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KMID : 0941820140240020135
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Korean Journal of Clinical Pharmacy
2014 Volume.24 No. 2 p.135 ~ p.143
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Perceptions held by Investigators, IRB Members and IRB Administrators on the Bioethical Oversight System of National R&D Projects
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Kang Young-Hee
Lee Sang-Mi
Kwon Kwang-II
Kim Eun-Young
Huh Woo-Seong
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Abstract
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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.
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KEYWORD
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national R&D projects, perception, human subjects & derivatives, bioethical oversight, IRB
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