Discussion on ethics review approval criteria and review key points of life science and medical research involving humans
10.12026/j.issn.1001-8565.2025.04.04
- VernacularTitle:涉及人的生命科学和医学研究的伦理审查批准标准及审查要点探讨
- Author:
Niu ZHANG
1
;
Haihong ZHANG
2
Author Information
1. Institutional Review Board, the Affiliated Hospital of Nantong University, Nantong 226001, China
2. Peking University Health Science Center, Beijing 100191, China
- Publication Type:Journal Article
- Keywords:
ethics review approval criteria;
scientific value;
social value;
risk control;
informed consent
- From:
Chinese Medical Ethics
2025;38(4):428-433
- CountryChina
- Language:Chinese
-
Abstract:
The ethics review approval criteria are the basis for ethical review committees to make review decisions. A thorough understanding of the requirements of the ethics review approval criteria is a prerequisite for ensuring the quality of ethical reviews. The Measures for the Ethics Review of Life Science and Medical Research Involving Humans made significant adjustments to the ethics review approval criteria, such as new provisions regarding the qualifications of researchers and research institutions, and the release of research results. In combination with the 2024 edition of the Declaration of Helsinki, this paper analyzed the requirements of the Measures for ethics review approval criteria, as well as explored the corresponding ethical principles and corresponding ethical review key points, with a view to providing a reference for standardizing ethics review practice and effectively improving the quality of ethics review.