Ethical and Regulatory Issues for Clinical Trials in Xenotransplantation
Research output: Contributions to collected editions/works › Chapter › peer-review
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Xenotransplantation: methods and protocols. ed. / Cristina Costa ; Rafael Máñez . Vol. 885 Humana Press, 2012. p. 281-305 (Methods in Molecular Biology; Vol. 885).
Research output: Contributions to collected editions/works › Chapter › peer-review
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TY - CHAP
T1 - Ethical and Regulatory Issues for Clinical Trials in Xenotransplantation
AU - Guerra González, Jorge
PY - 2012
Y1 - 2012
N2 - Clinical trials in xenotransplantation (XTx) that have just started to fulfil a long delayed promise should certainly be performed under the same guarantees for the subjects involved as any other experimentation in human medicine. The most important is the absolute respect for their fundamental rights and freedoms, especially for their autonomy, which is expressed through their informed consent as essential requirement for the carrying out of any clinical trial. This chapter focuses on the legal and ethical adaption of the clinical trial’s general rules to the particular conditions of xenografting. They are mainly related to the possibility that transmissible xenogeneic agents come into being and become a risk for third parties, even for the whole society. This aspect makes XTx different from any other therapy in (bio)medicine. According to most literature and norm proposals, such xenogeneic infection risk would justify important changes in clinical trial regulation: last but not least, it could mean fundamental right limitations for the xenografted subjects. However, an analysis of the present ethical and legal background at national and international levels shows that such special treatment would be awkwardly acceptable. Information and recommendations on XTx and on its chances and risks when consenting to the trial would be more advisable than right constraining approaches.
AB - Clinical trials in xenotransplantation (XTx) that have just started to fulfil a long delayed promise should certainly be performed under the same guarantees for the subjects involved as any other experimentation in human medicine. The most important is the absolute respect for their fundamental rights and freedoms, especially for their autonomy, which is expressed through their informed consent as essential requirement for the carrying out of any clinical trial. This chapter focuses on the legal and ethical adaption of the clinical trial’s general rules to the particular conditions of xenografting. They are mainly related to the possibility that transmissible xenogeneic agents come into being and become a risk for third parties, even for the whole society. This aspect makes XTx different from any other therapy in (bio)medicine. According to most literature and norm proposals, such xenogeneic infection risk would justify important changes in clinical trial regulation: last but not least, it could mean fundamental right limitations for the xenografted subjects. However, an analysis of the present ethical and legal background at national and international levels shows that such special treatment would be awkwardly acceptable. Information and recommendations on XTx and on its chances and risks when consenting to the trial would be more advisable than right constraining approaches.
KW - Law
KW - Biomedicine
KW - clinical trials
KW - Fundamental rights limitation
KW - Informed consent
KW - Xenogeneic infection risk
KW - Xenografting
KW - Xenosis
KW - Xenotransplantation
KW - Xenozoonosis
UR - http://www.scopus.com/inward/record.url?scp=84864141636&partnerID=8YFLogxK
U2 - 10.1007/978-1-61779-845-0_18
DO - 10.1007/978-1-61779-845-0_18
M3 - Chapter
C2 - 22566003
SN - 9781617798443
VL - 885
T3 - Methods in Molecular Biology
SP - 281
EP - 305
BT - Xenotransplantation
A2 - Costa , Cristina
A2 - Máñez , Rafael
PB - Humana Press
ER -