Analysis of Key Elements in Informed Consent Forms for Biobanks.

内容摘要

With the rapid development of biomedical research in China,biobanks have been widely established as crucial infrastructure supporting precision medicine and big data research.However,at the practical level,informed consent-central to safeguarding the rights and interests of research participants-often shows a disconnection between ethical principles and technological realities.This study first examines the Chinese translation of the term "biobank", arguing that "biological sample data bank" better reflects both the data-centric nature and governance complexity of such entities.It then systematically reviews the ethical debates surrounding various models of informed consent,including blanket consent,broad consent,dynamic consent,and meta-consent.Building on this analysis,this paper identifies key ethical elements that an effective informed consent form should include.Special attention is paid to the legitimacy and practical challenges of components such as research purpose,data collection,data use,storage duration,risk disclosure,and return of results.This study aims to provide an ethical foundation and practical guidance for improving the informed consent framework in China's biobank governance,thereby promoting a shift from mere regulatory compliance to robust ethical engagement and fostering a virtuous cycle between public trust and sustainable research development. 随着中国生物医学研究的快速发展,生物样本数据库(Biobank)广泛建立,成为支持精准医学与大数据研究的重要基础设施。然而,在实践层面,知情同意作为保障研究参与者权益的核心机制,其内容设计在伦理理念与技术现实之间存在一些脱节。本文首先对“Biobank”概念的中文译名进行辨析,提出“生物样本数据库”更能体现其数据性与治理复杂性。继而系统梳理不同知情同意模式,包括一揽子知情、广泛知情、动态知情、元知情之间的伦理分歧,并在此基础上归纳出一份有效知情同意书应当包含的关键伦理要素,重点分析研究目的、数据采集、数据使用、储存时间、风险告知与结果反馈等维度的正当性与实践困境。本文旨在为中国生物样本数据库知情同意制度的完善提供伦理依据和实践参考,促进科研治理从合规导向走向伦理充分,实现公众信任与科研可持续性的良性互动。.