The Journal of KAIRB (대한기관윤리심의기구협의회지)

Korean Association of Institutional Review Boartds (대한기관윤리심의기구협의회)
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A Survey on the Current Status of Human Research Protection Program Settlement and Subject Protection Activities in Korea

국내 임상시험 및 대상자 보호프로그램 도입 현황과 안전관 리체계에 대한 설문조사 연구

  • Park, Sinyoung (Human Research Protection Center, Severance Hospital, Yonsei University Health System) ;
  • Cho, Su Jin (Center for Human Research Protection Program, Seoul National University Hospital) ;
  • Seo, Kyung Jeong (Center for Human Research Protection Program, Seoul National University Bundang Hospital) ;
  • Kim, Jin Seok (Human Research Protection Center, Severance Hospital, Yonsei University Health System)
  • 박신영 (세브란스병원 임상연구관리실 임상연구보호센터) ;
  • 조수진 (서울대학교병원 임상연구윤리센터) ;
  • 서경정 (분당서울대병원 임상연구윤리센터) ;
  • 김진석 (세브란스병원 임상연구관리실 임상연구보호센터)
  • Received : 2021.08.27
  • Accepted : 2021.09.13
  • Published : 2021.09.30
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Abstract

Purpose: The purpose of this study is to assess the status of the Human research Protection Program (HRPP) within a hospital or a research institute in Korea. Methods: Survey was conducted during June 12th-21th 2019. Survey was distributed to the members of Korean Association of IRB (KAIRB) through each IRB office. Descriptive statistics were performed using SPSS ver. 26. Results: A total of 86 people responded, and 75 (87.0%) answered that they have perceived the HRPP. Seventy out of 86 respondents (81.4%) were conducting internal audit, several institutions were operated simultaneously the other form of audits such as IRB audit, system audit. Regarding the management of Suspected Unexpected Serious Adverse Reaction (SUSAR), 62.8% answered that they have regulation that can decide to suspend the study when there is a risk to subject safety. Among the respondents, 66.3% performed 'Help desk.' Conclusion: In this study, we assessed the current status of HRPP operation at each research institution based on Ministry of Food and Drug Safety (MFDS) HRPP guidelines. The HRPP accredited institution operated the subject protection activities according to this program, and even if the HRPP was not officially operated, the related activities were conducted focusing on the cases that could have a significant impact on the safety of research subjects. In order to ensure the quality of domestic clinical trials and to stably establish the HRPP, efforts at the individual institution level will be required.

Keywords

Acknowledgement

This study was funded by Ministry of Food and Drug Safety with Grant no. 20190404A54-00.

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