An international commission has been convened by the U.S. National Academy of Medicine, the U.S. National Academy of Sciences, and the Royal Society of the U.K., with the participation of science and medical academies around the world, to develop a framework for scientists, clinicians, and regulatory authorities to consider when assessing potential clinical applications of human germline genome editing.  The framework will identify a number of scientific, medical, and ethical requirements that should be considered, and could inform the development of a potential pathway from research to clinical use — if society concludes that heritable human genome editing applications are acceptable.

The commission is the latest action from the international science community to address issues around human genome editing.  It follows the Second International Summit on Human Genome Editing in Hong Kong – convened last November by the U.S. National Academies, the Royal Society, and the Academy of Sciences of Hong Kong. The topic became a focus on global attention when a scientist from China revealed at the summit that as a result of his research, twins had been born whose embryonic genomes had been edited. The scientist was widely condemned by the global scientific community for violating longstanding scientific principles and ethical norms.

“These revelations at the summit in Hong Kong underscore the urgent need for an internationally accepted framework to help scientists, medical experts, and regulators address the complex scientific and medical issues surrounding clinical use of germline genome editing,” said NAM President Victor J. Dzau and Royal Society Vice-President John Skehel, co-chairs of the commission’s international oversight board, in a joint statement. “We also welcome the formation of the World Health Organization’s Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome editing that will operate in parallel to our commission.”

The U.S. National Academies and the Royal Society will serve as secretariats of the commission, which includes representatives from 10 nations.  Kay Davies, professor of genetics at the MDUK Oxford Neuromuscular Centre at the University of Oxford, England, and Richard Lifton, president of the Rockefeller University in New York City, will co-chair the commission. A complete roster of those nominated to serve on the commission is available here.

The commission will:

• identify the scientific issues — as well as societal and ethical issues, where inextricably linked — that must be evaluated for any possible clinical application of germline genome editing;
• identify protocols and preclinical validation for evaluating the potential for off-target effects, mosaicism, and any potential long-term side effects that may result;
• discuss ways to assess the balance between potential benefits and harms of germline editing applications to a child and to subsequent generations;
• design appropriate protocols for obtaining patient consent and ethical approval from review committees, and for satisfying requirements of regulatory authorities;
• assess possible mechanisms for long-term monitoring of children born with edited genomes; and
• outline research and clinical characteristics that would form part of an oversight structure, including defining criteria for heritable genome editing, monitoring any clinical use, and bringing forward concerns about human experiments.

The commission will hold public meetings and an international workshop, and will also issue a call for public input to inform their work.  The commission’s final report is expected to be issued in the spring of 2020.

Journalists who would like more information should contact:

Bronwyn Friedlander
Press Office
The Royal Society
press@royalsociety.org
+44 (0)207 451 2514

Molly Galvin
Office of News and Public Information
U.S. National Academies of Sciences, Engineering, and Medicine
news@nas.edu
+1 202-334-2138

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