Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost

Lázaro‐Muñoz, Gabriel; Pham, Michelle; Muñoz, Katrina A.; Kostick, Kristin M.; Sanchez, Clarissa E.; Torgerson, Laura; Robinson, Jill O.; Pereira, Stacey; Outram, Simon; Koenig, Barbara A.; Starr, Philip A.; Gündüz, Ayşegül; Foote, Kelly D.; Okun, Michael S.; Goodman, Wayne K.; McGuire, Amy L.; Zuk, Peter

doi:10.1016/j.brs.2022.07.051

Cited by 17 publications

(13 citation statements)

References 23 publications

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“…was counted as both a neuroscientist and a patient with a neurological device implant. Figure 1 summarizes the search strategy, which revealed that of 734 articles identified, 7 articles were related to or addressed neurological device abandonment.…”

Section: Resultsmentioning

confidence: 99%

“…This can lead to possible therapeutic misconception and misperception by the patient of clinical abandonment. 3 Second, participants should be notified if and when the trial is being terminated. Finally, researchers in charge of the study should provide participating patients resources and vectors for other therapeutics that meet accepted standards of care.…”

Section: Operationally Defining This Context Of Abandonmentmentioning

confidence: 99%

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Definition of Implanted Neurological Device Abandonment

Okun,

Marjenin,

Ekanayake

et al. 2024

JAMA Netw Open

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ImportanceEstablishing a formal definition for neurological device abandonment has the potential to reduce or to prevent the occurrence of this abandonment.ObjectiveTo perform a systematic review of the literature and develop an expert consensus definition for neurological device abandonment.Evidence ReviewAfter a Royal Society Summit on Neural Interfaces (September 13-14, 2023), a systematic English language review using PubMed was undertaken to investigate extant definitions of neurological device abandonment. Articles were reviewed for relevance to neurological device abandonment in the setting of deep brain, vagal nerve, and spinal cord stimulation. This review was followed by the convening of an expert consensus group of physicians, scientists, ethicists, and stakeholders. The group summarized findings, added subject matter experience, and applied relevant ethics concepts to propose a current operational definition of neurological device abandonment. Data collection, study, and consensus development were done between September 13, 2023, and February 1, 2024.FindingsThe PubMed search revealed 734 total articles, and after review, 7 articles were found to address neurological device abandonment. The expert consensus group addressed findings as germane to neurological device abandonment and added personal experience and additional relevant peer-reviewed articles, addressed stakeholders’ respective responsibilities, and operationally defined abandonment in the context of implantable neurotechnological devices. The group further addressed whether clinical trial failure or shelving of devices would constitute or be associated with abandonment as defined. Referential to these domains and dimensions, the group proposed a standardized definition for abandonment of active implantable neurotechnological devices.Conclusions and RelevanceThis study’s consensus statement suggests that the definition for neurological device abandonment should entail failure to provide fundamental aspects of patient consent; fulfill reasonable responsibility for medical, technical, or financial support prior to the end of the device’s labeled lifetime; and address any or all immediate needs that may result in safety concerns or device ineffectiveness and that the definition of abandonment associated with the failure of a research trial should be contingent on specific circumstances.

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Section: Resultsmentioning

confidence: 99%

Section: Operationally Defining This Context Of Abandonmentmentioning

confidence: 99%

Definition of Implanted Neurological Device Abandonment

Okun,

Marjenin,

Ekanayake

et al. 2024

JAMA Netw Open

Self Cite

View full text Add to dashboard Cite

show abstract

“…That's always what keeps researchers up at night […]. I think that you have to find a way to keep it in if the patient finds it to be beneficial.” 7 But despite widespread recognition of the problem of post‐trial obligations for neural‐device research, and despite a growing literature on the conceptual resources that might be brought to bear on it, 8 the problem remains unresolved.…”

Section: Neuroscience and Societymentioning

confidence: 99%

Brain Pioneers and Moral Entanglement: An Argument for Post‐trial Responsibilities in Neural‐Device Trials

Goering,

Brown,

Klein

2024

Hastings Center Report

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We argue that in implanted neurotechnology research, participants and researchers experience what Henry Richardson has called “moral entanglement.” Participants partially entrust researchers with access to their brains and thus to information that would otherwise be private, leading to created intimacies and special obligations of beneficence for researchers and research funding agencies. One of these obligations, we argue, is about continued access to beneficial technology once a trial ends. We make the case for moral entanglement in this context through exploration of participants’ vulnerability, uncompensated risks and burdens, depth of relationship with the research team, and dependence on researchers in implanted neurotechnology trials.

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“…Finally, candidates must be made aware of how or indeed whether they will have long-term access to the device. At this time, most iBCIs are only made available to users in the context of a clinical trial, which raises questions about the enduring responsibilities of investigators to maintain the device after the trial ends [56].…”

Section: Safety Well-being and Riskmentioning

confidence: 99%

Applying the IEEE BRAIN neuroethics framework to intra-cortical brain-computer interfaces

Soldado-Magraner,

Antonietti,

French

et al. 2024

J. Neural Eng.

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Brain-computer interfaces (BCIs) are neuroprosthetic devices that allow for direct interaction between brains and machines. These types of neurotechnologies have recently experienced a strong drive in research and development, given, in part, that they promise to restore motor and communication abilities in individuals experiencing severe paralysis. While a rich literature analyzes the ethical, legal, and sociocultural implications (ELSCI) of these novel neurotechnologies, engineers, clinicians and BCI practitioners often do not have enough exposure to these topics. Here, we present the IEEE Neuroethics Framework, an international, multiyear, iterative initiative aimed at developing a robust, accessible set of considerations for diverse stakeholders. Using the framework, we provide practical examples of ELSCI considerations for BCI neurotechnologies. We focus on invasive technologies, and in particular, devices that are implanted intra-cortically for medical research applications. We demonstrate the utility of our framework in exposing a wide range of implications across different intra-cortical BCI technology modalities and conclude with recommendations on how to utilize this knowledge in the development and application of ethical guidelines for BCI neurotechnologies.

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Post-trial access in implanted neural device research: Device maintenance, abandonment, and cost

Cited by 17 publications

References 23 publications

Definition of Implanted Neurological Device Abandonment

Definition of Implanted Neurological Device Abandonment

Brain Pioneers and Moral Entanglement: An Argument for Post‐trial Responsibilities in Neural‐Device Trials

Applying the IEEE BRAIN neuroethics framework to intra-cortical brain-computer interfaces

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