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提出重要问题——作为改善神经技术临床试验知情同意程序工具的问题提示清单。

Asking questions that matter - Question prompt lists as tools for improving the consent process for neurotechnology clinical trials.

作者信息

Schönau Andreas, Goering Sara, Versalovic Erika, Montes Natalia, Brown Tim, Dasgupta Ishan, Klein Eran

机构信息

Department of Philosophy, University of Washington, Seattle, WA, United States.

Dana Foundation, New York, NY, United States.

出版信息

Front Hum Neurosci. 2022 Jul 29;16:983226. doi: 10.3389/fnhum.2022.983226. eCollection 2022.

Abstract

Implantable neurotechnology devices such as Brain Computer Interfaces (BCIs) and Deep Brain Stimulators (DBS) are an increasing part of treating or exploring potential treatments for neurological and psychiatric disorders. While only a few devices are approved, many promising prospects for future devices are under investigation. The decision to participate in a clinical trial can be challenging, given a variety of risks to be taken into consideration. During the consent process, prospective participants might lack the language to consider those risks, feel unprepared, or simply not know what questions to ask. One tool to help empower participants to play a more active role during the consent process is a Question Prompt List (QPL). QPLs are communication tools that can prompt participants and patients to articulate potential concerns. They offer a structured list of disease, treatment, or research intervention-specific questions that research participants can use as support for question asking. While QPLs have been studied as tools for improving the consent process during cancer treatment, in this paper, we suggest they would be helpful in neurotechnology research, and offer an example of a QPL as a template for an informed consent tool in neurotechnology device trials.

摘要

诸如脑机接口(BCI)和深部脑刺激器(DBS)等可植入神经技术设备在治疗或探索神经和精神疾病的潜在治疗方法中所占比重日益增加。虽然只有少数设备获得批准,但许多未来设备的前景广阔,正在进行研究。鉴于需要考虑多种风险,决定参与临床试验可能具有挑战性。在同意过程中,潜在参与者可能缺乏考虑这些风险的语言能力,感到准备不足,或者根本不知道该问什么问题。一种有助于使参与者在同意过程中发挥更积极作用的工具是问题提示清单(QPL)。QPL是一种沟通工具,可以促使参与者和患者阐明潜在的担忧。它们提供了一份针对疾病、治疗或研究干预的结构化问题清单,研究参与者可以将其用作提问的支持。虽然QPL已被作为改善癌症治疗同意过程的工具进行研究,但在本文中,我们认为它们对神经技术研究也会有所帮助,并提供一个QPL示例,作为神经技术设备试验中知情同意工具的模板。

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