Operation and Reflection on Exemption from Ethical Review
10.12026/j.issn.1001-8565.2023.10.11
- VernacularTitle:免除伦理审查的操作与思考
- Author:
Longfang MIAO
1
;
Hua BAI
1
;
Jiyin ZHOU
2
;
Yingshuo HUANG
3
;
Meixia WANG
4
Author Information
1. Office of Research, Peking Union Medical College Hospital, Beijing 100730, China
2. Clinical Medicine Research Center, the Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
3. Office of Research, Beijing Friendship Hospital, Capital Medical University, Beijing 100050, China
4. Phase I Clinical Trial Laboratory, Beijing Jishuitan Hospital, Beijing 100035, China
- Publication Type:Journal Article
- Keywords:
Exemption from Ethical Review;
Subject Protected;
Life Sciences and Medical Research Involving Humans
- From:
Chinese Medical Ethics
2023;36(10):1127-1131
- CountryChina
- Language:Chinese
-
Abstract:
Ethical review is an important protective measure for research participants when conducting life sciences and medical research involving humans. "Exemption from ethical review" was proposed in The Measures for Ethical Review of Human Life Sciences and Medical Research Involving Humans issued in February 2023. To implement the exemption from ethical review within the permitted scope of laws and regulations, and to protect the privacy and rights of research participants when utilizing their data information and biological samples, multiple factors need to be considered, including the person responsible for exemption from ethical review, the conditions for exemption from ethical review, and the specific process for exemption from ethical review. As with other review procedures, exemption from ethical review also required the development of corresponding systems, implementation of responsibilities, and reliance on the construction of subject protection systems. It is hoped that this discussion can provide considerations for the implementation of exemption from ethical review.
