Guidelines for Ethical Review Entrustment Contract of Life Science and Medical Research Involving Humans
10.12026/j.issn.1001-8565.2023.05.04
- VernacularTitle:涉及人的生命科学和医学研究伦理审查委托合同指引
- Author:
Aijuan SHENG
1
;
Meixia WANG
2
;
Qiang LIU
3
;
Zhongguang YU
4
;
Hu CHEN
5
;
Hui JIANG
6
;
Jiyin ZHOU
7
;
Xiaoqi WANG
1
;
Haibin YU
1
;
Mingjie ZI
8
;
Yifeng JIANG
9
;
Lei XU
10
;
Tao SHI
11
;
Guizhen SUN
1
;
Dongxiang ZHENG
1
Author Information
1. Ethical Review Committee, Beijing You’an Hospital Affiliated to Capital Medical University, Beijing 100069, China
2. Institution of Clinical Trial, Beijing Jishuitan Hospital, Beijing 100035, China
3. Center for Evaluation, World Federation of Chinese Medicine Societies, Beijing 100101, China
4. Center for Respiratory, China-Japan Friendship Hospital, Beijing 100029, China
5. Office of Scientific Research, Cangzhou Central Hospital, Cangzhou 061001, China
6. Department of Science and Education, Zhangzhou Affiliated Hospital of Fujian Medical University, Zhangzhou 363000, China
7. Institution of National Drug Clinical Trial, the Second Affiliated Hospital of Army Medical University, Chongqing 400037, China
8. Xiyuan Hospital, China Academy of Chinese Medical Sciences, Beijing 100091, China
9. Office of Ethics, Shanghai General Hospital Affiliated to Shanghai Jiao Tong University, Shanghai 200080, China
10. Office of Ethics, the First Affiliated Hospital of Dalian Medical University, Dalian 116000, China
11. Ethical Review Committee, the Second People’s Hospital of Shenzhen, Shenzhen 518025, China
- Publication Type:Journal Article
- Keywords:
Life Science and Medical Research Involving Human;
Entrustment Ethical Review;
Ethical (Review) Committee;
Entrustment Contract;
Principal;
Trustee;
Research Participants
- From:
Chinese Medical Ethics
2023;36(5):492-498
- CountryChina
- Language:Chinese
-
Abstract:
The passing of ethical review is a necessary conditions and prerequisite for the development of life science and medical research involving humans. At present, some medical and health institutions have no or insufficient ethical review capabilities. The lack of ethical review ability has become a bottleneck restricting the development of life science and medical research involving humans. According to documents such as Opinions on Deepening the Reform of the Review and Approval System and Encouraging the Innovation of Pharmaceutical and Medical Devices, Opinions on Strengthening the Ethical Governance of Science and Technology, institutions can entrust competent institutional ethics review committees or regional ethics review committees in writing to conduct ethical review. Entrustment ethical review provides a viable solution for institutions that need to carry out life science and medical research involving humans but do not have an ethics (review) committee or the ethics (review) committee is not competent to review. To conduct the entrustment ethical review, the entrustment between the principal and the trustee is required. According to The Measures for Ethical Review of Life Sciences and Medical Research Involving Humans, if medical and health institutions and their ethical review committees do not accept the formal entrustment to provide the ethical review opinions for other institutions, the local health authorities at or above the county level will impose administrative penalties and sanctions on the relevant institutions and personnel in accordance with the law. Signing the entrustment ethical review contract, implementing legal compliance entrusted ethical review to protect the rights and interests of the trustee and the principal, and protect the research participants.
