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探索关于人类挑战研究的伦理问题:对受控人类疟疾感染研究参与者的动机和态度的定性研究

Exploring Ethical Concerns About Human Challenge Studies: A Qualitative Study of Controlled Human Malaria Infection Study Participants' Motivations and Attitudes.

作者信息

Kraft Stephanie A, Duenas Devan M, Kublin James G, Shipman Kelly J, Murphy Sean C, Shah Seema K

机构信息

1 Seattle Children's Research Institute, WA, USA.

2 University of Washington School of Medicine, Seattle, USA.

出版信息

J Empir Res Hum Res Ethics. 2019 Feb;14(1):49-60. doi: 10.1177/1556264618820219. Epub 2018 Dec 26.

Abstract

Controlled human malaria infection (CHMI) studies deliberately infect healthy participants with malaria to test interventions faster and more efficiently. Some argue the study design and high payments offered raise ethical concerns about participants' understanding of risks and undue inducement. We conducted baseline and exit interviews with 16 CHMI study participants to explore these concerns. Participants described themes including decision-making tension with friends and family, mixed motivations for participating, low study risks but high burdens, fair compensation, sacrificing values, deceiving researchers, and perceived benefits. Our findings do not support concerns that high payments limit understanding of study risks, but suggest participants may lack appreciation of study burdens, withhold information or engage in deception, and experience conflict with others regarding study participation.

摘要

受控人类疟疾感染(CHMI)研究故意让健康参与者感染疟疾,以便更快、更有效地测试干预措施。一些人认为,该研究设计和提供的高额报酬引发了对参与者对风险的理解以及不当诱导的伦理担忧。我们对16名CHMI研究参与者进行了基线和结束访谈,以探讨这些担忧。参与者描述了包括与朋友和家人的决策紧张关系、参与的复杂动机、低研究风险但高负担、公平补偿、牺牲价值观、欺骗研究人员以及感知到的益处等主题。我们的研究结果不支持高额报酬会限制对研究风险的理解这一担忧,但表明参与者可能对研究负担缺乏认识、隐瞒信息或进行欺骗,并且在参与研究方面与他人发生冲突。

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