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

Korean Society for Clinical Pharmacology and Therapeutics (대한임상약리학회)
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Novel Classification of the Informed Consent Process in Clinical Research and the Ways to Improve Each Detailed Stage

임상연구 동의 과정의 새로운 분류와 각 단계별 개선방안

  • Shim, Myung-Jin (Clinical Trial Center, Chonnam National University Hospital) ;
  • Lim, Young-Chai (Department of Pharmacology, Chonnam National University Medical School)
  • 심명진 (전남대학교 병원 임상시험센터) ;
  • 임영채 (전남대학교 의과대학 약리학교실)
  • Received : 2009.05.25
  • Accepted : 2009.06.11
  • Published : 2009.06.30

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Abstract

The informed consent process (ICP) is still not enacted adequately despite its importance in clinical research. The researches on ICP have been mostly focused on the process to get a signature on the informed consent form and have not investigated ICP in a broad perspective. This article presented a novel classification of ICP closely related with the whole process of clinical research. ICP swere classified into 3 major stages, i.e. ICPs before, during and after the execution of clinical research. The first ICP before the execution of clinical research is composed of 3 detailed stages; 1) planning stage of clinical research, 2) preparatory stage of ICP, and 3) review stage of ICP. The second ICP, which is done during the execution of clinical research and a well-known ICP from the current narrow perspective, has 4 detailed stages; 1) notifying stage of clinical research, 2) providing stage of clinical research information, 3) deciding stage of clinical research participation, and 4) ICP stage during the execution of clinical research. The last ICP done after the execution of clinical research consists of 2 stages; 1) closing stage of clinical research, and 2) stage of sharing research results and final review. The activities, problems and ways to improve ICP in each detailed stage were further discussed.

Keywords

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