He Jiankuis application for registration of the Gene Edited Infant trial has been rejected by the China Clinical Trial Registry recently because the original data were not submitted for examination by the Beijing News Express. According to the centers website, He Jiankui failed to provide original data on the promised 28 November practice and did not answer two inquiries from the center about the ethical review, informed consent process, research design, place of implementation and source of funds of the experiment. He decided to reject his application for supplementary registration and update the status of the experiment to suspend or suspend from 30 November.
Previously, He Jiankuis Gene Edited Infant test submitted a supplementary registration application to the China Clinical Trial Registry and obtained a temporary registration number in accordance with academic research practice.
According to public data, the China Clinical Trials 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 website of China Clinical Trial Registry, the Gene Edited Infant test has rejected the application for registration because it could not provide the original data for examination. Screenshot of the website of China Clinical Trials Registry
At present, the application for supplementary registration of the Gene Edited Infant test has been rejected. According to the clinical trial registration page of Safety and Effectiveness Assessment of HIV Immune Gene CCR5 Embryo Gene Editing on the website of China Clinical Trial Registry, the application for supplementary registration has been rejected because the original data can not be provided for examination.
Reporters noted that the China Clinical Trial Registry has issued a special note on its official website. The Special Note on Rejecting the Application for Supplementary Registration of HIV Immune Gene CCR5 Embryo Gene Editing for Clinical Trials mentions that on November 8, 2018, the Chinese Clinical Trial Registry notified two researchers, Chen Jinzhou and He Jiankui, that they had accepted the application for Supplementary Registration of HIV Immune Gene CCR5 Embryo Gene Editing for Clinical Trials, and that the application for Supplementary Registration of HIV Immune Gene CCR5 Embryo Gene Editing for Safety and Effectiveness Evaluation The trial registration number ChiCTR1800019378 is provisionally given, and they are required to provide the original data for review.
The Special Note mentions that because it failed to provide the original data for the promised 28 November practice and did not answer our two queries on the ethical review, informed consent process, research design, place of implementation and source of funds of the experiment, we have informed the applicant that the experiment did not meet the registration requirements and decided to reject the application for supplementary registration, which will be implemented from 30 November 2018. The status of the test is updated to suspend or suspend.
Source: Wang Zheng_N7526, responsible editor of Beijing News