Discussion on whether ethics committee should serve as the review subject of compassionate drug use
10.12026/j.issn.1001-8565.2024.02.16
- VernacularTitle:关于伦理委员会是否应作为同情用药审查主体的探讨
- Author:
Xi GENG
1
;
Cuifeng GU
;
Junjian MA
Author Information
1. 上海中医药大学附属曙光医院伦理委员会办公室,上海 201203
- Keywords:
compassionate drug use;
ethics committee;
ethical review;
kisk-benefit katio
- From:
Chinese Medical Ethics
2024;37(2):214-218
- CountryChina
- Language:Chinese
-
Abstract:
Under the premise that the relevant laws and regulations in China do not specify the review subject of compassionate drug use,it is controversial who should bear the responsibility for the review and approval.This paper summarized and elaborated on the characteristics of compassionate drug use,and discussed the responsibilities,professionalism,and necessity of review of the ethics committee.It is believed that the ethics committee should serve as the review subject of compassionate drug use,and focus on doctor qualifications,risk-benefit ratio,informed consent forms,and conflicts of interest.
