2020, Vol.21, No.1

Necessity and directions of changing approach to vulnerability in research involving humans

Sujung Yoo , Seulbi Choi , Eun-Ae Kim | 2020, 21(1) | pp.1~24 | number of Cited : 7

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To protect the vulnerable individuals and groups (thereafter referred to as "vulnerable subjects") is an important concern in research involving human subjects such as clinical trials. The responsibility for protecting the vulnerable subjects lies with researchers and the Institutional Review Boards (thereafter referred to as the "IRBs"). In order for researchers and IRBs to protect the vulnerable subjects, they must be able to answer what the vulnerability is as well as to identify who the vulnerable subjects are. However, under the current law such as 「Bioethics and Safety Act」 and Pharmaceutical Affairs Act」, the definition of vulnerable subjects focuses more on grouping and listing those who should be considered vulnerable. Therefore, there is a lack of clear identifying criteria or methods to determine the vulnerability and the vulnerable subjects, or to accurately and flexibly identify the vulnerable subjects for each research involving human subjects and to come up with practical protection measures for them. In addition, the conventional definition and traditional approach to the vulnerability can be criticized because it involves categorical exclusion of all members of a group that have a certain characteristic. Accordingly, this approach marginalizes the vulnerable subjects, rather than protects them. In this context, this article analyzes the problems of the conventional approach to the vulnerability and the concerns related to the definition of vulnerable subjects. This article also discusses the ways to modify the legal definition of vulnerable subjects and existing approach to the vulnerability. This article analyze the contents of the Helsinki Declaration, the Belmont Report, and the International ethical guidelines for health-related research involving humans 2016 by the CIOMS. Based on the results of this analysis, we argue that the legal definition of vulnerable subjects should be presented appropriately in identifying the vulnerable subjects in research involving human subjects as a higher concept. Furthermore, we also argue that the vulnerability should be amended to understand why attention should be paid to the vulnerable subjects. Finally, we argue that the vulnerability and the vulnerable subjects should be judged not only by considering various types of vulnerability but also by comprehensively considering the overall context surrounding the research and the research subjects, and the reasons for participating as well as the reasons for excluding vulnerable subjects should also be considered.

Characteristic of neuroscience as the neuroethics research subject and the necessity of a concrete technology ethics scenario

Kuk jin-ho , Ryu, Young-Joon | 2020, 21(1) | pp.25~40 | number of Cited : 2

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'Neuroscience and technology' refers to a study that researches the structure, function, and development of the animal's nervous system and studies how to regulate the function of the nervous system through the results. It is also refer to the legal definition of the 'Brain Research Promotion Act'. Broadly, it can be included that all research areas targeting the animal nervous system can fall into this category. Specifically, all brain-related research fields, such as natural science, medicine, pharmacology, engineering, psychology, cognitive science, and anthropology, can be included in brain research. In this field, new fields are rapidly created every year, and the existing fields are differentiating or converging with other fields. In addition, the humanities research is also active in line with the rapid expansion of the domain. In 2002, at the conference hosted by the Dana Foundation in San Francisco, USA, the new definition of neuroethics suggested that neuroethical responses to neuroscience research products should not be limited to existing ethical issues, but should be addressed in a complex way, including social and legal issues. To this end, each country has begun efforts to respond to neuroethics in earnest, but due to its vagueness and confusion, it faced difficulties. Due to the characteristics of the brain research field that are different from those of other science fields, the traditional bioethical approach is facing limitations. Despite this difficulty in the recognition of brain neuroscience and technology, humanities research cannot be put off due to the large social impact of the results. This study aims to find out why it is difficult to recognize brain research as a research subject of humanities and to find solutions. In addition, the reason for the confusion of words and academic difficulties used by the brain research community is found in the complex system characteristics of the neuroscience research and its community. For that purpose, the 'Brain Research Promotion Act' and the Korea Research Foundation's academic classification are analyzed, and it is checked whether the brain research field satisfies the characteristics of the complex system. It is intended to argue that the humanities approach to the brain field with these unique characteristics requires a very specific and reality-based technology ethics scenario and the preparation of multiple scenarios for multi-domain brain neuroscience.

Accreditation for genetic counselors and a master’s program in genetic counseling and its ethics education

In Hee Choi , Koo， Young-Mo | 2020, 21(1) | pp.41~56 | number of Cited : 3

It took a long time in western medicine to come up with the NSGC definition of genetic counseling(2006), stating that genetic counseling is the process of helping people understand and adapt to the medical, psychological, and familial implication of the genetic contribution to disease. In Korea, little consensus has been made among healthcare professionals regarding the concept of genetic counseling service in hospitals. We, authors, are dissatisfied with the words of Korean translation because they are both equivocal and confusing. Believing that the Korean public’s call for supplying genetic counseling service will be in increasing demand, we examine in this article accreditation systems, home and abroad, for genetic counselors. This examination includes accreditation bodies, requirements and qualifications. We present a successful case of a master’s program in genetic counseling, open in Seoul, Korea in 2018. Charts show the composition of academic/professional backgrounds of the 29 registered students. Followed by medical ethics course syllabus from Fall 2019 semester, and in turn detailed discussion of five ethical issues described in it. They are: prenatal genetic testing for diagnosis or assisted reproductive technology; adult onset genetic disease; newborn screening and predictive/confirmatory genetic testing for minors; Direct-To-Consumer DNA testing; secondary findings in genomic research. Lastly but not the least, a sensitive issue that concerns with genetic data and the family is also examined from a genetic counselor’s point of view. We conclude this article with a suggestion that a future community of the Korean genetic counselors, should take the lead in managing potential conflicts with stakeholders, including various medical practitioners, on one hand, and promoting collaboration with each other on the other.

Necessity and condition of terms for ‘Human Embryo and Germ-line genetic modification’

Moon Hannah | 2020, 21(1) | pp.57~70 | number of Cited : 1

Can Artificial Intelligence become an Agent Like a Human Being?

Kyungsuk Choi | 2020, 21(1) | pp.71~85 | number of Cited : 7

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Journal Central

Journal of the Korea Bioethics Association 2023 KCI Impact Factor : 0.55

2020, Vol.21, No.1