Nearly six months after He Jiankui, Ph.D., stunned the world by disclosing, then defending, his controversial germline editing research resulting in the birth of twins, the U.S. National Academy of Medicine (NAM), the U.S. National Academy of Sciences (NAS), and the Royal Society of the U.K., have joined with science and medical academies worldwide to convene an international commission to address the controversial technique.
The commission would create a regulatory framework designed identify scientific, medical, and ethical requirements for applying germline genome editing—subject to a societal consensus that heritable human genome editing applications are acceptable. The framework could also inform the development of a potential pathway from research to clinical use, the U.S. academies and Royal Society said.
Creation of the commission 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. During the Summit, He detailed his rationale, screening, and regulatory procedures that led to the birth of the twins, who had received genome editing of the CCR5 gene in the hopes of preventing HIV infection.
In January, He was fired by his university, the Southern University of Science and Technology (SUSTech) in Shenzhen, China, after being condemned by Summit organizers and the global scientific community—which contended that the Chinese researcher violated 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,” NAM President Victor J. Dzau and Royal Society Vice-President John Skehel, co-chairs of the commission’s international oversight board, said 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.”
According to the U.S. academies and Royal Society, the commission will:
- Identify scientific issues, and 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.
- Discuss how to balance the 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.
- Outline the research and clinical characteristics that would underpin 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, an international workshop, and will also solicit public input. A final report is expected to be issued in the spring of 2020.
The U.S. National Academies and U.K. Royal Society will serve as secretariats of the commission, which includes representatives from 10 nations.
Dame Kay E. Davies, Ph.D., professor of genetics at the MDUK Oxford Neuromuscular Centre at the University of Oxford, U.K.; and Richard Lifton, president of the Rockefeller University in New York City, will co-chair the commission. The Commission’s 16 other members are:
- Hidenori Akutsu, M.D., Ph.D., Director, Department of Reproductive Medicine, National Research Institute for Child Health and Development in Tokyo.
- Robert Califf, M.D., Duke University, Durham, NC; an advisor to Verily Life Sciences and a former FDA Commissioner.
- Dana Carroll, Ph.D., University of Utah School of Medicine, Salt Lake City.
- Susan Golombok, Ph.D., Director of the Centre for Family Research, University of Cambridge (U.K.).
- Andy Greenfield, Ph.D., MRC Harwell Institute, Oxfordshire, U.K.
- Rahman A. Jamal, M.D., Ph.D., Universiti Kebangsaan Malaysia, Kuala Lumpur.
- Jeffrey Kahn, Ph.D., MPH, Andreas C. Dracopoulos Director, Berman Institute of Bioethics, Johns Hopkins University, Baltimore.
- Bartha Maria Knoppers, Ph.D., McGill University, Montreal.
- Eric Lander, Ph.D., President and Founding Director, Broad Institute of MIT and Harvard; faculty positions at MIT and Harvard Medical School, Cambridge, MA.
- Jinsong Li, Ph.D., Shanghai Institutes for Biological Sciences, Chinese Academy of Sciences, Shanghai.
- Michèle Ramsay, Ph.D., Director and Research Chair, Sydney Brenner Institute for Molecular Bioscience, University of the Witwatersrand, Johannesburg, South Africa
- Julie Steffann, M.D., Hôpital Necker-Enfants Malades and Paris Descartes University, Paris.
- K. Thelma, Ph.D., University of Delhi, New Delhi, India
- Sir Douglas Turnbull, Ph.D., Director, Wellcome Trust Centre for Mitochondrial Research, Newcastle University, Newcastle upon Tyne, U.K.
- Haoyi Wang, Ph.D., Principal Investigator, State Key Laboratory of Stem Cell and Reproductive Biology Institute of Zoology, Chinese Academy of Sciences, Beijing.
- Anna Wedell, M.D., Ph.D., Head of Clinic, Centre for Inherited Metabolic Diseases, Karolinska Institutet/Karolinska University Hospital,