Jeffrey Kahn, Andreas C. Dracopoulos Director of the Berman Institute and Robert Henry Levi and Ryda Hecht Levi Professor of Bioethics and Public Policy, has been appointed to an international commission 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.
Prof. Kahn has served on numerous state and federal advisory panels. He is currently chair of National Academies of Sciences, Engineering, and Medicine’s Board on Health Sciences Policy, and has previously chaired its committee on the Use of Chimpanzees in Biomedical and Behavioral Research (2011); the committee on Ethics Principles and Guidelines for Health Standards for Long Duration and Exploration Spaceflights (2014); and a committee on the Ethical, Social, and Policy Considerations of Mitochondrial Replacement Techniques (2016). He also formerly served as a member of the National Institutes of Health (NIH) Recombinant DNA Advisory Committee.
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 of 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 long-standing scientific principles and ethical norms.
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.