Thinking from the Perspective of Medical Institutions on Measures for Ethical Review of Life Science and Medical Research Involving Humans
10.12026/j.issn.1001-8565.2023.05.02
- VernacularTitle:从医疗机构视角思考《涉及人的生命科学和医学研究伦理审查办法》
- Author:
Zhonglin CHEN
1
;
Mengjie YANG
2
;
Xumin HOU
1
;
Xuening LI
2
;
Danni DONG
3
;
Yu FENG
1
Author Information
1. Office of Ethics, Shanghai Chest Hospital/Affiliated Chest Hospital of Shanghai Jiao Tong University School of Medicine, Shanghai 200030, China
2. Ethics Committee, Zhongshan Hospital Affiliated to Fudan University, Shanghai 200032, China
3. School of Public Health, Shanghai Jiao Tong University School of Medicine, Shanghai 200025, China
- Publication Type:Journal Article
- Keywords:
Life Science and Medical Research Involving Humans;
Ethics Review;
Ethical Review Committee;
Exemption from Ethics Review
- From:
Chinese Medical Ethics
2023;36(5):482-487
- CountryChina
- Language:Chinese
-
Abstract:
From the perspective of medical institutions, this paper sorted out the background of the promulgation and important changes of Measures for Ethical Review of Life Science and Medical Research Involving Humans, and summarized the changes that may significantly affect the ethical review of medical institutions. It involved terminology changes and expansion of the scope of ethic review, clarification of the responsibilities and independence of the ethics committee, the refinement of the ethical review process, the emphasis on the protection of personal information and the rights and interests of subjects, and first proposal to exempt from ethical review. In addition, based on the concept of strengthening the ethical governance of science and technology in the new version of regulations, this paper shared the consideration on the governance of ethical review within medical institutions, including safeguarding the dignity and rights of subject, clarifying the role and position of ethical review, exempting the implementation of ethical review, and managing entrusted ethical review. With a view to providing a certain reference for the ethics practitioners and researchers in various medical institutions.
