China issued a national regulation on ethics reviews of life sciences and medical research involving humans, which experts regard as a “landmark document” in the wake of the controversial scientists He Jiankui’s illegal human genome editing case in 2018.
Human life sciences and medical research includes the use of human biological samples and data to conduct research on reproduction, growth, development, and aging using physical, chemical, biological, and traditional Chinese medicine techniques.
According to the regulation published on the website of the National Health Commission (NHC) last month, it also applies to human body experiments involving new technologies or products.
According to an explanation on the document by the NHC, the newly revised regulation expands the application scope beyond medical institutes to include colleges and scientific research institutes and clarifies the regulatory responsibilities of various related authorities.
It also permits institutes that had not previously established ethics review commissions to delegate the conduct of ethics reviews to a competent commission. Companies may also entrust a competent commission with ethics reviews or project oversight.
The new regulation also specifies the particular steps of the ethics review. It was emphasized that ethics review commissions should conduct regular reviews of life sciences and medical research involving humans and organize educational and training sessions for research fellows, students, and management personnel.
In a time-sensitive manner, reviews of ethics should also be conducted in emergency situations. During the onset of an epidemic, for instance, such reviews must be conducted within 72 hours, with equivalent requirements during normal times.
As per Global Times, the regulation noted that life sciences and medical research involving humans should be of scientific and social value, and special attention should be paid to research involving fertilized eggs, embryos, fetuses, or those that could be affected by assisted reproductive technology.
According to experts contacted by the Global Times, the new regulation is a “landmark regulatory document” in the wake of the controversial scientist He Jiankui’s illegal genome-editing case in 2018. He, a genome-editing researcher at the Southern University of Science and Technology of China in Shenzhen, Guangdong Province, claimed to have created the first genetically modified humans in 2018.
In December 2019, he was sentenced to three years in prison for illegally editing human embryos for reproduction purposes. According to reports, he was released from prison in April 2022.
Early in February, he made a high-profile return by attending an academic seminar on the social values of CRISPR technology, sparking a heated debate on the ethical issues of scientific advancement.
The Immigration Department of Hong Kong Special Administrative Region invalidated the Top Talent Pass visa it had issued to He for “false statements” on February 22, less than a day after He informed the media that he had obtained the visa.
