Aspectos éticos y legales relativos al tratamiento de muestras biológicas humanas en ensayos clínicos con medicamentos. Propuesta de criterios de evaluación para los Comités Éticos de Investigación Clínica

Farnós, Iciar Alfonso; Jiménez, Pilar Nicolás; Uzquiano, Emma Fernández de

doi:10.1016/j.reml.2015.10.003

Cited by 3 publications

(1 citation statement)

References 3 publications

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“…This "Governance-by-Committee" approach, although it has the merit of ensuring adequate ethical oversight to biobanking services, lacks a set of uniform criteria of decision-making which would make the evaluation more homogeneous across the country (Garcia-Merino et al 2015;Alfonso Farnós et al 2016).…”

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%

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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Investigación biomédica con muestras biológicas de origen humano: un nuevo reto para la Bioética y los Comités Éticos de Investigación Clínica

Sospedra

Gené

2016

Revista Española de Medicina Legal

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Biomedical research with human biological samples: A new challenge for Bioethics and for the Clinical Research Ethics Committees

Sospedra

Gené

2016

Spanish Journal of Legal Medicine

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Aspectos éticos y legales relativos al tratamiento de muestras biológicas humanas en ensayos clínicos con medicamentos. Propuesta de criterios de evaluación para los Comités Éticos de Investigación Clínica

Cited by 3 publications

References 3 publications

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

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

Investigación biomédica con muestras biológicas de origen humano: un nuevo reto para la Bioética y los Comités Éticos de Investigación Clínica

Biomedical research with human biological samples: A new challenge for Bioethics and for the Clinical Research Ethics Committees

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