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KMID : 1142820230070020055
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Bio, Ethics and Policy
2023 Volume.7 No. 2 p.55 ~ p.77
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Pediatric Vaccine Clinical Trials and Changes in Research Ethics Regulation in 20th Century Korea
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Park Sin-Young
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Abstract
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Vaccine clinical trials in Korea prior to the 1990s were limited to observing the ad- verse reactions of foreign, imported vaccines. The 1990s marked the beginning of clinical trials for domestically developed vaccines. In 1987, the Korean Ministry of Health and Social Affairs established research regulations related to the management of pharmaceu- tical trials; however, these regulations were not up to prevailing international standards. As the National Assembly raised issues of child consent and vulnerability in vaccine trials, Korean media and society at large began to recognize the importance of protect- ing human subjects, which finally prompted health authorities to revise research ethics guidelines in the 1990s. Since then, Korea has taken substantial steps toward protecting vulnerable research subjects. The pediatric vaccine research of the 1990s demonstrates that the initiation and evolution of research ethics, regulations, and research environment change originate from reflections on researchers’ mistakes or deficiencies. Further, they mutually influence each other to strengthen legal regulations and institutions.
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KEYWORD
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vaccine clinical trials, research ethics, vulnerable subjects, subject protection, obtain-ing consent
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