Introduction to informed consent mode of health data utilization in medical institutions and analysis of key points of selection
10.3760/cma.j.cn113565-20230629-00168
- VernacularTitle:医疗机构健康数据利用知情同意模式介绍及选择要点分析
- Author:
Min JIA
1
;
Xiaoyun CHEN
;
Hao XU
;
Zhixu YANG
;
Xiaoqiang JIA
;
Mingjie ZI
Author Information
1. 中国中医科学院西苑医院医学伦理委员会，北京 100091
- Keywords:
Health data of medical institutions;
Real-world research/study;
Informed consent mode;
Personal privacy;
Intervention research;
Observational study
- From:
Chinese Journal of Medical Science Research Management
2023;36(6):419-426
- CountryChina
- Language:Chinese
-
Abstract:
Objective:With the rapid increase in the number of real world studies, especially the use of health data in medical institutions, ethical issues such as the use of patient health data and the protection of patient′s privacy rights and the right to know have been gradually exposed. To strike a good balance between promoting data sharing and maintaining subjects′ personal privacy, the mode of informed consent appears to be crucial. This paper provided guidance for the selection of informed consent models for real world research health data utilization.Methods:The authors extensively studied the relevant laws and regulations of health data utilization worldwide, conducted extensive searches in Chinese and English databases, sorted out and analyzed various alternative informed consent models, and summarized their characteristics and applications.Results:At present, five alternative informed consent models were used to conduct real world research based on health data utilization. Researchers can choose informed consent models according to the research purpose, research design, research risk, operability of informed consent, and vulnerable groups.Conclusions:Different alternative informed consent models have varied characteristics. Researchers need to choose informed consent models based on the above factors to ensure the maximum protection of patients' privacy rights while using health data.
