원문정보
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
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