국가연구개발과제 생명의학윤리 감독체계에 대한 인식조사 및 제언

Abstract

Purpose: Aim of this study was to gather and evaluate perceptions of investigators, IRB members, and IRB administratorson 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 conveniencesampling and survey questionnaires were partially group-specialized to consider any differences between thegroups. Results: Participants included 29 investigators, 37 IRB members, and 17 administrators with response rate of100% (83 of 83). According to the responses obtained, insufficient preparation time for constructing protocol and gainingIRB approval was one of the main problems in the IRB review process (investigator 79.3%, IRB administrator88.2%). 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 IRBapproval. Moreover, it was reported that 13.8% of investigators and 31.3% of IRB administrators did not submit midyearreports to IRB and for bioethical issues of NR&D projects, 17.2% of investigators did not include information onproject status and safety issues in the annual reports. Conclusion: In conclusion, for successful and ethical completionof R&D projects, revision of both IRB review process and NR&D project protocol formats as well as implementationof appropriate bioethical oversights are necessary.