• Journal of Korean Society of Archives and Records Management
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• v.17 no.3
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• pp.1-21
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• 2017

Oral history research is carried out through collecting information about a living person. The data collected from an oral history project is not a mere fact or a mass of information but accounts of persons who reveal their own personalities. For this reason, oral history research and data collection and the use of such data must be based on rigorous ethical standards. The Bioethics and Safety Law shares a similar view on human subject research, and the Institutional Review Boards includes human subject research as a subject of review and management. However, the Bioethics and Safety Law's protection of personalities and human rights focuses on life sciences methodologies, which are not suitable for qualitative research, such as an oral history of a value oriented and critical approach to human beings. This study examines the details of the Bioethics and Safety Law related to human subject research and the problems that may arise when this law is applied to subjects in humanities and social sciences such as oral history. Through this study, alternative methodologies, which can be used for oral history research, while maintaining academic autonomy, are suggested.

• The Korean Society of Law and Medicine
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• v.12 no.1
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• pp.99-131
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• 2011

To strengthen the protection of human research subjects and human materials, the Korean Ministry of Health and welfare proposed the amendment bill of Bioethics and Safety Law(2010) to the Congress. It includes so many meaningful clauses. According to the bill, the scope that this act shall apply will be expended to the research involving human subjects and human materials. In the bill, there are the principles of this act; the protection of the life, health, and dignity of the human subjects, the obtaining of the adequate informed consent, the protection of the human subject's information confidentiality and the human subject's privacy, the assessment and minimizing of the risks involved and the guarantee of the safety for the human subjects, the preparation of the special protection program for the vulnerable human subjects, and so on. According to the bill, Institutional Bioethics Review Board(the same as Institutional Review Board) will be responsible for the auditing and monitoring on the research that was approved by IBRB, conducting the education program for the researchers, IBRB members and administrative staffs, preparing of the special protection program for the vulnerable human subjects, and forming the guidelines for the researchers as well as the review of the research protocols. And the State and local governments shall take necessary measures to support the expending of the social infrastructure. In addition to, IBRB will have to be assessed and to be gained the accreditation by the Korean Ministry of Health and welfare. So, if Bioethics and Safety Law is amended, it will contribute enormously to enhance the level of the human research subjects protection. Also, if this Law is amended, IBRB will play a major role for the conduct of the ethically, scientifically, and legally proper research. But now, as a matter of fact, the capability of IBRB members and IBRB office members is not enough to charge of this role because some people and some organizations does not know the importance of IBRB exactly. In spite of, IBRB shall be able to this role to protect the human subjects and to develop the level of the research On the international level. Therefore, the State, local governments and the Organization shall back up the administrative and financial terms of the IRB and IRB Office.

• Korean Journal of Childcare and Education
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• v.14 no.2
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• pp.1-17
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• 2018

Objective: The purpose of this paper is to understand the bioethics and the Institutional Review Board (IRB) in the social and behavioral research area through "The Bioethics and Safety Act" and to examine the IRB's present situation, roles, responsibilities, and tasks. Methods: This paper reviewed articles, materials for education, and "The Bioethics and Safety Act" related with the IRB. Results: Bioethics included all the research in the social and behavioral area, and "The Bioethics and Safety Act" has been enforced in every research projects targeting human subjects since February 2, 2013. Accoding to the law, the IRB must review the research proposals for human subjects and was introduced in social and behavioral research as a self-regulating system. At present, all the related institutions including universities must establish and run the IRB. This paper introduced the definition of bioethics, the IRB's roles and review types, the total number of registered IRB, and "The Bioethics and Safety Act". Conclusion/Implications: Both the central government and the local government have to make an effort for the establishment and settlement of the IRB system. This paper also presented some of the problems of the IRB.

• Health Policy and Management
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• v.19 no.2
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• pp.1-20
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• 2009

This paper examines some relations on national crisis management and bioethics. This study stars to discuss that chance and risk of biotechnology which is the 21st century's pioneering core technology. This study reviews the traditional method that a nation(law) copes with the new scientific technique. The study also examines some difficulties of social agreement on the problems of bioethics because of nature of the rational disagreement. Then this paper attempts to incorporate the crisis of biotechnology, especially bioethics, in the system of national crisis management. this paper reviews the contents of the domestic "Act on Bioethics and Safety" on the side of the protection and restoration of crisis management. And this paper proposes some changes to manage the crisis of bioethics better, as it were, some problems of IRB and schems for improvement of it.

• The Korean Society of Law and Medicine
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• v.20 no.2
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• pp.111-140
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• 2019

The Bioethics and Safety Act provides a set of rules to regulate biobanks and research activities using human biological material, but the law seems to be defective in several folds. The law requires that, prior to collection or use of human biological materials, researchers should obtain the informed consent of the donors, but the law does not obligate biobanks to do so. Even in cases where the law requires informed consent, the ordinance of the Ministry of Health and Welfare allows open (or blanket) consent. In addition, a new article in the Act, Article 42-2 which will take effect from October 24, 2019, allows medical institutions to provide biobanks with remaining biospecimens collected in the course of diagnosis and treatment, unless the donors express their intent to opt-out, without obtaining specific consent from them. Given the need to protect the autonomy of donors and the unique characteristics of biobanks and research activities that use human biological materials, this paper concludes that such open consent-based law may not be suitable to protect the autonomy of the donors and that the broad consent requirement may be a desirable policy option. The paper acknowledges that the international community has long questioned whether broad consent (as well as open consent) is an effective choice to regulate the use of human biological materials. The paper stresses that the baseline requirement in designing the law is that the secondary use of human biological materials should be based on informed consent of the donors; the core value of the law should be a governance structure that promotes transparency and protects donor participation.

• Korean Medical Education Review
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• v.21 no.3
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• pp.143-149
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• 2019

In 2018, The Ministry of Health and Welfare announced its first comprehensive plan for patient safety, which included the imperative to develop a patient safety curriculum for students studying to become health professionals. The aim of this study is to assess current patient safety education and points of consideration for introducing new curriculum. An online survey was used to understand the status of patient safety education in medical schools, and key informant interviews and focus group interviews were used to collect qualitative data on the experience of patient safety education. The results of the online survey from 16 out of 40 medical schools (40% response rate) and the qualitative data analysis were integrated and analyzed. Twelve schools (75%) had established courses related to patient safety. The qualitative responses suggest that patient safety education is appropriate both before and after clinical training through a variety of educational methods, and that the topics should be linked with clinical training. The challenge of securing lecture time to address patient safety was mentioned as a realistic obstacle. When patient safety education is integrated in future curriculum, it is necessary to consider it as a priority. Moreover, in the early stages of introducing patient safety education, a step-by-step, policy-based approach is required for seamless adoption and settlement.

• The Journal of KAIRB
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• v.1 no.2
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• pp.30-42
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• 2019

In pharmaceutical clinical trials as human material research, the collection, use, storage and provision of human materials must be in accordance with the criteria stipulated in 「Bioethics and Safety Act」, except in the case that some criteria about it is in the law related to clinical trials such as 「Pharmaceutical Affairs Act」 and 「Enforcement Rule on Safety of Drugs, etc.」 so these take precedence over. Under 「Bioethics and Safety Act」, the core aspect of the legal standard for obtaining informed consent is the use of statutory form . The use of statutory form ensure that both those who obtain informed consent and those who give it can know the contents contained this form as well as recognize its importance. Thus, the person who has the right to informed consent can sign the statutory form after correct understanding of the contents. In reality, however, some researchers and IRB members determine that only the main informed consent form is to be used because most of contents on statutory from are included in the main informed consent form. Some other researchers and IRB members judge that the use of statutory form is not needed if human materials may only be used for laboratory testing and the rest will not be stored and provided for future use. Most of these determination and judgement is based on the interpretation of the Korea National Institute for Bioethics Policy(hereafter, KoNIBP) on IRB Information Portal Site. But, it is questionable whether the KoNIBP's interpretation is legally valid and the KoNIBP is the legal entity having authority to interpret existing statute. In some cased not only using the main informed consent form including enough information about the collection, use, storage and provision of human materials but also collecting necessary minimum human materials, and discarding the rest, unusing the statutory form may not cause the problem to respect and protect the research participant's rights. Therefore, the provision stipulating the criteria about the use of statutory form as the legal standard of obtaining informed consent that applies all human material research without exception should review to revise. At least, straighten out the confusion surrounding whether or not the statutory form is to be used, before the revision of related provision, considering the logical opinions of some researchers and IRB Members, the Ministry of Health and Welfare as the legal entity having authority to interpret existing statute should represent its opinion about permission of the acceptable exceptions.

• 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.

• The Korean Society of Law and Medicine
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• v.22 no.3
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• pp.57-95
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• 2021

Korea's period for preservation of embryos is up to five years (the Bioethics Act). However, the study reviewed domestic and foreign laws and drew issues due to the recent demand that the development of related science and technology and the period limitation limit the rights of consent holder for embryo production. the first issue is that preserved embryos are intended for pregnancy, and it is important to ensure that the autonomy of the consent holder is protected through careful consideration based on information such as scientific evidence. the second is that regulations regarding the obligation to manage embryonic preservation institutions are needed. the third is to create a social atmosphere in which embryo creation, preservation, and disposal take place in a minimum range, considering the special status of embryos. based on this issue, the first of the proposals for rational improvement of the regulation and system about embryo preservation is the introduction of an environment in which sufficient explanation and appropriate consent can be exercised and to extend the reasons for the extension of the period, rather than specifying the specific period in law. the second is that institutionalization is necessary considering not only the obligation to manage preservation institutions but also the overall site, such as concerns that may arise as a result. lastly, we propose the introduction of a management method considering the future use of embryos, such as transfer to provide research purposes and donation of pregnancy purposes by others. this process should be a method of sufficient social discussion and consensus, as well as a general consideration of the family relationship with the born child.

• The Korean Society of Law and Medicine
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• v.18 no.1
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• pp.237-264
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• 2017

With the onset of the Human Genome Project, social concerns about 'genetic information discrimination' have been raised, but the problem has not yet been highlighted in Korea. However, non-medical institutions' genetic testing which is related to disease prevention could be partially allowed under the revised "Bioethics and Safety Act" from June 30, 2016. In the case of one domestic insurance company, DTC genetic testing was provided for the new customer of cancer insurance as a complimentary service, which made the social changes related to the recognition of the genetic testing. At a time when precision medicine is becoming a new standard for medical care, discipline on genetic information discrimination has become a problem that can not be delayed anymore. Article 46 and 67 of the Bioethics Act stipulate the prohibition of discrimination on grounds of genetic information and penalties for its violation. However, these broad principles alone can not solve the problems in specific genetic information utilization areas such as insurance and employment. The United States, Canada, the United Kingdom, and Germany have different regulations that prohibit genetic information based discrimination. In the United States, Genetic Information Non-Discrimination Act takes a form that adds to the existing law about the prohibition of genetic information discrimination. In addition, the range of genetic information includes the results of genetic tests of individuals and their families, including "family history". Canada has recently enacted legislation in 2017, expanding coverage to general transactions of goods or services in addition to insurance and employment. The United Kingdom deals only with 'predictive genetic testing results of individuals'. In the case of insurance, the UK government and Association of British Insurers (ABI) agree to abide by a policy framework ('Concordat') for cooperation that provides that insurers' use of genetic information is transparent, fair and subject to regular reviews; and remain committed to the voluntary Moratorium on insurers' use of predictive genetic test results until 1 November 2019, and a review of the Concordat in 2016. In the case of employment, The ICO's 'Employment Practices Code (2011)' is used as a guideline. In Germany, Human Genetic Examination Act(Gesetz ${\ddot{u}}ber$ genetische Untersuchungen bei Menschen) stipulates a principle ban on the demand for genetic testing and the submission of results in employment and insurance. The evaluation of the effectiveness of regulatory framework, as well as the form and scope of the discipline is different from country to country. In light of this, it would be desirable for the issue of genetic information discrimination in Korea to be addressed based on the review of related regulations, the participation of experts, and the cooperation of stakeholders.