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Review

Heritable Human Genome Editing

The Royal Society; National Academy of Sciences; National Academy of Medicine; International Commission on the Clinical Use of Human Germline Genome Editing.
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Excerpt

Heritable human genome editing — making changes to the genetic material of eggs, sperm, or any cells that lead to their development, including the cells of early embryos, and establishing a pregnancy — raises not only scientific and medical considerations but also a host of ethical, moral, and societal issues. Human embryos whose genomes have been edited should not be used to create a pregnancy until it is established that precise genomic changes can be made reliably and without introducing undesired changes — criteria that have not yet been met, says Heritable Human Genome Editing. From an international commission of the U.S. National Academy of Medicine, U.S. National Academy of Sciences, and the U.K.'s Royal Society, the report considers potential benefits, harms, and uncertainties associated with genome editing technologies and defines a translational pathway from rigorous preclinical research to initial clinical uses, should a country decide to permit such uses. The report specifies stringent preclinical and clinical requirements for establishing safety and efficacy, and for undertaking long-term monitoring of outcomes. Extensive national and international dialogue is needed before any country decides whether to permit clinical use of this technology, according to the report, which identifies essential elements of national and international scientific governance and oversight.

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Grants and funding

This activity was supported by Contract No. HHSN263201800029I / Order No. 75N98019F00852 from the U.S. National Institutes of Health, Grant No. 2019 HTH 009 from the Rockefeller Foundation, and Grant 218375/Z/19/Z from the Wellcome Trust, with additional support from the Royal Society of the United Kingdom, the Cicerone Endowment Fund of the U.S. National Academy of Sciences, and the NAM Initiatives Fund of the U.S. National Academy of Medicine. Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

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