基于德尔菲法制定北京地区泛知情同意书模板研究

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[关键词]泛知情同意；生物样本；康数据；德尔菲法

[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）08-1003-06

DOI：10.12026/j.issn.1001-8565.2025.08.07

Research on the establishment of a template of broad informed consent form in Beijing basedontheDelphi method

XU Wenjing1，WANG Xueqin1， YANG Jian²，CHANG Suhua1， SUN Siwei1 ，SUN Hongqiangl （1.Medical Ethics Commitee，Peking University Sixth Hospital/ Institute ofMental Health，Peking

University/National Health Commission Key LaboratoryofMental Health /National

Clinical Research Center for Mental Disorders（Peking University Sixth Hospital），Beijing 1Ool91，China; 2.School ofPublic Health，Peking University，Beijing lOol91，China）

Abstract： Objective：To establish an element framework and template of broad informed consent applicable to clinical research，and to standardize thecollction，storage，and reuseof medicaldata and biological samples， making them comply with ethical and legal requirements.Methods：A literature review and group discussion were employed to construct the draft of the element framework and template of broad informed consent form.The Delphi expert consultation method was used to conduct two rounds of correspondence with13 experts in relevant fields to determine the two-level element framework and template ofbroad informed consent form.Results：The response rates for the two rounds of expert consultation questionnaires were above 90% ，the experts’positive coefficients were good，and the coefficients of authority （ Cr） ） were higher than O.85. In the second round of consultation， the average importance value was ⩾4.4 ，the coefficient of variation（CV）was <0.17 ，and Kendall'sW was 0.184（ P<0.001 ，indicating that the expert opinions tended to be consistent.Ultimately，an elementframework and templateof broad informed consent form was established，consisting of 4 first-level items and 2l second-level items.Conclusion：The constructed element framework and template of broad informed consent form is highly scientific and applicable，providing references for clinical research.

Keywords： broad informed consent;biological sample；health data;Delphi method

0背景

随着生物样本库、医疗大数据研究的发展，信息共享和数据再利用的伦理问题凸显。（剩余6668字）