Clinical studies of gene-editing tech projects subjected to approval from the State Council

Source:Global Times Published: 2019/2/27 22:08:41

Chinese scientist He Jiankui presents his gene-editing experiment at the Second International Summit on Human Genome Editing in Hong Kong on Wednesday. Photo: AFP

High-risk clinical research projects including gene-editing technology have to be approved by the health department of the State Council, according to a new draft regulation on new biomedical technology released on Tuesday, three months after the scandal of Chinese scientist He Jiankui's gene-edited babies sparked concerns around the world. 

Clinical research of small and medium-risk new biomedical technology is subjected to be managed by provincial level health departments, and those of high risks have to be managed by the National Health Commission (NHC) of State Council. 

High-risk new biomedical technologies involve gene-editing and stem cell technology, assisted reproductive technology and new biological or biological products applied to the human body, according to the draft regulation published on the website of the NHC. The regulation is soliciting public opinions until March 27. 

The new regulation also stipulates that clinical research has to pass academic review and ethical review, and clinical studies cannot be conducted for biomedical technologies that have major ethics issues, are banned by laws and regulations or fail to go through animal testing to prove its safety and effectiveness.  

The academic review and the ethics review committees established by the medical institution have to review the necessity, legitimacy, scientificity, feasibility, safety and ethical adaptability of a research project after project managers submit their clinical research applications to the medical institution. 

Then the applications would be sent to the provincial health authority or even NHC for review if the project is categorized as high-risk. 

The regulation aims to standardize clinical studies and transform the applications of biomedical new technologies, ensure medical quality and safety, and safeguard human dignity and health.

Biomedical technology is the fastest growing and most challenging technology in the biological sciences, but if its application and clinical research are inappropriate, it will result in problems in privacy protection, biosafety, public safety and social ethics, according to the commission. 

The regulation also contains punishment for medical institutions and individuals that conduct clinical research in violation the regulations. Institutions and individuals face fines of up to 100,000 yuan or may even be held criminally accountable if they conduct clinical studies without getting practicing licenses.

He announced in November, 2018 that he have altered the DNA of twin girls born to prevent them from contracting HIV.

Others involved in his experiment will face serious punishment, and will be turned over to police, said the Guangdong provincial government investigators in January.

Global Times

Newspaper headline: Gene-editing projects examined

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