Korean Journal of Clinical Pharmacy (한국임상약학회지)

Korean College Of Clinical Pharmacy (한국임상약학회)
권호 표지

Perceptions held by Investigators, IRB Members and IRB Administrators on the Bioethical Oversight System of National R&D Projects

국가연구개발과제 생명의학윤리 감독체계에 대한 인식조사 및 제언

  • Kang, Young Hee (Department of Pharmacy, Eulji University Hospital) ;
  • Lee, Sang Mi (Department of Pharmacy, Eulji University Hospital) ;
  • Kwon, Kwang Il (College of Pharmacy, Chungnam National University) ;
  • Kim, Eun Young (College of Pharmacy, Chung-Ang University) ;
  • Huh, Woo Sung (Department of Nephrology, Samsung Medical Center, Sungkyukwan University School of Medicine)
  • 강영희 (을지대학교병원 약제부) ;
  • 이상미 (을지대학교병원 약제부) ;
  • 권광일 (충남대학교 약학대학) ;
  • 김은영 (중앙대학교 약학대학) ;
  • 허우성 (성균관대학교 의과대학 삼성서울병원 신장내과)
  • Received : 2014.03.09
  • Accepted : 2014.06.23
  • Published : 2014.06.30
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Abstract

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.

Keywords

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