• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.125-144
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• 2016

All forms of Clinical trial should be fully equipped with protection systems for experimental subjects considering their uncertainty and various risks. Existing laws have some regulations in pharmaceutical affairs act and medical device act. Nonetheless, there is a limit to protect the subjects considering law objective to perform administration of medicine. Furthermore, the clinical trial on minor has no direct regulations in pharmaceutical affairs act, but prescribes certain portion in clinical trial assessment guideline on infants or medicine clinical trial management standard, however there is a limit because that is just recommendation not having legal effectiveness. The legislative solution would be possible for legal problems of clinical trial on minor by examining treatment system on minor in organ transplant act and clinical trial on minor in other foreign laws stronger than usual medical practice in terms of degree of human body invasion. I suppose that the control system of clinical trial being done focusing on the pharmaceutical affairs act, medical device act and other guidelines in existing laws system should be resolved by legislating 'trial subject protection law', in addition, this would be well balanced in organ transplant act on protection system of minor organ donors. Furthermore, the judgement on the consent ability and spontaneity in clinical trial on minor should be judged considering maturity and mentality of minor by clinical trial institutional review board based on legislative solution mentioned above.

• Journal of the HCI Society of Korea
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• v.7 no.2
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• pp.25-34
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• 2012

A veterinary student learns and experiences veterinary processes though experiments and practices using real animals. However, animal protection laws regulate animal experiments and restrict number of the experiments on laboratory animals, veterinary students would have less chances of the experiments and the practices for their veterinary training with real animals. This paper proposes a simulator for veterinary education based on augmented reality (AR). We selected an intravenous injection procedure for the simulation because the injection procedure is the most frequently used procedure during veterinary training and the most difficult stage for beginning veterinary students. The proposed AR simulator provides with a tangible prop, of which shape looks like a leg of a real dog. It also has a injection simulator, which receives user's input and sends force feedbacks to indicate results of the injection simulation. We developed a WorkBench type AR system with an LED display and cameras for visual information processing. Finally, we evaluated its performance through experiments and user studies to check its acceptance level and usability of the proposed system. We compared the proposed system with a traditional video based education and an AR based system using a head mounded display (HMD). The results that the proposed system showed better performances over these systems.

• The Korean Society of Law and Medicine
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• v.20 no.1
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• pp.109-132
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• 2019

Recently, medical accidents related to surgical procedures have increased. In addition, the media reported that some of these accidents were involved in health crimes. Patient-advocate groups have called for mandatory establishment and management of CCTV in operating rooms. There is a lot of discussion among the interested parties, so it is necessary to review the relevant laws and regulations. The purpose of this study is to identify the characteristics of CCTV in operating rooms and to review legislations related to establishment and management of the CCTV in operating rooms. Medical institutions use CCTV for management of facilities and patient safety and install it in operating rooms optionally. The Constitution guarantees the privacy and the privacy of correspondence of every citizen, but it can be limited by the law for public welfare. Currently, however, there is no existing law about establishment and management of the CCTV in operating rooms and it can be defect of legal system. Under the current legislations, it is likely that the Self-determination can be violated due to the characteristic of healthcare provider when CCTV is mandatorily installed in operating room. In addition, the regulations on access and leakage of confidential information known by operator are insufficient. So that, the safety of the visual data might be threatened. Furthermore, unless the period and the place of storage of the visual data are clearly defined, it is highly unlikely to meet the original purpose of patient safety and prevention of medical accidents. This study is meaningful as there is few previous study on this topic although the need for legal review about this is growing and several bills are being proposed. It is expected that the results of this study can be utilized as basic data for enactment or amendment of the laws and regulations about establishment and management of CCTV in operating rooms.

• 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 Korean Society of Law and Medicine
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• v.16 no.2
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• pp.263-291
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• 2015

In May, 2015, a 68 years old man, who has been Middle East Saudi Arabia and the United Arab Emirates, had high fever, muscle aches, cough and shortness of breath. he went two local hospital near his house and the S Medical Center emergency center. He was diagnosed MERS(Middle East respiratory syndrome) and the diseases had put South Korea the fear of epidemics for three months. Especially, this disease has firstly reported in Middle East Asia in September 2012 and spreaded to twenty-six countries. In 21, July, 2015, European Center for disease prevention and control reported 533 people were died and in South Korea, 186 people were infected, 36 people were died and 16,693 people were isolated from MERS. South Korea government were faced into epidemic control and blamed from public. Especially, hospital acquired infection, disease control chain, opening of information, ventilation, lack of isolation bed, the problem of function of local health center, the issue of reparation for hospital and insurance cover rate, the classification of disease, the role of Korea Centers for disease control and prevention, the culture of visiting hospital to see sick people, the issue of hospital multiple room and other related social support policy. it is time to study and discuss to solve these problems. South Korea citizens felt fear and fright from MERS. What is wore, they thought the dieses were out of their government control. It was unusual case for word except Middle East Asia. numerous tourists canceled visiting korea. South korea economic were severly damaged especially, tourism industry. South korea government should admit that they had failed initial action against MERS and take full reasonability from any damages. The government have to open information to public in terms of epidemic diseases and try to prevent any other epidemic diseases and try to work with local governments.

• The Korean Society of Law and Medicine
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• v.16 no.2
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• pp.55-84
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• 2015

The tuberculosis is the infectious disease. Generally, the active tuberculosis patient can infect the 10 persons for one year within the daily activities like casual conversation and singing together. The infectivity of tuberculosis can continue for a life time, and infected persons can remain at risk for developing active tuberculosis. To control this contagious disease, along with the active tuberculosis patients, non-infectious but non-compliant patients who can be infectious if their immune systems become impaired have to be managed. To control the non-complaint patients, medical treatment order should be combined with the public order. Because tuberculosis is the risk of community health, the human rights like liberty and freedom of movement can be restricted for public welfare under the article 37(2) of constitution. Even when such restriction is imposed, no essential aspect of the freedom or right shall be violated. The degree of restriction on the rights of citizens is different what methods are chosen to non-complaint patients. For example, under the directly observed therapy program, the patients and medical staffs make an appointment and meet to confirm the drug intakes according to the schedule, which is the medical treatment combined with the mildest public order. If the patients break the appointments or have the history of disobedient, the involuntary detention can obtain the legitimate cause. The Tuberculosis Prevention Act has the two step programs on this involuntary detention, The admission order (Article 15) is issued when the patients are infectious. The quarantine order (Artle 15-2) is issued when the patients are infectious and non-complaint. The legal criteria for involuntary detention are discussed and published through the international conventions and covenants. For example, World Health Organization had made guidance on human rights and involuntary detention for tuberculosis control. The restrictions should be carried out in accordance with the our law and in the legitimate objective of public interest. And the restriction should be based on scientific evidence and not imposed in an unreasonable or discriminatory manner. We define and adopt these international criteria under our constitution and legal system. Least restrictive alternative principle, proportionality principle and the individual evaluation methods are explained through the reviews of United States court decisions. Habeas Corpus Act is reviewed and adopted as the procedural due process to protect the patient rights as a citizen. Along with that, what conditions and facilities which are needed to performed quarantine order are discussed.

• The Korean Society of Law and Medicine
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• v.21 no.2
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• pp.163-207
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• 2020

Korea has been positioned as the leading country in the industry of clinical trials as the clinical trail of Korea has developed for the recent 10 years. Clinical trial has plays a significant role in the development of medicine and the increase of curability. However, it has inevitable risk as the purpose of the clinical trial is to prove the safety and effectiveness of new drugs. Therefore, the clinical trial should be controlled properly to protect the health of the subjects of clinical trial and to ensure that they exercise a right of self-determination. In this context, the fiduciary duties of doctors who conduct clinical trials is especially important. The Pharmaceutical Affairs Act and the relevant regulations define several duties of doctors who conduct clinical trials. In particular, the duty to protection of subjects and the duty to provide information constitute the main fiduciary duties to the subjects. Those are essentially similar to the fiduciary duties of doctors in usual treatment from the perspective of the values promoted by the law and the content of the law. Nonetheless, clinical trials put more emphasis on the duties to provide explanation than in usual treatment. Further research and study are required to establish the concrete standard for the duty of care. However, if the blind pursuit of higher standards for the duty of care or to pass the burden of proof to doctors may result in disrupting the development of clinical trials, limiting the accessibility of patients to new treatment and even violating the principle of sharing damage equally and properly. In addition to these duties, the laws of clinical trials define several duties of doctors. Any decision on whether the violation of the law constitutes the violation of the fiduciary duty and justifies the demand for compensation of damages should be based on whether relevant law aims to protect the safety and benefit of subjects, even if in an incidental way, the degree to which such violation breaches the values promoted by the law and the concrete of violation of benefit of law, the detailed acts of such violation. The legal interests of the subjects can be protected effectively by guaranteeing compliance with those duties and establishing judicial and administrative controls to ensure that the benefit of subjects are protected properly in individual cases.