Banking together : a unified model of informed consent for biobanking

Informed consent models designed to appropriately regulate biobank-based research are characterized by a maze of laws, policies and ethical recommendations. Many physicians, ethicists and policy-makers regard this fragmentation of the regulatory systems as a serious obstacle to biomedical research. The fragmentation in biobanking regulations regarding the use of samples and related data affects prospective research more than retrospective research. We have analyzed the different consent models, including: i) broad consent, ii) partially restricted consent, iii) multi-layered consent and iv) specific informed consent. We describe here the process of drafting and implementing in our academic institution a unified, partially restricted informed consent form, with the goal of maximizing the scientific yield of research projects without sacrificing the rights of the donors.