Informed Consent to Collect, Store and Use Human Biological Materials for Research Purposes

Abstract

The increased buildup of human biobanks developed out a need for rethinking traditional research ethics. In particular, the advancement of research using samples of human origin (namely body fluids, cells, tissues, intra-cellular substance, DNA) calls for the definition of a new model of informed consent appropriate to biobank research.

Even though some recent studies doubt the importance attributed to informed consent, the international debate on ethical and legal aspects of research using human biospecimens and associated data focuses on consent as the priority issue of biobanking research.

This paper contains a review of the international ethical and legal framework of consent requisites for retrospective and prospective research using biobank samples. Critical terms and definitions are examined to show that different standards and recommendations concerning informed consent are present at regional, national and international levels. Additionally, different contexts in which a waiver of informed consent can be accepted are discussed and the question of criteria for future regulations is raised. The ultimate aim of this paper is to highlight that there is no unified recommendation concerning the type of consent that should be sought among patients interested in biobanking research at present. Accordingly, the review concludes by calling for a specific biobanking research ethics to deal with the meta-ethical questions raised by informed consent appropriately.