生物样本库研究泛化知情同意模板的探讨

Study on the Broad Informed Consent Template for Biobank

生物样本库研究涉及生物样本材料以及数据的长期保存,用于将来未特定的研究,因此,如何恰当地向受试者解释生物样本库研究的性质、风险、获益等信息是生物样本库研究面临的一大挑战。通过具体工作实践,参考国内外法规、文献、指南提取了泛化知情同意书的19个条目,内容涉及研究的一般信息、数据和生物材料的处理、风险、获益、退出、结果反馈等方面,并针对每个条目进行了相应内容的描述,期望为生物样本库以及其他大数据研究的知情同意提供参考。

Biobank research involves the long-term preservation of biological sample materials and data for future unspecified research. Therefore, how to properly explain the nature, risks, benefits and other information of biobank research to participants is a major challenge for biobank research.In this paper, 19 items of the broad informed consent template were extracted by referring to domestic and foreign regulations, literature and guidelines, mainly involving general information, data and biomaterials processing, risk, benefit, withdrawal and result feedback.This paper described each item in order to provide reference for broad informed consent of biobank and other big data research.