KJCKorea
Journal Central

Korean bioethics has to study responses to ethical, legal, and social issues raised neuroscience and technology, data science and technology, nano science and technology like ELSI research. In addition, Korean bioethics needs to focus on fundamental issues like the relevance of core ethical notions with neural activities, the possibility of commercial use of information, citizens’ participation in the investment and allocation of public fund for scientific research. The traditional topics of bioethics tends to be extended into the whole areas of our life by the development of scientific technology and its fusion beyond the area of medicine and bio-sciences. Thus, the discourse bioethics has developed has a responsibility to deal with new issues in the comprehensive scope of our life. Bioethics developed in the U.S.A. has the limitation in that it has gave weight to policies. However, the study of life is considered to be a main topic of bioethics in the East Asia where “bio” in “bioethics” has been thought to refer to “life” rather than “biology.” Thus, bioethics in the East Asia is required to do interdisciplinary research on fundamental concepts in a human life like reproduction, family, healthy life, aging, and death that dominate a human life as well as the status of embryo or fetus. Further, Korean bioethics struggles with the conflicts between the Western and the Eastern values and between the old and the new. Thus it has to contribute to an international bioethical discourses by providing a perspective the Western loses. Korean bioethics has focused on policy issues related to legislation. But it has to study the balance between the role of law and that of ethics, and to boost the research related to communication for social consensus, even for policy-making.

Since the 2000s, medical science researches in South Korea have been governed by three major laws - the Bioethics and Safety Act, the Pharmaceutical Affairs Act, and the Medical Devices Act. The Pharmaceutical Affairs Act is in charge of regulating clinical trials that authorize new medical products; meanwhile, human subject researches other than clinical trials are subjects to the Bioethics Act. However, the development of new cutting-edge medical research, such as new health technology and 3D printers, has gradually blurred the boundaries of clinical trials and non-clinical trials. Governance system has been challenged by demands from medicine and pharmaceutical industry, especially in areas other than clinical trials. For example, in South Korea, clinical trials should be conducted only in clinical trial institutions under the Pharmaceutical Affairs Act and the Medical Devices Act. Besides, the number of cases is growing to offer highly advanced treatments such as cellular therapy and conduct human subject research other than clinical trials, which can demonstrate positive effects without complying with the strict standards of clinical trials. Developing new medical products and devices or developing off-label uses of existing medicines and medical devices is subject to the application of 'clinical tests' under the Pharmaceutical Affairs Act and the Medical Devices Act. Meanwhile, examining these new medical techniques with existing medical procedures is often ambiguous to apply to the Pharmaceutical Act. Although the Advanced Regenerative Medicine Act was enacted in August 2019 to fill these regulatory gaps, there is a limit to providing regulations equivalent to the previous level of regulations. This study explores two examples of challenging the boundaries of these clinical trials and non-clinical trials: cellular therapy and 3D bioprinter technology. In the case of cellular therapy, if it is proven effective through treatment in a hospital, the government recognizes the treatment as a 'limited medical technology' and is allowed to introduce clinical trials. However, the KFDA believes that research on the effectiveness of medical treatment is not a traditional clinical trial. This position, which strictly distinguishes medicines from medical treatment, makes it difficult to assess the ethics and safety of medical treatments. 3D bioprinter technology is also controversial whether each of the equipment made by this technology is a new medical device. Every time 3D bioprinter makes products, evaluating compatibility with regulations, and developing guidelines toward the components of products becomes uneasy tasks for industries and authorities. If advanced medicine evolves into a pre-created, clinical, fast-track in the future, like precision medicine, it is likely to challenge a standardized regulatory approach, and difficult to interpret as traditional clinical trials. Such cutting-edge medical treatments are expected to pose a new challenge to Korea's medical science regulations in the future.

Despite recent developments in medical and biotechnology, most people die while undergoing intensive life-sustaining treatments in emergency rooms or intensive care units. Amid these social practices, the “Grandmother Kim case” opened a forum for public debate about the necessity to improve social awareness and about the legalization of life-sustaining treatments that are indiscriminately applied to dying patients. As a result, the “Act on Hospice and Palliative Care and Decisions on Life-Sustaining Treatments for Patients at the End of Life” was enacted and has been in effect since February of 2018. The ‘Life-sustaining Treatment Decision-making Act’, currently in effect, was enacted for the purpose of comprehensively considering the patient's autonomy regarding the application of life-sustaining treatments and the quality of death through hospice and palliative care during the medical decision-making process at the end of life. However, because this law does not properly consider the reality of the medical setting in the intensive care unit environment and the various dilemma situations that arise during the actual intensive care unit life-sustaining treatment decision process, this law has fundamental limitations in securing a dignified death for patients. The purpose of this study is to examine the various experiences of intensive care unit nurses in life-sustaining care decisions-making and end-of-life care after the implementation of the Life-sustaining Treatment Decision-making Act ultimately to determine whether the law is properly operating in accordance with the purpose of its enactment in the actual medical field. In addition, by grasping the significant strengths and weaknesses of related systems which have arisen since the implementation of the Life-sustaining Treatment Decision-making Act, this study attempts to derive improvement measures pertaining to life-sustaining treatment decision-making for the dignified death of patients and end-of-life care environments. This study is expected to provide important research data for both institutions and those involved in policy development, leading to practical improvements of end-of-life care environments. However, since this study focused on the experiences of nurses in the intensive care unit of a local general hospital, there are limits to generalizing the results of this study.