Eisuke Nakazawa

Ethics of Decoded Neurofeedback in Clinical Research, Treatment, and Moral Enhancement

Decoded neurofeedback is a new technology that allows the improvement or modification of human cognitive and moral capacities and has a wide range of potential applications. As decoded neurofeedback will have an impact on society, ethical concerns about this technology should be examined. As decoded neurofeedback modifies the default mode network due to a voxel-based pattern analysis, it enables a tailor-made intervention. However, it is difficult to assess the safety and efficacy of decoded neurofeedback-based interventions in clinical trials because of a shortage of reliable preclinical data. Decoded neurofeedback used for moral enhancement is a noninvasive intervention with a high selectivity for the targeted brain state, and therefore, moral uniformity, the most often discussed problem, can be avoided. However, it remains uncertain whether decoded neurofeedback is reversible, safe, or efficacious.

Handling incidental findings in neuroimaging research in Japan: current state of research facilities and attitudes of investigators and the general population.

BackgroundTo establish appropriate measures that deal with incidental findings (IFs), the neuroscience community needs to address various ethical issues. The current state of research facilities regarding IFs and investigator attitudes as well as potentially eligible research participants must be assessed prior to future discussions and before the development of policies and guidelines. To this end, we conducted two questionnaire surveys to clarify i) how IFs are addressed at neuroimaging research facilities in Japan and ii) the views of investigators and potential research participants regarding the handling of IFs.MethodsThirty-one principal investigators (PIs) involved in the Strategic Research Program for Brain Sciences (SRPBS), a government-funded project, were asked to fill out a questionnaire regarding ways IFs were handled at the facility. A total of 110 investigators engaged in SRPBS tasks, including 31 PIs who participated in the research facility survey and researchers conducting studies under the management of the PIs, and 500 individuals from the general public (i.e., general population) were asked to select the most appropriate way to deal with IFs in two scenarios, namely the medical school and humanities and social sciences department scenarios.ResultsMore than 40% of PIs responded that they did not know or were unsure of what type of approach was employed to handle IFs at their research facilities. Nevertheless, they were willing to improve the current status if sufficient resources were provided. With regard to specialist involvement, 37.7% of investigators responded that it was appropriate to have a specialist check all images in the medical school scenario, whereas 13.3% responded that such involvement was appropriate in the humanities and social sciences department scenario. In contrast, 76.1% and 61.0% of the general population indicated that specialist involvement was appropriate in the medical school and humanities and social sciences department scenarios, respectively. These results show that expectations of the general population exceed those of investigators regarding measures to address IFs. Both investigators and the general population demanded more responsibility from PIs at medical institutions, compared to PIs at non-medical institutions.ConclusionsBased on our preliminary results, we recommended that a licensed physician perform a screening test to appropriately examine clear abnormalities. These recommendations were implemented by the SRPBS as guidelines for handling IFs in national research projects in Japan.

Discovery and informing research participants of incidental findings detected in brain magnetic resonance imaging studies: Review and multi-institutional study

Brain imaging studies using magnetic resonance imaging (MRI) sometimes reveal incidental findings (IFs) that might be relevant to some of the health issues in research participants. Although professional communities have discussed how to manage these IFs, there is no global consensus on the concrete handling procedures including how to inform participants of IFs.

Twenty years after enactment of the Organ Transplant Law in Japan: Why are there still so few deceased donors?

BACKGROUND Twenty years have passed since the 1997 enactment of the Organ Transplant Law in Japan, but the number of deceased donors remains extremely low. In this study we examine why deceased donation has continued to remain so infrequent. METHODS This investigation was a secondary analysis of published data from the Japan Organ Transplant Network, 2016 Fact Book of Organ Transplantation in Japan, and International Registry on Organ Donation and Transplantation. RESULTS In the past 20 years, donation intent declarations, knowledge, and respect for family members wishes have increased, whereas resistance toward transplantation has decreased. Despite this, the traditional perspective on corpses of gotai manzoku (ie, the soul cannot be put to rest without being physically intact and without defect), the family-centricism, and reward-seeking altruism have not changed much. Living organ transplants have alleviated the organ deficiency somewhat, and the law requiring family consent seems to have contributed to the observed small increase in deceased donors. CONCLUSION The number of deceased donors is unlikely to increase suddenly. However, 8 strategies are proposed to increase the number of deceased donors, including: increasing the number of donor procurement coordinators and establishing a training system; increasing the number of organ procurement facilities; creating hub transplant centers and training transplant surgeons; implementing radical reform in public education; reducing workload and improving education of emergency physicians, neurosurgeons, and pediatricians; revisiting the stringent standards of brain-death determination; revisiting the registration process; and considering development of a Japanese version of organ procurement organizations as well as revisions to the Organ Transplant Law. The Japanese government and academic societies must work together to increase the number of deceased donors in Japan.

Endangerment of the iPSC stock project in Japan: on the ethics of public funding policies

We examined the ethical justification for a national policy governing public funding for the induced pluripotent stem cell (iPSC) stock project in Japan and argue that the initiation of the iPSC stock project in 2012, when no clinical trial using iPSC-derived products had yet succeeded, was premature and unethical. Our analysis considers a generally accepted justice criterion and shows it fails to justify public funding of the iPSC stock project. We also raise concerns related to the massive amounts of public funding at stake and the absence of evidence supporting claimed success rates. We conclude that the iPSC stock project should be re-considered and deferred until a substantial number of clinical trials using iPSC-derived products are deemed successful. This analysis should benefit others worldwide as they consider their own public funding policies.

Should the Japanese government support travels for transplantation as a policy under the National Health Insurance system

On December 22nd , 2017, the Japanese Ministry of Health, Labor and Welfare (MHLW) issued a Notice of a policy in support of transplant tourism under strict conditions [1] (Table). It decided to pay approximately ¥10,000,000 (USD 100,000) from national health insurance for each patient (insured) who undergoes transplant surgery overseas [2]. Patients can use the money to pay for medical fees and travel expenses, etc., but not to buy organs, which is prohibited by The Japanese Organ Transplant Law. This article is protected by copyright. All rights reserved.

Reuse of cardiac organs in transplantation: an ethical analysis

BackgroundThis paper examines the ethical aspects of organ transplant surgery in which a donor heart is transplanted from a first recipient, following determination of death by neurologic criteria, to a second recipient. Retransplantation in this sense differs from that in which one recipient undergoes repeat heart transplantation of a newly donated organ, and is thus referred to here as “reuse cardiac organ transplantation.”MethodsMedical, legal, and ethical analysis, with a main focus on ethical analysis.ResultsFrom the medical perspective, it is critical to ensure the quality and safety of reused organs, but we lack sufficient empirical data pertaining to medical risk. From the legal perspective, a comparative examination of laws in the United States and Japan affirms no illegality, but legal scholars disagree on the appropriate analysis of the issues, including whether or not property rights apply to transplanted organs. Ethical arguments supporting the reuse of organs include the analogous nature of donation to gifts, the value of donations as inheritance property, and the public property theory as it pertains to organs. Meanwhile, ethical arguments such as those that address organ recycling and identity issues challenge organ reuse.ConclusionWe conclude that organ reuse is not only ethically permissible, but even ethically desirable. Furthermore, we suggest changes to be implemented in the informed consent process prior to organ transplantation. The organ transplant community worldwide should engage in wider and deeper discussions, in hopes that such efforts will lead to the timely preparation of guidelines to implement reuse cardiac organ transplantation as well as reuse transplantation of other organs such as kidney and liver.

From “Cannot” Function to “Might” Function: Assessment of Actual Levels of Consciousness and Potential Consciousness in Patient Care: Japanese Experiences

Vukov (2018) argues that in cases for which it is unclear whether a patient has consciousness or not, a patient’s potential consciousness (PC) must be considered along with actual levels of consciousness (ALC). Although Vukov (2018) introduced the concept of PC in order to distinguish between a vegetative state (VS) and a minimally conscious state (MCS), caution is necessary when adopting the concept of PC because it has not been clearly defined. More studies are needed to better understand the actual nature of PC. Here, we focus on the practical dimensions of patient care. To this end, we discuss the basic stance and premise toward VS that is unique to Japan: that is, the stance and premise that view responses shown by VS patients in terms of whether they “might” function consciously, rather than that they “cannot” function consciously. We also note the importance of epidemiological research, and pursue a discussion aimed at improving the future clinical welfare of patients with disorders of consciousness (DOC).

Bridging Matters of Uncertainty: The Importance of Focusing on “States in Between” for Disorders of Consciousness

Johnson and Lazaridis (2018) renounce the taxonomy of “vegetative state,” arguing that there are various uncertainties that are inevitable and impossible to eliminate. They classify these uncertain...