@article{ART002120289},
author={Eunae Kim},
title={A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment},
journal={Korean Journal of Medical Ethics },
issn={2005-8284},
year={2016},
volume={19},
number={2},
pages={185-210},
doi={10.35301/ksme.2016.19.2.185}
TY - JOUR
AU - Eunae Kim
TI - A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment
JO - Korean Journal of Medical Ethics
PY - 2016
VL - 19
IS - 2
PB - The Korean Society For Medical Ethics
SP - 185
EP - 210
SN - 2005-8284
AB - 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.
KW - use of investigational product for patient treatment;informed consent;investigational product;use of investigational product for emergency patient;clinical trial
DO - 10.35301/ksme.2016.19.2.185
ER -
Eunae Kim. (2016). A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment. Korean Journal of Medical Ethics , 19(2), 185-210.
Eunae Kim. 2016, "A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment", Korean Journal of Medical Ethics , vol.19, no.2 pp.185-210. Available from: doi:10.35301/ksme.2016.19.2.185
Eunae Kim "A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment" Korean Journal of Medical Ethics 19.2 pp.185-210 (2016) : 185.
Eunae Kim. A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment. 2016; 19(2), 185-210. Available from: doi:10.35301/ksme.2016.19.2.185
Eunae Kim. "A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment" Korean Journal of Medical Ethics 19, no.2 (2016) : 185-210.doi: 10.35301/ksme.2016.19.2.185
Eunae Kim. A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment. Korean Journal of Medical Ethics , 19(2), 185-210. doi: 10.35301/ksme.2016.19.2.185
Eunae Kim. A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment. Korean Journal of Medical Ethics . 2016; 19(2) 185-210. doi: 10.35301/ksme.2016.19.2.185
Eunae Kim. A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment. 2016; 19(2), 185-210. Available from: doi:10.35301/ksme.2016.19.2.185
Eunae Kim. "A Study on the Ethical and Legal Standards to Obtain the Patient’s Informed Consent about the Use of Investigational Product for Patient Treatment" Korean Journal of Medical Ethics 19, no.2 (2016) : 185-210.doi: 10.35301/ksme.2016.19.2.185
