Shanghai Dismisses Researchers After Probe Into Child's Death in Gene Therapy Study

Shanghai authorities announced on November 13 that two researchers had been dismissed following an investigation into a gene-editing study in which a child died, citing failures in safety reporting, clinical review and disclosure of financial conflicts of interest.

The findings were released in a statement by Shanghai's municipal investigation team. The investigation followed a Science magazine report linking the child's death to research by a Shanghai Jiao Tong University School of Medicine team published in Nature in February 2026.

The child had Snijders Blok-Campeau syndrome, a rare neurodevelopmental disorder for which there is currently no effective treatment. After seeking care at several hospitals without success, the family approached a researcher identified only by the surname Qiu at the medical school's Songjiang Research Institute in July 2023, hoping for a customized gene-editing therapy targeting the central nervous system.

Qiu's team conducted preclinical research at the institute. A biotechnology company in Guangzhou prepared the viral vectors, while another in Sichuan conducted safety testing in large animals.

The ethics committee at Xinhua Hospital, affiliated with the medical school, approved the clinical study on January 2, 2025. The child and family signed an informed consent form on February 20. The child received an injection at the hospital on March 24 and died on March 31 despite resuscitation efforts.

At an emergency review on April 2, the hospital's ethics committee concluded that the death was caused by thrombotic microangiopathy, a complication of the gene therapy, and ordered the study to stop, the statement said.

The team had submitted its paper to Nature on December 21, 2024. After several rounds of revision and additional animal experiments and data, it was published on February 18, 2026.

Investigators found that Qiu's team had failed to promptly inform the hospital's clinical study leader of findings in a nonhuman primate safety report, leaving warning signals unheeded. When publishing the paper, the team also failed to disclose in a timely manner the safety report, completed in February 2025, and the child's death.

The investigation found no data fabrication in the Nature paper. It did, however, identify academic irregularities, including discrepancies between the methods used and those described, and the presentation of data from the same batch in separate portions without explanation.

At Xinhua Hospital, investigators found that the scientific review had not independently and comprehensively assessed the study's design and safety. The ethics committee approved the study despite insufficient toxicology and safety evidence, even though additional materials it had requested had not been supplied.

The consent form disclosed the possibility of serious complications and adverse events but did not prominently warn the family of the risk of death, the statement said.

The family contributed 5.337 million yuan to support the research: 3.458 million yuan for viral vector production, 1.379 million yuan for large-animal toxicology research and a 500,000-yuan donation to an education development foundation.

Separately, researchers received money and gifts from the family worth about 1.06 million yuan. Qiu received premium liquor and electronic products worth about 100,000 yuan. A Xinhua Hospital researcher surnamed Yang received 900,000 yuan and premium liquor. Two other team members, surnamed Zhang and Yuan, each received 30,000 yuan. The statement said the money and gifts had been returned or handed over as required.

Qiu, Yang, Zhang and Yuan failed to accurately disclose conflicts of interest in the paper, investigators found.

Qiu, the Songjiang institute's deputy director and the principal person responsible for the preclinical research, and Yang, the paper's first author and a co-corresponding author, were dismissed. Both were barred for five years from undertaking or participating in science and technology program projects and from eligibility for awards and honors. They were also entered into a database of serious research integrity violations.

The clinical study leader, surnamed Yu, was removed as head of Xinhua Hospital's research department and demoted by two grades. Yu received five-year restrictions on promotion, research projects, awards and postgraduate recruitment, and was entered into the same database.

Other sanctions included removal from posts, demotions and Party disciplinary penalties for hospital officials responsible for ethics review and clinical research oversight. Zhang and Yuan received administrative warnings.

Authorities also ordered corrective action at the medical school, its Songjiang institute and Xinhua Hospital. District health authorities imposed administrative penalties on Xinhua Hospital and Songjiang District Central Hospital; the statement did not specify the penalties or detail the latter hospital's role.

Shanghai's health commission has drawn up a special inspection plan for clinical research involving new biomedical technologies and begun inspections and corrective work, the statement said.