Korean Journal of Medical Ethics
The Korean Society for Medical Ethics
Article

임상시험에서 취약성(vulnerability) 판단 기준 재정립과 임상시험심사위원회의 역할

배현아1,*
Bae Hyuna1,*
1이화여자대학교 법학전문대학원
1Law School, Ewha Womans University
*이화여자대학교 법학전문대학원. 02-3277-6661. sincerebae@ewha.ac.kr

ⓒ Copyright 2011 The Korean Society for Medical Ethics. This is an Open-Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (http://creativecommons.org/licenses/by-nc/4.0/) which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

Received: Jan 28, 2011; Accepted: Mar 10, 2011

Published Online: Mar 31, 2011

ABSTRACT

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.

Keywords: 취약성; 임상시험; 추가적인 보호장치; 임상시험심사위원회(IRB)
Keywords: vulnerability; clinical trial; additional safeguard; IRB(institutional review board)