Abstract
The chapter tackles the legal issues concerning scientific research involving chimeras and hybrids. It discusses domestic and international law, the regulatory needs and challenges, as well as offering recommendations for further implementation. Especially the Council of Europe and the EU should consider appropriate methods of governance. A definite requirement concerning chimbrids related research lies in the prior review by a qualified independent body.
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Notes
- 1.
Whereas chimbrids can be either interspecies or intraspecies mixtures, the project only dealt with human-animal chimbrids. Therefore, in this project, and in accordance with it, in the article at hand, the term “chimbrids” refers only to human-animal mixtures unless otherwise specified.
- 2.
In the USA, xenotransplantation is governed by the Food and Drug Administration (FDA) through case by case decisions. FDA-promulgated non-binding regulations “Source Animal, Product, Preclinical, and Clinical Issues Concerning the Use of Xenotransplantation Products in Humans.” Available from: http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Xenotransplantation/ucm092707.pdf
- 3.
In Israel, the Director-General of the Ministry of Health issued a circular on xenotransplantation in August 2000, followed by detailed guidelines promulgated in February 2002 and expressly designating xenotransplantation as a clinical experiment, which is subject to the regulatory regime established by the Public Health (Medical Experiments on Humans) Regulations (1980).
References
Taupitz J, Weschka M (Eds.). CHIMBRIDS – chimeras and hybrids in comparative European and international research. Heidelberg: Springer; 2009.
Art. 11 of the UNESCO Universal Declaration on the Human Genome and Human Rights, Resolution 16, adopted on the Report of Commission III at the 26th plenary meeting, on 11 November 1997 (29 C/Resolution 16), Records of the General Conference, Twenty-ninth Session, Paris, 21 October to 12 November 1997, Volume 1: Resolutions, Paris 1998, pp. 41–46. Available from: http://unesdoc.unesco.org/images/0011/001102/110220e.pdf
UN Declaration on Human Cloning, adopted on 8 March 2005 (A/RES/59/280). Available from: http://www.nrlc.org/UN/UN-GADeclarationHumanCloning.pdf
The Additional Protocol to the Convention for the Protection of Human Rights and Dignity of the Human Being with regard to the Application of Biology and Medicine, on the Prohibition of Cloning Human Beings (Council of Europe, CETS No.: 168), from 12 January 1998, entered into force on 1 March 2001 for Georgia, Greece, Slovenia, Spain and Slovakia. Currently, the Additional Protocol has been signed but not ratified by 13 member states of the Council of Europe, while further 18 member states have already ratified. Available from: http://conventions.coe.int/Treaty/en/Treaties/Html/168.htm
cf. Council of Europe, Recommendation Rec (2003) 10 of the Committee of Ministers to member states on xenotransplantation, adopted by the Committee of Ministers on 19 June 2003 at the 844th meeting of the Ministers’ Deputies. Available from: https://wcd.coe.int/ViewDoc.jsp?id=45827
French Public Health Code (art. L. 1125-2 et seq.), modified by Ordonnance n°2005–1087. Available from: http://www.legifrance.gouv.fr/affichCode.do;jsessionid=D1679774100246CE5410FB944671AA48.tpdjo02v_3?idSectionTA=LEGISCTA000006171005&cidTexte=LEGITEXT000006072665&dateTexte=20091215
Art. 43-48 of the Swiss Federal Act on the Transplantation of Organs, Tissues and Cells (Transplantation Act) from 8 October 2004 (in force since 1 July 2007). Available from: http://www.admin.ch/ch/d/as/2007/1935.pdf
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Taupitz, J. (2011). Chimeras + Hybrids = Chimbrids: Legal Aspects. In: Hug, K., Hermerén, G. (eds) Translational Stem Cell Research. Stem Cell Biology and Regenerative Medicine. Humana Press, Totowa, NJ. https://doi.org/10.1007/978-1-60761-959-8_17
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