基于法规指南探讨生物样本库建库伦理审查要素  

Study on Ethical Review Elements of Biobank Construction Based on Regulations and Guidelines

作　　者：吴翠云[1] 伍蓉[1] 曹国英[1] 邹和建[1] WU Cuiyun;WU Rong;CAO Guoying;ZOU Hejian(Ethics Review Committee,Huashan Hospital,Fudan University,Shanghai 200040,China)

机构地区：[1]复旦大学附属华山医院伦理审查委员会,上海200040

出　　处：《中国医学伦理学》2020年第5期570-574,共5页Chinese Medical Ethics

基　　金：上海市卫生健康委员会课题“医院人类遗传资源管理模式探讨”(201940026)。

摘　　要：与药物/器械临床试验相比,目前我国的伦理审查相关法规指南中鲜有涉及生物样本库的伦理审查相关内容,此外虽然关于伦理委员会建设和伦理审查的国际指南文件较多,但也少有涉及生物样本库伦理审查内容,仅两个国际指南文件有较为明确的规定:一是国际医学科学理事会2016年更新的《涉及人的健康相关研究国际伦理指南》,当中第11章节“生物材料及相关数据的采集、存储和使用”和第12章节“健康相关研究数据的采集、存储和利用”主要讲解了生物样本/数据储存、管理和使用的相关内容,对样本入库知情同意的方式、知情同意书要素,样本库管理、样本出库使用的伦理问题等提出了要求,在一定程度上为生物样本库建设提供了管理和伦理审查依据;二是国际生物和环境样本库协会(ISBER)2018最新版《生物样本库最佳实践》中的“生物样本的法律和伦理章节”也包含部分生物样本伦理审查相关内容。通过查阅文献、研习国际国内伦理审查法规指南和专家访谈等方式,重点围绕国际指南中有关生物样本库伦理审查相关要求,结合我国的伦理审查法规指南要求,围绕生物样本库的治理系统、生物样本/数据入库的知情同意、豁免知情同意的条件、知情同意的撤回规定、样本信息的隐私和保密、使用样本/信息后研究结果的反馈几个方面,探讨分析生物样本库建库伦理审查管理要求和审查基本要素,包括伦理委员会制度建设、生物样本库伦理审查范围、生物样本库建库方案的审查、生物样本库知情同意的审查、生物样本信息的隐私和保密措施审查,以及结合国家最新的《人类遗传资源管理条例》规定,针对人类遗传资源的保护问题进行讨论和建议,期望为生物样本库建库伦理审查提供参考依据。Compared with drug/device clinical trials,there are few relevant contents related to ethical review of biobank in the current ethical review related regulatory guidelines in China.In addition,there are many international guidelines on the construction of ethics committees and ethical reviews,but few of them involve the content of ethical review of biobank.Only two international guidelines have relatively clear provisions.One is the International Ethical Guidelines for Health-Related Research Involving Humans,which is updated in 2016 by the Council for International Organizations of Medical Sciences(CIOMS).Among them,in Chapter 11 Collection,Storage,and Use of Biological Materials and Related Data and Chapter 12 Collection,Storage,and Use of Health-Related Research Data,the main topics of biological sample/data storage,management and use are explained.Requirements are put forward on the way of informed consent for sample warehousing,the elements of informed consent,the management of sample database,and the ethical issues of sample outbound use,etc.,which provides management and ethical review basis for the construction of the biobank in a certain extent.The second is that the Legal and Ethical Section of Biological Samples in the latest edition of Best Practices in Biological Sample Banks,which updated by the International Society for Biological and Environmental Repositories(ISBER)in 2018,also contains some content related to ethical review of biological samples.The research team is mainly through the literature,the study guide ethical review of international and domestic regulations and expert interview,focus on international guidelines in the biobank ethical review requirements and combining guide our ethical review laws and regulations,surrounding the biological sample library management system,biological samples/data warehousing informed consent,waiver of informed consent,withdraw the regulation of informed consent,the condition of sample information privacy and confidentiality,the results after using samples

关 键 词：生物样本库 伦理审查 知情同意 法规 人类遗传资源 

分 类 号：R-052[医药卫生]