TY - JOUR
T1 - Asking questions that matter – Question prompt lists as tools for improving the consent process for neurotechnology clinical trials
AU - Schönau, Andreas
AU - Goering, Sara
AU - Versalovic, Erika
AU - Montes, Natalia
AU - Brown, Tim
AU - Dasgupta, Ishan
AU - Klein, Eran
N1 - Funding Information:
This work was supported by the National Institutes of Health (MH117800-01) and National Science Foundation (EEC-1028725).
Publisher Copyright:
Copyright © 2022 Schönau, Goering, Versalovic, Montes, Brown, Dasgupta and Klein.
PY - 2022/7/29
Y1 - 2022/7/29
N2 - 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.
AB - 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.
KW - BCI (brain computer interface)
KW - DBS (deep brain stimulation)
KW - QPL (question prompt list)
KW - neurotechnology
KW - participant perspective
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U2 - 10.3389/fnhum.2022.983226
DO - 10.3389/fnhum.2022.983226
M3 - Article
AN - SCOPUS:85135900542
SN - 1662-5161
VL - 16
JO - Frontiers in Human Neuroscience
JF - Frontiers in Human Neuroscience
M1 - 983226
ER -