Skip to main content
Premium Trial:

Request an Annual Quote

NAS Human Genome Editing Report Braces for Germline Modifications


NEW YORK (GenomeWeb) – It's not too early to being thinking about how to regulate attempts to make heritable edits to the human genome, a National Academy of Sciences-led report has concluded.

Though currently prohibited by the US and several other countries, technical advances in genome editing technology, especially CRISPR, "have made it realistic to contemplate the eventual feasibility of applying these techniques to the human germline," the report said. If circumstances change and rule makers around the world are forced to approve or deny clinical trials pursuing such strategies, the committee behind the report suggested a set of absolute minimal criteria that such studies should meet.

"In the past, there has been a line drawn by many that says you should refrain [from germline editing]," Richard Hynes, a cancer researcher at the Massachusetts Institute of Technology and co-chair of the report's issuing committee said at a meeting in Washington, DC marking the report's release. "That was mostly because there was no way of considering how to do that at all. It was a theoretical idea. That's still true. We're not in a position to do it as yet. But one can look forward to see it is possible at some point. Not now, probably not in five or ten years, but we need to think about how to address it when the situation changes."

"We can no longer say simply, 'It cannot be done,'" he said during the meeting, which was webcast. "Because perhaps it can. Quite likely, it can."

The conditions include restricting studies to "serious" diseases or conditions; providing "maximum transparency" and "rigorous oversight; and requiring both credible pre-clinical data and long-term follow-up.

University of Wisconsin-Madison bioethicist and committee co-chair Alta Charo said the conditions were "strict and stringent" criteria that must be met before any such trials should be considered. "If those conditions are met, germline heritable editing clinical trials would be permissible. Not obligatory, but permissible," she said. "Caution is needed but being cautious does not mean prohibition."

These conditions are among the recommendations, both overarching and specific, that the lengthy peer-reviewed report provides. In addition to considering clinical germline editing, the committee addressed technical, social, and governance-related concerns about human genome editing in basic research, non-heritable clinical applications, and genomic enhancement.

Commissioned and supported by numerous federal and private philanthropical funding sources, the report is the second major event in the NAS and National Academy of Medicine's Human Gene-Editing Initiative. In December 2015, the National Academies, along with the Royal Society of the UK and the Chinese Academy of Sciences, hosted an international summit on human genome editing.

Erik Parens, a bioethics researcher at the Hastings Institute who was not involved in writing or reviewing the report, called it "a worthy attempt to find a middle way between too much caution and not enough." He added that the report's repeated calls for public engagement was a subtle, but ultimately important, shift in the presentation of genome editing, specifically its potential to cause social harm.

"The ungenerous reading is that they kicked the ethical can down the road by turning it over to public debate," Parens said in a phone call. Throughout the report, the authors stressed the necessity for public engagement, participation, and input in governing genome editing. "A more generous reading is that they have acknowledged broad and long-term social concerns. That might sound like incredibly bland acknowledgement, but it's not, if you place it into the history of reports on human genetic engineering in the US," he said.

In a break with past reports, specifically the 1982 report from the President's Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research entitled "Splicing Life," the new document considers more than just physical harms and scientific concerns, Parens said.

Along with technical considerations, the committee considered how countries might harmonize their approaches to prevent regulatory havens and genome-editing tourism.

Transnational cooperation was one of seven overarching principles the committee recommended, along with: promoting well-being, transparency, due care, responsible science, respect for all persons, and fairness.

"These are overarching principles any country can adopt," Charo said.