Legal analysis: For incapacitated subjects, if the ethics committee agrees in principle and the researcher believes that the subject's participation in the trial is in their own interests, these patients can also enter the trial, and they should also With the consent of their legal guardian. As subjects, children must obtain the consent of their legal guardians and sign an informed consent form. When children can make a decision to participate in the research, their consent must also be obtained. If the child is unable to sign the informed consent form, his or her legal representative must sign on his or her behalf. If the child is able to sign, both the child and his or her legal representative must sign at the same time.

Legal basis: "GCP Good Clinical Practice for Drugs" Article 15 Obtain informed consent after a full and detailed explanation of the test conditions:

(1) From the subject The researcher or his legal representative shall sign and date the informed consent form, and the researcher who performs the informed consent process must also sign and date the informed consent form;

(2) For those who are incapacitated If the ethics committee agrees in principle and the researcher believes that the subject's participation in the trial is in their own interests, then these patients can also enter the trial. At the same time, they must obtain the consent, signature and date of their legal guardian;

(3) As subjects, children must obtain informed consent from their legal guardians and sign an informed consent form. When children can make a decision to participate in the research, their consent must also be obtained;< /p>

(4) In emergency situations, it is impossible to obtain the informed consent of the person and his legal representative, such as there is a lack of proven effective treatment methods, and experimental drugs are expected to save lives, restore health, or relieve pain. , can be considered as subjects, but the method of accepting these subjects needs to be clearly stated in the trial plan and relevant documents, and the approval of the ethics committee must be obtained in advance;

(5) If it is found that the trial drug is involved For important new information, the informed consent form must be revised in writing and submitted to the ethics committee for approval, and the subject's consent must be obtained again.