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Research Involving Participants with Cognitive Disability and DifferenceEthics, Autonomy, Inclusion, and Innovation$
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M. Ariel Cascio and Eric Racine

Print publication date: 2019

Print ISBN-13: 9780198824343

Published to Oxford Scholarship Online: October 2019

DOI: 10.1093/oso/9780198824343.001.0001

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PRINTED FROM OXFORD SCHOLARSHIP ONLINE (oxford.universitypressscholarship.com). (c) Copyright Oxford University Press, 2021. All Rights Reserved. An individual user may print out a PDF of a single chapter of a monograph in OSO for personal use. date: 22 June 2021

Informed Consent for Next-Generation Deep Brain Stimulation Psychiatric Research

Informed Consent for Next-Generation Deep Brain Stimulation Psychiatric Research

Engaging End Users to Understand Risks and Improve Practice

Chapter:
(p.149) 13 Informed Consent for Next-Generation Deep Brain Stimulation Psychiatric Research
Source:
Research Involving Participants with Cognitive Disability and Difference
Author(s):

Eran Klein

Publisher:
Oxford University Press
DOI:10.1093/oso/9780198824343.003.0013

Deep brain stimulation (DBS) for psychiatric illness raises challenges for informed consent. Some of these are well recognized, such as vulnerability and unrealistic expectations, problems with capacity to consent, and scientific and safety uncertainties in implantable device research. The next generation of DBS for treatment of psychiatric illnesses may be closed-loop (or brain–computer interface-modulated) or volitionally controlled. That is, the activity of deep brain stimulating electrodes will be modulated with feedback from additional cortical or deep brain implanted recording electrodes. Six challenges for informed consent in next-generation psychiatric DBS are reviewed. These challenges are illustrated by expanding on results of a recently published qualitative study of individuals in research trials of DBS for depression and obsessive–compulsive disorder. An argument is offered that engaging with end users and potential end users of neural devices about ethical concerns is an important step in improving informed consent practices related to emerging neurotechnologies.

Keywords:   deep brain stimulation, psychiatry, depression, user-centered design, informed consent, vulnerability, capacity, authenticity, agency, family

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