Abstract:
The establishment of clinical research resource platforms, including research databases and bio-sample library, is an important development in the field of clinical research. The international academic community proposes broad informed consent to regulate the ethical management of the issue. However, the broad informed consent fails to capture the main features of incomplete informed consent and authorization, misleads researchers and managers and leads to miss ethical management for clinical research projects. Therefore, the author proposes a named partial informed consent to improve ethical management for clinical research projects. Partial informed consent separates ethical management for establishing clinical research resource platforms and clinical research projects. After reviewing the legal and ethical foundation of clinical research ethics management, the author discussed the similarities and differences between project management and task management in the two informed consent solutions, the basis for approval of exempted informed consent signatures by the ethics committee, issues to be noted in the ethics management of multi-center research at the task level, and explained the substantive differences between broad informed consent and partial informed consent.
研究资源平台,包括研究数据库和生物样本库的建立,是临床研究领域的重要进展。国际学术界提出广泛知情同意签字(以下简称泛知情)以规范该类研究的伦理管理。但泛知情解决方案没有体现建立知情告知和同意授权不完整的主要特征,存在误导研究者和管理者,进而可能导致课题研究伦理管理缺位的问题。为此,本文提出部分知情同意授权解决方案,将资源平台建设与课题研究的伦理管理彻底分离,形成两个独立的伦理管理模块,分别纳入临床研究伦理管理框架。在回顾临床研究伦理管理法理基础和伦理基础的前提下,本文分析了项目管理与课题管理的异同、伦理委员会批准豁免知情同意签字的基础、课题层面的多中心研究伦理管理中需要注意的问题,解读了广泛知情同意签字和部分知情同意授权的背后实质内涵及操作层面的差异。.