Current situation of the protection of participants'rights and interests in international Phase Ⅰ clinical trials and its enlightenment to China
10.12026/j.issn.1001-8565.2025.08.04
- VernacularTitle:国际Ⅰ期临床试验参与者权益保护现状及对中国的启示
- Author:
Hao YANG
1
;
Mei YIN
1
Author Information
1. 哈尔滨医科大学人文社会科学学院,黑龙江 哈尔滨 150081
- Publication Type:Journal Article
- Keywords:
Phase Ⅰ clinical trial;
trial participant;
protection of rights and interests;
informed consent;
ethical review
- From:
Chinese Medical Ethics
2025;38(8):981-988
- CountryChina
- Language:Chinese
-
Abstract:
By analyzing the problems found in the Phase I clinical trials stage in the United Kingdom,the United States,Japan,and other countries internationally and their countermeasures,based on the rights and interests of trial participants such as the right to respect for autonomy,life and health,personal privacy,and informed consent,as well as combining with the current research situation at home and abroad and drawing on international experience,this paper considered feasible methods to the protection of participants'rights and interests in Phase I clinical trials in China.These rights and interests involve multiple aspects,and each factor is related to and constrained by each other.More importantly,it is essential to improve the relevant systems and laws and introduce appropriate medical policies,which can not only promote the development of China's medical and healthcare industry but also pay attention to the ethical and moral issues existing in clinical trials.In addition,strengthening ethical review work is an important part of ensuring the effective protection of participants'rights and interests.It is also necessary to continuously expand the scope of protection of the rights and interests of clinical trial participants in China and improve the protection capacity,thereby establishing a sound system for protecting the rights and interests of trial participants.
