Prior to the beginning of the trial, the investigator shall obtain the approval from the Ethics Committee for the informed consent form and any other written information to be provided to subjects.
The approval referred to in the preceding paragraph should be made in writing.

The informed consent form and any other written information to be provided to subjects should be revised whenever important new information becomes available that may be relevant to the subject’s consent. The subject or the subject’s legally acceptable representative should be informed in a timely manner if new information becomes available.
Any revised informed consent form, and written information shall be approved by the Ethics Committee in advance of use; For those clinical trials which are approved by the Competent Authority, the revised documents shall be resubmitted for approval.
The communication and approval referred to in preceding paragraph1 and paragraph 2 should be made in writing.

None of the informed consent form and any other written information to be provided to subjects shall contain any language that causes the subject or the subject's legally acceptable representative to waive or to appear to waive any legal rights, or that releases or appears to release the investigator, the institution, the sponsor, or their agents from liability for negligence.
Statements in contradiction to the rules specified in the preceding paragraph are invalid.

The language used in the oral and written information about the trial, including the informed consent form, should be as non-technical as practical and should be understandable to the subject or the subject's legally acceptable representative and the impartial witness, where applicable.

Prior to a subject’s participation in the trial, the informed consent form shall be signed and personally dated by the subject or by the subject's legal representative and the legally acceptable representative.
Before informed consent may be obtained, the investigator, or a person designated by the investigator, should provide the subject or the subject's legally acceptable representative ample time and opportunity to inquire about details of the trial.
All questions about the trial should be answered to the satisfaction of the subject or the subject's legal representative and the legally acceptable representative.
Informed consent forms shall be signed by all parties mentioned in paragraph 2.
In clinical trials of emergency cases, prior consent of the subject or the subject’s legally representatives could be waived only when the emergency procedures are well described in the protocol. When consent of the subject or the subject's legal representative and the legally acceptable representative is possible, the consent shall be obtained immediately.

If the subject or the subject's legal representative and legally acceptable representative. is unable to read, an impartial witness shall be present during the entire informed consent discussion.
The impartial witness should read the informed consent form and any other written information to be provided to subjects and attests that the information were accurately explained by the investigator or designated person, and were fully understood by the subject or by the subject's legal representative and the legally acceptable representative.
Under the circumstances referred to in paragraph 1, the subject or the subject's legal representative and legally acceptable representative. shall still sign and date the informed consent form. Finger print is an acceptable substitute for signature.
After finishing the work described in paragraph 2, the impartial witness attests that informed consent was freely given by the subject or the subject's legal representative and legally acceptable representative. by signing and dating the informed consent form.
Trial staff shall not acts as the impartial witness.

The informed consent form and any other written information to be provided to subjects shall include explanations of the following:
1.That the trial involves research.
2.The purpose of the trial.
3.The trial treatment(s) and the probability for random assignment to each treatment.
4.The trial procedures to be followed, including all invasive procedures.
5.The subject's responsibilities.
6.Those aspects of the trial that are experimental.
7.The reasonably foreseeable risks or inconveniences to the subject and, when applicable, to an embryo, fetus, or nursing infant.
8.The reasonably expected benefits.
9.The alternative procedure(s) or course(s) of treatment that may be available to the subject, and their important potential benefits and risks.
10.The compensation and/or treatment available to the subject in the event of trial-related injury.
11.The anticipated prorated payment, if any, to the subject for participating in the trial.
12.The anticipated expenses, if any, to the subject for participating in the trial.
13.That the subject's participation in the trial is voluntary and that the subject may refuse to participate or withdraw from the trial, at any time, without penalty or loss of benefits to which the subject is otherwise entitled.
14.That the monitor(s), the auditor(s), the Ethics Committee, and the Competent Authority will be granted direct access to the subject's original medical records for verification of clinical trial procedures and/or data, without violating the confidentiality of the subject, to the extent permitted by the applicable laws and regulations and that, by signing a written informed consent form, the subject is authorizing such access.
15.That records identifying the subject will be kept confidential and, to the extent permitted by the applicable laws and/or regulations, will not be made publicly available. If the results of the trial are published, the subject’s identity will remain confidential.
16.That the subject or the subject's legally acceptable representative will be informed in a timely manner if information becomes available that may be relevant to the subject's willingness to continue participation in the trial.
17.The person(s) to contact for further information regarding the trial and the rights of trial subjects, and whom to contact in the event of trial-related injury.
18.The foreseeable circumstances and/or reasons under which the subject's participation in the trial may be terminated.
19.The expected duration of the subject's participation in the trial.
20.The approximate number of subjects involved in the trial.

Prior to participation in the trial, the subject or the subject's legal representative and the legally acceptable representative shall receive a copy of the signed and dated informed consent form and any other written information provided to the subjects. The clinical trials intended for treating emergency cases when prior consent is not possible are exceptional.
During a subject’s participation in the trial, the subject or the subject's legal representative and the legally acceptable representative. shall receive a copy of the signed and dated consent form updates and a copy of any amendments to the written information provided to subjects.

The subject’s legally acceptable representative can not represent the subject to provide consent to participate in non-therapeutic trials, except for those non-therapeutic trials with the following conditions are fulfilled:
1.The objectives of the trial can not be met by means of a trial in subjects who can give informed consent personally.
2.The foreseeable risks to the subjects are low.
3.The negative impact on the subject’s well-being is minimized and low.
4.The trial is not prohibited by law.
5.The written approval of the Ethics Committee.
Under the exceptional circumstances referred to in the preceding paragraph, those trials shall be conducted in patients having a disease or condition for which the investigational product is intended. Subjects in these trials shall be particularly closely monitored and shall be withdrawn if they appear to be unduly distressed.