Security controls in an integrated Biobank to protect privacy in data sharing: rationale and study design.

BACKGROUND: With the goal of realizing genome-based personalized healthcare, we have developed a biobank that integrates personal health, genome, and omics data along with biospecimens donated by volunteers of 150,000. Such a large-scale of data integration involves obvious risks of privacy violation. The research use of personal genome and health information is a topic of global discussion with regard to the protection of privacy while promoting scientific advancement. The present paper reports on our plans, current attempts, and accomplishments in addressing security problems involved in data sharing to ensure donor privacy while promoting scientific advancement. METHODS: Biospecimens and data have been collected in prospective cohort studies with the comprehensive agreement. The sample size of 150,000 participants was required for multiple researches including genome-wide screening of gene by environment interactions, haplotype phasing, and parametric linkage analysis. RESULTS: We established the T ohoku M edical M egabank (TMM) data sharing policy: a privacy protection rule that requires physical, personnel, and technological safeguards against privacy violation regarding the use and sharing of data. The proposed policy refers to that of NCBI and that of the Sanger Institute. The proposed policy classifies shared data according to the strength of re-identification risks. Local committees organized by TMM evaluate re-identification risk and assign a security category to a dataset. Every dataset is stored in an assigned segment of a supercomputer in accordance with its security category. A security manager should be designated to handle all security problems at individual data use locations. The proposed policy requires closed networks and IP-VPN remote connections. CONCLUSION: The mission of the biobank is to distribute biological resources most productively. This mission motivated us to collect biospecimens and health data and simultaneously analyze genome/omics data in-house. The biobank also has the mission of improving the quality and quantity of the contents of the biobank. This motivated us to request users to share the results of their research as feedback to the biobank. The TMM data sharing policy has tackled every security problem originating with the missions. We believe our current implementation to be the best way to protect privacy in data sharing.

Public Attitudes toward an Epidemiological Study with Genomic Analysis in the Great East Japan Earthquake Disaster Area.

UNLABELLED: Introduction The Great East Japan Earthquake of March 11, 2011 may have influenced the long-term health of those in the disaster area. It is important to collect current and future health information of the people living in the post-disaster area to provide appropriate health support and quality-oriented care. However, public perceptions of health and genomic studies in the Great East Japan Earthquake disaster area are still unknown. METHODS: A questionnaire survey was conducted in one town affected by the Great East Japan Earthquake and subsequent tsunami. The results of the questionnaire were tailed and the differences in responses to each question were assessed by sex and age. RESULTS: In 284 eligible people (137 men, 147 women), almost all participants agreed to join a health survey investigating the adverse effects of the disaster, and over 80% of the total participants agreed to genomic analysis. Over 70% of the participants wanted to receive pharmacogenetic testing and to receive feedback on which medications were suitable or unsuitable for them. CONCLUSIONS: Most people living in the disaster area are interested in health surveys. Most of the participants also showed interest in genomic analysis. Ishikuro M , Nakaya N , Obara T , Sato Y , Metoki H , Kikuya M , Tsuchiya N , Nakamura T , Nagami F , Kuriyama S , Hozawa A , the ToMMo Study Group. Public attitudes toward an epidemiological study with genomic analysis in the Great East Japan Earthquake disaster area. Prehosp Disaster Med. 2016;31(3):330-334.