Illustration of a scientist editing a DNA strand

Establishing Standards for Gene Editing: Initial Steps from Private and Public Actors

By Phebe Hong

Nine months have passed since the startling news broke in November 2018 that Chinese researcher He Jiankui had used CRISPR/Cas9 to genetically modify the embryos of twin girls. The controversial news spurred the scientific and regulatory community into action. In late August 2019, two influential organizations — one from the private sector and one from the public sector — independently released statements announcing their efforts to establish standards for the nascent field of gene editing.

First, the Alliance for Regenerative Medicine (ARM), the advocacy organization representing cell and gene therapy companies, released its “Therapeutic Developers’ Statement of Principles,” offering an industry perspective on the use of gene editing technologies. Shortly thereafter, the World Health Organization (WHO) announced its plans to build a new registry and governance framework to track and regulate human gene editing trials. The statements symbolize an initial step by both private and public organizations to build consensus around responsible stewardship principles to prevent future scientific and ethical transgressions. It remains to be seen how such statements and plans will be implemented and how they will influence the field of genome editing research going forward.

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Regulation of Human Genome Editing in the Dawn of the CRISPR Era

By Scott J. Schweikart

With the advent of CRISPR and the first babies born with edited genomes, gene editing technology is now cheaper and more accurate than it has been. And there is now a verifiable occurrence of heritable genome modification using CRISPR.

As such, human genome editing is naturally (and quite rightly) receiving world-wide attention. Scientists, bioethicists, lawyers, and policy makers are questioning what is the best course of action in the face of this new technology that promises great medicinal benefits, but also poses great and unknown risks. Read More