Abstract – 2015 International Summit Statement
Clinical Use: Germline.
Gene editing might also be used, in principle, to make genetic alterations in gametes or embryos, which will be carried by all of the cells of a resulting child and will be passed on to subsequent generations as part of the human gene pool. Examples that have been proposed range from avoidance of severe inherited diseases to ‘enhancement’ of human capabilities. Such modifications of human genomes might include the introduction of naturally occurring variants or totally novel genetic changes thought to be beneficial.
Germline editing poses many important issues, including:
- the risks of inaccurate editing (such as off-target mutations) and incomplete editing of the cells of early-stage embryos (mosaicism);
- the difficulty of predicting harmful effects that genetic changes may have under the wide range of circumstances experienced by the human population, including interactions with other genetic variants and with the environment;
- the obligation to consider implications for both the individual and the future generations who will carry the genetic alterations;
- the fact that, once introduced into the human population, genetic alterations would be difficult to remove and would not remain within any single community or country;
- the possibility that permanent genetic ‘enhancements’ to subsets of the population could exacerbate social inequities or be used coercively;
- and the moral and ethical considerations in purposefully altering human evolution using this technology.
It would be irresponsible to proceed with any clinical use of germline editing unless and until
- the relevant safety and efficacy issues have been resolved, based on appropriate understanding and balancing of risks, potential benefits, and alternatives,
- and there is broad societal consensus about the appropriateness of the proposed application.
Moreover, any clinical use should proceed only under appropriate regulatory oversight. At present, these criteria have not been met for any proposed clinical use: the safety issues have not yet been adequately explored; the cases of most compelling benefit are limited; and many nations have legislative or regulatory bans on germline modification. However, as scientific knowledge advances and societal views evolve, the clinical use of germline editing should be revisited on a regular basis.
Sources and More information
- On Human Gene Editing: International Summit Statement,
The National Academies of Sciences, Engineering, and Medicine, Dec. 3, 2015.
- Scientists urge caution on human gene editing, aljazeera, December 4, 2015.
- Center for Genetics and Society releases open letter and report calling for prohibitions on human germline engineering,
geneticsandsociety, November 29th, 2015.
- US scientists urge ban on human genetic modification, aljazeera, 30 Nov 2015.