According to Article 14 of the Quality Management Standard for Drug Clinical Trials, researchers or their designated representatives must explain the details of clinical trials to the subjects:
(1) Subjects should voluntarily participate in the trial, and have the right to withdraw from the trial at any stage without discrimination or retaliation, and their medical treatment and rights and interests will not be affected;
(2) Subjects must be made aware that personal data during their participation in the experiment and the experiment are confidential. When necessary, the pharmaceutical supervisory and administrative department, the ethics committee or the applicant may consult the information of the subjects who participated in the experiment in accordance with the regulations;
(3) the purpose of the test, the test process and duration, the inspection operation, the expected possible benefits and risks of the subjects, and inform the subjects that they may be assigned to different test groups;
(4) Subjects must be given enough time to consider whether they are willing to participate in the experiment. For subjects who cannot express their consent, the above introduction and explanation shall be provided to their legal representatives. The informed consent procedure should adopt the language and words that the subject or legal representative can understand, and the subject can know the relevant information at any time during the experiment;
(5) When the damage related to the experiment occurs, the subjects can get treatment and corresponding compensation.
Extended data:
Article 8 of the Quality Management Standard for Drug Clinical Trials In the process of drug clinical trials, the personal rights and interests of the subjects must be fully protected to ensure the scientificity and reliability of the trials. The rights and interests, safety and health of the subjects must be higher than the consideration of scientific and social interests. Ethics Committee and informed consent form are the main measures to protect the rights and interests of subjects.
Article 9 In order to ensure the rights and interests of subjects in clinical trials, an independent ethics committee shall be established and filed with the US Food and Drug Administration. The ethics committee shall be composed of at least five medical professionals, non-medical professionals, legal experts and personnel from other units, with members of different genders. The composition and work of the Ethics Committee should not be influenced by any participant.
US Food and Drug Administration-Quality Management Standards for Drug Clinical Trials