임상시험에서 취약성(vulnerability) 판단 기준 재정립과 임상시험심사위원회의 역할
Re-conceptualization of vulnerability in clinical trials and the role of Institutional Review Board
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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.
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.
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