Bioresearch, Biobanks and Informed Consent from Vulnerable Donors in Spanish Law

Abstract

In this paper we will carry out a detailed exegesis of Law 14/2007 on Biomedical Research, from the 3 July, and of Royal Decree 1716/2011, from the 18 November, through which the basic requirements for the authorisation and functioning of biobanks for biomedical research, as well as for the handling of human samples, are established. It is also through this Decree that the functioning and organisation of the Spanish National Register of Biobanks for biomedical research is established. This register allows us to check whether the regulatory provisions of each biobank are adapted to the guidelines set out both in international treaties and specific Spanish legislation, whether they are suited to the legal status of vulnerable persons and whether the rights of minors and persons with disabilities are duly safeguarded by Spanish legislation. At the same time, we put forward a number of interpretive doubts brought about by inaccuracies or technical omissions made in the wording of legislative texts.