In February the National Academy of Sciences and the National Academy of Medicine issued a new report on the technical, social and regulatory concerns surrounding gene editing, entitled, “Human Genome Editing: Science, Ethics, and Governance.” Authored by a 22 member panel of scientists, ethicists, lawyers, physicians and geneticists from around the world, the report said that using gene editing technologies for applications like making generations more intelligent or stronger should not be permitted at this time. Technical advances in genome editing — most notably CRISPR — are not yet sufficiently advanced to allow such germline changes.
At the same time, however, the panel conceded that scientists would likely be in a position to accomplish such activities safely within 5-10 years and so it was not too soon to consider the issues involved and how best to regulate such potential uses of gene editing. As a result, they gave a cautious and controversial — but realistic — acknowledgement that the editing of DNA in the human germline could in theory, in the future, be ethically allowable — but only following much more research on the risks and benefits of such an action and only for compelling reasons and under strict oversight.
Human germline modification is currently prohibited in the United States and 40 other nations, and by a binding international treaty, The Council of Europe Convention on Human Rights and Biomedicine. In the United States, the U.S. Food and Drug Administration is forbidden from considering the approval of a clinical trial involving “research in which a human embryo is intentionally created or modified to include a heritable genetic modification.”
Looking forward, the new report concludes that germline edits might be acceptable in instances related to “serious diseases or condition,” with “maximum transparency,” and “rigorous oversight.” The panel also calls for the availability of credible preclinical data and rigorous long-term oversight and follow up on the potential benefits and risks of any procedure. Moreover, they also stress the necessity for public engagement and input on how such technology would be used and overseen. The panel had fewer concerns related to the use of gene editing in basic research and on somatic cells, for non-heritable changes related to the treatment of diseases or disabilities.
The panel’s recommendations are not binding on the United States or elsewhere. Genome research is an international endeavor. As such the report’s authors state that any clinical applications should reflect societal values and be subject to appropriate oversight and regulation, and that international coordination could enhance the consistency of such regulation.