ABSTRACT
This chapter presents the regulatory framework for human biobanks in Japan as it has been set out in two recent sets of guidelines; the Fundamental Principles of Research on the Human Genome (issued in June 2000) and the Ethical Guidelines for Analytical Research on the Human Genome/Genes (issued on 29 March 2001 and subsequently revised in full on 28 December 2004 and revised in part on 29 June 2005). Where appropriate, these guidelines are compared and contrasted with the UK Biobank project’s Ethics and Governance Framework, and points of convergence and significant differences between the Japanese and British approaches are highlighted. An attempt has been made to discuss the main streams of thought in the Japanese academic literature and to draw out possible weaknesses or areas of uncertainty within the Japanese approach, as well as its strengths. Whilst every effort has been made to ensure the accuracy of Japanese-English translations, the author accepts full responsibility for any changes in nuance which may have occurred. The chapter provides an update to the author’s 2004 paper ‘The Regulation of Human Genetic Databases in Japan’.1
