Publication: Aspectos generales de la regulación española de ensayos clínicos. El consentimiento informado
Authors
Vieito Villar, Miguel
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info:eu-repo/semantics/article
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Abstract
La reciente aprobación y entrada en vigor del nuevo Reglamento Europeo 536/2014 ha supuesto una actualización del régimen legal de los ensayos clínicos en el territorio de la Unión. De entre las materias abordadas con mayor profundidad en este texto, destaca el consentimiento informado, que pasa a tener un papel central como mecanismo de garantía de la autonomía de los sujetos participantes.Es nuestra finalidad con el presente trabajo, ofrecer una visión general del consentimiento informado para ensayos clínicos, como introducción y toma de contacto con esta institución. Comenzaremos por delimitar qué debemos entender por ensayo para, posteriormente, analizar qué supone el consentimiento informado, tanto desde un punto de vista formal, en relación con la documentación que habrá de aportarse para poder llevar a cabo un ensayo clínico, como desde un punto de vista substantivo. Por último, analizaremos las normas técnicas de la investigación con relación al consentimiento, con gran peso específico entre la comunidad científica.
The recent adoption and entry into force of the new European Regulation 536/2014 has led to an update of the legal regime concerning clinical trials in the territory of the Union. Among all issues regulated on it, the informed consent has a leading role as a mechanism to guarantee the autonomy of the participants. It is our purpose with this paper to provide a general overview of informed consent for clinical trials, as an introduction and first contact with this legal institution. Firstly, we will define what should we understand by “clinical trial” and then, we will analyse what constitutes informed consent, from a formal point of view, regarding the documentation that will be required to conduct a clinical trial, as well as from a substantive point of view. Lastly, we will analyse the technical rules of research, with great specific weight among the scientific community.
The recent adoption and entry into force of the new European Regulation 536/2014 has led to an update of the legal regime concerning clinical trials in the territory of the Union. Among all issues regulated on it, the informed consent has a leading role as a mechanism to guarantee the autonomy of the participants. It is our purpose with this paper to provide a general overview of informed consent for clinical trials, as an introduction and first contact with this legal institution. Firstly, we will define what should we understand by “clinical trial” and then, we will analyse what constitutes informed consent, from a formal point of view, regarding the documentation that will be required to conduct a clinical trial, as well as from a substantive point of view. Lastly, we will analyse the technical rules of research, with great specific weight among the scientific community.
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