NEW YORK (GenomeWeb) – The US National Academy of Medicine, the US National Academy of Sciences, and the Royal Society of the UK announce today that they are working with science and medical academies around the world to develop a framework for scientists, clinicians, and regulatory authorities on the appropriate use of human germline genome editing.
The framework will identify the scientific, medical, and ethical requirements that should be considered before CRISPR research can be applied to the clinical, if society concludes that heritable human genome editing applications are acceptable, the commission said.
The commission's formation came as a response to the work of He Jiankui, the Chinese scientist who shocked the world last November when he announced that he had edited the germlines of twin embryos. He was widely condemned by the global scientific community for violating scientific principles and ethical norms.
"These revelations at the [the Second International Summit on Human Genome Editing] 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," National Academy of Medicine President Victor Dzau and Royal Society Vice President John Skehel, cochairs of the commission's international oversight board, said in a 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."
In mid-December, the World Health Organization announced that it planned to establish a global, multi-disciplinary panel of experts to examine the scientific, ethical, social, and legal implications of both somatic and germline genomic editing. The panel — whose members were appointed in February and who will meet for the first time on March 18 — will review the current research and review social attitudes towards genome editing technology, then advise the WHO on appropriate oversight and governance mechanisms.
The US 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, and Rockefeller University President Richard Lifton will cochair the commission.
The commission will seek to identify the scientific, societal, and ethical issues surrounding the clinical application of germline genome editing; identify protocols and preclinical validation for evaluating possible off-target effects, mosaicism, and potential long-term side effects; 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, ethical approval from review committees, and the approval 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.
The commission will hold public meetings and an international workshop, and will also issue a call for public input. Its final report is expected in the spring of 2020.