Human gene editing is no longer the stuff of science fiction, and the powerful new technologies that make it possible raise important scientific, ethical, and societal questions.
The organizing committee for a 3-day International Summit On Gene Editing that convened experts from around the world to discuss the issues associated with human gene-editing research, has called upon the international community to work together to establish norms for acceptable uses of human gene editing.
In a statement issued Dec. 3 at the close of the summit, the committee asked the summit cohosts – the U.S. National Academy of Sciences and U.S. National Academy of Medicine, the Royal Society (United Kingdom), and the Chinese Academy of Sciences – to take the lead in creating an ongoing international forum on gene editing and to work on formulating recommendations and guidelines.
“While each nation ultimately has the authority to regulate activities under its jurisdiction, the human genome is shared among all nations,” the committee wrote. “The international community should strive to establish norms concerning acceptable uses of human germline editing and to harmonize regulations, in order to discourage unacceptable activities while advancing human health and welfare.”
The committee also concluded that:
• Intensive basic and preclinical research is needed, with a specific research focus on technologies for editing genetic sequences in human cells, potential benefits and risks of proposed clinical uses for gene editing, and understanding of the biology of human embryos and germline cells. Any early human embryo or germline cells that undergo gene editing should not be used to establish a pregnancy, the committee wrote.
• Improved understanding of the risks of somatic cell editing – such as inaccurate editing – is needed, as is understanding of the potential benefits of each proposed genetic modification. Such uses of gene editing, which are intended to affect only the individual who receives them, can be “appropriately and rigorously evaluated within existing and evolving regulatory frameworks for gene therapy,” they noted.
• Germline editing poses particularly important issues, such as the challenges with predicting harmful effects of genetic changes, including interactions with other genetic variants and with the environment. Moral and ethical considerations, such as the possibility of permanent genetic enhancements that could exacerbate social inequalities or be used coercively, must also be considered. The committee said that “it would be irresponsible to proceed with any clinical use of germline editing” unless and until the safety and efficacy issues have been resolved, and there is broad consensus about the appropriateness of a proposed application.
“At present these criteria have not been met for any proposed clinical use,” the committee wrote, adding that safety issues have not been adequately explored, and the cases of most compelling benefit are limited.
As the science advances and social views evolve, the clinical use of germline editing should be regularly revisited, they wrote.
The presidents of each of the organizations that hosted the summit welcomed the call for ongoing global discussion on issues related to human gene editing.
In a written response they said that they “stand ready to establish a continuing forum for assessment of the many scientific, medical, and ethical questions surrounding the pursuit of human gene-editing applications,” and will coordinate with other academies around the world and other international scientific and medical institutions in that endeavor.
“This is an important moment in human history and we have a responsibility to provide all sections of society with an informed basis for making decisions about this technology, especially for uses that would affect generations to come,” they wrote.