The He Jiankui affair is a scientific and bioethical controversy concerning the use of genome editing following its first use on humans by Chinese scientist He Jiankui, who edited the genomes of human embryos in 2018.[1][2] He became widely known on 26 November 2018[3] after he announced that he had created the first human genetically edited babies. He was listed in Time magazine's 100 most influential people of 2019.[4] The affair led to ethical and legal controversies, resulting in the indictment of He and two of his collaborators, Zhang Renli and Qin Jinzhou. He eventually received widespread international condemnation.
He Jiankui, working at the Southern University of Science and Technology (SUSTech) in Shenzhen, China, started a project to help people with HIV-related fertility problems, specifically involving HIV-positive fathers and HIV-negative mothers. The subjects were offered standard in vitro fertilisation services and in addition, use of CRISPR gene editing (CRISPR/Cas9), a technology for modifying DNA. The embryos' genomes were edited to remove the CCR5 gene in an attempt to confer genetic resistance to HIV.[5] The clinical project was conducted secretly until 25 November 2018, when MIT Technology Review broke the story of the human experiment based on information from the Chinese clinical trials registry. Compelled by the situation, he immediately announced the birth of genome-edited babies in a series of five YouTube videos the same day.[6][7] The first babies, known by their pseudonyms Lulu (Chinese: 露露) and Nana (娜娜), are twin girls born in October 2018, and the second birth or the third baby born was in 2019,[8][9] named Amy.[10] He reported that the babies were born healthy.[11]
His actions received widespread criticism,[12][13] and included concern for the girls' well-being.[5][14][15] After his presentation on the research at the Second International Summit on Human Genome Editing at the University of Hong Kong on 28 November 2018, Chinese authorities suspended his research activities the following day.[16] On 30 December 2019, Chinese authorities announced that he was found guilty of forging documents and unethical conduct; he was sentenced to three years in prison with a three-million-yuan fine (US$430,000).[17][18] Zhang Renli and Qin Jinzhou received an 18-month prison sentence and a 500,000-yuan fine, and were banned from working in assisted reproductive technology for life.[19]
He Jiankui has been variously referred to as a "rogue scientist",[20] "China's Dr Frankenstein",[21] and a "mad genius".[22] The impact of human gene editing on resistance to HIV infection and other body functions in experimental infants remains controversial. The World Health Organization has issued three reports on the guidelines of human genome editing since 2019,[23] and the Chinese government has prepared regulations since May 2019.[24] In 2020, the National People's Congress of China passed Civil Code and an amendment to Criminal Law that prohibit human gene editing and cloning with no exceptions; according to the Criminal Law, violators will be held criminally liable, with a maximum sentence of seven years in prison in serious cases.[25][26]