Gene-editing alliance releases bioethical framework
An alliance of companies that use gene-editing technologies has released a bioethical framework, as controversy over gene-editing continues.
Last week, advocacy organisation the Alliance for Regenerative Medicine (ARM) published five key principles for the ethical use of gene editing and genetic modification.
Signed by 13 therapeutic developers, including Sangamo Therapeutics, CRISPR Therapeutics and Editas Medicine, the principles agree that the developers do not support germline gene editing (the process by which the genome of an individual is changed so that the change is heritable) in human clinical trials or for human implantation.
Sandy Macrae, CEO of Sangamo Therapeutics and co-chair of ARM’s gene-editing task force, said: “With our current base of knowledge this means focussing solely on approaches that do not alter the germline unless and until ethical and potential safety questions with respect to germline gene editing are adequately addressed.”
Under the principles, ARM has endorsed the investigation of therapeutic applications of somatic cell gene editing.
“Regulated, clinical validation of somatic cell-based gene editing technologies for non-inherited genetic modification is, and should remain, the primary objective of the therapeutic development community,”’ said the framework.
The principles also support the use of gene-editing standards to facilitate the development of safe and efficacious therapies, while also calling for the “continued evolution” of national and regional regulatory frameworks governing the development of somatic cell gene-editing techniques.
According to ARM, evolving national and regional regulatory frameworks are important to support appropriate development of these technologies. It added: “It is our belief that arbitrary and ancillary oversight bodies or processes may carry the risk of delaying research and development efforts, which in turn would adversely impact afflicted patient populations.”
Finally, the principles also assert that germline gene editing is currently inappropriate in human clinical settings.
Janet Lambert, CEO of ARM, said: “As with all breakthrough biotechnologies, we need to exercise caution and good stewardship in our research and development practices and ensure that work involving the genetic modification of cells takes place within the bioethical framework outlined in these principles.”
Yesterday, LSIPR reported that the World Health Organization (WHO) had launched a global registry to track research on human genome editing and called on all relevant research and development initiatives to register their trials.
WHO’s committee of experts had called for a central registry in March this year, among a consensus that it would be irresponsible for any scientist to conduct gene-editing studies in people.
The principles and registry were set in motion after reports surfaced that a Chinese scientist had successfully created CRISPR ‘edited’ twins in December 2018.
Following the news, scientists began to policymakers to implement regulations around the use of gene-editing technology.
Since then, another scientist announced he was planning to create CRISPR-edited babies.
Did you enjoy reading this story? Sign up to our free newsletters and get stories like this sent straight to your inbox.
