• 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.

• The Journal of KAIRB
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• v.2 no.1
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• pp.1-5
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• 2020

The U.S. Department of Health and Human Services and fifteen other Federal Departments and Agencies have issued final revisions to the Federal Policy for the Protection of Human Subjects (the Common Rule, 45 CFR 46, Subpart A). The Common Rule was initially promulgated in 1991 and amended in 2005. The Final Rule to update the current regulations was published in the Federal Register on 19 January 2017. The final compliance date of the revised Common Rule including the cooperative research requirement is effective on 20 January 2020 after twice to delay. The revised Common Rule aims to make more effective conduct of minimal risk research reflecting modern research activities and recognize evolving technologies, including mobile technologies, internet, and the growth in computing power. The revisions to the Common Rule were based on a variety of sources of public, stakeholder, and expert comments. The author summarized the key changes and the implications to Korean human research regulations.

• Korean Security Journal
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• no.2
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• pp.227-258
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• 1999

In a broad sense, ‘After-care SYSTEM’ for discharged prisoners mean legal actions of prisoners who have been released from lawful detention In its narrow sense, mean preventive protection and observation activities under regular guidance and supervision against those released from penal facilities after a certain period of detention Therefore, they should not be viewed as objects of mere concern or social work programs but preventive protection should he provided to them as part of national criminal policy After-care system is in the following two ways, The one is based on individual prisoner's request and consent, which is called 'Voluntary After-care system', The other is the one which is not based in personal request or consent but is based on obligation, which is named 'Compulsory After-care system In Korea, however no Compulsory After-care system is in practice Voluntary After-care system is to be carried out 6 method in the following by existing Probation, Parole Law. (1) offer of board and lodging (2) allowance of Traveling expense (3) allowance of occupation instrument or lending rehabilitation fund (4) training of occupation and vocational guidance (5) self-reliance support for After-care probationer (6) guidance of good deed And then to establish the society without offenders is the ideal of human beings, but criminal acts don't fade away, so in the field of the science of criminology, the importance of correctional system has become greater. The correctional idea has moved from severe punishment to educational rehabilitation for the goal of protecting both offender and security from the threat of crime in to day Some it is required that Compulsory After-care system is most important system in effective measures, and that existing Probation, Parole Law in Korea is renewed into Compulsory After-care system in the future.

• The Journal of Asian Finance, Economics and Business
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• v.8 no.5
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• pp.979-986
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• 2021

Online food delivery and food delivery apps have continued to grow exponentially in Malaysia. Fundamental aspects in entrepreneurship of the food and beverage industry, such as knowledge and attitudes towards online food delivery services being outsourced, have yet to be extensively recognized. The present study intends to explore this area of subject matter within the Malaysian context by using behavioral reasoning theory. The actual interview for this study took place in May 2020, and 14 interviews had been carried out. All interviews were audio-recorded with the consent from the respondents for reference purposes and subsequently transcribed verbatim. The transcripts were then checked against audio records. Content analysis was used to analyze the transcripts by focusing on n frequency counts and coding of themes. A qualitative method has been adopted by employing an interview to elicit the perspectives of entrepreneurs from Sarawak on the determinants and barriers in outsourcing online food delivery services. Results indicate that high potential in revenue, broad exposure to reach customers, convenience, and provision of job opportunities are the four factors that determine to outsource. In contrast, food quality maintenance, trustworthiness, high cost incurred, and consumer technology resistance are four factors that serve as barriers towards outsourcing third-party online delivery.

• The Korean Society of Law and Medicine
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• v.13 no.1
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• pp.359-395
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• 2012

In a broad term, health and medical data means all patient information that has been generated or circulated in government health and medical policies, such as medical research and public health, and all sorts of health and medical fields as well as patients' personal data, referred as medical data (filled out as medical record forms) by medical institutions. The kinds of health and medical data in medical records are prescribed by Articles on required medical data and the terms of recordkeeping in the Enforcement Decree of the Medical Service Act. As EMR, OCS, LIS, telemedicine and u-health emerges, sharing and protecting digital health and medical data is at issue in these days. At medical institutions, health and medical data, such as medical records, is classified as "sensitive information" and thus is protected strictly. However, due to the circulative property of information, health and medical data can be public as well as being private. The legal grounds of health and medical data as such are based on the right to informational self-determination, which is one of the fundamental rights derived from the Constitution. In there, patients' rights to refuse the collection of information, to control recordkeeping (to demand access, correction or deletion) and to control using and sharing of information are rooted. In any processing of health and medical data, such as generating, recording, storing, using or disposing, privacy can be violated in many ways, including the leakage, forgery, falsification or abuse of information. That is why laws, such as the Medical Service Act and the Personal Data Protection Law, and the Guideline for Protection of Personal Data at Medical Institutions (by the Ministry of Health and Welfare) provide for technical, physical, administrative and legal safeguards on those who handle personal data (health and medical information-processing personnel and medical institutions). The Personal Data Protection Law provides for the collection, use and sharing of personal data, and the regulation thereon, the disposal of information, the means of receiving consent, and the regulation of processing of personal data. On the contrary, health and medical data can be inspected or delivered of the copies, based on the principle of restriction on fundamental rights prescribed by the Constitution. For instance, Article 21(Access to Record) of the Medical Service Act, and the Personal Data Protection Law prescribe self-disclosure, the release of information by family members or by laws, the exchange of medical data due to patient transfer, the secondary use of medical data, such as medical research, and the release of information and the release of information required by the Personal Data Protection Law.