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KMID : 1011120180110030049
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Bioethics Policy Studies
2018 Volume.11 No. 3 p.49 ~ p.79
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A Study on the Law and Policies Related to the Education to People Engaged in Clinical Trials: Focusing on the Suggestions of Improvement Measures to Overcome Its Limitations
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Kim Eun-Ae
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Abstract
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Everyone has a desire to live a healthy life, but no one is free from disease and aging. Therefore, various efforts are being made to overcome health precariousness. A representative example in the biomedical science and technology field is clinical trials(CTs) conducted to develop safer and more effective drugs. However, since CTs are research to confirm safety and efficacy of investigational products for which safety and efficacy have not yet been identified, which could have a negative impact on the participants in CTs. Thus, the protection of these people has long been emphasized, and it has been of paramount importance that researchers conducting CTs have the capability to conduct CTs ethically and scientifically. In particular, considering the quantitative increase of CTs conducted in Korea as well as changes of the major field in CTs conducted in Korea, this capability will be emphasized not only to researchers who are the mainstay of CTs, but also to those who are working on the tasks directly or indirectly involved in CTs. This capability is basically directly related to the education of these people. In recent years, the education for these people has become legally compulsory education under the name of ‘education to people engaged in CTs’, and this education is aimed ‘to improve their specialty' and 'to protect the participants in CTs'. In this article, I tried to analyze the significance and limitations of the current law and policies related to the education to people engaged in CTs by observing the main contents of the law and policies such as the educational institution for CTs, subjects to legally compulsory education, time of education, educational contents and methods. And, I would like to give some suggestions on how to overcome its limitations through improvement measures in order to ensure that the education is appropriately carried out and that it achieves what it is aiming to do.
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KEYWORD
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Health Precariousness, Clinical Trials, Education to People Engaged in Clinical Trials, Institutional Review Board, Educational Institution for Clinical Trials
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