Issues Concerning Clinical Research Using Human Pathologic Bioresources in the Biobank Era

Biobanks storing human pathologic resources have recently emerged as critical research platforms throughout the world for the discovery of biomarkers. Pathologists have not yet established policy consensus, regulations, or informed consent (IC) guidelines for the clinical use of archival pathologic resources. Obtaining broad consent from donors for biobanks in Japan is based on the expression of passive consent to use the remaining resources after pathologic diagnosis. However, genetic and proteomic studies using pathologic formaldehyde-fixed paraffin-embedded blocks (FFPE) have been developed recently and IC for the use of FFPE has become critical. In the current paper, we reviewed the Japanese guidelines for the use of human resources and discuss medical ethics criteria pertaining to IC for the use of FFPE and other formats when IC is not possible because of difficulties in contacting relatives of deceased donors. We propose the use of archival FFPE could be possible after providing official notification of its general use for clinical studies through a webpage or other information technology platform. Furthermore, we also suggest that access to samples over a sufficient term, i.e., greater than several years, is necessary. In conclusion, it is important to establish a common consent form for these institutions.

Abbreviation: MEXT: the Japanese Ministry of Education, Culture, Sports, Science and Technology; MHLW: the Japanese
Ministry of Health, Labor and Welfare.