The Journal of KAIRB (대한기관윤리심의기구협의회지)
- Volume 1 Issue 2
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- Pages.30-42
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- 2019
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- 2734-0724(pISSN)
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- 2671-4388(eISSN)
Legal issues of obtaining informed consent in pharmaceutical clinical trial as human material research : Focusing on the use of statutory form
인체유래물연구에 해당되는 의약품임상시험에서 동의 획득 기준의 법적 문제: <인체유래물연구동의서> 법정 서식의 사용을 중심으로
- Yoo, Sujung (Pre-Medical Science, School of Medicine, Kyung Hee University) ;
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Kim, Eunae
(Ewha Institute for Biomedical Law & Ethics, Ewha Womans University)
- Published : 2019.09.30
Abstract
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
Keywords
- Pharmaceutical clinical trial;
- Human material research;
- Informed conset;
- Human material research informed consent form as statutory form;
- Bioethics and Safety Act