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KMID : 1172020060070010089
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Journal of Korean Bioethics Association
2006 Volume.7 No. 1 p.89 ~ p.99
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The improvement plan for organization and management of Institutional Review System
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Kim Jang-Han
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Abstract
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The institutions which study the human embryo and genetic materials should establish the Institutional
Review Board(IRB) according to the “Bioethics and Safety Act" and the violations of the act are punished as crimes. According to the recently occurred korean scandal "Hwang’s research", Hwang’s student, even a vulnerable subject, was enforced to donate her eggs and the results of somatic cell nuclear transfer studies were totally falsified. Adding to those scandal, the IRBs which related to Hwang’s studies also showed severe problems. The IRB of Hanyang University which reviewed the initial study protocol could not fulfilled its duty to protect human subject so it couldn’t protect the vulnerable subjects. The IRB of Seoul National University College of Veterinary Medicine which acted as an Office of Research Integrity had already been organized by the Hwang. Some members of the IRB weren’t conscious their appointment and the external member of IRB was longing for the success of Hwang’s study to save the life of his son which was the violation of conflict of interests. The internal peer review system and the initial investigation to the Hwang’s scandal was turned out to be complete failure. Those facts indicate that IRB as an internal peer review system is very unstable to fulfill its duties and inspection system managed by the national level is mandatorily necessary. The national body should inspect the local IRBs ordinarily times and the sanctions should be imposed to the managing institutions as well as local IRBs.
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KEYWORD
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Institution, Review, Board, Research, Integrity.
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