대한기관윤리심의기구협의회지 (The Journal of KAIRB)

  • 제5권2호
  • /
  • Pages.43-50
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  • 2023
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  • 2734-0724(pISSN)
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  • 2671-4388(eISSN)
대한기관윤리심의기구협의회 (Korean Association of Institutional Review Boartds)
권호 표지

Institutional Review Board 심의에 대한 연구자 만족도 및 임상연구보호프로그램 개선 요구도에 대한 설문조사 연구

A Survey Study on Researchers' Satisfaction with Institutional Review Board Reviews and Demands for Enhancing Human Research Protection Programs

  • 박신영 (세브란스병원 임상연구관리실 임상연구보호센터) ;
  • 안초롱 (세브란스병원 임상연구관리실 임상연구보호센터) ;
  • 노양희 (세브란스병원 임상연구관리실 임상연구보호센터) ;
  • 김세주 (세브란스병원 임상연구관리실 임상연구보호센터) ;
  • 라선영 (세브란스병원 연구심의위원회)
  • Sinyoung Park (Human Research Protection Center, Severance Hospital) ;
  • Cho Rong Ahn (Human Research Protection Center, Severance Hospital) ;
  • Yang Hee Noh (Human Research Protection Center, Severance Hospital) ;
  • Se Joo Kim (Human Research Protection Center, Severance Hospital) ;
  • Sun Young Rha (Institutional Review Board, Severance Hospital)
  • 투고 : 2023.08.08
  • 심사 : 2023.09.07
  • 발행 : 2023.09.27
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초록

Purpose: Due to the stringency of regulations related to clinical research, researchers face various requirements in the Institutional Review Board (IRB) review process. Specifically, they encounter time constraints and administrative burdens. In order to cultivate a more favorable review culture and establish a robust research environment, it is necessary to analyze researchers' perceptions of the IRB review. Therefore, this study aims to assess researchers' overall experiences with the IRB and identify researchers' educational needs and demands for research-related policies. Methods: A semistructured questionnaire with 34 items was developed and refined in consultation with advisors from IRB and Human Research Protection Program (HRPP). The questionnaire was distributed via an online survey to researchers with experience in IRB review. The survey covered general characteristics, satisfaction with the IRB review process (rated on a 10-point scale), experiences with IRB review, HRPP policy demands. Results: The study's descriptive statistics revealed a moderate satisfaction level (average rating, 6.75 out of 10) with the IRB review. Researchers from clinical medicine and other disciplines showed similar satisfaction scores of 6.65 and 6.87, respectively. However, respondents with over 5 years of research experience expressed higher satisfaction (mean score, 7.03) compared to those with less experience (mean score, 6.57). Institutional support was emphasized for improving the IRB review process. Certain training topics generated higher demands for addressing frequently raised IRB issues among minor discipline researchers compared to clinical medicine (p=0.017). Conclusion: We conducted an analysis of researchers' perceptions regarding the IRB as well as their demands concerning educational and HRPP policies. It is imperative to address the pinpointed areas for enhancement and integrate a range of perspectives in order to effectively cultivate a robust research ethics culture and ensure comprehensive participant protection.

키워드

과제정보

이 논문은 2023년 대한기관윤리심의기구협의회 학술연구과 제지원사업의 지원으로 수행되었습니다(KAIRB-과2022-01). IRB 심의와 점검에 애써 주시고, 논문 작업에도 많은 도움 주시는 세브란스병원 임상연구보호센터 모든 선생님들께 감사드립니다.

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