Gene Therapy: Ethics and Regulation

Ethical and regulatory considerations are paramount in gene therapy, which is the deliberate introduction of genetic material into human somatic cells for therapeutic, prophylactic or diagnostic purposes.

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 References
    book Chadwick R (1998) "Gene therapy". In: Kuhse H and Singer P (eds.) A Companion to Bioethics, chap. 19, pp. 189–197. Oxford, UK: Blackwells.
    book Clothier Committee (1992) Report of the Committee on the Ethics of Gene Therapy (Clothier Report, Cm 1788). London, UK: Her Majesty's Stationery Office.
    book Council of Europe (1997) Convention on Human Rights and Biomedicine. Oviedo: Council of Europe.
    book European Parliament (2001) Directive 2001/20/EC. Luxembourg: European Parliament and Council of European Union.
    Grundfast K and Rosen J (1992) Ethical and cultural considerations in research on hereditary deafness. Molecular Biology and Genetics 25(5): 973–978.
    book GTAC (1998) Report on the Potential Use of Gene Therapy in Utero. London, UK: Gene Therapy Advisory Committee.
    book GTAC (2000) Sixth Annual Report. London, UK: Gene Therapy Advisory Committee.
    book GTAC (2001) Seventh Annual Report. London, UK: Gene Therapy Advisory Committee.
    book Harris J (1992) Wonderwoman & Superman: The Ethics of Human Biotechnology. Oxford, UK: Oxford University Press.
    Humpherys D, Eagan K, Akutsu H, et al. (2001) Epigenetic instability in ES cells and cloned mice. Science 293: 95–97.
    Nevin N and Spink J (2000) Long term monitoring of patients participating in gene therapy. Human Gene Therapy 11: 1253–1255.
    book UNESCO (1997) Universal Declaration on the Human Genome and Human Rights. Paris: United Nations Educational, Scientific and Cultural Organization.
    book WMA (2000) Declaration of Helsinki, 5th revision. Edinburgh, UK: World Medical Association General Assembly.
 Web Links
    ePath Gene Therapy Advisory Committee (GTAC) http://www.doh.gov.uk/genetics/gtac
    ePath Health and Safety Executive http://www.hse.gov.uk/
    ePath Medicines Control Agency http://www.mca.gov.uk/
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Harrison, Michael T(Sep 2006) Gene Therapy: Ethics and Regulation. In: eLS. John Wiley & Sons Ltd, Chichester. http://www.els.net [doi: 10.1002/9780470015902.a0005652]