National ethics review body needed: expert

By Fan Lingzhi and Leng Shumei Source:Global Times Published: 2018/11/30 0:18:39

Chinese scientists’ reputations may be ‘totally ruined’ if issue not addressed


 

Huang Jiefu, former Chinese vice minister of health and head of the National Human Organ Donation and Transplant Committee, talks during an exclusive interview with the Global Times on Wednesday in Beijing. Photo: Leng Shumei/ GT


 
Former Chinese vice minister of health Huang Jiefu called for the establishment of a national-level authority and improved legal system to supervise biological and human experiments, noting that the controversy surrounding gene-edited twins has had a negative impact on the international reputation of the country's bioscience sector.

The remarks were made by Huang in an exclusive interview with the Global Times on Wednesday, amid growing outrage in and outside of China over scientist He Jiankui's experiment on embryos that resulted in the birth of twins, who He claims are resistant to HIV.  

"I strongly condemn the so-called 'head transplant' surgery in 2017 [which was done on cadavers by an Italian surgeon] and I received the support of the scientific community. But that case slowly faded from the public eye. He Jiankui's case is more serious as the abuse of gene-editing technology will have an impact on the future of human kind," Huang said.

Italian surgeon Sergio Canavero in November 2017 claimed to have conducted the world's first head transplant using corpses at a hospital in Northeast China's Heilongjiang Province.

Canavero had dismissed ethical concerns, saying he performed the operation in China as it was "the right place."

"That case definitely damaged the international image of the Chinese scientific community. If we don't deal with He's case seriously, the reputation of Chinese scientists will be totally ruined," said Huang.

Zhao Haitao, a scholar from Peking Union Medical College Hospital (PUMCH) who specializes in gene studies, told the Global Times that He's experiment cannot be guaranteed accurate and could result in "off-target" editing.

If the molecular editing tools are off target and alter the wrong spot in the genome, it could have serious consequences, said Zhao. "What is most terrifying is that we will never know what the twins' gene will turn into," Zhao said.

Chaotic situation

Whether He's experiment was approved by a strict ethics review has been the focus of debate.

A document circulated online shows an application to the ethics committee of the Shenzhen HarMoniCare Women and Children's Hospital to review He's experiment was forged.

During the Second International Summit on Human Genome Editing on Wednesday in Hong Kong, He claimed that his "research has been submitted to ethics committee for supervision," but he didn't clarify which ethics committee.

Ethics committees in China lack certification standards and a regulatory mechanism, Huang noted.

"Some hospitals' ethics review committees are doing 'paper work.' They are formalistic and not strictly organized," Huang said.

It's difficult to prevent scientists crossing the red line due to a lack of related laws, Huang noted.

Zhong Shouxian, an 85-year-old medical expert from PUMCH, said there is not a complete organizational structure and legal system governing ethics committees in the country.

"Detailed regulations and laws covering all aspects of the committees' work need to be promulgated," Zhong said.

Need for national authority

The regulation on ethical experimentation to guide experiments related to humans, embryos and stem cells was enacted in 2003.

Huang said China's science and technology have now developed far beyond the scope of the regulation that was established 15 years ago.

Huang said China needs to set up a national authority to take charge of ethics reviews.

"I hope China can start to pay attention to the problem after the gene-edited babies. There is an urgent need for a national ethics review committee and legal system to regulate bioscience," he said.

Huang stressed ethics committees should not only include medical experts, but ethics and legal professionals, and members of the public.

To guarantee the fairness of a committee, members should not have a conflict of interest with the project they are reviewing, Huang pointed out.

Xu Hailin and Zhang Han contributed to this story



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