@article{ART001541367},
author={Hyun A Bae},
title={Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board},
journal={Korean Journal of Medical Ethics },
issn={2005-8284},
year={2011},
volume={14},
number={1},
pages={55-77},
doi={10.35301/ksme.2011.14.1.55}
TY - JOUR
AU - Hyun A Bae
TI - Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board
JO - Korean Journal of Medical Ethics
PY - 2011
VL - 14
IS - 1
PB - The Korean Society For Medical Ethics
SP - 55
EP - 77
SN - 2005-8284
AB - Vulnerability typically has been understood in terms of the ability to give or withhold informed consent and the likelihood of being misled, mistreated, or otherwise taken advantage of in research. The re-conceptualization of vulnerability from something that emerges primarily from membership in a specific population to a reality that emerges from characteristics of persons or the environment in which research is conducted also can inform IRB(Institutional Review Board)s’ interpretation and application of the regulations and guidelines on clinical trials.
Vulnerability should be evaluated by IRBs, which have the responsibility of identifying those persons who may require additional protections. This article argues that the widespread and inconsistent use of the concept of vulnerability in Korea has hindered the development of substantive ethical guidance and concrete regulations. It is argued, furthermore, that in order to protect patient welfare and justice, the category of vulnerability should be specified at the time at which a subject consents to participate in medical research.
KW - vulnerability;clinical trial;additional safeguard;IRB(institutional review board)
DO - 10.35301/ksme.2011.14.1.55
ER -
Hyun A Bae. (2011). Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board. Korean Journal of Medical Ethics , 14(1), 55-77.
Hyun A Bae. 2011, "Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board", Korean Journal of Medical Ethics , vol.14, no.1 pp.55-77. Available from: doi:10.35301/ksme.2011.14.1.55
Hyun A Bae "Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board" Korean Journal of Medical Ethics 14.1 pp.55-77 (2011) : 55.
Hyun A Bae. Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board. 2011; 14(1), 55-77. Available from: doi:10.35301/ksme.2011.14.1.55
Hyun A Bae. "Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board" Korean Journal of Medical Ethics 14, no.1 (2011) : 55-77.doi: 10.35301/ksme.2011.14.1.55
Hyun A Bae. Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board. Korean Journal of Medical Ethics , 14(1), 55-77. doi: 10.35301/ksme.2011.14.1.55
Hyun A Bae. Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board. Korean Journal of Medical Ethics . 2011; 14(1) 55-77. doi: 10.35301/ksme.2011.14.1.55
Hyun A Bae. Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board. 2011; 14(1), 55-77. Available from: doi:10.35301/ksme.2011.14.1.55
Hyun A Bae. "Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board" Korean Journal of Medical Ethics 14, no.1 (2011) : 55-77.doi: 10.35301/ksme.2011.14.1.55
