Earticle

초록

영어

Background: Oversight on the bioethical compliance of national R&D projects or research personnel is currently conducted exclusively by IRB (Institutional Review Board) within the relevant research institute. Considering current state of affairs in Korea, there is an imperative to establish a national oversight system for bioethical compliance, conduct comprehensive oversight on bioethical compliance of national R&D projects, and enhance subject protection system. Methods: We examined opinions from researchers and IRB personnels regarding ethical oversight system on R&D projects. Additionally, we looked at IRB assessment by KAIRB (Korea Association of Institutional Review Board) in order to identify status and problems with current IRB system in Korea. Assessment was also done for four other countries (US, UK, Germany, Singapore) through in-person visits as well as surveys in writing for a total of 6 months (2012.12.1~2013.5.31). The research comprised of two aspects: system management and R&D project audit. Based on this, we examined current status and problems of the existing system in Korea and made recommendations for improvement. Results: Regulatory objectives and backgrounds of biomedical researches are different from each country due to different characteristics of bioethical oversight system. This shows that each country sets up its own regulations and procedures to fit each situation. Bioethical compliance oversight system greatly varied between the countries. From this study, it can be seen that improvement of existing procedures and oversight system or establishment of new ones are essential in Korea. Conclusion: In terms of system management, a dedicated government organization need to be established for bioethical compliance, subject protection, IRB inspection, training, evaluation, and certification of systems, and also support for IRB e-system. Regarding R&D project oversight, it is essential to confirm IRB review results before start of a research, to conduct a review on ethical aspects of research plans, and to carry out continued oversight on bioethical compliance through interim reports.

목차

ABSTRACT
 연구 방법
  연구 대상 및 기간
  연구방법 및 조사 항목
  자료처리
 연구 결과
  국가별 생명의학연구윤리 관리체계 비교
  국가별 생명의학연구윤리관련 과제 관리
 고찰
 결론
 참고문헌

키워드

저자

• 장성미 [ Seong Mi Jang | 중앙대학교 약학대학, 중앙대학교병원 약제부 ]
• 정경혜 [ Kyeong Hye Jeong | 중앙대학교 약학대학 ]
• 김보연 [ Bo Yeon Kim | 중앙대학교 약학대학 ]
• 김영남 [ Young Nam Kim | 중앙대학교병원 약제부 ]
• 조현인 [ Hyeon In Cho | 삼성서울병원 기관윤리 심의국 ]
• 김은영 [ Eun Young Kim | 중앙대학교 약학대학 ] Corresponding author
• 허우성 [ Woo Sung Huh ] Co-correspondence to

참고문헌

발행기관

간행물

표지보기 관심저널 등록

• 간행물명

  한국임상약학회지 [Korean Journal of Clinical Pharmacy]

• 간기

  계간

• pISSN

  1226-6051

• 수록기간

  1991~2026

• 등재여부

  KCI 등재

• 십진분류

  KDC 518 DDC 615