임상약리학회지 (Journal of Korean Society for Clinical Pharmacology and Therapeutics)

대한임상약리학회 (Korean Society for Clinical Pharmacology and Therapeutics)
권호 표지

국내 공동연구윤리심의위원회 수요도 및 타당성 검토를 위한 설문조사 연구

A Questionnaire Survey for Evaluating Current Needs and Preferred Model of Joint Institutional Review Boards in Korea

  • 김화정 (서울대학교 의과대학 예방의학교실) ;
  • 이승미 (서울대학교 의과대학 예방의학교실) ;
  • 김선하 (서울대학교 의과대학 예방의학교실) ;
  • 김옥주 (서울대학교 의과대학 의사학교실) ;
  • 박병주 (서울대학교 의과대학 예방의학교실)
  • Kim, Hwa-Jung (Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Lee, Seung-Mi (Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Kim, Seon-Ha (Department of Preventive Medicine, Seoul National University College of Medicine) ;
  • Kim, Ock-Joo (Seoul National University College of Medicine) ;
  • Part, Byung-Joo (Department of Preventive Medicine, Seoul National University College of Medicine)
  • 발행 : 2006.12.30

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초록

?Background: Rapidly increasing scale of multicenter clinical studies (MCTs) is pressing the need of joint institutional review boards(IRB) in Korea. The purpose of this survey was to evaluate demand for joint IRE and appropriate form. Methods: We constructed a questionnaire on the present IRE state on MCTs, agreement for joint IRB, ideal organization and operation method. This questionnaire was sent by mail to active clinical trial investigator group and head or secretary of all IREs registered to KFDA. Results: Totally 187 participants replies, with 67.4% of investigators and 32.6% of head of IRBs. 79.9% responders reported repeated review on same MCT among each participating IRBs, and proportion of for and against of joint IBE were 74.3%, 24.1% respectively. Discussion: Construction of joint IRB is supposed to have various strengths such as activation of MCTs due to reduced unnecessary review process, efficacy increment due to standardized review standards and resolutions. Before, preparatory works are necessary for successful achievement.

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