Deep brain stimulation as investigational intervention for symptomatic relief from Alzheimer disease 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. We 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. The 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. Based on our empirical analysis, we argue that clinical research on interventions of risk class III 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. (shrink)

Scientific progress in recent neurofeedback research may bring about a new type of moral neuroenhancement, namely, neurofeedback-based moral enhancement; however, this has yet to be examined thoroughly. This paper presents an ethical analysis of the possibility of neurofeedback-based moral enhancement and demonstrates that this type of moral enhancement sheds new light on the moral enhancement debate. First, I survey this debate and extract the typical structural flow of its arguments. Second, by applying structure to the case of neurofeedback-based moral enhancement, (...) I examine the ethical, legal, and social issues to show that this technique is unique and traditionalist, which makes it compatible with almost all our conservative notions, so that it, accordingly, can be seen as an ethically acceptable option. Third, by rejecting the premise in the moral enhancement debate that bio/neuro-enhancement has its unique ELSI that traditional methods would never create, I demonstrate that, by virtue of its traditional or conservative features, neurofeedback-based moral enhancement can be incorporated into the traditional moral education network. Finally, I conclude that, being a part of the traditional moral education network, neurofeedback-based moral enhancement can be a unique and ethically acceptable option of moral neuroenhancement. (shrink)