Keiji Wada (ed.)Neurodegenerative Disorders as Systemic Diseases10.1007/978-4-431-54541-5_13

13. Social Implementation of Neurodegenerative Disease Research and Neuroethics

Tamami Fukushi¹

(1)

Platform for Regenerative Medicine, Foundation for Biomedical Research and Innovation (FBRI), Kobe, Japan

Tamami Fukushi

Abstract

Twenty-first century research and development into neuroscience has brought about new methodologies that can be used to investigate the biological basis of neurodegenerative diseases and to provide new insights into understanding neurodegenerative diseases. There is a recognition that functional and structural networks across the neural system and other biological systems in the human body may affect the occurrence and ingravescence of neurodegenerative diseases. There is also suggestion that diseases which were once considered to be different or independent may have closer relationship. Thus, it can confidently be said that neurodegenerative diseases are caused not only by the direct deficit of brain and nerves, but also by the effect on the neural system by deficits in other functional systems in the human body. This idea provides researchers with a new biological approach to neurodegenerative diseases. Various clinical studies will be conducted for subjects with neurodegenerative diseases in the near future on this basis. From the perspective of bioethics research, this chapter discusses current issues and future views regarding the research and development of treatment technology for neurodegenerative diseases by focusing on protection of the subject.

Keywords

Neurodegenerative diseaseNeuroethicsNeuroscienceNeurologyPsychiatryBrain stimulation

13.1 Introduction

13.1.1 Progress of Neurodegenerative Disease Research

Advances in neuroscience have led in recent years to changes in the environment surrounding neurodegenerative diseases. In particular, disease research into the development of treatment technology has moved on from basic biology using animal models to clinical medicine directly targeting the human brain.

For example, the visualization technologies for pathology and diagnosis have advanced. The introduction of induced pluripotent stem cell (iPS) technology has enabled reproduction of more detailed pathogenic mechanisms and pathologies at the cellular level. As a result, molecular biological understanding of neurodegenerative diseases has progressed. The approach has expanded from one that only covers neurons or part of the brain to systemic one in which the structural and functional links between organs and the brain are targeted. In addition, researcher interest has now expanded to the interaction between the material and social environments surrounding the brain and body.

The extent to which scientific understanding of neurodegenerative diseases has advanced has already been written about by many researchers. The focus of this chapter is the process by which scientific understanding of neurodegenerative diseases can be implemented socially. This process may include conducting clinical studies with patients and therapeutic intervention. Such intervention is expected to reveal which changes in the brain function of patients impact personality or cognitive ability. The results of such studies per se may provide a new research target. Taken together, it is important to impart accurate knowledge about clinical research and neurodegenerative diseases to society as well as to progress patient treatment by insuring social participation and human rights.

13.1.2 Possibility of Neuroethics for Appropriate Conduct of Neurodegenerative Disease Research

Neuroethics comprehensively treats the various issues and challenges associated with implementing neurodegenerative disease studies on behalf of society such as the social, legal, ethical, and policy implications related to advances in neuroscience. Neuroethics was established at the international conference Neuroethics: Mapping the Field held in San Francisco in 2002. Conference topics included neuroscience research into the ethics of human research into the understanding of morality. Neuroethics can also be explained as the process in which neuroscience studies with human subjects is practiced, which includes academic analysis aimed at resolving ethical issues in society. It is a discipline that fuses neuroscience with humanities and social sciences (Marcus 2002).

The origin of the word “neuroethics” is fully explained by Fukushi and Sakura (2008a, b). Cranford advocated the word “neuroethicist” as a metaphor for the role played by a neurologist in end-of-life care (Cranford 1989). Cranford’s paper emphasizes the responsibility and role played by the neurologist in an institutional ethical committee, with regard to patient care after diagnosis of neurological disorder. By contrast, Pontius (1973) used the word “neuroethics” to criticise excessive intervention in the study of development of nerve function in infants and to point up the importance of considering the long-term effect of neuroscience research on subjects’ quality of life. These two articles suggested the conceptual schema of neuroethics as originating from multiple views of neuroscience and humanity studies including bioethics, medical ethics, philosophy of mind, and research ethics (Fins 2008).

Indeed, the factors covered by neuroethics extend well beyond concerns for neuroscience research in infant development and end-of-life care. For example, there is the problem of the application criteria used for deep-brain stimulation in the treatment of Alzheimer’s disease and mental illness (New Energy and Industrial Technology Development Organization 2008, 2009). There is the problem of the psychotropic drugs used for the enhancement of cognitive ability rather than disease treatment. There is the problem of judicial decisions based on brain function measurement technologies including brain imaging. Moreover, there is the problem of the ethical process and interpretation of research results concerning human morality, religious beliefs, and a sense of discrimination which are so close to human privacy and personal secrecy (Illes 2006).

In Japan researchers have tended to use the term “nerve” as part of the translation of “neuroethic.” However, Osamu Sakura, who has played a leading role in introducing this academic area to Japan, pointed out that the Japanese translation of neuroethics should reflect the extensiveness of neuroscience and the problems posed by the involvement of unprofessional stakeholders (Fukushi et al. 2006: 2). He also recommended using the term “brain” as part of the Japanese translation.

13.2 Protection of Subjects in Neurodegenerative Disease Research

13.2.1 Suggestion from Neuroethics

Neurodegenerative disease study is expected to provide treatment technologies for patients with impaired brain function. However, since it is still in the embryonic stage, the study itself is not ready for medical service to be provided to the patient.

Ando et al. (2009) split differences in the ethical positioning of subjects between psychological research and medical research. In the case of medical research, the very existence of the patient led to the social demand for doctors and medical care. As a result medical professionals and medical research were born. The simple fact that most of the people engaged in medical research are patients is the cornerstone of the contractual relationship between doctors who provide the treatment and patients who receive it. This relationship led to the second contractual relationship in which experimental cooperation was established between subjects (patients) and researchers (doctors). Such a relationship is considered a win–win relationship in which benefits accrue to both parties by the development of new medical technologies and their application to the patient. In addition, to progress the experiment, the procedures and theories of medical ethics and bioethics are applied to the conclusion of contract.

The author now turns to how researcher’s position subjects in psychological research. Unlike medical research, the demand for psychological research is not brought on by others, it stems rather from the interests of psychologists themselves. Hence, psychological research hinges on the existence of psychologists. In other words, the contractual relationship between subjects and researchers is established using a different format from that of medical research. The goodwill of subjects is necessary since no clear practical benefits can be provided to them as a result of psychological experiments. Researchers involved in psychological research must still show as much respect to subjects as in the case of medical research, albeit in different ways. When requesting experimental cooperation, respect and acknowledgement of subjects should be kept firmly in mind.

13.2.2 Lessons from Neuroethical Discussion for the Protection of Subjects

The above discussion means that psychological research can be considered curiosity-driven research. Moreover, if medical research is at a very early stage, the ethical positioning of subjects can also be considered curiosity-driven research, or very close to it. This means that two ethical positions – medical research and curiosity-driven research – may be applied to subjects in the early stages of neurodegenerative disease research. The balance between these two ethical positions may change depending on the developmental stage, characteristics of the target disease, and whether society understands the target disease and accepts the social participation of patients. The author now introduces several examples of ethical practice designed to protect subjects, which may trigger neuroethical discussion on how best to do so in neurodegenerative disease research.

13.2.2.1 Procedures for Notification and Follow-up in Case of Incidental Findings of Subjects Who Run Potential Risks of Neurological Disease or Even Death

This issue has been debated by many stakeholders (Wolf 2011; Seki et al. 2010). In the United States, despite official guidelines not yet being established, the federal government requests funded researchers to identify procedures for adoption in research protocols regarding incidental findings (National Institutes of Health 2010; Illes et al. 2008). It is much the same in Japan, where no unified governmental guidelines have yet been established. However, the Japan Neuroscience Society highlights the necessity for proper handling of incidental findings in their revised guidelines (Japan Neuroscience Society 2009). There is also a management protocol in Japan that is project specific. For example, in the case of the Japan Children’s Study Group, the researchers found incidental findings in 40 of the 110 participants in a structural MRI study conducted in a pediatric cohort in Japan (Seki et al. 2010). They categorized these cases into four classes based on referral emergency. The parents of two participants were recommended the “routine referral” category for their child and the parents of one participant the “urgent referral” category. This led to establishment of a management protocol to deal with incidental findings of MRI research using children for non-clinical purposes. In this protocol a wide range of stakeholders are involved not only in evaluating incidental findings but also how best to handle them further, dependent of course on whether participants want to be informed of incidental findings.

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