Informed consent in biobanking and genetic research

Abstract

Partially as a consequence of the results of the Human Genome Project, reductionist and determinist positions in genetics have been generally replaced by a more systemic view. In this paper we examine some consequences of this paradigm shift upon biobanks and the way research is to take place through them. Biobanks are shown to challenge to a certain degree the traditional rules in genetic research. Although there are pressing issues concerning privacy and confidentiality, the most visible area of disagreement has to do with informed consent. There is a gap between theory and practice, as most documents and declarations at the global level insist on the need of genuine informed consent, but this requirement faces serious problems of implementation. Thus the demands of research are bringing about new "open consent" models, which are making their way into legislation, as in the new Spanish Low on Biomedical Research.