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July 14, 2021

Is it safe—or ethical—to edit human DNA? Here's what WHO recommends.

Daily Briefing

    Largely prompted by 2018 scandal involving the use of CRISPR to genetically edit DNA in human embryos, the World Health Organization (WHO) on Monday issued new recommendations regarding human gene editing—calling for stronger limits on acceptable experiments and equitable distribution of ethical treatments, Gina Kolata writes for the New York Times.

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    Research into editing human embryos is highly controversial and has divided the scientific community since 2015, when a team in China first edited a human embryo's genes in a laboratory. 

    In November 2018, the Chinese scientist He Jiankui announced he had altered the DNA of twin girls born earlier. Clinical trial documents posted before the announcement suggested that He's research used the gene-editing tool CRISPR to modify human embryos before they were implanted into a woman's uterus. He said the clinical trial aimed to create a child who would be immune to HIV.

    On Dec. 30, 2019, the People's Court of Nanshan District of Shenzhen announced that He and two of his colleagues had falsified regulatory paperwork and deliberately violated regulations and medical ethics in pursuit of "fame and profit." He and his collaborators were sentenced to prison and permanently banned from working with human reproductive technology again, and from applying for research funding from the science ministry.

    WHO calls for proper gene-editing techniques, equitable distribution of ethical treatments

    In response to the backlash that developed following He's announcement, WHO in 2018 convened an 18-member committee to assess the scientific, legal, and ethical issues surrounding germline editing—which involves genetic editing in reproductive cells, thus being passed to future generations—and somatic editing—which involves genetically editing DNA only some cells and affecting only the patient being treated.

    To meet the demand for guidance on this issue, the WHO committee on Monday released two reports, which together condemn the technology used by He, saying it’s unethical to use. The WHO recommendation aims to complement standards developed by the International Commission on the Clinical Use of Human Germline Genome Editing.

    In the first WHO committee report, the committee addressed governance issues—identifying hypothetical scenarios and key questions how to address various values, ethical issues, and financial situations—for five different areas of genome editing, including the editing of:

    • Somatic, or adult, cells after someone is born
    • Somatic cells in-utero
    • Germline cells, such as eggs, sperm, and embryos
    • How DNA is expressed
    • Genes with the purpose of enhancing a person's genetic material, rather than eradicating disease

    "It's not prescriptive, but rather is a well-thought-out and accessible document with a lot of cognizance toward the differences between different countries," said Bartha Maria Knoppers, who directs the Centre for Genomics and Policy at McGill University and served on the International Commission. "I'm very impressed, it's an excellent policy toolkit."

    In the second report, the committee details nine suggestions for WHO to address itself, including establishing a system for whistleblowers to flag unsafe or unethical gene editing research and publishing an ethics statement that—at minimum—affirms WHO Director-General Tedros Adhanom Ghebreyesus' 2019 statement that "it would be irresponsible at this time for anyone to proceed with clinical applications of human germline genome editing."

    The committee also recommended that WHO improve and expand its registry to monitor any ongoing clinical trials or preclinical experiments involving gene editing. WHO's current version of the registry includes 156 experiments involving genes in non-reproductive cells, the New York Times reports.

    WHO on Monday said it will move forward with some of the suggestions, including establishing a committee to assess next steps for the registry and gathering a larger group of stakeholders to establish a better whistleblowing system. (Kolata, New York Times, 7/12; Molteni, STAT News, 7/12)

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