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학술연구/단체지원/교육 등 연구자 활동을 지속하도록 DBpia가 지원하고 있어요.
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연구자들이 자신의 연구와 전문성을 널리 알리고, 새로운 협력의 기회를 만들 수 있는 네트워킹 공간이에요.
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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.
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참고문헌 (25)
참고문헌 신청
/ / NIH guide: Required education in the protection of human research participants
/ / NIH guide: Revised policy for IRB review of human subject protocols in grant applications
/ / NIH policy: FAQs Human Subjects Research - Requirement for Education
/ / Role of Accreditation
/ 2013 / Bioethics and Safety Act (Act No. 11690). Enforcement Date May 23 /
/ / NIH guide: Revised policy for IRB review of human subject protocols in grant applications
/ / NIH policy: FAQs Human Subjects Research - Requirement for Education
/ / Role of Accreditation
/ 2013 / Bioethics and Safety Act (Act No. 11690). Enforcement Date May 23 /
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