Utilización de muestras biológicas de origen humano con fines de investigación

Gil, Cristina

doi:10.4321/s1886-58872012000200003

Cited by 2 publications

(1 citation statement)

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“…Thus, while is true that the core mission of biobanks lies in collecting, organizing and providing high-quality biospecimens for the scientific community on the basis of an altruistic-based model, they are not immune to the logic and influence of the economic and cultural contexts in which they operate and, in particular, to the trends set by our market and information society (de Lecuona 2017). "any biological material of human origin capable of conservation and that can hold information on the genetic endowment that is characteristic of a person", the LIB acknowledges the dual nature of human biological samples: along with their material value, samples are also data because they are sources of information of a personal nature (Gil 2012).…”

Section: Remarkable Points Of Spanish Regulation On Biobankingmentioning

confidence: 99%

Regulating Biobanks: An ethical analysis of the Spanish law and the new challenges of the big data-driven biomedical research

Iacomussi

2021

RBD

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In the European landscape, Spain represents a positive reference point when it comes to biobank regulation. Indeed, at the beginning of XXI century, the Spanish legislation has promptly responded to challenges posed by new biotechnologies and advances in genomics in the field of biomedical research by enacting in 2007 the Ley de Investigación Biomédica in order to keep up with the paradigm shift. Over the past 10 years, this Spanish framework along with the Real Decreto 1716/2011 has hold the merit to tackle the most controversial ethical issues related to use of human samples and personal data in biomedical research and biobanking (e.g. broad consent, secondary uses, governance, etc.). However, today the regulation of biomedical research and biobanks has to deal with big data, artificial intelligence and data-intensive research which have brought a number of challenges and controversies. The aim of this paper is two-fold. First, I will analyse from an ethical point of view the merits of Spanish regulation on biobanking in order to draw some lessons for the still unregulated situation in other Member States. Secondly, I will discuss the big data paradigm shift in biomedical research and question if the ethical and legal framework introduced the Spanish law at the beginning of the century is still able to hold the ground with the new contextual and societal challenges. In this respect, I will identify some opportunities for implementation and suggest strategies to achieve them in the specific context of biobanks.

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Section: Remarkable Points Of Spanish Regulation On Biobankingmentioning

confidence: 99%