[Governance and measures for the ethical and social aspects of biobanks]

This paper provides an overview of measures regarding the ethical and social aspects of biobanks from the perspective of governance. A Biobanks is a system that manages samples taken from humans along with data of the sample donor(genetic information, information on medical records, information on lifestyle habits, etc.)in a centralized manner according to a set quality standard. In recent years, biobanks have become an essential research infrastructure, especiallyin the field of genome medical research and research concerning common diseases such as cancer and diabetes. Simultaneously, this indicates that biobanks are strongly linked to the realization of benefits that are highly public. For this reason, biobanks need to consider not only the promotion of medical research, but must also practice consideration for the ethical, social, and public aspects. In other words, biobanks need to be subject to governance. In this paper, three specific issues concerning the ethical and social aspects of biobank have been discussed: (i)issues regarding boroad or future consent, (ii)risks related to the handling of samples and data, and (iii) feedback on incidental findings. These are issues that accompany rapid advances in genome medicine and involve complex elements that cannot be completely resolved by the existing principles of life ethics and rules. For this reason, the parties managing biobanks are required to make an effort toward realizing an ethically and socially feasible operation of the biobank, with consideration paid not only to compliance but also to the reaction of research participants and society. Furthermore, there is an urgent need to establish a system of governance that enables organizational management with the wide perspective discussed here.