Human Rights and Ethical Considerations in the Genomic Era

Document Type : Original Article

Author

Department of Law, Baqir al-Olum University, Qom, Iran.

10.22081/phlq.2025.77883

Abstract

The rapid advancement of genome editing technologies, particularly CRISPR-Cas9, has revolutionized biomedical science while raising unprecedented ethical and human rights concerns. This paper examines the implications of genetic engineering through a human rights lens, focusing on three critical challenges: threats to equality from potential genetic enhancement, consent paradoxes in germline editing, and emerging forms of genetic discrimination. Using an interdisciplinary methodology that integrates bioethics, political philosophy, and international law, supplemented by case studies like the He Jiankui affair and DIY biohacking movement, the study reveals how current governance frameworks remain inadequate against these challenges. Key findings demonstrate that unequal access to genetic technologies risks creating "genetic privilege" and new forms of biological stratification, while germline interventions pose unresolved intergenerational justice issues. Furthermore, existing protections like GINA fail to address contemporary genetic privacy risks in direct-to-consumer testing and data commercialization. The paper proposes a tripartite governance model combining international cooperation (through WHO/UNESCO frameworks and a global registry), adaptive national policies (including regulatory sandboxes), and strengthened institutional oversight (with mandatory ethics training). These recommendations aim to balance scientific innovation with ethical safeguards, preventing genetic technologies from becoming tools of inequality while harnessing their therapeutic potential. The conclusion emphasizes the need for ongoing monitoring of social impacts and development of culturally sensitive implementation strategies, as the genomic revolution continues to challenge fundamental notions of human dignity, equality, and self-determination in the 21st century.

Keywords

References

Aagaard, K. & et al. (2023). Regulatory sandboxes for biotechnology innovation. Science and Public Policy, 50(2), pp. 110-125.
Adashi, E.Y. & Cohen, I.G. (2018). Mitochondrial replacement therapy: Unmade in the USA. JAMA, 319(4), pp. 337-348.
Appleby, J.B. (2019). The ethical challenges of mitochondrial replacement therapy. Bioethics, 33(1), pp. 10-26.
Baylis, F. & McLeod, C. (2022). The limits of genetic responsibility: Justice and global inequality. Bioethics, 36(3), pp. 1-38.
Baylis, F. (2017). Human germline genome editing: On the nature of our reasons to genome edit. The American Journal of Bioethics, 17(3), pp. 30-42.
Baylis, F. (2019). Altered inheritance: CRISPR and the ethics of human genome editing. Harvard University Press.
Berg, J.S. & et al. (2021). Newborn sequencing in genomic medicine and public health. Pediatrics, 147(2), pp. 12-31.
Bostrom, N. (2014). Superintelligence: Paths, dangers, strategies. Oxford University Press.
Bubela, T. & et al. (2021). Public engagement in genome editing governance. Science and Public Policy, 48(1), pp. 85-97.
Buchanan, A. & et al. (2000). From chance to choice: Genetics and justice. Cambridge University Press.
Clayton, E.W. & et al. (2019). The law of genetic privacy: Applications, implications, and limitations. Journal of Law and the Biosciences, 6(2), pp. 343-356.
Cohen, I.G. (2019). The FDA and the case of the three-parent baby. JAMA, 321(11), pp. 10-32.
Cohen, J. (2022). The DIY CRISPR dilemma. Science, 375(6581), pp. 414-436.
Cook-Deegan, R. & et al. (2022). Managing conflicts of interest in genomic research. Genetics in Medicine, 24(3), pp. 65-81.
Cyranoski, D. (2019). The CRISPR-baby scandal: What’s next for human gene-editing. Nature, 566(7745), pp. 440-452.
Delfanti, A. (2020). Biohackers: The politics of open science. Pluto Press.
Doudna, J.A. (2022). A crack in creation: Gene editing and the unthinkable power to control evolution. Houghton Mifflin Harcourt.
Erlich, Y. & et al. (2018). Identity inference of genomic data using long-range familial searches. Science, 362(6415), pp. 680-694.  
https://doi.org/10.1126/science.aau4832
Evans, B.J. (2021). The limits of GINA and the rise of genetic exceptionalism. Vanderbilt Law Review, 74(2), pp. 343-370.
FDA. (2019). Mitochondrial replacement therapy: Regulatory considerations. Federal Register, 84(45), pp. 123-135.
Fisher, C.B. & Kalbaugh, C.A. (2021). Ethics education for genetic researchers. Accountability in Research, 28(1), pp. 55-70.
Global Alliance for Genomics and Health. (2023). Framework for responsible sharing of genomic and health-related data. GA4GH. URL= https://www.ga4gh.org
Greely, H.T. (2019). CRISPR people: The science and ethics of editing humans. MIT Press.
Gronvall, G.K. (2020). Biosecurity and DIY biology. Health Security, 18(2), pp. 82-97.
Habermas, J. (2003). The future of human nature. Polity Press.
Haimes, E. & et al. (2021). Mitochondrial donation: Ethical challenges of translating radical interventions into clinical practice. Bioethics, 35(2), pp. 110-128.
Harris, J. (2007). Enhancing evolution: The ethical case for making better people. Princeton University Press.
Health Canada. (2023). Regulatory framework for gene therapies. Government of Canada. URL= https://www.canada.ca
Herbert, M. & Turnbull, D. (2018). Progress in mitochondrial replacement therapies. Nature Reviews Molecular Cell Biology, 19(2), pp. 71-88.
Hildt, E. (2019). Germline genome editing: Ethical considerations. Science and Engineering Ethics, 25(5), pp. 5-22.
Hyun, I. & et al. (2022). Ethical standards for mitochondrial replacement. Cell Stem Cell, 30(1), pp. 6-10.
Ishii, T. (2017). Germline genome-editing research and its socioethical implications. Trends in Molecular Medicine, 23(10), pp. 937-950.
Jasanoff, S. & et al. (2021). CRISPR democracy: Gene editing and the need for inclusive deliberation. Issues in Science and Technology, 37(3), pp. 345-360.
Javitt, G.H. & Hudson, K. (2022). Regulating CRISPR: Adaptive governance for genome editing. Science, 375(6582), pp. 10-34.
Jonas, H. (1984). The imperative of responsibility: In search of an ethics for the technological age. University of Chicago Press.
Kaye, J. & et al. (2021). Dynamic consent for genomic research. European Journal of Human Genetics, 29(3), pp. 12-38.
Kirksey, E. & et al. (2020). The CRISPR baby crisis. Anthropology Today, 36(2),
pp. 32-51.
Kofler, N. & et al. (2018). DIY CRISPR. Nature Biotechnology, 36(1), pp. 1-3. https://doi.org/10.1038/nbt.4061
Kuiken, T. (2016). Governance: Learn from DIY biologists. Nature, 531(7593),
pp. 156-176.
Lander, E.S. & et al. (2021). Adopt a moratorium on heritable genome editing. Nature, 567(7747), pp. 165-196.
Ledford, H. (2017). CRISPR treatment inserted directly into the body for first time. Nature, 543(7643), pp. 438-454.
Liang, PP. & et al. (2019). The CRISPR-baby scandal: A Chinese perspective. Protein & Cell, 10(5), pp. 360-385.
Marchant, G.E. (2023). The growing gap between emerging technologies and legal-ethical oversight. Springer.
Middleton, A. & et al. (2020). Genetic data escrows. Nature Genetics, 52(1), pp. 5-32.
National Academy of Medicine. (2020). Heritable human genome editing. National Academies Press.
O’Doherty, K.C. & et al. (2016). The psychological and behavioral impacts of genetic testing. Annual Review of Genomics and Human Genetics, 17(1), pp. 102-118.
Parens, E. & et al. (2019). Human flourishing in an age of gene editing. Oxford University Press.
Phillips, A.M. (2018). Only a click away—DTC genetics for ancestry, health, and more. New England Journal of Medicine, 378(2), pp. 110-134.
Price, W.N. & Cohen, I.G. (2019). Privacy in the age of medical big data. Nature Medicine, 25(1), pp. 37-53.
Ram, N. & et al. (2019). Genealogy databases and the future of criminal investigation. Science, 360(6393), pp. 108-127.
Rasmussen, N. (2022). Gene jockeys: Life science and the rise of biotech enterprise. Johns Hopkins University Press.
Rothstein, M.A. (2015). GINA at ten and the future of genetic nondiscrimination law. Hastings Center Report, 45(6), pp. 882-898.
Sandel, M.J. (2007). The case against perfection: Ethics in the age of genetic engineering. Harvard University Press.
Shao, Y. & et al. (2022). China’s biosecurity law and governance of genome editing. Science, 375(6580), pp. 7-30.
Stark, L. (2022). Genetic phishing: The rise of DNA data markets. MIT Press.
Sulmasy, D.P. & et al. (2023). Ethics education for genomic researchers. Journal of Medical Ethics, 49(1), pp. 78-92.
Suter, S.M. (2020). GINA at 12: The rise of genetic exceptionalism. American Journal of Law & Medicine, 46(2-3), pp. 213-230.
Van Hoyweghen, I. & et al. (2022). The genetic divide: Social inequality in genomic medicine. Social Science & Medicine, no. 298, pp. 1-28.
Wang, Y. & & Yang, H. (2021). The CRISPR baby scandal: A Chinese governance failure. Science and Public Policy, 48(5), pp. 1-8.  
https://doi.org/10.1093/scipol/scab012
WHO. (2021). Human genome editing: Recommendations. World Health Organization.
Wolf, S.M. & et al. (2022). IRBs and genomic research oversight. IRB: Ethics & Human Research, 44(2), pp. 76-92.
Zarin, D.A. & et al. (2021). The ClinicalTrials.gov registry. New England Journal of Medicine, 384(12), pp. 100-115.
Zayner, J. (2018). DIY genetic engineering: The future of biotechnology. The ODIN.
Zettler, P.J. & et al. (2023). Conflict of interest in genomic research. JAMA, 329(5), pp. 34-48.
Zhang, L. & Xue, Y. (2021). China’s biosecurity law and governance of genome editing. Science, 371(6534), pp. 11-34.
Zhang, Y. & et al. (2023). The MyHeritage breach: Lessons for genomic privacy. Nature Biotechnology, 41(1), pp. 3-21.
 
 
Journal of Philosophy of Law
Volume 4, Issue 1
May 2025
Pages 182-161

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  • Receive Date: 22 July 2025
  • Accept Date: 22 July 2025

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