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Bioethics of Gene Therapy

  1. David B Resnik

Published Online: 15 MAR 2012

DOI: 10.1002/9780470015902.a0003480.pub2



How to Cite

Resnik, D. B. 2012. Bioethics of Gene Therapy. eLS. .

Author Information

  1. National Institutes of Health, Research Triangle Park, North Carolina, USA

Publication History

  1. Published Online: 15 MAR 2012


Gene therapy in human beings raises a variety of important ethical, legal and social issues. Somatic gene therapy (SGT) is similar to other forms of medical treatment in that the goal is to treat or prevent diseases in individuals. SGT raises questions concerning safety and efficacy of treatments and protection for human research subjects. Germline gene therapy is different from traditional medicine because it involves manipulation of the human genome to prevent the birth of children with genetic diseases. Germline gene therapy has been much more controversial than SGT, because it creates risks not only to patients but also to future generations, and because it may lead to genetic enhancement. Genetic enhancement raises a number of difficult issues, including the ethics of changing human traits, parental control over children's lives, exacerbation of discrimination and social inequalities and eugenics.

Key Concepts:

  • Advances in genetics and biotechnology in the 1970s and 1980s made possible the first somatic gene therapy experiments, which took place in the 1990s.

  • Somatic gene therapy has had some successes but still faces significant technical challenges.

  • Somatic gene therapy can pose significant risks to patients and some have died in somatic gene therapy experiments.

  • Germline gene therapy has been more controversial than somatic gene therapy because it involves deliberate, inheritable changes in the genome.

  • Germline gene therapy poses risks not only to patients but also to future generations.

  • Germline gene therapy raises difficult ethical questions related to tampering with human nature, enhancing human traits, parental control over children, discrimination, social justice and eugenics.

  • The distinction between therapy (which aims to prevent or treat disease) and enhancement (which aims to improve human traits), plays a key role in debates about gene therapy.

  • The therapy/enhancement distinction is not as clear as some have assumed, because the concept of disease is not purely objective and includes social, cultural and ethical dimensions.

  • Investigators and institutions should take appropriate steps to protect the rights and welfare of gene therapy patients participating in clinical research.

  • In thinking about the balance of benefit and risks of a gene therapy study, it is important to consider the safety and efficacy of the proposed research and the availability of alternatives.


  • somatic gene therapy;
  • germline gene therapy;
  • human enhancement;
  • bioethics;
  • human subjects research;
  • assisted reproduction