A Shanghai inquiry dismissed two researchers and disqualified them for five years from undertaking or participating in science and technology plan projects and from award selection after finding failures in safety reporting and hospital review in a study preceding a child's death.
The Shanghai municipal investigation and handling work group said researchers surnamed Qiu and Yang were also entered into a database of serious research-integrity violations. Other participants faced demotions, removal from posts or disciplinary penalties.
The child had Snijders Blok-Campeau syndrome, a rare neurodevelopmental disorder for which the inquiry said no effective treatment was available. The family approached Qiu in July 2023 about a customized gene-editing treatment for the central nervous system. Xinhua Hospital approved the study Jan. 2, 2025; the child received an injection March 24 and died March 31 after resuscitation efforts failed. At an April 2 meeting, the hospital's ethics committee attributed the death to thrombotic microangiopathy, a gene-therapy complication, and ordered the study to end.
The work group found that Qiu's team did not promptly provide nonhuman-primate safety-test results to the hospital's clinical-study lead. Xinhua Hospital's scientific review did not fully assess the study's basis and safety, the group said. The ethics committee approved the study before receiving additional materials it had requested, while toxicology and safety evidence remained insufficient. The consent form disclosed possible severe complications and adverse events but did not prominently disclose the risk of death.
The inquiry said a paper in Nature omitted the animal-test findings and the child's death, and that researchers did not disclose conflicts of interest. The review found no fabricated data, but flagged differences between the research methods and the paper's description, along with unexplained presentations of data from the same batch in separate installments.
The family donated 5.337 million yuan to support the research, including viral-vector production and large-animal toxicology work. Investigators said team members received about 1.06 million yuan in money and valuables from the family; the items were returned or turned over under applicable rules.
The work group ordered Shanghai Jiao Tong University School of Medicine, Xinhua Hospital and Songjiang District Central Hospital to make corrections. Shanghai health authorities said special inspections of clinical studies involving new biomedical technologies are underway.
