Biobancos y utilización de muestras de origen humano en investigación quirúrgica. Marco normativo actual
Martín Arribas, María Concepción
Arias Díaz, Javier
Cirugía española 2011 Apr; 89(4): 207-12
In recent years, there has been a growing interest in the development of biological samples and biobanks that make it easier for investigators to have access to quality samples and their associated clinical and epidemiological data. Thus, biobanks have become indispensible technological platforms for the development of both basic and clinical research. The properties of the biological sample as a support medium of personal and family information require that they are treated in accordance with new ethical standards. For this reason, the Law on Biomedical Research, provides a new regulatory framework in the process of obtaining samples and their storage for research purposes, where the consent of the source subject, data protection, the favourable opinion of a Research Ethics Committee, the prior taking out of an insurance policy against possible adverse effects, and the quality and safety requirements in the handling and management of these materials are key elements.
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. = Recomendaciones sobre los aspectos éticos de los programas de cribado de población para enfermedades raras. Pàmpols Ros, Teresa; Terracini, Benedetto; de Abajo Iglesias, Francisco J; Feito Grande, Lydia; Martín-Arribas, M Concepción; Fernández Soria, José María; Redondo Martín Del Olmo, Tomás; Campos Castelló, Jaime; Herrera Carranza, Joaquín; Júdez Gutiérrez, J (2010-03)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 ...
de Sá, Maria de Fátima Freire; Moureira, Diogo Luna (2009-07)
de Sá, Maria de Fátima Freire; Moureira, Diogo Luna (2009-07)Beginning with the assumption that the heated tension between research freedom and the protection of human life and integrity has not been overcome, this article discusses the issue of regulatory framework for the protection ...