Analysis of Key Elements in Informed Consent Forms for Biobanks.

Abstract

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.