Indicadores de calidad en gastroscopia. Procedimiento de la gastroscopia / Quality indicators in gastroscopy. Gastroscopy procedure

Enmarcado dentro del proyecto "Indicadores de calidad en endoscopia digestiva", liderado por la Sociedad Española de Patología Digestiva (SEPD), el objetivo de esta investigación es proponer los procedimientos e indicadores de estructura, proceso y resultado necesarios para aplicar y evaluar la calidad en la gastroscopia. Primero, se ha diseñado un diagrama con los pasos a seguir durante el procedimiento de gastroscopia. En segundo lugar, un grupo de expertos en calidad asistencial y/o endoscopia han realizado una revisión cualitativa de la literatura haciendo referencia a la búsqueda de indicadores de calidad en los procedimientos endoscópicos, incluidas las gastroscopias. Posteriormente, por un procedimiento de análisis por pares se ha hecho la selección y el análisis de la literatura seleccionada. Se ha identificado para gastroscopias un total de nueve indicadores de procesos (uno de preprocedimiento y ocho de procedimiento). La calidad de la evidencia se ha analizado aplicando la escala de clasificación utilizada en GRADE (Grading of Recommendations Assessment, Development and Evaluation)

Within the project "Quality indicators in digestive endoscopy", pioneered by the Spanish Society for Digestive Diseases (SEPD), the objective of this research is to suggest the structure, process, and results procedures and indicators necessary to implement and assess quality in the gastroscopy setting. First, a chart was designed with the steps to be followed during a gastroscopy procedure. Secondly, a team of experts in care quality and/or endoscopy performed a qualitative review of the literature searching for quality indicators for endoscopic procedures, including gastroscopies. Finally, using a paired analysis approach, a selection of the literature obtained was undertaken. For gastroscopy, a total of nine process indicators were identified (one preprocedure, eight intraprocedure). Evidence quality was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification scale

Quality indicators in gastroscopy. Gastroscopy procedure.

Within the project "Quality indicators in digestive endoscopy", pioneered by the Spanish Society for Digestive Diseases (SEPD), the objective of this research is to suggest the structure, process, and results procedures and indicators necessary to implement and assess quality in the gastroscopy setting. First, a chart was designed with the steps to be followed during a gastroscopy procedure. Secondly, a team of experts in care quality and/or endoscopy performed a qualitative review of the literature searching for quality indicators for endoscopic procedures, including gastroscopies. Finally, using a paired analysis approach, a selection of the literature obtained was undertaken. For gastroscopy, a total of nine process indicators were identified (one preprocedure, eight intraprocedure). Evidence quality was assessed with the Grading of Recommendations Assessment, Development and Evaluation (GRADE) classification scale.

Indicadores de calidad en colangiopancreatografía retrógrada endoscópica. Procedimiento de la colangiopancreatografía retrógrada endoscópica / Quality indicators for endoscopic retrograde cholangiopancreatography. The procedure of endoscopic retrograde cholangiopancreatography

El objetivo del proyecto en el que se inscribe este trabajo es proponer procedimientos e indicadores de calidad y seguridad útiles para facilitar la mejora de la calidad en unidades de endoscopia digestiva. En este tercer resultado se proponen procedimientos e indicadores de la colangiopancreatografía retrógrada endoscópica (CPRE). Primero, se ha diseñado un diagrama de los pasos previos y consecutivos a la realización de la CPRE. Un grupo de expertos en calidad asistencial y/o endoscopia, bajo el amparo de la Sociedad Española de Patología Digestiva (SEPD), ha realizado una revisión cualitativa de la literatura haciendo referencia a la búsqueda de indicadores de calidad en la CPRE. Posteriormente, por un procedimiento de análisis por pares se ha hecho la selección y análisis de la literatura seleccionada. Se han identificado un total de seis indicadores específicos, independientemente de los ya descritos comunes, todos de proceso (dos de preprocedimiento y cuatro de procedimiento). Se ha analizado la calidad de la evidencia de cada uno de ellos aplicando la clasificación utilizada en Grading of Recommendations Assessment, Development and Evaluation) GRADE

The goal of the project encompassing the present paper is to propose useful quality procedures and indicators in order to improve quality in digestive endoscopy units. In this third part outcome procedures and indicators are suggested for endoscopic retrograde cholangiopancreatography (ERCP). First, a diagram of pre- and post-ERCP steps was developed. A group of experts in healthcare quality and/or endoscopy, under the shelter of the Spanish Society of Digestive Diseases (Sociedad Española de Patología Digestiva - SEPD), carried out a qualitative review of the literature regarding quality indicators for ERCP. Then, a paired analysis was used for the selection of identified references. A total of six specific indicators, apart from the common indicators already described, were identified, all of them process indicators (two pre-procedure and four post-procedure). Evidence quality was analyzed for each indicator using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) classification

Quality indicators for endoscopic retrograde cholangiopancreatography. The procedure of endoscopic retrograde cholangiopancreatography.

The goal of the project encompassing the present paper is to propose useful quality procedures and indicators in order to improve quality in digestive endoscopy units. In this third part outcome procedures and indicators are suggested for endoscopic retrograde cholangiopancreatography (ERCP). First, a diagram of pre- and post-ERCP steps was developed. A group of experts in healthcare quality and/or endoscopy, under the shelter of the Spanish Society of Digestive Diseases (Sociedad Española de Patología Digestiva - SEPD), carried out a qualitative review of the literature regarding quality indicators for ERCP. Then, a paired analysis was used for the selection of identified references. A total of six specific indicators, apart from the common indicators already described, were identified, all of them process indicators (two pre-procedure and four post-procedure). Evidence quality was analyzed for each indicator using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) classification.

Manejo del déficit de hierro y la anemia ferropénica en la enfermedad inflamatoria intestinal. Resultados de la encuesta "Gestiona Hierro-EII" / Managing iron deficiency and iron deficiency anemia in inflammatory bowel disease. The results of the "Gestiona hierro-EII" survey

Introducción: la anemia ferropénica es una manifestación común y muy relevante de la enfermedad inflamatoria intestinal (EII). Aunque se han publicado guías de práctica clínica y puestas al día sobre el tema, el manejo práctico de esta complicación dista de ser óptimo. Objetivo: conocer el manejo real, las necesidades y las limitaciones de la anemia en la EII mediante una encuesta a especialistas de digestivo. Material y métodos: encuesta telemática autoadministrada, realizada entre abril- mayo 2017, y dirigida a socios de la SEPD con actividad clínica. La encuesta incluye cuatro apartados: demografía de los participantes, monitorización, tratamiento y limitaciones/necesidades. Resultados: ciento veintidós encuestas evaluables procedentes de todas las comunidades autónomas. La anemia ferropénica se considera una manifestación frecuente de la EII y que se monitoriza en todos los pacientes mediante determinación de la hemoglobina y la ferritina. En caso de anemia, los encuestados consideran necesario descartar la existencia de actividad de la EII, aunque solo el 14,8% indica el hierro intravenoso si la EII está activa. La dosis necesaria de hierro intravenoso es mayoritariamente calculada según las necesidades del paciente, pero solo el 33,1% utiliza dosis por infusión de 1 g o más elevadas. Conclusiones: la encuesta "Gestiona Hierro EII" sobre el manejo de la anemia en la EII demuestra una alta calidad asistencial, pero con aspectos a mejorar como la indicación de hierro intravenoso en los pacientes con actividad, el uso de hierro intravenoso de altas dosis o la aplicación de algoritmos en la práctica asistencial (AU)

Introduction: iron deficiency anemia is a common and very relevant manifestation of inflammatory bowel disease (IBD). Although clinical practice guidelines have been published and updated on this subject, the management in the daily practice of this complication is far from optimal. Objective: to determine the actual management, needs and limitations of anemia in IBD by means of a survey of gastroenterology specialists. Material and methods: a self-administered telematic survey was carried out between April and May 2017 and was sent to SEPD members. The survey included four sections: participant demographics, monitoring, treatment and limitations/needs. Results: a total of 122 evaluable surveys were received from all Spanish autonomous communities. Iron deficiency anemia is considered as a frequent manifestation of IBD and is monitored in all patients via the measurement of hemoglobin and ferritin. In the case of anemia, the survey respondents found it necessary to rule out the presence of IBD activity. However, only 14.8% prescribed intravenous iron when IBD was active. The required dose of intravenous iron is mainly calculated according to patient needs but only 33.1% of clinicians infused doses of 1 g or more. Conclusions: the "Gestiona Hierro EII" survey on the management of anemia in IBD demonstrated a high quality of care, even though some aspects need to be improved. These included the prescription of intravenous iron for patients with disease activity, the use of high-dose intravenous iron and the implementation of algorithms into clinical practic (AU)

Managing iron deficiency and iron deficiency anemia in inflammatory bowel disease. The results of the "Gestiona hierro-EII" survey.

INTRODUCTION: iron deficiency anemia is a common and very relevant manifestation of inflammatory bowel disease (IBD). Although clinical practice guidelines have been published and updated on this subject, the management in the daily practice of this complication is far from optimal. OBJECTIVE: to determine the actual management, needs and limitations of anemia in IBD by means of a survey of gastroenterology specialists. MATERIAL AND METHODS: a self-administered telematic survey was carried out between April and May 2017 and was sent to SEPD members. The survey included four sections: participant demographics, monitoring, treatment and limitations/needs. RESULTS: a total of 122 evaluable surveys were received from all Spanish autonomous communities. Iron deficiency anemia is considered as a frequent manifestation of IBD and is monitored in all patients via the measurement of hemoglobin and ferritin. In the case of anemia, the survey respondents found it necessary to rule out the presence of IBD activity. However, only 14.8% prescribed intravenous iron when IBD was active. The required dose of intravenous iron is mainly calculated according to patient needs but only 33.1% of clinicians infused doses of 1 g or more. CONCLUSIONS: the "Gestiona Hierro EII" survey on the management of anemia in IBD demonstrated a high quality of care, even though some aspects need to be improved. These included the prescription of intravenous iron for patients with disease activity, the use of high-dose intravenous iron and the implementation of algorithms into clinical practice.

¿Cómo se maneja la enfermedad inflamatoria intestinal en los servicios de digestivo en España? Resultados de la Encuesta GESTIONA-EII / How is inflammatory bowel disease managed in Spanish gastroenterology departments? The results of the GESTIONA-EII survey

Introducción: no en todos los centros nacionales existen unidades ni especialistas dedicados a la EII. El objetivo de la SEPD fue conocer, a través de una encuesta a sus socios, datos sobre el manejo de la EII en los servicios de digestivo de España. Material y métodos: encuesta en línea (telemática) realizada entre el 2 de febrero y el 9 de marzo de 2015, a socios de la SEPD (remitida a 2.017 socios numerarios con actividad clínica) divididos en tres categorías: jefes de servicio, digestivos generales y digestivos especializados en EII. Se muestran los resultados de las últimas dos incluyendo preguntas demográficas y otras más específicas sobre el modo y recursos con los que se cuenta para atender a estos pacientes. Resultados: se recibieron 166 encuestas completas (tasa de respuesta del 8,19%, con distribución entre todas las CC. AA. menos La Rioja), excluyendo las de los jefes de servicio. Sesenta digestivos se consideraban expertos en EII y 106 se consideraban no expertos en EII, bien generales o especializados en otros ámbitos, siendo el principal el área de endoscopias. Un 28% de los digestivos no expertos afirmaron que sus hospitales tienen unidades de EII y en un 46% existe una consulta monográfica. Pero un 26% refería que ellos mismos son los que ven y tratan los pacientes de EII. Los digestivos expertos en EII refieren disponer de una estructura con recursos para desarrollar su tarea aunque existe carencia de cirujanos expertos en EII sobre todo en centros comarcales. Conclusiones: al menos 2 de cada 3 expertos en EII, socios de la SEPD parecen disponer de recursos para desarrollar su tarea (enfermería, unidad de día, línea telefónica, base de datos, derivación, sesiones conjuntas). Existe ámbito de mejora (correo-e para contacto con pacientes, cirujano con dedicación específica, ausencia de protocolos de derivación) y 2 de cada 3 están preocupados por el control del gasto farmacéutico. Dado que un número de pacientes considerable sigue siendo tratado por médicos generalistas, programas para favorecer una rápida derivación podrían ayudar (AU)

Introduction: Not all national health centers include specialized units or clinicians devoted to inflammatory bowel disease. The goal of the survey was to gain an insight into the management of this disease within Spanish gastroenterology departments via a survey among their members. Material and methods: An online survey was conducted in February and March 2015, among SEPD members (2017 clinician members), who were split into three categories: heads of department, general gastroenterologists, and experts in this disease. The results of the last two surveys are reported, including demography-related questions and specific questions on the strategies and resources available for the care of these patients. Results: A total of 166 responses were received (response rate 8.19%), excluding those from heads of department (previously published). Sixty gastroenterologists considered themselves experts in inflammatory bowel disease, and 106 non-experts in it, the latter being either general gastroenterologists or specialists in other areas, mainly endoscopy. Twenty-eight percent of non-expert gastroenterologists said their hospitals had specific units, with a monographic clinic in 46%. However, 26% reported that they were treating affected patients themselves. Experts in inflammatory bowel disease reported that their institute had resources to support their work, but there was a lack of surgeons with expertise in this condition, particularly in county hospitals. Conclusions: At least, within SEPD members, 2 out of 3 experts in inflammatory bowel disease seem to have the resources available for their work (nurses, day unit, telephone line, database, referrals, joint sessions). Although there is room for improvement (email to contact patients, devoted surgeon, absence of referral protocols), and 2 out of 3 are concerned about pharmacy costs. Since a substantial number of patients remain treated by general practitioners, rapid referral programs might be helpful in this setting (AU)

Proton-pump inhibitors adverse effects: a review of the evidence and position statement by the Sociedad Española de Patología Digestiva.

INTRODUCTION: In the last few years a significant number of papers have related the use of proton-pump inhibitors (PPIs) to potential serious adverse effects that have resulted in social unrest. OBJECTIVE: The goal of this paper was to provide a literature review for the development of an institutional position statement by Sociedad Española de Patología Digestiva (SEPD) regarding the safety of long-term PPI use. MATERIAL AND METHODS: A comprehensive review of the literature was performed to draw conclusions based on a critical assessment of the following: a) current PPI indications; b) vitamin B12 deficiency and neurological disorders; c) magnesium deficiency; d) bone fractures; e) enteric infection and pneumonia; f) interactions with thienopyridine derivatives; e) complications in cirrhotic patients. RESULTS: Current PPI indications have remained unchanged for years now, and are well established. A general screening of vitamin B12 levels is not recommended for all patients on a PPI; however, it does seem necessary that magnesium levels be measured at therapy onset, and then monitored in subjects on other drugs that may induce hypomagnesemia. A higher risk for bone fractures is present, even though causality cannot be concluded for this association. The association between PPIs and infection with Clostridium difficile is mild to moderate, and the risk for pneumonia is low. In patients with cardiovascular risk receiving thienopyridines derivatives it is prudent to adequately consider gastrointestinal and cardiovascular risks, given the absence of definitive evidence regardin potential drug-drug interactions; if gastrointestinal risk is found to be moderate or high, effective prevention should be in place with a PPI. PPIs should be cautiously indicated in patients with decompensated cirrhosis. CONCLUSIONS: PPIs are safe drugs whose benefits outweigh their potential side effects both short-term and long-term, provided their indication, dosage, and duration are appropriate.

Recomendaciones sobre aspectos éticos de la investigación cualitativa en la salud / Recommendations on ethical aspects of qualitative research in health

Desde el punto de vista ético, la investigación cualitativa debe cumplir un conjunto de requisitos éticos que son comunes a cualquier tipo de investigación. Además, presenta una serie de problemas peculiares que son abordados en 13 recomendaciones que inciden principalmente en los siguientes puntos: la necesidad de que las relaciones entre el investigador y los sujetos participantes en la investigación se caractericen por la confianza mutua y la integridad profesional; la obligación de informar de las características de la investigación como un proceso abierto que podría hacer necesario solicitar un nuevo consentimiento o revisarlo durante el proceso de investigación; la exigencia de informar y verificar que el participante comprende la diferencia entre investigación y acto terapéutico. Los investigadores han de tener especial cuidado en la publicación de los resultados para mantener la confidencialidad y evitar estigmatización (AU)

From the ethical point of view, qualitative research must meet a set of ethical requirements that are common to any type of research. In addition, it presents a series of unique problems that are addressed in 13 recommendations that impact primarily on the following points: the need for relations between the researcher and the subjects participating in research should be characterized by mutual trust and professional integrity, the obligation to inform of the characteristics of research as an open process that could make it necessary to request a new consent form or review the existing consent form during the investigation process; the requirement to provide information and verify that the participant understands the difference between research and therapeutic act. Researchers should take special care when publishing the results to maintain patient confidentiality and to avoid stigmatization (AU)

[The ethical aspects of population screening programme of rare diseases]. / Recomendaciones sobre los aspectos éticos de los programas de cribado de población para enfermedades raras.

The Committee on Ethics of the Instituto de Investigación de Enfermedades Raras (CEIIER) of the Spanish National Institute of Health Carlos III, presents this article dealing with ethical guidelines regarding the implementation of screening population programmes with special emphasis on genetic screening. After a critical review it has been addressed 24 recommendations concerning 14 topics: evaluation of the opportunity of the programme, including ethical analysis besides scientific evidences and cost/benefits issues; the need to differentiate between research and public health intervention and to built a specific and comprehensive programme; the creation of an interdisciplinary working group which control its implementation and prepare a protocol including justification, development, therapeutic or preventive actions and follow-up activities; the review of the programme by an independent Ethical committee; the guarantee of the voluntary, universal and equitable population access, which requires sufficient information on the programme and their specific relevant facts, as incidental detection of heterozygous state in minors in newborn screening and the relevance of non directive genetic counselling specially in prenatal screening offered to pregnant women; considerations regarding future uses of samples for research purposes; total quality and periodic programme evaluation; guarantee of personal data confidentiality and the conflict of interest statement of the members of all the Committees involved in the programme.

Recomendaciones sobre los aspectos éticos de los programas de cribado de población para enfermedades raras / The ethicals aspects of population screening programme of rare diseases

El Comité de Ética del Instituto de Investigación de EnfermedadesRaras (CEIIER) del Instituto de Salud Carlos III, dentro de lasactividades que desarrolla, ha preparado el presente documento derecomendaciones éticas con respecto a la puesta en marcha de programasde cribado de población, con especial referencia a los cribadosgenéticos. Basándose en una revisión crítica se han elaborado 24recomendaciones concernientes a 14 apartados que inciden principalmenteen los siguientes puntos: la evaluación de la pertinencia delprograma, incorporando al proceso el análisis ético, de las evidenciascientíficas y de la oportunidad de los costes; la necesidad de diferenciarentre investigación e intervención y de que el programa seaespecífico e integral; la creación de un grupo de trabajo interdisciplinarque controle su desarrollo y elabore un protocolo de programaque incluya su justificación, desarrollo y ejecución incluyendo lasactividades terapéuticas o preventivas y actividades de seguimiento;la revisión necesaria del programa por un Comité de Ética independiente;la garantía de acceso voluntario, universal y equitativo querequiere de la información sobre el programa y hechos específicos silos hubiera, como la detección accidental del estado heterocigoto enmenores en los programas de cribado neonatal y las necesidades deconsejo genético; la consideración del uso futuro de las muestrasremanentes; la calidad total y evaluación periódica del programa; lasgarantías de confidencialidad de los datos de carácter personal; ladeclaración de conflictos de intereses de los miembros de losComités implicados en el programa(AU)

The Committee on Ethics of the Instituto de Investigación deEnfermedades Raras (CEIIER) of the Spanish National Institute ofHealth Carlos III, presents this article dealing with ethical guidelinesregarding the implementation of screening population programmeswith special emphasis on genetic screening. After a critical review ithas been addressed 24 recommendations concerning 14 topics: evaluationof the opportunity of the programme, including ethical analysisbesides scientific evidences and cost/benefits issues; the need todifferentiate between research and public health intervention and tobuilt a specific and comprehensive programme; the creation of aninterdisciplinary working group which control its implementationand prepare a protocol including justification, development, therapeuticor preventive actions and follow-up activities; the review of theprogramme by an independent Ethical committee; the guarantee ofthe voluntary, universal and equitable population access, which requiressufficient information on the programme and their specific relevantfacts, as incidental detection of heterozygous state in minors innewborn screening and the relevance of non directive genetic counsellingspecially in prenatal screening offered to pregnant women; considerationsregarding future uses of samples for research purposes;total quality and periodic programme evaluation; guarantee of personaldata confidentiality and the conflict of interest statement of themembers of all the Committees involved in the programme(AU)

Revisión de la literatura sobre el uso del testamento vital por la población mayor / Review of literature about the use of living bill by elderly population

El Testamento Vital (TV) recoge las preferencias detratamiento de una persona para cuando sea incapazde tomar decisiones por sí misma. Nuestro país estádando los primeros pasos para su implantación. Paraque el TV sea accesible y útil para las personas mayores,conviene conocer cómo se ha desarrollado en otrospaíses. En EE.UU., el TV ha pasado de una concepciónformal y burocrática a otra integral, denominadade Planificación Anticipada de Decisiones Sanitarias.La población mayor española tiene una opinión favorablesobre el TV si se incluye en una estrategia de comunicacióncon la familia y los profesionales. Teneren cuenta los hallazgos de la literatura facilitará eldesarrollo de un modelo organizativo efectivo que normaliceen España el uso del testamento vital por partede los mayores(AU)

The Living Will (LW) gathers the treatment preferencesof a person. Spain is starting the LW’ implantation.In order to the TV will be accessible and usefulfor the older people, we have to know how it has beendeveloped in other countries. In United States, TV hashappened through different stages: from a formal andbureaucratic conception to an integral concept, denominatedAdvance Care Planning. Spanish oldadults have a favourable opinion about TV, but it isnecessary to include it in a strategy of communicationand dialogue with its family and its professionals caregivers.Review literature findings will facilitate the developmentof an effective organizational model thatstandardizes in Spain the use of the TV by the oldadults(AU)

[Ethics guidelines for the creation and use of registries for biomedical research purposes]. / Directrices éticas sobre la creación y uso de registros con fines de investigación biomédica.

The clinical information stored in registries and records of different types is a fundamental tool for biomedical research. Up until just a few years ago, hardly any limitations existed on the creation and use of epidemiological registries or the use of information from pre-existing records for research purposes. This situation has changed substantially due mainly to the growing importance current laws place upon the safeguarding of the privacy and confidentiality of personal data. Although the legal framework is already quite explicit, a certain degree of leeway exists for ethical debate and prudence advice for the purpose of conducting valid, useful research with this information which will also respect the rights of the subjects and the laws in force. These guidelines deal with those aspects which have been considered relevant from an ethical standpoint in the handling of records and registries for research-related purposes, including not only the use but also the creation proper of the registries. A total of twenty-four recommendations are provided, grouped into ten sections: warranting of the creation of registry, organization and definition of responsibilities, scientific validity of the research project, ethical requirements of the collections of anonymous and anonymized data, ethical requirements of the registries including personal data, uses of medical records for research purposes, use of historical records of deceased individuals, contact with the research subjects, notification of results and review by a Research Ethics Committee.

Directrices éticas sobre la creación y uso de registros con fines de investigación biomédica / Ethics guidelines for the creation and use of registries for biomedical research purposes

La información clínica almacenada en registros de diverso tipo constituye una herramienta fundamental para la investigación biomédica. Hasta hace pocos años la creación y uso de registros epidemiológicos, o la utilización de información procedente de registros pre-existentes con fines de investigación, apenas tenía limitaciones. Esta situación ha cambiado de modo sustancial debido básicamente a la creciente importancia que las leyes actuales conceden a la protección de la intimidad, la privacidad y la confidencialidad de los datos de carácter personal. Aunque el marco legal es ya muy explícito, hay un cierto espacio para la deliberación ética y el consejo prudente, al objeto de realizar con dicha información una investigación válida y útil y que, al mismo tiempo, respete los derechos de los sujetos y la legalidad vigente. En las presentes directrices se abordan aquellos aspectos que se han considerado relevantes desde un punto de vista ético en el manejo de registros con fines de investigación, incluyendo no sólo el uso sino la creación misma del registro. Se proporcionan 24 recomendaciones agrupadas en 10 apartados: justificación de la creación de un registro, organización y definición de responsabilidades, validez científica del proyecto de investigación, requisitos éticos de las colecciones de datos anónimos y de los registros anonimizados, requisitos éticos de los registros que contienen datos de carácter personal, usos de la historia clínica con fines de investigación, uso de registros históricos y de personas fallecidas, contacto con los sujetos de investigación, comunicación de resultados y revisión por un Comité de Ética de la Investigación (AU)

The clinical information stored in registries and records of different types is a fundamental tool for biomedical research. Up until just a few years ago, hardly any limitations existed on the creation and use of epidemiological registries or the use of information from pre-existing records for research purposes. This situation has changed substantially due mainly to the growing importance current laws place upon the safeguarding of the privacy and confidentiality of personal data. Although the legal framework is already quite explicit, a certain degree of leeway exists for ethical debate and prudence advice for the purpose of conducting valid, useful research with this information which will also respect the rights of the subjects and the laws in force. These guidelines deal with those aspects which have been considered relevant from an ethical standpoint in the handling of records and registries for research-related purposes, including not only the use but also the creation proper of the registries. A total of twenty-four recommendations are provided, grouped into ten sections: warranting of the creation of registry, organization and definition of responsibilities, scientific validity of the research project, ethical requirements of the collections of anonymous and anonymized data, ethical requirements of the registries including personal data, uses of medical records for research purposes, use of historical records of deceased individuals, contact with the research subjects, notification of results and review by a Research Ethics Committee (AU)

[Recommendations on the ethical aspects of specimen collections and human biobanks for biomedical research purposes]. / Recomendaciones sobre los aspectos éticos de las colecciones de muestras y bancos de materiales humanos con fines de investigación biomédica.

The collecting and storing of human biospecimens and associated data are a historical fact in medicine, but the biobank is a very recent concept. The advent of new technologies making it possible to store all types of specimens, including cells capable of staying alive outside the human body for an indefinite length of time, and to obtain scientific data of all types, including genetic information, has opened up a whole new realm of possibilities for research. All of the above has led to complex ethical issues coming to fore concerning the specimen donors, the researchers handling the specimens and society as a whole. This document is aimed at providing some recommendations to serve as a guideline and encourage responsible deliberation among all those involved, thus contributing to society's recognition and trust in the forthrightness of the research and the solidary end purposes thereof. A total of nineteen recommendations have been drafted concerning the following aspects: Biobank organization and operation, degree of specimen identification, data management guarantees, consent for taking part in research and for the incorporation of specimens into the biobank, the right to know and the right not to know, consent for transferring specimens to third parties, specimen harvesting in deceased individuals, management of the pre-existing biospecimen collections, title to and commercialization of specimens and research findings and resulting payback benefiting the community.

La capacidad de los pacientes para tomar decisiones / Ability of patients to take decisions

No disponible

Gestión de las bajas laborales / Management of sick leaves

No disponible

Consentimiento informado / Informed consent

No disponible