March 13, 2019

Statement on Call for Moratorium on and International Governance Framework for Clinical Uses of Heritable Genome Editing

A commentary published in Nature calls for a moratorium on clinical uses of heritable human genome editing and the establishment of an international governance framework. (We responded to the commentary with a joint letter, which is an abbreviated version of this statement.) The call comes following claims by a scientist in China to have edited the genes of early embryos, in treatments that resulted in the birth of twins. The scientist’s work – revealed at the Second International Summit on Human Genome Editing in Hong Kong, jointly organized by our Academies, was condemned by the summit organizers and by much of the wider scientific community.

We share concerns raised in the commentary. Indeed, statements from the organizing committees of both the 2015 and 2018 international summits made it clear that any clinical use of heritable genome editing would be irresponsible at this time. A 2017 U.S. National Academies report also concluded that clinical use, including clinical trials, of heritable germline editing should not proceed until peer-reviewed preclinical research clarifies the potential risks and benefits, and should be considered only for compelling medical reasons, in the absence of reasonable alternatives, and with maximum transparency and strict oversight. In addition, a 2018 report from the Nuffield Council on Bioethics recommended that much more research is needed in order to establish standards for clinical use, along with many more opportunities for broad societal engagement on these issues.

The commentary in Nature underscores the urgent need for an internationally accepted framework that addresses these complex scientific, ethical, and societal issues. Toward that end, the U.S. National Academies and the Royal Society are leading an international commission to detail the scientific and the ethical issues that must be considered in planning any genome editing, and to define specific criteria and standards for evaluating whether proposed clinical trials or applications that involve germline editing should be permitted. We are pleased that dozens of other scientific academies around the world are joining us and lending their support to the commission. We also welcome the establishment by the World Health Organization of its expert panel on human genome editing with which we have agreed to liaise closely.

We intend for the commission’s work to be an important step forward in reaching international consensus on standards that should apply to decisions about germline editing. As emphasized previously by our Academies and others, we also recognize the need to reach beyond the scientific and medical communities to achieve broad societal consensus before making any decisions, especially given the global implications of heritable genome editing.

Victor J. Dzau, President, U.S. National Academy of Medicine

Marcia McNutt, President, U.S. National Academy of Sciences
Venkatraman Ramakrishnan, President, Royal Society of the U.K.