Discussion on Ethical Review Elements of Clinical Research Regarding Artificial Intelligence Medical Devices
10.12026/j.issn.1001-8565.2022.12.11
- VernacularTitle:人工智能医疗器械临床研究伦理审查要素研究
- Author:
Wenqian GENG
1
;
Wan ZHU
1
;
Lei MA
1
Author Information
1. Scientific Research Department, Shanghai General Hospital, Shanghai 200080, China
- Publication Type:Journal Article
- Keywords:
Artificial Intelligence Medical Devices;
Clinical Research;
Ethical Review;
Subjects
- From:
Chinese Medical Ethics
2022;35(12):1352-1356
- CountryChina
- Language:Chinese
-
Abstract:
Clinical research of artificial intelligence (AI) medical devices is one of the most important links in the process of AI medical devices product development. This paper discusses the key elements of the ethical review of clinical research of artificial intelligence medical devices and the four aspects including strengthening the legislative construction and supervision, strengthening the capacity building of the ethics committee, improving the ethical review system and system construction, expanding platform construction and strengthening regional linkage that can improve the quality of ethical review in the future, protect the safety of subjects, and ensure the efficiency and quality of clinical research.
