Liu Min, Hu Qingli
Shanghai Clinical Research Center Independent Ethics Committee in Shanghai Clinical Research Center, International Bioethics Committee, UNESCO.
Bioethics. 2014 May;28(4):181-6. doi: 10.1111/j.1467-8519.2012.01985.x. Epub 2012 Jul 5.
Biobanks are potential goldmines for genomics research. They have become increasingly common as a means to determine the relationship between lifestyle, environmental exposures and predisposition to genetic disease. More and more countries are developing massive national scale biobanks, including Iceland, the UK and Estonia. Now several large-scale regional and national biobanks are planned in China, such as Shanghai Biobank, which is defined as a key-element in Shanghai's twelfth five-year Development Plan of Science and Technology. It is imperative that the authors who are in charge of the ethical aspect of Shanghai Biobank discuss the ethical aspects of these biobanks up front. Currently there is a great deal of heterogeneity in the approaches to informed consent taken by different countries. In the article, after briefly introducing the biobanks in China, we focus on the three most common approaches: classical informed consent, tiered consent, and one-time general (or blanket) consent, and propose a version of the latter for China, based on compelling arguments.
生物样本库是基因组学研究的潜在宝库。作为确定生活方式、环境暴露与遗传疾病易感性之间关系的一种手段，它们已变得越来越普遍。越来越多的国家正在建设大规模的国家级生物样本库，包括冰岛、英国和爱沙尼亚。目前中国也在规划几个大规模的区域和国家级生物样本库，比如上海生物样本库，它被定义为上海“十二五”科技发展规划的一个关键要素。负责上海生物样本库伦理方面的作者必须预先讨论这些生物样本库的伦理问题。目前不同国家在知情同意的方式上存在很大差异。在本文中，在简要介绍中国的生物样本库之后，我们将重点关注三种最常见的方式：经典知情同意、分层同意和一次性通用（或全面）同意，并基于令人信服的论据为中国提出一个后者的版本。
