Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences.
Exit from Brain Device Research: A Modified Grounded Theory Study of Researcher Obligations and Participant Experiences.
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DOI：
10.1080/21507740.2021.1938293
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发表时间：
2022-10-01
影响因子：
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通讯作者：
Ford, Paul J
中科院分区：
文献类型：
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作者：
Sankary, Lauren R;Zelinsky, Megan;Ford, Paul J
随着临床试验的结束，人们对退出临床试验的参与者如何处理与研究性脑植入物（如脑深部电刺激（DBS）设备）的移除或试验后使用相关的决定知之甚少。这项经验主义的生物伦理学研究探讨了研究参与者在植入神经设备的临床试验结束时如何经历退出研究的过程。使用修改后的扎根理论研究设计，我们进行了半结构化的，深入的采访，从DBS和反应性神经刺激（RNS）的临床试验的16名前研究参与者。开放式问题引出了参加试验的动机、在初始知情同意时对研究程序的理解、退出研究的过程以及关于器械移除或试验后器械使用的决定。主题分析确定了与以下方面相关的类别：对研究参与结束的准备有限、直接决定取出或保留器械、与研究参与结束协调一致、协调试验后期望以及在退出研究后获得一种结束感。一个初步的理论模型描述了影响退出研究的过程和经验的背景因素。临床试验参与者的经验应指导研究实践，以加强DBS和其他脑装置临床试验的伦理设计和实施。
As clinical trials end, little is understood about how participants exiting from clinical trials approach decisions related to the removal or post-trial use of investigational brain implants, such as deep brain stimulation (DBS) devices. This empirical bioethics study examines how research participants experience the process of exit from research at the end of clinical trials of implanted neural devices. Using a modified grounded theory study design, we conducted semi-structured, in-depth interviews with 16 former research participants from clinical trials of DBS and responsive neurostimulation (RNS). Open-ended questions elicited motivations for joining the trial, understanding of study procedures at the time of initial informed consent, the process of exiting from research, and decisions about device removal or post-trial device use. Thematic analysis identified categories related to: limited preparedness for the end of research participation, straightforwardness of decisions to explant or keep the device, reconciling with the end of research participation, reconciling post-trial expectations, and achieving a sense of closure after exit from research. A preliminary theoretical model describes contextual factors influencing the process and experience of exit from research. Experiences of clinical trial participants should guide research practices to enhance the ethical design and conduct of clinical trials in DBS and other brain devices.