He Jiankui's gene-edited baby trial registration application has been rejected by the China Clinical Trial Registration Center for failing to submit raw data for review.
According to the website of the registration center quoted by the Beijing News, because He Jiankui failed to provide the original data as promised on November 28, and did not answer the center's questions about the trial's ethical review, informed consent process, research design, trial implementation location, funding source, etc.In response to two inquiries, it decided to reject its supplementary registration application, and update the status of the trial to suspended or suspended from November 30.
Previously, He Jiankui's gene-edited baby experiment had submitted a supplementary registration application to the China Clinical Trial Registration Center in accordance with academic research practices, and obtained a temporary registration number.
According to public information, the China Clinical Trial Registration Center is managed by the World Health Organization (WHO) and is a non-profit academic institution.In 2004, the former Ministry of Health appointed him to represent China to participate 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 regulations of the China Clinical Trial Registration Center, all clinical trials should apply for registration before the start of recruitment of subjects or before the inclusion of the first subject; subsequent applications for registration are all supplementary registrations.For re-registration trials, the center stipulates that in addition to submitting research plans, informed consent forms, and ethics committee approval documents, original data must be submitted for review to ensure the authenticity of the trial.
According to the website of the China Clinical Trial Registration Center, the gene-edited baby trial has rejected the application for supplementary registration because it could not provide original data for review.Screenshot of the website of China Clinical Trial Registration Center
So far, a supplementary registration application for the gene-edited baby trial has been rejected.According to the China Clinical Trial Registration Center website, the HIV immune gene CCR5 embryo gene editing safety and effectiveness evaluation clinical trial registration page shows that the supplementary registration application has been rejected because the original data cannot be provided for review.
The reporter noticed that the China Clinical Trial Registration Center had issued a special statement on this on its official website.The special note on the refusal of the supplementary registration application for the evaluation of the safety and effectiveness of the HIV immune gene CCR5 embryo gene editing in clinical trials mentioned that on November 8, 2018, the China Clinical Trial Registration Center notified two researchers, Qin Jinzhou and He Jiankui, that their clinical trials had been accepted.The supplementary registration application for the evaluation of the safety and effectiveness of the HIV immune gene CCR5 embryo gene editing is temporarily given the trial registration number ChiCTR1800019378, and they are required to provide raw data for review.
The special note mentioned that because it failed to provide the original data on November 28 as promised, and did not answer our two inquiries about the trial ethics review, informed consent process, research design, trial implementation location, funding sources, etc., we have notified the applicant that the trial did not meet the registration requirements, and decided to reject its supplementary registration application, and update the status of the trial to suspended or suspended from November 30, 2018.
