The Standard of Ethical Research Involving Vulnerable Populations: Implications of Korea’s 1997 Japanese Encephalitis Vaccine Trial Incident
0
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
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.
Abstract
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.
참고문헌 (18)
- "Nuremberg Code" (1947)[URL]
- "US Department of Health and Human Services Regulations, 45 C.F.R. § 46 (1974)", ~ (1974)
- "Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" (1979)[URL]
- "Bioethics and Safety Act" (2008)[URL]
- "International Ethical Guidelines for Health-related Research Involving Humans" (2016)[URL]
- 손영모, "Japanese Encephalitis Immunization in South Korea: Past, Present, and Future", Emerging Infectious Diseases, 6(2), pp.17~24 (2000)
- "Pharmaceutical Affairs Act" (1996)[URL]
- "Pharmaceutical Affairs Act" (2017)[URL]
- "동아일보, May 25, 1998", 1998
- Monica A. McArthur, "Japanese Encephalitis Vaccines", Journal of Bioterrorism & Biodefense, 1 (2011)
- ". Yonhap News 연합뉴스, May 14, 1998" (1998), 채삼석[URL]
- ". Yonhap News 연합뉴스, May 14, 1998" (1998), 채삼석[URL]
- ". Hankyoreh21 한겨레21, June 4, 1998" (1998), 김수병[URL]
- "동아일보, May 25, 1998", 1998
- Korean Ministry of Health and Welfare, "Pharmaceutical Affairs Act", ~ (1996)
- Wendler David, "Minimal Risk in Pediatric Research as a Function of Age", Archives of Pediatrics & Adolescent Medicine, 163(2), pp.115~118 (2009)
- "Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects" (1964)[URL]
- Pirkko Lepola, "Informed Consent for Paediatric Clinical Trials in Europe", Archive of Disease in Childhood, 101(11), pp.1017~1025 (2016)