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논문KCI 등재

바이오장기이식 환자와 가족 등의 관리

Surveillance of Xenotransplanted Patients and Their Family

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Xenotransplantation is one of the hottest field in biomedical research. Xenotransplantation defines as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source,or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.”29)NMany suggest that life-long surveillance of recipients and their family members should be done when we introduce xenotransplantation into the clinical practices. The reason of life-long surveillance are the risk of zoonosis and the need to find the long-term complications of xenotransplantation and their mechanism. However, life-long surveillance mat harm the privacy or other basic human rights. Because of these reasons, we should carefully design life-long the surveillance system. Obligation of life-long surveillance of xenografted patients or their family members can be justified based on the risk of xoonosis. The medical purposes, such as investigation of long-term complications of xenotransplantation, are not the appropriate reason to impose obligatory life-long surveillance to patients and their family members. It can be justified only based on the informed consent of patients and their family members. New biomedical technologies, such as xenotransplantation may not be ruled properly by current legal system. We should try to make new principles or means to regulate these kind of new technologies for effective regulation.

Abstract

Xenotransplantation is one of the hottest field in biomedical research. Xenotransplantation defines as “any procedure that involves the transplantation, implantation, or infusion into a human recipient of either (a) live cells, tissues, or organs from a nonhuman animal source,or (b) human body fluids, cells, tissues, or organs that have had ex vivo contact with live nonhuman animal cells, tissues, or organs.”29)NMany suggest that life-long surveillance of recipients and their family members should be done when we introduce xenotransplantation into the clinical practices. The reason of life-long surveillance are the risk of zoonosis and the need to find the long-term complications of xenotransplantation and their mechanism. However, life-long surveillance mat harm the privacy or other basic human rights. Because of these reasons, we should carefully design life-long the surveillance system. Obligation of life-long surveillance of xenografted patients or their family members can be justified based on the risk of xoonosis. The medical purposes, such as investigation of long-term complications of xenotransplantation, are not the appropriate reason to impose obligatory life-long surveillance to patients and their family members. It can be justified only based on the informed consent of patients and their family members. New biomedical technologies, such as xenotransplantation may not be ruled properly by current legal system. We should try to make new principles or means to regulate these kind of new technologies for effective regulation.

참고문헌 (10)

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  6. Center for Biologics Evaluation and Research, "Guidance for Industry: Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans: Final Guidance", ~ (2003)
  7. C. Hammer, "Comments on Ethics in Human Xenotransplantation. in: Xenotransplantation: The transplantation of Organs and Tissues between Species" (1997), Springer-Verlag
  8. Monique A. Spillman, "Clinical trials of xenotransplantation: waiver of the right to withdraw from a clinical trial should be required", J. L. Med & Ethics, 35, pp.265~271 (2007)
  9. R. M. Baertschiger, "Xenotransplantation Literature Update November-December, 2004", Xenotransplantation, 12, pp.156~160 (2005)
  10. United States Public Health Service, "Guidelines on Infectious Disease Issues in Xenotransplantation", ~ (2001)

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