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[원보]

국가연구개발과제 생명의학윤리 감독체계에 대한 인식조사 및 제언

원문정보

Perceptions held by Investigators, IRB Members and IRB Administrators on the Bioethical Oversight System of National R&D Projects

강영희, 이상미, 권광일, 김은영, 허우성

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초록

영어

Purpose: Aim of this study was to gather and evaluate perceptions of investigators, IRB members, and IRB administrators on the appropriateness of IRB review process and bioethical oversight system of national R&D (NR&D) projects. Method: Investigators, IRB members, and IRB administrators at 17 different institutions were surveyed using convenience sampling and survey questionnaires were partially group-specialized to consider any differences between the groups. Results: Participants included 29 investigators, 37 IRB members, and 17 administrators with response rate of 100% (83 of 83). According to the responses obtained, insufficient preparation time for constructing protocol and gaining IRB approval was one of the main problems in the IRB review process (investigator 79.3%, IRB administrator 88.2%). Also, discrepancy between NR&D and IRB’s protocol formats was another major issue (IRB members 96.4%, IRB administrator 100%) and most investigators (89.7%) had to modify the original NR&D protocol to obtain IRB approval. Moreover, it was reported that 13.8% of investigators and 31.3% of IRB administrators did not submit midyear reports to IRB and for bioethical issues of NR&D projects, 17.2% of investigators did not include information on project status and safety issues in the annual reports. Conclusion: In conclusion, for successful and ethical completion of R&D projects, revision of both IRB review process and NR&D project protocol formats as well as implementation of appropriate bioethical oversights are necessary.

목차

Abstract
 연구 방법
  설문 대상자 선정
  설문지 설계
  설문 진행과 자료처리
 연구 결과
  IRB위원의 일반적인 특성
  국가 R&D 과제 연구계획서 제출과 IRB 심의 현황
  국가 R&D 과제 연구계획서 변경 안에 대한 선호도
  국가 R&D 과제에 대한 IRB와 선정기관의 관리 현황
  생명의학 연구윤리 의식 수준
 고찰
 결론
 감사의 말씀
 참고문헌

저자정보

  • 강영희 Young Hee Kang. 을지대학교병원 약제부
  • 이상미 Sang Mi Lee. 을지대학교병원 약제부
  • 권광일 Kwang Il Kwon. 충남대학교 약학대학
  • 김은영 Eun Young Kim. 중앙대학교 약학대학
  • 허우성 Woo Sung Huh. 성균관대학교 의과대학 삼성서울병원 신장내과

참고문헌

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