Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

Klein, Eran; Ojemann, Jeffrey G.

doi:10.1088/1741-2560/13/4/043001

Cited by 26 publications

(28 citation statements)

References 58 publications

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“…Ethical concerns are critical to address for any engineered device which is implanted in a patient. A previous review has explored some of the ethical concerns for BCIs (Klein and Ojemann, 2016), and we seek here to highlight some of the concerns which are particularly relevant to ECoG-BCIs with DES.…”

Section: Financial Translational Regulatory and Ethical Concerns Fmentioning

confidence: 99%

“…Articulating the potential risks and long-term requirements for an ECoG-BCI, particularly with DES, is essential for appropriate informed consent. Biologic risks such as infection, seizures, and tissue damage from stimulation (Cogan et al, 2016) are accompanied by technological concerns such as repeated surgeries for battery replacements, heating due to potential wireless charging, and lifetime electrode wear from repeated stimulation (Klein and Ojemann, 2016).…”

Section: Financial Translational Regulatory and Ethical Concerns Fmentioning

confidence: 99%

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Direct Electrical Stimulation in Electrocorticographic Brain–Computer Interfaces: Enabling Technologies for Input to Cortex

2019

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Electrocorticographic brain computer interfaces (ECoG-BCIs) offer tremendous opportunities for restoring function in individuals suffering from neurological damage and for advancing basic neuroscience knowledge. ECoG electrodes are already commonly used clinically for monitoring epilepsy and have greater spatial specificity in recording neuronal activity than techniques such as electroencephalography (EEG). Much work to date in the field has focused on using ECoG signals recorded from cortex as control outputs for driving end effectors. An equally important but less explored application of an ECoG-BCI is directing input into cortex using ECoG electrodes for direct electrical stimulation (DES). Combining DES with ECoG recording enables a truly bidirectional BCI, where information is both read from and written to the brain. We discuss the advantages and opportunities, as well as the barriers and challenges presented by using DES in an ECoG-BCI. In this article, we review ECoG electrodes, the physics and physiology of DES, and the use of electrical stimulation of the brain for the clinical treatment of disorders such as epilepsy and Parkinson’s disease. We briefly discuss some of the translational, regulatory, financial, and ethical concerns regarding ECoG-BCIs. Next, we describe the use of ECoG-based DES for providing sensory feedback and for probing and modifying cortical connectivity. We explore future directions, which may draw on invasive animal studies with penetrating and surface electrodes as well as non-invasive stimulation methods such as transcranial magnetic stimulation (TMS). We conclude by describing enabling technologies, such as smaller ECoG electrodes for more precise targeting of cortical areas, signal processing strategies for simultaneous stimulation and recording, and computational modeling and algorithms for tailoring stimulation to each individual brain.

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Section: Financial Translational Regulatory and Ethical Concerns Fmentioning

confidence: 99%

Section: Financial Translational Regulatory and Ethical Concerns Fmentioning

confidence: 99%

Direct Electrical Stimulation in Electrocorticographic Brain–Computer Interfaces: Enabling Technologies for Input to Cortex

2019

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“…As implantable Brain Computer Interface (BCI) research moves rapidly ahead, concern about its potential effects on patients’ sense of self, autonomy and identity is growing (Klein 2015 ; Glannon 2016 ; Klein and Jeffrey 2016 ; Clausen 2013 ; Gilbert 2015a , b ; Brown et al 2016 ; Hildt 2015 ). 1 For instance, the evolution of prosthetic limbs controlled through BCI introduces questions about body ownership, self-image and self-understanding.…”

Section: Introductionmentioning

confidence: 99%

Embodiment and Estrangement: Results from a First-in-Human “Intelligent BCI” Trial

et al. 2017

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While new generations of implantable brain computer interface (BCI) devices are being developed, evidence in the literature about their impact on the patient experience is lagging. In this article, we address this knowledge gap by analysing data from the first-in-human clinical trial to study patients with implanted BCI advisory devices. We explored perceptions of self-change across six patients who volunteered to be implanted with artificially intelligent BCI devices. We used qualitative methodological tools grounded in phenomenology to conduct in-depth, semi-structured interviews. Results show that, on the one hand, BCIs can positively increase a sense of the self and control; on the other hand, they can induce radical distress, feelings of loss of control, and a rupture of patient identity. We conclude by offering suggestions for the proactive creation of preparedness protocols specific to intelligent-predictive and advisory-BCI technologies essential to prevent potential iatrogenic harms.

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“…The public has expressed some privacy concerns around neurotechnology (Jebari and Hansson, 2013) and the acquisition of private information from neurotechnologies (Higashijima et al, 2011). In brain computer interface (BCI) research, privacy concerns have been discussed in the context of how to offer appropriate informed consent (Klein and Ojemann, 2016). In the case of increasingly large ''big data'' set analysis in neuroscience, it may be the case that maintaining de-identification (i.e., stripping information that will link data back to the individual) is no longer possible (Choudhury et al, 2014).…”

Section: Neuroethics Questions For Neuroscientistsmentioning

confidence: 99%

Neuroethics Questions to Guide Ethical Research in the International Brain Initiatives

Delegates

Rommelfanger

Jeong

et al. 2018

Neuron

127

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Informed consent in implantable BCI research: identification of research risks and recommendations for development of best practices

Abstract: Development of best practices should be guided by processes that are: multidisciplinary, systematic and transparent, iterative, relational and exploratory.

Cited by 26 publications

References 58 publications

Direct Electrical Stimulation in Electrocorticographic Brain–Computer Interfaces: Enabling Technologies for Input to Cortex

Direct Electrical Stimulation in Electrocorticographic Brain–Computer Interfaces: Enabling Technologies for Input to Cortex

Embodiment and Estrangement: Results from a First-in-Human “Intelligent BCI” Trial

Neuroethics Questions to Guide Ethical Research in the International Brain Initiatives

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