A global conclave of gene-editing experts said it would be “irresponsible” to attempt to create gene-modified babies until the safety of the idea can be established, and until there is broad social consensus on whether such a step is desirable.
“The human genome is shared among all nations,” said David Baltimore, a Nobel Prize-winning biologist at the California Institute of Technology. “These criteria have not been met for any proposed clinical use.”
The statement is likely to discourage anyone from rushing ahead and trying to make a genetically modified baby, but isn’t binding. Individual countries will need to rely on their own regulations and laws to manage the technology.
The statement was released by the organizing committee for the International Summit on Human Gene Editing, a gathering of several hundred scientists and ethicists this week in Washington, D.C., meant to study gene editing’s use in ways that could alter human heredity—that is, by altering eggs, sperm, or embryos, cells of the so-called “germ line.”
The committee’s statement strongly endorsed basic research, including manipulation of these types of human cells in the laboratory, work that could help perfect the techniques. “The modified cells should not be used to try to establish a pregnancy,” said Baltimore. “That is the important statement for the present.”
The emergence of technology capable of creating genetically modified babies raises the theoretical possibility of correcting genes that cause inherited diseases, like sickle-cell anemia. But it also stoked fears that some researchers might rush ahead, prompting calls earlier this year for global debate about the “responsible use” of gene-editing technologies, particularly a powerful method called CRISPR.
The committee, which included a dozen other scientists and bioethicists, was appointed by the U.S. National Academy of Sciences and included representatives of the Chinese Academy of Sciences and the Royal Society in the U.K.
A larger study also launched this week will produce a more detailed report and recommendations. Today’s statement consciously fell short of a call for a ban or a moratorium, Baltimore said.
Alta Charo, a bioethicist at the University of Wisconsin-Madison, said the statement, finalized over the course of two days, should be regarded as “another milestone in the public discussion.” Among the recommendations of the group was to create an international forum to more widely discuss the technology.
“Almost everyone says it’s premature for clinical use and there should be a delay, but it doesn’t mean it should be ruled out forever,” said Richard Hynes, the MIT cancer biologist who co-chairs the larger study with Charo. “It’s like stem-cell research. It needs to be regulated but without too much constraint or endangering the whole enterprise.”
It’s clearly possible to alter the germ line today, since the techniques are used on many kinds of animals. But it could be years before the technology might be considered safe enough to work on humans. Many scientists also see few concrete medical problems that can be solved with it at this time, although some families affected by inherited disease dispute that assessment.
The problem facing the world is that humanity has a shared gene pool, but there’s no single body able to decide whether it should be modified with technology. An individual country, or even an individual doctor, could decide to reject today’s statement and embrace the technology.
Based on prior legislation and treaties, genetic engineering of the human germ line is banned in several dozen countries, mainly in Europe. In Germany, intervening in the germ line is considered a criminal act punishable by jail. Yet no concrete legal ban exists in any of the three most important bastions of gene-editing research—the U.S., China, and the United Kingdom—and the odds of any of these nations legislating against the idea seem slim.
In the U.K., embryo research is closely regulated, but the country has adopted a permissive position. Earlier this year it approved a different kind of genetic manipulation, involving swapping DNA between eggs from different women, called mitochondrial transfer, and an application by scientists to manipulate embryos with CRISPR for scientific purposes is pending there.
The situation in China has been less clear—one reason why scientists there were first to try altering human embryos with CRISPR in laboratory experiments. Qi Zhou, a member of the Chinese Academy, has described human germ-line editing as “not forbidden, but not permitted” in China.
In the U.S., embryo experiments are already prohibited if federal funds are involved, but there are few restrictions on private clinics. However, any attempt to create a gene-modified child would require approval by the U.S. Food and Drug Administration, just as with a new drug, and the agency would be unlikely to grant it, at least for now.
Already, censure by academic authorities may have put the brakes on germ-line research. Phillip Campbell, the executive of Nature, the world’s most influential science journal, said it has rejected several papers involving editing human embryos, either because they were poorly done or did not meet local ethics rules.
The committee’s four major recommendations were as follows:
- Research: “Intensive” research is needed and should proceed including on human embryos, subject to appropriate legal and ethical oversight.
- Clinical use (somatic): Treating adults with gene editing, to treat diseases like sickle-cell anemia, should proceed in existing regulatory frameworks.
- Clinical use (germ line): Making gene-altered children is “irresponsible” until safety issues can be addressed and until there is broad societal consensus on the proposed applications.
- Ongoing forum: Recognizing that every nation makes its own laws, the international community should create an ongoing forum to establish “norms” on gene-modified children. <