The DOI matches its Crossref record; 26 of the 26 references it cites were found in a registry or an index.
Intergenerational monitoring in clinical trials of germline gene editing
Abstract
Design of clinical trials for germline gene editing stretches current accepted standards for human subjects research. Among the challenges involved is a set of issues concerning intergenerational monitoring—long-term follow-up study of subjects and their descendants. Because changes made at the germline would be heritable, germline gene editing could have adverse effects on individuals’ health that can be passed on to future generations. Determining whether germline gene editing is safe and effective for clinical use thus may require intergenerational monitoring. The aim of this paper is to identify and argue for the significance of a set of ethical issues raised by intergenerational monitoring in future clinical trials of germline gene editing. Though long-term, multigenerational follow-up study of this kind is not without precedent, intergenerational monitoring in this context raises unique ethical challenges, challenges that go beyond existing protocols and standards for human subjects research. These challenges will need to be addressed if clinical trials of germline gene editing are ever pursued.
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“However, in an i-HGE study, the researchers ‘have generated risks for the edited subjects and their descendants’ (Cwik 2020a, pp. 185–186).”
From Initial heritable genome editing: mapping a responsible pathway from basic research to the clinic (2023) · cites this paper as Cwik 2020a, pp. 185–186
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“The researchers will therefore have some responsibility for certain aspects of the subject’s health, even if they withdraw from long-term monitoring.”
From Initial heritable genome editing: mapping a responsible pathway from basic research to the clinic (2023) · cites this paper as Cwik 2020a
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The UK Biobank resource with deep phenotyping and genomic data
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Kosicki, M., Tomberg, K., & Bradley, A. (2018) · Nature Biotechnology · doi:10.1038/nbt.4192 · Cited by 1,883
Correction of a pathogenic gene mutation in human embryos
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The Key Role of Epigenetics in Human Disease Prevention and Mitigation
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Adopt a moratorium on heritable genome editing
Lander, E. S., Baylis, F., Zhang, F., Charpentier, E., Berg, P., Bourgain, C., Friedrich, B., Joung, J. K., Li, J., Liu, D., et al. (2019) · Nature · doi:10.1038/d41586-019-00726-5 · Cited by 512
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Research works printed but not linked: 1
- Committee on Human Genome Editing, National Academies of Science, Engineering, and Medicine . Human genome editing: science, ethics, and governance. Washington, DC: National Academies Press, 2017: 123.
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
- Cwik, B.
- Venue
- Journal of Medical Ethics
- Publisher
- BMJ
- Published
- 2019-08-31
- Volume
- 46
- Issue
- 3
- Pages
- 183-187
- ISSN
- 0306-6800
- 1473-4257
- PMC
- PMC7036322
- Cited by
- 20
- References
- 26
- Language
- en
- Funders
- National Human Genome Research Institute (R03HG010417)
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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
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