RAPS is closely monitoring developments in the Coronavirus (COVID-19) outbreak. See our public safety page for the latest updates.

Regulatory Focus™ > News Articles > 2019 > 9 > NASEM, Royal Society Consult on Human Genome Editing Framework

NASEM, Royal Society Consult on Human Genome Editing Framework

Posted 17 September 2019 | By Michael Mezher 

NASEM, Royal Society Consult on Human Genome Editing Framework

The US National Academies of Sciences, Engineering and Medicine (NASEM) and the UK's Royal Society issued a call for evidence on human germline genome editing as the two scientific bodies prepare to host an international commission to develop a framework for the scientific, medical, regulatory and ethical requirements necessary for such applications.
The commission, which met for the first time in August in Washington, DC, will consider submissions to the consultation ahead of at a two-day workshop in London this November.
The meeting comes one year after Chinese scientist He Jiankui announced he had edited the genes of infant twin girls using CRISPR in an attempt to make them more resistant to HIV infection. Jiankui’s announcement prompted swift international backlash, with regulators in China proposing rules to restrict gene editing in humans and experts around the world calling for a moratorium on human germline editing.
Since then various groups and organizations have proposed principles or oversight mechanisms for human genome editing, with most cautioning that it is too early to proceed with human germline genome editing.
Call for Evidence
The Royal Society and NASEM consultation includes twelve questions the commission is seeking input and evidence on, including what diseases and conditions, if any, are appropriate to consider for applications of human germline genome editing and what evidence would be necessary to support first-in-human use of the technology.
The consultation also seeks evidence on the current state of the technology, including information on the status of editing techniques and validation methods for ensuring edits are correct and characterizing off target effects in human embryos.
Other questions request input on matters such as obtaining informed consent in the context of germline genome editing, the need for inter-generational monitoring and how to address "untoward effects" that might arise from heritable changes.
Interested parties are instructed to submit responses by 27 September, with submissions set to be made available to the public at a later date.
Royal Society

Regulatory Focus newsletters

All the biggest regulatory news and happenings.