대한기관윤리심의기구협의회지 (The Journal of KAIRB)

  • 제4권2호
  • /
  • Pages.30-35
  • /
  • 2022
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  • 2734-0724(pISSN)
  • /
  • 2671-4388(eISSN)
대한기관윤리심의기구협의회 (Korean Association of Institutional Review Boartds)
권호 표지

국내 Human Research Protection Program 도입 과정과 발전 방향에 대한 고찰

The Korea Human Research Protection Program: Present and Future Direction

  • 박신영 (세브란스병원 임상연구관리실 임상연구보호센터) ;
  • 김진석 (세브란스병원 임상연구관리실 임상연구보호센터)
  • 투고 : 2022.08.18
  • 심사 : 2022.09.25
  • 발행 : 2022.09.30
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초록

The Human Research Protection Program (HRPP) includes all subject protection activities and entities involved in the process of planning, reviewing, and conducting clinical research and it ultimately aims that research can be conducted ethically and scientifically while protecting the rights and welfare of research subjects. At the beginning of its introduction in Korea, it was settled down by adopting the United States HRPP, especially the form of AAHRPP element and regulations. However, regulations and operating forms of HRPP have been changed according to the Korean domestic research environment. Actually, all the Korean institutions are adopted the Korean HRPP guidelines that have been officially announced by the Ministry of Food and Drug Safety in Korea. Recently, Korean domestic laws such as the "Advanced Regenerative Biology Act" or "In Vitro Diagnostic Medical Device Act" have been dramatically innovated and our research environment becomes to be more complicated. Therefore, the development of a suitable Korean HRPP model considering the Korean research environment is strongly demanded. For the early settle down of the Korean HRPP model, the positive incentive method should be applied, when the HRPP is operated and/ or properly operated. These improvements in the Korean HRPP environment will eventually lead to the appropriate protection of subjects who are participating in human clinical research and the quality improvement of clinical research.

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참고문헌

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