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研究参与者补偿权保障探析

盛艾娟 王小琪 孙李妍 郑东翔 刘芳

中国医学伦理学2024,Vol.37Issue(5):507-513,7.
中国医学伦理学2024,Vol.37Issue(5):507-513,7.DOI:10.12026/j.issn.1001-8565.2024.05.02

研究参与者补偿权保障探析

Analysis of the protection of compensation rights for research participants

盛艾娟 1王小琪 1孙李妍 2郑东翔 1刘芳3

作者信息

  • 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
  • 折叠

摘要

Abstract

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

Key words

clinical research/research participant/compensation/ethical review

分类

医药卫生

引用本文复制引用

盛艾娟,王小琪,孙李妍,郑东翔,刘芳..研究参与者补偿权保障探析[J].中国医学伦理学,2024,37(5):507-513,7.

基金项目

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) (京伦2024-2)

中国医学伦理学

OA北大核心CSTPCD

1001-8565

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