Exploration of the misunderstandings， challenges， and countermeasures of exemption from ethical review from the perspective of medical and health institutions
10.12026/j.issn.1001-8565.2024.04.05
- VernacularTitle:从医疗卫生机构视角探讨免除伦理审查的误区、挑战与对策
- Author:
Honglei NIAN
1
;
Hui JIANG
2
;
Jihong LI
1
;
Min LIU
1
;
Jiyin ZHOU
3
Author Information
1. Beijing Shijitan Hospital， Capital Medical University， Beijing 100038， China
2. Zhangzhou Municipal Hospital Affiliated to Fujian Medical University， Zhangzhou 363000， China
3. Clinical Medical Research Center， the Second Affiliated Hospital of Army Medical University， Chongqing 400037， China
- Publication Type:Journal Article
- Keywords:
medical institutions;
exemption from ethical review;
ethical review;
board consent
- From:
Chinese Medical Ethics
2024;37(4):408-414
- CountryChina
- Language:Chinese
-
Abstract:
In the implementation of exemption from ethical review， medical institutions equate exemption from ethical review with no ethical review or simple review， misunderstand the scope of exemption from ethical review， confuse the concepts of de-identification and anonymization， and equate privacy with personal information. The implementation faced challenges such as the coordination of conditions for exempt review with other regulations， the lack of clear decision-making subjects for exempting from ethical review， the legality and compliance of using general informed consent for biological samples and information data， as well as non-traceability and the risk of being re-identified of anonymous information for exemption from ethical review. Measures such as improving relevant laws and regulations， perfecting the construction and management of information databases and biological sample libraries， strengthening the project management and process supervision of exemption from ethical review， and implementing scientific review can ensure the legal and compliant implementation of exemption from ethical review by medical and health institutions.
