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Lessons Learned

The debate over mitochondrial replacement could inform the looming one regarding genome editing, say Brown University's Eli Adashi and Glenn Cohen from Harvard Law School in a Cell commentary. The two approaches, they note, share similar ethical implications, including the potential to affect the human germline.

"Both must contend with breaching the germline barrier. Both entail the manipulation of a human embryo. Both must address significant safety concerns. Both must engage a skeptical public," Adashi and Cohen write.

Mitochondrial genome replacement therapy was approved last year for use in certain circumstances in the UK. The approval, the authors note, came after a six-month inquiry by the Nuffield Council on Bioethics, public consultation through workshops, interviews, and public meetings, and now falls under the auspices of a strong regulatory body, the Human Fertilisation and Embryology Authority.

A similar approach could be followed in the US with the Presidential Commission for the Study of Bioethical Issues or the Hastings Center taking on the ethical inquiry or through the nascent National Academy of Medicine initiative, the authors say. However, they note that the regulatory circumstances in the US are a bit murkier, especially in light of the Dickey-Wicker Amendment, which prevents Department of Health and Human Services funds to be applied to research that creates or destroys human embryos and thus the Recombinant DNA Advisory Committee from considering it.

Still, Adashi and Cohen say that "[a]pplying the principles relied upon in the regulatory evaluation of [mitochondrial replacement] will go a long way toward assuring that the prospect of therapeutic genome editing in the human is the subject of a thorough, inclusive, ethical, safety-minded, and confidence-inspiring process."