Abstract
Legally, the investigational product (IP) can be used only in the clinical trial (CT) since its safety and effectiveness are still under investigation. Nevertheless, on the humanitarian grounds and in the exceptional cases, IP can be used legally for the patients with life-threatening critical illness and no other treatment options (Treatment Use, TU) as well as for those in emergency situation as a result of life-threatening illness (Emergency Use, EU). It is important that informed consent (IC) should be obtained in all cases in which IP is used. However, unlike the cases of CT and EU, there are no specific legal standards regarding IC process for TU, other than that it should be in accordance with the legal standards for obtaining IC for CT. Recently, the Korean Ministry of Food and Drug Safety announced the guideline related to EU and TU, but the specific standards related to obtaining IC for TU were not included in that guideline. So in this article, I propose the ethical and legal standards for obtaining IC for TU. For this, I compare TU with CT and EU to identify their similarities and differences. In particular, I analyze the specific legal standards for obtaining IC for CT and EU.
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