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.


Chadwick R (1998) Gene therapy. In: Kuhse H and Singer P (eds.) A Companion to Bioethics, chap. 19, pp. 189–197. Oxford, UK: Blackwells.

Clothier Committee (1992) Report of the Committee on the Ethics of Gene Therapy (Clothier Report, Cm 1788). London, UK: Her Majesty's Stationery Office.

Council of Europe (1997) Convention on Human Rights and Biomedicine. Oviedo: Council of Europe.

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.

GTAC (1998) Report on the Potential Use of Gene Therapy in Utero. London, UK: Gene Therapy Advisory Committee.

GTAC (2000) Sixth Annual Report. London, UK: Gene Therapy Advisory Committee.

GTAC (2001) Seventh Annual Report. London, UK: Gene Therapy Advisory Committee.

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.

UNESCO (1997) Universal Declaration on the Human Genome and Human Rights. Paris: United Nations Educational, Scientific and Cultural Organization.

WMA (2000) Declaration of Helsinki, 5th revision. Edinburgh, UK: World Medical Association General Assembly.

Web Links

Gene Therapy Advisory Committee (GTAC)

Health and Safety Executive

Medicines Control Agency

Contact Editor close
Submit a note to the editor about this article by filling in the form below.

* Required Field

How to Cite close
Harrison, Michael T(Sep 2006) Gene Therapy: Ethics and Regulation. In: eLS. John Wiley & Sons Ltd, Chichester. [doi: 10.1002/9780470015902.a0005652]