• 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.

• Journal of Korean Academy of Nursing
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• v.45 no.3
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• pp.315-322
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• 2015

Purpose: This paper was written to introduce methods of using the research ethics committee (RES) from requesting the initial review to reporting the close-out for nursing researchers. Methods: General ethical principles were described by reviewing the 'Bioethics and Safety Act' and other related guidelines, and constructing some questions and answers. Results: The results were composed of three parts; definition of RES, steps in using RES, and archiving. The 7 steps for using RES were; identifying whether the study needed to be reviewed, by the RES identifying whether the study could be exempted, requesting the initial review after preparing documents, requesting the re-review, requesting an amendment review, requesting a continuing review and reporting the close-out. Conclusion: Nursing researchers need to receive RES approval before starting nursing research involving human subjects. Nursing researchers are urged to use the steps reported in this paper to receive RES approval easily and quickly.

• 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.

• The Korean Society of Law and Medicine
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• v.19 no.1
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• pp.81-111
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• 2018

Recently in Korea, public interest about patient safety has increased because patient safety incidents occurred continuously. In addition, as the way of coping with medical personnel and medical institutions after occurrence of patient safety incident became controversial, the necessity of introducing apology law and disclosure law was raised. We analyzed the contents of apology law and disclosure law in U.S.A and critically examined the legislative movements in Korea. First, the Apology law requires that a medical personnel provide apology, consolation, sympathy to the patient for discomfort, pain, damage or death, and that the expression of apology shall be inadmissible as evidence of an admission of liability in civil action or administrative proceeding. The Apology law is divided into 'full apology law' and 'partial apology law' depending on whether mistake, error, fault, liability, and legal liability shall be inadmissible. Meanwhile, Disclosure law enforces or voluntarily enforces the law to communicate with the patient regarding the disclosure of the incident, the cause of incident, the compensation plan, and the measures to prevent the recurrence in the adverse incident that serious harm to the patient. In Korea, the concern about patient safety incidents has been amplified, and as the importance of communication between the medical personnel and patient has been recognized, the revision bill for the "Patient Safety Act", which adopted the U.S.A apology or disclosure law, was submitted to the National Assembly. The purpose of this study was to critically review the contents of the revised legislation based on the analysis of the apology law and disclosure law in U.S.A. and to provide implications for future legislative direction.

• 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.

• Journal of Science and Technology Studies
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• v.14 no.1
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• pp.59-85
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• 2014

This study aims to highlight the social aspects of genetic discrimination as another shadow that biotechnology can influence on social life. To do so, the definition of "genetic discrimination" and three perspectives (exceptionalism, expressivism, and human right discourse) were reviewed. In addition, the Genetic Information Nondiscrimination Act (GINA) of the United States and the Bioethics and Safety Act of Korea were analyzed. Several social implications for establishing the research and policies of genetic discrimination based on the existing research results of perceived genetic discrimination (the experiences, fears, and coping strategies of genetic discrimination) were suggested. These included public consensus on the definition of genetic discrimination and emphasis on a human rights approach against genetic discrimination; concerns regarding genetic discrimination in both the personal and public domains; raising the consciousness of both health care providers and the public regarding genetic discrimination; and developing psycho-social coping strategies for decreasing the fear of discrimination of asymptomatic people (hereditary carriers).

• 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.

• 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.