Guidelines for Ethical Review Project Entrustment of Life Science and Medical Research Involving Humans
10.12026/j.issn.1001-8565.2023.05.03
- VernacularTitle:涉及人的生命科学和医学研究项目委托伦理审查指引
- Author:
Jiyin ZHOU
1
;
Aijuan SHENG
2
;
Qiang LIU
3
;
Hui JIANG
4
;
Meixia WANG
5
;
Hua BAI
6
;
Yifeng JIANG
7
;
Lei XU
8
;
Dan LIU
1
;
Ningning XIONG
9
Author Information
1. Center for Clinical Medical Research, the Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
2. Office of Ethics, Beijing You’an Hospital Affiliated to Capital Medical University, Beijing 100069, China
3. Center for Evaluation, World Federation of Chinese Medicine Societies, Beijing 100101, China
4. Department of Science and Education, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou 363000, China
5. Office of National Drug Clinical Trial Institution, Beijing Jishuitan Hospital, Beijing 100034, China
6. Office of Scientific Research, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Beijing 100073, China
7. Office of Ethics, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200080, China
8. Office of Ethics, the First Affiliated Hospital of Dalian Medical University, Dalian 116000, China
9. Ethics Committee, Jiangsu Provincial Hospital of Chinese Medicine, Nanjing 210029, China
- Publication Type:Journal Article
- Keywords:
Life Science and Medical Research Involving Humans;
Ethical Review;
Entrust;
Guideline
- From:
Chinese Medical Ethics
2023;36(5):488-491
- CountryChina
- Language:Chinese
-
Abstract:
The seventh article of Measures for the Ethical Review of Biomedical Research Involving Humans (2016) stipulated that medical and health institutions without an ethics committee shall not carry out biomedical research involving Humans. The Opinions on Strengthening the Governance of Ethics in Science and Technology, issued in March 2022, clearly stated that the institutions that do not meet the conditions for establishing a scientific and technological ethics (review) committee should entrust other institutions to conduct the review. The fourteenth article of Measures for Ethical Review of Life Science and Medical Research Involving Humans (2023) proposes that if an institution, which carries out life science and medical research involving humans, has not established an ethics committee or its ethics committee is not competent for ethics review, it can entrust a competent ethics committee or regional ethics committee in writing to carry out ethical review. Most medical institutions at or above the second level in China have set up ethics committees. While most universities and colleges, scientific research institutions, enterprises and grass-roots medical and health institutions have not set up ethics committees, which lack a working system to protect the safety and interests of the participants, and is difficult to conduct life sciences and medical research involving humans. At present, there is a need for some research institutions that do not have the conditions to establish ethics committees to entrust their projects of life science and medical research involving humans to other institutions for ethical review. The entrusted review is still in the exploratory stage, and there is no relevant specification. The hasty implementation of entrusted review may not achieve the goal of effectively protecting the safety and interests of the participants, and even cause legal disputes. Based on the thematic discussion, with reference to the relevant laws and regulations, departmental rules, ethical standards, and the experience of the ethics committees of some domestic institutions in implementing the entrusted review, the guideline was formulated for the reference of the current entrusted review to ensure the safety and interests of the participants.
