Commentary

Fins, Joseph J.

doi:10.1227/neu.0000000000001253

Cited by 4 publications

(2 citation statements)

References 20 publications

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“…DBS received also FDA approval under a Humanitarian Device Exemption for the indication obsessive-compulsive disorder [ 1 ]. The question how research on DBS for new indications should be regulated and which ethical requirements need to be fulfilled is a hot topic in current bioethics [ 2 – 6 ]. 1…”

Section: Introductionmentioning

confidence: 99%

“…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.…”

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confidence: 99%

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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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Section: Introductionmentioning

confidence: 99%

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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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Call of Duty at the Frontier of Research: Normative Epistemology for High-Risk/High-Gain Studies of Deep Brain Stimulation

Bittlinger¹

2018

Camb Q Healthc Ethics

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Research participants are entitled to many rights that may easily come into conflict. The most important ones are that researchers respect their autonomy as persons and act on the principles of beneficence, nonmaleficence, and justice. Since 2014, research subjects from numerous states in the United States of America also have a legal "right to try" that allows them, under certain circumstances, to receive experimental (i.e., preliminarily tested) interventions, including medical devices, before official approval from the United States Food and Drug Administration. In the context of experimental interventions, such as deep brain stimulation (DBS) for Alzheimer's disease, this article argues that research participants ought never to have a legal "right to try" without a corresponding "right to be sure." The latter refers to external epistemic justification construed in terms of reliance on reliable evidence. This article demonstrates that the mere complexity of intervention ensembles, as in the case of DBS for Alzheimer's disease which serves as a paradigm example, illustrate how unanswered and/or unasked open questions give rise to a "combinatorial explosion" of uncertainties that require epistemic responses that no single research team alone is likely able to provide. From this assessment, several epistemic asymmetrical relations between researchers and participants are developed. By elucidating these epistemic asymmetries, this article unravels the reasons why open science, transparent exhaustive data reporting, preregistration, and continued constant critical appraisal via pre- and postpublication peer review are not scientific virtues of moral excellence but rather ordinary obligations of the scientific work routine required to increase reliability and strength of evidence.

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Letter: Commentary: Deep Brain Stimulation as Clinical Innovation: An Ethical and Organizational Framework to Sustain Deliberations about Psychiatric Deep Brain Stimulation

et al. 2017

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Commentary

Cited by 4 publications

References 20 publications

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

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

Call of Duty at the Frontier of Research: Normative Epistemology for High-Risk/High-Gain Studies of Deep Brain Stimulation

Letter: Commentary: Deep Brain Stimulation as Clinical Innovation: An Ethical and Organizational Framework to Sustain Deliberations about Psychiatric Deep Brain Stimulation

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