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Clinical trials of germline gene editing: The exploitation problem
Abstract
The birth of the world’s first genetically edited babies in 2018 provoked considerable ethical outrage. Nonetheless, many scientists and bioethicists now advocate the pursuit of clinical uses of human germline gene editing. Progress towards this goal will require research, including clinical trials where genetically edited embryos are implanted into a woman’s uterus, gestated, and brought to term. This paper argues that such trials would likely conflict with the fundamental research ethical requirement of non‐exploitation. This is because they would expose people who are in a vulnerable situation to risks and burdens that are substantial and not obviously offset by compensating benefits. I consider how the potential for exploitation in such trials might be mitigated, arguing that a feasible and justifiable approach is not easily found. If this analysis is correct, there is a significant ethical obstacle on the path towards clinical use of human germline gene editing.
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“Although i-HGE may only be justifiable if there are no reasonable alternatives, it should be noted that the lack of alternatives could also increase the vulnerability of the prospective parents and thereby produce new moral concerns (Malmqvist 2021).”
From Initial heritable genome editing: mapping a responsible pathway from basic research to the clinic (2023) · cites this paper as Malmqvist 2021
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Research works printed but not linked: 12
- Ranisch, R., & Ehdi, H.-J. (2020). Fading red lines? Bioethics of germline genome editing. Bioethics, 34(1), 3-6.
- National Academies of Sciences, Engineering, and Medicine (NASEM). (2017). Human genome editing: Science, ethics, and governance. The National Academies Press; Nuffield Council on Bioethics (NCoB). (2018). Genome editing and human reproduction: Social and ethical issues. Nuffield Council on Bioethics;
- Miller, H. I. (2015). Germline gene therapy: We're ready. Science, 348(6241), 1325;
- Savulescu, J., Pugh, J., Douglas, T., & Gyngell, C. (2015). The moral imperative to continue gene editing research on human embryos. Protein & Cell, 6(7), 476-479;
- Gyngell, C., Douglas, T., & Savulescu, J. (2017). The ethics of germline gene editing. Journal of Applied Philosophy, 34(4), 498-513.
- Influential discussions include Buchanan, A., Brock, D., Daniels, D., & Wikler, D. (2000). From chance to choice: Genetics and justice. Cambridge University Press, and Habermas, J. (2003). The future of human nature. Polity.
- Nordgren, A. (2019). Designing preclinical studies in germline gene editing: Scientific and ethical aspects. Journal of Bioethical Inquiry, 16(4), 559-570;
- Cwik, B. (2020b). Intergenerational monitoring in clinical trials of germline gene editing. Journal of Medical Ethics, 46(3), 183-186.
- Bentley, J. P., & Thacker, P. G. (2004). The influence of risk and monetary payment on the research participation decision making process. Journal of Medical Ethics, 30(3), 293-298.
- Wertheimer, A. (2013). Is payment a benefit? Bioethics, 27(2), 105-116;
- Emanuel, E. J. (2006). Undue inducement: Nonsense on stilts? American Journal of Bioethics, 5(5), 9-13.
- Nordgren, op. cit. note 8. MALMQVIST | 4 694 694 14678519, 2021, 7, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/bioe.12903, Wiley Online Library on [06/09/2026]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
Cited by
Initial heritable genome editing: mapping a responsible pathway from basic research to the clinic
Ranisch, R., Trettenbach, K., & Arnason, G. (2023) · Medicine, Health Care and Philosophy · doi:10.1007/s11019-022-10115-x · Cited by 19
Metadata
- Authors
- Malmqvist, E.
- Venue
- Bioethics
- Publisher
- Wiley
- Published
- 2021-06-15
- Volume
- 35
- Issue
- 7
- Pages
- 688-695
- ISSN
- 0269-9702
- 1467-8519
- Cited by
- 3
- References
- 0
- Language
- en
- Funders
- Fondation Brocher
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