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Published online by Cambridge University Press: 20 December 2018
There is a role for regulatory oversight over new genetic technologies. Research must ensure the rights of human subjects, and all medical products and techniques should be ensured to be safe and effective. In the United States, these forms of regulation are largely the purview of the National Institutes of Health and the Food and Drug Administration. Some have argued, however, that human genetic therapies require new regulatory agencies empowered to enforce cultural norms, protect against hypothetical social harms, or ensure that the human genome remains unchanged. Focusing on the United States, this essay will briefly review these arguments and argue that the current limited regulatory role over human gene therapies is sufficient to protect public health, bodily autonomy, and reproductive freedom.
1. Nuffield Council on Bioethics. Genome Editing and Human Reproduction: Social and Ethical Issues. London: Nuffield Council on Bioethics; 2018.Google Scholar
2. Fukuyama, F. Our Posthuman Society: Consequences of the Biotechnology Revolution. New York: Farrar, Straus and Giroux; 2003.Google Scholar
3. Agar, N. Liberal Eugenics: In Defence of Human Enhancement. Oxford: Blackwell; 2008.Google Scholar
4. Greely, HT. The End of Sex and the Future of Human Reproduction. Cambridge: Harvard University Press; 2018.Google Scholar
5. National Academies of Sciences, Engineering, and Medicine. Human Genome Editing: Science, Ethics, and Governance. Washington, DC: The National Academies Press; 2017. doi: https://doi.org/10.17226/24623
6. Annas, GJ, Andrews, LB, Isasi, R. Protecting the endangered human: Toward an international treaty prohibiting cloning and inheritable alterations. American Journal of Law & Medicine 2002;28(2-3):151–78.Google ScholarPubMed
7. Fukuyama F, Fulger F. Beyond Bioethics: A Proposal for Modernizing the Regulation of Human Biotechnologies. Washington, DC: Paul H. Nitze School of Advanced International Studies; 2006.
8. United Nations General Assembly. General Assembly adopts United Nations Declaration on Human Cloning by vote of 84-34-37. United Nations; 2005; available at https://www.un.org/press/en/2005/ga10333.doc.htm (last accessed 1 Apr 2018).
9. Society for Developmental Biology. Position Statement from the Society for Developmental Biology on Genomic Editing in Human Embryos. Bethesda, MD: Society for Developmental Biology; 2015; available at http://www.sdbonline.org/uploads/files/SDBgenomeeditposstmt.pdf (last accessed 1 Apr 2018).
10. Friedmann, T, Jonlin, EC, King, NMP, Torbett, BE, Wivel, NA, Kaneda, Y, et al. ASGCT and JSGT joint position statement on human genomic editing. Molecular Therapy 2015;(8):1282. doi: 10.1038/mt.2015.118CrossRefGoogle ScholarPubMed
11. Collins F. Statement on NIH funding of research using gene-editing technologies in human embryos; 2015; available at https://www.nih.gov/about-nih/who-we-are/nih-director/statements/statement-nih-funding-research-using-gene-editing-technologies-human-embryos (last accessed 15 Jul 2018).
12. Evitt, NH, Mascharak, S, Altman, RB. Human germline CRISPR-Cas modification: Toward a regulatory framework. The American Journal of Bioethics 2015;15(12):25-29. doi: 10.1080/15265161.2015.1104160CrossRefGoogle Scholar
13. Grant, EV. FDA regulation of clinical applications of CRISPR-CAS gene-editing technology. Food & Drug Law Journal 2016;71:608–633.Google ScholarPubMed
14. US Food and Drug Administration. Guidance for Industry: Considerations for the Design of Early-Phase Clinical Trials of Cellular and Gene Therapy Products; available at http://www.fda.gov/downloads/Biologi.../UCM359073.pdf (last accessed 1 Apr 2018).
15. Evitt, NH, Mascharak, S, Altman, RB. Human germline CRISPR-Cas modification: Toward a regulatory framework. The American Journal of Bioethics 2015;15(12):25–29. doi: 10.1080/15265161.2015.1104160CrossRefGoogle Scholar
16. Darnovsky, M. Genetically modifying future children isn’t just wrong: It would harm all of us. The Guardian ; 2018 Jul 17; available at https://www.theguardian.com/commentisfree/2018/jul/17/genetically-modifying-future-children-embryos-nuffield-council-bioethics (last accessed 1 Oct 2018).Google Scholar
