Iwae Sosuke, Masui Tohru
Dept. of Disease Bioresources Research, Office of Policy and Ethics Research, National Institute of Biomedical Innovation.
Gan To Kagaku Ryoho. 2012 Apr;39(4):493-7.
This paper provides an overview of measures regarding the ethical and social aspects of biobanks from the perspective of governance. A Biobanks is a system that manages samples taken from humans along with data of the sample donor(genetic information, information on medical records, information on lifestyle habits, etc.)in a centralized manner according to a set quality standard. In recent years, biobanks have become an essential research infrastructure, especiallyin the field of genome medical research and research concerning common diseases such as cancer and diabetes. Simultaneously, this indicates that biobanks are strongly linked to the realization of benefits that are highly public. For this reason, biobanks need to consider not only the promotion of medical research, but must also practice consideration for the ethical, social, and public aspects. In other words, biobanks need to be subject to governance. In this paper, three specific issues concerning the ethical and social aspects of biobank have been discussed: (i)issues regarding boroad or future consent, (ii)risks related to the handling of samples and data, and (iii) feedback on incidental findings. These are issues that accompany rapid advances in genome medicine and involve complex elements that cannot be completely resolved by the existing principles of life ethics and rules. For this reason, the parties managing biobanks are required to make an effort toward realizing an ethically and socially feasible operation of the biobank, with consideration paid not only to compliance but also to the reaction of research participants and society. Furthermore, there is an urgent need to establish a system of governance that enables organizational management with the wide perspective discussed here.
本文从治理的角度概述了生物样本库在伦理和社会方面的相关措施。生物样本库是一个按照既定质量标准集中管理取自人类的样本以及样本捐赠者的数据（基因信息、病历信息、生活习惯信息等）的系统。近年来，生物样本库已成为重要的研究基础设施，尤其是在基因组医学研究以及癌症和糖尿病等常见疾病研究领域。同时，这也表明生物样本库与高度公共利益的实现紧密相关。因此，生物样本库不仅要考虑促进医学研究，还必须兼顾伦理、社会和公共方面。换句话说，生物样本库需要接受治理。本文讨论了生物样本库伦理和社会方面的三个具体问题：（i）宽泛或未来同意的问题，（ii）样本和数据处理相关的风险，以及（iii）偶发发现的反馈。这些是随着基因组医学的快速发展而出现的问题，涉及现有生命伦理原则和规则无法完全解决的复杂因素。因此，管理生物样本库的各方需要努力实现生物样本库在伦理和社会层面可行的运作，不仅要考虑合规性，还要考虑研究参与者和社会的反应。此外，迫切需要建立一个治理体系，以便能从这里所讨论的广泛视角进行组织管理。
