Application for registration of infant trials without submitting original data for genetic editing has been rejected

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 Application for registration of infant trials without submitting original data for genetic editing has been rejected


The reason for the rejection was that He Jiankui did not submit the original data and did not answer the inquiry of the Chinese Clinical Trial Registry on the ethical review of the trial.

Beijing News (Reporter Xu Wen) yesterday, a reporter searched the website of the China Clinical Trial Registration Center and found that the application for registration of the Gene Edited Infant test had been rejected by the center because the original data had not been submitted for examination.

According to the centers website, He Jiankui decided to reject his application for supplementary registration because he failed to provide the original data on the commitment date and did not answer the two inquiries of the center. The status of the experiment was updated to suspend or suspend from November 30.

The trial was previously provisionally registered

Previously, the Gene Edited Infant experiment led by He Jiankui, associate professor of biology, Southern University of Science and Technology, submitted a supplementary registration application to the China Clinical Trials Registry in accordance with academic research practice and obtained a temporary registration number.

Data show that the China Clinical Trial Registry is managed by the World Health Organization (WHO), and is a non-profit academic institution. In 2004, the former Ministry of Health designated it to represent China in the WHO International Clinical Trial Registration Platform. Registration on the platform is one of the basic conditions for researchers to publish clinical research articles in international medical journals.

According to the provisions of the China Clinical Trial Registry, all clinical trials should apply for registration before they begin to recruit subjects or before they are included in the first case; after that, all applications for registration are for supplementary registration. For the supplementary registration test, the center stipulates that in addition to submitting the research plan, informed consent and ethics committee approval, the original data must be submitted for examination to ensure the authenticity of the test. According to the centers website, on November 8 this year, as early as March 2017, the clinical trial of Gene Editor Infant was launched and applied for re-registration. The registration title was Safety and Effectiveness Assessment of Gene Editing of HIV Immune Gene CCR5 Embryo, and basic information about the projects research purpose, research time and sample size was submitted.

At present, the application for supplementary registration of the Gene Edited Infant test has been rejected. The Gene Edited Infant test registration page shows that because the original data can not be provided for audit, the application for supplementary registration has been rejected. The column Recruitment of research subjects has also been changed from ongoing to suspension or interruption.

The Centre sent two inquiries to He Jiankui, but no response was received.

Reporters noted that the China Clinical Trial Registry had issued a special note on rejecting the application for supplementary registration of the clinical trial Evaluation of the safety and effectiveness of CCR5 embryonic gene editing of HIV immune gene (hereinafter referred to as Special Note), which disclosed that on November 8, 2018, the Chinese Clinical Trial Registry notified Xu Jinzhou and He Jiankui that two researchers had accepted their clinical trials. The application for the supplementary registration of Safety and Effectiveness Assessment of HIV Immune Gene CCR5 Embryo Gene Editing is provisionally submitted with the test registration number ChiCTR1800019378, and they are required to provide the original data for review.

The Special Note mentions that because it failed to provide original data for the promised 28 November practice and did not answer two queries concerning the ethical review, informed consent process, research design, place of implementation and source of funds of the trial, the Centre has notified the applicant that the trial did not meet the registration requirements and decided to reject its application for supplementary registration, which will be tested from 30 November 2018. The progress status of the test is updated to stop or pause.

Background

Gene Editing Babies arouses strong doubts

On November 26, a controversy arose over the news of the birth of the worlds first HIV gene editor baby in China. Sources said that the above results were led by He Jiankui, associate professor of Biology Department of Southern University of Science and Technology, and the project was ethically reviewed by Shenzhen and Meimei Hospital of Gynecology and Pediatrics.

Because the project involves gene editing of human embryos, it arouses public concern about the safety and ethics of research, as well as strong doubts from the scientific and legal circles. Some experts believe that genetic editing has limited benefits for humans, and the risks are long-term and unpredictable. Law experts also point out that gene editing baby is suspected of being illegal.

Subsequently, the Medical Ethics Expert Committee of Shenzhen Health and Family Planning Committee indicated that the project had not been filed as required and had initiated an investigation of ethical issues in Shenzhen and American gynecological and pediatric hospitals.

At the same time, the Ministry of Medicine and Health of the Chinese Academy of Engineering, the Committee for the Construction of Scientific Ethics, the Association of Life Sciences of the Chinese Association of Science and Technology, and many other organizations have voiced their voices on this issue, condemning the study of gene edited infants as contrary to basic ethical norms and scientific ethics. On November 28, the State Health and Health Commission and the Ministry of Science and Technology responded that relevant departments are conducting investigations and verifying and resolutely investigating and dealing with violations of laws and regulations. On the same day, the Health and Health Commission of Guangdong Province announced that a joint investigation team had been set up in Guangdong and Shenzhen to investigate the gene edited baby incident.

Source: New Beijing Daily Responsible Editor: Yao Liwei_NT6056