• The Korean Society of Law and Medicine
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• v.22 no.4
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• pp.37-55
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• 2021

On March 19, 2021, the Korean Bioethics Association and related academic circles published a joint statement criticizing the partial revision of Infectious Disease Control And Prevention Act. However, according to the Bioethics And Safety Act of Korea, research conducted by the state or local governments for public welfare is excluded from human subjects research project. In addition, since the Korean legal system is not based on the dichotomy between research and surveillance, the discussion of the US Common Rule cannot be directly applied to Korea. For the harmonious operation of the state's duty to manage infectious diseases and the Institutional Review Boards, institutional alternatives should be prepared in consideration of the following issues. First, the related academic community should first pay attention to the problems of the current laws in Korea. Second, it should be understood that the state is carrying out many tasks without the consent of the parties in order to fulfill its duty to manage infectious diseases. Third, when presenting institutional alternatives, it is necessary to consider the feasibility of implementation in Korea. An in-depth discussion of the institutional alternatives by the Medical Law Society and other related academic circles is necessary.

• The Korean Society of Law and Medicine
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• v.23 no.1
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• pp.121-148
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• 2022

CRISPR-Cas9 is one of the gene-editing technologies that infinite potential. It may provide human beings with many benefits or cause unanticipated challenges. The governance as standards setting or regulation of gene-editing technologies can contribute to keeping a balance between scientific value and ethical commitments. Guaranteeing public participation provides an additional opportunity to think about ethical and moral considerations: For whose benefit the internationally discussed governance of gene-editing technologies is directed at? There is a doubt regarding whether the governance justifies scientific researchers' gene-editing research. Suppose that governance promotes the advancement of CRISPR-Cas9, it should also encourage greater research responsibility. If not, there may be tragedies brought about by the misconduct of researchers. Thus, the essential matter on the governance for the research of CRISPR-Cas9 is the researchers' responsibility.

• Quality Improvement in Health Care
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• v.23 no.2
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• pp.37-54
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• 2017

Objectives: The purpose of this preliminary study was to identify the nurses' perception regarding disclosure of patient safety incidents (DPSI) and to evaluate the effectiveness of education for DPSI. Methods: DPSI education was conducted for nurses majoring in clinical nurse specialist at an university. Before and after the education, the nurses made a questionnaire to evaluate the perception of DPSI. The questionnaires were divided into four categories: first, overall perception of the DPSI; second, recognition evaluation of the DPSI using hypothetical case, third, opinion on legal and nonlegal measures for facilitating the DPSI; and fourth, socio-demographic factors. The Wilcoxon signed rank test was performed on the DPSI questionnaire response to compare the perceptions before and after the education. Results: A total of 10 nurses participated in the education. DPSI education showed the possibility of improving the overall perception, necessity, effect, obstacle, and promotion method of DPSI, although there were also several responses where there was no statistical significance. In particular, DPSI education led to statistically significance change in the perception of obstacles for DPSI. For example, the number of respondents who agreed to the item "DPSI will increase the incidence of medical lawsuits." was 7 before education but decreased to 3 after education (P-value: .025) Furthermore, nurses' perception of DPSI from this study was generally positive regardless of education. Conclusion:In the future, it will be necessary to carry out DPSI education and training and to evaluate its effectiveness for more nurses.

• Development and Reproduction
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• v.21 no.3
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• pp.343-349
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• 2017

tWith the development of the third-generation gene scissors, CRISPR-Cas9, concerns are being raised about ethical and social repercussions of the new gene-editing technology. In this situation, this article explores the legislation and interpretation of the positive laws in South Korea. The BioAct does not specify and regulate 'gene editing' itself. However, assuming that genetic editing is used in the process of research and treatment, we can look to the specific details of the regulations for research on humans as well as gene therapy research in order to see how genetic editing is regulated under the BioAct. BioAct differentiates the regulation between (born) humans and embryos etc. and the regulation differ entirely in the manner and scope. Moreover, due to the fact that gene therapy products are regarded as drugs, they fall under different regulations. The Korean Pharmacopoeia Act put stringent sanctions on clinical trials for gene therapy products and the official Notification "Approval and Examination Regulations for Biological Products, etc." by Food and Drug Safety Administration may be applied to gene editing for gene therapy purposes.

• Quality Improvement in Health Care
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• v.29 no.2
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• pp.15-31
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• 2023

Purpose: This study aimed to identify the characteristics of patient safety incidents (PSIs) related to nursing and to provide primary data for preventing the recurrence of similar incidents. Methods: This secondary analysis study included damage claims rulings filed for clinical negligence from 2014 to 2018 that contained the keyword 'nurse'. It excluded judgments irrelevant to nursing care and in which clinical negligence or causal damages were overruled. A total of 93 cases were analyzed. The characteristics of PSIs were derived through descriptive statistics, and two instances of nursing-related PSIs were examined by qualitative content analysis focusing on root causes. Results: The analysis of PSIs related to nursing suggested that the medical institutions where the PSIs occurred most frequently were hospitals, and the most common types of PSIs were medication, surgery, and treatment/procedure, in that order. In addition, it indicated that nursing-related PSIs occurred most frequently in general wards during the day shift, with the most common related nursing practice being managing potential risk factors. The qualitative analysis showed that careless monitoring and institutional inertia were causes of PSIs. Conclusion: To prevent nursing-related PSIs, nurses need to individually monitor and assess patient conditions. In addition, support should be accompanied by the improvement in the systems in place aimed at preventing the recurrence of nursing-related PSIs at the institutional and national level, such as securing appropriate nursing personnel and improving labor conditions.

• Journal of the Korea Society of Computer and Information
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• v.18 no.4
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• pp.161-169
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• 2013

Currently, there is no bill about Maternal Inference and the Family Law about surrogate birth in Korea. Also, Problems of surrogate mother were reported by media socially, but these discussions did not discuss continuously. Early in the course that establishing process of Bioethics and Safety Act, there was a discussion. But it cannot acceptance as Act, it issued legally and ethically. Despite the difficult of legal interpretation and ethical problem, the surrogate birth practiced covertly and frequently. And about this, our law just declared its invalidity because it is contrary to public order and good moral until recently. Therefore, if it leaves as invalidation, the problem about right of surrogate mother and the baby from her it may occur a serious social problem. From now, about the issue of surrogacy contracts the legal and medical countermeasures to be taken. Therefore, to solve many problems about surrogacy contract, consider the problem of surrogacy contract, also suggest legislative study about Korean surrogate mother based on legislative cases of foreign countries.

• Journal of Korean Academy of Nursing
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• v.49 no.6
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• pp.760-770
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• 2019

Purpose: The role of registered nurses is expanding in scope as the healthcare paradigm shifts from acute, hospital-based care to community and population-based care. Given this paradigm shift, this study explores the legal aspects of the role of a registered nurse. Methods: We used document analysis for extracting laws and legal orders related to nursing from the entirety of Korean law. Using textualism approach, we examined the contents utilizing a framework that was developed based on the role classification of community nurses by Clark in this study. Results: A total of 119 items related to nursing were derived from 64 laws. Of these, 71.4 % can be performed by people in multiple types of occupations including nurses. As a result of analyzing required qualifications, 45.4% of 119 items required additional qualifications besides registered nurse license. Analysis of workplace and activity type demonstrated that 26.1% of the 119 items were related to medical institutions, with nurses performing mostly "Client-oriented role." More than half (68.9%) were non-medical institutions, with nurses performing mostly "Delivery-oriented role." Some, however, did not stipulate the nurse's roles clearly. Conclusion: Therefore, to match the enhanced scope and responsibilities of registered nurses and to appropriately recognize, guide, and hold these nurses accountable, laws and policy must reflect these changes. In doing so, these updated laws and policies will ultimately serve as a basis for improving the quality and safety of nursing services.

• Quality Improvement in Health Care
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• v.26 no.1
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• pp.23-34
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• 2020

Purpose: This qualitative study was conducted to examine the current status and problems concerning the collection of present on admission (POA) indicators and determine how to use these indicators for evaluating the quality of care and degree of patient safety. Methods: A total of 11 health information managers were divided into two groups according to the size of their hospitals. Two focus group discussions (FGDs) were conducted, one for each group, which followed a pre-developed semi-structured guideline. The verbatim transcriptions of the FGDs were analyzed. Results: The majority of participants were concerned about entering POA flags honestly because they did not know how future POA indicators would be used. In particular, for some participants, POA N was a burden that could imply a signal of mismanagement within the medical institution. In addition, the lack of awareness and indifference of physicians regarding POA indicators were some of the difficulties for POA flag entry. Although medical institutions are making efforts to improve the accuracy of POA flagging, many participants mentioned the need to develop real case-oriented POA entry guidelines to improve the accuracy of POA flagging. Conclusion: To increase the validity of POA indicators, it is necessary to increase the level of awareness of POA indicators in physicians and other medical professionals. Furthermore, efforts related to POA indicators by individual medical institutions need to be reflected in the process evaluation.

• Health Policy and Management
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• v.23 no.4
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• pp.314-325
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• 2013

Background: Stem cell research competition is accelerating globally since President Obama signed an executive order, repealing Bush-era policy that limited use of federal tax dollars for embryonic stem cell research. Methods: In this paper, we conducted a comparative analysis of stem cell research policy changes in three countries, including the Human Fertilisation Embryology Act (HFEA) of UK, executive order 13,505 (removing barriers to responsible scientific research involving human stem cells) of USA, and Bioethics and Safety Act of South Korea. Debates on stem cell research are based on conflicts of fundamental beliefs that exist in the supporting and opposing coalitions. We compared regional characteristics of the advocacy coalitions in three countries and presented various factors that might be related to the policy changes. Results: The UK government, parliament, and the HFEA have sought expert consultations and public opinions to establish guidelines. UK has made social consensus through continued discussion for a long time. US President's veto power was one strongest factors influencing policy. South Korean policy was influenced by public opinion and policy brokers. Also, South Korea has not made social consensus. UK had a strong leadership and strong adjustment of coalitions but US and South Korea had not. Dr. Hwang's scandal has had one of the greatest impacts on policy decision in South Korea. Conclusion: The power of public opinion was critical in all three countries. In particular, the influence of public opinion was noticeable in South Korea. Also it turned out that in US and South Korea, the presence of a policy broker who could pursue his or her goals was the most powerful factor among the advocacy coalition factors.

• The Korean Society of Law and Medicine
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• v.22 no.3
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• pp.31-55
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• 2021

The Personal Information Protection Act, one of the revised 3 Data Laws, established a special cases concerning pseudonymous data. As a result, a personal information controller may process pseudonymized information without the consent of data subjects for statistical purposes, scientific research purposes, and archiving purposes in the public interest, etc. In addition, as a follow-up to the revised Personal Information Protection Act, a 'Guidelines for Utilization of Healthcare Data' was prepared, which deals with the pseudonymization in the medical sector. The guidelines are meaningful in that they provide practical criteria for accomplices by defining specific interpretations and examples that take into account the characteristics of healthcare data. However, the guidelines need to clarify the purpose of using pseudonymous data and strengthen the fairness of the composition of the data deliberation committee. The guidelines also require establishing a healthcare data compensation framework and strengthening the protection of rights for vulnerable subjects. In addition, the guidelines need to be adjusted for inconsistency with the Bioethics and Safety Act and the Medical Service Act. It is expected that this study will contribute to the creation of a safe environment for the utilization of healthcare data as well as the improvement of related laws and systems.