Deep Brain Stimulation as Clinical Innovation

Bell, Emily; Leger, Philip; Sankar, Tejas; Racine, Éric

doi:10.1227/neu.0000000000001207

Cited by 24 publications

(14 citation statements)

References 41 publications

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“…Various terms have emerged to discuss how to govern science and technology, such as democratizing science and technology [34][35][36][37][38], participatory technology assessment [39][40][41][42][43], anticipatory governance [44][45][46], upstream engagement [47][48][49][50] and responsible innovation [51][52][53][54][55]. Neuroethics was coined as a term and further developed as a field to investigate various ethical, social, and legal issues raised by neuro-advancements as a whole [56][57][58][59][60][61][62][63] and in relation to particular neuro-advancements, such as brain computer interfaces (BCI) [64,65] and deep brain stimulation (DBS) [19]. A 2018 Organization for Economic Co-operation and Development (OECD) report on the issues of neurotechnology governance argued for the importance of understanding the ethical effects of neuroscience and that neurotechnology governances are necessary to ensure responsible advancements and innovation within the neuro field [11].…”

Section: Neuroethics and Neuro-governancementioning

confidence: 99%

“…"Trainees from diverse healthcare professions (e.g., nursing, social work, physiotherapy) are not well prepared to handle many of the ethical issues associated with psychiatric DBS [deep brain stimulation] because, among other reasons, they may be unprepared to engage in ethical reflection, they have a limited understanding of issues associated with scientific uncertainty, and they may lack an interdisciplinary understanding about ethical issues". [19], p. 6…”

Section: Introductionmentioning

confidence: 99%

“…Given the role expectations of nurses, their interactions with clients, such as disabled people, and the gaps in ethical knowledge in health professionals identified [19], our objective was to better understand the role expectations of nurses evident in the academic literature and newspaper literature surrounding neuro-advancement, and whether the literature engaged with the topic of nurses obtaining the necessary knowledge in order to contribute effectively to the ethical and governance discussions of neuro-advancements. Although the above rationale for this study applies to other health professionals as well, we chose nursing for this scoping review because initial research indicated that nursing generated a greater amount of data we could analyze than other health professions.…”

Section: Introductionmentioning

confidence: 99%

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Neuro-Advancements and the Role of Nurses as Stated in Academic Literature and Canadian Newspapers

Deloria

Wolbring

2019

Societies

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Neurosciences and neurotechnologies (from now on called neuro-advancements) constantly evolve and influence all facets of society. Neuroethics and neuro-governance discourses focus on the impact of neuro-advancements on individuals and society, and stakeholder involvement is identified as an important aspect of being able to deal with such an impact. Nurses engage with neuro-advancements within their occupation, including neuro-linked assistive technologies, such as brain-computer interfaces, cochlear implants, and virtual reality. The role of nurses is multifaceted and includes being providers of clinical and other health services, educators, advocates for their field and their clients, including disabled people, researchers, and influencers of policy discourses. Nurses have a stake in how neuro-advancements are governed, therefore, being influencers of neuroethics and neuro-governance discourses should be one of these roles. Lifelong learning and professional development could be one mechanism to increase the knowledge of nurses about ethical, social, and legal issues linked to neuro-advancements, which in turn, would allow nurses to provide meaningful input towards neuro-advancement discussions. Disabled people are often the recipients of neuro-advancements and are clients of nurses, therefore, they have a stake in the way nurses interact with neuro-advancements and influence the sociotechnical context of neuro-advancements, which include neuro-linked assistive devices. We performed a scoping review to investigate the role of narrative around nurses in relation to neuro-advancements within academic literature and newspapers. We found minimal engagement with the role of nurses outside of clinical services. No article raised the issue of nurses having to be involved in neuro-ethics and neuro-governance discussions or how lifelong learning could be used to gain that competency. Few articles used the term assistive technology or assistive device and no article covered the engagement of nurses with disabled people within a socio-technical context. We submit that the role narrative falls short of what is expected from nurses and shows shortcomings at the intersection of nurses, socio-technical approaches to neuro-assistive technologies and other neuro-advancements and people with disabilities. Neuro-governance and neuroethic discourses could be a useful way for nurses and disabled people to co-shape the socio-technical context of neuro-advancements, including neuro-assistive technologies. Lifelong learning initiatives should be put in place to provide the knowledge necessary for nurses to take part in the neuroethics and neuro-governance discussion.

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Section: Neuroethics and Neuro-governancementioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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Neuro-Advancements and the Role of Nurses as Stated in Academic Literature and Canadian Newspapers

Deloria

Wolbring

2019

Societies

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“…Neurotechnologies that enable measuring and modulating brain function are already, and likely increasingly will be, used for non-medical purposes, but NIH focuses solely on biomedical applications. Thus we recognize that NIH’s neuroethics efforts are only a piece of a broader landscape of inquiry and scholarship, which exists thanks to many experts who have written about various neuroethical issues (a small sampling: Bell et al 2016; Farah 2015; Fins et al 2011; Illes & Bird 2006).…”

Section: The Brain Initiative: Implications and Aspirations For Neuromentioning

confidence: 99%

Neuroethics and the NIH BRAIN Initiative

Ramos

Rommelfanger

Greely

et al. 2017

Journal of Responsible Innovation

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The Brain Research through Advancing Innovative Neurotechnologies® (BRAIN) Initiative is focused on developing new tools and neurotechnologies to revolutionize our understanding of how the brain functions in health and disease, in large part to address the growing societal impact of neurological, mental health, and substance abuse disorders. Recent advances in neurotechnology are delivering unprecedented ways to interrogate and modulate brain function, and the BRAIN Initiative is focused on translation for human medical uses over the next decade. Since its inception, the NIH component of the BRAIN Initiative has utilized an iterative model of integrating ethics into the scientific trajectory of the Initiative, most recently with the creation of a Neuroethics Division of the NIH BRAIN Initiative Multi-Council Working Group. The Division serves as a resource of expertise, to help the BRAIN Initiative navigate issues involving ethics. Here we discuss the BRAIN Initiative, and its implications and aspirations for neuroethics. We also discuss new opportunities for collaboration and for integrating stakeholder voices.

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“…If “compassionate use” becomes altogether indistinguishably from normal research, then the different labels are only of legal relevance, but not relevant for the context of research ethics. A controversial question is whether emerging new DBS indications may also be studied in the context of surgical innovation [ 2 , 3 ]. Because we focus on the ethical aspects of research, not on the legal aspects of regulation, the analysis of different regulation frameworks is beyond the scope of this article.…”

mentioning

confidence: 99%

Opening the debate on deep brain stimulation for Alzheimer disease – a critical evaluation of rationale, shortcomings, and ethical justification

Bittlinger

Müller

2018

BMC Med Ethics

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BackgroundDeep brain stimulation (DBS) as investigational intervention for symptomatic relief from Alzheimer disease (AD) has generated big expectations. Our aim is to discuss the ethical justification of this research agenda by examining the underlying research rationale as well as potential methodological pitfalls. The shortcomings we address are of high ethical importance because only scientifically valid research has the potential to be ethical.MethodWe performed a systematic search on MEDLINE and EMBASE. We included 166 publications about DBS for AD into the analysis of research rationale, risks and ethical aspects. Fifty-eight patients were reported in peer-reviewed journals with very mixed results. A grey literature search revealed hints for 75 yet to be published, potentially enrolled patients.ResultsThe results of our systematic review indicate methodological shortcomings in the literature that are both scientific and ethical in nature. According to our analysis, research with human subjects was performed before decisive preclinical research was published examining the specific research question at stake. We also raise the concern that conclusions on the potential safety and efficacy have been reported in the literature that seem premature given the design of the feasibility studies from which they were drawn. In addition, some publications report that DBS for AD was performed without written informed consent from some patients, but from surrogates only. Furthermore, registered ongoing trials plan to enroll severely demented patients. We provide reasons that this would violate Art. 28 of the Declaration of Helsinki, because DBS for AD involves more than minimal risks and burdens, and because its efficacy and safety are not yet empirically established to be likely.ConclusionBased on our empirical analysis, we argue that clinical research on interventions of risk class III (Food and Drug Administration and European Medicines Agency) should not be exploratory but grounded on sound, preclinically tested, and disease-specific a posteriori hypotheses. This also applies to DBS for dementia as long as therapeutic benefits are uncertain, and especially when research subjects with cognitive deficits are involved, who may foreseeably progress to full incapacity to provide informed consent during the required follow-up period.

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Deep Brain Stimulation as Clinical Innovation

Abstract: DBS, deep brain stimulationIRB, institutional review boardOCD, obsessive-compulsive disorder.

Cited by 24 publications

References 41 publications

Neuro-Advancements and the Role of Nurses as Stated in Academic Literature and Canadian Newspapers

Neuro-Advancements and the Role of Nurses as Stated in Academic Literature and Canadian Newspapers

Neuroethics and the NIH BRAIN Initiative

Opening the debate on deep brain stimulation for Alzheimer disease – a critical evaluation of rationale, shortcomings, and ethical justification

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