《生命科学》 2025, 37(11): 1439-1444

生物样本库泛知情同意的规范化路径研究

张露远 , 邓志勇 , 张志琴 , 金安琪 , 姜明珠^*

昆山市第一人民医院，昆山 215300

摘　要：

随着生物样本库在医学研究中的应用日益广泛，如何在促进科学研究与保护参与者权益之间寻求平衡，已成为亟待解决的关键问题。作者研究团队认为泛知情同意(broad consent) 作为一种新知情同意机制，为解决这一矛盾提供了可能路径。本文基于文献研究方法，系统探讨了泛知情同意在中国生物样本库管理中的应用现状。研究发现，我国现有法律框架对泛知情同意的规制存在模糊性，实践中面临伦理审查标准不统一、参与者认知不足等挑战。通过分析某三甲医院的实践经验，本文提出了双轨制知情同意体系、分级撤回管理等创新性解决方案。研究认为，完善泛知情同意制度需要从完善立法、伦理审查、信息平台建设和公众教育等多个维度协同推进。

通讯作者：姜明珠 , Email:275965966@qq.com

Standardized pathway research on broad consent in biobanks

ZHANG Lu-Yuan , DENG Zhi-Yong , ZHANG Zhi-Qin , JIN An-Qi , JIANG Ming-Zhu^*

The First People's Hospital of Kunshan, Kunshan 215300, China

Abstract:

With the increasingly widespread application of biobanks in medical research, how to strike a balance between promoting scientific research and protecting participants' rights has become a critical issue that urgently needs to be addressed. Broad consent, as a novel consent mechanism, is proposed as a viable approach to addressing this tension. Using a literature-based approach, we systematically explore the current application status of broad consent in biobank management in China. We find that China's existing legal framework exhibits ambiguity in regulating broad consent, and faces challenges in practice such as inconsistent ethical review standards and insufficient participant awareness. Through analyzing the practical experience of a tertiary hospital, we proposeinnovative solutions including a dual-track informed consent system and hierarchical withdrawal management. The research concludes that improving the broad consent system requires coordinated advancement across multiple dimensions including legislative improvement, ethical review, information  platform construction, and public education.

Communication Author：JIANG Ming-Zhu , Email:275965966@qq.com