The Standard of Ethical Research Involving Vulnerable Populations: Implications of Korea’s 1997 Japanese Encephalitis Vaccine Trial Incident
- Dongju Lee Kyungsuk Choi
- 이화여자대학교 생명의료법연구소
- 생명윤리정책연구(Asia Pacific Journal of Health Law & Ethics)
- Vol.11 No.3
- 등재여부 : KCI등재
- 2018.07
- 27 - 48 (22 pages)
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
I. Introduction
II. The Japanese Encephalitis Vaccine Trial Scandal
III. Morally Problematic Aspects of the JE Vaccine Trial
IV. Considerations for Future Regulations to Ensure Ethical Research Involving Vulnerable Participants
V. Conclusion