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KMID : 1142820220060020025
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Bio, Ethics and Policy
2022 Volume.6 No. 2 p.25 ~ p.52
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Revision Study of the Ministry of Food and Drug Safety Guidelines for Safe Xenotransplantation Research
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Park Soo-Kyung
Kwon Ivo
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Abstract
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The recent case of xenotransplantation in the U.S. drew attention since it was a clinical trial of a gene-edited pig organ in a living person using advanced gene editing technology. It is anticipated that xenotransplantation could replace homologous organ transplantation in the near future. The researchers investigate the current status of do- mestic and international regulations and propose measures to improve guidelines based on them as follows. In terms of structure, the current guidelines are classified into three categories: animal donor, quality and infection control, preclinical and clinical trials, and tried to specify clinical trials by classifying them into four categories: animal donor, quality and infection control, nonclinical tests, and clinical trials. As an revision plan, the first step was to clarify the concept by modifying and changing the terms and definitions. Second, the list of infection sources was revised to strengthen infection control. Third, animal ethics provisions for animal research were newly established or strengthened. Fourth, it was intended to secure the stability of clinical trials considering the safety and human rights of patients. Finally, in order to strengthen the ethical and social responsibil- ity of researchers, a new declarative principle for researchers was prepared and contained. In conclusion, it is hoped that xenotransplantation researchers can study smoothly, reorganize guidelines so that patients can participate in the study safely, and that xeno- transplantation can serve as an alternative to organ transplantation.
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KEYWORD
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xenotransplantation, guidelines, source animals, clinical trials, research ethics
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