大数据时代知情同意原则的困境与出路――以生物资料库的个人信息保护为例

知情同意原则根植于自主价值，是个人信息保护之基石。在大数据时代，知情同意原则陷入困境之中，海量信息的批量处理、多方共享、目的不特定之频繁利用加大了有效同意获取的难度，同意作为个人信息处理正当性基础之地位受到质疑。生物资料库是管窥知情同意原则困境与解困之路的最佳范例，围绕使用库存样本是否需重新获得同意，存在特别同意与概括同意之争，各种折中改良方案继而被提出。革新而非放弃知情同意原则，是应对大数据挑战的应然立场。知情同意原则之重塑，应坚持以自主为核心价值，以保护与利用的平衡为理念，巧妙设计适应大数据需求的新型知情同意模式。应从整齐划一的同意向基于信息分类、场景化风险评估的分层同意转变，从一次性同意向持续的信息披露与动态同意转变，容许有条件的宽泛同意＋退出权模式。
The principle of informed consent is rooted in autonomy, and acts as the cornerstone of individual data protection in the information age. It is in a crisis under the background of big data era. The mass processing and sharing of information make it difficult to get effective consent. It is even challenged that whether consent is the legitimate foundation for personal information processing. The bio-bank is the best example to rethink the crisis of informed consent principle and the solution. The arguments focus on whether re-consent is necessary for uses of stored samples. There is a serious conflict between specific consent and broad consent. Many new ideas are put forward to reform the informed consent. The correct standpoint for facing the challenges of big data times is reforming but not abandoning the principle. Autonomy should be enshrined as the supreme value when reshaping informed consent. New consent model should be designed to adapt to big data era,balancing protection and utilization well. The uniformed consent should be replaced by diversified and tiered consent. On-going mechanism of information disclosure and dynamic consent should be set up. Broad consent should be adopted with certain limitations,and the right to opt out should be ensured.？？