Commentary: The Value of Patient Benefit: Consideration of Framing Contingencies to Guide the Ethical Use of DBS—a Case Analysis

Abstract

Here we have a case in which (1) the outcome(s) for the patient do not comport with the projected-or initially defined-outcomes of the research study, and (2) these outcomes represent cognitive and behavioral effects that are positively interpreted by the patient, but not by the patient's immediate family. The 6Cs approach, which frames the technique or technology-and its effects-within defined considerations of domains and dimensions, can be used as part of a multistep approach to addressing issues arising from the use of neurotechnology. 1 The approach recommends that the medical team consider the following domains and dimensions when engaging neuroethical analyses: • The capacities and limitations of current neuroscience and technology (neuroS/T), and the capacity of the patient • The consequences incurred by neuroS/T on recipients, families, and society in the short, intermediate, and long term • The character of the recipient (e.g., patterns of cognition, emotion, and behavior) affected by neuroS/T • The continuity of research and clinical care • The contexts of need and value that influence the use or nonuse of neuroS/T • Consent through provision of the most information possible 2.

Neuroethics of neuromodulation: An update

“…If so, are there ways to nonetheless address or accommodate the objections of researchers? Related considerations arise in cases of family disagreement with a subject’s preference to continue device use[13]. …”

Proceedings of the Eighth Annual Deep Brain Stimulation Think Tank: Advances in Optogenetics, Ethical Issues Affecting DBS Research, Neuromodulatory Approaches for Depression, Adaptive Neurostimulation, and Emerging DBS Technologies

“…As we have noted, such new horizons of possibility must be approached with ethical probity (Giordano, 2015). The novelty of utilizing DBS in such ways mandates explication of current uncertainties about the durability of clinical benefit, future side effects, and sustainability of intervention as contingencies for informed patient consent (Giordano, 2016).…”

“…Provocative questions have arisen whether closed-loop neuromodulation could induce changes to a patients' sense of identity and agency. Ongoing discussions in the literature have been equivocal, noting a paucity of data and arguing that such concerns may be overdrawn (Giordano, 2016). To address the need for empirical investigations, we at UCSF examined constructs and the subjective experience of identity in patients with refractory epilepsy undergoing responsive neurostimulation (RNS)-the first FDA-approved, commercially available closed-loop brain stimulation system.…”

Proceedings of the Seventh Annual Deep Brain Stimulation Think Tank: Advances in Neurophysiology, Adaptive DBS, Virtual Reality, Neuroethics and Technology

“…Thus, while some ethical issues can be similar or identical (e.g., risks of neurosurgery; inherent uncertainties of new technology), others may not (Martin et al, 2016;Becker et al, 2017). As we have noted, even fundamental ethical concepts (e.g., meanings, value, and questions about autonomy, as affected by DBS such as those described below) can be viewed and regarded through differing cultural lenses (Giordano, 2016). Laudably, several intra-and multi-national groups have committed resources to address the ethical-legal and social issues generated by DBS research and use (for example, the efforts of the United States' National Institutes of Health; and Asociación Mexicana de Neuroética, as reported in this article, as well as numerous others).…”