国际工期临床试验参与者权益保护现状及对中国的启示

[中图分类号]R-052 [文献标志码]A [文章编号]1001-8565（2025）08-0981-08

DOI：10.12026/j.issn.1001-8565.2025.08.04

Current situation of the protectionof participants’rights and interests in international Phase Iclinical trialsand itsenlightenmenttoChina

YANGHao，YINMei

（School ofHumanities and Social Sciences，Harbin Medical University，Harbin 15Oo8l，China）

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 wellas 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 PhaseIclinical 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 alsopayatention to the ethical and moral issues existing in clinical trials.In additio，strengthening ethical review work isan important part of ensuring the effctive 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 Chinaand improve the protection capacity，thereby establishing a sound system for protecting the rights and interests of trial participants.

Keywords： Phase I clinical trial； trial participant；protection of rights and interests；informed consent; ethical review

1 I期临床试验

I期临床试验，是指在试验早期阶段药物对人体安全与药物毒理性开展的评价性测试。（剩余13546字）