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Genetics Organizations Urge 'Cautious But Proactive' View on Genome Editing

NEW YORK (GenomeWeb) – A groups of 11 genetics organizations have published a policy statement on germline genome editing in humans in the American Journal of Human Genetics today, recommending a "cautious but proactive approach" to the technology.

The statement — which comes on the heels of a blockbuster study in Nature in which researchers reported using the gene-editing tool CRISPR/Cas9 to correct a heart disease mutation in viable human embryos for the first time — recommended against genome editing that culminates in human pregnancy. Rather, the organizations said, genome editing research should be supported through public funding, and investigators should undertake in vitro research into its potential clinical applications. Further, the authors outlined the scientific and societal steps that will be necessary before the implementation of such clinical applications can be considered.

The statement was jointly authored by the American Society of Human Genetics, the Association of Genetic Nurses and Counsellors, the Canadian Association of Genetic Counsellors, the International Genetic Epidemiology Society, and the National Society of Genetic Counselors. It was also endorsed by the American Society for Reproductive Medicine, the Asia Pacific Society of Human Genetics, the British Society for Genetic Medicine, the Human Genetics Society of Australasia, the Professional Society of Genetic Counselors in Asia, and the Southern African Society for Human Genetics.

"Our workgroup on genome editing included experts in several subfields of human genetics as well as from countries with varying health systems and research infrastructure," said Kelly Ormond, lead author of the statement and professor of genetics at Stanford University, said in a statement. "Given this diversity of perspective, we are encouraged by the agreement we were able to reach and hope it speaks to the soundness and wider acceptability of our recommendations."

The group considered two types of ethical issues for genome editing — those arising from its potential failure and those arising from its success. Failure exposes individuals to a variety of health consequences, both known and unknown, while success could lead to societal concerns about eugenics, so-called designer babies, or issues of social justice and equal access to medical technologies.

Accordingly, the group wrote, as these issues are still being debated it would be inappropriate and unethical to being editing embryos with the goal of resulting in human pregnancy. "Scientifically, preclinical studies should establish reliability, validity, safety, and efficacy before attempting any germline genome editing that leads to the potential for implantation or human pregnancy at any post-implantation stage," they wrote. "New methods will need to be developed for identifying and monitoring off-target mutation sites in vivo after somatic genome editing (whether in preclinical animal models or, eventually, in humans) and — if human germline genome editing is to be at all considered — within human germ cells and embryos."

However, they added, there is no rationale to prevent in vitro research or to prohibit public funds from supporting such research.

"Many scientific, medical, and ethical questions remain around the potential for human germline genome editing," the authors concluded. "We encourage ethical and social consideration in tandem with basic science research in the upcoming years."

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