Research on the establishment of a template of broad informed consent form in Beijing based on the Delphi method
10.12026/j.issn.1001-8565.2025.08.07
- VernacularTitle:基于德尔菲法制定北京地区泛知情同意书模板研究
- Author:
Wenjing XU
1
;
Xueqin WANG
;
Jian YANG
;
Suhua CHANG
;
Siwei SUN
;
Hongqiang SUN
Author Information
1. 北京大学第六医院/北京大学精神卫生研究所/国家卫生健康委员会精神卫生学重点实验室<北京大学>/国家精神心理疾病临床医学研究中心<北京大学第六医院>医学伦理委员会,北京 100191
- Publication Type:Journal Article
- Keywords:
broad informed consent;
biological sample;
health data;
Delphi method
- From:
Chinese Medical Ethics
2025;38(8):1003-1008
- CountryChina
- Language:Chinese
-
Abstract:
Objective:To establish an element framework and template of broad informed consent applicable to clinical research,and to standardize the collection,storage,and reuse of medical data 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 with 13 experts in relevant fields to determine the two-level element framework and template of broad 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 0.85.In the second round of consultation,the average importance value was≥4.4,the coefficient of variation(CV)was<0.17,and Kendall's W was 0.184(P<0.001),indicating that the expert opinions tended to be consistent.Ultimately,an element framework and template of broad informed consent form was established,consisting of 4 first-level items and 21 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.
