カストディアンシップとバイオバンク ―人由来試料・情報の第三者提供の新たな枠組みの提案―

抄録

Biobanks have been established in many countries worldwide for a couple of decades. The main research ethics issues related to biobanks that have been discussed include consent for biobanks; human biological sample, data transfer agreements, and their provisions; the absence of laws or regulations on biobanks, especially in Japan; and the sustainability of biobanks. To address these issues, we propose that the notion of custodianship, which has been discussed in Europe and the United States, is imperative and are of the opinion that this notion is intertwined with public trust related to handling human biological samples and data in biobanks. Given the concept of custodianship, we examined the traditional dichotomy of the provision of samples and data in biobanks in Japan: provision via joint research agreements and provision via samples or data transfer agreements (MTA or DTA). Consequently, we developed a new framework for the provision of biospecimens and data in biobanks, which is based on the notion of custodianship. Finally, we also noted the possibility that this Custodianship Model for biobanks can work in conjunction with the Charitable Trust model, which may provide a rationale for charging actual costs for provision by biobanks.