渡部 麻衣子

This paper introduces methods used to communicate with participants in the 'Biobank Japan Project (BBJP)', which is a disease-focused biobanking project. The methods and their implications are discussed in the context of the ethical conduct of the biobanking project. Informed consent, which ensures the autonomous decisions of participants, is believed to be practically impossible for the biobanking project in general. Consequently, the concept of 'trust', which is 'judgement and action in conditions of less than perfect information', has been suggested to compensate for this limitation. As a means to maintain the trust participants feel for the project, this paper proposes communication with participants after receiving their consent. After describing the limitations of informed consent within the BBJP, based on a survey we conducted, we introduce our attempts to communicate with participants, discussing their implications as a means to compensate for the limitations of informed consent at the biobanking project. Journal of Human Genetics (2011) 56, 358-363; doi: 10.1038/jhg.2011.19; published online 10 March 2011

As one of the countries that have invested greatly in the field of bioscience, Japan is facing difficulties introducing human genetic research to the market. A key issue is how to regulate the quality of genetic testing. Since genetic testing is a part of clinical laboratory tests, the regulatory framework for these tests should cover the regulation of genetic testing. Nevertheless, the quality of clinical laboratory tests has been regulated largely by the authority of medical professionals. The fact that genetic testing can be provided without supervision of medical professionals reveals the necessity for the regulation of quality of genetic testing. While medical geneticists have publicly criticized direct-to-consumer (DTC) genetic testing, a group of industries related to DTC genetic testing have established self-regulatory guidelines on the quality control of genetic analysis, based on the OECD guidelines. This article describes the regulatory framework for clinical laboratory tests including genetic tests, and the gaps in regulation, which are particularly highlighted by the appearance of DTC genetic testing. Furthermore the current initiatives taken by different organizations, especially the self-regulatory initiatives by related industries, will be discussed. To conclude the article, recommendations to improve the situation will be made. Copyright (C) 2009 S. Karger AG, Basel

本稿では、全国社会意識調査(N=3402)から、エンハンスメント論の中でも特に主題となることの多い、「体力や身体能力」「頭のよさ(知能)」「老化」の各カテゴリーに対する日々の日常的関心度および遺伝学的エンハンスメント(Genetic Enhancement)に対する意識の度合いを従属変数とし、基礎属性・家族変数、及び遺伝意識変数(遺伝子決定感)の因子分析結果を独立変数とする二項ロジットモデル(比較モデル)を組み立て、遺伝子技術利用のエンハンスメント領域への活用に対する意識の特性を析出した。結果、日常的関心度には性別・年齢・学歴がその意識の形成・規定要因として大きく寄与していた一方で、遺伝学的エンハンスメントには、性別および就業形態の影響が高いという意識の構造的差異が析出された。また、遺伝学的エンハンスメントに対しては、遺伝子決定感に関する「身体・外面性因子(第一因子)」および「医療因子(第四因子)」がその意識の形成・規定要因として寄与している、という、遺伝子決定感内部での効果の差異が明らかになった。