临床科研项目受试者权益保护策略初探

Preliminary Study on the Protection Strategy of Subjects' Rights and Interests in Clinical Scientific Research Projects

做好受试者权益保护工作是医院开展临床科学研究的前提。从受试者应享有的权利及其目前所处的真实境况着手,分别从伦理委员会、项目负责人的保护受试者意识、增强受试者的自主权利和自我保护意识、建立医院受试者保护体系、完善政府层面的法制体系这五个方面探讨了在临床科研项目开展实施过程中受试者权益保护的策略。

To protect the subjects’ rights and interests is the premise for the hospital to carry out clinical scientific research.Starting from the subjects’ rights and their real situation, this paper preliminarily discussed the strategies of protecting the subjects’ rights and interests in the implementation of clinical research projects from the following five aspects.Namely, the awareness of protecting subjects of ethics committee and project leaders, enhancing the subjects’autonomy and self-protection consciousness, establishing the protection system for hospital subjects, and perfecting the legal system at the government level.