometric analysis in the sagittal analysis. At the transverse level it was determined the facial transverse dimension, maxillary transverse dimension and mandibular transverse dimension. At a vertical level it is determined the occlusal vertical dimension and total vertical dimension. When comparing cross-sectional and vertical measurements between female and male subjects, it was observed that male subjects presented greater dimensions than female subjects (p=0.0001). Class III subjects present greater facial transverse dimension (p=0.0002) and mandibular transverse dimension (p=0.001) than class II subjects. Also, it was observed that class III subjects had a greater total vertical dimension (p=0.002) than class II subjects; It is possible to conclude that there are facial characteristics transverse and vertical that can be related with the sagittal position of the maxillo-mandibular structures.

Análisis comparativo de las pautas del consejo de organizaciones internacionales de ciencias médicas (CIOMS) 2016. (Parte 1 de 3) / Comparative analysis of the standards of the council of international organizations of medical sciences (CIOMS) 2016. (Part 1 of 3)

Para la realización de investigaciones científicas en seres humanos es fundamental el cumplimiento de la Declaración de Helsinki, cuya última actualización se publicó en el 2013. Para los países de América Latina esta declaración se adaptó como las Pautas CIOMS, por lo que también fue necesario actualizar y su publicación ocurrió en el 2016. Como parte de la evaluación de la asignatura Bioética e Investigación, se solicitó a los estudiantes de la VI Cohorte de la Maestría en Bioética de la Facultad de Medicina, UCV, que realizarán un análisis comparativo de éstas con las pautas contempladas en la edición anterior del 2002 a fin de proporcionar a los investigadores un aporte en su formación y una rápida adaptación a la nueva propuesta. Para el desarrollo de estos trabajos se agruparon las pautas en grandes temas afines y se presentan en tres entregas(AU)

To carry out scientific research on human beings, compliance with the Declaration of Helsinki, whose last update was published in 2013, is essential. For Latin American countries, this statement was adopted as the CIOMS Guidelines, which were last updated and published in 2016. As part of the evaluation of the subject Bioethics and Research, students of the VI Cohort of the Master in Bioethics of the Faculty of Medicine, UCV, were asked to perform a comparative analysis of these with the guidelines contemplated in the previous edition of 2002 to provide researchers with a contribution in their training and a rapid adaptation to the new proposal. For the development of these works, the guidelines were grouped into large related topics and presented in three installments(AU)

Prevalence of anemia in pregnant Iraqi women

Bachkgrond: Anemia is a very important nutritional disorder in the world, it has multiple etiologies and pregnancy is associated with a deficit in the intake of iron and physiological changes of pregnancy. Aim of the study: To assess the prevalence of anemia in pregnant Iraqi women. Patients and method: A cross-sectional study carried at Al-Elwyia maternity teaching hospital in the period from the 1st of Jan. 2018 to the end of October 2018, in which 1000 pregnant women were enrolled in the study and divided into 2 groups: case group (n=652) and control group (n=348) according to the level of Hb. Results: The mean age of the case group was (27.8±7.1) years old and (26.1±2.3) years for the control group. The anemia was found in (6521000) patients and Iron deficiency anemia is the main type of anemia (80.2%) while (19.8%) was another type of anemia. Poor diet (65%) is the common cause of anemia were found commonly in the 3rd trimester (50.2%). Conclusion: The prevalence of anemia was 65.2% in the current study (AU)

Características clínicas y quirúrgicas de pacientes sometidos a cirugía de válvula mitral en una ins titución de salud de Barranquilla, Colombia / Clinic al and surgic al characteristics of patients undergoing mitral valve surgery at a health ins titution in Barranquilla, Colombia

Introducción: la incidencia de las anomalías valvulares cardiacas ha aumentado entre otras razones por los avances en métodos diagnósticos y conocimiento de predecesores etiológicos como desenca­ denantes de la condición clínica, que inicia la probabilidad diagnostica y seguimiento temprano en pa­ cientes en estadios iniciales de la enfermedad, disminuyendo de esta manera el impacto económico por aumento de la morbimortalidad. Objetivo: describir las características clínicas y quirúrgicas de pa­ cientes sometidos a cirugía de válvula mitral en una institución prestadora de servicios de salud de re­ ferencia para el distrito de Barranquilla, Colombia, durante los años 2014 a 2016. Metodología: estudio descriptivo, en el que se revisó de forma retrospectiva las historias clínicas de pacientes con patología mitral que requirieron intervención quirúrgica de tipo plastia, cambio biológico o mecánico, entre los años 2014 y 2016. El análisis de la información se realizó a través del software SPSS. Re­ sultados: durante el periodo de estudio se realizaron 276 cirugías valvulares en la institución de salud objeto de estudio, de las cuales 98 fueron cirugías sobre válvula mitral, excluyéndose 20 historias clí­ nicas que no contenían la totalidad de las variables analizadas. El antecedente clínico más frecuente fue la enfermedad coronaria (38,5%), seguido del infarto de miocardio (23,1%); el 20,5% de los pa­ cientes presentaron arritmia tipo fibrilación auricular y la cirugía sobre válvula mitral más realizada fue recambio biológico (42%). Conclusión: las características clínicas y quirúrgicas de los pacientes inclui­ dos en el estudio, son similares a las descritas en la literatura nacional e internacional, por lo que podría tomarse como precedente de presentación y de esta manera ir construyendo una clínica para la identificación rápida y veraz de los pacientes con alteraciones valvulares, permitiendo su abordaje temprano y disminuyendo la carga económica para el sistema de salud.

Introduction: cardiac valvular anomalies have increased their presentation, in part due to advances in diagnostic methods and knowledge of etiological predecessors as triggers of the clinical condition that initiates the diagnostic probability and early follow­up in patients in the initial stages of the di­ seas e, thus decreasing the economic impact due to increased morbidity and mortality. Objective: to describe the clinical and surgical characteristics of patients undergoing mitral valve surgery at a re­ference center in the district of Barranquilla during the years 2014 to 2016.Methodology: descriptive, retrospective, cross­sectional study in a health institution in the district of Barranquilla. Patients with mitral pathology who required surgical intervention of the plasty type, biological or mechanical chan­ ge, were included between 2014 and 2016. Data analysis performed in SPSS according to the natu­ re of the variables. Results : during the study period, 276 valve surgeries were performed, of which 98 were valve surgeries, 20 patients were excluded due to incomplete clinical history; the most pre­ valent antecedent was coronary disease in 38.5% followed by myocardial infarction with 23.1%; 20.5% of the patients presented arrhythmia type atrial fibrillation; the most performed mitral valve surgery was a 42% biological replacement. Conclusion: the clinical and surgical characteristics of the patients included in the study, correspond to those described in national and international litera­ ture, so it could be taken as a precedent for presentation and thus build a presentation clinic for quick and accurate identification of the patients with valvular alterations, allowing their early ap­ proach and decreasing the economic burden for the health system.

Opinión de adolescentes y jóvenes argentinos sobre ser interrogados para la identificación del riesgo de suicidio / OPINION OF ADOLESCENTS AND YOUNG PEOPLE FROM ARGENTINA IN ORDER TO IDENTIFY THOSE AT RISK OF SUICIDE

En Argentina hay 17,4 casos de suicidios de niños y jóvenes por semana, y sobre 3.202 casos registrados en el año 2015, 905 fueron en niños, adolescentes y jóvenes. Un alto % de ellos tuvieron contacto con el sistema de salud en el año previo de su muerte, por ello la detección es un primer paso hacia su prevención. El objetivo general: analizar la opinión que tienen los adolescentes y jóvenes de cinco provincias argentinas acerca de ser interrogados en el marco de los sistemas de salud con el objeto de identificar los que presentan riesgo de suicidio. El estudio es observacional, descriptivo y de corte transversal. La población fue de 1.153 adolescentes y jóvenes (10-24 años) asistentes a establecimientos educativos públicos y privados, y usuarios servicios de salud pública o privada de las provincias argentinas de Buenos Aires (325), Santiago del Estero (322), La Rioja (301), Córdoba (128) y Salta (77). Se utilizó un muestreo intencional, y se aplicó un cuestionario semi-estructurado. Se utilizó un abordaje cuantitativo y tratamiento cualitativo de algunas variables. El promedio de edad fue 17.2 años, con respecto al sexo predominaron las mujeres, y al estrato social el medio. Un 68,7% nunca fueron consultados por su estado de ánimo, y a 8 de cada 10 tampoco se les preguntó por autolesiones. Les cuesta muchísimo expresarse sobre estos temas. Pero un 87% considera importante que los profesionales les preguntemos sobre estos temas, y lo perciben como un problema dentro de la sociedad, sobre todo en las provincias donde el suicidio es más alto. Nuestros adolescentes y jóvenes están de acuerdo en ser interrogados sobre la problemática de suicidio, por ello no debemos perder la oportunidad, más allá del motivo de consulta, considerando es parte de nuestro trabajo y responsabilidad

In Argentina there are 17.4 cases of suicides of children and young people per week, and of 3,202 cases registered in 2015, 905 were in children, adolescents and young people. A high percentage of them had contact with the health system in the year before their death, so detection is a first step towards prevention. The general objective is to analyze the opinion of adolescents and young people in five Argentine provinces about being questioned within the framework of health systems in order to identify those at risk of suicide. The study is observational, descriptive and cross-sectional. The population was 1,153 adolescents and young people (10- 24 years old) attending public and private educational institutions, and users of public or private health services in the Argentine provinces of Buenos Aires (325), Santiago del Estero (322), La Rioja (301), Córdoba (128) and Salta (77). Intentional sampling was used, and a semi-structured questionnaire was applied. We used a quantitative approach and qualitative treatment of some variables. The average age was 17.2 years, with respect to the sex predominated the women, and to the social layer the means. 68.7% were never consulted for their state of mind, and 8 out of 10 were also not asked about self-harm. They have a hard time expressing themselves on these issues. But 87% consider it important for professionals to ask about these issues, and perceive it as a problem within society, especially in the provinces where suicide is highest. Our adolescents and young people agree to be questioned about the problem of suicide, so we should not miss the opportunity, beyond the reason for consultation, considering it is part of our work and responsibility

Declaración de Helsinki: cambios y exégesis / Helsinki Declaration: changes and interpretation

La Declaración de Helsinki es muy citada de en el ámbito de las ciencias médicas y de la salud. En Cuba se utiliza para valorar los aspectos éticos de las investigaciones, sin embargo es escasa la literatura dedicada a la valoración crítica de la misma. Referir sus versiones presupone conocer su devenir histórico para interpretar sus aciertos y limitaciones. La intención del estudio es contribuir a actualizar los conocimientos de los profesionales de la salud sobre la Declaración de Helsinki. Se realizó revisión de la literatura publicada entre 2008 y 2014 (agosto) en las bases de datos bibliográficos Cumed, Lilacs, SciELO PubMed, MedLine, Clinical Key, Cochrane y el motor de búsqueda Google utilizando vocabulario controlado con los siguientes descriptores: Declaración de Helsinki, placebo, ensayo clínico, ética y bioética. Los temas más polémicos fueron: uso del placebo, doble estándar en las investigaciones clínicas y garantía de continuidad de tratamiento a los pacientes participantes. Se destacaron méritos en la versión de 2013 tales como la insistencia para aumentar la transparencia en la investigación, su nuevo diseño estructural y la consideración de la competencia ética como un requisito para los investigadores. Los comentarios sobre la Declaración de Helsinki oscilan desde el elogio hasta la sugerencia de su desaparición o sustitución. La polémica sobre la misma es considerada necesaria por algunos autores pero también estéril por otros. Los problemas más álgidos tratados en las últimas versiones emanan del enfrentamiento entre los intereses de la industria farmacéutica y los derechos de los participantes en las investigaciones(AU)

In the fields of medical and health sciences, the Helsinki Declaration is quoted very often. The Helsinki Declaration is used to evaluate the ethical aspects of research studies; however, literature devoted to critical assessment of those studies is scanty. Making reference to the declaration versions presupposes the knowledge about its historical development in order to construe its good things and limitations. The intention of this study is to help to update the health professionals' knowledge about the Helsinki Declaration. A literature review published between 2008 and August 2014 was made and collected on the following databases: Cumed, Lilacs, SciELO PubMed, MedLine, Clinical Key, Cochrane and Google, using controlled vocabulary with the f subject headings Helsinki Declaration, placebo, clinical trial, ethics and bioethics. The most controversial topics were the use of placebo, application of the double standard possition in clinical research, and guaranteed continuous treatment for the participating patients. The following 2013 version's merits were highlighted: insistence on the research transparency its new structural design, and the concern for ethical competence as a requirement for researchers. Comments about the Helsinki Declaration range from praise to disappearance or replacement suggestions. Some authors deem the controversy necessary but others think it is a wasteful argument. The hottest problems in the most recent versions come from the confrontation between the pharmaceutical industry interests and the rights of participants in research studies(AU)

Vivencias de los pasantes de enfermería, en la resolución de problemas clínicos / Experiences of unregistered nursing graduates while solving clinical problems / Vivências dos estagiários de enfermagem, na resolução de problemas clínicos

Objetivo: Comprender las vivencias de los pasantes de enfermería, en la resolución de problemas clínicos, a través de su descripción e interpretación. Métodos: Estudio cualitativo, descriptivo e interpretativo, tradición fenomenológica, método fenomenológico, técnica: Entrevista semiestructurada a profundidad a 8 pasantes de enfermería asignadas a un Hospital de Sinaloa, México; instrumento: Guía de entrevista, selección de participantes: Intencional hasta saturación teórica, carta de consentimiento informado y protección de la intimidad y confidencialidad, con base en el Código de Ética de las y los enfermeros de México y Declaración de Helsinki. Análisis de contenido tipo temático de acuerdo a Souza Minayo, del que emergieron 4 categorías. Resultados: Del análisis se seleccionó la categoría "Resolver problemas, un arte profesional", con las subcategorías: a) Incertidumbre y ambigüedad en la identificación y resolución del problema; b) Percepción del problema como caso único; c) Presencia de conflicto de valores en la resolución del problema, y d) Saber práctico, aprender al observar, reflexionar y hacer. Conclusiones: Al inicio del servicio social, los pasantes de enfermería muestran dificultad no solo para identificar y solucionar problemas clínicos, sino para comprender el significado de resolver problemas desde su conceptualización. Sin embargo, a punto de concluir su servicio social, empieza a emerger en ellos el arte de la enfermería, puesto que ya son capaces de identificar y dar solución a situaciones de cuidados que se presentan en los pacientes.

Objective: Through their own description and interpretation to understand the experiences of unregistered nursing graduates while solving clinical problems. Methods: This is a qualitative, descriptive and interpretative study. With a phenomenological tradition and method, this study uses in-depth structured interviews on eight unregistered nursing graduates assigned to a hospital in Sinaloa, Mexico. The main instrument is the interview guide. The selection of participants was intentional until theoretical saturation was reached. Based on the Nurses Ethics Code of Mexico, and also on the Helsinki Declaration, participants were given informed consent documentation as well as protection of their intimacy and confidentiality. From a thematic type content analysis which was aligned with Souza Minayo guidelines, four categories emerged. Results: From the category "Problem solving, a professional art" four sub-categories were proposed: (a) uncertainty and ambiguity while identifying and solving a problem; (b) perception of the problem as a unique case; (c) presence of conflict of values during the resolution of the problem; and (d) practical knowledge-learning while watching, realizing and doing. Conclusions: At the beginning of their social service, unregistered nursing graduates show difficulties, not only to identify and solve clinical problems, but also to understand the meaning of solving the problems based on their own conceptualization. However, as they near the end of their social services, the art of nursing gradually emerges from them as they manifest better performances at identifying and solving the diverse care situations of their patients.

Objetivo: Compreender as vivências dos estagiários de enfermagem, na resolução de problemas clínicos, a través de sua descrição e interpretação. Métodos: Estudo qualitativo, descritivo e interpretativo, tradição fenomenológica, método fenomenológico, técnica: entrevista semiestruturada a profundidade a oito estagiários de enfermagem assignados a um Hospital de Sinaloa, México, instrumento: Guia de entrevista, seleção de participantes: intencional até saturação teórica, carta de carta de consentimento informado e proteção da intimidade e confidencialidade, com base no Código de Ética das e dos enfermeiros do México e a Declaração de Helsinki. Análise de conteúdo tipo temático de acordo a Souza Minayo, da qual emergiram as quatro categorias. Resultados: Da análise selecionou-se a categoria "Resolver problemas, uma arte profissional", com as subcategorias: a) Incerteza e ambiguidade na identificação e resolução do problema, b) Percepção do problema como caso único, c) Presença de conflito de valores na resolução do problema, e d) Saber prático, aprender observando, refletir e fazer. Conclusões: No início do estágio, os estagiários de enfermagem mostram dificuldade não só para identificar e solucionar problemas clínicos, senão para compreender o significado de resolver problemas desde sua conceptualização. Porém, quase por concluir seu estágio, começa a emergir neles a arte da enfermagem, visto que já são capazes de identificar e dar solução a situações de cuidados que se apresentam nos pacientes.

Publication Trends of Clinical Trials Performed in South Africa

BACKGROUND:Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results; whether positive or negative; in a timely manner.OBJECTIVES:To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not.METHODS:A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ); the Cochrane Library; Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central; all of which are indexed on MEDLINE via PubMed. In addition; a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed. RESULTS:Of the 79 clinical trials surveyed; 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal; the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published; 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled.CONCLUSION:The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner

O código civil brasileiro na disciplinada pesquisa com seres humanos / Brazilian Civil Code in the area of research on human subjects

Este artigo tem por objetivo relacionar as normas éticas sobre pesquisas com seres humanos com o Código Civil brasileiro, lei que trata de diversos aspectos relacionados à proteção da pessoa humana. Em geral, os pesquisadores da área médica desconhecem a legislação civil, não se dando conta das consequências jurídicas dos erros causados pelas pesquisas realizadas. Apresenta-se, no início, um resumo da disciplina ética sobre pesquisas com seres humanos, com o Código de Nuremberg e a Declaração de Helsinque, além da disciplina infralegal no Brasil, realizada pelo Conselho Nacional de Saúde. Em seguida, com o intuito de demonstrar a inexistência de um vazio legislativo nessa matéria, analisaram-se os aspectos do Código Civil relativos às pesquisas com seres humanos, como a personalidade jurídica, a capacidade de agir, os direitos da personalidade e a responsabilidade civil.

This study seeks to relate the ethical norms for research on human subjects with Brazilian Civil Code, a law that considers many aspects of protection for individuals. In general, medical researchers are unaware of civil legislation and do not realize the legal consequences of any errors caused by their research. First, a summary of the ethical aspect of research on humansubjects is presented, along with the Nuremberg Code and the Declaration of Helsinki, as well as the non-statutory aspect of Brazilian law, which is performed by the Brazilian NationalHealth Council. Second, to demonstrate the inexistence of a lack of legislative consistency in this area, the study analyzes the aspects of Civil Code relative to research on human subjects,as well as legal status, the ability to act, rights to legal status, and civil liability.

Eticidade do uso de placebo em pesquisa clínica: proposta de algoritmos decisórios / Ethics of the use of placebos in clinical research: a proposal for decision-making algorithms

O uso de placebo em pesquisa clínica tem sido motivo de debate nos últimos anos, sobretudo após a Associação Médica Mundial publicar, em 2002, nota de esclarecimento do parágrafo 29 da Declaração de Helsinki. O Brasil tem se destacado por sua posição firme e contrária ao uso flexível de placebo. Tanto o Conselho Federal de Medicina quanto o Conselho Nacional de Saúde editaram resoluções que normatizam seu uso no Brasil, de forma a não admiti-lo em caso da existência de um método terapêutico melhor. O presente artigo reforça essa posição e tem por objetivo descrever as diversas aplicações de placebo em pesquisa clínica, bem como trazer à luz a complexa decisão sobre a eticidade de seu uso. Além disso, os autores propõem uma reflexão acerca da utilização de placebo no âmbito da pesquisa, por meio de algoritmos decisórios baseados nas normativas éticas brasileiras...

The use of placebos in clinical research has been a matter of considerable debate in recent years, notably when the World Medical Association published, in 2002, a note of clarification for paragraph 29 of the Helsinki Declaration. Brazil is known for its strong opposition to the flexible use of placebos. Both the Federal Council of Medicine and the National Health Council have published resolutions regulating the use of placebos in Brazil, preventing their use if there is a more effective therapeutic method already in place. The present study reinforces that position and aims to describe the various uses of placebos in clinical research, as well as examining the complex decisions relating to the ethics of their use. Additionally, the authors propose a reflection on the use of placebos through decision-making algorithms based on Brazilian ethical standards...

El uso del placebo en la investigación clínica ha sido un tema de debate en los últimos años, sobre todo después de que la Asociación Médica Mundial publicara, en 2002, una nota aclaratoria del párrafo 29 de la Declaración de Helsinki. Brasil se ha destacado por su firme posición en contra de la utilización flexible del placebo. Tanto el Consejo Federal de Medicina como el Consejo Nacional de Salud editaron resoluciones que regulan el uso del placebo en Brasil, no admitiéndose su uso cuando existe un mejor método terapéutico. El presente artículo refuerza esa posición y tiene como objetivo describir diferentes usos del placebo en la investigación clínica, así como contribuir en la discusión sobre la ética de su uso. Además, los autores proponen una reflexión sobre el uso del placebo en la investigación a través de algoritmos para la toma de decisiones, los cuales se basan en las normativas éticas de Brasil...

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...

Caracterização de riscos em protocolos submetidos a um comitê de ética em pesquisa: análise bioética / Characterization of risks in search of an ethics committee in research protocols: bioethical analysis

Estudo descritivo realizado com o objetivo de identificar como os pesquisadores descreveram os riscos e as medidas de proteção/prevenção de suas pesquisas submetidas à análise por um comitê de ética em pesquisa. Foram incluídos 175 protocolos de pesquisa de um comitê de ética em pesquisa da cidade de Divinópolis, Minas Gerais. Como resultado, encontrouse que somente 38 (24,7%) pesquisadores descreveram os riscos nos formulários e 36 (23,5%) no termo de consentimento. Entretanto, 110 (62,9%) descreveram as medidas de prevenção nos formulários e 143 (93,5%) as descreveram no termo de consentimento. Concluiu-se que, embora os pesquisadores tenham identificado as medidas de prevenção, não descreveram quais seriam propriamente os riscos de suas pesquisas. É possível que tenham certa dificuldade em descrever os riscos por associá-los a danos...

Estudio descriptivo con el fin de conocer cómo los investigadores describieron los riesgos y las medidas de protección/prevención de sus investigaciones sometidas a análisis por un comité de ética en investigación. Se evaluaron 175 protocolos de investigación de un comité de ética en investigación de la ciudad de Divinópolis, Minas Gerais. Como resultado sólo 38 (24,7%) de los investigadores describieron los riesgos en los formularios y 36 (23,5%) en el término de consentimiento informado. Sin embargo, 110 (62,9%) describieron las medidas de prevención en los formularios y 143 (93,5%) en el término de consentimiento informado. Se concluye que aunque los investigadores han identificado las medidas de prevención, no describieron exactamente cuáles son los riesgos de sus investigaciones. Es posible que tengan alguna dificultad en la descripción de los riesgos por asociarlos a daños...

Análisis de los principales conflictos éticos entre la Declaración de Helsinki 2008 y su propuesta de cambio / Analysis of the main ethical conflicts in the 2008 declaration of Helsinki and the proposed changes in the new version

The Declaration of Helsinki (DoH) of the World Medical Association is the basis of the rules governing research on human beings. The latest version (enacted in Korea, 2008) has been a source of ethical discussions, particularly regarding the use of placebos, the measures to assure the access of study subjects to interventions identified as beneficial once the study has ended, and the need of a better protection of potentially vulnerable groups. These issues led to draft a revised version, that was approved in 2013. In this paper, we present an ethical analysis of the main changes contained in the DoH, including the proposed changes in the new version, referring, when appropriate, to relevant Chilean laws governing research on human subjects. In our opinion, the 2008 DoH contains significant imprecisions on some of these issues, making a new version of the declaration necessary to fully protect subjects participating in biomedical research, as stated by the new version approved in 2013.

Practical issues in implementation of WMA's draft Declaration of Helsinki.

The working group of the World Medical Association (WMA) has published a revised draft of the Declaration of Helsinki for public consultation till June 15, 2013. There are many positive changes in the document with respect to compensation, education of investigators, informed consent in the case of stored samples, etc. The changes represent a step forward for ethics. However, there may be certain points of concern regarding the implementation of the Declaration.

The new 2013 seventh version of the Declaration of Helsinki – more old wine.

The eagerly awaited seventh version of the Declaration of Helsinki (DoH) was released by the World Medical Assembly (WMA) on October 19, 2013 at the 64th General Assembly . It has been 13 years since the most debated version of the DoH, the fifth one, was released in 2000, followed by two related notifications in 2002 and 2004 and the less debated sixth version of 2008. The decade following the fifth version has witnessed many conceptual changes and debates all over the world. Of special note is the fact that most research participants are drawn from the developing countries and are considered to have a higher degree of vulnerability than their counterparts in the developed countries. Since 2000, a landmark year from many perspectives, national and international ethical guidelines have been updated or new ones developed to address the current and emerging issues facing the research community.

Emancipação na luta pela equidade em pesquisas com seres humanos / Emancipation in the struggle for equality in research involving human volunteers

Este artigo apresenta como estudo de caso os aspectos mais controversos de pesquisa conduzida na Guatemala (1946-1948), patrocinada pelo Serviço de Saúde Pública dos Estados Unidos e envolvendo participantes infectados intencionalmente pelo Treponema pallidum. Analisando as alterações de 2008 na Declaração de Helsinque e a ainda pequena adesão a outros instrumentos internacionais, como a Declaração Universal sobre Bioética e Direitos Humanos, da Unesco, a discussão enfatiza a importância da implantação de diretrizes éticas internacionalmente aceitas para impedir que voluntários humanos sejam envolvidos em pesquisas não éticas. Conclui considerando que é indispensável o envolvimento de cientistas e ativistas para alcançar padrões éticos universalmente aceitos e aplicáveis, visando evitar duplo standard. Além disso, que a participação igualitária em pesquisas e distribuição justa de seus benefícios será importante passo para atingir o acesso universal a cuidados de saúde de qualidade para todos.

This manuscript presents as a case study the most controversial aspects of a research conducted in Guatemala(1946-1948), sponsored by the United States Public Health Service in which participants were intentionallyinfected with Treponema pallidum. The analysis of changes in the 2008 Declaration of Helsinki and the stillinsufficient adherence to UNESCO ́s Universal Declaration on Bioethics and Human Rights emphasizes theimportance of applying internationally accepted ethical standards for human volunteers to prevent unethicalresearch. It concludes that the involvement of scientists and activists is crucial to achieve internationally accepted ethical standards to be equally applied throughout the world, avoiding the risks of double standards,and also that egalitarian participation in research and fair distribution of its benefits will be an important steptowards universal access to good quality healthcare for all people.