Abstract
Human biospecimens with detailed clinical information is critical for drug discovery research, in order to augment advanced medical care. To obtain reliable results, it is advisable to use the human biospecimens centrally-stored by biobank. Establishment of biobank is increasingly becoming popular year by year in Japan. Although the preservation of the human biospecimens is actively performed, they are rarely utilized effectively in research. It is necessary to examine about the contents of the informed consent (IC), intellectual property rights of the research products, and the quality of the samples in order to construct delivery systems for human biospecimens. The Tsukuba Human Tissue Biobank Center (THB) was established at the University of Tsukuba Hospital in November 2013. THB accepts applications of providing samples with clinical data from researchers from industry and/or academia, and provides the samples after the research applications has been approved by ethical review committee in the University of Tsukuba Hospital. The document containing detailed information about THB obtaining IC from the patients is comprehensive. The ethical guidelines for medical research using of human biospecimens such as ethical guidelines for human genome/gene analysis research and ethical guidelines for medical and health research involving human subjects have recently been amended. The restrictions on the use of human biospecimens for medical research are less strict than they were earlier. Thus, biobanks are now easy to access. We hope that our approach for biobank would trigger development in the field of drug discovery.
