What Should Be Paid Attention To When Submitting Ethical Documents Related To Clinical Trials In The IVD Reagent Registration?

Clinical trials of IVD reagents should follow the ethical principles determined in the Helsinki Declaration of the World Medical Association and be reviewed and agreed by the ethics committee. For the registration of IVD reagents, the review document of the ethics committee to agree with the conducting of the clinical trial and the manuscript of the subject informed consent form (if any) should be submitted.

The original review document (but not a copy) of the ethics committee should be submitted, in which the following information must be made clear, including the approval of the conduct of the clinical trial according to the approved protocol, the version number and date of the approved protocol and the manuscript of the subject informed consent form, the principal investigator and the date permitting the clinical trial to be conducted. It should be noted that in the review document of the ethics committee the information about the product and clinical trial should be consistent with the actual situation, including the product name, sponsor, investigator and the version of the protocol and the manuscript of the subject informed consent form. If the clinical trial is exempted from the subject’s informed consent after being reviewed, it should be clearly mentioned in the opinion of the ethics committee, and should be consistent with the actual situation of the clinical trial, avoiding situations, for example, during the implementation of a clinical trial it is exempted from the subject informed consent while the requirements for the informed consent form are included in the ethics committee’s review document.

If the protocol revision occurs during the trial, it should be submitted to the ethics committee for approval or reported to the ethics committee for filing in a timely manner. The ethics committee’s comments on the protocol revision should be submitted during the registration.

The review documents of the ethics committees for all institutions participating in the clinical trial should be submitted. For clinical trials conducted in special medical institutions before January 1, 2019, in accordance with the requirements of the Notice of CFDA on the Implementation of the Provisions for Medical Device Registration and the Provisions for In-vitro Diagnostic Reagent Registration (SYJXG No. 144 of 2014), if the clinical trial institution does not have an ethics committee, the institution should issue a non-ethics committee statement and clarify opinions on ethical review.