Ética en investigación: de los principios a los aspectos prácticos / Research ethics: From principles to practical aspects

La realización de cualquier investigación con seres humanos o sus muestras biológicas requiere una valoración ética previa con el fin de evitar riesgos y problemas a todos los actores del proceso. La legislación al respecto es muy amplia, y hace hincapié en la preservación de los derechos de los pacientes en relación con los principios universales de autonomía, beneficencia y justicia. En este manuscrito se revisan las normativas sobre ensayos clínicos, estudios observacionales con medicamentos, proyectos de biobanco o cualquier otro tipo de estudio que se pueda realizar en el ámbito de la salud. Así mismo se analiza el papel de los comités de ética en investigación, la protección de datos y las bases de la integridad científica. (AU)

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity. (AU)

Research ethics: From principles to practical aspects.

Any research conducted on human beings or human biological samples requires a prior ethical assessment to avoid risks and problems for all involved parties. The legislation in this regard is very broad and emphasizes the safeguarding of patient rights in relation to the universal principles of autonomy, beneficence and justice. The present article reviews the regulations applicable to clinical trials, observational studies with drugs, biobank projects or any other type of study that may be conducted in the health care field. It also addresses the role of research ethics committees, data protection and the foundations of scientific integrity.

Chronic Kidney Disease-Associated Pruritus and Quality of Life: Learning from Our Patients.

Chronic kidney disease-associated pruritus is itching directly related to kidney disease that cannot be explained by any other condition. Despite technological advances in the different aspects of dialysis sessions and the best treatment for chronic kidney disease patients, it is still a common problem in our patients. The many complex physiological mechanisms involved, the different hypotheses made over the years on the aetiology of the condition, and the great clinical variability may partially explain the limited knowledge about this problem and the difficulties in treating it. The presence of all these factors leads to the persistence of unpleasant symptoms, which must affect the disease burden and quality of life of kidney patients. Through the presentation of an illustrative clinical case, the aim of this review article is to highlight the need for adequate diagnosis and an improved approach to all aspects of chronic kidney disease-associated pruritus, in view of the heavy burden of the disease and the huge impact on the patient's quality of life.

Perception of Spanish nephrologists on an old unsolved problem: Pruritus associated with chronic kidney disease (CKD-aP).

INTRODUCTION: Pruritus associated with chronic kidney disease is defined as the sensation of itching, in people with chronic kidney disease, in a one area or all over the body that causes the need to scratch, after having ruled out other dermatological or systemic causes. It is an old and known problem whose prevalence has been able to decrease with the improvement of dialytic techniques but which still persists and is underdiagnosed. OBJECTIVES: The objective of this study was to analyse the current perception of nephrologists about this problem that influences the quality of life of people with chronic kidney disease through a survey. RESULTS: 135 nephrologists, most of them engaged in haemodialysis, participated. 86% considered that pruritus associated with chronic kidney disease is still a problem today that affects the quality of life. Most nephrologists believe that the main pathophysiological cause is uremic toxins (60%) and only 16% believe that it is due to the dysregulation of the opioid system/endorphins-dynorphins. Only 16% comment that the prevalence of pruritus in their centre is greater than 20%. 40% believe that the diagnosis is made because it is manifested by the patient and only 27% because it is asked by the doctor. Moreover, it is not usual to use scales to measure it or the codification in the medical records. The main treatment used is antihistamines (96%), followed by moisturizers/anaesthetics (93%) and modification of the dialysis regimen (70%). CONCLUSIONS: Pruritus associated with chronic kidney disease is still a current problem, it is underdiagnosed, not codified and with a lack of indicated, effective and safe treatments. Nephrologists do not know its real prevalence and the different pathophysiological mechanisms involved in its development. Many therapeutic options are used with very variable results, ignoring their efficacy and applicability at the present time. The new emerging kappa-opioid-receptor agonist agents offer us an opportunity to reevaluate this age-old problem and improve the quality of life for our patients with chronic kidney disease.

Percepción de los nefrólogos españoles sobre un problema antiguo no resuelto: Prurito asociado a la enfermedad renal crónica (Pa-ERC) / Perception of Spanish nephrologists on an old unsolved problem: Pruritus associated with chronic kidney disease (CKD-aP)

Introducción: El prurito asociado a enfermedad renal crónica se define como la sensación desagradable que provoca la necesidad de rascarse en una parte del cuerpo o en todo en personas con enfermedad renal crónica, tras haberse descartado otras causas dermatológicas o sistémicas. Es un problema antiguo y conocido cuya prevalencia ha podido disminuir con la mejoría de la eficacia dialítica pero que todavía persiste y está infradiagnosticado. Objetivos: El objetivo de este estudio fue analizar la percepción y práctica actual de los nefrólogos sobre este problema que impacta en la calidad de vida de las personas con enfermedad renal crónica a través de una encuesta anónima. Resultados: Participaron 135 nefrólogos, la mayoría dedicados a hemodiálisis. Un 86% consideró que el prurito asociado a enfermedad renal crónica sigue siendo un problema en la actualidad que afecta a la calidad de vida. La mayoría de los nefrólogos opinan que la principal causa fisiopatológica son las toxinas urémicas (60%) y solo un 16% cree que se debe a la desregulación del sistema opioide/endorfinas-dinorfinas. Únicamente un 16% comenta que la prevalencia de prurito en su centro es mayor del 20%. Un 40% cree que el diagnóstico se realiza porque lo manifiesta el paciente y solo un 27% porque lo pregunta el facultativo. Además, no es habitual usar escalas ni codificarlo en la historia clínica. El tratamiento más común son los antihistamínicos (96%), seguido de las cremas hidratantes/anestésicas (93%) y la modificación de la pauta de diálisis (70%). (AU)

Introduction: Pruritus associated with chronic kidney disease is defined as the sensation of itching, in people with chronic kidney disease, in a one area or all over the body that causes the need to scratch, after having ruled out other dermatological or systemic causes. It is an old and known problem whose prevalence has been able to decrease with the improvement of dialytic techniques but which still persists and is underdiagnosed. Objectives: The objective of this study was to analyze the current perception of nephrologists about this problem that influences the quality of life of people with chronic kidney disease through a survey. Results: 135 nephrologists, most of them engaged in hemodialysis, participated. 86% considered that pruritus associated with chronic kidney disease is still a problem today that affects the quality of life. Most nephrologists believe that the main pathophysiological cause is uremic toxins (60%) and only 16% believe that it is due to the dysregulation of the opioid system/endorphins-dynorphins. Only 16% comment that the prevalence of pruritus in their center is greater than 20%. 40% believe that the diagnosis is made because it is manifested by the patient and only 27% because it is asked by the doctor. Moreover, it is not usual to use scales to measure it or the codification in the medical records. The main treatment used is antihistamines (96%), followed by moisturizers/anesthetics (93%) and modification of the dialysis regimen (70%). (AU)

Investigación clínica en enfermedades raras: nuevos retos, oportunidades e implicaciones éticas / Clinical research in rare diseases: new challenges, opportunities and ethical issues

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Evaluación de estudios de intervención por un Comité de Ética de la Investigación / Evaluation of intervention studies by a Research Ethics Committee

Los estudios experimentales con intervenciones diferentes a los ensayos clínicos con medicamentos o con productos sanitarios se regulan por la Ley 14/2007, de 3 de julio, de Investigación biomédica, que establece que toda investigación biomédica que comporte algún procedimiento invasivo en el ser humano deberá recogerse en un proyecto de investigación que será evaluado previamente por el Comité de Ética de la Investigación correspondiente. El objetivo de este trabajo es analizar los principios éticos y legales aplicables a la realización de los estudios de intervención y revisar los criterios de evaluación de este tipo de proyectos por un Comité de Ética de la Investigación

Experimental studies with interventions which are different than clinical trials with medicines or health products are regulated by Law 14/2007, of 3 July, on Biomedical Research, which establishes that all biomedical research involving an invasive procedure in human beings must be included in a research project that will be previously evaluated by the corresponding Research Ethics Committee. The aim of this work is to analyse the ethical and legal principles applicable to the carrying out of intervention studies. Likewise, the purpose of this paper is to review the criteria for evaluating this type of project by a Research Ethics Committee

Cuestionario/guía para la evaluación de proyectos de investigación con datos por un CEI / Questionnaire/guide for the evaluation of research projects with personal data by a Research Ethics Committee

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Utilización de tecnología Big Data en investigación clínica / Use of Big Data technology in clinical research

La utilización de la tecnología Big data en la práctica clínica puede suponer grandes avances para el sistema sanitario, tanto para la asistencia como para la investigación clínica. Para conseguir este objetivo es imprescindible la integración de las diferentes fuentes de información actualmente disponibles. De forma simultánea a estas ventajas potenciales, la aplicación de estas tecnologías puede suponer una fuerte amenaza para la intimidad, por lo que es imprescindible disponer de medidas adecuadas de control de la información, así como implantar procedimientos adecuados, transparentes y seguros, que garanticen el máximo nivel de confidencialidad asegurando el respeto a los derechos y libertades de las personas. Para poder utilizar de forma segura esta tecnología es imprescindible disponer de un marco ético y jurídico adecuado, que permita compaginar la protección de datos con la investigación clínica relevante y la mejora de la asistencia

The use of Big data technology in clinical practice can mean great advances for the healthcare system, both for care and for clinical research. To achieve this goal, it is essential to integrate the different sources of information currently available. Simultaneously with these potential advantages, the application of these technologies can pose a strong threat to privacy, so it is essential to have adequate control measures for information, as well as to implement adequate, transparent and secure procedures, which guarantee the highest level of confidentiality ensuring respect for the rights and freedoms of individuals. In order to be able to use this technology safely, it is essential to have an adequate ethical and legal framework that allows data protection to be combined with relevant clinical research and improved care

Evaluación de proyectos de investigación con tecnología Big Data por un Comité de Ética de la investigación / Evaluation of research projects with Big Data technology by a Research Ethics Committee

La investigación con tecnología Big Data en el ámbito sanitario debe realizarse en el contexto de un marco ético y jurídico que garantice el máximo nivel de protección en el tratamiento de datos de carácter personal. Los comités de ética de la investigación, como garantes de los derechos, seguridad y bienestar de los sujetos que participan en un proyecto de investigación biomédica, deben verificar el cumplimiento de los principios éticos y legales aplicables a la investigacion con datos de salud. En este trabajo se revisan los principios éticos y legales aplicables a la investigación con Big Data, así como las funciones que deben desempeñar los comités de ética de la investigación en la evaluación de este tipo de estudios

Research with Big Data technology in the world of health must be carried out within an ethical and legal framework that guarantees the highest level of protection in the processing of personal data. The research ethics committees, as guarantors of the rights, safety and welfare of the subjects participating in a biomedical research project, must verify compliance with the ethical and legal principles applicable to research with health data. In this paper, we review the ethical and legal principles applicable to research with Big Data, as well as the functions that the research ethics committees must perform in the evaluation of this type of studies

El acceso a la historia clínica en la investigación observacional / Access to medical records in observational research

La legislación vigente española no contempla excepciones al consentimiento del paciente para acceder a su historia clínica con motivos de investigación, a diferencia de otros países de la Unión Europea o de lo estipulado en la Declaración de Helsinki. Las diferentes normas éticas internacionales exigen la evaluación de los estudios observacionales por un Comité de ética de la investigación para garantizar la confidencialidad y el respeto a los derechos de los participantes. Este artículo tiene como objetivo revisar los requisitos legales para acceder a la historia clínica para investigación, tanto en la evaluación ética como en la exigencia de consentimiento informado. Deberían desarrollarse herramientas que permitan acceder a la historia clínica electrónica para investigación cumpliendo los requisitos legales de protección de datos. El nuevo Reglamento Europeo autoriza a los Estados miembros a establecer excepciones legales a los derechos de protección de datos de los sujetos para facilitar la investigación científica

In accordance with current Spanish legislation, patient consent is required without exception in order to access their medical records for research purposes, which is not the case in other countries of the European Union or as established in the Declaration of Helsinki. The various international ethical regulations require observational studies to be reviewed by an Independent Ethics Committee to guarantee confidentiality and respect of the participants' rights. The objective of this paper is to review the legal requirements to access medical records for research, regarding both the ethical review and the request for informed consent. Tools should be developed that facilitate access to electronic medical records for research purposes in compliance with legal requirements pertaining to data protection. The new European Regulation allows the Member States to establish legal exceptions to the data protection rights of subjects to facilitate scientific researchs

El acceso a la historia clínica con motivos de investigación / Accessing medical records for research purposes

Las normativas fundamentales que regulan en España la historia clínica son por una parte, la Ley Orgánica 15/1999 de 13 de diciembre, de Protección de Datos de Carácter personal (LOPD) y la Ley 41/2002, de 14 de noviembre, básica reguladora de la autonomía del paciente y de derechos y obligaciones en materia de información y documentación clínica (LAP). No obstante, la falta de desarrollo específico de estas leyes en cuanto a la protección de datos en la investigación clínica, en especial en lo referente al acceso a la historia clínica, origina en numerosas ocasiones dudas de interpretación en los Comités de Ética de la investigación. Por este motivo, el objetivo de este artículo es analizar la normativa que regula el accesoa a la historia clínica con motivos de investigación, haciendo un especial énfasis en los problemas habituales que se plantean en los Comités durante la evaluación ética de estos proyectos y estableciendo finalmente una seria de recomendaciones. Se aborda también en este trabajo la utilización para investigación de esos datos genéticos de carácter personal contenidos en la historia clínica. En este sentido, una contribución trascendental de la Ley de Investigación Biomédica es la regulación específica de los datos genéticos de carácter personal, tanto en lo que concierne a su obtención, como en el acceso a los datos para asistencia o su utilización con fines de investigación (AU)

The organic Law 15/1999 of 13 December on the Protection of Personal Data and the Law 41/2002 of 14 November regulating patient autonomy and rights and obligations of information and clinical documentation are the basic rules which govern the medical history in Spain. However, the lack of development of these laws regarding data protection in clinical research, particularly in terms of access to the medical history, repeatedly causes doubts about its construction by the Research Ethics Committees. Therefore, the aim of this paper is to analyze the rules with govern the access to the medical history for research purposes, with particular emphasis on the common problems that arise in the Committees for the ethical evaluation of these projects and finally setting a series of recommendations. The use for research purpose of genetic personal data contained in the medical history is also addressed in this paper. In this sense, a key contribution of the Law of Biomedical Research is relating to the specific regulation of the genetic personal data, both with respect to their production and access to the data as a support and regarding to its use for research purpose (AU)

[Accessing medical records for research purposes]. / El acceso a la historia clínica con motivos de investigación.

The Organic Law 15/1999 of 13 December on the Protection of Personal Data and the Law 41/2002 of 14 November regulating patient autonomy and rights and obligations of information and clinical documentation are the basic rules which govern the medical history in Spain. However, the lack of development of these laws regarding data protection in clinical research, particularly in terms of access to the medical history, repeatedly causes doubts about its construction by the Research Ethics Committees. Therefore, the aim of this paper is to analyze the rules which govern the access to the medical history for research purposes, with particular emphasis on the common problems that arise in the Committees for the ethical evaluation of these projects and finally setting a series of recommendations. The use for research purpose of genetic personal data contained in the medical history is also addressed in this paper. In this sense, a key contribution of the Law on Biomedical Research is relating to the specific regulation of the genetic personal data, both with respect to their production and access to the data as a support and regarding to its use for research purpose.