研究参与者补偿权保障探析  

Analysis of the protection of compensation rights for research participants

作　　者：盛艾娟[1] 王小琪[1] 孙李妍 郑东翔 刘芳[3] SHENG Aijuan;WANG Xiaoqi;SUN Liyan;ZHENG Dongxiang;LIU Fang(Ethics Committee,Beijing Youan Hospital,Capital Medical University,Beijing 100069,China;Office of Drug Clinical Trials Institution,Yantaishan Hospital of Yantai,Yantai 264003,China;School of Medical Humanities,Capital Medical University,Beijing 100069,China)

机构地区：[1]首都医科大学附属北京佑安医院伦理委员会,北京100069 [2]烟台市烟台山医院药物临床试验机构办公室,山东烟台264003 [3]首都医科大学医学人文学院,北京100069

出　　处：《中国医学伦理学》2024年第5期507-513,共7页Chinese Medical Ethics

基　　金：北京市医学伦理管理质量提高项目“北京市区域伦理审查委员会运行评估与提高策略研究”(京伦2024-2)。

摘　　要：涉及人的生命科学和医学研究离不开研究参与者的支持,研究参与者的安全、健康和权益是临床研究中首要考虑因素,研究参与者的权益包含补偿权、隐私权、健康权等。保护研究参与者补偿权是研究相关部门和人员的主要职责。在法规规范和文献研读的基础上,结合实践经验对补偿权深入探讨,提出了补偿类别(常规补偿、研究相关损害补偿)、补偿原则(必要性、及时性、适当性、公平性)、补偿要素(补偿方式、补偿额度、补偿计划、补偿同意、补偿告知、补偿参照)、特殊情况下的补偿(无民事行为能力或者限制民事行为能力的研究参与者的补偿、中途退出研究参与者的补偿)、补偿权保障措施(申办者/合同研究组织、研究机构、研究管理部门、〈主要〉研究者及研究团队、伦理〈审查〉委员会等单位的保障措施),落实补偿权,保护研究参与者。Life science and medical research involving human beings cannot be separated from the support of research participants.The safety,health,and rights and interests of research participants are the primary considerations in clinical research,and their rights and interests include the right of compensation,privacy protection,health and so on.Protecting the compensation rights of research participants is a necessary responsibility of the research-related departments and personnel.Based on laws and regulations and literature review,and combined with practical experience,this paper made an in-depth discussion on compensation rights.It puts forward the types of compensation(conventional compensation,research-related damage compensation),compensation principles(necessity,timeliness,appropriateness,fairness),compensation elements(method,amount,plan,consent,notification,and reference of compensation),compensation under special circumstances(compensation for participants without or with limited informed consent ability and withdraw from the study midway),protection measures of compensation right(sponsor/contract research organizations,research institutions,research management departments,(main)researchers and research teams,ethics(review)committee).The compensation rights should be implemented to protect research participants.

关 键 词：临床研究 研究参与者 补偿 伦理审查 

分 类 号：R-052[医药卫生]