Shanghai Jiao Tong University School of Medicine has opened an investigation into reports that a six-year-old girl died after receiving an experimental gene-therapy procedure and that her death was not disclosed in later published research.
The university said on Sunday, July 26, that it had formed a special working group to conduct a comprehensive investigation. It said it places importance on research integrity and ethics and would take action in line with the findings.
The patient, identified by the pseudonym Mei, died last year about a week after a spinal infusion involving viral vectors intended to deliver a treatment to the brain, according to a joint investigation by Science and Retraction Watch. The experimental treatment was designed for a rare genetic condition associated with delayed cognitive development.
Questions about disclosure and consent
The reports said the child’s family funded the experiment and was not adequately informed of the risks. Those allegations have not yet been independently resolved by the university’s review.
Neuroscientist Zilong Qiu, identified as the lead researcher, later published a paper on related animal studies in Nature. The paper did not mention the child’s death, according to the reports.
The distinction between an experimental clinical intervention and related animal research will be central to the inquiry, alongside questions about ethics approval, informed consent, adverse-event reporting and the responsibilities of researchers and institutions.
A high-stakes field
The project aimed to develop a brain-directed gene-editing therapy that could correct a mutation in neurons and restore production of a vital protein. Such work sits at the frontier of biotechnology, where potential benefit is matched by unusually demanding safety and governance requirements.
The case also places renewed attention on China’s research-oversight framework after the 2018 gene-edited babies scandal. For now, the confirmed development is the university’s investigation; conclusions about responsibility or causation must wait for its findings.
Source note: Shanghai Jiao Tong University School of Medicine’s July 26 statement and reporting by Science, Retraction Watch, AFP and CNA.
