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NIH Places Human Germline out of Bounds for Genome Editing Funding

NEW YORK (GenomeWeb) – Reacting to research published last week in which Chinese scientists conducted germline editing on a non-viable human zygote, the National Institutes of Health today firmly came down in opposition to the use of gene editing technologies in the human germline.

"NIH will not fund any use of gene-editing technologies in human embryos," NIH Director Francis Collins wrote in a statement published on the NIH website.

While technologies like CRISPR/Cas9 provide an "elegant" way of editing the genome, Collins said safety and ethical issues outweighed any potential benefits and added that germline editing "has been viewed almost universally as a line that should not be crossed."

NIH's stand comes a week after scientists from Sun-yat Sen University in China published a study reporting CRISPR/Cas9 gene editing of the beta-thalassemia gene in nonviable tripronuclear human zygotes. The study confirmed rumors that scientists were using the technology to alter the human germline and precipitated widespread backlash in the US scientific and popular press.

In his statement, Collins mentioned several legal and regulatory barriers to conducting such research in the US, including the Dickey-Wicker amendment, which forbids federal funding for the creation of human embryos for research, as well as research in which human embryos are destroyed; NIH Guidelines pertaining to the Recombinant DNA Advisory Committee, which states that research proposals for germline changes will not even be considered; and the authority given to the US Food and Drug Administration to regulate gene therapy products under the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

"NIH will continue to support a wide range of innovations in biomedical research, but will do so in a fashion that reflects well-established scientific and ethical principles," Collins said.