Document Detail


Spanish regulatory approach for biobanking.
MedLine Citation:
PMID:  23188043     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
The Spanish regulatory framework for storage of samples for research responds to most issues raised by both researchers and society regarding biobanking. The Spanish regulation currently foresees three possible ways in which these samples are to be handled: (a) gathering for use in a specific project, (b) storage in a collection, and (c) storage in a Biobank. Samples incorporated into a 'collection' can only be used by the investigator who requested them and cannot be transferred to third parties or used in research projects outside the particular research line foreseen in the original consent. On the other hand, the legal entity 'Biobank' refers not only to a set of physical facilities but to the management of the samples stored under that label, and particularly to the requirements for their cession. An approach based on putting most of the regulatory weight on the biobank side has been chosen in order to guaranty the rights of the donors as well as to ease the task of the researchers. A Biobank requires both to be authorized and to be registered in a public Registry. The requirements are quite stringent, allowing for the consent to be given as 'broad' in scope without implying being 'blank.' In this regard, for Biobanks to justify the taking on of some of the donors' rights, a key requirement is to have an external ethics committee supervising the adequacy of samples cession and use, notwithstanding the need for a previous bioethical supervision of the target protocol.
Authors:
Javier Arias-Diaz; María C Martín-Arribas; Javier García del Pozo; Carlos Alonso
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Publication Detail:
Type:  Journal Article     Date:  2012-11-28
Journal Detail:
Title:  European journal of human genetics : EJHG     Volume:  21     ISSN:  1476-5438     ISO Abbreviation:  Eur. J. Hum. Genet.     Publication Date:  2013 Jul 
Date Detail:
Created Date:  2013-06-13     Completed Date:  2013-11-04     Revised Date:  2014-07-01    
Medline Journal Info:
Nlm Unique ID:  9302235     Medline TA:  Eur J Hum Genet     Country:  England    
Other Details:
Languages:  eng     Pagination:  708-12     Citation Subset:  IM    
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MeSH Terms
Descriptor/Qualifier:
Bioethics*
Biological Specimen Banks / ethics,  legislation & jurisprudence*,  organization & administration
Biomedical Research*
Government Agencies
Humans
Informed Consent
Spain
Comments/Corrections

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