Almacenamiento de muestras humanas aptas para investigación: autonomía y datos genéticos / Storage of human samples for research: Autonomy and genomic data

No disponible

Percepción del fraude científico en las revistas biomédicas españolas / Perception of scientific fraud in the Spanish biomedical journals

No disponible

Revisión ética de proyectos. Experiencia de un comité de ética de la investigación / Ethical review of research protocols: experience of a research ethics committee

Introducción y objetivos. Desde la aprobación de la Ley de Investigación Biomédica, se incorpora al ámbito de actuación de los comités de ética de la investigación la evaluación de los aspectos metodológicos, éticos y legales de toda investigación que se realice en seres humanos o con muestras biológicas humanas. El objetivo de este estudio es plasmar la experiencia del Comité de Ética de la Investigación del Instituto de Salud Carlos III en la evaluación ética de los proyectos de investigación en seres humanos. Métodos. Estudio descriptivo de las observaciones realizadas a los proyectos de investigación registrados desde el 1 de junio de 2009 al 30 de junio de 2010. Resultados. Aproximadamente dos tercios de los proyectos evaluados en este periodo necesitaron algún tipo de enmienda. La mayor parte de las observaciones se dirigieron a la mejora del consentimiento informado y de los procedimientos de garantía de confidencialidad (153 observaciones, el 57,6%). Las observaciones relacionadas con los principios de beneficencia y no maleficencia fueron 50 (18,9%) y el resto, con deficiencias de la información aportada sobre aspectos concretos del estudio o de carácter administrativo. Conclusiones. El ejercicio de la autonomía de los participantes en las investigaciones ha supuesto la mayor parte de las observaciones realizadas. Es necesario que los profesionales sanitarios se sensibilicen con las implicaciones del respeto al derecho de autonomía de los participantes. Los comités de ética de la investigación, por lo tanto, deben promover la toma de conciencia sobre las cuestiones éticas de la investigación biomédica (AU)

Introduction and objectives. Since the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples. The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessment of research proposals involving human subjects. Methods. A descriptive study of the observations made on research projects registered between June 1, 2009 and June 30, 2010. Results. About two thirds of the projects evaluated in this period needed some type of amendment. Most of the comments were aimed at improving informed consent and procedures to ensure confidentiality (153 observations, 57.6%). Fifty (18.9%) observations related to the principles of beneficence and nonmaleficence. The remaining observations involved incomplete or incorrect documentation, or requests for additional information. Conclusions. The largest number of observations related to the autonomy of research participants. It is important for researchers to be aware of the principle of autonomy in their interaction with study participants. Research ethics committees should therefore promote greater understanding of ethical issues on biomedical research (AU)

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)

Ethical review of research protocols: experience of a research ethics committee.

INTRODUCTION AND OBJECTIVES: Since the passing of the Law on Biomedical Research it has been the task of research ethics committees to assess the methodological, ethical and legal aspects of all research carried out on humans or human biological samples. The aim of the study is to analyze the experience of the Research Ethics Committee for the Carlos III Health Institute in the ethical assessment of research proposals involving human subjects. METHODS: A descriptive study of the observations made on research projects registered between June 1, 2009 and June 30, 2010. RESULTS: About two thirds of the projects evaluated in this period needed some type of amendment. Most of the comments were aimed at improving informed consent and procedures to ensure confidentiality (153 observations, 57.6%). Fifty (18.9%) observations related to the principles of beneficence and nonmaleficence. The remaining observations involved incomplete or incorrect documentation, or requests for additional information. CONCLUSIONS: The largest number of observations related to the autonomy of research participants. It is important for researchers to be aware of the principle of autonomy in their interaction with study participants. Research ethics committees should therefore promote greater understanding of ethical issues on biomedical research.

Versión española del cuestionario de calidad de vida para niños y adolescentes con cardiopatías (PedsQL TM) / The spanish version of the health-related quality of life questionnaire for children and adolescents with heart disease (PedsQL TM)

Introducción y objetivos. Adaptar al español el cuestionario de calidad de vida Pediatric Quality of Life Inventory (PedsQLTM) (Módulo General y Módulo Cardiaco, versión 3.0). Métodos. Metodología de traducción directa e inversa. La entrevista cognitiva se utilizó para probar la versión previa al test. Se realizó la evaluación de las propiedades psicométricas de la versión española. Resultados. La nueva versión contiene algunos cambios de formato con intención de facilitar la lectura de los enunciados y la comprensión de las instrucciones de respuesta (versión para niños de 5-7 años). Se identificaron algunos problemas de «descontextualización» en relación con el desarrollo evolutivo de los niños en las versiones para los niños más pequeños y sus padres (2-4 y 5-7 años). El porcentaje de ítems sin respuesta osciló entre 0 y el 5,9%. Se encontraron efectos techo elevados, especialmente en el Módulo Cardiaco, donde osciló en un 19-48,6%. La consistencia interna fue > 0,7, excepto en la dimensión de Apariencia Física y Funcionamiento Escolar en los niños. Los grados de acuerdo entre la información dada por los niños y la dada por los padres fueron en general muy altos. Se observó una tendencia de descenso de las puntuaciones en todas las escalas en relación con la gravedad de la cardiopatía, pero sólo en algunas dimensiones las diferencias fueron estadísticamente significativas. Conclusiones. La versión española del PedsQLTM presenta algunas diferencias con la versión original, concretamente con las dimensiones de Funcionamiento Escolar y Apariencia Física, como se observó en las entrevistas cognitivas. Por otro lado, no se ha demostrado que tenga validez predictiva (AU)

Introduction and objectives. To adapt the Pediatric Quality of Life Inventory (PedsQLTM) (General Module and Cardiac Module, 3.0 version) into Spanish. Methods. Forward and back translation methodology. Cognitive interviewing was used to check the pre-test version. Psychometric properties were computed for the PedsQLTM Cardiac Module Scales. Cross-informant variance between children and parents was assessed. Results. The Spanish version has some format changes to make it easier to read and to clarify response choices (version for 5-7 years age group). Some semantically complex terms were replaced with synonyms and others illustrated with examples. Some "out of context" problems were identified with respect to some items (version for children 2-4 and 5-7 years). The percentage of missing item responses ranged from 0% to 5.9%. A high ceiling effect was found, especially in the Cardiac Module, which ranged from 19% to 48.6%. Internal consistency was higher than 0.7, except for Physical Appearance Scale and School Functioning in children. Agreement between information given by children and parents was generally very high. A decreasing trend in scores on all scales was observed in relation to the severity of heart disease, but the differences were only statistically significant in some dimensions. Conclusions. The Spanish version of the PedsQLTM differs somewhat from the original version, particularly on the School Functioning and Physical Appearance Scales, as observed in cognitive interviews. Predictive validity was not demonstrated (AU)

The Spanish version of the health-related quality of life questionnaire for children and adolescents with heart disease (PedsQL(TM)).

INTRODUCTION AND OBJECTIVES: To adapt the Pediatric Quality of Life Inventory (PedsQL(TM)) (General Module and Cardiac Module, 3.0 version) into Spanish. METHODS: Forward and back translation methodology. Cognitive interviewing was used to check the pre-test version. Psychometric properties were computed for the PedsQL(TM) Cardiac Module Scales. Cross-informant variance between children and parents was assessed. RESULTS: The Spanish version has some format changes to make it easier to read and to clarify response choices (version for 5-7 years age group). Some semantically complex terms were replaced with synonyms and others illustrated with examples. Some "out of context" problems were identified with respect to some items (version for children 2-4 and 5-7 years). The percentage of missing item responses ranged from 0% to 5.9%. A high ceiling effect was found, especially in the Cardiac Module, which ranged from 19% to 48.6%. Internal consistency was higher than 0.7, except for Physical Appearance Scale and School Functioning in children. Agreement between information given by children and parents was generally very high. A decreasing trend in scores on all scales was observed in relation to the severity of heart disease, but the differences were only statistically significant in some dimensions. CONCLUSIONS: The Spanish version of the PedsQL(TM) differs somewhat from the original version, particularly on the School Functioning and Physical Appearance Scales, as observed in cognitive interviews. Predictive validity was not demonstrated.

[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)

[Efficacy of nursing planning after hospital discharge of patients over 65 to reduce their readmission]. / Eficacia de la planificación del alta de enfermería para disminuir los reingresos en mayores de 65 años.

OBJECTIVES: To evaluate the efficacy of nursing care and monitoring of patients over 65 in primary care, to reduce the rate of readmission and to extend time till readmission. DESIGN: Non-randomised clinical trial with control. SETTING: Base Area 8, Madrid, Spain. Primary and specialist care. PARTICIPANTS: Patients over 65 admitted from home with the pathologies under study. There were 97 patients in the study, 49 in the intervention group and 48 in the control group. INTERVENTIONS: In the intervention group, link nursing conducted visits every 48 hours and provided health education to carer and patient. Patients in the control group received conventional care. Patients in both groups were contacted by phone by primary care nurses 2, 6, 12, and 24 weeks after their hospital discharge. MEASUREMENTS: Readmission for the same reason was recorded. As a secondary variable, time till readmission was recorded. RESULTS: Patients in the control group were admitted more often than those in the experimental group (OR, 3.3; 95% CI, 1.13-9.52; adjusted for the admission diagnosis). The result was consistent, on conducting an analysis of the time elapsed before readmission (HR, 2.29; 95% CI, 1.03-5.10; adjusted in the same way). CONCLUSIONS: A planned intervention into discharges with full, individual evaluation reduces readmissions and increases the time till readmission in patients over 65.

Eficacia de la planificación del alta de enfermería para disminuir los reingresos en mayores de 65 años / Efficacy of nursing planning after hospital discharge of patients over 65 to reduce their readmission

Objetivos. Evaluar la eficacia de la planificación del alta y seguimiento en atención primaria de pacientes mayores de 65 años, para disminuir la tasa de reingresos y la reducción del tiempo hasta el reingreso. Diseño. Ensayo clínico controlado, no aleatorizado. Emplazamiento. Área Sanitaria 8 de Madrid. Participantes. Mayores de 65 años que ingresaran procedentes de sus domicilios con las patologías de estudio. Participaron en el estudio 97 pacientes, 49 en el grupo intervención y 48 en el grupo control. Intervenciones. El personal de enfermería de enlace realizaba visitas cada 48 horas y proporcionaba educación sanitaria al cuidador y al paciente. Los pacientes en el grupo control recibieron la atención convencional. El personal de enfermería de atención primaria contactó telefónicamente con los pacientes de ambos grupos a las 2, 6, 12 y 24 semanas después de su alta hospitalaria. Mediciones. Se registró el reingreso por la misma causa y el tiempo hasta el reingreso. Resultados. Los pacientes del grupo control ingresaron con más frecuencia que los del grupo experimental (OR = 3,3; IC del 95%, 1,13-9,52; ajustado por el diagnóstico al ingreso). El resultado concordaba al realizar un análisis considerando el tiempo hasta el reingreso (HR = 2, 29; IC del 95%, 1,03-5,10; ajustando de la misma manera). Conclusiones. Una intervención planificada del alta con una valoración integral individualizada disminuye los reingresos y el tiempo hasta el reingreso en mayores de 65 años

Objectives. To evaluate the efficacy of nursing care and monitoring of patients over 65 in primary care, to reduce the rate of readmission and to extend time till readmission. Design. Non-randomised clinical trial with control. Setting. Base Area 8, Madrid, Spain. Primary and specialist care. Participants. Patients over 65 admitted from home with the pathologies under study. There were 97 patients in the study, 49 in the intervention group and 48 in the control group. Interventions. In the intervention group, link nursing conducted visits every 48 hours and provided health education to carer and patient. Patients in the control group received conventional care. Patients in both groups were contacted by phone by primary care nurses 2, 6, 12, and 24 weeks after their hospital discharge. Measurements. Readmission for the same reason was recorded. As a secondary variable, time till readmission was recorded. Results. Patients in the control group were admitted more often than those in the experimental group (OR, 3.3; 95% CI, 1.13-9.52; adjusted for the admission diagnosis). The result was consistent, on conducting an analysis of the time elapsed before readmission (HR, 2.29; 95% CI, 1.03-5.10; adjusted in the same way). Conclusions. A planned intervention into discharges with full, individual evaluation reduces readmissions and increases the time till readmission in patients over 65

[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.

Bioethical issues in neuropsychiatric genetic disorders.

Neurogenetic disorders share many characteristics with other rare disorders and raise complex bioethical issues for clinical practice and research. Because patients frequently present with cognitive or communicative impairments, special measures to guarantee consent and assent are required. Many neurogenetic disorders present with autistic behavior or borderline sociocommunicative aspects. The likelihood that early educational intervention benefits the adaptive skills of these persons leads to screening programs that pose bioethical challenges. The biggest conflicts come from the lack of research in clinical care and the limited application of biomedical ethics in the personal support services arena. Alternatives include the development of personal services portfolios, establishing and supporting bioethical committees, reviewing and improving ethical aspects in research initiatives in this population, and empowering clients (and their legally authorized representatives) for participation and representation.

[Neonatal screening for congenital metabolic pathologies. Ethical and social aspects. Implications for nurses and midwives]. / Cribado neonatal de metabolopatías congénitas. Aspectos eticos y sociales. Implicaciones para enfermeras y matronas.

The authors describe the diseases which are detectable by means of neonatal screening programs available in the different Spanish Autonomous Communities. They analyze some of the ethical and social implications which may occur and they emphasize what those programs mean for nursing professionals, fundamentally midwives and nurses who work in primary health care units or pediatric units.