Ethical issues of returning participants' individual genomic data in medical research

2015 Fiscal Year Final Research Report

• Project/Area Number: 26882012
• Research Category: Grant-in-Aid for Research Activity Start-up
• Allocation Type: Single-year Grants
• Research Field: Sociology/History of science and technology
• Research Institution: The University of Tokyo
• Principal Investigator: Takashima Kyoko 東京大学, 医科学研究所, 特任研究員 (10735749)
• Project Period (FY): 2014-08-29 – 2016-03-31
• Keywords: 研究倫理 / ELSI / 研究結果の開示 / ゲノム情報の開示 / ゲノム研究 / Whole genome sequencing / 家族

Outline of Final Research Achievements

The goal of this study project was to suggest an appropriate model for offering individual genomic results or incidental/secondary findings to research participants in genomic research including whole genome sequencing (WGS). To achieve this goal, literature research and case analysis of national and international genomic research or biobanks were conducted. As a result, currently researchers do not have an active duty to offer individual genomic results unless informed consent documents indicated it would be offered, because it is difficult to confirm analytical validity, evaluate clinical utility, and make genetic counseling and adequate follow-up care available in the research context. However, researchers should be responsible for continuing to discuss the best way for not only research participants but also their families as genome sequencing technology is advanced more.

Free Research Field

生命・医療倫理学、研究倫理、公衆衛生学