The collection and use of human biological samples in biomedical research in the Spanish Legal system

  • Sergio Romeo Malanda Universidad de las Palmas de Gran Canaria
DOI: https://doi.org/10.18543/ed-59(1)-2011pp183-228
Keywords: human biological material, biomedical research, informed consent, Studies of genetic diversity, Research Ethics Committee

Abstract

The Law 14/2007 of 3 July on Biomedical Research (LBR) acknowledges that biomedical research and health sciences are key tools to improve the quality of life and life expectancy of people and increasing their well being. Specifically, it emphasises that the collection, use and transfer of biological samples for diagnostic and research purposes has increased significantly, and that ethical and legal uncertainties have been created that have to be properly regulated. The LBR has attempted to respond to the challenges that biomedical research raises in general and particularly in relation to human biological samples, and at the same time guarantee the protection of the rights of individuals who could be affected. In this article, the author analyses the legal aspects related to the collection, use and transfer of biological samples in biomedical research. Logically, the legal framework depends upon the consent of the source of the samples and on the previous information that must be provided in this regard. Recognising that there is a divergence between the grant of completely generic or specific consent on the use or latter uses of the sample, the Law has chosen an intermediate and flexible option. 

Published online: 04 December 2014

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Author Biography

Sergio Romeo Malanda, Universidad de las Palmas de Gran Canaria
Profesor Ayudante Doctor de Derecho Penal
Published
2014-12-04
How to Cite
Romeo Malanda, Sergio. 2014. “The Collection and Use of Human Biological Samples in Biomedical Research in the Spanish Legal System”. Estudios De Deusto 59 (1), 183-228. https://doi.org/10.18543/ed-59(1)-2011pp183-228.
Issue
Vol. 59 No. 1 (2011)
Section
Studies

Last update: 08/02/2022

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