泛知情同意的发展现状与思考

Development status and thinking of broad consent

随着大数据时代的来临,泛知情同意这一新的知情模式逐渐走入公众视野。泛知情同意既能保障医学研究中研究参与者的基本权益,又能为医学科研人员采集生物样本或获取医疗数据用于未来研究提供一种获得预先知情同意的方案,但同时也面临着伦理、个人信息保护等方面的挑战。根据国内外泛知情同意发展现状与相关法规,我国泛知情同意在实施过程中应注意信息披露、授权后研究参与者的再联系、医疗数据的共享与个人身份识别信息的保护以及伦理审查等问题。为了更合理地开展泛知情同意,研究者与相关管理部门应不断规范泛知情同意书的撰写、提高社区参与度、加强法律监管等。

With the arrival of big data era, the new informed form of broad consent has gradually come into public view. Broad consent can not only protect the basic rights and interests of subjects in medical research, but also provide a way for medical researchers to collect biological samples or obtain medical data for future research. However, it also faces some challenges, for example ethics and protection of personal information. According to the development status and relevant regulations of broad consent at home and abroad, the issues such as information disclosure, re-contact of research participants after authorization, sharing of medical data, protection of personally identifiable information, and ethical review should be paid attention during the implementation process. To carry out broad consent more reasonably, researchers and relevant management departments should constantly standardize the writing of broad consent, improve community participation, and strengthen legal supervision, etc.