Ethical Issues and Ethical Review of Human Genetic Resource Management in Real-world Studies
10.12026/j.issn.1001-8565.2022.12.09
- VernacularTitle:真实世界研究中人类遗传资源管理的伦理问题及其伦理审查
- Author:
Lihan XING
1
;
Yingshuo HUANG
1
;
Yan CUI
2
;
Yue LI
1
;
Xu ZUO
1
;
Shuilong GUO
1
Author Information
1. Office of Science and Technology, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
2. Office of Clinical Drug Trial Institution, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
- Publication Type:Journal Article
- Keywords:
Real-world Study;
Ethical Review;
Human Genetic Resource Management;
Ethical Issues
- From:
Chinese Medical Ethics
2022;35(12):1341-1345
- CountryChina
- Language:Chinese
-
Abstract:
Human genetic resources are an important strategic resource for the development of science and technology in China. In order to fully utilize and effectively protect human genetic resources in real-world studies, through analyzing the status and characteristics of real-world studies, this study found that the number of real-world studies was increasing year by year, and with some characteristics, such as many uncontrollable factors, strict requirements for evidence formation, and easy information acquisition and disclosure. Combined with the characteristics of real-world studies, the ethical issues of human genetic resource management in real-world studies were summarized into three aspects, including scientific and value of research development, informed consent and privacy protection of subjects, and fairness and justice in benefit sharing. Accordingly, the key points of ethical review were proposed as scientific rationality, fully informed consent and privacy, as well as data security and stakeholders. In addition, it is necessary to give full play to the role of ethical review in research access and process supervision responsibilities, guide researchers to make full use of human genetic resources by strengthening training and process management, and further promote the standardization of real-world studies.
