Gene Therapy pp 283-292 | Cite as

Ethical and Social Problems of Gene Therapy

  • Mauro Giacca


Since the early days of gene therapy at the end of the 1980s, both the scientific community and the public have perceived the ethical and social problems intrinsic to this discipline. On one hand, the technologies for gene transfer are still largely experimental and thus pose important safety issues. On the other hand, the objective of several gene therapy applications is the stable modification of the genetic characteristics of an individual. Whether such modification is ethically acceptable and might also be applied to the embryo or fetus before birth, or to the germinal cells, has always been the subject of intense debate. Finally, while gene therapy is largely accepted when its application is to allow survival or improvement in the health of an individual, the gene transfer technologies of this discipline can also be exploited for the improvement of aesthetic appearance or physical and intellectual performance. These, and other major themes currently at the center of the ethical and social debate accompanying the development of gene therapy, are discussed in this chapter.


Germ Cell Gene Therapy Gene Transfer Embryonic Stem Cell Ornithine Transcarbamylase 
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Further Reading

  1. Caplan AL (2008) If it’s broken, shouldn’t it be fixed? Informed consent and initial clinical trials of gene therapy. Hum Gene Ther 19:5–6CrossRefPubMedGoogle Scholar
  2. Chan S, Harris J (2006) Cognitive regeneration or enhancement: the ethical issues. Regen Med 1:361–366CrossRefPubMedGoogle Scholar
  3. Chan S, Harris J (2006) The ethics of gene therapy. Curr Opin Mol Ther 8:377–383PubMedGoogle Scholar
  4. Coutelle C, Themis M, Waddington SN et al (2005) Gene therapy progress and prospects: fetal gene therapy — first proofs of concept — some adverse effects. Gene Ther 12:1601–1607CrossRefPubMedGoogle Scholar
  5. Deakin CT, Alexander IE, Kerridge I (2009) Accepting risk in clinical research: is the gene therapy field becoming too risk-averse? Mol Ther 17:1842–1848CrossRefPubMedGoogle Scholar
  6. Harris J, Chan S (2008) Enhancement is good for you!: understanding the ethics of genetic enhancement. Gene Ther 15:338–339CrossRefPubMedGoogle Scholar
  7. Kahn J (2008) Informed consent in human gene transfer clinical trials. Hum Gene Ther 19:7–8CrossRefPubMedGoogle Scholar
  8. Kiuru M, Crystal RG (2008) Progress and prospects: gene therapy for performance and appearance enhancement. Gene Ther 15:329–337CrossRefPubMedGoogle Scholar
  9. Spink J, Geddes D (2004) Gene therapy progress and prospects: bringing gene therapy into medical practice: the evolution of international ethics and the regulatory environment. Gene Ther 11:1611–1616CrossRefPubMedGoogle Scholar
  10. Wells DJ (2008) Gene doping: the hype and the reality. Br J Pharmacol 154:623–631CrossRefPubMedGoogle Scholar

Selected Bibliography

  1. Batshaw ML, Wilson JM, Raper S et al (1999) Recombinant adenovirus gene transfer in adults with partial ornithine transcarbamylase deficiency (OTCD). Hum Gene Ther 10:2419–2437CrossRefPubMedGoogle Scholar
  2. Frank KM, Hogarth DK, Miller JL et al (2009) Investigation of the cause of death in a gene-therapy trial. N Engl J Med 361:161–169CrossRefPubMedGoogle Scholar
  3. Grimm D, Streetz KL, Jopling CL et al (2006) Fatality in mice due to oversaturation of cellular microRNA/short hairpin RNA pathways. Nature 441:537–541CrossRefPubMedGoogle Scholar
  4. Kaiser J (2007) Clinical research. Death prompts a review of gene therapy vector. Science 317:580CrossRefPubMedGoogle Scholar
  5. Reay DP, Bilbao R, Koppanati BM et al (2008) Full-length dystrophin gene transfer to the mdx mouse in utero. Gene Ther 15:531–536CrossRefPubMedGoogle Scholar

Copyright information

© Springer-Verlag Italia 2010

Authors and Affiliations

  • Mauro Giacca
    • 1
  1. 1.International Centre for Genetic Engineering and Biotechnology (ICGEB)TriesteItaly

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