ABSTRACT
Enacted in July 2007, the Law on Biomedical Research (Ley de Investigación Biomédica, Ley 14/2007) provides a specific and novel regime for biobanks in Spain. This is not a specific law for biobanks, but a more general one attempting to strike the difficult balance between scientific advancement and traditional ethical values in the regulation of human biological samples, their collection and use in diagnosis and biomedical research. It also seeks to promote the interests of research institutions and companies. In doing so, the new legal regime for biobanks in Spain relies heavily on the decision-making by research ethics committees. How this will work is currently unclear, as key concepts in the legislation are not yet defined. Such ambiguity makes room for many possible outcomes, and the new law might eventually set in place something very similar to an ‘open consent’ or ‘consent waiver’ model, far away from the traditional demand of informed consent.1 To succeed, this movement from the traditional requirements of informed consent towards a ‘governance-by-committee’ model will need, in the short term, recommendations and new research ethics committees to take on the role of making decisions on behalf of participants. In this chapter, we discuss the Spanish context, the way the new legislation deals with informed consent, and our concerns about this new development.
