An international committee convened by the U.S. National Academy of Sciences (NAS) and National Academy of Medicine released a report on Feb. 14 concluding that clinical trials of heritable germline genome editing "could be initiated," but "only within a robust and effective regulatory framework" and "if limited to only the most compelling circumstances."
Germline genome editing means making changes to human DNA that can then be passed down to later generations.
The report is seen by some as a shift away from the academies' previous position against genome editing of human embryos that would be implanted in a woman's womb and carried to term.
The report states that heritable genetic editing trials "must be approached with caution, but caution does not mean they must be prohibited." However, such trials should only be carried out "if limited to only the most compelling circumstances, subject to a comprehensive oversight framework that would protect the research subjects and their descendants; and have sufficient safeguards to protect against inappropriate expansion to uses that are less compelling or less well understood."
This latter category would include edits to improve physical and intellectual ability. The authors also point out that, while there are as yet no concrete research plans to carry out this kind of genetic alteration, gene editing technology is advancing quickly, and the time to consider implementing regulations is at hand.
Meanwhile, many observers are also calling for extreme caution regarding germline genome editing, pointing out that many serious technical and safety hurdles remain. For example, the chances of altering the wrong gene remain high with present technology. After editing embryonic DNA, there is also a danger that, as the embryo grows, some of the cells will carry the edit and some will not. It is also unknown what effects edits will have on later generations.
In Japan, the Cabinet Office's expert committee on bioethics released an interim report in April last year approving basic genetic editing research on fertilized human eggs on condition that they would not then be implanted in a woman's womb. However, the government has not yet moved to draw up legislation or guidelines on germline editing.
Meanwhile, the Japan Society of Gene and Cell Therapy (JSGCT) and three other related academic organizations are currently drawing up a screening regime for genetic editing research plans.
"This isn't something that should be left up to academic organizations alone," commented Hokkaido University bioethics professor Tetsuya Ishii. Furthermore, "Japanese researchers should not be aiming to create easy clinical applications for this technology, and should not use this report to support a sudden acceleration" in embryonic gene editing work, he said.