Exploration of the model of broad informed consent in clinical data acquisition in medical institutions
10.13699/j.cnki.1001-6821.2023.23.032
- VernacularTitle:临床数据获取广泛性知情同意在医疗机构实施中的模式探讨
- Author:
Zhao YANG
1
;
Jiu-Xiu LIU
;
Meng-Xian FENG
;
Rong-Hui YU
;
Yu XIANG
Author Information
1. 北京大学第一医院科研处,北京 100034
- Keywords:
broad informed consent;
medical institutions;
clinical data;
implementation path
- From:
The Chinese Journal of Clinical Pharmacology
2023;39(23):3491-3494
- CountryChina
- Language:Chinese
-
Abstract:
Objective To study how to promote the rational use of clinical data and orderly conduct health care Big data research by establishing a broad informed consent system and an effective implementation path.Methods The research methods of Document retrieval and expert interviews were mainly used to formulate management rules and regulations,clarify work processes and department responsibilities of the broad informed consent,and draw up patient informed consent forms.Results and Conclusion Based on the current implementation status of broad informed consent in domestic medical institutions,Peking University First Hospital has identified an effective path for obtaining clinical data in the implementation of broad informed consent in medical institutions,laying a preliminary foundation for the pilot implementation of related work.At the same time,discussions were conducted on the protection of patient rights,policy promotion and interpretation,information system support capabilities,and effective data application after the implementation of the broad informed consent system for clinical data,which will help promote and apply the work of broad informed consent for clinical data acquisition in China.
