Shanghai announces investigation results of "gene editing research incident at Jiaotong University School of Medicine"

Today, the Shanghai Investigation and Disposal Working Group issued a briefing on the "Gene Editing Research Incident at Jiaotong University School of Medicine." The full text is as follows:

Recently, Science magazine published a report stating that a paper published by the scientific research team of Shanghai Jiao Tong University School of Medicine in Nature magazine in February 2026 involved the death of a child who was conducting clinical research at Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine (hereinafter referred to as Xinhua Hospital), which aroused social concern. The Shanghai Municipal Party Committee and Municipal Government attached great importance to it and established the Shanghai Investigation and Disposal Working Group. It established four expert groups for on-site verification, scientific research integrity, medical ethics, and data verification. They communicated with the families of the children to understand the situation, and conducted a comprehensive and in-depth investigation of the relevant institutions and personnel involved in preclinical research, clinical research, and original data of the paper. The investigation and handling status are now reported as follows.

1. Basic situation

The children involved were diagnosed with Snijders Blok-Campeau syndrome, a rare childhood neurodevelopmental disorder for which there is currently no effective treatment. The patient traveled to many well-known hospitals in China but failed to get any results. In July 2023, the family members of the children took the initiative to contact Qiu Moumou of Songjiang Research Institute of Shanghai Jiao Tong University School of Medicine (hereinafter referred to as Songjiang Research Institute), hoping to customize a gene editing therapy for the central nervous system through Qiu Moumou's research. Qiu's team carries out relevant preclinical basic research at Songjiang Research Institute. During this period, a biotechnology company in Guangzhou prepared research-related viral vectors, and a biotechnology company in Sichuan conducted large animal safety trials. On January 2, 2025, the Xinhua Hospital Ethics Committee agreed to conduct this clinical study. On February 20, the children and their families signed an informed consent form. On March 24, the child completed injection treatment at Xinhua Hospital. On March 31, the child died after resuscitation failed. On April 2, the Ethics Committee of Xinhua Hospital held an emergency review meeting for serious adverse events. It believed that the cause of death of the child was thrombotic microangiopathy, a complication of gene therapy, and requested that the study be terminated.

On December 21, 2024, Qiu's team submitted a paper to the magazine "Nature" (Qiu is the last corresponding author, and the first author is Yang from Xinhua Hospital). The paper was revised several times and supplemented with animal experiments and data, and was officially published on February 18, 2026.

2. Main issues identified

After investigation, Qiu's team from Songjiang Research Institute (responsible for preclinical research) and relevant personnel of Xinhua Hospital (responsible for clinical research) did not strictly implement relevant system regulations during the research process.

(1) Problems in preclinical research. Qiu's team failed to promptly inform the person in charge of the clinical research project of Xinhua Hospital of the results of the non-human primate experiment safety report, resulting in the warning signs in the safety report not being taken seriously. When publishing the paper, the results of the non-human primate experimental safety report completed in February 2025 and the negative clinical research results of the death of the child in the clinical study case were not disclosed in a timely manner. Qiu, Yang, Zhang, and Yuan accepted property from the family members of the children and failed to truthfully disclose conflicts of interest when publishing papers.

After verification, no data fraud was found in the paper published by Qiu's team in the journal Nature. However, there were academic irregularities such as inconsistency between the actual research methods and the description of the paper, and the lack of explanation for the presentation of data from the same batch in batches.

(2) Problems existing in clinical research. Xinhua Hospital’s scientific review of clinical research was insufficient, and it did not conduct an independent professional and comprehensive evaluation of the scientificity and safety of the clinical research plan design. The hospital ethics committee did not strictly control the review. When there was insufficient toxicological and safety evidence in the early stage, although the research team was asked to supplement relevant information, it still approved the clinical research without supplementing the information, and the ethical review responsibilities were not fulfilled. There were flaws in the informed consent. Although the informed consent document disclosed to the patient's family that the study might cause serious complications and adverse events, it failed to disclose the key risks of death.

(3) Regarding research fees and the fact that some personnel accept property from children’s family members. The families of the children funded the research through donations, with a total investment of 5.337 million yuan, including 3.458 million yuan paid to a biotechnology company in Guangzhou for the production and preparation of research-related viral vectors, 1.379 million yuan paid to a biotechnology company in Sichuan for large animal toxicology research, and 500,000 yuan donated to an education development foundation. The family members of the children gave some personnel a total of about 1.06 million yuan in property, of which Qiu received high-end liquor and electronic products equivalent to about 100,000 yuan, Yang received 900,000 yuan and high-end liquor, and Zhang and Yuan (Qiu’s team members) each received 30,000 yuan. The relevant properties have been returned and handed over in accordance with regulations.

3. Handling of relevant personnel and institutions

Based on the discovered facts and determination of responsibilities, relevant personnel and institutions will be dealt with in accordance with the Disciplinary Punishment Regulations of the Communist Party of China, the Basic Medical Hygiene and Health Promotion Law of the People's Republic of China, the Punishment Regulations for Staff of Public Institutions, and the Investigation and Handling Regulations on Violations in Scientific and Technological Activities.

(1) Treatment of relevant personnel.

Qiu Moumou (Vice President of Songjiang Research Institute, the initiator and main person in charge of preclinical research, and the last corresponding author of the paper in Nature): He will be expelled; his qualifications to undertake or participate in science and technology projects, awards and awards will be revoked for 5 years, and he will be recorded in the database of serious breaches of trust in scientific research integrity.

Yang (key member of Qiu’s team, associate researcher at Xinhua Hospital, first author and co-corresponding author of the paper in Nature): He will be expelled; his qualifications to undertake or participate in science and technology projects, awards and evaluations will be revoked for 5 years, and he will be recorded in the database of serious breaches of trust in scientific research integrity.

Yu Moumou (head of clinical research, director of the scientific research department of Xinhua Hospital): Removed from the position of director of the scientific research department; lowered his job level by two levels; canceled his qualifications for job promotion, undertaking or participating in science and technology planning projects, awards and evaluations, and graduate student enrollment for 5 years, and recorded in the database of serious breaches of trust in scientific research integrity.

Shi Mou (Director of the Ethics Committee Office of Xinhua Hospital): revoked from the party position; removed from the position of Director of the Ethics Committee Office; lowered the position level by one level.

Sun Mou (then director of the Clinical Research and Innovation Center of Xinhua Hospital): revoked from the party position; lowered the position level by one level.

Xu Moumou (then vice president of Xinhua Hospital and chairman of the ethics committee): Severe warning and punishment within the party.

Zhang Moumou and Yuan Moumou (members of Qiu Moumou’s team): Administrative warning.

(2) Handling of relevant institutions.

For the Shanghai Jiao Tong University School of Medicine, relevant departments in Shanghai will interview it and instruct it to reflect deeply and strengthen the management of its affiliated units; the Shanghai Jiao Tong University School of Medicine will instruct the Songjiang Research Institute to make written inspections and make practical rectifications.

For Xinhua Hospital, the relevant departments of Shanghai will interview it and instruct it to make written inspections and make practical rectifications; the Yangpu District Health Commission of Shanghai will make an administrative penalty decision on Xinhua Hospital in accordance with laws and regulations.

For Songjiang District Central Hospital, the Shanghai Songjiang District Health Commission will make an administrative penalty decision on Songjiang District Central Hospital in accordance with laws and regulations; conduct an interview with the hospital and instruct it to make written inspections and make practical rectifications.

4. Strengthen supervision and management

The Shanghai Investigation and Disposal Working Group urged relevant units to use cases to promote changes, draw inferences from one instance and strengthen supervision throughout the entire process. The Shanghai Municipal Health Commission has formulated a special inspection plan for clinical research on new biomedical technologies and organized inspections and rectifications.

With the rapid development of new biomedical technologies, relevant institutions and practitioners should fully realize that clinical research on new biomedical technologies such as cell and gene therapy has high-risk characteristics, and they must abide by industry norms while courageously exploring. Industry authorities must conscientiously implement the "Regulations on the Management of Clinical Research and Clinical Transformation Application of New Biomedical Technologies", continue to strengthen policy publicity and training, and strengthen clinical research supervision. At the same time, we will continue to pay close attention to the health needs of patients with diseases for which there are no effective treatments, promote relevant scientific research and management work, improve diagnosis and treatment capabilities, and better meet the needs of patients.