Guo, J. & Xin, H. Chinese gene therapy. Splicing out the West? Science 314, 1232–1235 (2006).
Booth, C. et al. Management options for adenosine deaminase deficiency; proceedings of the EBMT satellite workshop (Hamburg, March 2006). Clin. Immunol. 123, 139–147 (2007).
Branca, M. A. Gene therapy: cursed or inching towards credibility? Nature Biotechnol. 23, 519–521 (2005).
President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research. Splicing Life: A Report on the Social and Ethical Issues of Genetic Engineering with Human Beings. (US Government Printing Office, Washington, 1982).
Raper, S. E. et al. Fatal systemic inflammatory response syndrome in a ornithine transcarbamylase deficient patient following adenoviral gene transfer. Mol. Genet. Metab. 80, 148–158 (2003).
Baum, C. What are the consequences of the fourth case? Mol. Ther. 15, 1401–1402 (2007).
Kaiser, J. Clinical research. Death prompts a review of gene therapy vector. Science 317, 580 (2007).
Horstmann, E. et al. Risks and benefits of Phase 1 oncology trials, 1991 through 2002. N. Engl. J. Med. 352, 895–904 (2005).
Kimmelman, J. Recent developments in gene transfer: risk and ethics. BMJ 330, 79–82 (2005).
Dettweiler, U. & Simon, P. Points to consider for ethics committees in human gene therapy trials. Bioethics 15, 491–500 (2001).
Gaspar, H. B. et al. Gene therapy of X-linked severe combined immunodeficiency by use of a pseudotyped γ-retroviral vector. Lancet 364, 2181–2187 (2004).
Will, E. et al. Importance of murine study design for testing toxicity of retroviral vectors in support of Phase I trials. Mol. Ther. 15, 782–791 (2007).
Manno, C. S. et al. Successful transduction of liver in hemophilia by AAV-Factor IX and limitations imposed by host immune response. Nature Med. 12, 342–347 (2006).
Freedman, B. Equipoise and the ethics of clinical research. N. Engl. J. Med. 317, 141–145 (1987).
Orkin, S. H. & Motulsky, A. G. Report and Recommendations of the Panel to Assess the NIH Investment in Research on Gene Therapy. (National Institutes of Health, Bethesda, Maryland, 1995).
Kimmelman, J. Stable ethics: enrolling non-treatment-refractory volunteers in novel gene transfer trials. Mol. Ther. 15, 1904–1906 (2007).
Evans, J. H. Playing God: Human Genetic Engineering and the Rationalization of Public Debate. (University of Chicago Press, 2002).
King, N. M. RAC oversight of gene transfer research: a model worth extending? J. Law Med. Ethics 30, 381–389 (2002).
Ashcroft, R. E. Gene therapy in the clinic: whose risks? Trends Biotechnol. 22, 560–563 (2004).
Danzon, P. & Towze, A. The economics of gene therapy and of pharmacogenetics. Value Health 5, 5–13 (2002).
Danzon, P. & Towze, A. The genomic revolution: is the real risk under-investment rather than bankrupt health care systems? J. Health Serv. Res. Policy 5, 253–255 (2000).
National Hemophilia Foundation. Financial and Insurance Issues. [online], (2006).
Herper, M. Avigen Leads Gene Therapy Charge. Forbes [online], (2006).
Ja, H. & Kling, J. China offers alternative gateway for experimental drugs. Nature Biotechnol. 24, 117–118 (2006).
Jia, H. Controversial Chinese gene-therapy drug entering unfamiliar territory. Nature Rev. Drug Discov. 5, 269–270 (2006).
Jia, H. Gene therapy finds welcoming environment in China. Nature Med. 12, 263–264 (2006).
Marshall, E. Gene therapy. Panel reviews risks of germ line changes. Science 294, 2268–2269 (2001).
Kazazian, H. H. An estimated frequency of endogenous insertional mutations in humans. Nature Genet. 22, 130 (1999).
Kaplan, J. & Roy., I. Accidental germ-line modifications through somatic cell gene therapies: Some ethical considerations. Am. J. Bioeth. 1, w13 (2001).
King, N. M. Accident & desire. Inadvertent germline effects in clinical research. Hastings Cent. Rep. 33, 23–30 (2003).
Cohen, J., Scott, R., Schimmel, T., Levorn, J. & Wiladsen, S. Birth of infant after transfer of anucleate donor oocyte cytoplasm into recipient eggs. Lancet 350, 186–187 (1997).
Zoon, K. C. Letter to sponsors/researchers: human cells used in therapy involving the transfer of genetic material by means other than the union of gamete nuclei. FDA Center for Biologies Evaluation and Research. [online], (2001).
Firfer, H. How Far Will Couples Go To Conceive? CNN [online], (2004).
Robertson, J. A. Oocyte cytoplasm transfers and the ethics of germ-line intervention. J. Law Med. Ethics 26, 211–220 (1998).
Council of Europe. Convention for the Protection of Human Rights and Dignity of the Human Being with Regard to the Application of Biology and Medicine: Convention on Human Rights and Biomedicine. European Treaty Series 164 (4 Apr 1997).
Hébert, M., Chenier, N. M. & Norris, S. Bill C-6 Assisted Human Reproduction Act. Statutes of Canada, chapter 2 (2004). Available at http://www.parl.gc.ca/common/Bills_ls.asp?Parl=37&Ses=3&ls=C6
Indian Council of Medical Research, New Delhi. Ethical guidelines for biomedical research on human participants. [online], (2006).
Steinbock, B. in Designing Our Descendants: The Promises and Perils of Genetic Modifications. (eds Chapman, A. R. & Frankel, M. S.) 179–198 (Johns Hopkins University Press, Baltimore, 2003).
Genetics and Public Policy Center, Johns Hopkins University. Attitudes about Reproductive Genetics. [online], (2002)
Garber, K. RAC urges changes to retinoblastoma plan. Science 284, 2066 (1999).
RAC Department of Health and Human Services National Institutes of Health Recombinant DNA Advisory Committee. Minutes of meeting, June 14 1999 [online], (1999).
Melman, A., Bar-Chama, N., McCullough, A., Davies, K., Christ, G. hMaxi-K gene transfer in males with erectile dysfunction: results of the first human trial. Hum. Gene Ther. 17, 1165–1176 (2006).
RAC Department of Health and Human Services National Institutes of Health Recombinant DNA Advisory Committee. Minutes of meeting, March 10 2004 [online], (2004).
Baoutina, A., Alexander, I. E., Rasko, J. E. & Emslie, K. R. Potential use of gene transfer in athletic performance enhancement. Mol. Ther. 15:, 1751–1766 (2007).
Parens, E. Is better always good? The enhancement project. Hastings Cent. Rep. 28, S1–S17 (1998)
Sandel, M. J. The Case Against Perfection: Ethics in the Age of Genetic Engineering. (Harvard University Press, Cambridge, 2007)
Buchanan, A., Brock, D. W., Daniels, N. & Wikler, D. From Chance to Choice: Genetics and Justice. (Cambridge University Press, New York, 2001).
Mehlman, M. J. Genetic enhancement: plan now to act later. Kennedy Inst. Ethics J. 15, 77–82 (2005).
Mehlman, M. J. & Rabe, K. M. Any DNA to declare? Regulating offshore access to genetic enhancement. Am. J. Law Med. 28, 179–213 (2002).
Parens, E. Should we hold the (germ) line? J. Law Med. Ethics 23, 173–176 (1995).
Imperiale, M J. Gene therapy and biosecurity. Mol. Ther. 15, 648–649 (2007).
Billings, P. R. In utero gene therapy: the case against. Nature Med. 5, 255–256 (1999).
Waddington, S. N. et al. In utero gene therapy: current challenges and perspectives. Mol. Ther. 11, 661–676 (2005).
Dresser, R. Genetic modification of preimplantation embryos: toward adequate human research policies. Milbank Q. 82, 195–214 (2004).
Dennis, M. B. Welfare issues of genetically modified animals. ILAR J. 43, 100–108 (2002).
Massiello, S. A. Warning letter to James M. Wilson, Institute for Human Gene Therapy. FDA Freedom of Information [online], (2000).
Munson, R. in Outcome Uncertain: Cases and Contexts in Bioethics. (Munson, R. ed) (Wadsworth, Toronto, 2003).
Cornetta, K. & Smith, F. O. Regulatory issues for clinical gene therapy trials. Hum. Gene Ther. 13, 1143–1149 (2002).
Spink J. & Geddes, D. Gene therapy progress and prospects: bringing gene therapy into medical practice: the evolution of international ethics and the regulatory environment. Gene Ther. 11, 1611–1616 (2004).