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@article{ART002730367},
author={Eunjoo Chung and KIM Myung-Hee and Su Jin Baik},
title={Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule},
journal={Korean Journal of Medical Ethics },
issn={2005-8284},
year={2021},
volume={24},
number={2},
pages={221-244},
doi={10.35301/ksme.2021.24.2.221}

TY - JOUR
AU - Eunjoo Chung
AU - KIM Myung-Hee
AU - Su Jin Baik
TI - Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule
JO - Korean Journal of Medical Ethics
PY - 2021
VL - 24
IS - 2
PB - The Korean Society For Medical Ethics
SP - 221
EP - 244
SN - 2005-8284
AB - In accordance with the recent revision of the Common Rule (Subpart A of the U.S. Department of Health and Human Service’s regulations for the protection of human subjects in research at 45 CFR 46), the use of single IRB has become mandatory for cooperative research in the U.S. Thus, interest has grown in operating alternative IRB models, including central IRBs and/or joint IRBs. However, since the single IRB mandate has risks as well as benefits, such revision should be carefully considered before adopting it. Accordingly, this study examined the institutional changes and progress of the U.S. research ethics review system, the efforts that have been made to avoid inefficiencies caused by duplicate reviews for multi-center cooperative research, and the single IRB-related policies and regulations that have been enacted or revised thereafter. Additionally, this study compared the differences between the regulations and guidelines in the Korean Good Clinical Practice (KGCP) and those in the Bioethics and Safety Act. On the basis of this examination, it is argued that before a single IRB review model is adopted in Korea, it is necessary for all relevant parties to conduct a full review of the current responsibilities of researchers and institutions under existing laws and regulations and to determine how those responsibilities would be shared in the event of a single IRB review model.
KW - Institutional Bioethics Committee(IRB);single IRB;cooperative research;joint IRB;Bioethics and Safety Act;Korean Good Clinical Practice(KGCP)
DO - 10.35301/ksme.2021.24.2.221
ER -

Eunjoo Chung, KIM Myung-Hee and Su Jin Baik. (2021). Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule. Korean Journal of Medical Ethics , 24(2), 221-244.

Eunjoo Chung, KIM Myung-Hee and Su Jin Baik. 2021, "Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule", Korean Journal of Medical Ethics , vol.24, no.2 pp.221-244. Available from: doi:10.35301/ksme.2021.24.2.221

Eunjoo Chung, KIM Myung-Hee, Su Jin Baik "Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule" Korean Journal of Medical Ethics 24.2 pp.221-244 (2021) : 221.

Eunjoo Chung, KIM Myung-Hee, Su Jin Baik. Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule. 2021; 24(2), 221-244. Available from: doi:10.35301/ksme.2021.24.2.221

Eunjoo Chung, KIM Myung-Hee and Su Jin Baik. "Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule" Korean Journal of Medical Ethics 24, no.2 (2021) : 221-244.doi: 10.35301/ksme.2021.24.2.221

Eunjoo Chung; KIM Myung-Hee; Su Jin Baik. Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule. Korean Journal of Medical Ethics , 24(2), 221-244. doi: 10.35301/ksme.2021.24.2.221

Eunjoo Chung; KIM Myung-Hee; Su Jin Baik. Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule. Korean Journal of Medical Ethics . 2021; 24(2) 221-244. doi: 10.35301/ksme.2021.24.2.221

Eunjoo Chung, KIM Myung-Hee, Su Jin Baik. Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule. 2021; 24(2), 221-244. Available from: doi:10.35301/ksme.2021.24.2.221

Eunjoo Chung, KIM Myung-Hee and Su Jin Baik. "Policy Suggestions for Institutional Bioethics Committees: Based on the U.S. Single IRB Mandate in the Revised Common Rule" Korean Journal of Medical Ethics 24, no.2 (2021) : 221-244.doi: 10.35301/ksme.2021.24.2.221