American Journal of Bioethics.

Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework

CRISPR germline editing therapies (CGETs) hold unprecedented potential to eradicate hereditary disorders. However, the prospect of altering the human germline has sparked a debate over the safety, efficacy, and morality of CGETs, triggering a funding moratorium by the NIH. There is an urgent need for practical paths for the evaluation of these capabilities. We propose a model regulatory framework for CGET research, clinical development, and distribution. Our model takes advantage of existing legal and regulatory institutions but adds elevated scrutiny at each stage of CGET development to accommodate the unique technical and ethical challenges posed by germline editing.

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Volume 15, Issue 12
December 2015

Target Articles.

“Editing” Genes: A Case Study About How Language Matters in Bioethics Meaghan O'Keefe, Sarah Perrault, Jodi Halpern, Lisa Ikemoto, Mark Yarborough & UC North Bioethics Collaboratory for Life & Health Sciences
CRISPR Critters and CRISPR Cracks R. Alta Charo & Henry T. Greely
Human Germline CRISPR-Cas Modification: Toward a Regulatory Framework Niklaus H. Evitt, Shamik Mascharak & Russ B. Altman