국가연구개발과제 생명의학윤리 감독체계에 대한 인식조사 및 제언Perceptions held by Investigators, IRB Members and IRB Administrators on the Bioethical Oversight System of National R&D Projects
- Other Titles
- Perceptions held by Investigators, IRB Members and IRB Administrators on the Bioethical Oversight System of National R&D Projects
- Authors
- 강영희[강영희]; 이상미[이상미]; 김은영[김은영]; 권광일[권광일]; 허우성[허우성]
- Issue Date
- 2014
- Publisher
- 한국임상약학회
- Keywords
- national R& D projects; perception; human subjects & derivatives; bioethical oversight; IRB
- Citation
- 한국임상약학회지, v.24, no.2, pp.135 - 143
- Indexed
- KCI
- Journal Title
- 한국임상약학회지
- Volume
- 24
- Number
- 2
- Start Page
- 135
- End Page
- 143
- URI
- https://scholarworks.bwise.kr/skku/handle/2021.sw.skku/55720
- ISSN
- 1226-6051
- 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.
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Collections - Medicine > Department of Medicine > 1. Journal Articles
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