Reflection and Practice on Exemption from Ethical Review
10.12026/j.issn.1001-8565.2023.10.09
- VernacularTitle:免除伦理审查的思考与实践
- Author:
Yingshuo HUANG
1
;
Xu ZUO
1
;
Yue LI
1
;
Lihan XING
1
;
Shuilong GUO
1
;
Miaorong XIE
2
Author Information
1. Department of Science and Technology, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050, China
2. Ethics Committee, Beijing Friendship Hospital Affiliated to Capital Medical University, Beijing 100050, China
- Publication Type:Journal Article
- Keywords:
Life Science and Medical Research Involving Humans;
Ethic Review;
Exemption from Ethic Review;
Informed Consent;
Anonymization;
Sensitive Information;
Clinical Research
- From:
Chinese Medical Ethics
2023;36(10):1116-1121
- CountryChina
- Language:Chinese
-
Abstract:
According to the Ethical Review Measures for Life Sciences and Medical Research Involving Humans jointly issued by the National Health Commission, the Ministry of Education, the Ministry of Science and Technology and the State Administration of Traditional Chinese Medicine in 2023, to optimize the ethical review process and reduce the burden on clinical researchers, it is proposed that some eligible situations can be "exempted from ethical review". This is a breakthrough progress in China’s ethical review management measures that firstly aimed at "exemption from ethical review". This paper reviewed and sorted out the relevant situations about exemption from review at home and abroad, focused on analyzing and exploring the four situations of exemption from review, especially discussed and analyzed the understanding of anonymization and personal sensitive information in exemption from review, and proposed practical suggestions for the four situations. Based on the actual situation of ethical review work, this paper also explored the establishment of practical standards and processes for exemption from review, providing reference for other medical institutions to implement the exemption from ethical review process.
