The trusted source for
healthcare information and
By Gary Evans
A rogue scientist who shocked the research community by genetically editing human embryos has been sentenced to three years in prison in China, according to the state-run press.
“Chinese researcher He Jiankui was sentenced to three years in prison and fined 3 million yuan (about $430,000) for illegally carrying out human embryo gene-editing intended for reproduction, in which three genetically edited babies were born,” the Xinhua news service reported.1
The court in Shenzhen, China, handed down the ruling, which said in part that He Jiankui, who obtained a PhD at Rice University in Houston, was not qualified to work as a physician.
“He has no medical training and no training in running clinical trials — really no qualifications whatsoever to be overseeing a clinical trial, if you want to call it that,” says Kiran Musunuru, MD, PhD, MPH, a cardiologist and the director of the Genetic and Epigenetic Origins of Disease Program at the University of Pennsylvania.
Gathering what limited information is available, Musunuru has been following the case carefully, expressing outrage at the flagrant breaches of common ethical principles. (For more information, see the story in the January 2020 issue of IRB Advisor at: https://bit.ly/2NuxeY5.)
“It involved experimentation on unborn babies,” he says. “There were problems with informed consent and misrepresenting the benefits and risks. All these are things that a proper IRB would have considered before letting him go forward. He was nailed on misrepresenting himself as a physician.”
A former associate professor at Southern University of Science and Technology in Shenzhen, He Jiankui was convicted along with two colleagues from medical institutes in Guangdong Province, the news service reported. They received jail terms of two years and 18 months, respectively, but were given a “two-year reprieve” that was not fully explained in the Xinhua article.
“According to the verdict, the three, not qualified to work as doctors, had knowingly violated the country’s regulations and ethical principles to practice gene editing in assisted reproductive medicine,” the Chinese news service reported. “[The court] said their acts were ‘in the pursuit of personal fame and gain’ and have seriously ‘disrupted medical order.’”1
There is a diversity of opinion on the verdict, with some seeing the prison time as excessive.
“If this was in the West he probably would have lost his position, been unable to get funding. There would have been professional implications,” says Craig Klugman, PhD, a bioethicist and member of the IRB at DePaul University in Chicago. “I do have a concern about the fact that he was arrested and imprisoned. I think the best deterrents are ones that effect people’s professional lives.”
The sentencing could have a chilling effect on researchers who want to push the boundaries while staying within legal and ethical obligations, he adds.
“The response should be proportional,” Klugman says. “To me, this seems disproportional. I am afraid that it could dissuade somebody who wants to do something cutting-edge, but fully within the law with full informed consent and within ethical guidelines.”
He Jiankui announced at a November 2018 scientific meeting in Hong Kong that he had genetically modified twin embryos. It has since been learned that a third modified baby has been born, Xinhua reported. The researcher used CRISPR-Cas9 to edit the human genome to confer resistance to HIV infection.1
The experiment shocked the scientific community, which cited widespread agreement that there were too many unknowns to proceed with CRISPR in human subjects. Given the gravity of the situation and possible downstream adverse effects on the gene-edited children, Musunuru says the punishment fits the crime.
“I tend to feel that having jail time as part of the sentence along with the financial penalty is appropriate,” he says. “He had many ethical breaches. Whether he, strictly speaking, broke Chinese law is a little bit ambiguous, but a Chinese court determined that he did.”
Currently in the United States, the FDA is not allowed to consider any application for clinical trials that involve modification of a germline or modification of human embryos, Musunuru says.
“In the United States, if you did this sort of thing, you would be breaking U.S. law in violating the Food, Drug, and Cosmetic Act,” he says. “An individual who commits a felony violation of that act could get a maximum penalty of three years and a fine of $250,000. It is actually not that different to what He Jiankui received as a sentence in China. On an ethical basis, I feel like he got off pretty light, considering all of the things that he did.”
Financial Disclosure: Author Melinda Young, Medical Writer Gary Evans, Editor Jill Drachenberg, Editor Jonathan Springston, Editorial Group Manager Leslie Coplin, and Physician Editor Lindsay McNair, MD, MPH, MSB, report no consultant, stockholder, speaker’s bureau, research, or other financial relationships with companies having ties to this field of study. Nurse Planner Kay Ball, PhD, RN, CNOR, CMLSO, FAAN, is a consultant for Ethicon USA and Mobile Instrument Service and Repair.