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. 2022 Jul 29:16:983226.
doi: 10.3389/fnhum.2022.983226. eCollection 2022.

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

Andreas Schönau  1 , Sara Goering  1 , Erika Versalovic  1 , Natalia Montes  1 , Tim Brown  1 , Ishan Dasgupta  2 , Eran Klein  3
Affiliations

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

Andreas Schönau et al. Front Hum Neurosci. .

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.

Keywords: BCI (brain computer interface); DBS (deep brain stimulation); QPL (question prompt list); neurotechnology; participant perspective.

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Conflict of interest statement

The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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