• 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.

• Journal of Korean Public Health Nursing
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• v.15 no.2
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• pp.398-411
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• 2001

The separation system of pharmacy and clinic has begun on the purpose of preventing drug misuse and abuse since July 1st of 2000. The system revealed some conflicts between doctors. pharmacists and consumers. Consequently pharmaceutical law and related policies undergone some change. Now in an early period of the implementation of the system, the necessity to examine relevance of those policies and law enforcement to medical doctors' prescriptions pattern evolves. This study tries to verify the pattern through a field study. For the purpose, 930 prescriptions collected in May of 2001, from a pharmacy located in Gangnam-gu in Seoul, were analysed. The prescriptions were issued from several clinics: 459 prescriptions from otorhinolaryngological clinic(ENT), 177 from internal medicine clinic(IM), 130 from ophthalmic clinic(Opt), 52 from obstetric and gynecologic clinic(OB & GY), and 112 from miscellaneous clinics. ENT, IM, Opt. OB & GY are situated in a clinic building of 40m distance. The general findings are following: 1) $88.8\%$ of the total patients came from 5clinics in nearby single clinic building. 2) Average prescribing days were 6.2 days and the average number of used drugs were 4.0 drugs, i.e. 2-4 times of WHO criteria 1-2 drugs. 3) Use of antibiotics in the oral administration drugs rated $71.8\%(WHO: \;22.7\%)$ 4) Use of injection rated $31.3\%(WHO:\;17.2\%)$ 5) $96.2\%$ of the patients use multiple antibiotics in the injection and oral administration together. 6) The patients had multiple disease : ENT patients 1.7 disease and 1M patients has 2.7 disease in average and several regular prescribing types evolved particularly in the ENT prescription. With this result we found that drugs. especially antibiotics are still abused a lot, and there were significant differences in the number of used drugs and prescrbing days between the clinics. It implies somes differences of the preparation work and time for pharmacists. And preparation can be done in advance by pharmacists' own efforts through noticing regular prescribing types. The study suggests the followings: 1) Patient counseling should be done to minimize the incidence of adverse events. 2) The enforcement of the standardized differential preparation price system should be reconsidered. 3) Preparation of typical regularly appeared prescription in advance. which is regarded as 'a prearranged work between doctors and pharmacists' and has been prohibited should be reconsidered. 4) Drug utilization review program should be established to prevent drugs abuse. especially antibiotics abuse.

• The Korean Society of Law and Medicine
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• v.11 no.2
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• pp.113-145
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• 2010

Nowadays, it is surely the quack which stands as one of the most controversial, problematic. the quack has been a consistent target of contested public protection strategies in the past few centuries in many countries. Recently, complementary and alternative medicine (CAM) is increasingly utilized and accepted by patients and providers throughout the health care system in the world, most accounts attribute this growing acceptability to the shortcomings of conventional medicine, the appeal of CAM's core beliefs, and the growing body of research indicating that CAM actually works. However, the governments of western countries have called for measures to ensure that the public are protected from incompetent and dangerous practitioners. Common to these controversies has been a suggestion to ban, exclude or limit the medical practice of those deemed to be damaging rather than improving the health of individuals as a measure of public protection. This article describes the experiences of western counties' health care system which is moving in a more pluralistic direction. By examining the ways in which regulatory efforts in the countries have come to address what is invariably described as a growing interest in CAM, this study show how the problem of CAM/quackery today is increasingly located in an ethical field of practitioner competency, qualifications, conduct, responsibility and personal professional development, regardless of the form of therapy in question. Many countries developed a series of measures and strategies to contain the acceptance of CAM groups, such as insisting on scientific evidence of safety and efficacy, resisting integration of CAM with conventional medicine and opposing government support for research and education. In a sense, those countries' movements serve to protect not only patients, but the dominant position of medicine and its allied professions, and to maintain existing jurisdictional boundaries within the healthcare system. The popular support for CAM will require that health professional stakeholders continue to address the challenges this poses, and at the same time protect their position at healthcare system. To cope with the quack, professional body, public sector and health authorities should consider the safety of consumers of healthcare and responding to the demands of the community for CAM therapies as well as the claims of the established healthcare professions. Finally, some implications for future health care were suggested.

• Archives of design research
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• v.20 no.1 s.69
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• pp.253-262
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• 2007

The postpartum care center is a facility which made its debut only about 10 years ago but has now changed the nation's postpartum care culture. Women delivered of a child use the postpartum care center at this time since the low rate of childbirth has become a social phenomenon. However, while the postpartum care center is not supported legally and systematically, anybody can run it after they only file a report on businessman status with the tax office. So there are disordered wave of postpartum care startups which do not have basic facilities. Thus, this study is intended to suggest an interior environment plan considering an efficient space and users' benefits of a postpartum care center which has a characteristic difference from that of ordinary facilities in terms of targeted persons or operations but for which standards are not clear in terms of the Health and Welfare Law and the Medical Service Law. This study was conducted by investigating the actual condition of the entrance space, living space, common-use space, nursing space, administration and attached space in the six postpartum care centers selected from Seoul and Kyeonggi-do region and suggesting the direction of improvements, thus establishing the direction of interior designs and an interior environment plan. Hopefully, this study would be used as basic data on interior building plans, thus being helpful in enhancing the satisfaction of the postpartum care center user and operating the facility.

• The Korean Society of Law and Medicine
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• v.17 no.2
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• pp.315-346
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• 2016

With the development of big data processing technology, the potential value of healthcare big data has attracted much attention. In order to realize these potential values, various research using the healthcare big data are essential. However, the big data regulatory system centered on the Personal Information Protection Act does not take into account the aspect of big data as an economic material and causes many obstacles to utilize it as a research purpose. The regulatory system of healthcare information, centered on the primary purpose of patient treatment, should be improved in a way that is compatible with the development of technology and easy to use for public interest. To this end, it is necessary to examine the trends of overseas legal system reflecting the concerns about the balance of protection and utilization of personal information. Based on the implications of the overseas legal system, we can derive improvement points in the following directions from our legal system. First, a legal system that specializes in healthcare information and encompasses protection and utilization is needed. De-identification, which is an exception to the Privacy Act, should also clearly define its level. It is necessary to establish a legal basis for linking healthcare big data to create synergy effects in research. It is also necessary to examine the introduction of the opt-out system on the basis of the discussion on the foreign debate and social consensus. But most importantly, it is the people's trust in these systems.

• Journal of Biomedical Engineering Research
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• v.35 no.3
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• pp.50-54
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• 2014

It is being tried to control robot arm using brain signal in the field of brain-machine interface (BMI). This study is focused on applying guidance laws for efficient robot arm control using 3D coordinates obtained from Magnetoencephalography (MEG) signal which represents movement of upper limb. The 3D coordinates obtained from brain signal is inappropriate to be used directly because of the spatial difference between human upper limb and robot arm's end-effector. The spatial difference makes the robot arm to be controlled from a third-person point of view with assist of visual feedback. To resolve this inconvenience, guidance laws which are frequently used for tactical ballistic missile are applied. It could be applied for the users to control robot arm from a first-person point of view which is expected to be more comfortable. The algorithm which enables robot arm to trace MEG signal is provided in this study. The algorithm is simulated and applied to 6-DOF robot arm for verification. The result was satisfactory and demonstrated a possibility in decreasing the training period and increasing the rate of success for certain tasks such as gripping object.

• Research in Community and Public Health Nursing
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• v.15 no.4
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• pp.551-565
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• 2004

Purpose: The purpose of this study is to develop a day care center model focused on public health institutions for the elderly residing in their homes. Method: Research design for this study was a mult-level research, which consisted of a related literature review, an Internet search for knowledge of the current situation at home and abroad, on-site interviews, questionnaires collected from a sample of residents in a rural area, and a key-informants approach. Results: 1) The subjects of service - Generalized service should be provided to the elderly, 65 years and older, regardless of their assets. 2) The contents of service - Providing pre-health oriented and post-social welfare service that can integrate and satisfy a wide variety of public health and welfare needs of the elderly would strengthen the health care service of a day care center for the elderly. 3) Delivery system - Basic-level local self-governments should become a central operating body, and establishing a properly adjusted delivery system to a rural area after considering the efficiency and the access of vulnerable rural areas is needed based on modification of 'a Special Law for Agricultural and Fishery Areas' (rural public health center>rural health sub-center ${\rightarrow}$ unified health sub-center ${\rightarrow}$ public health hospital (public health center) ${\rightarrow}$ public welfare office). 4) Facility - Public health facilities such as public health centers and sub-centers should be located in areas that can easily access the facilities. 5) Funding - For day care center for the elderly in local self-government, the central government should modify a relevant implementation of subsidy in and provide some facilities and service regardless of the degree of self reliance of local self-government. 6) Human resources - It is needed to guarantee the period of workers of a day care center for the elderly, at least 3 to 5 years, with considering their specialty on aged care and avoiding circulation based positions. Furthermore, appropriate specially trained personnel such as medical workers and social workers should be placed to take care of both health service and welfare through strengthening of 'rules of law of elderly welfare,' Conclusion: future research is needed to test the model through a demonstration study using a model which may be developed in the future and to standardize the appraisal criteria of people hoping to enter a day care center for the elderly.

• Journal of Environmental Health Sciences
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• v.47 no.3
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• pp.193-204
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• 2021

Objectives: In January 2021, the former heads of the manufacturer SK Chemical and the vendor Aekyung were acquitted for manufacturing and selling humidifier disinfectant (HD) containing 5-chloro-2-methylisothiazol-3(2H)-one/2-methylisothiazol-3(2H)-one (CMIT/MIT). In this article, we analyzed the rationale used in this judgement in the light of scientific consideration. Methods: The sentencing document for the judgements was obtained from the Korea Supreme Court Service. In particular, the judgements made by the court related to the toxicological and individual association with HD perspectives were discussed based on scientific evidence. Results: The ruling stated that the necessary conditions for causality between CMIT/MIT and such diseases were not met based on the fact that asthma and lung damage were not found in the inhalation exposure animal experiments. The judgment overlooked the inevitable limitations of using animal experiments for verifying health effects in humans, which are often inconsistent with the observations in animals. Among 11 governmentaffirmed lung injury cases with CMIT/MIT usage, three patients' humidifier disinfectant-associated lung injury (HDLI) pathology proved that CMIT/MIT could cause lung injury similar to that caused by PHMG and PGH. In addition, five children showed decreased lung function related to damage caused by humidifier disinfectant exposure. Conclusions: We conclude that there is sufficient evidence supporting the assertion that HDs containing CMIT/MIT cause lung injuries, including asthma, contrary to the court's decision.

• The Korean Society of Law and Medicine
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• v.22 no.3
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• pp.125-144
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• 2021

The purpose of this study is to present a legal improvement plan for health protection of the health-vulnerable class in our society in the 'COVID-19'. The contents of the first study examined the meaning of the existing (social) vulnerable class, and then critically considered the health-vulnerable class as an expanded concept in connection with the social risk of health. The term "vulnerable class" tends to have both meaning as the traditionally marginalized class such as the elderly, the disabled, and women, as well as the condition of having no ability to live due to low income, such as the low-income class. The concept of the health-vulnerable class is meaningful in that it appears as a recently expanded concept as it is linked to the concept of the vulnerable class and social risks such as health threats. The content of the second study looked at the problems that appeared when the health-vulnerable class was used together with the health care-vulnerable class in laws. Due to the laws used in both terms, there was a problem that the social security system related to health and health care could create blind spots. The contents of the third study suggested legal improvement directions for social security measures for health for the underprivileged.

• The Korean Society of Law and Medicine
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• v.22 no.1
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• pp.27-55
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• 2021

Bisher wurde kein Beruf zwischen Recht und Berufsethik so diskutiert wie Ärzte. Diskussionen über die Qualifikation(od. Approbation) von Ärzten sind nicht nur eine Frage Koreas, sondern in den meisten zivilisierten Ländern ein wichtiges Diskussionsthema, wenn ein Arzt insbesondere für eine Straftat bestraft wird. Vor kurzem hat sich die koreanische Ärztekammer (the Korean Medical Association) weitgehend gegen das, "Entwurf eines Gesetzes zur Reform des Medizingesetzes" stark ausgesprochen, das die Grunde für den Entzug einer Approbation für ein Verbrechen eines Arztes erweitert. Vor allem wird auf die Gefahr hingewiesen, eine Approbation für Straftaten zu entziehen, die nicht mit beruflichen Pflichten zusammenhängen. Es ist jedoch vernünftig, den Beruf bzw. das Gewerbe zu verbieten, wenn ein Fachmann unter Missbrauch seines Beruf oder grober Pflichtverletzung die Tat begangen hat und die Gefahr bestehet, dass er bei weiterer Ausübung seines Berufs erhebliche rechtswidrige Taten der bezeichneten Art begangen wird. Die Untersagung der Berufsausübung soll die Allgemeinheit gegen die spezifischen Gefahren schützen, die mit der Ausübung eines Berufs oder Gewebes verbunden sind. Da das Berufsverbot nur die Berufsausübung untersagt, die Approbation selbst aber bestehen lässt, kann die Approbationsbehörde in eigener Entscheidungskompetenz die Approbation zurücknehmen, wiederrufen, oder in Ruhen anordnen. Entsprechend dem Verhätnismäßigkeitsgrundsatz ist aber auch das Berufsverbot auf bestimmte Tätigkeiten im Bereich des Berufs zu beschränken, wenn dies zur Erreichung des Maßregelzwecks, dem schutz der Allgemeinheit, ausreichend ist. In diesem Beitrag wurden die Voraussetzunen des Berufsverbots und die tatsächlich an Ärzte bzw. medizinische Personal gerichteten Fälle untersucht.