Building upon the Second International Summit on Human Genome Editing, the US National Academy of Sciences, the US National Academy of Medicine (NAM), and the Royal Society of the United Kingdom convened the International Commission on the Clinical Use of Human Germline Genome Editing. This Commission's formation is a direct consequence of the international controversy stemming from a Chinese scientist's claims of successfully having edited the genomes of human embryos that eventually were born.
In a press release, NAM President Victor J. Dzau and Royal Society Vice-President John Skehel, co-chairs of the Commission’s International Oversight Board, said, "These revelations at the [Second International] 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."
The commission has been tasked with several goals, including:
- Identifying scientific issues regarding the clinical application of germline genome editing and any related societal and ethical issues;
- Identifying methods for evaluating potential off-target effects, mosaicism, and long-term side effects;
- Discussing a means for assessing the pros and cons of germline editing for a child and subsequent generations;
- Designing protocols for obtaining patient consent and ethics review approval as well as satisfying regulatory requirements;
- Assessing the potential for long-term monitoring of children with edited genomes; and
- Outlining the research and clinical components of a potential oversight structure.
The Commission will hold a total of three meetings and will write a final report upon the conclusion of this series. Comments for the International Commission can be submitted online.
This first meeting, held on August 13, 2019 in Washington, DC, focused on identifying scientific, societal, and ethical issues pertaining to the potential clinical applications of human germline genome editing. An agenda for this meeting as well as videos of each talk can be found on the National Academies website. At this meeting, speakers provided expert input on the translation pathways from laboratory to therapy from the different perspectives of the scientific field, regulatory bodies, and potential patient communities.
The second meeting will be held November 14 and 15, 2019 in London. On the agenda for this meeting are sessions on the Commission’s task, alternative and future technologies, regulations and oversight, the rights of future individuals, and translation pathways.
In addition to this International Commission, the World Health Organization has also formed an Expert Advisory Committee to address genome editing. The co-chairs of the International Commission said, "We also welcome the formation of the World Health Organization [WHO]’s Expert Advisory Committee on Developing Global Standards for Governance and Oversight of Human Genome Editing that will operate in parallel to our Commission.” This WHO meeting occurred on March 18 – 19, 2019.
Though currently the US does not ban human germline editing research, there has been a ban preventing the FDA from approving clinical trials. Both the WHO and the International Commission hope to establish regulatory frameworks for governing bodies worldwide.