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KMID : 1011120180110030027
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Bioethics Policy Studies
2018 Volume.11 No. 3 p.27 ~ p.48
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The Standard of Ethical Research Involving Vulnerable Populations: Implications of Korea’s 1997 Japanese Encephalitis Vaccine Trial Incident
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Lee Dong-Ju
Choi Kyung-Suk
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Abstract
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This paper examines the 1997 Japanese Encephalitis (JE) Vaccine clinical trials that were conducted in Korea, on a vulnerable population of participants. Reviewing the reactions that emerged shows that critics of the clinical trial focused on the characteristic vulnerability of the participants as the reason the trials were morally problematic. However, the authors of this paper propose that it was actually the presence of undue influence in the consent process, through improper compensation, and lack of additional safeguards for participant rights and welfare, which made the JE Vaccine Trials morally problematic. If these issues are addressed in future research, the authors believe it is possible to conduct ethical research involving vulnerable populations, while still being sensitive to the risk of exploitation.
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KEYWORD
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Japanese Encephalitis Vaccine Clinical Trial, Vulnerable Populations, Pediatric Trials, Undue Influence, Exploitation
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