Research Information System
in: Precision Medicine Tools and Quantitative Approaches, Hans-Peter Deigner,Matthias Kohl, Editor, Academic Press , Oxford, pp.57-77, 2018
Biobanking is a recent field where human biospecimens and related personal and clinical data are collected and stored for long-term use in biomedical research. The governance models for biobanking research need to involve all stakeholders and must be organized in both ethics and legal aspects and quality management systems. Today, biobanking is moving toward a global scale, and harmonization of all governance steps must be well defined to ensure that a larger research community can benefit from shared materials of high standards. Main ethical issues involved are mostly around protection of donor privacy, informed consent where individual autonomy must be exercised should be a norm, and use of harmonized consent model can facilitate international networking. Quality management of biobanks assures high quality and security of biosamples and associated data; this further fosters public trust and utility of sample collections. This chapter summarizes current governance structures and challenges for international harmonization of biobanks.